Technical Update December 2010

Laboratories Technical Update December 2010 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 demographics, 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 216.444.5755 or 800.628.6816 or via email at clientservices@ccf.org. Specimen Requirement Days Performed/Reported Special Information Test Discontinued Reference Range Component Change Name Change Test Update Page # Biling Code Order Code Methodology New Test Summary of Changes by Test Name CPT 2 Acylglycines, Quantitative Urine 2 Allergen, Ampicilloyl IgE 2 Allergen, Blueberry IgE 2 Allergen, Chili Pepper IgE 2 Alpha Galactosidase, Leukocytes 7 CA 72-4 3 Cathartic Laxative, Urine 3 CMT Evaluation Complete 3 CMT Evaluation Partial 7 Complement C3, Fluid 7 Complete Ataxia Evaluation 3 Diagnostic CFTR Intron 8 3 Fatty Acid Profile of Lipids 7 Fee Increase 3 Fragile X Syndrome DNA Analysis 7 HCG, Fluid 3 Herpes Simplex Type 1 and 2 IgG Antibodies 3 Hyperoxaluria, Urine 6 Immunoglobulin Heavy Chain Using Biomed-2 PCR Primers 6 Immunoglobulin Kappa Chain Using Biomed-2 PCR Primers 4 KIT Gene Mutation AML 4 Leflunomide as Metabolite 7 NeoCerebellar Degeneration Paraneoplastic Profile 4 NeoComplete Paraneoplastic Profile with Recombx 4 NeoEncephalitis Paraneoplastic Profile with Recombx 1

Technical Update December 2010 (cont.) Days Performed/Reported Specimen Requirement Special Information Test Discontinued Reference Range Component Change Test Update Page # Name Change Biling Code Order Code Methodology New Test Summary of Changes by Test Name CPT 4 NMP22 Bladder Tumor Marker 7 Pain Panel Drug Screen 4 Pipecolic Acid, Serum 4 Pipecolic Acid, Urine 4 Prealbumin 4 Protein Electrophoresis, Serum 4 Protein Electrophoresis, Serum with IFE 5 Purine and Pyrimidine Panel 5 Quant Pain Panel, Urine 7 Rheumatoid Factor, Body Fluid 5 Syphilis IgG (T pallidum) 5 Syphilis IgG with Confirmation 6 T-Cell Receptor Beta using Biomed-2 PCR Primers 5 Vitamin B6 Test Changes Acylglycines, Quantitative Urine Allergen, Ampicilloyl IgE Allergen, Blueberry IgE Allergen, Chili Pepper IgE Alpha Galactosidase, Leukocytes UACYLG 83755 Reference Range: Ethylmalonic Acid: 0.5-20.2 mg/g Creat 2-Methylsuccinic Acid: 0.4-13.8 mg/g Creat Glutaric Acid: 0.6-15.2 mg/g Creat Isobutyrylglycine: 0.00-11.0 mg/g Creat n-butyrylglycine: 0.1-2.1 mg/g Creat 2-Methylbutyrylglycine: 0.3-7.5 mg/g Creat Isovalerylglycine: 0.3-14.3 mg/g Creat n-hexanolyglycine: 0.2-1.9 mg/g Creat n-octanoylglycine: 0.1-2.1 mg/g Creat 3-Phenylpropionylglycine: 0.00-1.1 mg/g Creat Suberylglycine: 0.00-11.0 mg/g Creat trans-cinnamoylglycine: 0.2-14.7 mg/g Creat Dodecanedioic Acid: (12:0): 0.00-1.1 mg/g Creat Tetradecanedioic Acid: (14:0): 0.00-1.0 mg/g Creat Hexadecanedioic Acid: (16.0): 0.00-1.0 mg/g Creat AMPCIL 83046 Specimen Requirement: 0.1 ml serum from a serum separator tube, Refrigerated Reported: 1-3 days BLUBRY 83961 Specimen Requirement: 0.1 ml serum from a serum separator tube, Refrigerated Reported: 1-3 days CHILI 82946 Specimen Requirement: 0.1 ml serum from a serum separator tube, Refrigerated Reported: 1-3 days AGAL 87795 Methodology: Fluorimetry (FLM) Reference Range: 23.1 nmol/h/mg protein Test build may need to be modified 12/2/2010 2

Test Changes (cont.) Cathartic Laxative, Urine CMT Evaluation Complete CMT Evaluation Partial Diagnostic CFTR Intron 8 Fatty Acid Profile of Lipids Fragile X Syndrome DNA Analysis Herpes Simplex Type 1 and 2 IgG Antibodies UCATH 83316 Effective Date: Revised from 11/1/10 Includes: Desacetyl Bisacodyl (Bisacodyl diphenol), Rhein, Emodin, Aloe-Emodin Test build may need to be modified Specimen Requirement: 5 ml urine in a clean container, Refrigerated Methodology: Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS) Days Performed: Wednesday Reported: 4-10 days CMTCOM 82413 CPT: 83891, 83896x11, 83898x143, 83900, 83901x9, 83904x143, 83909x17, 83914x11 CMTEVL 82114 CPT: 83891, 83896x11, 83898x68, 83900, 83901x9, 83904x68, 83909x12, 83914x11 CFTR 80937 Clinical Information: Poly(T) analysis is performed reflexively for those individuals identified as R117H-positive since poly(t) modifies the clinical effects for R117H. This is consistent with the ACOG/ACMG recommendations and their goal of offering screening to identify couples at risk for having a child with CF. Additionally, poly(t) testing is ordered in certain diagnostic situations (e.g. congenital bilateral absence of the vas deferens (CVBAVD) and idiopathic pancreatitis). Reported: 6-10 days CFA 76258 Specimen Requirement: 1 ml serum from a serum separator tube; Remove serum from cells within 45 minutes and freeze FRAGIL 82365 Specimen Requirement: 3 ml whole blood in an EDTA lavender top tube, Ambient Days Performed: Monday Reported: 15-23 days HSVG12 82513 Methodology: Multiplex Reference Range: Herpes Simplex IgG 1: Negative: <0.91 AI Equivocal: 0.9-1.0 AI Positive: >1.0 A1 Herpes Simplex IgG 2: Negative: <0.91 AI Equivocal: 0.9-1.0 AI Positive: >1.0 AI Days Performed: Sunday - Friday Reported: 1-4 days Hyperoxaluria, Urine UHYPER 87816 Reference Range: Glycolate: Age: 0-31 Days: 0-57 mg/g Creat Age: 1-5 Months: 0-54 mg/g Creat Age: 6-12 Months: 0-60 mg/g Creat Age: 1-5 Years: 0-89 mg/g Creat Age: 6 Years: 0-78 mg/g Creat Glycerate: Age: 0-31 Days: 0-38 mg/g Creat Age: 1-5 Months: 0-71 mg/g Creat Age: 6-12 Months: 0-56 mg/g Creat Age: 1-5 Years: 0-17 mg/g Creat Age: 6 Years: 0-8 mg/g Creat Glyoxylate: Age: 0-31 Days: 0.0-7.9 mg/g Creat Age: 1-5 Months: 0.0-11.4 mg/g Creat Age: 6-12 Months: 0.0-5.5 mg/g Creat Age: 1-5 Years: 0.0-3.9 mg/g Creat Age: 6 Years: 0.0-2.9 mg/g Creat Oxalate: Age: 0-31 Days: 0-301 mg/g Creat Age: 1-5 Months: 0-398 mg/g Creat Age: 6-12 Months: 0-280 mg/g Creat Age: 1-5 Years: 0-128 mg/g Creat Age: 6-10 Years: 0-72 mg/g Creat Age: 11 Years: 0-56 mg/g Creat 12/6/2010 1/13/2011 1/20/2011 1/13/2011 1/6/2011 3

Test Changes (cont.) KIT Gene Mutation AML Leflunomide as Metabolite NeoComplete Paraneoplastic Profile with Recombx NeoEncephalitis Paraneoplastic Profile with Recombx NMP22 Bladder Tumor Marker Pipecolic Acid, Serum KITAML 84158 Specimen Requirement: 7 ml whole blood in an EDTA lavender top tube; Ambient Methodology: Polymerase Chain Reaction (PCR), Sequencing LEFLUN 83212 Days Performed: Sunday - Saturday Reported: 4-5 days 1/13/2011 1/6/2011 NEOPAR 82398 CPT: 83516, 83519x3, 83520, 84181, 84182x6, 86255 12/2/2010 CEPHAL 82188 Includes: anti-cv2, anti-hu, anti-ma, anti-ta, GAD Antibodies, VGKC Antibodies, Amphiphysin, NMDA Receptor (NR1) Specimen Requirement: 3 ml serum from a red top tube, Refrigerated Methodology: Enzyme-Linked Immunosorbent Assay (ELISA), Western Blot (WB), Immunoprecipitation, Indirect Fluorescent Antibody (IFA) Reference Range: anti-cv2: Negative anti-hu: Negative anti-ma: Negative anti-ta: Negative VGKC Antibodies: Negative Amphiphysin: Negative GAD Antibodies: Initial run at neat; negative = 0; If result is positive, sample is diluted and reference ranges are as follows: Negative: 1-600 Borderline: 600-1200 Positive: >1200 NMDA Receptor (NR1): Negative Days Performed: Monday - Thursday Reported: 29-30 days CPT: 83519, 83520, 84182x2, 83516, 84181, 86255 NMP22 79588 Days Performed: Wednesday, Saturday Reported: 2-6 days PIPE 84130 Reference Range: 0-1 week: 3.75-10.8 nmol/ml >1 week: 0.7-2.5 nmol/ml Pipecolic Acid, Urine UPIPE 84129 Reference Range: 0-6 months: 9.81-84.5 nmol/mg creat >6 months: 0.15-13.6 nmol/mg creat Prealbumin PREALB 32108 Methodology: Immunoturbidimetric Assay Days Performed: Sunday - Saturday Reported: 1-2 days Protein Electrophoresis, Serum Protein Electrophoresis, Serum with IFE SEPG 84165 Special information: When a M Protein is present, the calculation of the percent change from a previous M Protein result will no longer be performed. SEPGRX 82257 Special information: When a M Protein is present, the calculation of the percent change from a previous M Protein result will no longer be performed. 12/23/2010 1/3/2011 12/21/2010 12/21/2010 4

Test Changes (cont.) Purine and Pyrimidine Panel Quant Pain Panel, Urine Syphilis IgG (T pallidum) Syphilis IgG with Confirmation UPURPY 82921 Reference Range: Uracil: Age: 0-2 Years: < 32 mmol/mol crt Age: 3-5 Years: < 21 mmol/mol crt Age: 6-11 Years: < 17 mmol/mol crt Age: 12-99 Years: < 12 mmol/mol crt Uric Acid: Age: 0-2 Years: 359-2644 mmol/mol crt Age: 3-5 Years: 185-1134 mmol/mol crt Age: 6-11 Years: 199-1034 mmol/mol crt Age: 12-99 Years: 49-692 mmol/mol crt Hypoxanthine: Age: 0-2 Years: < 99 mmol/mol crt Age: 3-5 Years: < 59 mmol/mol crt Age: 6-11 Years: < 52 mmol/mol crt Age: 12-99 Years: < 29 mmol/mol crt Xanthine: Age: 0-2 Years: < 66 mmol/mol crt Age: 3-5 Years: < 40 mmol/mol crt Age: 6-11 Years: < 32 mmol/mol crt Age: 12-99 Years: < 20 mmol/mol crt UQNTPP 82347 Test Name: Previously Pain Panel with Methadone Order Code: Previously PAINME Components: Cannabinoid (marijuana), Amphetamine, Methamphetamine, Benzoylecognine (Cocaine), Codeine, Morphine, Dihydrocodeine, Hydrocodone, Oxycodone, Hydromorphone, Oxymorphone (Opiates), Methadone, EDDP (methadone metabolite), Tramadol, Desmethyltramadol (Tramadol metabolite), Propoxyphene, Norpropoxyphene (Propoxyphene metabolite), Fentanyl, Norfentanyl (Fentanyl metabolite), Creatinine, ph, Specific Gravity, Oxidants Special Information: For medical purposes only; not valid for forensic use. Confirmation testing is not included with this analysis Specimen Requirement: 10 ml unpreserved random urine in a clean container, Refrigerated Methodology: Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS) Performed: Monday, Wednesday Reported: 3-7 days CPT: 82145x2, 82520, 80299, 83840x2, 83925x12, 82646 SYPHG 84565 Reference Range: Non-Reactive: 0.8 AI Weakly Reactive: 0.9-5.9 AI Reactive: 6.0 AI SYPHGX 84566 Special Information: Patients > 6 months of age: A weakly reactive or reactive Syphilis IgG (SYPHG) result will be confirmed by RPR at an extra cost. A non-reactive RPR result will have FTA, Syphilis IgG Confirmation test (FTAABS) performed at an extra fee. A reactive RPR result will have a RPR quant with titer (RPRQNT) performed at an extra fee. Patients <6 months of age: A weakly-reactive or reactive SYPHG result will be reported without confirmation. Reference Range: Non-reactive: 0.8 AI Weakly Reactive: 0.9-5.9 AI Reactive: 6.0 AI Test build may need to be modified 12/20/2010 12/6/2010 12/8/2010 12/8/2010 Vitamin B6 VITB6 84207 Reference Range: 20.0-125.0 nmol/l 11/15/2010 5

New Tests Test Name Order Code Billing Code Test Information Effective Date Immunoglobulin Heavy Chain Using Biomed-2 PCR Primers Immunoglobulin Kappa Chain Using Biomed-2 PCR Primers T-Cell Receptor Beta using Biomed-2 PCR Primers IGHPCR 87960 Specimen Requirement: 10 mm square fresh tissue in clean container, Ambient *OR* 10 mm square frozen tissue in clean container; Fresh or frozen tissues should be delivered to Surgical Pathology.*OR* Paraffin-embedded tissue block, Ambient. Deliver to Anatomic Pathology. *OR* 2 ml bone marrow in an EDTA lavender top tube, Refrigerated *OR* 8 ml whole blood in an EDTA lavender top tube, Refrigerated *OR* 6 μg extracted DNA, Frozen Methodology: Polymerase Chain Reaction (PCR), Capillary Electrophoresis (CE) Reference Range: Negative Days Performed: Tuesday, Thursday Reported: 10-14 days CPT: 83891, 83898x3, 83909x3, 83912 Price: $725.00 (non-discountable) IGKPCR 87954 Specimen Requirement: 10 mm square fresh tissue in clean container, Ambient *OR* 10 mm square frozen tissue in clean container; Fresh or frozen tissues should be delivered to Surgical Pathology. *OR* Paraffin-embedded tissue block, Deliver to Anatomic Pathology, Ambient *OR* 2 ml bone marrow in an EDTA lavender top tube, Refrigerated *OR* 8 ml whole blood in an EDTA lavender top tube, Refrigerated *OR* 6 μg extracted DNA, Frozen Methodology: Polymerase Chain Reaction (PCR), Capillary Electrophoresis (CE) Reference Range: Negative Days Performed: Tuesday, Thursday Reported: 10-14 days CPT: 83891, 83900, 83901x4, 83909x2, 83912 Price: $725.00 (non-discountable) TCRB 87965 Specimen Requirement: 10 mm square tissue in a clean container; Deliver to Surgical Pathology, Frozen *OR* 10 mm square paraffin embedded tissue block; Deliver to Anatomic Pathology, Ambient *OR* 2 ml bone marrow in an EDTA lavender top tube, Refrigerated *OR* 2 ml body fluid in a clean container; Fluid must contain at least 3 million cells, Refrigerated *OR* 5 ml whole blood in an EDTA lavender top tube, Refrigerated *OR* 6 μg extracted DNA, Frozen Methodology: Polymerase Chain Reaction (PCR), Capillary Electrophoresis (CE) Reference Range: Negative Days Performed: Tuesday, Thursday Reported: 10-14 days CPT: 83891, 83898, 83900, 83901x3, 83909x3, 83912 Price: $725.00 (non-discountable) 6

Discontinued Tests Test Name Order Code Billing Code Test Information Effective Date CA 72-4 CA724 81300 This test will no longer be available. 11/24/2010 Complement C3, Fluid FC3 78200 This test will no longer be available. Suggest ordering Body Fluid, Misc (FMISCT) Complete Ataxia Evaluation ATAXIA 82115 This test will no longer be available. 1/6/2011 HCG, Fluid FHCG 77928 This test will no longer be available. Suggest ordering Body Fluid, Misc (FMISCT) NeoCerebellar Degeneration Paraneoplastic Profile Pain Panel Drug Screen Rheumatoid Factor, Body Fluid Special Information FEE INCREASE CERDEG 82187 This test will no longer be available. 1/6/2011 PAINPL 81505 This test will no longer be available. Suggest ordering Quant Pain Panel, Urine (UQNTPP) FRF 78219 This test will no longer be available. Suggest ordering Body Fluid, Misc (FMISCT) 12/6/2010 Effective January 1, 2011, Cleveland Clinic Laboratories is implementing an overall 3 percent price increase for its List Fee schedule of tests. 7