Cleveland Clinic Laboratories

Special Edition: Technical Update • June 2012

Cleveland Clinic Laboratories is dedicated to keeping you updated and informed about recent testing changes. That's why we are happy to provide this special edition technical update.

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 Acetazolamide 3 Allergen Alpha Lactalbumin IgE 3 Allergen, Beta Lactoglobulin IgE 3 Allergen Whey IgG 3 Amoxapine & Metabolite 3-4 Androstenedione 4 Angiotensin II 4 Antithrombin III Antigen 4 Benztropine 4 Bupivacaine 5 Calcitonin 5 Chlamydia Amplification 5 Cimetidine 5 Complement Component C8 5 Copper, Urine 24 hour 5 Copper, Urine Random 5 Creatine, Serum 5 Cyanide, Blood 6 Cystatin C 6 DHEA 6 Diltiazem 7 Diphtheria/Tetanus Antibody 7 DPD 5FU GenotypR 7 Ethambutol 7 Ethosuximide

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1 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

15 FISH for CCND1 7 Flecainide 7 Flunitrazepam, Serum 7 Free T3 Tracer Dialysis 8 Fructosamine 8 G-6 PD Quantitative 8 GC/Chlamydia Amplification 8 GC Amplification 8 Gliadin (Deamidated) IgA Ab 8 Gliadin (Deamidated) IgG Ab 9 Glyburide 9 Glycoproteins 9 Hepatitis Be Antibody 9 Herpesvirus 7 IgG and IgM Antibodies 9 HIV Quant RNA by PCR 9 Hyperoxaluria, Urine 9 Immunofixation Screen, Serum 10 Inhibin B 10 Insulin Like Growth Factor II 10 Magnesium, Urine 24 hour 10 Magnesium, Urine Random 10 Measles IgM Antibody 10 Meperidine & Normeperidine 15 Methemalbumin 10 Monoclonal Protein, 24 Hour Urine 10 Monoclonal Protein, Blood 11 Monoclonal Protein, Fluid 11 Monoclonal Protein, Urine 11 Myositis AssessR 11-12 NMR Lipoprofile 12 Norwalk Like Virus Antigen 12 Parvo B19 PCR, plasma 12 Pregnenolone 13 Proinsulin 13 Ritalin 13 Selenium, Plasma 13 Strychnine 13 Toxic Shock Syndrome Antibodies 13 Transketolase 13 Urine Culture 13-14 Urine Culture/Special 15 Voriconazole 14 Whole Genome SNP Microarray 14 Zinc, Urine 24 hour 14 Zinc, Urine Random

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2 Test Changes (cont.)

Test Name Order Code Billing Code Change Effective Date Acetazolamide ACETAZ 75502 Days Performed: Varies 6/20/2012 Reported: 4 - 11 days Allergen Alpha LACALB 83025 Specimen Requirement: 0.3 mL serum from a serum separator tube; 6/19/2012 Lactalbumin IgE Separate serum from cells within 2 hours of collection; Refrigerated Methodology: Quantitative ImmunoCAP Fluorescent Enzyme Immunoassay Reference Range: < 0.10 kU/L : No significant level detected 0.10 - 0.34 kU/L: Clinical relevance undetermined 0.35 - 0.70 kU/L: Low 0.71 - 3.50 kU/L: Moderate 3.51 - 17.50 kU/L: High ≥ 17.51 kU/L: Very High Days Performed: Sunday - Saturday Reported: 2 - 3 days Allergen, Beta BLACGL 83026 Specimen Requirement: 0.3 mL serum from a serum separator tube; 6/27/2012 Lactoglobulin IgE Remove serum from cells within 2 hours of collection; Refrigerated Days Performed: Sunday - Saturday Reported: 2 - 3 days Allergen Whey IgG WHEYG 83079 Reference Range: Refer to report 6/21/2012 Days Performed: Varies Reported: 4 - 7 days Amoxapine & Metabolite AMOX 34421 Reference Range: 200 - 400 ng/mL 6/19/2012 Days Performed: Monday - Saturday Reported: 4 - 7 days Androstenedione ANDROS 82157 Specimen Requirement: 1 mL serum from a serum separator tube; 6/14/2012 (continued on next page) Collect between 6 - 10 a.m.; Refrigerated Methodology: Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS) Reference Range: Female: Premature Infants, 26 - 28 weeks - 4 days: 0.92 - 2.82 ng/mL Premature Infants, 31 - 35 weeks - 4 days: 0.80 - 4.46 ng/mL Full-term Infants: 1 - 7 days: 0.2 - 2.90 ng/mL 8 - 30 days: 0.18 - 0.80 ng/mL 1 - 5 months: 0.06 - 0.68 ng/mL 6 - 24 months: < 0.15 ng/mL 2 - 3 years: < 0.16 ng/mL 4 - 5 years: 0.02 - 0.21 ng/mL 6 - 7 years: 0.02 - 0.28 ng/mL 8 - 9 years: 0.04 - 0.42 ng/mL 10 - 11 years: 0.09 - 1.23 ng/mL 12 - 13 years: 0.24 - 1.73 ng/mL 14 - 15 years: 0.39 - 2.00 ng/mL 16 - 17 years: 0.35 - 2.12 ng/mL 18 - 39 years: 0.26 - 2.14 ng/mL 40 years and older: 0.13 - 0.82 ng/mL Premenopausal: 0.26 - 2.14 ng/mL Postmenopausal: 0.13 - 0.82 ng/mL Tanner Stage I: 0.05 - 0.51 ng/mL Tanner Stage II: 0.15 - 1.37 ng/mL Tanner Stage III: 0.37 - 2.24 ng/mL Tanner Stage IV - V: 0.35 - 2.05 ng/mL

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 Androstenedione Reference Range (continued) (continued) Male: Premature Infants, 26 - 28 weeks - 4 days: 0.92 - 2.82 ng/mL Premature Infants, 31 - 35 weeks - 4 days: 0.80 - 4.46 ng/mL Full-term Infants, 1 - 7 days: 0.20 - 2.90 ng/mL 8 - 30 days: 0.18 - 0.80 ng/mL 1 - 5 months: 0.06 - 0.68 ng/mL 6 - 24 months: 0.03 - 0.15 ng/mL 2 - 3 years: < 0.11 ng/mL 4 - 5 years: 0.02 - 0.17 ng/mL 6 - 7 years: 0.01 - 0.29 ng/mL 8 - 9 years: 0.03 - 0.30 ng/mL 10 - 11 years: 0.07 - 0.39 ng/mL 12 - 13 years: 0.10 - 0.64 ng/mL 14 - 15 years: 0.18 - 0.94 ng/mL 16 - 17 years: 0.30 - 1.13 ng/mL 18 - 39 years: 0.33 - 1.34 ng/mL 40 years and older: 0.23 - 0.89 ng/mL Tanner Stage I: 0.04 - 0.32 ng/mL Tanner Stage II: 0.08 - 0.48 ng/mL Tanner Stage III: 0.14 - 0.87 ng/mL Tanner Stage IV - V: 0.27 - 1.07 ng/mL Days Performed: Sunday - Saturday Reported: 2 - 5 days Angiotensin II ANGII 79535 Specimen Requirement: 1 mL plasma from an EDTA lavender top tube; 6/27/2012 Patient prep: Patient should remain in a lying down posture for at least 30 minutes prior to specimen collection; Remove plasma from cells ASAP and freeze; Critical Frozen Reference Range: Refer to report Days Performed: Varies Reported: 4 - 14 days Antithrombin III Antigen AT3AG 76561 Special Information: A double centrifuged specimen is critical for accurate 6/14/2012 results as platelet contamination may cause spurious results. Specimen Requirement: 1 mL plasma from a sodium citrate light blue top tube; Overnight fasting is preferred; Tube must be completely filled; Remove plasma from cells ASAP, then recentrifuge the plasma and transfer to a second tube; Freeze immediately Methodology: Latex Immunoassay Reference Range: Adults: 80 - 130% Pediatric, full term infants: May have decreased levels (≥35 - 40%) which reach adult levels by 180 days Pediatric, premature infants (30-36 weeks gestation): May have decreased levels which reach adult levels by 180 days Days Performed: Monday - Friday Reported: 2 - 5 days Benztropine BENZTR 79202 Specimen Requirement: 2 mL serum from a red top tube; Do not use serum 7/31/2012 separator tube; Refrigerated Methodology: Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS) Days Performed: Sunday - Saturday Reported: 4 - 8 days CPT: 82542 Bupivacaine BUPIV 76365 Specimen Requirement: 1.5 mL serum from a red top tube; Do not use 6/19/2012 serum separator tubes; Refrigerated Methodology: Gas Chromatography / Mass Spectrometry (GCMS) Reference Range: No established reference values Days Performed: Monday Reported: 2 - 9 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 Calcitonin CALCIT 82038 Specimen Requirement: 2 mL serum from a serum separator tube; Remove 6/28/2012 serum from cells within 2 hours of collection; Refrigerated Methodology: Quantitative Chemiluminescent Immunoassay (CLIA) Reference Range: Male: ≥ 3 years: 0.0 - 7.5 pg/mL Female: ≥ 3 years: 0.0 - 5.1 pg/mL Days Performed: Sunday - Saturday Reported: 2 - 3 days Chlamydia Amplification CT 79809 Specimen Requirement: 15 mL random urine in a clean container; 5/31/2012 Note: Patients providing urine specimens should not have urinated within two hours of collection. Refrigerate immediately; Transport refrigerated within 24 hours. ~~ OR ~~ One Endocervical Swab in M4; Note: Collect endocervical swabs on females; Refrigerated ~~ OR ~~ One Swab in a GenProbe APTIMA Swab Specimen Transport Tube; Transport: Ambient; Note: Endocervical swabs on females and urethral swabs on males. White swab is used for cleaning excess mucus. Blue swab is used for specimen collection. ~~ OR ~~ One urethral swab in M4; Note: Collect urethral swabs on males; Refrigerated; ~~ OR ~~ Cervical specimen in Cytyc Thin Prep PreservCyt; Refrigerated; Note: The use of PreservCyt solution is not recommended unless performed in conjunction with a Thin Prep PAP test. Refrigerate if delay in transport. Must be transferred to GenProbe APTIMA Specimen Transport Tube within 30 days of collection Cimetidine CIMET 80313 Specimen Requirement: 3 mL serum from a red top tube; Do not use serum 6/20/2012 separator tubes; Refrigerated Days Performed: Varies Reported: 3 - 9 days Complement COMPF8 79282 Specimen Requirement: 1mL serum from a red top tube; Do not use serum 7/31/2012 Component C8 separator tubes; Patient should be fasting; Frozen Methodology: Turbidometric Reference Range: 33 - 58 U/mL Days Performed: Monday - Saturday Reported: 2 - 4 days CPT: 86161 Copper, Urine 24 hour UCOPD 82526 Methodology: Inductively Coupled Plasma/Mass Spectrometry (ICP-MS) 6/1/2012 Copper, Urine Random UCOPR 77599 Methodology: Inductively Coupled Plasma/Mass Spectrometry (ICP-MS) 6/1/2012 Creatine, Serum CRTSER 81301 Includes: Creatine (µmol/L), Creatine (mg/dL) 8/16/2012 Test build may need to be modified Specimen Requirement: 1 mL serum from a serum separator tube; Remove serum from cells within 2 hours of collection; Frozen Methodology: Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS) Reference Range: Refer to report Days Performed: Monday Reported: 3 - 10 days Cyanide, Blood CYANID 82600 Specimen Requirement: 4 mL whole blood in an EDTA lavender top tube; 6/20/2012 Keep container tightly capped; Ambient Methodology: Quantitative Colorimetric Reference Range: Normal: < 20 µg/dL Toxic: > 50 µg/dL Days Performed: Sunday - Saturday Reported: 2 - 3 days

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 Cystatin C CYSTC 83644 Specimen Requirement: 1 mL serum from a serum separator tube; 6/27/2012 Remove serum from cells within 2 hours of collection; Refrigerated Methodology: Quantitative Nephelometry Reference Range: 0 - 3 months: 0.8 - 2.3 mg/L 4 - 11 months: 0.7 - 1.5 mg/L 1 - 3 years: 0.5 - 1.3 mg/L 4 - 8 years: 0.5 - 1.3 mg/L 9 - 17 years: 0.5 - 1.3 mg/L ≥ 18 years: 0.5 - 1.0 mg/L Days Performed: Sunday - Saturday Reported: 1 - 2 days DHEA DHEA 75487 Specimen Requirement: 1 mL serum from a serum separator tube; Collect 6/21/2012 between 6 - 10 a.m.; Remove serum from cells within 2 hours of collection; Refrigerated Reference Range: Female: Premature: < 40 ng/mL 0 - 1 day: < 11 ng/mL 2 - 6 days: < 8.7 ng/mL 7 days - 1 month: < 5.8 ng/mL 1 - 5 months: < 2.9 ng/mL 6 - 24 months: < 1.9 9 ng/mL 2 - 3 years: < 0.85 ng/mL 4 - 5 years: < 1.03 ng/mL 6 - 7 years: < 1.79 ng/mL 8 - 9 years: 0.14 - 2.35 ng/mL 10 - 11 years: 0.43 - 3.78 ng/mL 12 - 13 years: 0.89 - 6.21 ng/mL 14 - 15 years: 1.22 - 7.01 ng/mL 16 - 17 years: 1.42 - 9.00 ng/mL 18 - 39 years: 1.33 - 7.78 ng/mL 40 years and older: 0.63 - 4.70 ng/mL Postmenopausal: 0.60 - 5.73 ng/mL Tanner Stage I: 0.14 - 2.76 ng/mL Tanner Stage II: 0.83 - 4.87 ng/mL Tanner Stage III: 1.08 - 7.56 ng/mL Tanner Stage IV-V: 1.24 - 7.88 ng/mL Male: Premature: < 40 ng/mL 0 - 1 day: < 11 ng/mL 2 - 6 days: < 8.7 ng/mL 7 days - 1 month: < 5.8 ng/mL 1 - 5 months: < 2.9 ng/mL 6 - 24 months: < 2.5 ng/mL 2 - 3 years: < 0.63 ng/mL 4 - 5 years: < 0.95 ng/mL 6 - 7 years: 0.06 - 1.93 ng/mL 8 - 9 years: 0.10 - 2.08 ng/mL 10 - 11 years: 0.32 - 3.08 ng/mL 12 - 13 years: 0.57 - 4.10 ng/mL 14 - 15 years: 0.93 - 6.04 ng/mL 16 - 17 years: 1.17 - 6.52 ng/mL 18 - 39 years: 1.33 - 7.78 ng/mL 40 years and older: 0.63 - 4.70 ng/mL Tanner Stage: 0.11 - 2.37 ng/mL Tanner Stage II: 0.37 - 3.66 ng/mL Tanner Stage III: 0.75 - 5.24 ng/mL Tanner Stage IV-V: 1.22 - 6.73 ng/mL Days Performed: Sunday - Saturday Reported: 2 - 5 days Diltiazem DILTIA 79519 Specimen Requirement: 3 mL of serum from a red top tube; Do not use 7/31/2012 serum separator tubes; Refrigerated Reference Range: 50 - 200 ng/mL Days Performed: Monday - Saturday Reported: 4 - 8 days CPT: 82491

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

Test Name Order Code Billing Code Change Effective Date Diphtheria/Tetanus DIPTET 75455 Specimen Requirement: 1 mL serum from a serum separator tube; Remove 6/28/2012 Antibody serum from cells within 2 hours of collection; Refrigerated Methodology: Quantitative Multiplex Bead Assay Reference Range: Antibody concentrations of > 0.1 IU/mL are usually considered protective for diphtheria or tetanus Days Performed: Sunday - Saturday Reported: 2 - 3 days DPD 5FU GenotypR 5FU 84203 Includes: DPD Gene Mutation 8/17/2012 Interpretation Reviewed by Test build may need to be modified Days Performed: 2 days per week Reported: 6 - 15 days CPT: 83891, 83892x3, 83898, 83909, 83914 Ethambutol ETHAMB 80342 Specimen Requirement: 1 mL serum from a red top tube; Do not use serum 6/20/2012 separator tubes; Refrigerated Methodology: Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS) Reference Range: Refer to report Days Performed: Varies Reported: 3 - 9 days Ethosuximide ETHO 82692 Specimen Requirement: 1 mL serum from a red top tube; Do not use serum 6/21/2012 separator tubes; Remove serum from cells within 2 hours of collection; Refrigerated Reference Range: 40 - 100 µg/mL Toxic: > 150 µg/mL Flecainide FLEC 1024 Specimen Requirement: 2 mL serum from a red top tube; Do not use serum 6/20/2012 separator tubes; Separate serum from cells within 6 hours of collection; Refrigerated Methodology: Quantitative Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) Reference Range: Therapeutic Range: 0.20 - 1.00 µg/mL Toxic: >1.50 µg/mL Days Performed: Sunday - Saturday Reported: 2 - 3 days Flunitrazepam, Serum FLUNS 82106 Reference Range: Refer to report 6/28/2012 Days Performed: Sunday - Saturday Reported: 6 - 10 days Free T3 Tracer Dialysis T3DIAL 81700 Special Information: Some patients who have been exposed to animal 8/15/2012 antigens, either in the environment or as part of treatment or imaging procedures, may have circulating anti-animal antibodies present. These antibodies may interfere with the assay reagents to produce unreliable results. Includes: Free T3 Test build may need to be modified Specimen Requirement: 0.6 mL serum from a serum separator tube; Refrigerated Methodology: Enzyme Immunoassay (EIA) Reference Range: ≥ 1 year: 2.0 - 3.5 pg/mL Days Performed: Monday - Saturday Reported: 2 - 4 days CPT: 84481

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 7 Test Changes (cont.)

Test Name Order Code Billing Code Change Effective Date Fructosamine FRUCTO 76672 Special Information: Hemolysis may cause falsely elevated results. High 6/27/2012 levels of ascorbic acid interfere with the Fructosamine assay. Patients should abstain from ascorbic acid supplements for a minimum of 24 hours prior to sample collection. Specimen Requirement: 0.5 mL serum from a serum separator tube; Refrigerated Methodology: Quantitative Spectrophotometry Reference Range: 170 - 285 µmol/L Days Performed: Sunday - Saturday Reported: 1 - 2 days G-6 PD Quantitative G6PDQT 30039 Specimen Requirement: 3 mL whole blood in an EDTA Lavender tube; 6/20/2012 Refrigerated Methodology: Quantitative Enzymatic Reference Range: 7.0 - 20.5 U/g Hb Days Performed: Sunday - Saturday Reported: 2 - 3 days GC/Chlamydia GCCT 79830 Specimen Requirement: 15 mL random urine in a clean container; Note: 5/31/2012 Amplification Patients providing urine specimens should not have urinated within two hours of collection. Refrigerate immediately. Transport Refrigerated within 24 hours. ~~ OR ~~ One Endocervical swab in M4; Note: Collect endocervical swabs on females; Refrigerated; ~~ OR ~~ One swab; Note: Endocervical swab on females and urethral swabs on males. White swab is used for cleaning excess mucus. Blue swab is used for specimen collection. Place swab in GenProbe APTIMA Swab Specimen Transport Tube; Ambient ~~ OR ~~ One urethral swab in M4; Note: Collect urethral swabs on males; Refrigerated ~~ OR ~~ Cervical specimen in Cytyc Thin Prep PreservCyt; Refrigerated; Note: The use of PreservCyt solution is not recommended unless performed in conjunction with a Thin Prep PAP test. Refrigerate if delay in transport. Must be transferred to GenProbe APTIMA Specimen Transfer Tube within 30 days of collection GC Amplification GC 79810 Specimen Requirement: 15 mL random urine in a clean container; 5/31/2012 Note: Patients providing urine specimens should not have urinated within two hours of collection. Refrigerate immediately. Transport refrigerated within 24 hours. ~~ OR ~~ One Endocervical swab in M4; Refrigerated; Note: Collect endocervical swabs on females ~~ OR ~~ One swab; Ambient; Note: Endocervical swabs on females and urethral swabs on males. White swab is used for cleaning excess mucus. Blue swab is used for specimen collection. Place swab in GenProbe APTIMA Swab Specimen Transport Tube. ~~ OR ~~ One Urethral swab in M4; Note: Collect urethral swabs on males; Refrigerated ~~ OR ~~ Cervical specimen in Cytyc Thin Prep PreservCyt; Refrigerated; Note: The use of PreservCyt solution is not recommended unless performed in conjunction with a Thin Prep PAP test. Refrigerate if delay in transport. Must be transferred to GenProbe APTIMA Specimen Transfer Tube within 30 days of collection. Gliadin GLIIGA 88659 Test Name: Previously listed Gliadin (Deaminated) IgA Ab 6/26/2012 (Deamidated) IgA Ab Specimen Requirement: 1 mL serum from a serum separator tube; Refrigerated Gliadin GLIIGG 88660 Test Name: Previously listed as Gliadin (Deaminated) IgG Ab 6/26/2012 (Deamidated) IgG Ab Specimen Requirement: 1 mL serum from a serum separator tube; Refrigerated

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 8 Test Changes (cont.)

Test Name Order Code Billing Code Change Effective Date Glyburide GLYBUR 80351 Specimen Requirement: 3 mL serum from a red top tube; Do not use serum 6/20/2012 separator tubes; Refrigerated Reference Range: Refer to report Days Performed: Varies Reported: 3 - 9 days Glycoproteins GLYCO 83864 Specimen Requirement: 1 mL serum from a serum separator tube; 6/21/2012 Remove serum from cells within 2 hours of collection; Refrigerated Reference Range: 47 -125 mg/dL Days Performed: Wednesday, Saturday Reported: 2 - 6 days Hepatitis Be Antibody AHBE 82689 Methodology: Chemiluminescence Immunoassay (CLIA) 6/28/2012 Herpesvirus 7 IgG and HHV7 81733 Special Information: This assay is performed using a kit labeled 'For 7/12/2012 IgM Antibodies Research Use Only' by the kit manufacturer. The kit's performance characteristics have been established and validated by the performing laboratory for in-vitro diagnostic use. Days Performed: Thursday Reported: 2 - 11 days HIV Quant RNA by PCR HIVRNA 79261 Special Information: 7/16/2012 Following are Improved features of the FDA cleared version 2.0 HIV RNA Test: * The version 2.0 HIV-1 Test quantifies the HIV-1 RNA based on the co-amplification of two distinct regions of the HIV-1 Genome, LTR and gag, providing broad coverage of the evolving HIV-1 genome a. Linear dynamic Range: 20 - 10,000,000 copies/mL b. Analytical Specificity: 100% c. Genotype Inclusivity: HIV Group M subtypes A - H, including Group O and Circulating Recombinant Forms (CRF) d. Sensitivity: 20 copies/mL across Group M subtypes Same as previous version 1.0: e. Quantitation Standard (QS) - Internal control also serves as an inner-sample calibrator f. Correlations - 95% of samples +/- 0.3 log10 difference to version 1.0 g. Standardization - calibration and controls are anchored to WHO standard - NIBSC Code 97/656 (just as FYI) h. Automation - COBAS AmpliPrep / COBAS Taqman 48; AmpliLInk 3.2 software. Includes: HIV-1 RNA (copies/mL) HIV-1 (log copies/mL) Test build may need to be modified Specimen Requirement: 3 mL plasma in an EDTA white top tube; Separate plasma from cells within 24 hours of collection; Do not pour off; Refrigerated Days Performed: 2 days per week Reported: 10 days Hyperoxaluria, Urine UHYPER 87816 Components: Glycolate 6/28/2012 Glycerate Oxalate Glyoxylate Interpretation Reviewed by Test build may need to be modified Immunofixation Screen, IFESC 88134 Components: Result 6/21/2012 Serum Interpretation Test build may need to be modified Reference Range: Result: No protein identified Interpretation: Refer to report

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 9 Test Changes (cont.)

Test Name Order Code Billing Code Change Effective Date Inhibin B INHIBB 82819 Special Information: Research Use Only 6/20/2012 Specimen Requirement: 0.5 mL serum from a serum separator tube; Refrigerated Methodology: Enzyme Linked Immunosorbent Assay (ELISA) Reference Range: Male: 0 - 23 months: <430 pg/mL 2 - 4 years: <269 pg/mL 5 - 7 years: <184 pg/mL 8 - 10 years: <214 pg/mL 11 - 13 years: <276 pg/mL 14 - 17 years: <273 pg/mL Adults: <399 pg/mL Female: 0 - 23 months: <111 pg/mL 2 - 4 years: <44 pg/mL 5 - 7 years: <27 pg/mL 8 - 10 years: <67 pg/mL 11 - 13 years: <120 pg/mL 14 - 17 years: <136 pg/mL Premenopausal Follicular: <139 pg/mL Luteal: <92 pg/mL Postmenopausal: <10 pg/mL Days Performed: Tuesday Reported: 2 - 8 days Insulin Like Growth IGFII 79460 Days Performed: Wednesday 6/21/2012 Factor II Reported: 3 - 9 days Magnesium, Urine UMAGD 83765 Methodology: Inductively Coupled Plasma/Mass Spectrometry (ICP-MS) 6/1/2012 24 hour Magnesium, Urine UMAGR 77600 Methodology: Inductively Coupled Plasma/Mass Spectrometry (ICP-MS) 6/1/2012 Random Measles IgM Antibody MEAIGM 77119 Specimen Requirement: 0.5 mL serum from a serum separator tube; 6/26/2012 Remove serum from cells within 2 hours of collection; Refrigerated Methodology: Enzyme Linked Immunosorbent Assay (ELISA) Reference Range: ≤ 0.79 AU: Negative 0.80-1.20 AU: Equivocal - Repeat testing may be helpful ≥ 1.21: Positive - IgM antibodies to measles virus detected Meperidine & MEPNO 80337 Specimen Requirement: 2 mL serum from a red top tube; Do not use serum 7/31/2012 Normeperidine separator tubes; Remove serum from cells within 2 hours of collection; Refrigerated Methodolgy: Liquid Chromatography - Tandem Mass Spectrometry (LC-MS/MS) Reference Range: Refer to report Days Performed: Tuesday Reported: 2 - 8 days CPT: 83925 Monoclonal Protein, U24MPA 87911 Components: Result 6/21/2012 24 Hour Urine Interpretation Test build may need to be modified Reference Range: Result: No protein identified Interpretation: Refer to report Monoclonal Protein, MPASRM 41 Components: Monoclonal Protein, IgG 6/21/2012 Blood Monoclonal Protein, IgA Monoclonal Protein, IgM Kappa Lambda Monoclonal Protein Kappa/Lambda Ratio M Protein Interpretation Test build may need to be modified Reference Range: M Protein: No M Protein is identified Interpretation: Refer to report All other components are unchanged

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 10 Test Changes (cont.)

Test Name Order Code Billing Code Change Effective Date Monoclonal Protein, Fluid FMPA 77079 Components: Fluid type 6/21/2012 Result Interpretation Test build may need to be modified Reference Range: Result: No protein identified Interpretation: Refer to report Monoclonal Protein, Urine URMPA 75391 Components: Result 6/21/2012 Interpretation Test build may need to be modified Reference Range: Result: No protein identified Interpretation: Refer to report Myositis AssessR MYOSIT 84462 Components: PL-7 Autoantibodies 8/15/2012 PL-12 Autoantibodies Mi-2 Autoantibodies Ku Autoantibodies EJ Autoantibodies OJ Autoantibodies SRP Autoantibodies U2 snRNP Autoantibodies Test build may need to be modified Specimen Requirement: 3 mL serum from a red top tube; Refrigerated Methodology: Immunoprecipitation (IPP) Reference Range: PL-7: Negative PL-12: Negative Mi-2: Negative Ku: Negative EJ: Negative OJ: Negative SRP: Negative U2 snRNP: Negative Days Performed: 1 day per week Reported: 15 - 19 days CPT: 83516x8 NMR Lipoprofile NMRLIP 82739 Specimen Requirement: 2 mL serum from a red top tube; Do not use serum 7/11/2012 (continued on next page) separator tubes; Patient should be fasting; Refrigerated Reference Range: HDL-P (total): Low Risk: >34.9 µmol/L Intermediate: 34.9 - 26.7 µmol/L High Risk: <26.7 µmol/L Small LDL-P: Low Risk: <117 nmol/L Intermediate: 117 - 526 nmol/L Borderline: 527 - 839 nmol/L High Risk: >839 nmol/L LDL Size: Large (Pattern A): 23.0 - 20.6 nm Small (Pattern B): 20.5 - 18.0 nm Large VLDL-P: Insulin Sensitive: <0.9 nmol/L Intermediate: 0.9 - 6.9 nmol/L Insulin Resistant: >6.9 nmol/L Large HDL-P: Insulin Sensitive: >7.3 µmol/L Intermediate: 7.3 - 3.1 µmol/L Insulin Resistant: <3.1 µmol/L VLDL Size: Insulin Sensitive: <42.4 nm Intermediate: 42.4 - 52.5 nm Insulin Resistant: >52.5 nm

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 11 Test Changes (cont.)

Test Name Order Code Billing Code Change Effective Date NMR Lipoprofile Reference Range (continued) (continued) LDL Size: Insulin Sensitive: >21.2 nm Intermediate: 21.2 - 20.4 nm Insulin Resistant: <20.4 nm HDL Size: Insulin Sensitive: >9.6 nm Intermediate: 9.6 - 8.9 nm Insulin Resistant: <8.9 nm LP-IR Score (0-100) Insulin Sensitive: <27 Intermediate: 27 - 63 Insulin Resistant: >63 LDL- P (LDL Particle Number) Low: <1,000 nmol/L Moderate: 1,000 - 1,299 nmol/L Borderline-High: 1,300 - 1,599 nmol/L High: 1,600 - 2,000 nmol/L Very High: >2,000 nmol/L LDL-C (calculated): Optimal <100 mg/dL Near or above optimal: 100 - 129 mg/dL Borderline-high: 130 - 159 mg/dL High: 160 - 190 mg/dL Very High: >190 mg/dL HDL-Cholesterol: Desirable: ≥40 mg/dL Triglycerides: Desirable: <150 mg/dL Total Cholesterol: Desirable: <200 mg/dL Days Performed: Monday - Saturday Reported: 4 - 8 days Norwalk Like Virus NORWLK 82968 Reference Range: Negative 7/12/2012 Antigen Days Performed: Monday, Wednesday, Friday Reported: 2 - 10 days Parvo B19 PCR, plasma PARPLS 87609 Specimen Requirement: 1 mL plasma from an EDTA lavender top tube; 7/12/2012 Frozen Reference Range: Refer to report Days Performed: Monday, Wednesday, Friday Reported: 2 - 5 days Pregnenolone PREG 80398 Specimen Requirement: 1 mL serum from a serum separator tube; 6/21/2012 Remove serum from cells ASAP and freeze; Transport Frozen Reference Range: CHILDREN Males 0 - 6 years: not established 7 - 9 years: <206 ng/dL 10 - 12 years: <152 ng/dL 13 - 15 years: 18 - 197 ng/dL 16 - 17 years: 17 - 228 ng/dL TANNER STAGES Stage I: <157 ng/dL Stage II: <144 ng/dL Stage III: <215 ng/dL Stage IV - V: 19 - 201 ng/dL Females 0 - 6 years: not established 7 - 9 years: <151 ng/dL 10 - 12 years: 19 - 220 ng/dL 13 - 15 years: 22 - 210 ng/dL 16 - 17 years: 22 - 229 ng/dL TANNER STAGES Stage I: <172 ng/dL Stage II: 22 - 229 ng/dL Stage III: 34 - 215 ng/dL Stage IV - V: 26 - 235 ng/dL ADULTS: ≥18 years: 33 - 248 ng/dL Days Performed: Tuesday, Thursday Reported: 3 - 9 days

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 12 Test Changes (cont.)

Test Name Order Code Billing Code Change Effective Date Proinsulin PROINS 79206 Specimen Requirement: 1 mL serum from a serum separator tube; Patient 6/28/2012 MUST fast 12-15 hours prior to collection; Remove serum from cells within 2 hours of collection; Frozen Methodology: Quantitative Enzyme-Linked Immunosorbent Assay (ELISA) Reference Range: 0 - 1 year: Not established ≥ 2 years: ≤ 26.8 pmol/L Days Performed: Tuesday, Thursday Reported: 2 - 7 days Ritalin RITAL 77096 Specimen Requirement: 3 mL serum from a red top tube; Do not use serum 6/19/2012 separator tubes; Remove serum from cells ASAP and freeze; Transport Frozen Reference Range: 5.0 - 20.0 ng/mL Days Performed: Sunday - Saturday Reported: 4 - 5 days Selenium, Plasma PSELEN 82905 Special Information: Diet, medication, and nutritional supplements may 6/28/2012 introduce interfering substances. Patients should be encouraged to discontinue nutritional supplements, vitamins, minerals, and non-essential over-the-counter medications (upon the advice of their physician). Specimen Requirement: 2 mL plasma from an EDTA navy blue top tube; Do not use plasma separator tubes; Remove plasma from cells ASAP; Ambient Reference Range: 23 - 190 µg/L Days Performed: Sunday - Saturday Reported: 2 - 3 days Strychnine STRYCH 80555 Specimen Requirement: 5 mL serum from a red top tube; Do not use serum 7/31/2012 separator tubes; Refrigerated Reference Range: Refer to report Days Performed: Varies Reported: 4 - 11 days CPT: 82542 Toxic Shock Syndrome TSS 76679 Reference Range: Refer to report 6/21/2012 Antibodies Days Performed: Varies Reported: 4 - 16 days Transketolase TKETO 88603 Specimen Requirement: THIS ASSAY REQUIRES MULTIPLE SPECIMEN 6/14/2012 TYPES: 3 mL whole blood in a sodium heparin green top tube; Frozen *AND* 2.5 mL of whole blood in an EDTA lavender top tube; Ambient CPT: 84425 Urine Culture URCUL 76839 Special Information: (continued on next page) • Normal flora from the urethra, vagina and perineum often contaminate urine specimens. Quantitation of bacteria in urine cultures helps the labora- tory to distinguish contaminated specimens from those representing infec- tion. The most common uropathogens are normal intestinal flora organisms such as Escherichia coli, Klebsiella spp. Enterobacter spp., Proteus spp. and Enterococcus spp. • Urine specimens are processed based on whether the specimen was col- lected with an invasive (straight catheter, suprapubic aspirate, cystoscopy) or noninvasive (midstream clean catch, indwelling catheter, stoma) method. A low colony count is performed on urine specimens collected via invasive methods. • No growth report includes the limit of detection based on amount of urine inoculated: <1,000 CFU/mL for noninvasive specimens and <100 CFU/ mL for invasive specimens. • The threshold for performing susceptibility testing is >10,000 CFU/mL for noninvasive and >1,000 CFU/mL for invasive specimens. The level of work up is based on the specimen type, number of different organisms growing, and the quantity of potential uropathogens in relation to urogenital flora. Urogenital flora organisms include viridans group streptococci, commensal Neisseria spp., Lactobacillus spp., Bacillus spp., Micrococcus spp., and Gardnerella vaginalis. Organisms such as diphtheroids, Staphylococcus spp., Aerococcus spp. and yeast are considered urogenital flora unless present in amounts 10-fold greater than other organisms in the culture. • Noninvasive cultures yielding 3 or more different organism with no predominant uropathogen are reported as Multiple organisms, no one type predominant, suggestive of collection contamination or delayed transport to laboratory. Recollect if clinically indicated.

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Test Name Order Code Billing Code Change Effective Date Urine Culture URCUL 76839 Specimen Requirement: 4 mL random urine in a BD Vacutainer C&S 6/28/2012 (continued) Preservative gray tube; Submerge the tip of transfer straw into urine specimen. Push the gray top C&S preservative tube into the transfer straw. Hold in position until flow stops. Must be filled to the minimum fill line on the tube (3 mL). Remove tube leaving transfer straw in urine specimen container. Shake tube vigorously to mix sample. If both a UA (red/yellow) and C&S tube (gray top) are being collected, transfer urine to C&S tube first: Ambient Collection Instructions: 1. Voided midstream clean catch method: Instruct patients to wash hands prior to collection, offer exam gloves. a. Female patients should be instructed to sit on toilet with legs apart and spread labia with one hand. First void in toilet and then, continuing to void, hold specimen container in midstream to collect sample. b. Male patients should be instructed to retract foreskin if uncircumcised. First void in toilet and then, continuing to void, hold specimen container in midstream to collect sample. 2. Indwelling (foley) catheter or suprapubic tube (SPT): Clamp catheter, separate the foley from the bag, clean the hub with 70% alcohol and col- lect freshly voided urine. Transfer to sterile container. Do not collect urine from collection bag. Indwelling catheter specimens are treated as voided midstream specimens. NOTE: Catheter tips from urinary catheters will not be cultured 3. Straight catheter: Thoroughly cleanse the urethral opening with betadine or chlorasept. Then pass catheter using sterile technique into the bladder. After discarding initial 15 to 30 mL of urine, collect urine for submission in a sterile container. 4. Cystoscopy: Label specimens obtained while cystoscope is in bladder CB for catheterized bladder. Label specimens of irrigated fluid passing from bladder though ureteral catheters WB (washed bladder urine). Label specimens collected with ureteral catheters passed to midureter or renal pelvis LK-1, RK-1, LK-2, and RK-2 (LK for left kidney, RK for right kidney). Submit all samples in a sterile container. 5. Stoma (i.e., ileal conduit, nephrostomy, ureterostomy, cystostomy): Remove the external device and discard urine within device. Gently cleanse the stoma. Using sterile technique, insert a catheter into the cleansed stoma, and collect the urine by aspirating back on the syringe. After discarding initial 15 to 30 mL of urine, transfer urine for submission in a sterile container. 6. Prostatic secretions: Multiple samples are cultured. If one specimen grows far more bacteria than others, the infection is localized to the urethra, bladder, or prostate VB1 (voided bladder 1) – 1st 10 mL of urine represents urethra VB2 – midstream urine represents bladder EPS (expressed prostatic fluid) – Prostate massaged; represents prostate VB3 – also represents prostate Voriconazole VORCON 84568 Specimen Requirement: 1 mL serum from a red top tube; Do not use serum 6/27/2012 separator tubes; Frozen Days Performed: Tuesday, Friday Reported: 2 - 7 days Whole Genome SNP WGSNP 88472 Specimen Requirement: THIS ASSAY REQUIRES MULTIPLE SPECIMEN 7/12/2012 Microarray TYPES: 3 - 5 mL whole blood in an EDTA lavender top tube; Ambient *AND* 3 - 5 mL whole blood in a sodium heparin green top tube; Ambient; Collect Monday - Thursday only; Both specimens must be received in Cleveland Clinic Laboratories on the day of collection before 3 p.m. Zinc, Urine 24 hour UZINCD 84635 Methodology: Inductively Coupled Plasma/Mass Spectrometry (ICP-MS) 6/1/2012 Zinc, Urine Random UZINCR 77601 Methodology: Inductively Coupled Plasma/Mass Spectrometry (ICP-MS) 6/1/2012

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Test Name Order Code Billing Code Change Effective Date FISH for CCND1 CCND1F 88674 Special Information: Please order by manual requisition and clearly indicate 7/2/2012 the specimen type on the requisition and the label on the tube Specimen Requirement: 7 mL whole blood in an EDTA lavender top tube; Refrigerated *OR* 4 mL bone marrow in an EDTA lavender top tube; Refrigerated *OR* Formalin fixed paraffin embedded tissue block containing representative tissue; Ambient *OR* Six unstained electrostatically charged slides, with 4 µm tissue sections representative of the tumor; Do not use B5 or PREFER fixative; Ambient Methodology: Fluorescent In-Situ Hybridization (FISH) Reference Range: Negative for CCND1 rearrangement Days Performed: 3 days per week Reported: 7 days CPT: 88368x2 (paraffin block) or 88367x2 (blood, bone marrow) Price: $808.00 (non-discountable)

Discontinued Tests

Test Name Order Code Billing Code Test Information Effective Date Methemalbumin METALB 83857 This test will no longer be available 7/3/2012 Urine Culture/Special URSP 77895 This test will no longer be available; 6/28/2012 Suggest ordering Urine Culture (URCUL)

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