Cleveland Clinic Laboratories

Technical Update • March 2011

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 [email protected].

Days Performed/Reported Specimen Requirement

Special InformationComponent Change Test Discontinued Reference Range Test Update Name Change Methodology Order CodeBiling Code New Test Page # Summary of Changes CPT by Test Name

3 Albumin Urine, Quantitative 3 Albumin Urine, Random 3 Aldolase 3 Alkaline Phosphatase Isoenzymes 3 Bronchopulmonary Aspergillosis 3 Bupivacaine 3 Cadasil DNA Test 3 Carnitine Free and Total, Plasma 3 Carnitine Free and Total, Urine 3 CMV Genotype 3 EBV by PCR Qualitative 3 EBV by PCR Qualitative, CSF 3 EGFR Mutation Analysis 6 FISH for BIRC3 (AP12)/MALT1 Translocation 6 FISH for IGH/MALT1 Translocation 4 Fluoride 4 Fluoxetine/Norﬂ uoxetine 4 GLA Gene Testing in Fabry Disease 7 Ham Test 7 Hepatitis C Antibody by RIBA 4 Hereditary Pancreatitis 4 Herpesvirus 6 PCR, Quant 4 Herpesvirus 7 PCR, Quant 4 Histoplasma Antibodies, CSF 4 HIV-1 Antibody EIA

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com

1 Technical Update • March 2011 (cont.)

Days Performed/Reported Specimen Requirement

Special InformationComponent Change Test Discontinued Reference Range Name Change Test Update Methodology Order CodeBiling Code New Test Page # Summary of Changes CPT by Test Name

4 HLA B5701 4 Inhibin B 4 Ketorolac 4 KIT Asp816Val Mutation Analysis 4 Lindane 4 Mephenytoin & Normephenytoin 4 Methazolamide 4 Methemalbumin 4 Metoclopramide 6 Mycobacterium tuberculosis ampliﬁ ed Detection , CSF 4 Oligosaccharides, Urine 7 OncoChip Copy Number 4 Organophosphate Pesticides 5 Phenelzine 5 Phenylpropanolamine 5 Pipecolic Acid, Serum 5 Propylene Glycol 5 Risperidone & Metabolite 5 Ristocetin Co-Factor 5 Sex Hormone Binding Globulin 5 Strychnine 7 Sugar Water 5 Torch Antibodies IgG & IgM 5 Toxoplasma PCR 5 Transthyretin DNA Sequencing 5 Universal PCR, Acid Fast Bacilli 5 Universal PCR, Bacterial 6 Universal Bacterial, Fungal and AFB PCR 6 Universal PCR, Fungal 6 Vaginal Pathogens DNA Direct Probes 6 Voltage-Gated Calcium Channel IgG Autoantibodies

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 2 Test Changes

Test Name Order Code Billing Code Change Effective Date Albumin Urine, UALBQ 41001 Methodology: Immunoturbidimetric Assay 3/15/2011 Quantitative Days Performed: Sunday - Saturday Reported: 1 - 2 days Albumin Urine, UALBR 77078 Methodology: Immunoturbidimetric Assay 3/15/2011 Random Days Performed: Sunday - Saturday Reported: 1 - 2 days Aldolase ALD 82085 Specimen Requirement: 1 mL serum from a serum separator tube; 2/18/2011 Allow specimen to clot completely at room temperature; Transport refrigerated Methodology: Enzymatic Reference Range: 0 - 30 days: 6.0 - 32.0 U/L 1 - 5 months: 3.0 - 12.0 U/L 6 - 35 months: 3.5 - 10.0 U/L 3 - 6 years: 2.7 - 8.8 U/L 7 - 17 years: 3.3 - 9.7 U/L >17 years: 1.5 - 8.1 U/L Days Performed: Sunday - Saturday Reported: 2 - 3 days Alkaline Phosphatase ALKISO 67 Specimen Requirement: 2 mL serum from a serum separator tube; 4/1/2011 Isoenzymes Frozen Bronchopulmonary ABPA 82603 Components: 2/23/2011 Aspergillosis Immunoglobulin E (IgE) Aspergillus fumigatus IgE IgE Class Aspergillus fumigatus IgG Aspergillus fumigatus Mix Gel Diffusion Test build may need to be modiﬁ ed Bupivacaine BUPIV 76365 Specimen Requirement: 1 mL serum from a red top tube; Do not use 4/1/2011 serum separator tubes; Remove serum from cells ASAP, Refrigerated Cadasil DNA Test CADASL 82122 Specimen Requirement: 10 mL whole blood in EDTA lavender top 3/17/2011 tube(s). If necessary, please collect two EDTA tubes so that adequate specimen will be obtained. Collect Monday - Wednesday only; Ambient CPT: 83891, 83898x23, 83904x23, 83909x23 Carnitine Free and CARNP1 79814 Reference Range: 2/9/2011 Total, Plasma Total Carnitine: 29.13 - 73.03 μmol/L Free Carnitine: 23.31 - 57.90 μmol/L Calculated Acylcarnitines: 4.35 - 21.60 μmol/L Acyl/Free ratio: 0.12 - 0.65 Butyrobetaine: 0.34 - 1.49 μmol/L Carnitine Free and UCARN1 79813 Reference Range: 2/9/2011 Total, Urine Total Carnitine: 62.74 - 368.19 μmol/g creatinine Free Carnitine: 7.87 - 237.34 μmol/g creatinine Calculated Acylcarnitines: 58.44 - 240.56 μmol/g creatinine Acyl/Free ratio: 0.69 - 10.60 Butyrobetaine: <4.92 μmol/g creatinine CMV Genotype CMVGEN 84053 Special Information: 3/24/2011 Minimum viral load: 1000 copies/mL; Specimen must be received within 96 hours of collection EBV by PCR EBPCR 79049 Days Performed: Monday - Friday 4/1/2011 Qualitative Reported: 2 - 6 days EBV by PCR EBVCSF 81366 Days Performed: Sunday - Saturday 4/1/2011 Qualitative, CSF Reported: 2 - 6 days EGFR Mutation EGFR 83969 Special Information: Specimen source is required 3/1/2011 Analysis Test build may need to be modiﬁ ed Days Performed: Monday - Friday Reported: 6 - 8 days

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 3 Test Changes (cont.)

Test Name Order Code Billing Code Change Effective Date Fluoride BFLUOR 82735 Specimen Requirement: 2 mL plasma from an EDTA lavender top 2/15/2011 tube; Remove plasma from cells ASAP; Do not use plasma separator tubes; Refrigerated Fluoxetine/ FLUOX 76252 Days Performed: Tuesday, Thursday 4/1/2011 Norﬂ uoxetine Reported: 4 - 8 days GLA Gene Testing FABRY 82954 Specimen Requirement: 3 mL whole blood in an EDTA lavender top 4/1/2011 in Fabry Disease tube, Ambient. Specimen must be sent to Cleveland Clinic Laborato- ries on the day of collection. Days Performed: Tuesday Reported: 2 - 3 weeks Hereditary HERPAN 82734 Specimen Requirement: 3 mL whole blood in an EDTA lavender 4/1/2011 Pancreatitis top tube, Congenital inherited diseases patient information sheet is required, Ambient. Specimen should be sent to Cleveland Clinic Labo- ratories on the day of collection. Methodology: Polymerase Chain Reaction (PCR), DNA Sequencing Days Performed: Thursday Reported: 6 - 13 days Herpesvirus 6 PCR, HV6QNT 84312 Reference Range: 4/1/2011 Quant 100 copies /mL - 1.0 x 10e8 copies/mL Herpesvirus 7 PCR, HV7QNT 84311 Reference Range: 4/1/2011 Quant 100 copies /mL - 1.0 x 10e8 copies/mL Histoplasma HISTCS 83601 Components: 3/8/2011 Antibodies, CSF Yeast Phase antibody Mycelial Phase antibody HIV-1 Antibody EIA HIV1AB 50136 Days Performed: Monday - Friday 2/21/2011 Reported: 7 days HLA B5701 B5701 84337 Methodology: Polymerase Chain Reaction (PCR), Ampliﬁ cation 4/1/2011 Inhibin B INHIBB 82819 Reference Range: 3/15/2011 Male: <400 pg/mL Female: post menopausal: <30 pg/mL normal menstrual cycle: 30 - 200 pg/mL Ketorolac KETOR 80422 Specimen Requirement: 1 mL serum from a red top tube; Protect from 4/1/2011 light; Do not use serum separator tubes; Remove serum from cells ASAP; Refrigerated KIT Asp816Val KITMST 84159 Specimen Requirement: 2 mL bone marrow in an EDTA lavender top 4/1/2011 Mutation Analysis tube; Send specimen to Cleveland Clinic Laboratories on the same day as collection; Ambient Lindane LIND 81731 Specimen Requirement: 3 mL serum from a red top tube; Do not use 4/1/2011 serum separator tubes; Remove serum from cells ASAP; Refrigerated Mephenytoin & MEPNOR 75053 Specimen Requirement: 2 mL serum from a red top tube; Do not use 4/1/2011 Normephenytoin serum separator tubes: Remove serum from cells ASAP; Refrigerated Methazolamide METHAZ 80424 Specimen Requirement: 1 mL serum from a red top tube; Do not use 4/1/2011 serum separator tubes; Remove serum from cells ASAP; Refrigerated Days Performed: Tuesday, Friday Reported: 3 - 7 days Methemalbumin METALB 83857 Specimen Requirement: 1 mL serum from a red top tube; Do not use 4/1/2011 serum separator tubes; Remove serum from cells ASAP; Refrigerated Metoclopramide METOCL 80428 Specimen Requirement: 3 mL serum from a red top tube; Do not use 4/1/2011 serum separator tubes; Remove serum from cells ASAP; Ambient Days Performed: Thursday Reported: 3 - 10 days Oligosaccharides, UOLIGS 82926 Days Performed: Tuesday, Thursday 4/1/2011 Urine Reported: 3 - 10 days Organophosphate ORGANO 80430 Specimen Requirement: 5 mL random urine in a clean container; 4/1/2011 Pesticides Frozen Days Performed: Thursday Reported: 3 - 10 days

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 4 Test Changes (cont.)

Test Name Order Code Billing Code Change Effective Date Phenelzine PHENEL 79236 Specimen Requirement: 4 mL serum from a red top tube; Protect from 4/1/2011 light; Do not use serum separator tubes; Remove serum from cells and freeze ASAP Phenylpropanolamine PHENYL 80434 Specimen Requirement: 1 mL serum from a red top tube; Do not use 4/1/2011 serum separator tubes; Remove serum from cells ASAP; Refrigerated Pipecolic Acid, PIPE 84130 Specimen Requirement: 1.5 mL serum from a serum separator tube; 4/1/2011 Serum Patient should fast for at least 4 hours; Infants should be collected just before feeding; Remove serum from cells within 45 minutes of collection; Frozen Propylene Glycol PROPYL 82920 Specimen Requirement: 2 mL serum from a red top tube; Do not use 4/1/2011 serum separator tubes; Remove serum from cells ASAP; Refrigerated Risperidone & RISPER 80438 Specimen Requirement: 1 mL serum from a red top tube; Do not use 4/1/2011 Metabolite serum separator tubes; Remove serum from cells ASAP; Refrigerated Days Performed: Tuesday Reported: 4 - 10 days Ristocetin Co-Factor RISCOF 26800 Reference Range: 35 - 153% 2/7/2011 Sex Hormone SHBG2 79803 Specimen Requirement: 0.5 mL serum from a serum separator tube; 3/10/2011 Binding Globulin Frozen Reference Range: Male: 10 - 57 nmol/L Tanner I: 31 - 167 nmol/L Tanner II: 47 - 179 nmol/L Tanner III: 5.8 - 182 nmol/L Tanner IV: 14 - 98 nmol/L Tanner V: 10 - 57 nmol/L Female (non-pregnant): 18 - 144 nmol/L Tanner I: 43 - 197 nmol/L Tanner II: 7.7 - 119 nmol/L Tanner III: 31 - 191 nmol/L Tanner IV: 31 - 166 nmol/L Tanner V: 18 - 144 nmol/L Strychnine STRYCH 80555 Specimen Requirement: 4 mL serum from a red top tube; Do not use 4/1/2011 serum separator tubes; Remove serum from cells ASAP; Refrigerated Days Performed: Monday, Wednesday, Friday Reported: 4 - 6 days Torch Antibodies TORCH 79189 Specimen Requirement: 3.5 mL serum from a serum separator tube, 4/1/2011 IgG & IgM Refrigerated Methodology: Enzyme Immunoassay (EIA) Reference Range: Toxoplasma IgG: < 0.91 Index Toxoplasma IgM: < 0.80 Index Rubella IgG: < 5 IU/mL Rubella IgM: <0.9 S/CO ratio CMV IgG: < 0.91 Index CMV IgM: < 0.90 Index HSV 1 & 2 IgG: < 0.90 Index HSV 1 & 2 IgM: <0.80 Index Toxoplasma PCR TXPCR 81737 Days Performed: Sunday - Saturday 4/1/2011 Reported: 2 - 6 days Transthyretin DNA TTRDNA 81481 Specimen Requirement: 6 mL whole blood in two EDTA lavender top 3/10/2011 Sequencing tubes. Please collect two tubes with 3 mL whole blood each. Ambient Methodology: Polymerase Chain Reaction (PCR), Amplifi cation Universal PCR, AFBPCR 87859 Specimen Requirement: 4/7/2011 Acid Fast Bacilli 1 mL body fl uid in a sterile container; Frozen *OR* Actively growing Isolate of organism; Ambient *OR* Fresh frozen tissue in a sterile container; Frozen *OR* Paraffi n embedded tissue block; Ambient Universal PCR, BACPCR 87852 Specimen Requirement: 4/7/2011 Bacterial 1 mL body fl uid in a sterile container; Frozen *OR* Actively growing Isolate of organism; Ambient *OR* Fresh frozen tissue in a sterile container; Frozen *OR* Paraffi n embedded tissue block; Ambient

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 5 Test Changes (cont.)

Test Name Order Code Billing Code Change Effective Date Universal Bacterial, FABPCR 87871 Specimen Requirement: 4/7/2011 Fungal and AFB PCR 1 mL body fl uid in a sterile container; Frozen *OR* Actively growing Isolate of organism; Ambient *OR* Fresh frozen tissue in a sterile container; Frozen *OR* Paraffi n embedded tissue block; Ambient Universal PCR, FUNPCR 87854 Specimen Requirement: 4/7/2011 Fungal 1 mL body fl uid in a sterile container; Frozen *OR* Actively growing Isolate of organism; Ambient *OR* Fresh frozen tissue in a sterile container; Frozen *OR* Paraffi n embedded tissue block; Ambient Voltage-Gated VOLTCA 82925 Days Performed: Wednesday 4/1/2011 Calcium Channel Reported: 3 - 6 days IgG Autoantibodies

New Tests

Test Name Order Code Billing Code Test Information Effective Date FISH for BIRC3 BMALFH 88037 Special Information: Specimens fi xed in any fi xative other than 10% 4/6/2011 (AP12)/MALT1 neutral buffered formalin are not suitable for this methodology. Translocation Specimen Requirement: Formalin fi xed paraffi n embedded tissue or slides with formalin fi xed embedded 0.4 μm tissue sections; Ambient Methodology: Fluorescent In-Situ Hybridization (FISH) Days Performed: Monday - Thursday (Excludes Cleveland Clinic ob- served holidays.) Specimen received in lab by 9 a.m. will be processed the same day. Test has a two day staining process. Reported: 7 days CPT: 88368x2 Price: $775.00 (non-discountable) FISH for IGH/MALT1 IGMAFH 88038 Special Information: Specimens fi xed in any fi xative other than 10% 4/6/2011 Translocation neutral buffered formalin are not suitable for this methodology. Specimen Requirement: Formalin fi xed paraffi n embedded tissue or slides with formalin fi xed embedded 0.4 μm tissue sections; Ambient Methodology: Fluorescent In-Situ Hybridization (FISH) Days Performed: Monday - Thursday (Excludes Cleveland Clinic ob- served holidays.) Specimen received in lab by 9 a.m. will be processed the same day. Test has a two day staining process. Reported: 7 days CPT: 88368x2 Price: $775.00 (non-discountable) Mycobacterium MTBCSF 88029 Special Information: This test is specifi c for, but does not differentiate 4/7/2011 tuberculosis among members of the M. tuberculosis complex. M. celatum and M. Amplifi ed terrae-like organisms will cross react if present at concentrations higher Detection, CSF than 30 CFU/test. However, those species are rare clinical isolates. Specimens with high levels of non-tuberculosis mycobacteria (greater than 1,000,000 cells/test) may cause low level positive MTB Amplifi - cation results when M. tuberculosis complex is not present. Specimen Requirement: 1 mL cerebrospinal fl uid in a sterile container; Refrigerated Methodology: Transcription Mediated Amplifi cation (Gen-Probe®) Reference Range: Negative Days Performed: Sunday - Friday Reported: 2 - 4 days CPT: 87556 Price: $515.00 (non-discountable)

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 6 New Tests (cont.)

Test Name Order Code Billing Code Test Information Effective Date OncoChip Copy CNE 88012 Specimen Requirement: 5 mL whole blood in an EDTA lavender top 3/8/2011 Number tube, Ambient Methodology: Comparative genomic hybridization Days Performed: Monday - Friday Reported: 8 - 11 days CPT: 83891, 88386 Price: $1,715.00 (non-discountable) Vaginal Pathogens VAGDNA 88033 Includes: Candida species 4/7/2011 DNA Direct Probes Gardnerella vaginalis Trichomonas vaginalis Specimen Requirement: Vaginal swab collected in BD Afﬁ rm™ VPIII Transport System; Ambient; Send swab within the transfer tube to Cleveland Clinic Laboratories on the same day as collection. For collection kit call client services at 1-800-628-6816 Methodology: Nucleic Acid Probe Reference Range: Negative Days Performed: Sunday - Saturday Reported: 2 - 3 days CPT: 87480, 87510, 87660 Price: $195.00 (non-discountable)

Discontinued Tests

Test Name Order Code Billing Code Test Information Effective Date Ham Test HAMSTS 29505 This test will no longer be available. Suggest ordering Paroxysmal 3/14/2011 Nocturnal Hemoglobinuria (PNH) Panel (PNHPNL) Hepatitis C Antibody HCRIBA 76510 This test will no longer be available. Suggest ordering Hepatitis C Virus 2/25/2011 by RIBA RNA by PCR (HCQPCR) Sugar Water SUGWAT 26350 This test will no longer be available. Suggest ordering Paroxysmal 3/14/2011 Nocturnal Hemoglobinuria (PNH) Panel (PNHPNL)

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 7