Cleveland Clinic Laboratories

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1 Cleveland Clinic Laboratories Technical Update July 2015 Cleveland Clinic Laboratories is dedicated to keeping you updated and informed about recent testing changes. That s why we are happy to provide this technical update on a monthly basis. Recently changed tests are bolded, and could include revisions to methodology, reference range, days performed or CPT code. For your convenience, tests are listed alphabetically and the order and billing codes are provided. If you wish to compare the new information with previous test information, refer to the Test Directory, which can be accessed at clevelandcliniclabs.com. Deleted tests and new tests are listed separately. Please update your database as necessary. For additional detail, contact Client Services at or or via at clientservices@ccf.org. Specimen Requirement Test Update Page # Special Information Test Discontinued New Test Name Change Billing Code Order Code Days Performed/Reported Reference Range Methodology Component Change Stability Summary of Changes by Test Name CPT Fee 3 Acyclovir 3 Alcohols 8 Alpha Globin (HBA1 & HBA2) Sequencing 9 Anti-HMGCR Autoantibodies 13 BCL 2 mbr (PCR) 3 Beta-2 Glycoprotein, IgG 3 Beta-2 Glycoprotein, IgM 9 Beta Globin (HBB) Gene Sequencing 3 Cardiolipin IgA Antibodies 3 Cardiolipin IgG Antibodies 3 Cardiolipin IgM Antibodies 3 Chromogranin A 3 Circulating Tumor Cells for Breast Cancer 4 Circulating Tumor Cells for Prostate Cancer 4 Cortisol Binding Globulin 4 DRPLA DNA Test 4 Fatty Acid Profile of Lipids 9 FISH for RET (10q11) 13 FISH for ROS1 (6q22) 4 Gliadin (Deamidated) IgA Antibody 9, 10 GlycoMark 13 HCV RNA bdna Quant with HCV Quant Reflex 9500 Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 1

2 Component Change Specimen Requirement Test Update Page # Special Information Test Discontinued Name Change Billing Code Order Code Days Performed/Reported Reference Range Methodology New Test Stability Summary of Changes by Test Name CPT Fee 4, 13 Iron, Urine 24 hours 4 Kappa, Free, Serum 5 Kappa/Lambda, Free, Serum 5 Kennedy's Disease DNA Test 5 L/S Ratio 5 Lambda, Free, Serum 5 Liver Kidney Microsome IgG Autoantibodies 13 LOH for 1p (PCR) 13 LOH for 19q 5 Lyme Western Blot 13 Maternal Cell Contamination, Integrated Genetics 6 Meperidine & Normeperidine 13 Methadone 10 Methadone & Metabolites 6 Myeloid Malignancy Mutation Panel by Next Generation Sequencing 6 Myeloperoxidase Autoantibodies 6 Natural Killer Cells, Functional 6 Neutrophil Cytoplasmic Antibody 10 Nitrogen, Total, Feces 6 Parvovirus B19 IgG Antibodies 6 Parvovirus B19 IgM Antibodies 11 Phospholipase A2 Receptor Antibody, IgG 13 PLA 1/2 by PCR 6 Proteinase 3 Autoantibodies 11 Retinal Dystrophy Panel 6 RPR 6 Synovial Fluid, Crystals ID and Staff Review 6 Synovial Fluid, Routine Analysis 7 Thiocyanate 7 Urticaria-Induced Basophil Activation 12 Uveal Melanoma, Prognostic 7 VIP 13 Vitamin D 25 Hydroxy 8 Y-Chromosome Microdeletion 9500 Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 2

3 Test Changes Test Name Order Code Billing Code Change Effective Date Acyclovir ACYCLO Methodology: High Performance Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) Reference Range: Usual therapeutic range (vs. Genital Herpes) during chronic oral daily divided dosages of mg: Peak: µg/ml Trough: µg/ml CPT: Alcohols ALCOS Specimen Requirement: 2 ml serum in a red top tube; Minimum: 0.3 ml; Do not use serum separator tubes; Submit specimen in a tightly capped ARUP Standard Transport tube. Separate serum from cells within 2 hours of collection; *OR* 2 ml plasma from an EDTA lavender top tube; Minimum: 0.3 ml; Do not use plasma separator tubes; Submit specimen in a tightly capped ARUP Standard Transport tube. Separate plasma from cells within 2 hours of collection; *OR* 2 ml plasma from a potassium oxalate/sodium fluoride gray top tube; Minimum: 0.3 ml; Do not use plasma separator tubes; Specimens collected in this tube may be transported in the original container; Reference Range: Ethanol: No therapeutic range Assay detection limit: 5 mg/dl Therapy for Methanol: mg/dl Toxic: > 250 mg/dl Methanol: No therapeutic range Assay detection limit: 5 mg/dl; Toxic: > 20 mg/dl Isopropanol: No therapeutic range Assay detection limit: 5 mg/dl; Toxic: > 50 mg/dl Acetone, Quant: Therapeutic range: Not well established Assay detection limit: 5 mg/dl; Toxic: > 100 mg/dl Days Performed: Sunday Saturday Reported: 2 3 days CPT: G6040, /1/2015 7/16/2015 Beta-2 Glycoprotein, IgG Beta-2 Glycoprotein, IgM Cardiolipin IgA Antibodies Cardiolipin IgG Antibodies Cardiolipin IgM Antibodies BETA2G Days Performed: Monday Friday Reported: 1 3 days BETA2M Days Performed: Monday Friday Reported: 1 3 days CARDIA Days Performed: Monday Friday Reported: 1 3 days CARDIG Days Performed: Monday Friday Reported: 1 3 days CARDIM Days Performed: Monday Friday Reported: 1 3 days 6/15/2015 6/15/2015 6/15/2015 6/15/2015 6/15/2015 Chromogranin A CHROMA Specimen Requirement: 0.8 ml serum from a serum separator tube; Minimum: 0.3 ml; Frozen *OR* 0.8 ml serum from a red top tube; Minimum: 0.3 ml; Frozen Methodology: Electrochemiluminescence (ECLIA) Reference Range: 15 ng/ml Days Performed: Sunday Friday Reported: 4 6 days 7/13/2015 Circulating Tumor Cells for Breast Cancer CTC Effective 6/1/2015, this test is once again available as an orderable test. However on the test build will change for interfaced clients. 6/1/ Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 3

4 Test Changes (Cont.) Test Name Order Code Billing Code Change Effective Date Circulating Tumor Cells for Prostate Cancer Cortisol Binding Globulin CTCP Effective 6/1/2015, this test is once again available as an orderable test. However on the test build will change for interfaced clients. CBG Specimen Requirement: 0.5 ml serum from a serum separator tube; Minimum: 0.1 ml; Remove serum from cells within one hour of collection; Frozen *OR* 0.5 ml serum from a red top tube; Minimum: 0.1 ml; Remove serum from cells within one hour of collection; Frozen Ambient: 2 days : 2 days Frozen: 10 months Reference Range: Adult: mg/dl Pediatric: Not established Days Performed: Monday, Thursday Reported: 3 10 days 6/1/2015 6/4/2015 DRPLA DNA Test DRPLA For Interfaced Clients Only: Test build will need to be modified Special Information: Required forms may be obtained by contacting Client Services at (800) or (216) The Congenital Inherited Diseases Patient Information sheet may also be found at MC _Molecular_Genetics-Congenital_Inherited_Diseases_ Patient_Information.pdf. The informed consent form may also be found at mayomedicallaboratories.com/it-mmfiles/informed_consent_for_ Genetic_Testing.pdf Fatty Acid Profile of Lipids CFA Billing code: Previously /18/2015 Gliadin (Deamidated) IgA Antibody GLIIGA Days Performed: Monday Friday Iron, Urine 24 hours UFE For Interfaced Clients only: Test build will need to be modified Includes: Iron Total Volume Specimen Requirement: 10 ml urine in a clean container from a well-mixed 24 hour collection; Minimum: 6 ml; Refrigerate during collection; Transport container should not have a metal cap or glued insert; Ambient: 4 days : 14 days Frozen: 14 days Methodology: Inductively Coupled Plasma/Mass Spectrometry (ICP/MS) Days Performed: Tuesday Saturday Reported: 2 6 days Kappa, Free, Serum FKAPPS Ambient: 7 hours : 6 weeks Frozen: 1 year Methodology: Turbidimetry (TURB) Reference Range: mg/l Days Performed: Monday Friday 6/16/2015 9/9/ Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 4

5 Test Changes (Cont.) Test Name Order Code Billing Code Change Effective Date Kappa/Lambda, Free, Serum Kennedy's Disease DNA Test KLFRS Ambient: 7 hours : 6 weeks Frozen: 1 year Methodology: Turbidimetry (TURB) Reference Range: mg/l Days Performed: Monday Friday KENEDY For Interfaced Clients Only: Test build will need to be modified Special Information: The Informed Consent form may be obtained by contacting Client Services at or It may also be found at: The Molecular Genetics-Congenital Inherited Diseases Patient Information form may be obtained by contacting Client Services at or It may also be found at: www. mayomedicallaboratories.com/it-mmfiles/mc _molecular_ Genetics_Congenital_Inherited_Diseases_Patient_Information.pdf Clinical Information: Detects CAG triplet repeat expansion in the androgen receptor gene. CAUTIONS: For predictive testing, it is important to first document the presence of a CAG-repeat amplification in the androgen receptor (AR) gene in an affected family member to confirm that molecular expansion is the underlying mechanism of disease in the family. Predictive testing of an asymptomatic child is not recommended. A previous bone marrow transplant from an allogenic donor will interfere with testing. 9/9/2015 L/S Ratio LSRAT Special Information: Amniocentesis fluid preferred. Do not centrifuge. Vaginally obtained samples (vaginal pools) are not an acceptable specimen. If vaginal pool is received, test must be cancelled. Lambda, Free, Serum Liver Kidney Microsome IgG Autoantibodies FLAMBS Ambient: 7 hours : 6 weeks Frozen: 1 year Methodology: Turbidimetry (TURB) Days Performed: Monday Friday LKM Specimen Requirement: 0.5 ml serum from a serum separator tube; Frozen 9/9/2015 7/2/2015 Lyme Western Blot LYMEWB Days Performed: Tuesday, Friday 9500 Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 5

6 Test Changes (Cont.) Test Name Order Code Billing Code Change Effective Date Meperidine & Normeperidine Myeloid Malignancy Mutation Panel by Next Generation Sequencing Myeloperoxidase Autoantibodies Natural Killer Cells, Functional Neutrophil Cytoplasmic Antibody Parvovirus B19 IgG Antibodies Parvovirus B19 IgM Antibodies Proteinase 3 Autoantibodies MEPNO For Interfaced Clients only: Test build will need to be modified Includes: Meperidine Normeperidine Meperidine Dose Meperidine Route Meperidine Dose Frequency Meperidine Type of Draw Special Information: Please provide the following information: 1. Dose List drug amount and include the unit of measure 2. Route List the route of administration (IV, oral, etc.) 3. Dose Frequency Indicate how often the dose is administered (per day, per week, as needed, etc.) 4. Type of Draw Indicate the type of blood draw (Peak, Trough, Random, etc.) Days Performed: Tuesday, Thursday Reported: 2 7 days MYENGS Special Information: Includes: ASXL1, BCOR, BCORL1, BRAF, BRINP3, CALR, CBL, CEBPA, CSF3R, DNMT1, DNMT3A, EED, ETV6, EZH2, FLT3, GATA1, GATA2, HNRNPK, IDH1, IDH2, JAK2, JAK3, KDM6A, KIT, KMT2A, KRAS, LUC7L2, MPL, NOTCH1, NPM1, NRAS, NSD1, PHF6, PRPF40B, PTPN11, RAD21, RUNX1, SETBP1, SF1, SF3A1, SF3B1, SMC1A, SMC3, SRSF2, STAG2, SUZ12, TET1, TET2, TP53, U2AF1, U2AF2, WT1, ZRSR2 Specimen Requirement: 5 ml whole blood in an EDTA lavender top tube; Minimum: 1 ml; Diagnosis under consideration MUST be included with the sample; ANCAP Days Performed: Monday Friday NKFUNC Days Performed: Tuesday Friday Reported: 3 7 days ANCA Days Performed: Monday Friday PARVOG Days Performed: Tuesday, Friday Reported: 1 5 days PARVOM Days Performed: Tuesday, Friday Reported: 1 5 days ANCAC Days Performed: Monday Friday 7/14/2015 7/30/2015 7/2/2015 RPR RPR Days Performed: Sunday Saturday Reported: 1 2 days Synovial Fluid, Crystals ID and Staff Review Synovial Fluid, Routine Analysis SFCRID Specimen Requirement: 2 ml synovial fluid in an EDTA lavender top tube; Ambient *OR* 2 ml synovial fluid in a sodium or lithium heparin green top tube; Ambient RTSYNF 30 Specimen Requirement: 2 ml synovial fluid in an EDTA lavender top tube; Ambient *OR* 2 ml synovial fluid in a sodium or lithium heparin green top tube; Ambient 9/1/2015 9/1/ Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 6

7 Test Changes (Cont.) Test Name Order Code Billing Code Change Effective Date Thiocyanate THIOCY Reference Range: 5.0 mg/dl For nitroprusside therapy: mg/dl Nonsmokers: < 0.4 mg/dl Smokers: < 1.2 mg/dl Toxicity: > 5.0 mg/dl 9/22/2015 Urticaria-Induced Basophil Activation UTBAS Special Information: Reference Interval: Negative: 27 % Indeterminate (Borderline basophil activation detected): % Positive (Basophil activation detected): 39 % A value of 38 % suggests the presence of basophil stimulating antibodies (or other serum factors). Chronic urticaria (CU) is a common and complex dermatological condition that is suspected when patients experience persistent hives for over 6 weeks. No published evidence of an exogenous allergen as the cause of this disorder exists. About 45 % of cases have autoantibodies directed against either basophil or mast cell-associated IgE or the high affinity IgE-Fc receptor (Fc epsilon R1 alpha). The presence of histamine releasing factors (including but not limited to IgE and Fc epsilon R1 alpha-specific autoantibodies) in the patient serum can be indirectly determined by evaluating basophil/mast cell activation status using histamine release assays, autologous serum-skin test, and flow cytometric measurement of the basophil and mast-cell specific marker CD203c. Serum from CU patients can activate donor basophils, which induces histamine release and CD203c upregulation. Reference Range: 27% 7/16/2015 VIP VIP Special Information: VIP is a neurotransmitter and its excess can cause secretory diarrhea. VIP-secreting tumors are most commonly found in the tail of the pancreas in adults. VIP-producing ganglioneuromas or ganglioneuroblastomas may be found in the adrenal glands in children. CAUTION: This test should not be requested in patients who have recently received radioisotopes, therapeutically or diagnostically, because of potential assay interference. A recommended time period before collection cannot be made because it will depend on the isotope administered, the dose given and the clearance rate in the individual patient. Specimens will be screened for radioactivity prior to analysis. Radioactive samples received in the laboratory will be held and assayed after the radioactivity has sufficiently decayed. This will result in a test delay. Specimen Requirement: 1 ml plasma from an EDTA lavender top tube; Minimum: 0.6 ml; Eight hours fasting is required prior to specimen collection; Place specimen on ice after collection; Remove plasma from cells ASAP and freeze; Transport Frozen Ambient: Unacceptable : Unacceptable Frozen: 90 days Methodology: Radioimmunoassay (RIA) Reference Range: < 75 pg/ml Days Performed: Monday, Wednesday Reported: 4 9 days 7/30/ Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 7

8 Test Changes (Cont.) Test Name Order Code Billing Code Change Effective Date Y-Chromosome Microdeletion YCMICR For Interfaced Clients Only: Test build will need to be modified Special Information: Informed consent is required for patients living in New York state. Specimen MUST be received at performing laboratory within 4 days of collection. Clinical Information: Tests for microdeletions in the AZFa, AZFb and AZFc regions of the Y Chromosome. CAUTIONS: This assay will not detect all of the causes of infertility or azoospermia. Therefore, the absence of a detectable microdeletion(s) does not rule out the presence of other genetic or nongenetic factors that may be the cause of clinical findings. Rare polymorphisms exist that could lead to false-negative or false-positive results. If results obtained do not match the clinical findings, additional testing should be considered. In rare cases, DNA alterations of undetermined significance may be identified. A previous bone marrow transplant from an allogenic donor will interfere with testing. Specimen Requirement: 3 ml whole blood in an ACD A or B yellow top tube; Minimum: 0.5 ml; Send to Cleveland Clinic Laboratories on the day of collection; Ambient *OR* 3 ml whole blood in an EDTA lavender top tube; Minimum: 0.5 ml; Send to Cleveland Clinic Laboratories on the day of collection; Ambient New Tests Test Name Order Code Billing Code Test Information Effective Date Alpha Globin (HBA1 & HBA2) Sequencing HBA12B Specimen Requirement: 3 ml whole blood in an EDTA lavender top tube; Minimum: 1 ml; A completed ARUP 'Patient History for Hemoglobinopathy/Thalassemia Testing' form is required; The required form may be obtained by calling Client Services at or The form is also available at ltd.aruplab.com/tests/pdf/39; *OR* 100 µl extracted DNA at a concentration of 50 ng/µl; A completed ARUP 'Patient History for Hemoglobinopathy/ Thalassemia Testing' form is required; The required form may be obtained by calling Client Services at or The form is also available at com/tests/pdf/39; Ambient: 72 hours : 1 week Frozen: Unacceptable Methodology: Polymerase Chain Reaction, Sequencing Days Performed: Varies Reported: days CPT: Price: $ (non-discountable) 9/9/ Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 8

9 New Tests (Cont.) Test Name Order Code Billing Code Test Information Effective Date Anti-HMGCR Autoantibodies Beta Globin (HBB) Gene Sequencing FISH for RET (10q11) HMGCR Specimen Requirement: 2 ml serum from a serum separator tube; Minimum: 2 ml; *OR* 2 ml serum from a red top tube; Minimum: 2 ml; *OR* 2 ml plasma from an EDTA lavender top tube; Minimum: 2 ml; Ambient: 7 days : 2 3 weeks Frozen: 6 months Methodology: Enzyme Immunoassay (EIA) Reference Range: < 20 Unit Days Performed: Monday Friday Reported: 8 9 days CPT: Price: $ (non-discountable) BGHBBB Specimen Requirement: 3 ml whole blood in an EDTA lavender top tube; Minimum: 1 ml; A completed ARUP 'Patient History for Hemoglobinopathy/Thalassemia Testing' form is required; *OR* 3 ml whole blood in an ACD A or B yellow top tube; Minimum: 1 ml; A completed ARUP 'Patient History for Hemoglobinopathy/Thalassemia Testing' form is required; *OR* 100 µl extracted DNA at a concentration of 50 ng/µl; A completed ARUP 'Patient History for Hemoglobinopathy/ Thalassemia Testing' form is required; The required form may be obtained by calling Client Services at or The form is also available at Ambient: 72 hours : 1 week Frozen: Unacceptable Methodology: Polymerase Chain Reaction (PCR), Sequencing Days Performed: Varies Reported: days CPT: Price: $ (non-discountable) RET CPT: Price: $ (non-discountable) 8/13/2015 9/9/2015 GlycoMark GLYMRK Special Information: GlycoMark reference ranges apply to persons without diabetes. The GlycoMark test may be performed monthly on individuals with moderately controlled diabetes and HbA1c of 6 8 % to detect glucose excursions, and to monitor efficacy of therapy changes in diabetic individuals with high HbA1c (> 8%). CLINICAL SIGNIFICANCE: Measures 1,5 anhydroglucitol (1,5-AG), a glucose derived carbohydrate whose urinary excretion varies inversely with mean blood glucose. 1,5-AG appears to integrate variation in mean blood glucose over a period of about two weeks. Low circulating levels of 1,5-AG are associated with elevated levels of urinary albumin and N-acetylglucosaminidase, both markers of renal damage. (continued on page 10) 7/30/ Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 9

10 New Tests (Cont.) Test Name Order Code Billing Code Test Information Effective Date GlycoMark (continued from page 9) Methadone & Metabolites Nitrogen, Total, Feces Specimen Requirement: 1 ml serum from a serum separator tube; Minimum: 0.5 ml; *OR* 1 ml plasma from an EDTA lavender top tube; Minimum: 0.5 ml; *OR* 1 ml serum from a red top tube; Minimum: 0.5 ml; Ambient: Not acceptable : 7 days Frozen: > 7 days Methodology: Enzymatic Reference Range: Male: µg/ml Female: µg/ml Days Performed: Tuesday, Friday Reported: 2 7 days CPT: Price: $48.00 (non-discountable) MMTAB Includes: Methadone EDDP (2-ethylidene-1,5-dimethyl-3-3-diphenylpyrrolidine) Specimen Requirement: 0.5 ml serum in a red top tube; Ambient: 14 days : 14 days Frozen: 14 days Methodology: Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) Reference Range: Not established Days Performed: Sunday Thursday Reported: 3 6 days CPT: Price: $78.00 (non-discountable) NITF Special Information: Send ENTIRE STOOL COLLECTION in a Mayo stool container (Supply T291). Include collection period and weight of entire collection with the sample. Call Cleveland Clinic Laboratories Client Services at or for stool containers. Specimen Requirement: 5 grams of stool in a 24, 48, 72, or 96 hour collection in a Mayo Stool collection container; Submit ENTIRE timed stool collection; Minimum: 2.5 grams; Frozen Ambient: 7 days : 7 days Frozen: 7 days Methodology: Dumas Combustion Reference Range: < 16 years: Not established 16 years: 1 2 g/24 hours Days Performed: Tuesday, Thursday Reported: 2 6 days CPT: Price: $ (non-discountable) 6/30/2015 8/27/ Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 10

11 New Tests (Cont.) Test Name Order Code Billing Code Test Information Effective Date Phospholipase A2 Receptor Antibody, IgG Retinal Dystrophy Panel PLA2R Special Information: If Phospholipase A2 Receptor Antibody, IgG is positive, then a Phospholipase Receptor A2 Antibody, IgG titer is reported. Additional charges apply. Specimen Requirement: 1 ml serum from a serum separator tube; Minimum: 0.2 ml; Remove serum from cells ASAP or within 2 hours of collection; *OR* 1 ml serum from a red top tube; Minimum: 0.2 ml; Remove serum from cells ASAP or within 2 hours of collection; Ambient: 2 days : 2 weeks Frozen: 1 year Methodology: Semi-Quantitative Indirect Fluorescent Antibody Reference Range: < 1:10 Days Performed: Wednesday Reported: 2 9 days CPT: Price: $ (non-discountable) RETDYS Includes: ABCA4, ABHD12, ADAM9, AIPL1, ALMSI, ASCC3L1/ SNRNP200, BBS1, BBS2, BBS3, BBS4, BBS5, BBS6, BBS7, BBS9, BBS10, BBS11, BBS12, BBS13/mks1, BBS15, BBS16, BBS17, BEST1, C1QTNF5, C2orf71, C8orf37, CA4, CABP4, CACNA2D4, CACNA1F, CDH23, CDHR1, CEP290/BBS14, CERKL, CHM, CLRN1, CNGA1, CNGA3, CNGB1, CNGB3, CNNM4, CRB1, CRX, DFNB31, DHDDS, ELOV4, EYS, FAM161A, FSCN2, GNAT1, GNAT2, GPR98, GPR179, GRK1, GRM6, GUCA1A, GUCA1B, GUCY2D, HARS, IDH3B, INPP5E, IMPDH1, IMPG2, IQCB1, KCNJ13, KCNV2, KLHL7, LCA5, LRAT, LRIT3, MAK, MERTK, MYO7A, NMNAT1, NR2E3, NRL, NYX, OFD1, OPA1, OPA3, OTX2, PCDH15, PDE6A, PDE6B, PDE6C, PDE6H, PDE6G, PDZD7, PITPNM3, PRCD, PROM1, PRPF3, PRPF6, PRPF8, PRPF31, RAX2, RBP3, RD3, RDH5, RDH12, RDS/PRPH2, RGR, RHO, RIMSI, RLBP1, ROM1, RP1, RP1L1, RP2, RP9, RPE65, RPGR, RPGRIP1, RS1, SAG, SEMA4A, SLC24A1, SPATA7, TOPORS, TRPM1, TTC8/BBS8, TULP1, USH1C, USHIG, USH1J-CIB2, UNC119, USH2A, ZNF513 Specimen Requirement: 4 ml whole blood in an EDTA lavender top tube; Minimum: 3 ml; Collect Monday Wednesday only. Send to Cleveland Clinic Laboratories on the day of collection. A signed, informed consent form and a completed CEI Molecular Diagnostics Lab requisition form are required with the specimen; Ambient *OR* 60 µg extracted DNA in a cryovial; Minimum: 10 µg; A signed, informed consent form and a completed CEI Molecular Diagnostics Lab requisition form are required with the specimen; Frozen Ambient: Whole blood: 5 days, Extracted DNA: Few weeks : Whole blood: 5 days, Extracted DNA: Few months Frozen: Whole blood: Unacceptable, Extracted DNA: Few years Available: Once in a lifetime Methodology: Next Gen Sequencing Polymerase Chain Reaction (PCR) Sanger Sequencing Amplification Days Performed: Twice a week Reported: 4 5 weeks CPT: Price: $ (non-discountable) 7/30/2015 7/30/ Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 11

12 New Tests (Cont.) Test Name Order Code Billing Code Test Information Effective Date Uveal Melanoma, Prognostic UVEAL Includes: GNAQ & GNA11 sequencing Microsatellite analysis on Chromosome 3 to detect chromosome copy loss and isodisomy Copy Number testing on Chromosomes 1p, 3, 6, and 8 to detect monosomy, disomy, and trisomy Specimen Requirement: THIS TEST REQUIRES MULTIPLE SPECIMEN TYPES: 10 ml whole blood in an ACD A or B yellow top tube; Ambient *OR* One cytology brush for buccal swab collection: 1) Gently rinse mouth with water 2) Scrape the inside of the patient's mouth using 10 strokes with one of the collection brushes in the kit. Either cheek is fine. 3) Cut handle from the collection brush using sterile scissors 4) Place brush in the collection tube in kit. 5) Label with patient's name and date of birth. 6) Briefly vortex to ensure sample is immersed in Cell Lysis Solution; *OR* 200 ng extracted DNA; *AND* Two fine need aspirates (FNA) in Qiagen Cell Lysis solution; *OR* Un-fixed, fresh or frozen tumor tissue biopsy in a sterile collection tube; Refrigerate/Freeze until ready to ship; Ship All samples should be transported in an Impact Genetics kit. Informed consent is required. Patient history, Specimen information, and Histology information are required. Kits are available through Impact Genetics ( ) or Cleveland Clinic Client Services at or Ambient: Whole blood: 2 weeks Buccal swab: 2 years in Cell Lysis Solution Tumor sample: 2 years in Cell Lysis Solution Extracted DNA: Not recommended : Whole blood: > 2 weeks Buccal swab: 2 years in Cell Lysis Solution Tumor sample: 2 years in Cell Lysis Solution Extracted DNA: 20 years Frozen: Whole blood: Unacceptable Buccal swab: Unacceptable Tumor sample: Undetermined Extracted DNA: Not recommended Methodology: Microsatellite Analysis (MSA) Multiplex-Ligation Probe Amplification (MLPA) Sequencing Days Performed: Monday Friday Reported: 4 7 weeks CPT: 81294, 81403x2, 81406, Price: $ (non-discountable) 8/6/ Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 12

13 Fee Increases Test Name Order Code Billing Code List Fee CPT Code Effective Date FISH for ROS1 (6q22) ROS $ (nondiscountable) Iron, Urine 24 hours UFE $99.00 (nondiscountable) /16/2015 Fee Reductions Test Name Order Code Billing Code List Fee CPT Code Effective Date Maternal Cell Contamination, Integrated Genetics MATRNL $ (nondiscountable) /30/2015 Vitamin D 25 Hydroxy VITD $ /14/2015 Discontinued Tests Test Name Order Code Billing Code Test Information Effective Date BCL 2 mbr (PCR) BCL This test will no longer be available 9/1/2015 HCV RNA bdna Quant with HCV Quant Reflex HCVQNT This test will no longer be available. Suggest ordering Hepatitis C RNA by PCR (HCQPCR) 7/1/2015 LOH for 1p (PCR) 1PPCRT This test will no longer be available 9/1/2015 LOH for 19q 19QPCT This test will no longer be available 9/1/2015 Methadone METHAD This test will no longer be available. Suggest ordering Methadone & Metabolites (MMTAB) 8/27/2015 PLA 1/2 by PCR PLAPCR This test will no longer be available 9/8/ Euclid Avenue Cleveland, Ohio clevelandcliniclabs.com 13