Directory of Services

Transcription

1 Directory of Services SLDOS Rev. 6/2013

2 TABLE OF CONTENTS Section 1- Introduction Section 2- General Test Listing Section 3- Microbiology Testing Services Section 4- Peritoneal Dialysis Testing Services Section 5- Water & Dialysate Testing Services

3 Section 1 Introduction

4 Section 1 - Introduction How to Use the Spectra Laboratories Directory of Services Spectra s Directory of Services provides detailed information related to Spectra s test offerings. Test information includes: Formal test name and corresponding abbreviations Specimen requirements Reference ranges Exception & alert values Test usage Test methodology Turnaround times Current Procedure Terminology (CPT) codes Getting Started Refer to the Table of Contents to find the test section that is of interest to you Look up the test listings by alphabetical order Updates to the Directory of Services Test Listings The Directory of Services will be updated on a periodic basis. REVISED This callout will appear next to those test listings that provide updated information. NEW This callout will appear next to those test listings that are newly added to the Directory of Services. About Spectra Laboratories Established in 1989, Spectra Laboratories is the leading provider of renal-specific testing services. Spectra utilizes state-of-the art specimen processing, analytical, and reporting techniques to provide accurate and timely results. Spectra has expanded its service offerings to other healthcare related markets including clinical research and correctional healthcare. Contact Us If you have any questions regarding the information contained in Spectra s Directory of Services, please contact your local Spectra Customer Service representative: : Milpitas, California : Rockleigh, New Jersey Section 1 Introduction Spectra Laboratories Directory of Services June

5 Section 2 General Test Listing

6 Section 2 - General Test Listing Test Information Whenever possible, each test description includes pertinent information related to the use of the test in the ongoing treatment and monitoring of dialysis patients. All tests are assumed to be drawn pre-dialysis unless specified as post-dialysis tests. Information for the test listings has been obtained from the following references: Chernecky CC, Krech RL, Berger BJ, edr. Laboratory Tests and Diagnostic Procedures, 5 th ed., Saunders Elsevier; Daugirdas JT, Blake PG, Ing TS, edr. Handbook of Dialysis. 4 th ed, Lippincott Williams & Wilkins; Jacobs DS, DeMott WR, Oxley DK, edr. Laboratory Test Handbook, 5 th ed., Lexi-Comp, Inc; 2001 Specimen Rejection Criteria Each test listing may include a list of factors that can affect test results (interferences). If a test cannot be performed on a specimen because of the presence of one or more of these factors, the laboratory will request a new specimen. These factors may include conditions such as: Hemolysis Lipemia Clotted Improper storage/transport temperature Other factors that can result in a request for a new specimen include: Inappropriate specimen for testing Collection of the specimen in the wrong tube/container Improper specimen collection techniques Specimen unlabeled Insufficient quantity to perform all tests Test Criteria Definitions: Alert: Alert values are the laboratory test results which will be called to your attention when the results are released by the laboratory. Exception: Exception values are the abnormal laboratory test results which will generate an immediate report re-transmission when the results are released by the laboratory. Section 2 General Test Listing Spectra Laboratories Directory of Services June

7 Section 2 - General Test Listing Information Found in Each Test Listing Sample Test Listing Heading: Test Name: (Synonyms) Specimen Requirements: Other Requirements: Reference Range: Exception Value: Alert Value: What information can be found Test name/abbreviation as listed on the requisition form or in your ordering system Common synonyms (including abbreviations) for the test The exact specimen requirements for the test Refer to the individual test for specimen collection instructions Any additional specimen collection or handling requirements The test reference range for normal, healthy individuals The range of test values that may indicate a condition which requires attention The range of test values that may indicate an extreme condition that requires immediate attention Specimen Stability: Refrigerated xx days Usage: Methodology: Interferences: Confirmatory Tests: TAT: CPT Code: HEPATITIS B VIRUS SURFACE ANTIGEN (HBsAg) Specimen Requirements: Reference Range: Alert Value: Specimen Stability: Usage: Methodology: Confirmatory Tests: Interferences: What the test is typically used for The method used for the analysis of the test Conditions that may alter test results Additional tests performed to confirm positive results The turnaround time for a test (from time of receipt in the lab) The Current Procedural Terminology code for standardized identification of laboratory tests 1.0 ml serum (SST Gel Tube) Negative All confirmed, first-time positives are sent to client s printer as an Alert or faxed to the facility Refrigerated 7 days Differential diagnosis and staging of Hepatitis B infection Chemiluminescence HBsAg Neutralization test performed on all first-time positive results and is not billed False reactives may occur following vaccination (positive results require an additional 2 to 4 days for confirmation) CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

8 Section 2 - General Test Listing Turnaround Times and Test Set-Up Days The following chart summarizes turnaround times (TAT) for tests performed at Spectra, along with the days a test is set up. NOTE: Turnaround times listed are from the time the specimen is received at Spectra. Keep in mind that actual turnaround times may be longer than the listed time if a specimen is received on a day that a test is not set up. For example, the turnaround time for a specimen received on a Saturday may be three days longer than the time listed if the test is set up Tuesday through Friday. Test Name Set-Up Days TAT ABO Group T-Sat 2 days Activated PTT M-Sat same day Activated PTT, Post M-Sat same day Activated PTT, Mid-treatment M-Sat same day A/G Ratio M-Sat. 1 day Albumin (BCG) Serum M-Sat 1 day Alkaline Phosphatase M-Sat 1 day Alpha Fetoprotein M-Sat 5 days ALT/SGPT M-Sat 1 day Aluminum, Serum M-Sat 5 days Amylase M-Sat 1 day Apolipoprotein A-1 M-Sat 2 days Apolipoprotein B M-Sat 2 days AST/SGOT M-Sat 1 day Beta-2 Microglobulin M-Sat 1 day Bicarbonate M-Sat 1 day B-Type Natriuretic Peptide M-Sat 3 days Bicarbonate, Post M-Sat 1 day Bicarbonate Dialysate Fluid M-Sat 1 day Bilirubin, Direct M-Sat 1 day Bilirubin, Indirect (Calc) M-Sat 1 day Bilirubin, Total M-Sat 1 day BUN M-Sat 1 day BUN/Creatinine Ratio (Calc) M-Sat 1 day BUN, Post M-Sat 1 day Calcium, Ionized M-Sat 1 day Calcium M-Sat 1 day Ca/Phos Product (Calc) M-Sat 1 day Calcium, Post M-Sat 1 day Ca/Phos Product, Post M-Sat 1 day Ca/Phos Product Corrected (Calc) M-Sat 1 day Section 2 General Test Listing Spectra Laboratories Directory of Services June

9 Section 2 - General Test Listing Test Name Set-Up Days TAT Carbamazepine M-Sat 1 day CD4 (T Helper Lymphocyte Absolute) M-Sat 3 days Chloride M-Sat 1 day Chloride, Post M-Sat 1 day Cholesterol M-Sat 1 day C-Reactive Protein-Wide Range M-Sat 1 day Creatine Kinase (CK) M-Sat 1 day Creatinine M-Sat 1 day Creatinine, Post M-Sat 1 day Creatinine Reduction Ratio (Calc) M-Sat 1 day Creatinine Urine,Timed M-Sat 1 day Creatinine Urine, Random M-Sat 1 day Dialysis Fluid Electrolytes M-Sat 1 day Digoxin M-Sat 1 day Dilantin M-Sat 1 day Dilantin, Free M-Sat 1 day Ferritin M-Sat 2 days Folate, Serum M-Sat 1 day run 6 days a week Folate, RBC T-F 2 days Follicle Stimulating Hormone M-Sat 5 days Gamma Glutamyl Transferase M-Sat 1 day Gentamicin, Random M-Sat 1 day Gentamicin, Peak M-Sat 1 day Gentamicin, Trough M-Sat 1 day Glucose M-Sat 1 day Glucose, Post M-Sat 1 day Hematocrit, (Hct) M-Sat 1 day Hemoglobin (Hgb) M-Sat 1 day Hemoglobin A1c M-Sat 1 day Hemoglobin Electrophoresis M-Sat 2 days Hemogram M-Sat 1 day Hepatitis A Virus Antibody, IgM M-Sat 2 days Hepatitis A Virus Antibody, Total M-Sat 2 days Hepatitis B Virus Core Antibody, IgM M-Sat 2 days Hepatitis B Virus Core, Total M-Sat 2 days Hepatitis Be Virus Antibody T-Sat 2 days Hepatitis Be Virus Antigen T-Sat 2 days Hepatitis B Virus Surface Antibody M-Sat 2 days Hepatitis B Virus Surface Antigen M-Sat 2 days Section 2 General Test Listing Spectra Laboratories Directory of Services June

10 Section 2 - General Test Listing Test Name Set-Up Days TAT Hepatitis C Virus Antibody M-Sat 2 days Hepatitis C Virus RNA Quant PCR M-Sat 5 days HDL Cholesterol M-Sat 1 day HIV 1/2 Anitbody Screen T-Sat 5 days HIV-1 RNA Quant Real-Time PCR M-Sat 5 days Homocysteine M-Sat 2 days Human Chorionic Gonadotropin, Quant M-Sat 5 days Iron, Serum M-Sat 1 day Lactic Dehydrogenase (LDH) M-Sat 1 day LDL Cholesterol (Calc) M-Sat 1 day LDL Cholesterol, Direct M-Sat 1 day Lipase T-Sat 1 day Lithium M-Sat 1 day Luteinizing Hormone M-Sat 5 days Lymphocyte Count, Absolute M-Sat 1 day Magnesium M-Sat 1 day Magnesium, Post M-Sat 1 day Microalbumin, Random Urine M-Sat 2 days PDF Cell Count M-Sat 1 day Phenobarbital M-Sat 1 day Phosphorus M-Sat 1 day Phosphorus, Post M-Sat 1 day Platelet Count M-Sat 1 day Potassium M-Sat 1 day Potassium, Post M-Sat 1 day Potassium, Plasma M-Sat 1 day Prealbumin M-Sat 1 day Prolactin M-Sat 5 days Prostate Specific Antigen (PSA), Screen M-Sat 2 days Prostate Specific Antigen (PSA), Diagnostic M-Sat 2 days Protein Electrophoresis M-Sat 3 days Protein, Total M-Sat 1 day Prothrombin Time/INR (PT-INR) M-Sat same day Prothrombin Time (PT) Post M-Sat same day PTH, Intact M-Sat 1 day Quinidine T-Sat 1 day Red Blood Cell Count M-Sat 1 day Section 2 General Test Listing Spectra Laboratories Directory of Services June

11 Section 2 - General Test Listing Test Name Set-Up Days TAT Recirculation Calculation M-Sat 1 day RA Factors M-Sat 1 day Reticulocyte Count M-Sat 1 day Reticulocyte Count, Absolute M-Sat 1 day Reticulocyte Hemoglobin Content (CHr) M-Sat 1 day Rh (D) Typing T-Sat 2 days RPR T-Sat 1 day Rubella Virus Ab IgG, Total T-F 2 days Rubeola Virus Ab lgg, Total T-Sat 3 days Sedimentation Rate (ESR) T-Sat 1 day Sickle Cell (Hemoglobin Solubility) M-Sat 2 days Sodium M-Sat 1 day Sodium, Post M-Sat 1 day Theophylline M-Sat 1 day Thyroid Stimulating Hormone, 3rd Generation (TSH3) M-Sat 1 day Thyroxine (T4) M-Sat 1 day Thyroxine (T4), Free M-Sat 1 day Triiodothyronine (T3), Free M-Sat 1 day Triiodothyronine (T3), Total M-Sat 1 day T Uptake M-Sat 1 day Total Iron Binding Capacity (Calc) M-Sat 1 day Tobramycin, Peak T-Sat 1 day Tobramycin, Trough T-Sat 1 day Tobramycin, Random T-Sat 1 day Transferrin M-Sat 1 day Transferrin Saturation (Calc) M-Sat 1 day Triglycerides M-Sat 1 day Triglycerides, Post M-Sat 1 day UIBC M-Sat 1 day Urea Nitrogen, Urine 24 hour M-Sat 1 day Urea Reduction Ratio (%) (Calc) M-Sat 1 day Uric Acid M-Sat 1 day Urinalysis M-Sat 1 day Valproic Acid M-Sat 1 day Vancomycin, Peak M-Sat 1 day Vancomycin, Trough M-Sat 1 day Vancomycin, Random M-Sat 1 day Vitamin B12 M-Sat 2 days Vitamin D, 25-Hydroxycalciferol T-Sat 2 days Section 2 General Test Listing Spectra Laboratories Directory of Services June

12 Section 2 - General Test Listing Test Name Set-Up Days TAT VLDL (Cal) M-Sat 1 day White Blood Cell Count (WBC) M-Sat 1 day WBC Differential M-Sat 1 day Zinc W-Sat 5 days Confirmatory and Reflex Testing Definitions Reflex testing occurs when a test result triggers additional testing. The additional tests may confirm a result or give the physician additional useful information on that sample. Certain analytical procedures are not specific enough to give an accurate diagnosis and additional testing referred to as confirmatory testing is performed. Confirmatory testing is frequently mandated by regulatory agencies and good medical practice. Policy Spectra s policy is not to perform reflex or confirmatory testing except where such testing is required by law (HIV or RPR) or is dictated by good medical practice (Culture or Urinalysis). In the latter case, the physician will be given the choice to order the tests individually without the reflex or confirmatory option. If the reflex or confirmatory option is selected and a positive result triggers the additional testing, all testing, including the additional test will be billed to the appropriate party. This policy is in accordance with Spectra s Medicare carrier which requires that a laboratory not perform reflex testing without a specific order from the physician. The case of HBsAg is unique in that all first-time positives are confirmed by neutralization and the neutralization is not billed. The neutralization is not orderable and only occurs as a reflex action for all first-time positives. The table below indicates those tests for which Spectra offers a reflex option. Test Ordered Reflex Test Performed By Billing Status Additional CPT HIV Antibody Western Blot Spectra Billed Laboratories RPR FTA-ABS Laboratory Billed Corporation of America (LabCorp) HBsAg Spectra Not Billed Laboratories Cultures Susceptibility Spectra Billed Laboratories Urinalysis Microscopic Examination Spectra Laboratories Billed Section 2 General Test Listing Spectra Laboratories Directory of Services June

13 A ABO GROUP (See Rh for Rh Typing) (Performed only at Spectra- Rockleigh, NJ) Specimen Requirements: 1 full lavender tube Other Requirements: Tube must be labeled with patient s name Specimen Stability: Refrigerated 7 days Usage: Determination of ABO antigen phenotype Methodology: Hemagglutination TAT: 2 days Test Set-up: T-Sat CPT Code: ACTIVATED PTT (Partial Thromboplastin Time; PTT: Activated (APTT)) Specimen Requirements: 1 full light blue top tube (3.2% Sodium Citrate, whole blood) Other Requirements: The fistula needle must be flushed thoroughly; draw blood culture bottles and tubes without additives prior to APTT tube Reference Range: Lot dependent. See patient clinical result report for Reference Range Exception Value: All results are sent to fax/printer Alert Value: All results are sent to fax/printer Specimen Stability: Refrigerated 2 days Usage: 1. Monitoring of heparin therapy 2. Screening for disorders of coagulation and platelet abnormalities Methodology: Dual: Photo & Electromagnetic clot detection Rejection Criteria: Incomplete filling of tube, over filling Interferences: Inadequate flushing of heparin from fistula, catheter TAT: Results faxed or sent to client s printer the same day specimen is received CPT Code: ACTIVATED PTT, POST (APTT) Specimen Requirements: 1 full light blue top tube (citrated whole blood) NOTE: Must be labeled POST (Refer to APTT for test information) ACTIVATED PTT, MID-TREATMENT (APTT) Specimen Requirements: 1 full light blue top tube (citrated whole blood) NOTE: Must be labeled MID-TREATMENT (Refer to APTT for test information) Section 2 General Test Listing Spectra Laboratories Directory of Services June

14 A A/G RATIO (CALC) (Albumin/Globulin Ratio includes Globulin calculation) Specimen Requirements: 1.0 ml serum (SST Gel Tube) Other Requirements: Calculated from Total Protein and Albumin Reference Range: Usage: Monitoring of protein loss Methodology: Calculation: Globulin = Total Protein - Albumin A/G Ratio = (Albumin/Globulin) Interferences: 1. Hemolyzed Specimen 2. Lipemic Specimen CPT Code: Calculation ALANINE AMINOTRANSFERASE (See ALT/SGPT) ALBUMIN (BCG), SERUM Reference Range: g/dl Exception Value: <2.0 > 8.0 g/dl Specimen Stability: Refrigerated 7 days Usage: 1. Evaluation of nutritional status 2. Monitoring of protein loss in dialysis patients Methodology: Colorimetric CPT Code: ALBUMIN, POST (Not an orderable test for FMCNA clients) Specimen Requirements: 0.5 ml Plasma Gold Post Tube (Refer to Albumin for test information) Section 2 General Test Listing Spectra Laboratories Directory of Services June

15 A ALKALINE PHOSPHATASE Reference Range: Males: U/L, > 15 yrs Females: U/L, > 15 yrs Alert Value: > 700 U/L Specimen Stability: Refrigerated 4 days Usage: 1. Aids in the diagnosis of bone disease and/or following its progression 2. Aids in the diagnosis of liver disease Methodology: Colorimetric Interferences: 1. Hemolyzed specimen 2. Leaving the specimen at room temperature can lead to falsely elevated results CPT Code: ALPHA FETOPROTEIN (Performed only at Spectra - Milpitas, CA) Specimen Requirements: 1.0 ml serum (SST Gel Tube) Reference Range: 0-8 ng/ml Usage: Assessment of risk for hepatocellular or testicular carcinoma Methodology: Chemiluminescence TAT: 5 days CPT Code: ALT/SGPT (Alanine Aminotransferase) Reference Range: 7-52 U/L Exception Value: > 90 U/L Specimen Stability: Refrigerated 3 days Usage: 1. Aids in the diagnosis of liver disease 2. Serial measurements help track the course of hepatitis Methodology: Kinetic Interferences: Hemolyzed specimen CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

16 A ALUMINUM (AL) Specimen Requirements: 2.0 ml serum (Royal Blue Tube) Other Requirements: Do not centrifuge, refrigerate Reference Range: 0-10 mcg/l, ICP and 0-10 mcg/l, AA Furnace Alert Value: > 100 mcg/l Specimen Stability: Refrigerated 7 days Usage: Monitoring of aluminum levels in order to detect/limit aluminum toxicity Methodology: Atomic Emission (ICP) at Milpitas Lab; Atomic Absorption Furnace at Rockleigh Lab TAT: 5 days CPT Code: AMINOPHYLLINE (See Theophylline) _ AMYLASE Reference Range: U/L Alert Value: > 500 U/L Specimen Stability: Refrigerated 7 days Usage: Aids in the diagnosis of pancreatic disease Methodology: Kinetic Interferences: 1. Hemolyzed specimen 2. Lipemic specimen (may give falsely low results) CPT Code: ANTI-HB CORE, IgM (See Hepatitis B Virus Core Antibody IgM) ANTI-HB CORE, TOTAL (See Hepatitis B Virus Core Total) ANTI-HBe (See Hepatitis Be Virus Antibody) Section 2 General Test Listing Spectra Laboratories Directory of Services June

17 A APOLIPOPROTEIN A-1 (Apo A1) (Performed only at Spectra - Rockleigh, NJ) Other Requirements: Fasting specimen preferred Reference Range: mg/dl Specimen Stability: Apo A1 cannot be added onto an existing sample Usage: Assessing risk for coronary artery disease Methodology: Turbidimetric Interferences: 1. Hemolyzed specimen 2. Lipemic specimen TAT: 2 days CPT Code: APOLIPOPROTEIN B (Apo B) (Performed only at Spectra - Rockleigh, NJ) Other Requirements: Fasting specimen preferred Reference Range: mg/dl Specimen Stability: Apo B1 cannot be added onto an existing sample Usage: Assessing risk for coronary artery disease Methodology: Turbidimetric Interferences: 1. Hemolyzed specimen 2. Lipemic specimen TAT: 2 days CPT Code: APTT (See Activated PTT) ASPARTATE AMINOTRANSFERASE (See AST/SGOT) AST/SGOT (Aspartate Aminotransferase) Reference Range: U/L Exception Value: > 90 U/L Specimen Stability: Refrigerated 7 days Usage: 1. Serial monitoring of liver damage 2. As an indication of other tissue damage Methodology: Kinetic Interferences: Hemolysis may cause falsely elevated levels CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

18 B BETA-2 MICROGLOBULIN Specimen Requirements: 1.0 ml serum (SST Gel Tube) Reference Range: mg/l Specimen Stability: Refrigerated 7 days Usage: 1. Evaluation of renal disease 2. Evaluation of AIDS progression Methodology: Turbidimetric Interferences: Administration of radioactive isotopes within one week prior to the test CPT Code: BICARBONATE Other Requirements: Do not open tube or expose to air Reference Range: meq/l Alert Value: < 12 or > 32 meq/l Exception Value: < 20 or > 29 meq/l Specimen Stability: Bicarbonate cannot be added onto an existing sample Usage: Assessment of acid-base balance Methodology: Enzymatic CPT Code: BICARBONATE, POST Specimen Requirements: 0.5 ml plasma (Gold Post Tube) Do not open tube or expose to air NOTE: Tube must be labeled POST (Refer to Bicarbonate for additional test information) BICARBONATE, DIALYSATE FLUID Specimen Requirements: 8.0 ml aliquot of dialysate fluid (Yellow Conical Tube) Usage: Verification of bicarbonate level of dialysate fluid Methodology: Enzymatic Section 2 General Test Listing Spectra Laboratories Directory of Services June

19 B BILIRUBIN, DIRECT (Conjugated Bilirubin, Bili) Other Requirements: Protect specimen from light Reference Range: mg/dl Specimen Stability: Refrigerated 3 days Usage: 1. Along with total bilirubin, provides a means to determine indirect (unconjugated) 2. Aids in the diagnosis of obstructive or hepatic jaundice Methodology: Colorimetric CPT Code: BILIRUBIN, INDIRECT (CALC) (Unconjugated Bilirubin) Specimen Requirements: Other Requirements: Reference Range: Methodology: 1.0 ml serum (SST Gel Tube) Calculated from Total and Direct Bilirubin mg/dl Calculation: Indirect Bilirubin = Total Bilirubin Direct Bilirubin TAT: Test Set-up: CPT Code: 1 day M-Sat Calculation BILIRUBIN, TOTAL (Direct and Indirect Bilirubin: Conjugated and Unconjugated Bilirubin) Other Requirements: Protect specimen from light Reference Range: mg/dl Specimen Stability: Refrigerated 3 days Usage: 1. Assessment of liver function 2. Differential diagnosis of liver diseases 3. Along with direct bilirubin, provides a means to determine indirect (unconjugated) bilirubin Methodology: Colorimetric CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

20 B B-TYPE NATRIURETIC PEPTIDE (BNP) (Performed only at Spectra - Milpitas, CA) Specimen Requirements: 1.0 ml EDTA plasma (LT tube) Other Requirements: Plasma Frozen Reference Range: pg/ml Usage: Aids in diagnosis of congestive heart failure Methodology: Chemiluminescence TAT: 3 days CPT Code: BUN (Blood Urea Nitrogen) Reference Range: 6-19 mg/dl Specimen Stability: Refrigerated 7 days Usage: 1. Used with Creatinine to monitor dialysis efficacy and/ or assess residual renal function 2. Assessment of nutritional status (adequacy of protein intake) Methodology: Kinetic Interferences: Hemolysis may cause falsely elevated results CPT Code: BUN/CREATININE RATIO (CALC) Specimen Requirements: 1.0 ml serum (SST Gel Tube) Other Requirements: Calculated using BUN and Creatinine values Usage: Assists in the interpretation of lab values in assessing dialysis efficacy and/or residual renal function Methodology: Calculation: BUN/Creatinine Ratio = BUN Creatinine Interferences: Hemolysis can alter results CPT Code: Calculation BUN/CREATININE RATIO POST (CALC) (See BUN/Creatinine Ratio (calc) for test information) Section 2 General Test Listing Spectra Laboratories Directory of Services June

21 BUN, POST (Blood Urea Nitrogen, Post) B C Specimen Requirements: 0.5 ml plasma drawn post-dialysis (Gold Post Tube) NOTE: Must be labeled POST Reference Range: 6-19 mg/dl Usage: Assessment of dialysis efficacy (Refer to BUN for test information) CALCIUM, IONIZED Specimen Requirements: 1.0 ml serum (SST Gel Tube) Other Requirements: Do not open tube or expose to air Reference Range: mg/dl Alert Value: < 3.0 or > 7.0 Specimen Stability: Ionized calcium cannot be added onto an existing sample Usage: 1. Evaluation of hypoparathyroidism and hyperparathyroidism Methodology: Ion-Selective Electrode (ISE) Interferences: Prolonged exposure of the serum to air causes increase in ph that causes increased ionized calcium level CPT Code: CALCIUM, SERUM Other Requirements: Fasting specimen preferred Reference Range: mg/dl Exception Value: < 8.0 or > 11.0 mg/dl Alert Value: < 6.0 or > 13.5 mg/dl Specimen Stability: Refrigerated 7 days Usage: Assessment of calcium status and/or hyperparathyroidism Methodology: Colorimetric Interferences: Hemolysis may result in falsely elevated levels CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

22 CALCIUM, CORRECTED (CALC) C ; not orderable; results automatically provided when Calcium and Albumin are ordered Reference Range: mg/dl Exception Value: < 8.0 or > 11.0 mg/dl Alert Value: < 6.0 or > 13.5 mg/dl Usage: Assessment of calcium status and/or hyperparathyroidism Methodology: Calculation: Calcium (corrected) = Calcium (measured) + (4-albumin) x 0.8 Interferences: Hemolysis may result in falsely elevated levels CPT Code: CALCIUM/PHOSPHORUS PRODUCT (CALC) Specimen Requirements: 1.0 ml serum (SST Gel Tube) Other Requirements: Calculated from calcium and phosphorus Reference Range: < 55 Usage: 1. Monitoring of calcium levels 2. Monitoring of patient compliance Methodology: Calculation: Ca x Phos Product = Calcium x Phosphorus Interferences: Hemolyzed specimen; cells in serum CPT Code: Calculation CALCIUM, POST Specimen Requirements: 0.5 ml plasma (Gold Post Tube) NOTE: Must be labeled POST (Refer to Calcium for test information) CALCIUM/PHOSPHORUS PRODUCT, POST (Refer to Calcium/Phosphorus Product for test information) CALCIUM/PHOSPHORUS PRODUCT, CORRECTED (CALC) (Refer to Calcium/Phosphorus for test information) Methodology: Calculation: Corrected Ca x Phos Product = Corrected Calcium x Phosphorus Section 2 General Test Listing Spectra Laboratories Directory of Services June

23 CARBAMAZEPINE (TEGRETOL) Specimen Requirements: Collect one 5.0 ml red no gel tube Pediatric Collect/Transport: 0.2 ml serum at 2-8 o C. After collection keep specimen refrigerated. NOTE: Separate serum from cells ASAP Unacceptable Conditions: EDTA plasma and samples collected in tubes containing separator gels Frozen - 6 months Therapeutic Range: mcg/ml Alert Value: Toxic: > 12.0 mcg/ml Exception Value: > 10 mcg/ml Specimen Stability: Refrigerated 2 days Usage: Monitoring for therapeutic dosing during Carbamazepine therapy Methodology: Fluorescence Polarization Immunoassay (FPIA) Interferences: Gross hemolysis; patients on multiple drugs may experience toxicity at levels within the therapeutic range CPT Codes: C CD4 ABSOLUTE AND CD4 PERCENT (Performed only at Spectra - Milpitas, CA) Specimen Requirements: 3.0 ml Lavender Tube (EDTA tube) Other Requirements: Keep tube at room temperature Reference Range: Cells/uL Usage: Monitor patient s helper/inducer T-call Status Methodology: Flow Cytometry Interferences: Hemolysis or refrigerated or frozen specimen CPT Codes: CHLORIDE Reference Range: meq/l Alert Value: < 85 or > 120 meq/l Specimen Stability: Refrigerated 7 days Usage: Used with other electrolytes to evaluate electrolyte acid-base balance Methodology: Ion-Selective Electrode (ISE) Interferences: Hemolyzed specimen CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

24 C CHLORIDE, POST Specimen Requirements: 0.5 ml plasma (Gold Post Tube) NOTE: Must be labeled POST Reference Range: meq/l Usage: Used with other electrolytes to evaluate electrolyte acid-base balance (Refer to Chloride for additional test information) CHOLESTEROL, TOTAL Other Requirements: 1. Fasting Specimen Preferred 2. Fasting Overnight (12-14 hours) Reference Range: < 200 mg/dl: Desirable mg/dl: Borderline 240 mg/dl: High Risk Specimen Stability: Refrigerated 7 days Usage: Aids in the assessment of cardiovascular risk Methodology: Enzymatic Interferences: Hemolyzed specimen CPT Code: CHOLESTEROL/HDL RATIO (CALC) Specimen Requirements: Reference Range: Methodology: 0.5 ml serum (SST Gel Tube) (Refer to individual test for additional information) (Standard) Calculation: CPT Code: Calculation Cholesterol/HDL Ratio = Cholesterol HDL CHOLESTEROL/TRIGLYCERIDE RATIO (CALC) Specimen Requirements: Methodology: CPT Code: Calculation 0.5 ml serum (SST Gel Tube) (Refer to individual test for additional information) Calculation: Cholesterol/Triglyceride Ratio = Cholesterol Triglyceride CHr (See Reticulocyte Hemoglobin Content) Section 2 General Test Listing Spectra Laboratories Directory of Services June

25 CREATINE KINASE (CK) (CPK, Creatine Phosphokinase) Reference Range: U/L Specimen Stability: CK cannot be added onto an existing sample Usage: Detection of acute myocardial infarct (AMI) or skeletal muscle damage or central nervous system damage Methodology: Kinetic Interferences: Hemolyzed specimen CPT Code: C C-REACTIVE PROTEIN (CRP), WIDE RANGE Reference Range: mg/l; lowest detectable limit <0.1 mg/l Specimen Stability: CRP cannot be added onto an existing sample Usage: 1. Elucidation of the cause of non-responsiveness to erythropoietin 2. Monitoring of inflammation, infection or tissue injury Methodology: Turbidimetric CPT Codes: CREATININE Reference Range: mg/dl Specimen Stability: Refrigerated 7 days Usage: 1. Aids in the determination of dialysis efficacy 2. As an indicator of renal function Methodology: Kinetic Interferences: Certain drugs may cause falsely elevated levels CPT Code: CREATININE CLEARANCE, URINE (Refer to Urine Creatine Clearance in this section for a complete description and its specimen requirements) CREATININE, POST Specimen Requirements: Reference Range: Usage: 0.5 ml plasma drawn post-dialysis (Gold Post Tube) NOTE: Must be labeled POST mg/dl Assessment of dialysis efficacy (Refer to Creatinine for test information) Section 2 General Test Listing Spectra Laboratories Directory of Services June

26 C CREATININE REDUCTION RATIO (CALC) (CRR) drawn pre-dialysis 0.5 ml serum (Gold Post Tube) drawn post-dialysis Other Requirements: Calculated from pre and post-dialysis Creatinine values Reference Range: Usage: Provides an indication of hemodialysis adequacy Methodology: The Creatinine Reduction Ratio is calculated as follows: TAT: Test Set-up: CPT Code: CRR% = 100 x (1 - Post-dialysis Creatinine) Pre-dialysis Creatinine 1 day M-Sat Calculation CREATININE, URINE TIMED (Creatinine, 24-Hour Urine) Specimen Requirements: 24-hour urine sample in a yellow conical tube Other Requirements: 1. Urine should be kept refrigerated during collection 2. Total urine volume required Reference Range: Males: g/24 hr Females: g/24 hr Usage: As an indicator of renal function Methodology: Kinetic Interferences: 1. Failure to collect the entire 24-hour urine specimen will lead to a falsely low result 2. Failure to refrigerate the specimen may yield a falsely low result 3. Certain drugs may cause falsely elevated or decreased results CPT Code: CREATININE, URINE RANDOM Specimen Requirements: Random urine sample in a yellow conical tube Other Requirements: 1. Urine should be kept refrigerated after collection. Failure to refrigerate the specimen may yield falsely low results 2. Certain drugs may cause falsely elevated or decreased results Specimen Stability: Refrigerated 7 days Usage: As an indicator of renal function CPT Code: (See Creatinine, Urine Timed for additional test information) Section 2 General Test Listing Spectra Laboratories Directory of Services June

27 REVISED 3/2013 CYCLOSPORINE (CSAII) Specimen Requirements: EDTA whole blood (minimum 1.0 ml) Reference Range: ng/ml Alert Value: > 400 ng/ml Specimen Stability: Refrigerated 7 days Usage: Used to monitor Renal Transplant Methodology: EMIT Interferences: Hemolysis, Icteria, Lipemia TAT: 24 hours Test Set-up: Sun-Sat CPT Code: C D DIALYSIS FLUID ELECTROLYTES (Includes Sodium, Potassium, Chloride, Bicarbonate, Calcium) Specimen Requirements: Usage: Methodology: TAT: Test Set-up: Aliquot of dialysis fluid in a yellow conical tube Verification of electrolyte concentrations in dialysis fluid prior to patient use Enzymatic, Ion-selective electrode (ISE) 1 day M-Sat DIGOXIN Other Requirements: Specimen should be drawn 6 to 8 hours after last dose Therapeutic Range: ng/ml Alert Value: > 3.0 ng/ml Specimen Stability: Refrigerated 2 days Usage: Monitoring for therapeutic dosing during digoxin therapy Methodology: Chemiluminescence Interferences: 1. Serum potassium, calcium or magnesium imbalances may falsely elevate results 2. Gross hemolysis CPT Code: DILANTIN (PHENYTOIN) Specimen Requirements: 0.5 ml plain red top (no gel) tube Therapeutic Range: mcg/ml Alert Value: > 30 mcg/ml Specimen Stability: Refrigerated 2 days Usage: Monitoring for therapeutic dosing during phenytoin therapy Methodology: Fluorescence Polarization Immunoassay (FPIA) CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

28 DILANTIN (PHENYTOIN), FREE D F Specimen Requirements: 0.5 ml plain red top (no gel) tube Therapeutic Range: mcg/ml Alert Value: > 3.5 mcg/ml Specimen Stability: Refrigerated 7 days Usage: Monitoring for therapeutic dosing during phenytoin therapy Methodology: Fluorescence Polarization Immunoassay (FPIA) CPT Code: ERYTHROCYTE SEDIMENTATION RATE (See Sedimentation Rate, ESR) FERRITIN Reference Range: Males: ng/ml Females: ng/ml Specimen Stability: Refrigerated 2 days Usage: 1. Assessment of a patient s iron stores 2. Aids in the differential diagnosis of anemia Methodology: Chemiluminescence Interferences: 1. Gross hemolysis 2. Gross lipemia TAT: 2 days CPT Code: FOLATE, SERUM (Folic Acid) Other Requirements: 1. Fasting specimen preferred 2. Protect specimen from light 3. Refrigerate Reference Range: ng/ml Specimen Stability: Refrigerated 2 days Usage: 1. Detection of folic acid deficiency 2. Evaluation of anemia/response to therapy Methodology: Chemiluminescence Interferences: 1. Hemolysis falsely elevates results 2. Specimen not protected from light run 6 days a week CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

29 FOLATE, RBC (Performed only at Spectra - Rockleigh, NJ) Specimen Requirements: Other Requirements: Reference Range: Specimen Stability: Usage: 2 full Lavender Top Tubes (EDTA whole blood) 1. Gently invert both tubes 2. Immediately freeze one lavender tube; ship frozen 3. Store and ship the second full lavender tube refrigerated ng/ml RBC Folate cannot be added onto an existing sample 1. Detection of folic acid deficiency 2. Evaluation of anemia/response to therapy Methodology: Chemiluminescence Interferences: Bacterial contamination may invalidate results TAT: 2 days Test Set-up: T-F CPT Code: F FOLLICLE STIMULATING HORMONE (FSH) (Performed only at Spectra - Milpitas, CA) Specimen Requirements: 1.0 ml serum (SST Gel Tube) Reference Range: Male: miu/ml Female: Normally Menstruating Follicular Phase miu/ml Midcycle Peak miu/ml Luteal Phase miu/ml Pregnant < 0.3 miu/ml Post Menopausal miu/ml Usage: Useful in distingushing primary gonadal failure, menstrual disturbances and amenorrhea. Methodology: Chemiluminescence TAT: 5 days CPT Code: FRUCTOSAMINE, SERUM (Glycated Serum Protein) Other Requirement: Fasting specimen preferred Reference Range: mcmol/l Specimen Stability: Refrigerated 7 days Usage: Monitor diabetic control over a shorter period of time (2-3 weeks) than that represented by glycated hemoglobin (4-8 weeks) Methodology: Colorimetric Interferences: Albumin levels < 3.0 may falsely lower Fructosamine CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

30 GAMMA GLUTAMYL TRANSFERASE (GGT, GGTP) G Other Requirements: Fasting specimen preferred; patients should refrain from alcohol for 24 hours prior to the test Reference Range: Males: 8-61 U/L Females: 5-36 U/L Specimen Stability: Refrigerated 7 days Usage: Evaluation of progression of liver disease and hepatic metastasis Methodology: Kinetic Interferences: Hemolyzed specimen CPT Code: REVISED 5/2013 GENTAMICIN, RANDOM Specimen Requirements: 0.5 ml serum (Red No Gel Tube) Therapeutic Range: mcg/ml (Peak) < 2.0 mcg/ml (Trough) Alert Value: > 10.0 mcg/ml Specimen Stability: Refrigerated 7 days Usage: Monitoring for therapeutic/safe dosing during Gentamicin therapy Methodology: Fluorescence Polarization CPT Code: REVISED 5/2013 GENTAMICIN, PEAK Specimen Requirements: 0.5 ml serum (Red No Gel Tube). Peak is drawn minutes after IM injection or 60 minutes after IV infusion NOTE: Label tube as Peak Therapeutic Range: mcg/ml (Peak) Alert Value: > 10.0 mcg/ml Usage: Monitoring for therapeutic/safe dosing during Gentamicin therapy (Refer to Gentamicin, Random for remaining test information) REVISED 5/2013 GENTAMICIN, TROUGH Specimen Requirements: 0.5 ml serum (Red No Gel Tube). Trough drawn within 30 minutes of next scheduled dose. NOTE: Label tube as Trough Therapeutic Range: < 2.0 mcg/ml (Trough) Alert Value: > 4.0 mcg/ml Usage: Monitoring for therapeutic/safe dosing during Gentamicin therapy (Refer to Gentamicin, Random for remaining test information) Section 2 General Test Listing Spectra Laboratories Directory of Services June

31 egfr - MDRD (Glomerular Filtration Rate - MDRD Study Equation). Label tube with accession/bar code; include patient name Other Requirements: Calculated from serum Creatinine value. On the requisition, indicate patient age and gender Reference Range: Predicted GFR is expressed in ml/min per 1.73 m 2 Usage: The MDRD Study prediction equation is used to predict GFR from serum creatinine concentration. Background: The Modification of Diet in Renal Disease (MDRD) Study, a multicenter, controlled trial, evaluated the effect of dietary protein restriction and strict blood pressure control on the progression of renal disease. During the baseline period, GFR, serum creatinine, and several variables that affect the relation between them were measured in patients with chronic renal disease. The purpose of the study was to develop an equation from MDRD Study data that could improve the prediction of GFR from serum creatinine concentration. Methodology: The estimated GFR - MDRD is calculated as follows: Est GFR = 175 x (serum Creatinine) x (age) x (0.742 if female) x (1.210 if African American) TAT: 1-2 days CPT Code: Calculation G Additional Information: The MDRD Study prediction equations seem to be more accurate (they demonstrate less bias and greater precision) in predicting GFR than measured creatinine clearance or other commonly used equations. As with all prediction equations based on serum creatinine concentration, the MDRD Study prediction equation is inaccurate for patients not in a steady state of creatinine balance (such as patients with acute renal failure). The equation is also inaccurate for patients in whom drugs or medical conditions interfere with creatinine secretion (for example, cimetidine or trimethoprim therapy) or creatinine assay (for example, diabetic ketoacidosis or administration of certain cephalosporins). In these circumstances, accurate assessment of GFR requires clearance measurements. GLUCOSE (Blood Sugar) Reference Range: mg/dl Alert Value: < 50 or > 500 mg/dl Specimen Stability: Refrigerated 3 days Usage: 1. Evaluation of blood sugar levels 2. Evaluation of carbohydrate metabolism Methodology: Enzymatic CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

32 GLUCOSE, POST Specimen Requirements: 0.5 ml plasma (Gold Post Tube) NOTE: Must be labeled POST (Refer to Glucose for test information) HAPTOGLOBIN REVISED (Performed only at Spectra - Rockleigh, NJ) 3/2013 G H Other Requirements: Serum free of gross lipemia and hemolysis Reference Range: mg/dl Specimen Stability: Refrigerated 7 days Usage: Decreased to absent levels occur more with intravascular than extravascular hemolysis: haptoglobin binds hemoglobin, and carries it to the reticuloendothelial system. Thus, haptoglobin is useful in work-up for hemolytic states. It is low in the megaloblastic anemias, which have a hemolytic component. It is decreased in infectious mononucleosis. Decreases can occur with hematoma or tissue hemorrhage. Haptoglobin can be low with liver disease. Congenital absence occurs (small fraction of African Americans/Asians have ahaptoglobinemia, absence of detectable haptoglobin). Frequently elevated as an acute phase reactant, in inflammatory disorders (e.g., collagen diseases, infections, tissue destruction, and with advanced malignant neoplasms). Methodology: Turbidimetry Interferences: Grossly hemolyzed specimens CPT Code: HEMATOCRIT (HCT) Specimen Requirements: 1 full Lavender Top Tube ( EDTA, whole blood ) NOTE: One tube is sufficient for all hematology tests Other Requirements: Specimen must be stored and transported cold with ice packs as HCT values can rise artifactually if left at room temperature Reference Range: Males: 42-52% Females: 37-47% Alert Value: < 18% or > 52% Usage: 1. Evaluation of anemia 2. Determination of efficacy of erythropoietin therapy Methodology: Automated Calculation from MCV and RBC Interferences: 1. Hemolyzed specimen 2. Specimen storage at room temperature can increase MCV, which in turn can lead to false elevations in HCT CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

33 REVISED 5/2013 HEMOGLOBIN (Hgb) Specimen Requirements: 1 full Lavender Top Tube (EDTA whole blood) NOTE: One tube is sufficient for all hematology tests Reference Range: Males: g/dl Female: g/dl Alert Value: <8.0, > 18.0 Exception Value: <10.0 NOTE: On the patient report, an Alert result will be flagged AL for Alert Low and AH for Alert High. For Exception the flag would be EL, Exception Low Usage: 1. Evaluation of anemia 2. Determination of efficacy of erythropoietin therapy Methodology: Colorimetric Interferences: 1. Hemolyzed specimen 2. Results falsely elevated by lipemic samples, chylomicrons, or extremely high bilirubin CPT Code: H HEMOGLOBIN A 1C (HBA 1c ) Specimen Requirements: 1 full Lavender Top Tube (EDTA whole blood) Reference Range: % Specimen Stability: Refrigerated 7 days Usage: Provides an indication of how well blood glucose levels have been controlled over the previous 3 to 4 month period Methodology: Immunoturbidimetric Interferences: 1. Hemolyzed specimen 2. Falsely decreased values can occur in the presence of anemia CPT Code: HEMOGLOBIN ELECTROPHORESIS (Performed only at Spectra - Milpitas, CA) Specimen Requirements: 3.0 ml Whole Blood (Lavender EDTA Tube) Reference Range: Total Protein: g/dl Albumin: g/dl Hemoglobin A: % Hemoglobin A2: % Hemoglobin C: Negative Hemoglobin F: % Hemoglobin S: Negative Usage: Diagnose thalassemia and hemoglobin variants Methodology: Capillary Electrophoresis TAT: 3 days CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

34 H REVISED HEMOGRAM 3/2013 A Hemogram includes the following individual test components: RBC (Red Blood Cell) WBC (White Blood Cell) HCT (Hematocrit) HGB (Hemoglobin) MCV (Mean Corpuscular Volume) MCH (Mean Corpuscular Hemoglobin) MCHC (Mean Corpuscular Hemoglobin Concentration) RDW (Red Cell Distribution Width) Specimen Requirements: 1 full Lavender Top Tube (EDTA whole blood) NOTE: One tube is sufficient for all hematology tests. You can also order the following Hemogram tests. Hemogram with Platelet Hemogram with Differential and Platelet Reference Range: See individual test components Alert Value: See individual test components Specimen Stability: Refrigerated 3 days Usage: 1. Evaluation of the cellular components of the blood as part of an evaluation for anemia 2. Monitoring of response to routine adjunctive or erythropoietin therapy for anemia 3. Evaluation of symptoms of infection 4. Also see individual test components Methodology: See individual test components Interferences: 1. Hemolyzed sample 2. Clotted sample 3. Incompletely filled tube 4. Diluted sample obtained from fistula needle which was not cleared of saline/heparin 5. Also see individual test components CPT Code: See individual test components for CPT information HEPATITIS A VIRUS ANTIBODY, IgM (Anti-HAV IgM, HAV-Ab IgM) Reference Range: Negative Specimen Stability: Refrigerated 2 days Usage: This assay is indicated for use as an aid in the diagnosis and monitoring of acute or recent Hepatitis A virus infection Methodology: Chemiluminescence TAT: 2 days CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

35 HEPATITIS A VIRUS ANTIBODY, TOTAL (Anti-HAV Total, HAV-Ab Total) Reference Range: Negative Specimen Stability: Refrigerated 7 days Usage: Assessment of Hepatitis A infection Methodology: Chemiluminescence TAT: 2 days CPT Code: REVISED 3/2013 HEPATITIS B VIRUS CORE ANTIBODY, IgM (Anti-HB Core IgM) H Reference Range: Negative Specimen Stability: Refrigerated 2 days Usage: Indicates acute Hepatitis B infection Methodology: Chemiluminescence TAT: 2 days CPT Code: HEPATITIS B VIRUS CORE ANTIBODY, TOTAL (Anti-HBc Total) Reference Range: Negative Specimen Stability: Refrigerated 3 days Usage: 1. Differential diagnosis of Hepatitis 2. In conjunction with other Hepatitis B markers, to assess the stage of infection Methodology: Chemiluminescence TAT: 2 days CPT Code: HEPATITIS Be VIRUS ANTIBODY (Anti-HBe, HBeAb) (Performed only at Spectra - Rockleigh, NJ) Other Requirements: Test should be ordered only when recent infection with Hepatitis B has been ascertained Reference Range: Negative Usage: Differential diagnosis and staging of Hepatitis infection Methodology: Enzyme immunoassay (EIA) TAT: 2 days Test Set-up: T-Sat CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

36 HEPATITIS Be VIRUS ANTIGEN (HBeAg, Hepatitis Be Ag) (Performed only at Spectra - Rockleigh, NJ) H Reference Range: Negative Specimen Stability: Refrigerated 2 days Usage: Differential diagnosis and staging of Hepatitis B infection Methodology: Enzyme immunoassay (EIA) TAT: 2 days Test Set-up: T-Sat CPT Code: HEPATITIS B VIRUS SURFACE ANTIBODY (HBsAb) Reference Range: < 10 miu/ml, Non-Immune Specimen Stability: Refrigerated 7 days Usage: Indicates clinical recovery or immunity to Hepatitis B and monitors response to vaccine Methodology: Chemiluminescence Interferences: Specimens containing precipitate TAT: 2 days CPT Code: HEPATITIS B VIRUS SURFACE ANTIGEN (HBsAg, Hepatitis B Surface Ag) Reference Range: Negative Alert Value: All confirmed, first-time positives are sent to client s printer or faxed to the facility Specimen Stability: Refrigerated 7 days Usage: Differential diagnosis and staging of Hepatitis B infection Methodology: Chemiluminescence Interferences: False reactives may occur following vaccination Confirmatory Test: HBsAg Neutralization test is performed on all first-time positive results and is not billed TAT: 2 days (positive results require an additional 2 to 4 days for confirmation) CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

37 HEPATITIS C VIRUS ANTIBODY Specimen Requirements: Other Requirements: 0.5 ml serum (SST Gel Tube) Hepatitis C Virus (HCV) antibody test, will include an additional result component, signal to cut off ratio (s/co ratio), along with interpretation. The Center for Disease Control (CDC) recommends the s/co ratio be used as a guidance to determine the next most logical steps in evaluating the status of Hepatitis C infection in your patients. 1 They recommend anti-hcv testing include an option for supplemental testing based on a positive s/co ratio 2 : Those with s/co ratio of 11.0 or greater have hepatitis C infection; however, further testing is recommended to distinguish the active from the resolved cases. Those whose s/co ratio is between , further testing is recommended in order to confirm or to exclude the presence of antibody to HCV. In those patients with s/co ratio of less than 0.80, HCV is negative. Sample Result Format Anti- HCV HCV s/co ratio (1) s/co ratio < =/>11.00 Result Units Negative (1) 0.03 Interpretation Negative Indeterminate Initially positive Positive Reference Negative Supplementary testing No further testing required RIBA for anti-hcv to confirm RIBA for anti-hcv to confirm HCV RNA (qualitative) is recommended to distinguish active from resolved cases. If HCV RNA is negative, RIBA for anti-hcv is recommended H Note: Positive anti-hcv results with s/co ratio =/>11.0 are =/>95% true positive. Because of intermittent viremia, a negative HCV RNA on a single specimen does not always rule out HCV. All test results should be interpreted in the context of clinical setting. References: 1http:// Testing.htm#section1 CDC.Division of Viral Hepatitis, Laboratory Testing, Hepatitis C, July http:// CDC.Guidelines for Laboratory Testing and Result Reporting of Antibody to Hepatitis C Virus, MMWR, Recommendations and Reports; February 7, 2003/ 52(RR03); 1-16 Reference Range: Negative Specimen Stability: Refrigerated 7 days Usage: 1. Aids in the diagnosis of HCV infection 2. Predicts responsiveness to therapy and monitors therapy 3. Useful in the differential diagnosis of severe autoimmune Hepatitis and Hepatitis C Methodology: Chemiluminescence TAT: 2 days CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

38 HEPATITIS C VIRUS RNA QUANTITATIVE PCR (HCV RNA QUANT PCR) (Performed only at Spectra - Milpitas,CA) H Specimen Requirements: 0.5 ml plasma (EDTA tube) Other Requirements: Plasma Frozen Reference Range: Not Detected Usage: Quantitation of Hepatitis C Virus Methodology: Polymerase chain reaction amplification TAT: 5 days CPT Code: HDL CHOLESTEROL (High-Density Lipoprotein Cholesterol) Specimen Requirements: 1.0 ml serum (SST Gel Tube) Other Requirements: Fasting specimen preferred Reference Range: < 40 mg/dl - Low HDL Cholesterol 60 mg/dl - High HDL Cholesterol Specimen Stability: Refrigerated 7 days Usage: Risk assessment of coronary heart disease Methodology: Enzymatic CPT Codes: HIV 1/2 ANTIBODY SCREEN (Human Immunodeficiency Virus Antibody) Specimen Requirements: 1.0 ml serum (SST Gel Tube) Reference Range: Non-reactive Specimen Stability: Refrigerated 7 days Usage: Diagnosis of acquired immune deficiency syndrome (AIDS) Methodology: Enzyme Immunoassay (EIA) TAT: 2 days Test Set-up: T-Sat CPT Codes: REVISED 3/2013 HIV-1 RNA QUANTITATIVE REAL-TIME PCR (HIV-1 RNA PCR) (Performed only at Spectra - Milpitas, CA) Specimen Requirements: Collect two lavender top tubes and freeze the plasma; The plasma needs to be removed within 4 hours of the draw and placed into a transport container suitable for freezing. Reference Range: Not Detected Usage: Detect and quantitate HIV-1 Methodology: Polymerase Chain Reaction Amplification TAT: 5 days CPT Codes: Section 2 General Test Listing Spectra Laboratories Directory of Services June

39 HOMOCYSTEINE Sample should be kept on ice until separated Reference Range: mcmol/l Specimen Stability: Refrigerated 2 days Usage: This diagnostic test is designed to quantitatively measure HCY in serum or plasma. Such measurement can aid in the diagnosis and treatment of patients suspected of having homocysteinuria or hyperhomocysteinemia. HCY may also be used as a weak-graded risk factor for cardiovascular disease or stroke. Methodology: Chemiluminescence Interferences: Certain drugs (e.g. carbamazepine, phenytoin, and methotrexate) may cause elevated levels. False elevations of plasma or serum homocysteine may occur if the plasma or serum is not promptly separated from the cells at the time of collection. Serum specimens that are hemolyzed, lipemic, icteric, proteinemic are prone to interferences, may cause false result. TAT: 2 days CPT Code: H L M HUMAN CHORIONIC GONADOTROPIN, QUALITATIVE (HCG QUALITATIVE) Specimen Requirements: 1.0 ml serum (SST Gel Tube) Reference Range: Negative < 10 miu/ml and Positive 10 miu/ml Specimen Stability: Refrigerated 2 days Usage: Determine the presence of hcg in patients with gestational trophoblastic disease, evaluate and monitor male patients with testicular tumors, and monitor molar pregnancy. Methodology: Chemiluminescence Interferences: Gross hemolysis, lipemia, icteria, proteinemia. Heterophilic antibodies in the human serum. TAT: 24 hours CPT Code: hcg qualitative Section 2 General Test Listing Spectra Laboratories Directory of Services June

40 HUMAN CHORIONIC GONADOTROPIN, QUANTITATIVE (HCG QUANT) (Performed only at Spectra - Milpitas, CA) H I Specimen Requirements: 1.0 ml serum (SST Gel Tube) Reference Range: Female, Non-Pregnant: <10 miu/ml Gestational Age: week 5-50 miu/ml 1-2 weeks miu/ml 2-3 weeks 100-5,000 miu/ml 3-4 weeks 1,000-50,000 miu/ml 5-6 weeks 10, ,000 miu/ml 6-8 weeks 15, ,000 miu/ml 2-3 months 10, ,000 miu/ml Specimen Stability: Refrigerated 2 days Usage: Determine the presence of hcg in patients with gestational trophoblastic disease, evaluate and monitor male patients with testicular tumors, and monitor molar pregnancy. Methodology: Chemiluminescence TAT: 3 days CPT Code: IRON, SERUM (Fe) Reference Range: Females: mcg/dl Males: mcg/dl Specimen Stability: Refrigerated 7 days Usage: 1.Monitoring for iron toxicity/overload or its treatment with deferoxamine 2. Evaluation of ferrokinetics during erythropoietin treatment 3. Evaluation of iron transport/metabolism Methodology: Colorimetric Interferences: 1. Severe hemolysis 2. Parenteral administration of iron dextran within one month of test date CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

41 Kt/V NATURAL LOG drawn pre-dialysis 0.5 ml serum (SST Gel Tube) drawn post-dialysis Usage: Determination of dialysis adequacy Methodology: Calculation: LN (URR-0.008* Time) + (4-3.5* URR) * UF/W Where Time= Time of dialysis treatment UF= Ultrafiltration Time W= Post weight CPT Code: Calculation Kt/V, STANDARD drawn pre-dialysis 0.5 ml serum (SST Gel Tube) drawn post-dialysis Usage: Determination of dialysis adequacy Methodology: Calculations: spkt/v= -In(post BUN/pre BUN * t) + (4-3.5 * post BUN/Pre BUN) * UF/W ekt/v=0.924 * spkt/v/v/t std Kt/V= 168 *[1-exp(-eKt/V)]/t/[(1-exp(-eKt/V))/eKt/V + 168/N/t -1] K L Kt/V, QUICK- FOR DEPNER, BASILE, KESHAVIAH drawn pre-dialysis 0.5 ml serum (SST Gel Tube) drawn post-dialysis Usage: Determination of dialysis adequacy Methodology: Calculations: DEPNER 0.026*URR BASILE 0.023*URR KESHAVIAH 1.162*LN (PRE BUN/POST BUN) CPT Code: Calculation LACTATE DEHYDROGENASE (LDH) Other Requirements: The test should be performed only on pre-dialysis specimens Reference Range: U/L Specimen Stability: LDH cannot be added onto an existing sample Usage: Aids in the diagnosis of a variety of disorders including renal infarction, liver disease, cardiomyopathy, neoplasm and certain types of anemia Methodology: Enzymatic Interferences: Excessive hemolysis CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

42 LDL CHOLESTEROL (CALC) (Low-Density Lipoprotein Cholesterol) Specimen Requirements: 2.0 ml serum (SST Gel Tube) Other Requirements: 1. Fasting specimen preferred 2. Calculated from cholesterol, HDL and triglycerides Reference Range: 0-99 mg/dl <100 mg/dl (Optimal) mg/dl (Near/above optimal) mg/dl (Borderline high) mg/dl (High) 190 mg/dl (Very high) Usage: Assessment of coronary atherosclerosis risk Methodology: LDL is calculated using the following formula: LDL = Cholesterol (HDL + Triglycerides/5) L Interferences: 1. This calculation is not valid for specimens with triglyceride levels > 400 mg/dl 2. Alcoholic beverage ingestion within the last 24 hours prior to the test CPT Code: Calculation NEW LDL CHOLESTEROL, DIRECT Specimen Requirements: 2.0 ml serum (SST Gel Tube) Reference Range: 0-99 mg/dl <100 mg/dl (Optimal) - Recommended mg/dl (Near/Above optimal) mg/dl (Borderline high) mg/dl (High) 190 mg/dl (Very high) Specimen Stability: Refrigerated 5 days Usage: Assessment of coronary atherosclerosis risk Methodology: Enzymatic CPT Code: LIPASE Specimen Requirements: 0.2 ml serum (SST Gel Tube) Reference Range: U/L Specimen Stability: Refrigerated 7 days Usage: Aids in the diagnosis of pancreatitis and other pancreatic disease, cholecystitis, peritonitis and strangulated bowel Methodology: Colorimetric Test Set-up: T-F CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

43 LIPID PROFILE NEW _ Includes: Cholesterol, Triglycerides, HDL Cholesterol Refer to individual tests for additional information Specimen Requirements: 2.0 ml serum (SST Gel Tube) LITHIUM (Performed only at Spectra - Milpitas, CA) Reference Range: mmol/l Specimen Stability: Refrigerated 7 days Usage: Monitor therapy in the treatment of manic depressive disorders. Methodology: Spectrophotometric CPT Code: L LUTEINIZING HORMONE (LH) (Performed only at Spectra - Milpitas, CA) Specimen Requirements: 2.0 ml serum (SST Gel Tube) Reference Range: Female: Normally Menstruating Follicular Phase: miu/ml Midcycle Peak: miu/ml Luteal Phase: miu/ml Pregnant: < miu/ml Post Menopausal: miu/ml Contraceptives: miu/ml Male: years: miu/ml > 70 years: miu/ml Children: < miu/ml Usage: Use in evaluating the normalcy of hypothalamic-pitiutarygonadal axis. Methodology: Chemiluminescence Interferences: 1. This calculation is not valid for specimens with triglyceride levels > 400 mg/dl. 2. Alcoholic beverage ingestion within the last 24 hours prior to the test CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

44 LYMPHOCYTES, ABSOLUTE COUNT Specimen Requirements: 1 full Lavender Top Tube (EDTA whole blood) NOTE: One tube is sufficient for all hematology tests Reference Range: x 1000/mcL Usage: 1. Provides an absolute number of lymphocytes for use in relating percentages (i.e., CD4 + cells, helper suppressor ratios, etc.) to actual cell numbers 2. Aids in the diagnosis of, and/or determination of, the progression of certain immune disorders and opportunistic infections 3. Aids in the assessment of nutritional status Methodology: Flow Cytometry Interferences: Steroids and general anesthesia may cause falsely low values CPT Code: L M MAGNESIUM (Mg) Reference Range: meq/l Specimen Stability: Refrigerated 7 days Usage: Detection of hypo or hypermagnesemia Alert Value: <1.0 - >4.0 meq/l Methodology: Colorimetric CPT Code: MAGNESIUM, POST Specimen Requirements: 0.5 ml plasma (Gold Post Tube) NOTE: Must be labeled POST (Refer to Magnesium for test information) MICROALBUMIN, URINE Specimen Requirements: 5.0 ml random urine (Yellow Conical Tube) Reference Range: 0-30 ug/mg Creatinine Specimen Stability: Refrigerated 7 days Usage: Useful in the management of patients with relatively early diabetes Methodology: Immunoturbidimetric CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

45 MCH (MEAN CORPUSCULAR HEMOGLOBIN) (Test is included as part of a Hemogram) Reference Range: pg/cell Usage: Aids in the diagnosis and differentiation of iron deficiency and/or anemia Methodology: Automated calculation Interferences: Hemolyzed specimen MCHC (MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION) (Test is included as a part of a Hemogram) Reference Range: g/dl Usage: Aids in the diagnosis and differentiation of iron deficiency and/or anemia Methodology: Automated calculation Interferences: Hemolyzed specimen MCV (MEAN CORPUSCULAR VOLUME) (Test is included as a part of a Hemogram) _ Reference Range: fl Usage: Aids in the diagnosis and differentiation of iron deficiency and/or anemia Methodology: Forward light scatter, automated, Flow Cytometry Interferences: Hemolyzed specimen M P PARATHYROID HORMONE (PTH), INTACT (PLASMA) (See PTH-Intact, Plasma) PARTIAL THROMBOPLASTIN TIME, ACTIVATED (See Activated, PTT, APTT) REVISED 5/2013 PHENOBARBITAL Specimen Requirements: 0.5 ml serum (Red No Gel Tube) Therapeutic Range: mcg/ml Alert Value: > 40.0 mcg/ml Specimen Stability: Refrigerated 2 days Usage: Monitoring for therapeutic dosing during phenobarbital therapy Methodology: Fluorescence Polarization Immunoassay (FPIA) CPT Code: PHENYTOIN (See Dilantin) Section 2 General Test Listing Spectra Laboratories Directory of Services June

46 PHOSPHORUS Other Requirements: Fasting specimen preferred Reference Range: mg/dl; lowest reportable value is <1.0 Alert Value: <1.0 or > 12.0 Exception Value: < 2.0 or > 10.0 Specimen Stability: Refrigerated 7 days Usage: Phosphate levels may be used in the diagnosis and management of a variety of disorders including bone, parathyroid and renal diseases Methodology: Colorimetric Interferences: Hemolysis causes falsely elevated results CPT Code: P PHOSPHORUS, POST Specimen Requirements: 0.5 ml plasma drawn post-dialysis (Gold Post Tube) NOTE: Must be labeled POST Reference Range: mg/dl Usage: To aid in the determination of efficacy of dialysis (Refer to Phosphorus for remaining test information.) PLATELET COUNT (Thrombocyte Count) Specimen Requirements: 1 full Lavender Top Tube (EDTA whole blood) NOTE: One tube is sufficient for all hematology tests Reference Range: /mcL NOTE: Smear review will trigger when the platelet count is >1,000,000 Exception Value: < 130 > /mcL Alert Value: < 50 > /mcL Usage: Evaluation, diagnosis and follow-up of bleeding disorders Methodology: Flow Cytometry Interferences: Hemolyzed specimen CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

47 POTASSIUM, SERUM (K + ) Reference Range: meq/l Alert Value: < 3.0 or > 7.0 meq/l Specimen Stability: Refrigerated 7 days Usage: Evaluation of electrolyte balance, cardiac arrhythmia, muscular weakness, hepatic encephalopathy, and renal failure Methodology: Ion-Selective Electrode (ISE) Interferences: Hemolyzed specimen Delay in centrifugation of sample CPT Code: POTASSIUM, PLASMA Specimen Requirements: 0.5 ml plasma (Green Top Plasma Separator Tube) Reference Range: meq/l Alert Value: < 3.0 or > 7.0 meq/l Usage: Evaluation/monitoring of electrolyte balance (Refer to Potassium for remaining test information) P POTASSIUM, POST Specimen Requirements: Reference Range: Usage: 0.5 ml of plasma drawn post-dialysis (Gold Post Tube) NOTE: Must be labeled POST meq/l Assessment of dialysis efficacy (Refer to Potassium for remaining test information) PREALBUMIN (Transthyretin) Reference Range: mg/dl Specimen Stability: Refrigerated 7 days Usage: Provides an early marker of nutritional status Methodology: Turbidimetric CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

48 PROLACTIN (Performed only at Spectra - Milpitas, CA) Reference Range: Females: Pregnant: ng/ml Non-Pregnant: ng/ml Post-menopausal: ng/ml Males: ng/ml Usage: Pituitary function test useful in the detection of prolactin secreting pituitary tumors with or without galactorrhea. Methodology: Chemiluminescence CPT Code: PROSTATE SPECIFIC ANTIGEN, SCREENING (PSA) P Specimen Requirements: Reference Range: Specimen Stability: Usage: Methodology: Interferences: TAT: Test Set-up: CPT Codes: 0.5 ml serum (SST Gel Tube) ng/ml Refrigerated 2 days 1. Aids in the diagnosis of prostate cancer 2. Enables prediction of survival and tumor recurrence in patients with prostate cancer Chemiluminescence 1. Rectal examination within 48 hours prior to the test may be associated with falsely elevated results 2. Gross hemolysis 2 days M-Sat G0103 PROSTATE SPECIFIC ANTIGEN, DIAGNOSTIC (PSA) Reference Range: ng/ml Specimen Stability: Refrigerated 2 days Usage: 1. Aids in the diagnosis of prostate cancer 2. Enables prediction of survival and tumor recurrence in patients with prostate cancer Methodology: Chemiluminescence Interferences: 1. Rectal examination within 48 hours prior to the test may be associated with falsely elevated results 2. Gross hemolysis TAT: 2 days CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

49 PROTEIN ELECTROPHORESIS (Performed only at Spectra - Milpitas, CA) Specimen Requirements: 1.0 ml serum (SST Gel Tube) Reference Range: Total Protein: g/dl Albumin: g/dl Alpha 1 globulin: g/dl Alpha 2 globulin: g/dl Beta globulin: g/dl Gamma globulin: g/dl Usage: Use for the detection of monoclonal gammopathies Methodology: Capillary Electrophoresis TAT: 2 days CPT Code: PROTEIN, TOTAL Reference Range: g/dl Specimen Stability: Refrigerated 7 days Usage: Evaluation of nutritional status and diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow Methodology: Colorimetric CPT Code: P PROTEIN, TOTAL URINE OR FLUID Specimen Requirements: Urine, PDF Other Requirements: No preservatives for urine Reference Range: mg/dl Specimen Stability: Refrigerated 2 days Usage: Used for the diagnosis and treatment of diseases associated with renal, cardiac and thyroid functions. Methodology: Colorimetric Interferences: Hemolysis CPT Code: Fluid 84157, urine Section 2 General Test Listing Spectra Laboratories Directory of Services June

50 P PROTHROMBIN TIME/INR (PT-INR, Protime-INR) REVISED 5/2013 Specimen Requirements: 1 full Light Blue Top Tube (citrated whole blood) with 3.2% of sodium citrate Other Requirements: The fistula needle must be flushed thoroughly; draw blood culture tubes and tubes without additives prior to PT Tube Reference Range: Lot Dependent. See patient clinical results report for reference range Exception Value: All results sent to fax/printer Alert Value: All results sent to fax/printer Specimen Stability: Refrigerated 3 days Usage: 1. Monitoring Warfarin (Coumadin) therapy 2. Evaluation of clotting disorders Methodology: Dual Photo-Optical & Electromagnetic Clot Detection Rejection Criterion: Incomplete filling of tube Interferences: 1. Hemolyzed specimen 2. Inadequate flushing of heparin from fistula TAT: Results are sent to the client s printer or faxed to the facility the same day the specimen is received CPT Code: Therapeutic INR: Std High PROTHROMBIN TIME/POST Specimen Requirements: 1 full Light Blue Top Tube NOTE: Must be labeled POST (Refer to Prothrombin for test information) PSA (See Prostate Specific Antigen) PTH-INTACT PLASMA (Parathyroid Hormone) Specimen Requirements: 1 full Lavender Top Tube NOTE: Plasma PTH does not need to be frozen Other Requirements: 1. Requires separate tube other than that submitted for hematology studies 2. Fasting specimen preferred Reference Range: pg/ml Specimen Stability: Refrigerated 3 days Usage: 1. Monitoring of levels of biologically active PTH as an indication of hyperparathyroidism and secondary hypercalcemia and bone disease 2. Monitoring of hypocalcemia Methodology: Chemiluminescence Interferences: 1. Severe hemolysis 2. Severe lipemia CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

51 RED BLOOD CELL COUNT (RBC) Specimen Requirements: 1 full Lavender Top Tube Reference Range: Males: mill/mcl Females: mill/mcl Usage: Evaluation of anemia and/or efficacy of its treatment Methodology: Flow Cytometry Interferences: 1. Hemolyzed specimen 2. Clotted specimen 3. The presence of cold agglutinins can lead to falsely low values 4. Very high WBC counts (> 200,000 thous/mcl) elevates the red blood cells Test Set Up: Mon-Sat CPT Code: RECIRCULATION (CALC) (Includes BUN Arterial, BUN Venous, BUN Peripheral) Specimen Requirements: ml SST tube for each BUN (arterial, venous and peripheral blood) Other Requirements: 1. Calculated from arterial, venous and peripheral BUN values 2. Ensure that tubes are identified with the proper label (arterial, venous and peripheral) Reference Range: 0-9% Usage: Determination of access recirculation as an indication of access dysfunction Methodology: Percentage recirculation is calculated as follows: R % Recirculation = 100 x (Peripheral BUN - Arterial BUN) (Peripheral BUN - Venous BUN) TAT: Test Set-up: CPT Code: 1 day M-Sat Calculation RA FACTORS (Performed only at Spectra - Milpitas, CA) Specimen Requirements: Reference Range: Specimen Stability: Usage: Methodology: TAT: Test Set-up: CPT Code: ml serum (SST Gel Tube) < 14.0 IU/mL Refrigerated 3 days Helps in the differential diagnosis and prognosis of arthritic disorders. Immunoturbidimetric 1 day M-Sat Section 2 General Test Listing Spectra Laboratories Directory of Services June

52 RETICULOCYTE COUNT Specimen Requirements: 1 full Lavender Top Tube (EDTA whole blood) NOTE: One tube is sufficient for all hematology tests Reference Range: % Usage: 1. Assessment of erythropoietic bone marrow activity in anemia and other hematologic conditions 2. Evaluation of response to therapeutic interventions Methodology: Flow Cytometry Interferences: 1. Hemolyzed specimen 2. Clotted specimen CPT Code: RETICULOCYTE COUNT, ABSOLUTE Specimen Requirements: Reference Range: 1 full Lavender Top Tube (EDTA whole blood) /mcL (Refer to Reticulocyte count for test information) RETICULOCYTE HEMOGLOBIN CONTENT (CHr) R Specimen Requirements: 1 full Lavender Top Tube (EDTA whole blood) NOTE: One tube is sufficient for all hematology tests Reference Range: Usage: Aids in the evaluation of iron deficiency Detection of functional iron deficiency in patients treated with recombinant EPO Methodology: Flow Cytometry Interferences: Hemolyzed specimen CPT Code: Rh (D) TYPING (Performed only at Spectra - Rockleigh, NJ) Specimen Requirements: 1 full Lavender Top Tube Other Requirements: Tube must be labeled with patient s name Specimen Stability: Refrigerated 7 days Usage: Determination of the presence or absence of the Rh antigen on red blood cells Methodology: Hemagglutination TAT: 2 days Test Set-up: T-Sat CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

53 RPR (Serology test for Syphilis, STS, Syphilis Screen) Other Requirements: Specimen should be drawn before meals Reference Range: Non-reactive Specimen Stability: Refrigerated 5 days Usage: Screening for syphilis Methodology: Particle flocculation Interferences: 1. False positives can be seen in specimens from persons who abuse drugs, have diseases such as lupus, mononucleosis, leprosy, malaria, viral pneumonia, or who are pregnant 2. Gross hemolysis Confirmatory Tests: Reactive tests confirmed by Fluorescence Treponema Antibody (FTA) test with titer (confirmatory tests are billed) Test Set-up: T-Sat CPT Codes: RUBELLA VIRUS Ab IgG, TOTAL (Anti-Rubella IgG) Reference Range: IU/mL <5.0 IU/mL Negative IU/mL Equivocal 10.0 IU/mL Positive Specimen Stability: Refrigerated 7 days Usage: Assessing immunity to rubella virus infection Methodology: Chemiluminescence TAT: 2-4 days (depending on the day sample arrives) Test Set-up: T-F CPT Code: R RUBEOLA VIRUS Ab IgG, TOTAL (Measles Antibody) (Performed only at Spectra - Rockleigh, NJ) Reference Range: EU/mL <15.0 EU/mL Negative EU/mL Equivocal 20.0 EU/mL Positive Specimen Stability: Refrigerated 2 days Usage: Assessing immunity to measles virus infection Methodology: Enzyme Immunoassay (EIA) TAT: 3 days Test Set-up: T-Sat CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

54 SEDIMENTATION RATE, SED RATE (ESR) (Erythrocyte Sedimentation Rate) Specimen Requirements: 1 full Lavender Top Tube (EDTA whole blood) NOTE: One tube is sufficient for all hematology tests Reference Range: Males: 0-15 mm/hr thru 49 years 0-20 mm/hr > 49 years Females: 0-20 mm/hr thru 49 years 0-30 mm/hr > 49 years Usage: Aids in the detection of the acute-phase reaction in inflammation and infection Methodology: Westergren, Modified Interferences: 1. Hemolyzed specimen 2. Clotted specimen 3. Heparin causes falsely increased results CPT Code: SERUM GLUTAMIC-OXALOACETIC TRANSAMINASE (See AST/SGOT) SERUM GLUTAMIC-PYRUVIC TRANSAMINASE (See AST/SGPT) SGOT (See AST) SGPT (See ALT) S SICKLE CELL HEMOGLOBIN SOLUBILITY (Performed only at Spectra - Milpitas, CA) Specimen Requirements: 1.0 ml Whole Blood (Lavender EDTA) Reference Range: Negative Usage: To determine the presence of Hemoglobin S, sickling hemoglobins. Methodology: Hemoglobin solubility CPT Code: SODIUM (Na) Reference Range: meq/l Alert Value: < 120 or > 150 meq/l Specimen Stability: Refrigerated 7 days Usage: Determination of electrolyte and acid-base balance Methodology: Ion-Selective Electrode (ISE) CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

55 SODIUM, PD FLUID Specimen Requirements: Yellow conical tube with PD Fluid Other Requirements: Unit of measure is meq/l Reference Range: No reference range CPT Code: SODIUM, POST Specimen Requirements: Reference Range: Alert Value: Usage: 0.5 ml plasma drawn post-dialysis (Gold Post Tube) NOTE: Must be labeled POST meq/l < 120 or > 150 meq/l Assessment of dialysis efficacy (Refer to Sodium for remaining test information) TEGRETOL (See Carbamazepine) THEOPHYLLINE REVISED (Aminophylline) (Performed only at Spectra - Rockleigh, NJ) 5/2013 Specimen Requirements: 0.5 ml serum (Red No Gel Tube) Therapeutic Range: mcg/ml Alert Value: > 20 mcg/ml Specimen Stability: Refrigerated 2 days Usage: Monitoring for therapeutic dosing during Theophylline therapy Methodology: Chemiluminescence Interferences: 1. Ingestion of substances containing xanthenes (i.e. chocolate, coffee, cola or tea) prior to the test may elevate levels 2. Gross hemolysis CPT Code: S T REVISED 3/2013 THYROID STIMULATING HORMONE, 3rd GENERATION (TSH3) Reference Range: miu/l Specimen Stability: Refrigerated 2 days Usage: 1. Determination of thyroid function/evaluation of treatment 2. Differentiation of primary hypothyroidism from pituitary/hypothalamic hypothyroidism Methodology: Chemiluminescence CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

56 THYROXINE (T4) (Total T4) Reference Range: mcg/dl Specimen Stability: Refrigerated 2 days Usage: Determination of thyroid function Methodology: Interferences: Chemiluminescence 1. Hemolyzed specimen 2. Lipemic specimen CPT Codes: THYROXINE (T4), FREE (Unbound T4,FT4) Reference Range: ng/dl Specimen Stability: Refrigerated 2 days Usage: Assessment of the severity of hyperthyroidism Evaluation of TSH changes for an accurate thyroid status in patients with abnormal thyroid-binding globulin (TBG) levels Methodology: Chemiluminescence Interferences: Gross hemolysis CPT Codes: TRIIODOTHYRONINE (T3), FREE (Unbound T3, Free T3, FT3) (Performed only at Spectra - Milpitas, CA) T Reference Range: pg/ml Specimen Stability: Refrigerated 2 days Usage: Certain conditions such as pregnancy and steroid therapy, can alter levels of T3 binding proteins, especially TBG. In these conditions, free T3 levels are unchanged Methodology: Chemiluminescence Interferences: Gross hemolysis CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

57 TRIIODOTHYRONINE (T3), TOTAL (Total T3) Specimen Requirements: 1.0 ml serum (SST Gel Tube) Reference Range: ng/ml Usage: Determination of thyroid function/evaluation of treatment Methodology: Chemiluminescence Interferences: 1. Hemolyzed specimen 2. Lipemic specimen CPT Code: T UPTAKE Reference Range: 22-37% Specimen Stability: Refrigerated 2 days Usage: Thyroid function test for the diagnosis of hypo - or hyperthyroidism Methodology: Chemiluminescence Interferences: 1. Heparin may cause falsely elevated results 2. Results may be falsely increased in severe acidosis CPT Code: TIBC (CALC) Specimen Requirements: 2.0 ml serum (SST Gel Tube) Other Requirements: Calculated from serum iron and UIBC Reference Range: mcg/dl Usage: 1. Differential diagnosis of anemia 2. Evaluation of iron toxicity/overload in renal dialysis patients Methodology: Calculated from serum iron and UIBC: T TIBC = Iron+UIBC Interferences: 1. Hemolyzed specimen 2. Parenteral administration of iron dextran within the last month CPT Code: Calculation Section 2 General Test Listing Spectra Laboratories Directory of Services June

58 TOBRAMYCIN, PEAK Specimen Requirements: 1 full red no gel tube, REFRIGERATED serum, tube must be labeled Peak. Do not use gel barrier tube. Tobramycin is offered as peak, trough, or random test. Please mark requisition and tube(s) with appropriate designation. Label with date and time of last dose. Peak: drawn minutes after IM injection; 60 minutes after ending IV infusion or oral dose of Tobramycin Therapeutic Range: Peak: mcg/ml Specimen Stability: Refrigerated 3 days Alert Value: Peak: > 10.0 mcg/ml Methodology: Fluorescence Polarization Immunoassay (FPIA) TAT: 2-3 days Test Set-up: Mon-Sun CPT Code: TOBRAMYCIN, TROUGH Specimen Requirements: Therapeutic Range: Alert Value: Tube must be labeled Trough Trough: draw within 30 minutes of next scheduled dose (Refer to Tobramycin, Peak for other test information) Trough: < 2.0 mcg/ml Trough: > 4 mcg/ml TOBRAMYCIN, RANDOM (Refer to Tobramycin Peak for test information) Specimen Requirements: Tube must be labeled Random T TOTAL IRON BINDING CAPACITY (CALC) (See TIBC) TRANSFERRIN Other Requirements: Fasting specimen preferred Reference Range: mg/dl Specimen Stability: Transferrin cannot be added onto an existing sample Usage: 1. Evaluation of iron stores 2. Evaluation of nutritional status Methodology: Immunoturbidimetric CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

59 TRANSFERRIN SATURATION (CALC) Other Requirements: Calculated from serum Iron and UIBC Reference Range: 20-55% Usage: 1. Determination of iron deficiency 2. Provides a measure of the iron immediately available for erythropoiesis Methodology: Calculated from serum iron and UIBC: %Saturation = (Iron/(Iron + UIBC) x 100 Interferences: 1. Hemolysis 2. Iron dextran administration within 1 month prior to test CPT Code: Calculation TRIGLYCERIDES Other Requirements: 1. Fasting specimen preferred (fasting overnight hours) 2. Specimen should be obtained prior to heparin administration Reference Range: mg/dl Report Comments: <150 mg/dl - Normal mg/dl - Borderline High mg/dl - High 500 mg/dl - Very High Specimen Stability: Refrigerated 7 days Usage: 1. Evaluation of hyperlipidemia 2. Evaluation of risk factors in individuals with elevated cholesterol values Methodology: Enzymatic Interferences: Recent heparin administration may lead to falsely elevated results CPT Code: T TRIGLYCERIDES, POST Specimen Requirements: 0.5 ml plasma (Gold Post Tube) NOTE: Must be labeled POST (Refer to Triglycerides for test information) TSH (Refer to Thyroid Stimulating Hormone, 3rd Generation (TSH3) for test details) Section 2 General Test Listing Spectra Laboratories Directory of Services June

60 UIBC (Unsaturated Iron Binding Capacity) Reference Range: mcg/dl Specimen Stability: Refrigerated 7 days Usage: 1. Differential diagnosis anemia 2. Evaluation of iron status Methodology: Colorimetric Test Set-up: T-Sat CPT Code: UREA CLEARANCE, URINE (See a complete description of this test and its specimen requirements in this section for Urine Urea Clearance) UREA NITROGEN, SERUM (See BUN) UREA NITROGEN, URINE Specimen Requirements: 8.0 ml aliquot of a 24-hr. urine collection in a yellow conical tube Other Requirements: Total volume of urine required. INDICATE URINE ON TUBE Reference Range: g/24 hrs Specimen Stability: Refrigerated 7 days Usage: Determination of renal function and nitrogen balance Methodology: Enzymatic CPT Code: U Section 2 General Test Listing Spectra Laboratories Directory of Services June

61 URIC ACID Specimen Requirements: Other Requirements: Reference Range: Alert Value: Specimen Stability: Usage: 0.5 ml serum (SST Gel Tube) Fasting specimen preferred Males: mg/dl Females: mg/dl > 15.0 mg/dl Refrigerated 5 days Uric acid measurements are useful in the diagnosis and treatment of gout, renal failure, and a variety of other disorders including leukemia, psoriasis, starvation, and other wasting conditions. Patients receiving cytotoxic drugs may be monitored with uric acid measurements. Only a minority of individuals with hyperuricemia develop gout. An increased uric acid level does not necessarily translate to a diagnosis of gout. The therapeutic goal for uric acid-lowering therapy is to promote crystal dissolution and prevent crystal formation. This is achieved by maintaining a uric acid level of less than 6 mg/dl. Elevated uric acid: Elevations of uric acid occur with increased purine synthesis, inherited metabolic disorders, excess dietary purine intake, increased nucleic acid turnover, malignancy, cytotoxic drugs, decreased excretion due to chronic renal failure, and increased renal reabsorption. Drugs: Drugs causing increased uric acid concentration include diurectics, pyrazinamide, ethambutol, and nicotinic acid. Endocrine: Hypothyroidism, hypoparathyroidism, hyperparathyroidism, pseudohypoparathyroidism, diabetes insipidus of nephrogenic type, and Addison disease can cause uric acid elevation. Lead poisoning from paint, batteries, and moonshine can cause elevated uric acid. Toxemia of pregnancy, diet, weight loss, fasting, or starvation can elevate uric acid levels. Decreased uric acid: Drugs bearing a relationship to low serum uric acid levels include aspirin (high doses), x-ray contrast agents, glyceryl guaiacolate, allopurinol corticosteroids, and probenecid. Massive doses of vitamin C increase urine uric acid secretion, lowering serum uric acid. Poor dietary intake of purines and protein can decrease serum uric acid. Diabetes, Fanconi syndrome, Wilson s disease, cystinosis, galactosemia, hypophosphatemia, heavy metal poisoning, malignant neoplasms, hypereosinophilic syndrome, and Xanthinuria (deficiency of xanthine oxidase) can lower serum uric acid. Hypouricemia is reported with acute intermittent porphyria and severe liver disease (especially obstructive biliary disease). Isolated defects in the tubular transport of uric acid have been associated with increased renal clearance of urate, hyprouricemia, hypercalciuria, and decreased bone density. U Methodology: Colorimetric CPT Code: Section 2 General Test Listing Spectra Laboratories Directory of Services June

62 REVISED 3/2013 URINALYSIS - COMPLETE Specimen Requirements: Collect specimen in yellow conical tube Reference Range: Dipstick Microscopic Color: Yellow RBC: 0-5 Appearance: Clear WBC: 0-5 Specific Gravity: ph: 5.0 to 9.0 Epithelial: few Leukocyte estrase: Negative Bacteria: Negative Protein: Negative Casts: Negative Glucose: Negative Crystals: Negative Ketones: Negative Yeast: Negative Urobilinogen: 0 to 1.0 Bilirubin: Negative Blood: Negative Nitrate: Negative Specimen Stability: Refrigerated 2 days Usage: To screen for urine abnormalities; to manage renal disease, urinary tract infections and other diseases Methodology: TAT: Test Set-up: CPT Codes: Dipstick, visual, and microscopic 1 day M-Sun with microscopic without microscopic U REVISED 3/2013 URINALYSIS - ROUTINE Specimen Requirements: Reference Range: Usage: Collect specimen in yellow conical tube Dipstick Color: Yellow Appearance: Clear Specific Gravity: ph: 5.0 to 9.0 Leukocyte estrase: Negative Protein: Negative Glucose: Negative Ketones: Negative Urobilinogen: 0 to 1.0 Bilirubin: Negative Blood: Negative Nitrate: Negative To screen for urine abnormalities; to manage renal disease, urinary tract infections and other diseases Methodology: Dipstick and visual Test Set-up: M-Sun CPT Codes: URINE, RANDOM NEW _ For sodium, potassium, chloride, phosphorus and calcium Refer to individual tests for additional information Section 2 General Test Listing Spectra Laboratories Directory of Services June

63 URINE CREATININE CLEARANCE Specimen Requirements: Reference Range: Usage: Methodology: Interferences: TAT: Test Set-up: CPT Code: 0.5 ml serum (SST Gel Tube) and a sample of the 24 hr. urine collection, mixed well before obtaining yellow conical tube of urine. Ship only the yellow conical tube Male: ml/min Female: ml/min Diagnosis of renal function Enzymatic Gross hemolysis 1 day M-Sat Calculation URINE UREA CLEARANCE Specimen Requirements: Reference Range: Usage: Methodology: Interferences: TAT: Test Set-up: CPT Code: 0.5 ml serum (SST Gel Tube) and a sample of the 24 hr. urine collection, mixed well before obtaining yellow conical tube of urine. Ship only the yellow conical tube ml/min Diagnosis of renal function Enzymatic Gross hemolysis 1 day M-Sat Calculation URINE, PROTEIN TOTAL (See a complete description of this test under Protein, Total Urine) UREA REDUCTION RATIO (CALC) (URR) Specimen Requirements: 0.5 ml serum drawn pre-dialysis (SST Gel Tube) 0.5 ml plasma drawn post-dialysis (Gold Post Tube) Other Requirements: Calculated from pre and post-dialysis BUN values Reference Range: 65-80% Alert Value: < 60% Usage: Provides an indication of hemodialysis adequacy Methodology: The URR is calculated as follows: U URR (%) = 100 x (1- (Post-dialysis BUN/Pre-dialysis BUN)) TAT: Test Set-up: CPT Code: 1 day M-Sat Calculation Section 2 General Test Listing Spectra Laboratories Directory of Services June

64 REVISED 5/2013 VALPROIC ACID (Performed only at Spectra - Milpitas, CA) Specimen Requirements: 0.5 ml serum (Red No Gel Tube) Therapeutic Range: mcg/ml Alert Value: > 100 mcg/ml Usage: Monitors compliance, efficacy and possible toxicity Methodology: Chemiluminescence Interferences: Gross hemolysis CPT Code: REVISED 5/2013 VANCOMYCIN, PEAK Specimen Requirements: 0.5 ml serum (Red No Gel Tube). Tube must be labeled Peak. Peak is drawn minutes after IM injection or 60 minutes after IV infusion Therapeutic Range: Peak mcg/ml Alert Value: Peak > 80.0 mcg/ml Specimen Stability: Refrigerated 2 days Usage: Monitoring for compliance, efficacy and possible toxicity Methodology: Chemiluminescence Interferences: Gross hemolysis CPT Code: REVISED 5/2013 VANCOMYCIN, TROUGH Specimen Requirements: 0.5 ml serum (Red No Gel Tube). Trough drawn within 30 minutes of next scheduled dose. Tube must be labeled Trough Therapeutic Range: mcg/ml Alert Value: Trough > 15.0 mcg/ml (Refer to Vancomycin, Peak for other test information) V VANCOMYCIN, RANDOM (Refer to Vancomycin, Peak for additional test information) Specimen Requirements: Tube must be labeled Random Section 2 General Test Listing Spectra Laboratories Directory of Services June

65 VITAMIN B12 Other Requirements: Fasting specimen preferred Reference Range: pg/ml Specimen Stability: Refrigerated 2 days Usage: Diagnosis of excess or deficiency of Vitamin B12 Methodology: Chemiluminescence Interferences: Hemolyzed specimen TAT: 2 days CPT Code: VITAMIN D, 25-HYDROXYCALCIFEROL (Calciferol, 25 OH-D) Specimen Requirements: Other Requirements: Reference Range: Specimen Stability: Usage: 0.5 ml serum (SST Gel Tube) Fasting specimens are recommended, but not required ng/ml Refrigerated 2 days Vitamin D insufficiency and Vitamin D deficiency are recognized as significant causes of metabolic bone disease in older adults. Maintaining the concentration of calcium and phosphate within the normal range is the major role of Vitamin D. Vitamin D is required for proper bone health and helps reduce fractures in older adults. Vitamin D, 25 OH Status Classification: Deficiency: < 10 ng/ml Insufficiency: ng/ml Sufficiency: ng/ml Toxicity: > 100 ng/ml Methodology: Chemiluminescence Interferences: Hemolysis and lipemia TAT: 3 days Test Set-up: T-F CPT Code: V Section 2 General Test Listing Spectra Laboratories Directory of Services June

66 VLDL (CALC) (Very Low Density Lipoprotein) Other Requirements: 1. Fasting specimen preferred (fasting overnight hours) 2. Calculated from Triglyceride Reference Range: mg/dl Usage: Aids in the determination of abnormal distribution and/or concentration of lipoproteins Methodology: Calculation from Triglyceride: VLDL = Triglycerides/5 TAT: Test Set-up: CPT Code: This calculation is not valid for specimens with triglyceride levels > 400 mg/dl 1 day M-Sat Calculation WHITE BLOOD CELL COUNT (WBC, also included as part of a Complete Blood Count (CBC) (Hemogram)) Specimen Requirements: 1 full Lavender Top Tube (EDTA whole blood) NOTE: One tube is sufficient for all hematology tests Reference Range: thous/mcl Alert Value: < 2.0 or > 30.0 thous/mcl Usage: 1. Evaluation of the symptoms of infection 2. Aids in the diagnosis of immunosuppression Methodology: Flow Cytometry Interferences: 1. Hemolyzed specimen 2. Clotted specimen 3. Incompletely filled tube 4. Samples with nucleated RBCs may falsely elevate the WBC count CPT Code: V W Section 2 General Test Listing Spectra Laboratories Directory of Services June

67 WBC DIFFERENTIAL (Included as part of Complete Blood Count (CBC)) _ Specimen Requirements: 1 full Lavender Top Tube (EDTA whole blood) NOTE: One tube is sufficient for all hematology tests Reference Range: Neutrophils: % Lymphocytes: % Monocytes: % Eosinophils: % Basophils: % LUC: % Usage: 1. Aids in the diagnosis, classification and staging of infection 2. Aids in the diagnosis of immunosuppression Methodology: Flow Cytometry Interferences: 1. Hemolyzed specimen 2. Clotted specimen 3. Incompletely filled tube 4. Circulating micromegakaryocytes may be counted as white blood cells 5. Incomplete RBC lysis in the peroxidase channel may be observed in specimens with elevated serum urea nitrogen (BUN > 75 mg/dl) CPT Code: ZINC _ Specimen Requirements: 2.0 ml serum (Royal Blue Tube) Reference Range: mcg/dl for ICP, mcg/dl for AA Furnace Alert Value: > 200 mcg/dl Specimen Stability: Refrigerated 7 days Usage: Determination of zinc deficiency Methodology: Atomic Emission (ICP), Milpitas Lab & AA Furnace, Rockleigh Lab Interferences: Spectroscopy TAT: 5 days Test Set-up: W-Sat CPT Code: Section 1 - Introduction W Z Section 2 General Test Listing Spectra Laboratories Directory of Services June

68 Section 3 Microbiology Testing Services

69 A NOTE: Susceptibilities will be performed on all positive clinically significant cultures (except environmental tests) unless the laboratory is instructed to do otherwise, as indicated on the test order. REVISED 3/2013 ACID FAST (TB) CULTURE BLOOD - PERFORMED AT REFERENCE LAB (AFB Culture, Mycobacterial Culture, TB Culture) Specimen Requirements: Collect 7 ml whole blood specimen in Yellow SPS tube. Call Spectra to obtain Yellow SPS tube; Store/transport specimen at room temperature Reference Range: No Acid-Fast Bacilli recovered Usage: To isolate, identify, and determine Mycobacterium species Methodology: Broth-based culture, and smear TAT: 6-8 weeks before reported as negative Test Set-up: T-Sat CPT Code: REVISED 3/2013 ACID FAST (TB) CULTURE OTHER - PERFORMED AT REFERENCE LAB (AFB Culture, Mycobacterial Culture, TB Culture) Specimen Requirements: Collect specimen in sterile container and tighten screw cap securely. Keep specimen at refrigerated temperature Reference Range: No growth Usage: To isolate, identify, and determine antimicrobial sensitivity of Mycobacterium species Methodology: Culture TAT: 6-8 weeks before reported as negative Test Set-up: T-Sat CPT Code: ANAEROBIC CULTURE (Includes Gram Stain) Specimen Requirements: Collect specimen in a blue swab. Keep specimen at ambient temperature. Fluids require sterile container. Keep refrigerated; transport with ice packs. Also indicate source Reference Range: No anaerobes isolated Usage: To isolate, identify possible anaerobic pathogens in body fluid/aspirates or deep wounds Methodology: Culture TAT: 3 days; interim reports are issued each day Test Set-up: M-Sun CPT Code: Section 3 Microbiology Testing Services Spectra Laboratories Directory of Services June

70 REVISED 3/2013 BLOOD CULTURE B C Specimen Requirements: Two blood culture bottles Other Requirements: A blood culture consists of an aerobic and anaerobic bottle collected from the same source at the same time. Inoculate each bottle with at least 10 ml of blood. Gram stains will also be performed from positive cultures only. Also indicate source Reference Range: No aerobic or anaerobic growth after 5 days of incubation NOTE: Blood cultures for set 2 and/or set 3 are available so all results are sent to one patient report. Please ensure the proper label is on the sample bottles. Usage: To isolate, identify, and determine antimicrobial sensitivity. This aids in the diagnosis of suspected sepsis, fever of unknown origin (FUO), endocarditis, etc Methodology: Culture TAT: 5 days; interim reports are issued each day in addition to whenever cultures are positive Test Set-up: M-Sun CPT Code: BODY FLUID CULTURE (Includes Gram Stain) Specimen Requirements: Collect specimen in sterile container, orange top. Keep refrigerated; transport with ice packs. Also indicate source Reference Range: Negative Usage: To isolate, identify, and determine antimicrobial sensitivity of potential pathogens from a body fluid culture Methodology: Culture TAT: 3 days; interim reports are issued each day Test Set-up: M-Sun CPT Code: 87071, CATHETER EXIT SITE CULTURE (Includes Gram Stain) Specimen Requirements: Reference Range: Collect specimen in a blue swab. Keep specimen at ambient temperature Negative Usage: To isolate, identify, and determine antimicrobial sensitivity of potential pathogens from a catheter site Methodology: Culture TAT: 3 days; interim reports are issued each day Test Set-up: M-Sun CPT Code: Section 3 Microbiology Testing Services Spectra Laboratories Directory of Services June

71 C E CELL COUNT WITHOUT DIFFERENTIAL Specimen Requirements: Collect specimen in full Lavender Top Tube. Keep specimen at refrigerated temperature Reference Range: Description: Clear, Colorless WBC Count: 0-50/mm 3 Usage: Evaluation of PD Fluid for the presence of cellular elements and for physical appearance Methodology: Microscopic and macroscopic examination/hemocytometer counting chamber CPT Code: CELL COUNT WITH DIFFERENTIAL Specimen Requirements: Collect specimen in full lavender top tube. Keep specimen at refrigerated temperature Reference Range: Description: Clear, Colorless WBC Count: 0-50/mm 3 WBC differential: Mononuclear cells: % Polymorphonuclear cells: 0-25% Usage: Evaluation of PD Fluid for the presence of cellular elements, differential of WBC, and for physical appearance Methodology: Microscopic and macroscopic examination/ Hemocytometer counting chamber CPT Code: EAR CULTURE Specimen Requirements: Collect specimen in a blue swab. Keep specimen at ambient temperature Reference Range: Negative Usage: To isolate, identify, and determine antimicrobial sensitivity of potential pathogens from an ear site Methodology: Culture TAT: 2 days Test Set-up: M-Sun CPT Code: Section 3 Microbiology Testing Services Spectra Laboratories Directory of Services June

72 EYE CULTURE Specimen Requirements: Collect specimen in a blue swab. Keep specimen at ambient temperature Other Requirements: Gram stain included Reference Range: Negative Usage: To isolate, identify, and determine antimicrobial sensitivity of potential pathogens from an eye site Methodology: Culture TAT: 2 days Test Set-up: M-Sun CPT Code: E F FUNGAL (MYCOLOGY) CULTURE (Mold Culture, Yeast Culture) (Performed only at Spectra - Rockleigh, NJ) Specimen Requirements: Collect specimen in a blue swab. Keep specimen at ambient temperature, OR collect in a sterile container, orange top. Keep refrigerated; transport with ice packs. Also indicate source Reference Range: No Fungi isolated Usage: To isolate and identify fungus from a culture specimen Methodology: Culture TAT: 4 weeks; Interim reports will be issued at 48 hrs, 1 week, 2 weeks, 3 weeks, 4 weeks or whenever the cultures are positive Test Set-up: M-Sun CPT Code: or FUNGAL CULTURE (BLOOD ONLY) Specimen Requirements: This culture consists of an aerobic and anaerobic bottle collected from the same source at the same time. Inoculate each bottle with at least 10 ml of blood. Gram stains performed on positive cultures only. Also indicate source Reference Range: No Fungi isolated Usage: To isolate and identify fungus from a blood culture specimen Methodology: Culture TAT: 4 weeks; Interim reports will be issued at 48 hrs, 1 week, 2 weeks, 3 weeks, 4 weeks or whenever the cultures are positive Test Set-up: M-Sun CPT Code: Section 3 Microbiology Testing Services Spectra Laboratories Directory of Services June

73 GC (GONORRHEA) CULTURE (Culture for GC only, Gonorrhea Culture, JEMBEC Culture) G K Specimen Requirements: Collect specimen in a blue swab. Keep specimen at ambient temperature OR, collect in a sterile container, orange top. Keep refrigerated; transport with ice packs. Also indicate source Reference Range: Gonorrhea not recovered Usage: To isolate and identify gonorrhea from a culture specimen Methodology: Culture TAT: 2 days Test Set-up: M-Sun CPT Code: GENITAL CULTURE Specimen Requirements: Collect specimen in a blue swab. Keep specimen at ambient temperature Reference Range: Normal genital flora Usage: To isolate, identify, and determine sensitivity of potential pathogens from the genital area. Aids in the diagnosis of suspected genital infection (not gonorrhea) Methodology: Culture TAT: 2 days Test Set-up: M-Sun CPT Code: GRAM STAIN KOH PREP Specimen Requirements: Representative sample using a sterile swab. Keep specimen at ambient temperature, OR collect in a sterile container, orange top. Keep refrigerated; transport with ice packs. Also indicate source Reference Range: Dependent on source of specimen (See Patient s Report) Usage: Microscopic observation of stained microorganisms Methodology: Gram Stain Test Set-up: M-Sun CPT Code: (Fungal Smear, Potassium Hydroxide Prep) Specimen Requirements: Collect specimen in a blue swab. Keep specimen at ambient temperature, OR collect in a sterile container. Keep specimen at refrigerated temperature Reference Range: No fungal elements seen Usage: Microscopic observation of specimens to detect the presence of fungal elements Methodology: Potassium Hydroxide treatment of specimen Test Set-up: M-Sun CPT Code: Q0112 Section 3 Microbiology Testing Services Spectra Laboratories Directory of Services June

74 NASOPHARYNGEAL CULTURE (Nasal Culture, Upper Respiratory Culture) Specimen Requirements: Collect specimen in an orange swab. Keep specimen at ambient temperature Reference Range: Normal upper respiratory flora. Does not include gram stain Usage: To isolate, identify, and determine potential pathogens present in the nasopharynx Methodology: Culture and antimicrobial sensitivity TAT: 2 days Test Set-up: M-Sun CPT Code: N NASOPHARYNGEAL CULTURE - STAPHYLOCOCCUS (To rule out Staphylococcus aureus) See test above for specimen requirements and other information Usage: To isolate, identify, and determine the specific presence of Staphylococcus in the nasal cavity CPT Code: NASOPHARYNGEAL CULTURE - MRSA (To rule out MRSA) See test above for specimen requirements and other information Usage: To isolate, identify and determine the specific presence of Methicillin Resistant Staphylococcus aureus in the nasal cavity CPT Code: NASOPHARYNGEAL CULTURE - PSEUDOMONAS (To rule out Pseudomonas) See test above for specimen requirements and other information Usage: To isolate, identify and determine the specific presence of Pseudomonas in the nasal cavity CPT Code: Section 3 Microbiology Testing Services Spectra Laboratories Directory of Services June

75 O S REVISED 3/2013 OCCULT BLOOD - STOOL (Guaiac Test) Specimen Requirements: Place stool sample on the Occult Blood Card. After collecting the specimen in a clean dry container, transfer a small portion to the Occult Blood Card before transporting to the laboratory. Each Occult blood specimen must have its own accession number Reference Range: Negative Usage: To detect hidden blood in stool or gastrointestinal bleeding Methodology: Guaiac Test Test Set-up: M-Sun CPT Code: PERITONEAL DIALYSIS FLUID CULTURE (PDF Culture) _ Specimen Requirements: Two blood culture bottles and yellow conical tube for gram stain Other Requirements: A culture consists of an aerobic and anaerobic bottle collect at the same time. Inoculate each bottle with at least 10 ml of PDF. Gram stains performed on positive cultures only Reference Range: No aerobic or anaerobic growth after 5 days of incubation Usage: To isolate, identify, and determine antimicrobial sensitivity in PDF; aids in the diagnosis of suspected peritonitis Methodology: Culture TAT: 5 days; interim reports are issued each day in addition to whenever cultures are positive Test Set-up: M-Sun CPT Code: 87070, SPUTUM CULTURE (Lower Respiratory Culture: Includes Gram Stain) _ Specimen Requirements: Collect specimen in sterile container, orange top. Keep refrigerated; transport with ice packs. Also indicate source Reference Range: Negative Usage: To isolate, identify, and determine antimicrobial sensitivity of potential pathogens in the lower respiratory tract Methodology: Culture TAT: 2 days; interim reports are issued whenever cultures are positive Test Set-up: M-Sun CPT Code: Section 3 Microbiology Testing Services Spectra Laboratories Directory of Services June

76 STOOL FOR CLOSTRIDIUM DIFFICILE ANTIGEN, TOXIN A AND TOXIN B (Antibiotic-Associated Colitis Toxin Test, Pseudomembranous Colitis Toxin Assay) _ Specimen Requirements: Collect 1 gram (1/2 teaspoon) of stool in sterile container, orange top. Freeze specimen Reference Range: Negative Usage: Detection of Clostridium Difficile toxin A and B in a stool sample. Aids in the diagnosis of suspected C. difficile antibiotic associated colitis Methodology: Rapid Membrane Enzyme Immunoassay TAT: 2 days Test Set-up: T-Sat CPT Code: STOOL CULTURE (Enteric Culture, Feces Culture) _ Specimen Requirements: Collect stool in sterile container, orange top. Keep specimen at refrigerated temperature Reference Range: No Shigella, Salmonella, Campylobacter, Aeromonas, Plesiomonas & E. coli 0157 isolated Usage: To isolate, identify, and determine antimicrobial sensitivity of pathogenic bacteria in the stool and/ or diagnosis of Shigella, Salmonella, Campylobacter, Aeromonas, Plesiomonas & E. coli 0157 infection Methodology: Culture and antimicrobial sensitivity TAT: 2 days Test Set-up: M-Sun CPT Code: 87045, S STOOL LACTOFERRIN (FECAL LEUKOCYTES) REVISED (Fecal Leukocyte Stain) 3/2013 _ Specimen Requirements: Collect 1 gram of stool in sterile container, orange top. Keep specimen at refrigerated temperature and transport specimen cool Reference Range: Negative Usage: An immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator for intestinal inflammation Methodology: Microscopic exam Test Set-up: M-Sun CPT Code: Section 3 Microbiology Testing Services Spectra Laboratories Directory of Services June

77 THROAT CULTURE (Strep Culture) _ Specimen Requirements: Collect specimen in a blue swab. Keep specimen at ambient temperature. Does not include gram stain Reference Range: Normal throat flora Usage: To isolate and identify potential pathogens (primarily Beta-Hemolytic Streptococcus) in throat Methodology: To isolate and identify potential pathogens in the throat TAT: 2 days Test Set-up: M-Sun CPT Code: T THROAT CULTURE - BETA STREP SCREEN _ Specimen Requirements: Collect specimen in a blue swab. Keep specimen at ambient temperature Reference Range: No Beta Strep Isolated Usage: To isolate and identify Beta-Hemolytic Streptococcus in throat Methodology: Culture TAT: 2 days Test Set-up: M-Sun CPT Code: Section 3 Microbiology Testing Services Spectra Laboratories Directory of Services June

78 REVISED 3/2013 URINALYSIS - COMPLETE Specimen Requirements: Collect specimen in yellow conical tube. Keep specimen at refrigerated temperature. Reference Range: Dipstick Microscopic Color: Yellow RBC: 0-2 Appearance: Clear WBC: 0-2 Specific Gravity: ph: to 9.0 Epithelial: few Leukocyte estrase: Negative Bacteria: None Seen Protein: Negative Casts: None Seen Glucose: Negative Crystals: None Seen Ketones: Negative Yeast: None Seen Urobilinogen: 0.2 to 1.0 Bilirubin: Negative Blood: Negative Nitrate: Negative Specimen Stability: Refrigerated 2 days Usage: To screen for urine abnormalities; to manage renal disease, urinary tract infections and other diseases Methodology: Dipstick, visual, and microscopic Test Set-up: M-Sun CPT Codes: U REVISED 3/2013 URINALYSIS - ROUTINE Specimen Requirements: Collect specimen in yellow conical tube Reference Range: Dipstick Color: Yellow Appearance: Clear Specific Gravity: ph: 5.0 to 9.0 Leukocyte estrase: Negative Protein: Negative Glucose: Negative Ketones: Negative Urobilinogen: 0.2 to 1.0 Bilirubin: Negative Blood: Negative Nitrate: Negative Usage: To screen for urine abnormalities; to manage renal disease, urinary tract infections and other diseases Methodology: Dipstick and visual Test Set-up: M-Sun CPT Codes: Section 3 Microbiology Testing Services Spectra Laboratories Directory of Services June

79 URINE CULTURE AND COLONY COUNT Specimen Requirements: Collect specimen in a urine grey top tube. Collect urine using the Urine Collection and Transport Kit # Transfer specimen to the grey top tube provided in the kit. Only submit the grey top tube to the laboratory Reference Range: No growth Usage: To isolate, identify and determine antimicrobial sensitivity of potential pathogens from a urine specimen Methodology: Culture, aerobic and anaerobic cultures TAT: 2 days Test Set-up: M-Sun CPT Code: VANCOMYCIN RESISTANT ENTEROCOCCUS SCREEN (VRE Screen) U W Specimen Requirements: Collect specimen in a blue swab. Keep specimen at ambient temperature. Indicate source Reference Range: No VRE isolated Usage: To isolate, and identify Vancomycin resistance Enterococcus from various sites Methodology: Culture TAT: 2 days Test Set-up: M-Sun CPT Code: WOUND CULTURE (Includes Gram Stain) Specimen Requirements: Collect specimen in a blue swab. Keep specimen at ambient temperature. Indicate source Reference Range: No pathogens isolated Usage: To isolate, identify and determine antimicrobial sensitivity of potential pathogens from a wound site Methodology: Culture, aerobic and anaerobic TAT: 3 days; interim reports are issued each day Test Set-up: M-Sun CPT Code: 87071, Section 3 Microbiology Testing Services Spectra Laboratories Directory of Services June

80 Listing of Antibiotic Susceptibilities Performed If a susceptibility is included in the test listing, the following antibiotic susceptibilities will be performed and reported for the indicated organism unless otherwise indicated. Upon request Spectra Laboratories will provide susceptibilities in addition to those listed. GRAM POSITIVE ORGANISMS Staphylococcus- All sites except urine a. Ampicillin/Sulbactam a. Ampicillin * b. Cefazolin b. Levofloxacin c. Chloramphenicol c. Linezolid d. Clindamycin d. Penicillin Enterococcus sp - All sites except urine e. Erythromycin e. Quinupristin/Dalfopristin f. Gatifloxacin f. Tetracycline g. Gentamicin g. Vancomycin* h. Levofloxacin *Combination therapy with an aminoglycoside i. Linezolid may be necessary in cases of endocarditis j. Moxifloxacin k. Oxacillin l. Pencilin m. Quinupristin/Dalfopristin n. Rifampin o. Tetracycline p. Trimeth-Sulfa q. Vancomycin Staphylococcus- Urine only Antibiotics a through q above plus: Enterococcus sp- Urine only Antibiotics a through d above plus: r. Nitrofurantoin h. Nitrofurantoin Section 3 Microbiology Testing Services Spectra Laboratories Directory of Services June

81 Listing of Antibiotic Susceptibilities Performed GRAM POSITIVE ORGANISMS (cont d) S. Pneumoniae - All sites (performed at Rockleigh only) a. Pencillin (oxacillin disk screen test) Streptococcus (not Enterococcus sp. or S pneumoniae) Sterile sites only (performed at Rockleigh only) Beta Hemolytic Streptococcus Group B (performed at Rockleigh only) a. Azithromycin a. Ampicillin b. Cefepime b. Cefepime c. Cefotaxime c. Cefotaxime d. Ceftriaxone d. Ceftriaxone e. Clindamycin e. Clindamycin f. Erythromycin f. Erythromycin g. Gatifloxacin g. Gatifloxacin h. Levofloxacin h. Levofloxacin i. Ofloxacin i. Linezolid j. Quinupristin/Dalfopristin j. Penicillin k. Linezolid k. Quinpristin/Dalfopristin l. Vancomycin l. Tetracycline m. Vancomycin Section 3 Microbiology Testing Services Spectra Laboratories Directory of Services June

82 Listing of Antibiotic Susceptibilities Performed GRAM NEGATIVE ORGANISMS Gram Negative Bacilli- All sites except urine Gram Negative Bacilli- Urine only a. Amikacin k. Cefuroxime b. Ampicillin l. Ciprofloxacin c. Ampicillin/Sulbactam m. Gentamicin d. Aztreonam n. Imipenem e. Cefzazolin o. Levofloxacin f. Cefepime p. Piperacillin g. Cefotetan q. Piperacillin/Tazobactam h. Ceftazidime r. Ticarcillin/Clavulanic Acid i. Ceftriaxone s. Tobramycin j. Trimethoprim/Sulfamethoxazole Stenotrophomonas maltophilia- All sites a. Ceftazidime b. Chloramphenicol (not for urine) c. Levofloxacin d. Ticarcillin/Clavulanic Acid e. Trimethoprim/Sulfamethoxazole Section 3 Microbiology Testing Services Spectra Laboratories Directory of Services June

83 Section 4 Peritoneal Dialysis Testing Services

84 Section 4 - Peritoneal Dialysis Testing Services Spectra Laboratories provides comprehensive laboratory testing services for the care of peritoneal dialysis patients. We have incorporated the most advanced and widely accepted clinical approaches for evaluating the appropriateness and adequacy of peritoneal dialysis therapy. Our peritoneal dialysis testing services include: 1. Peritoneal Dialysate Fluid (PDF) Sample Testing 2. Peritoneal Equilibrium Test (PET) Sample Testing and Transport Classification 3. Peritoneal Dialysis Adequacy Sample Testing and Calculations 4. Peritoneal Function Test (PFT) 5. Microbiology Testing for Suspected Peritonitis NOTE: All PDF Creatinine results are corrected for glucose interference. The Creatinine correction factor for glucose is Turnaround Time and Test Set-Up Days The following chart summarizes the turnaround time (TAT) for peritoneal dialysis tests performed at Spectra, along with the days a test is set up. NOTE: Turnaround times listed are from the time the specimen is received at Spectra. Keep in mind that actual turnaround times may be longer than the listed time if a specimen is received on a day that a test is not set up. For example, the turnaround time for a specimen received on a Saturday may be three days longer than the time listed if the test is set up Tuesday through Friday. Test Name Set-Up Days TAT PD Adequacy (Adult) M-Sat 2 days PD Adequacy (Child <18 yrs old) M-Sat 2 days PET Standard M-Sat 2 days PET Standard with Urea M-Sat 2 days PET Standard with Total Protein M-Sat 2 days PET Standard with Sodium M-Sat 2 days PET Fast (4 hr) M-Sat 2 days PET Fast (4 hr) with Urea M-Sat 2 days PFT Panel M-Sat 2 days PDF, Protein Total (See a complete description of this test in Section 2 for Protein, Total Urine, Fluid) Section 4 Peritoneal Dialysis Testing Services Spectra Laboratories Directory of Services June

85 Section 4 - Peritoneal Dialysis Testing Services PERITONEAL EQUILIBRATION TEST (PET) Spectra Laboratories offers both Standard and Fast PET testing, calculations, and interpretation. The Standard PET requires four specimens (0 hr PDF, 2 hr PDF, 4 hr PDF, and one serum specimen). The Fast PET requires two specimens (4 hr PDF and one serum specimen). Fast PET data can be used if there are missing or poorly collected specimens for the 0 and 2 hour time points, or if it is inconvenient for the patient to be at the clinic for the entire four hours of the procedure. PET Requirements: Standard PET Serum Glucose and Creatinine at 2 hours (SST Gel Tube) Dialysate Glucose and Creatinine at 0, 2, 4, hours (Yellow Conical Tubes labeled 0, 2, & 4 hours) Standard PET with Urea Same as above plus Serum Urea at 2 hours (SST Gel Tube) Same as Standard PET plus Dialysate Urea on 0, 2, & 4 hr specimens Standard PET with Total Protein Same as above plus Serum Total Protein at 2 hours (SST Gel Tube) Same as Standard PET plus Dialysate Total Protein at 0, 2, & 4 hr specimens Standard PET with Sodium Same as Standard PET plus Serum Sodium at 2 hours (SST Gel Tube) Same as Standard PET plus Dialysate Sodium at 0, 2, & 4 hr specimens FAST PET Serum Glucose and Creatinine at 4 hours (SST Gel Tube) Dialysate Glucose and Creatinine at 4 hours (Yellow Conical Tube labeled 4 hours) STEPS FOR PERFORMING PET Step 1: Step 2: Step 3: Step 4: Step 5: Step 6: Step 7: Step 8: Step 9: Step 10: 8-12 hours overnight 2 L, 2.5% dextrose dwell. Prepare 2 L, 2.5 % dextrose solution. Drain overnight dwell. If submitting sample, collect 8.5 ml PD Fluid in yellow conical tube. Label Timed PD Fluid Infuse fresh solution. 400 ml per 2 minutes. Note 0 hour dwell. Collect 8.5 ml PD Fluid in yellow conical tube at 0 hour dwell time. Label PD Fluid 0 hr Collect 8.5 ml PD Fluid in yellow conical tube at 2 hour dwell time. Label PD Fluid 2 hr Collect and spin SST at 2 hour dwell time. Drain exchange at 4 hour dwell time. Record volume. Collect 8.5 ml PD Fluid in yellow conical tube from 4 hour dwell. Label PD Fluid 4 hr Refrigerate and ship samples. Section 4 Peritoneal Dialysis Testing Services Spectra Laboratories Directory of Services June

86 Section 4 - Peritoneal Dialysis Testing Services STANDARD PET CALCULATIONS Step 1: 2 hr D/DO = 2 hr Peritoneal Dialysate Glucose 0 hr Peritoneal Dialysate Glucose 4 hr D/DO = 4 hr Peritoneal Dialysate Glucose 0 hr Peritoneal Dialysate Glucose Step 2: This determines Glucose Transport Classification 2 hr D/P= 2 hr Peritoneal Dialysate Creatinine Serum Creatinine 4 hr D/P= 4 hr Peritoneal Dialysate Creatinine Serum Creatinine This determines Creatinine Transport Classification Step 3: Additional Patient Solute Transport Classification information may be obtained by plotting the post PET drain volume. FAST PET CALCULATIONS Step 1: Plot 4 hr Peritoneal Dialysate Glucose to determine Glucose Transport Classification 4 hr D/P= 4 hr Peritoneal Dialysate Fluid Creatinine Serum Creatinine This determines Creatinine Transport Classification Step 2: Additional Patient Solute Transport may be obtained by plotting the Post PET Drain Volume. If all points plotted fall within the same range (within two adjacent classification categories, typically on either side of the dividing line), the test results are considered to be consistent and the actual Patient Solute Transport Classification probably falls between the reported Glucose and Creatinine Transport Classifications. If all points plotted do not fall within the same range, the test results are considered to be inconsistent. If the patient s clinical condition does not correlate with the Glucose and Creatinine Solute Transport Classifications, a repeat PET may be advisable. Section 4 Peritoneal Dialysis Testing Services Spectra Laboratories Directory of Services June

87 Section 4 - Peritoneal Dialysis Testing Services ADEQUACY OF DIALYSIS Monitoring Kt/V and Protein Catabolic Rate/Protein Nitrogen Appearance (PNA) has become widespread due to the growing body of research that indicates that they are the best indicators developed for PD Adequacy evaluation. Spectra s comprehensive Adequacy of Dialysis includes the testing and calculations needed to provide PD Fluid and Urine Clearance, Kt/V, and npcr (npna) for both adults and children. PNA estimates the patient s dietary protein intake by measuring the rate at which protein byproducts are removed from the blood. npna calculating patient s ideal body weight. Spectra Laboratories performs all laboratory tests and calculations, and provides reports containing the data, calculations, and final results. Adult Adequacy (Hume & Weyers Formula) includes: 1. Urea Clearance (PD) PD Volume and Collection Time 2. Measured Creatinine Clearance (PD) (See #3 for requirements) 3. Kt/V Measure PD Dialysate Total Volume Dialysate Total Time Urine Total Volume Urine Total Time Height and Weight of the Patient Amputee Status (if appropriate) Pediatric Adequacy (Mellits-Cheek Formula) includes: 1. Same information as for Adult Adequacy (see above) Specimen Requirements: Creatinine and Urea Nitrogen Serum (SST Gel Tube) Creatinine and Urea Clearances PD Creatinine, Urea, and Glucose 24 hr PD Fluid (yellow conical tube) with Total Volume recorded Creatinine and Urea Clearance Urine Creatinine and Urea Urine timed (hr) collection (yellow conical tube) with Total Volume recorded Kt/V Measured PD for Adult and Children includes: PNA, npna, PD Creatinine and Urine Clearances, weekly calculations, PD Fluid Kt/V, Urine Kt/V if urine is provided, Urea Volume, and Total Kt/V. To perform calculations, all tubes must be provided. All patient data (height, weight, and amputee status) and specimen volumes and collection times are necessary. Section 4 Peritoneal Dialysis Testing Services Spectra Laboratories Directory of Services June

88 CALCULATIONS Section 4 - Peritoneal Dialysis Testing Services REVISED 3/ Urine Creatinine Clearance: Timed Urine Creatinine (mg/dl) x Timed Urine Volume (ml) = Urine Creatinine Clearance (ml/min) Serum Creatinine (mg/dl) Urine Collection Time (min) 2. Urine Urea Clearance: Timed Urine Urea Nitrogen (mg/dl) x Time Urine Volume (ml) = Urine Urea Clearance (ml/min) Serum Urea Nitrogen (mg/dl) Urine Collection Time (min) 3. PD Fluid Creatinine Clearance: Timed PD Fluid Creat. (mg/dl) x Timed PD Fluid Volume (ml) = PD Fluid Creatinine Clearance (ml/min) Serum Creatinine (mg/dl) PD Fluid Collection Time (min) NOTE: Clearances are normalized to patient s body surface area. PDF Creatinine Corrected For Glucose Normalized Clearance (ml/min) = Clearance x (1.73 m 2 / Patient s Body Surface Area) NOTE: Body Surface Area (BSA) calculation (DeBois & DeBois): ( WT) *(HT) WT is the weight in kg HT is the ht in cm 4. PD Fluid Urea Clearance: Time PD Fluid Urea (mg/dl) x Timed PD Fluid Volume (ml) = PD Fluid Urea Clearance (ml/min) Plasma Urea (mg/dl) PD Fluid Collection Time (min) 5. Weekly Urine Creatinine Clearance: Urine Creatinine Clearance x 10,080 min/week = Weekly Urine Creatinine Clearance (L/week) 1,000 ml 6. Weekly PD Fluid Creatinine Clearance: PD Fluid Creatinine Clearance x 10,080 min/week = Weekly PD Fluid Creatinine Clearance (L/week) 1,000 ml 7. Weekly Urine Urea Clearance: Urine Urea Clearance x 10,080 min/week = Weekly Urine Urea Clearance (L/week) 1,000 ml 8. Total Weekly Creatinine Clearance: Weekly Urine Creatinine Clearance (L/week) + Weekly PD Fluid Creatinine Clearance (L/week) = Total Weekly Creatinine Clearance (L/week) 9. Total Weekly Urea Clearance: Weekly Urine Urea Clearance (L/week) + Weekly PD Fluid Urea Clearance (L/week) = Total Weekly Urea Clearance (L/week) 10. Urea Volume Distribution Adult Male: Urea Volume (L) = [ x Wt (kg) + ( x Ht (cm)] 11. Urea Volume Distribution Adult Female: Urea Volume (L) = [ x Wt (kg) + ( x Ht (cm)] Section 4 Peritoneal Dialysis Testing Services Spectra Laboratories Directory of Services June

89 Section 4 - Peritoneal Dialysis Testing Services 12. Urea Volume Distribution Pediatric Female: Urea Volume (L) = x Wt (kg) x Ht (cm) when Ht < cm = x Wt (kg) x Ht (cm) when Ht > cm 13. Urea Volume Distribution Pediatric Male: Urea Volume (L) = x Wt (kg) Ht (cm) when Ht < cm = x Wt (kg) x Ht (cm) when Ht > cm 14. Kt/V: Kt/V (per week) = Total Weekly Urea Nitrogen Clearance (L/Week) / Urea Volume 15. PNA and npna: Urea Generation Rate (UGR) = 0.01 x [ (PDF vol (ml) x PDF Urea Nitrogen (mg/dl) ] + [Urine Vol (ml) x Urine Urea Nitrogen (mg/dl)] [PD Collection Time (min) ] [Urine Collection Time (min)] PNA (g/day) = x 0.01 x UGR +1.46) PNA (g/kg/day) = PNA/Weight npna = [PNA (g/day) / (Ideal Weight) ] Ideal Weight = Urea Volume Distribution/0.58 PERITONEAL FUNCTION TEST (PFT) The Peritoneal Function Test (PFT) measures the peritoneal mass transfer area coefficient during routine exchanges instead of under highly controlled conditions required for the PET. In addition to peritoneal transport and fluid balance, this test allows the clinician to access the total delivered dose for Urea and Creatinine and collect information on protein and calorie nutrition. The PFT requires: 1. A sampling of each exchange 2. A written record of each exchange 3. Inflow and outflow volume and glucose concentration 4. Duration of dwell for each exchange in the 24 hours before a clinic visit 5. A urine collection and blood sample at the end of the collection 6. An exchange drained in the clinic at the time of the visit (QA sample) as a control Specimen Requirements: 1. 1 to 5 PDF samples in yellow conical tubes Tests required: Urea Nitrogen, Creatinine, Glucose, and Protein 2. Time Urine in yellow conical tube Tests required: Urea Nitrogen, Creatinine 3. Serum (SST Gel Tube) Tests required: BUN, Creatinine, Glucose, Protein, and Albumin Section 4 Peritoneal Dialysis Testing Services Spectra Laboratories Directory of Services June

90 Section 4 - Peritoneal Dialysis Testing Services Data Needed: 1. Collection Time for each PDF specimen 2. Volume in each PDF specimen (inflow volume) 3. Volume out for each PDF specimen (outflow volume) 4. Urine Collection Time, 24 hours 5. Urine Volume Procedure for PFT On the day of the PFT: The overnight exchange is discarded. All exchanges for the next 24 hours are collected. The exchange schedule would look like the following: 1. Overnight exchange completed and discarded. All other exchanges during the next 24 hours are collected noon exchange. This becomes bag #1. Record the following information: Drain Time Begins Fill Time Begins Solution Percentage Outflow Volume 3. The third exchange is performed and recorded as bag #2. 4. The fourth exchange is performed and recorded as bag #3. 5. The overnight exchange which is drained the next am is bag #4. (If 5 exchanges are done in the 24 hours, the times and bag numbers would reflect the additional exchange). 6. The morning exchange that is done will be drained in the clinic by the nurse and is labeled as the Quality Assurance (QA) exchange. This exchange should occur 2 to 4 hours after the morning drain. 7. All dialysate bags and urine collection should be measured for volumes and samples should be correctly labeled and recorded. Section 4 Peritoneal Dialysis Testing Services Spectra Laboratories Directory of Services June

91 Section 4 - Peritoneal Dialysis Testing Services NOTE: No calculations will be performed for PFT. Only raw data will be reported. See Collection and Data Worksheet below: BASELINE PERITONEAL FUNCTION TEST SPECIMEN COLLECTION AND DATA WORKSHEET Patient DOB Date M or F Clinic Physician Exchanges on Day of Test Drain Time Begins Fill Time Begins Solution % Outflow Volume Refrigerate all saved outflow bags #1 From overnight exchange Throw this drain bag out #2 From exchange #1 Save outflow and label as #1 #3 From exchange #2 Save outflow and label as #2 #4 From exchange #3 Save outflow and label as #3 #5 (If doing 5/day) From exchange #4 Save outflow and label as #4 (If doing 5/day) Next Morning #1 From exchange #4 or 5 Save outflow and label as #4 (If doing 4/day or #5 if doing 5) #2 or QA Come to CAPD Unit to do second exchange of the day. 24 hour Urine Collection: Start Date: Time: End Date: Time: Weight (lb/kg) Height Exchange Schedule Laboratory Results Volume IN (L) Dex. (%) Time (hrs) Urea N (mg/dl) Creat. (mg/dl) Gluc. (mg/dl) Prot. (g/dl) Volume outflow (ml) URINE SAMPLE SERUM SAMPLE QA EXCHANGE BAG 1 BAG 2 BAG 3 BAG 4 BAG 5 Serum Albumin (g/dl) All rights reserved. Fresenius USA, Inc Rev. B 8/ Shadelands Dr. Walnut Creek, CA (800) Section 4 Peritoneal Dialysis Testing Services Spectra Laboratories Directory of Services June

92 Section 4 - Peritoneal Dialysis Testing Services Section 4 Peritoneal Dialysis Testing Services Spectra Laboratories Directory of Services June