Test Bulletin. Rapid Influenza A+B Testing Implementation

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1 Test Bulletin Effective December March 1, Rapid Influenza A+B Testing Implementation Effective Monday, December 12, 2016, ACL Laboratories will begin on-site Rapid Influenza A & B Antigen Testing (Test FLUAG) utilizing the Quidel Sofia Influenza A+B fluorescent immunoassay at the Aurora Health Centers listed below. Grafton, Washington St. Good Hope Road Mayfair North New Berlin Menomonee Falls Brookfield Franklin, 9200 W. Loomis Rd. Kenosha 22nd Ave Zion Results will be available within minutes of specimen receipt in the laboratory and will be reported in Epic as Influenza, Rapid A/B. Nasopharyngeal (NP) and nasal swabs are acceptable specimen sources as well as nasal washes and nasal aspirates. However, nasal swabs are 5-10% less sensitive than the other specimen sources. These specimens should be collected within the patient care areas. Preferred Specimen Type for this testing: Nasopharyngeal swab Nasopharyngeal swab provided in UTM collection kit transferred to 3.0 ml UTM. Additional acceptable Specimen Types for this testing include: 1. Nasopharyngeal swab Mini-tip transfer to 3.0 ml UTM, 1.0 ml UTM or 1.0 ml saline recommended if testing will not be performed within one hour of collection. 2. Nasal swab Must use swab provided in the kit transfer to 3.0 ml UTM, 1.0 ml UTM or 1.0 ml saline recommended if testing will not be performed within one hour of collection. 3. Nasopharyngeal Aspirate/Wash Sample Transfer to 3.0 ml UTM, 1.0 ml UTM or 1.0 ml saline recommended if testing will not be performed within 1 hour of collection. ESwabs are unacceptable collections for this testing. Consult ACL Laboratories Directory of Services for further specimen collection and transport information ( There have been several publications comparing the results of the Sofia Influenza A+B Antigen assay to Reverse Transcription-Polymerase Chain Reaction (RT-PCR) testing. The Sofia assay can be completed much faster and more cost effectively than most RT-PCR assays and demonstrates an average sensitivity of approximately 80% and an average specificity of >95% compared to RT-PCR. Weekly comparisons of the Sofia Influenza antigen test with RT-PCR results for ACL are published on ACL Laboratories website ( For additional information on the Influenza collection process and testing, visit ACL Laboratories Directory of Services at

2 New Test s Test Description Test New Test Specimen Type Preferred Volume Tube Type Temperature to Transport Notes/Comments Barbiturates, Quantitative REF754 BARBQT Plasma 3.5 ml Gray (Sodium Fluoride) Refrigerated HNK1 (CD57) Profile REF536 CD57 Whole Blood Fill Tubes to Capacity Lavender (EDTA) and Yellow-Top (ACD-A or ACD B) Ambient Penta Maternal Screen REF381 PENTA Serum 4.0 ml Gold Gel Ambient Zinc, RBC REF675 ZNRBC Packed Red Blood Cells 2.0 ml Royal Blue (EDTA) Refrigerated Separate cells within 2 hours of collection. Transport 2.0 ml RBCs in the original collection tube. Transforming Growth Factor Beta, Plasma No Code TGFBPL Plasma 1.0 ml Green (Lithium Heparin) Frozen Transforming Growth Factor Beta, Serum Tick ID with Reflex to Borrelia species by PCR (Lyme Disease) Clozapine and Metabolite, Serum or Plasma, Quantitative Bacterial Overgrowth of the Small Intestine No Code TGFBSE Serum 1.0 ml Gold Gel Frozen REF620 TICKID Full intact tick, dead in 70% Ethanol NA REF492 CLOZAP Serum 1.0 ml Sterile Container Ambient Plain Red (No Additive) Refrigerated REF743 BOSI KIT KIT KIT Ambient If Tick Identification is positive, than Borrelia species by PCR (Test Order Code BORDNA) reflex test will be added. Additional charges apply. Kits are available from ACL Materials Management. JAK2 V617F Mutation, Qualitative with Reflex to Exons 12 and 13 Leumeta No Code JAK2R Whole Blood 3.0 ml Lavender (EDTA) Refrigerated Salivary Cortisol SCORT CORSAL Saliva Not Applicable Saturated Swab to Plain (noncitric acid) cotton Salivette Collection Device Refrigerated Specimen collection guidelines are to transfer the saturated swab to plain (non-citric acid) cotton Salivette collection device (available from ACL Materials Management). Specimens not collected using the Salivette collection device will be rejected. Record the time of collection on the test request form and on the Salivette transport container. 2

3 Test Description Test New Test Specimen Type Preferred Volume Tube Type Temperature to Transport Notes/Comments Striated Muscle Antibody Testosterone Free and Total (Includes Sex Hormone Binding Globulin), Female and Child Testosterone, Bioavailable and Sex Hormone Binding Globulin (includes Total Testosterone), Female and Child SKELS ASMAR Serum 1.0 ml Gold Gel Refrigerated TSTFTF TSTFFR Serum 1.0 ml Gold Gel Refrigerated TSTBSF TSSHFR Serum 1.0 ml Gold Gel Refrigerated Required for the ACHE Receptor AB Reflex Panel and Striated Muscle AB, IgG with Reflex to Titer (Test MGPNLR). The test will now be performed at ARUP Laboratory. The test will now be performed at ARUP Laboratory. Testosterone, Female and Child Testosterone Free, Female and Child TESTTW TESTFR Serum 1.0 ml Gold Gel Refrigerated TSTFF TSFFR Serum 1.0 ml Gold Gel Refrigerated The test will now be performed at ARUP Laboratory. The test will now be performed at ARUP Laboratory. Spinal Muscular Atrophy (SMA) SMACAR REF762 Whole Blood 3.0 ml Lavender Refrigerated This test is no longer offered at ARUP Laboratories. A miscellaneous test order code must be ordered for this test. Streptozyme with Reflex to Titer (Test STRPTO) Effective Wednesday, December, 14, 2016, when Streptozyme with Reflex to Titer (Test STRPTO) is positive, then Streptozyme Titer (Test STRPTT) reflex will be added. Additional charges will apply. ACL Laboratories Offers Gastrointestinal Parasites Panel by PCR (Test GPARPN) Effective Wednesday, December 14, 2016, ACL Laboratories will offer a new multiplex assay Gastrointestinal Parasites Panel by PCR (Test GPARPN). This new assay is based on FDA approved reagents from Luminex and is validated on stool samples with minimum volume 500uL of sample. Gastrointestinal Parasites Panel by PCR is designed to detect most common gastrointestinal parasites such as Cryptosporidium spp, Giardia lamblia and Entamoeba histolytica. Gastrointestinal Parasites Panel by PCR (Test GPARPN) will replace Test s: GIACSC, GIAEIA, and ENTEIA. For additional information regarding this assay, visit ACL Laboratories Directory of Services at 3

4 ACL Laboratories Test Code Update In an ongoing effort to deliver quality patient care in a timely manner, ACL Laboratories has identified several tests that will be performed onsite instead of being performed by a reference laboratory. In addition, improvements are being implemented with some tests, including updated algorithms, simplified ordering with panel codes and updated reference ranges. Below is a listing of new test order codes which will be effective Wednesday, December 14, If you need further information, please refer to ACL Laboratories Directory of Services at Test Description Test New Test Comment Specimen Collection Adrenocorticotropic Hormone ACTH ACT This test is a two-site sequential chemiluminescent immunometric assay used in the diagnosis of Cushing's syndrome, adrenal insufficiency, and congenital adrenal hyperplasia. It is also important in the differential diagnosis of these diseases. Collect: One lavender (EDTA) 3.0 ml on ice and immediately spin in a refrigerated centrifuge. Transport: 2.0 ml (min: 1.0 ml) plasma frozen. Separate plasma from cells and freeze ASAP. Adrenocorticotropic Hormone testing reference range will be pg/ml. Testing will be performed on Monday, Wednesday and Friday. The final result will be reported within 4 days. Gastrin GAST GAR This test is a chemiluminescent, enzyme-labeled immunometric assay used in the diagnosis and monitoring of Zollinger-Ellison syndrome, gastric ulcers, and gastrin-secreting tumors. Gastrin is elevated in pernicious anemia. Patient Preparation: 12 hours or more fasting preferred. Collect: One gold gel (GOG) 3.5 ml and separate from cells ASAP. Transport: 1.0 ml (min: 0.5 ml) serum frozen. Gastrin testing reference range will be pg/ml. Testing will be performed on Monday, Wednesday and Friday. The final result will be reported within 4 days. Collect: One gold gel (GOG) 3.5 ml and separate from cells ASAP. Human Growth Hormone GH HGH This test is a solid-phase, two-site chemiluminescent immunometric assay used to diagnose and monitor inappropriate secretion of growth hormone. Transport: 1.0 ml (min: 0.5 ml) serum frozen. Human Growth Hormone testing reference range will be 3.0 ng/ml for males; 8.0 ng/ml for females. Testing will be performed on Monday, Wednesday and Friday. The final result will be reported within 4 days. Insulin-Like Growth Factor - 1 IGLGF1 ILGF This test is a solid-phase, enzymelabeled chemiluminescent immunometric assay used to diagnose growth disorders. A normal concentration is strong evidence against growth hormone deficiency. A low IGF-1 implies growth hormone deficiency and requires additional testing to determine whether growth hormone secretion is subnormal. IGF-1 can also be measured to assess changes in nutritional status. Collect: One gold gel (GOG) 3.5 ml and separate from cells ASAP. Transport: 1.0 ml (min: 0.5 ml) serum frozen. Insulin-like Growth Factor 1 testing reference ranges are available in ACL Laboratories Directory of Services at test-catalog/. Testing will be performed on Monday, Wednesday and Friday. The final result will be reported within 4 days. 4

5 Test Description Test New Test Comment Specimen Collection Insulin-Like Growth Factor Binding Protein 3 IGFBP3 GFBP3 This test is a solid-phase, enzymelabeled chemiluminescent immunometric assay used as an aid in the evaluation of growth disorders. GFBP3 is growth hormone dependent and therefore useful in the evaluation of growth hormone secretion. Collect: One gold gel (GOG) 3.5 ml and separate from cells ASAP. Transport: 1.0 ml (min: 0.5 ml) serum frozen. Insulin-like Growth Factor Binding Protein 3 testing reference ranges are available in ACL Laboratories Directory of Services at Testing will be performed on Monday, Wednesday and Friday. The final result will be reported within 4 days. ACL Laboratories Offers New Test FISHRP for Prenatal Specimens (Prenatal FISH (Test FISHPN) with Reflex to Chromosomes or Microarray) In alignment with current practice and recommendations of the American College of Obstetrics and Gynecology, ACL Laboratories will offer a new test order code for a prenatal testing algorithm starting Wednesday, December 14, The Test FISHRP is applicable to both amniocentesis and chorionic villus samples. A maternal blood specimen should be submitted along with the prenatal specimen for maternal cell contamination studies. When FISHRP is ordered, a rapid prenatal FISH for chromosomes 13, 18, 21, X and Y will be performed. Results of the FISH testing will determine what testing is performed next. If the FISH result is normal, a prenatal microarray on a direct specimen will be performed. If the FISH result is abnormal, chromosome analysis will be performed. The creation of this test order code provides a single test order code that will trigger appropriate reflex testing. This will streamline processing and testing of specimens. For additional details regarding sample requirements and turn-around-time, please refer to the ACL Directory of Services ( Red Cell Genotyping Report Changes ACL Laboratories currently sends Red Cell Genotyping to the BloodCenter of Wisconsin. The testing is ordered internally by ACL Laboratories Transfusion Service located in both Illinois and Wisconsin, when appropriate, based upon results of serologic testing. Red Cell Genotyping Common Panel (Test COMPNL) should be utilized for patients with warm autoimmune hemolytic anemia; complicated serologic workups, especially in recently transfused patients; patients receiving anti-cd38 monoclonal antibody (mab) therapy; and new patients with sickle cell disease. Red Cell Genotyping, Rh Variant Panel (Test RHVARP) should be utilized with Rh System discrepancies. Testing will continue to be performed at the BloodCenter of Wisconsin. Results will display in the chart as see separate report and the BloodCenter report will be scanned into the chart. 5

6 Celiac Disease Screen for Patients Under 2 Years of Age (Test CELSR2) and Celiac Disease Screen (Test CELSCR) for Patients 2 Years of Age and Older In order to aid in the appropriate workup for possible celiac disease, ACL Laboratories has developed an algorithm based upon the recommendations from the American College of Gastroenterology. 1 This new algorithm replaces the current test panel (Test CDPNL), is more user-friendly and cost-effective and is aligned with current evidence-based best practices. Effective Wednesday, December 14, 2016, ACL Laboratories will perform two new Celiac Disease Screens. These screens are CELSR2 for patients under 2 years of age and CELSCR for patients 2 years of age or older. Test CELSR2 This screen consists of Immunoglobulin A, IgA (QIGA), Tissue Transglutaminase Antibody, IgA (TTABAP), Tissue Transglutaminase Antibody, IgG (TTABGP) and Gliadin Peptide Antibody IgG, Deamidated (GLIGGP). QIGA is performed by rate nephelometry, while TTABAP, TTABGP and GLIGGP are performed by an enzyme-linked immunosorbent assay (ELISA) method. See workflow Diagram A for more detail. Test CELSCR The first step in this algorithm is to run Immunoglobulin A, IgA (QIGA) and Tissue Transglutaminase Antibody, IgA (TTABAP). Based on these results, Tissue Transglutaminase Antibody, IgG (TTABGP) and Gliadin Peptide Antibody IgG, Deamidated (GLIGGP) may be reflexed (CELRX) if indicated. See workflow Diagram B for more detail. Specimen Collection Requirements for Test s CELSR2 and CELSCR Collect: Two gold gel (GOG) 3.5 ml tubes. Transport: Two 2.0 ml (min: 1.0 ml) serum refrigerated. Test CDPNL will be inactivated. The reference ranges for the four assays will remain the same. The test will be performed on Monday, Wednesday and Friday. The final result will be reported within four days. 1 Murray, J., Rubio-Tapia, A., Hill, I.D, Kelly, C.P., & Calderwood, A.H. (2013) ACG Clinical Guidelines: Diagnosis and Management of Celiac Disease article by Murray et al). American Journal of Gastroenterology, 108,

7 Celiac Disease Screen for Patients Under 2 Years of Age (Test CELSR2) Diagram A Celiac Disease Screen for Patients 2 Years of Age and Older (Test CELSCR) Diagram B 7

8 Pediatric Reference s ACL Laboratories completed an extensive review of chemistry analytes in regard to age specific reference ranges. A full year of ACL data was examined (some analytes had over 40,000 data points). This data was compared to a study done by Dr. Patti Jones, Director, Children s Medical Center, Dallas, TX, who did an extensive pediatric reference range study using the same Siemens methodology ACL uses. Several other references were also utilized from our vendors (Siemens and Beckman), Clinical Chemistry and Clinical Biochemistry publications, the National Cholesterol Education Program (NCEP) Expert Panel on Cholesterol Levels in Children, and the Lipid Research Clinics Prevalence Study. Proposed reference ranges were determined and then reviewed for feedback by physician specialists within Aurora Health Care and Advocate Health Care. Over 40 analytes will have adjustments made to accommodate the revised pediatric reference ranges. These changes will be phased in over the next three months. The first group of changes (listed below) will be implemented on Wednesday, December 14, Information on subsequent reference range updates will be communicated in the coming months. Test Order Code Test Name and Units Age Reference New Age New Reference A1AT Alpha1 Antitrypsin ALL up to 1 month A1AT 1 month up to 6 months A1AT 6 months up to 2 years A1AT 2 years up to 19 years A1AT 19 years and up AFET Alpha Feto Protein ng/ml ALL up to 14 days AFET 14 days up to 1 month AFET 1 month up to 2 months AFET 2 months up to 3 months AFET 3 months up to 4 months AFET 4 months up to 5 months AFET 5 months up to 6 months <91 AFET 6 months up to 1 year <100 AFET 1 year up to 2 years <37 AFET 2 years up to 3 years <13 AFET 3 years up to 7 years <6 AFET 7 years and up <10 ALB Albumin g/dl 0 up to 28 days up to 1 day ALB 28 days and up day up to 1 week ALB 1 week up to 5 years ALB 5 years and up

9 Test Order Code Test Name and Units Age Reference New Age New Reference ALKP Alkaline Phosphatase Units/L 0 up to 1 year up to 1 year ALKP 1 year up to 4 years year up to 4 years ALKP 4 years up to 7 years years up to 7 years ALKP 7 years up to 10 years years up to 10 years ALKP ALKP ALKP ALKP 10 years up to 12 years 12 years up to 14 years 14 years up to 16 years 16 years up to 19 years M: F: M: F: M: F: M: F: years up to 12 years 12 years up to 14 years 14 years up to 16 years 16 years up to 20 years M: F: M: F: M: F: M: F: ALKP 19 years and up years and up CA Calcium ALL up to 8 days CA 8 days to 18 years CA 18 years and up CERUL Ceruloplasmin ALL up to 1 month CERUL 1 month up to 6 months CERUL 6 months up to 19 years CERUL 19 years and up DBIL Direct Bilirubin 0 up to 15 days up to 7 days DBIL 15 days and up days to 19 years DBIL 19 years and up FERR Ferritin ng/dl ALL M: F: up to 91 days FERR 91 days up to 13 months FERR 13 months up to 4 years FERR 4 years up to 11 years FERR 11 years up to 15 years FERR 15 years up to 19 years FERR 19 years and up M: F: M: F: M: F: M: F: M: F: M: F: M: F:

10 Test Order Code Test Name and Units Age Reference New Age New Reference GGTP Gamma Glutamyl Transferase Units/L 0 up to 1 year up to 6 days GGTP 1 year up to 4 years days up to 1 month GGTP 4 years up to 10 years month up to 6 months 2-81 GGTP GGTP GGTP 10 years up to 12 years 12 years up to 19 years 19 years and up M: F: M: F: M: F: months up to 1 year year up to 6 years years up to 12 years 3-30 GGTP 12 years to 18 years 3-35 GGTP 18 years and up IGE Immunoglobulin E Units/mL M: F: 5-55 ALL <100 0 up to 1 years <18 IGE 1 year up to 6 years <60 IGE 6 years up to 10 years <90 IGE 10 years up to 15 years <200 IGE 15 years and up <100 IRON Iron mcg/dl ALL M: F: up to 91 days IRON 91 days up to 13 months IRON 13 months up to 4 years IRON 4 years up to 11 years IRON 11 years up to 15 years IRON 15 years up to 19 years IRON 19 years and up MG Magnesium M: F: M: F: M: F: M: F: M: F: M: F: M: F: ALL up to 7 days MG 7 days up to 2 years MG 2 years up to 6 years MG 6 years and up

11 Test Order Code Test Name and Units Age Reference New Age New Reference TIBC Total Iron Binding Capacity mcg/dl ALL up to 91 days TIBC 91 days up to 13 months TIBC 13 months up to 4 years TIBC 4 years up to 11 years TIBC 11 years up to 15 years TIBC 15 years up to 19 years M: F: M: F: M: F: M: F: M: F: M: F: TIBC 19 years and up TRANF Transferrin ALL up to 1 month TRANF 1 month up to 1 year TRANF 1 year up to 19 years TRANF 19 years and up /16 MC 2248

Test Bulletin. Specimen Type. Preferred Volume. PCA3 PCA3TM Urine 2.5 ml KIT Frozen. URCTFR Urine 2.5 ml Urine Refrigerated

Test Bulletin. Specimen Type. Preferred Volume. PCA3 PCA3TM Urine 2.5 ml KIT Frozen. URCTFR Urine 2.5 ml Urine Refrigerated Bulletin New Referral ing s Effective March January 1, 2017 2014 Description Current New Specimen Type Preferred Volume Tube Type Temperature to Transport Notes/Comments Prostate Cancer Biomarker PCA3