Cleveland Clinic Laboratories Technical Update • November 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].

T CP d te or ep /R e ed ng rm Ra rfo ce Pe gy en ys olo fer d Da Re ho et ge M an Ch t nt en ne m po e r i m n qu Co tio Re a en rm im Info d ec ue ial Sp tin ec on st Sp sc Te Di w st Te Ne ge n ha eC m de Na Co g e od

Albumin/Creatinine Ratio, Urine Timed

2

Anti Mullerian Hormone

2

Bloom Syndrome Mutation Analysis

6

Bordetella pertussis Antibody, IgA by Immunoblot

6

Bordetella pertussis Antibody, IgG by Immunoblot

6

Bordetella pertussis Antibody, IgM by Immunoblot

2

C Telopeptide, Beta Cross Linked

2

Cadmium Exposure Panel, OSHA

2

Canavan Disease Mutation, Fluid

2

Canavan Disease Mutation, Whole Blood

3

CDKL5-Related Atypical Rett Syndrome

3

Chromosome Analysis, Amniotic Fluid

3

Chromosome Analysis, Chorionic Villus

3

Cyclic AMP, Nephrogenous

3

Diagnostic CF Test

3

Duchenne/Becker Muscular Dystrophy DNA Carrier (females only)

3

EBV Antibody Panel

3

Estrogen, Serum Fractionated

3

Everolimus

3

FSH

3

Gaucher Disease Mutation, Fluid

3

Gaucher Disease Mutation, Whole Blood

4

GM1 Antibody Panel

4

HIV-2 IgG Abs, Confirmation

6

IBD Serology Disease Panel

rC

AFP L3% % Total, Hepatocellular Carcinoma

2

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2

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Summary of Changes by Test Name

9500 Euclid Avenue | Cleveland, Ohio 44195 | 216.444.5755 | 800.628.6816 | clevelandcliniclabs.com 1

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Summary of Changes by Test Name

4

Influenza A Antibody

4

Influenza A & B Antibodies

4

Influenza B Antibody

4

LH

4

Lysosomal Enzyme Screen

4

Maternal Cell Contamination

4

MEN2 and FMTC Mutation

4

Neutrophil Cytoplasmic Antibody

4

Niemann-Pick Disease Type A Mutation, Fluid

4

Niemann-Pick Disease Type A Mutation, Whole Blood

4

Prader-Willi/Angelman Methylation

7

Prometheus IBD Serology 7

7

Prometheus IBD sgi Diagnostic

4

PRO-Predict Infliximab/HACA, Serum

5

Prostate Cancer Biomarker

5

Respiratory Syncytial Virus Abs, IgG & IgM

5

Risperidone & Metabolite

5

Sulfonylurea Hypoglycemics, Urine

5

Torch Antibodies IgG & IgM

5

VAP

5

Vitamin B2

Test Changes Test Name

Order Code

Billing Code

Change

Effective Date

AFP L3% % Total, Hepatocellular Carcinoma

AFPL3

84384

Specimen Requirement: 1 mL serum from a serum separator tube; Remove serum from cells within two hours of collection; Frozen

10/21/2011

Reference Range: Alpha Fetoprotein Total: 0 - 15 ng/mL Alpha Fetoprotein L3%: 0 - 9.9% Days Performed: Thursday Reported: 2 - 9 days Albumin/Creatinine Ratio, Urine Timed

UACRT

80046

Reference Range: Creatinine, Random Urine: 20 - 300 mg/dL Albumin Urine Random: 0.0 - 23.0 mg/L Albumin/Creat Ratio: 0 - 30 mg/g Albumin Urine, Timed: 0.0 - 1.2 mg/hr

11/9/2011

Anti Mullerian Hormone

MULLER

84474

Days Performed: Monday - Friday

12/8/2011

Reported: 3 - 7 days Bloom Syndrome Mutation Analysis

BLOOM

83021

CPT: 83893, 83894, 83896, 83898

11/10/2011

C Telopeptide, Beta Cross Linked

CTELO

84398

Days Performed: Tuesday, Thursday, Saturday

1/3/2012

Cadmium Exposure Panel, OSHA

CADEXR

Canavan Disease Mutation, Fluid

CANV2

83013

CPT: 83891, 83893x4, 83894, 83896x4, 83900, 83901

11/10/2011

Canavan Disease Mutation, Whole Blood

CANVAN

83014

CPT: 83891, 83893x4, 83894, 83896x4, 83900, 83901

11/10/2011

Reported: 2 - 5 days 81903

Days Performed: Monday - Friday

1/3/2012

Reported: 2 - 6 days

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

2

Test Changes (cont.) Test Name

Order Code

Billing Code

Change

Effective Date

CDKL5-Related Atypical Rett Syndrome

CDKL5

87776

Specimen Requirement: 8 mL whole blood in an EDTA lavender top tube; Ambient

1/3/2012

Chromosome Analysis, Amniotic Fluid

FAMCYT

77375

CPT: 88235, 88267, 88280

11/10/2011

Chromosome Analysis, Chorionic Villus

CVCYTO

77376

CPT: 88235, 88267, 88280

11/10/2011

Cyclic AMP, Nephrogenous

CYCNEP

81998

Specimen Requirement: THIS ASSAY REQUIRES MULTIPLE SPECIMEN TYPES: 1 mL plasma from an EDTA lavender top tube; Place specimen on ice after collection; Remove plasma from cells ASAP or within 2 hours of collection; Frozen *AND* 5 mL random urine in a clean container; Freeze specimen ASAP after collection.

1/3/2012

Days Performed: Sunday - Saturday Reported: 3 - 11 days Diagnostic CF Test

CFDNA

80939

CPT: 83891, 83900, 83901x22, 83914x97

11/10/2011

Duchenne/Becker Muscular Dystrophy DNA Carrier (females only)

DBMDXS

83006

CPT: 83891, 83900, 83901x93, 83909x2, 83914x95

10/13/2011

EBV Antibody Panel

EBVPNL

46

Order Code: Previously EBVPAN

12/7/2011

Estrogen, Serum Fractionated

ESTGEN

75491

Reference Range: Male: 7 - 9 Years; < 10 pg/mL 10 - 12 Years; 1 - 19 pg/mL 13 - 15 Years; 3 - 62 pg/mL 16 - 17 Years; 4 - 64 pg/mL > 17 Years: 19 - 69 pg/mL Tanner Stage I: 1 - 11 pg/mL Tanner Stage II: 1 - 19 pg/mL Tanner Stage III: 3 - 61 pg/mL Tanner Stage IV: 4 - 62 pg/mL Female: 7 - 9 Years; 1 - 48 pg/mL 10 - 12 Years; 2 - 116 pg/mL 13 - 15 Years; 15 - 333 pg/mL 16 - 17 Years; 6 - 354 pg/mL > 17 Years, Early Follicular Phase: 30 - 250 pg/mL > 17 Years, Late Follicular Phase: 200 - 650 pg/mL > 17 Years, Luteal Phase: 50 - 350 pg/mL > 17 Years, Postmenopausal: 5 - 52 pg/mL Tanner Stage I: 1 - 86 pg/mL Tanner Stage II: 3 - 169 pg/mL Tanner Stage III: 23 - 351 pg/mL Tanner Stage IV: 8 - 341 pg/mL All other Reference Ranges remain unchanged

1/3/2012

Everolimus

EVEROL

88194

Specimen Requirement: 1 mL whole blood in an EDTA lavender top tube; Refrigerated

12/1/2011

Reference Range: 3.0 - 8.0 ng/mL Days Performed: Sunday - Saturday Reported: 1 - 2 days FSH

FSH

83001

Reference Range: Female: Follicular: 2 - 11 mU/mL Midcycle: 10 - 30 mU/mL Luteal: 1 - 9 mU/mL Postmenopausal: 20 - 100 mU/mL Male: 1.0 - 10.0 mU/mL

9/16/2011

Gaucher Disease Mutation, Fluid

GAUCH

83011

CPT: 83893x5, 83894x2, 83896x5, 83898, 83900

11/10/2011

Gaucher Disease Mutation, Whole Blood

GAUCHR

83012

CPT: 83893x5, 83894x2, 83896x5, 83898, 83900

11/10/2011

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

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Test Changes (cont.) Test Name

Order Code

Billing Code

Change

Effective Date

GM1 Antibody Panel

GM1ABP

77133

Includes: GM1 Antibody IgG, GM1 Antibody IgM

11/23/2011

Specimen Requirement: 0.5 serum from a serum separator tube; Place specimen on ice after collection; Centrifuge, aliquot and refrigerate within 2 hours of collection; Refrigerated Reference Range: GM1 Antibody IgG: Negative: ≤29 IV Equivocal: 30 - 50 IV Positive: 51 - 100 IV Strong positive: ≥ 101 IV GM1 Antibody IgM: Negative: ≤29 IV Equivocal: 30 - 50 IV Positive: 51 - 100 IV Strong positive: ≥ 101 IV CPT: 83516x2 HIV-2 IgG Abs, Confirmation

HIV2WB

78717

Includes: HIV 2 IgG Antibodies (Test build may need to be modified, bands are no longer included with this confirmation)

Influenza A Antibody

INFLUA

50092

Days Performed: Monday, Wednesday, Friday

11/9/2011

Reference Range: Negative 1/3/2012

Reported: 2 - 5 days Influenza A & B Antibodies

INFLAB

Influenza B Antibody

INFLUB

77992

Days Performed: Monday, Wednesday, Friday

1/3/2012

Reported: 2 - 7 days 75665

Days Performed: Monday, Wednesday, Friday

1/3/2012

Reported: 2 - 5 days LH

LH

83002

Reference Range: Female: Follicular: 1 - 12 mU/mL Midcycle: 20 - 90 mU/mL Luteal: 1 - 10 mU/mL Postmenopausal: >20 mU/mL Male: 1.0 - 7.0 mU/mL

9/16/2011

Lysosomal Enzyme Screen

LYSOSM

82915

Specimen Requirement: 8 mL whole blood in a sodium or lithium heparin green top tube; Draw Monday - Wednesday only; Specimen must be received in Cleveland Clinic Laboratories on the same day as collection and before 3 PM; Clinical and/or family history MUST accompany the specimen; Ambient

12/1/2011

Maternal Cell Contamination

MATRNL

83042

CPT: 83891, 83900, 83901x11, 83909

11/10/2011

MEN2 and FMTC Mutation

MEN2

83405

CPT: 83891x2, 83892x2, 83898x6, 83904x6, 83909x6

11/17/2011

Neutrophil Cytoplasmic Antibody

ANCA

76168

CPT: 86255x2

10/1/2011

Niemann-Pick Disease Type A Mutation, Fluid

NIEM2

83016

CPT: 83893x3, 83894, 83896x3, 83900

11/10/2011

Niemann-Pick Disease Type A Mutation, Whole Blood

NIEMAN

83015

CPT: 83893x3, 83894, 83896x3, 83900

11/10/2011

Prader-Willi/Angelman Methylation

PRADER

82164

CPT: 83891, 83892, 83894, 83900

11/10/2011

PRO-Predict Infliximab/ HACA, Serum

INFXMB

83041

Reference Range: Human Anti-Chimeric Antibody (HACA): < 1.69 μg/mL equivalents Serum Infliximab measurement: < 1.40 μg/mL

12/1/2011

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

Prostate Cancer Biomarker

PCA3

87736

Special Information: 10 mL urine using the following guidelines: 1) Perform attentive digital rectal exam (DRE) by applying firm pressure from the base to apex and from the lateral to midline of prostate. Three strokes per lobe. Firm pressure is enough pressure to depress the surface approximately 1 cm. 2) Collect first 20 - 30 mL of urine in a clean urine collection cup immediately following the DRE. 3) Immediately pipette 2 mL of urine into each of the four Aptima tubes. 4) Replace tube lid and invert 5 times. Do not shake or vortex. 5) Place labeled Aptima tubes in a biohazard transport bag. 6) Refrigerate specimen for pickup For specimen collection kits, please contact Client Services at 216-444-5755 or 800-628-6816.

12/6/2011

Specimen Requirement: 10 mL random urine collected in four Aptima tubes using special collection guidelines; Refrigerated. See Special information Days Performed: 2 days per week Reported: 4 days Respiratory Syncytial Virus Abs, IgG & IgM

RSVGM

Risperidone & Metabolite

RISPER

79802

Days Performed: Thursday

1/3/2012

Reported: 2 - 9 days 80438

Specimen Requirement: 3 mL serum from a red top tube; Do not use serum separator tubes; Refrigerated

11/23/2011

Reference Range: 10 - 120 ng/mL Days Performed: Sunday - Saturday Reported: 6 - 8 days CPT: 82542 Sulfonylurea Hypoglycemics, Urine

USULFO

Torch Antibodies IgG & IgM

TORCH

82894

Days Performed: Varies

1/3/2012

Reported: Varies 79189

Methodology: Enzyme Immunoassay (EIA) Immunoassay (IA) Reference Range: Toxoplasma IgG: < 0.91 Index Toxoplasma IgM: < 0.80 Index CMV IgG: < 0.91 Index CMV IgM: < 0.90 Index HSV 1 IgG Type Specific Ab: < 0.90 Index HSV 2 IgG Type Specific Ab: < 0.90 Index HSV Type 1 IgM Abs: < 0.80 Index HSV Type 2 IgM Abs: < 0.80 Index Rubella IgG: < 5 IU/mL Rubella IgM: < 0.90 Ratio

12/8/2011

Days Performed: Tuesday, Thursday, Saturday Reported: 2 - 4 days VAP

VAP

83811

Days Performed: Varies

1/3/2012

Reported: Varies Vitamin B2

VITB2

83756

Special Information: (Test build may need to be modified for interfaced clients because of a result code change.)

11/14/2011

Specimen Requirement: 2 mL plasma from an EDTA lavender top tube; Protect specimen from light; Remove plasma from cells within 4 hours of collection; Frozen

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

5

New Tests Test Name

Order Code

Billing Code

Test Information

Effective Date

Bordetella pertussis Antibody, IgA by Immunoblot

BPAA

88015

Specimen Requirement: 1 mL serum from a serum separator tube; Remove serum from cells ASAP; Refrigerated

11/23/2011

Methodology: Immunoblot (IB) Reference Range: Negative Days Performed: Tuesday Reported: 2 - 9 days CPT: 86615 Price: $85.00 (non-discountable)

Bordetella pertussis Antibody, IgG by Immunoblot

BPAG

88016

Specimen Requirement: 1 mL serum from a serum separator tube; Remove serum from cells ASAP; Refrigerated

11/23/2011

Methodology: Immunoblot (IB) Reference Range: Negative Days Performed: Tuesday Reported: 2 - 9 days CPT: 86615 Price: $85.00 (non-discountable)

Bordetella pertussis Antibody, IgM by Immunoblot

BPAM

88017

Specimen Requirement: 1 mL serum from a serum separator tube; Remove serum from cells ASAP; Refrigerated

11/23/2011

Methodology: Immunoblot (IB) Reference Range: Negative Days Performed: Tuesday Reported: 2 - 9 days CPT: 86615 Price: $85.00 (non-discountable)

IBD Serology Disease Panel

IBDSER

88298

Includes: Saccharomyces cerevisiae IgA Antibody Saccharomyces cerevisiae IgG Antibody Neutrophil Specific Antibodies

11/15/2011

Specimen Requirement: 0.5 mL serum from a serum separator tube; Refrigerated Methodology: Enzyme-Linked Immunosorbent Assay (ELISA) Indirect Immunofluorescent Assay (IFA) Reference Range: Saccharomyces cerevisiae IgA Ab: Negative: 0.0 - 20.0 U Equivocal: 20.1 - 24.9 U Weakly positive: 25.0 - 34.9 U Positive: >34.9 U Saccharomyces cerevisiae IgG Ab: Negative: 0.0 - 20.0 U Equivocal: 20.1 - 24.9 U Weakly positive: 25.0 - 34.9 U Positive: >34.9 U Neutrophil Specific Antibodies: Negative Days Performed: Varies Reported: 2 - 3 days CPT: 83520x2, 86255 Price: $130.00 (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

Prometheus IBD sgi Diagnostic

IBDSGI

88291

Includes: ASCA IgA, ASCA IgG, Anti-OmpC IgA, Anti-CBir1 IgG, Anti-A4-Fla2 IgG, Anti-FlaX IgG, IBD Specific pANCA Autoantibody, IBD Specific pANCA IFA Perinuclear Pattern, IBD Specific pANCA DNAse Sensitivity, ATG16L1 SNP (rs2241880), ECM1 SNP (rs3737240), NKX2-3 SNP (rs10883365), STAT3 SNP (rs744166), Intercellular Adhesion Molecule 1 (ICAM-1), Vascular Cell Adhesion Protein 1 (VCAM-1), Vascular Growth Factor, C-Reactive Protein, Serum Amyloid A Protein (SAA)

11/15/2011

Specimen Requirement: THIS TEST REQUIRES MULTIPLE SPECIMEN TYPES: 2 mL whole blood in an EDTA lavender top tube *AND* 2 mL serum from a serum separator tube; Refrigerated Methodology: Enzyme-Linked Immunosorbent Assay (ELISA) Indirect Immunofluorescence Assay (IFA) Polymerase Chain Reaction (PCR) Chemiluminescent Immunoassay (CLIA) Reference Range: ASCA IgA: