LABHORIZONS. New Procedures A NEWSLETTER FOR CLIENTS

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1 LABHORIZONS A NEWSLETTER FOR CLIENTS Volume XVII, No. 6 June 2017 New Procedures RheumAssure CPT 83520; 86200; Synonyms ; η Protein; ACPA; Anti-CCP; Anticitrullinated Protein Antibody; Augurex; CCP; eta; IdentRA; RF; RF Titer; Rheumatoid Factor Use Aid in the diagnosis of rheumatoid arthritis (RA) 1,2 Limitations Results of this panel should be used in conjunction with clinical findings and other laboratory tests. It is acknowledged that an individual patient may meet the definition of RA without requiring that all tests be performed. For example, patients with a sufficient number of joints involved and longer duration of symptoms will meet criteria regardless of their serologic or acute-phase response status. The classification criteria can be applied to any patient or otherwise healthy individual, as long as 2 mandatory requirements are met: First, there must be evidence of currently active clinical synovitis (i.e., swelling) in at least 1 joint as determined by an expert assessor. Second, the criteria may be applied only to those patients in whom the observed synovitis is not better explained by another diagnosis. 6 Methodology RA Factor: Immunoturbidimetry; CCP Antibodies: ELISA; eta protein: ELISA Reference Interval RA Factor: <14 IU/mL CCP Antibodies IgG, IgA: Units Negative: <20 Weak positive: Moderate positive: Strong positive: > eta protein: <0.2 ng/ml Additional Information This RheumAssure panel is comprised of three tests: RA Factor, CCP Antibodies, and eta protein. Used together, these three markers are able to diagnose established RA with a sensitivity of 88-96% and early RA with a sensitivity of 78-92%. 1,2 RA factor (also called RF) is elevated in established RA (sensitivity 72-85%) 2,3 and in early RA (sensitivity 44-63%). 1,4 Its specificity for RA is 80%. 3 CCP Antibodies have similar sensitivities for established RA (66-79%) and early RA (59%) 2,3 but higher specificity (90-96%). 3,5 Serum eta protein is elevated in both established RA (sensitivity 77%) and early RA (sensitivity 59-64%). 1,2 It may provide a 15-20% incremental benefit in identifying early RA. 1,4 Therefore, elevation of one or more markers of RheumAssure is consistent with a diagnosis of rheumatoid arthritis. When all three markers are negative, an RA diagnosis is less likely. Volume 2 ml Minimum Volume 0.8 ml Container Red-top or gel-barrier tube Storage Instructions Frozen preferred, refrigerate acceptable Stability Temperature Room temperature Refrigerated Frozen Freeze/thaw cycles Period 3 days 3 days 7 days stable x3 Footnotes 1. Maksymowych WP, Boire G, van Schaardenburg D, et al η Autoantibodies: Diagnostic Use in Early Rheumatoid Arthritis. J Rheumatol 2015;42(9): PubMed Maksymowych WP, Naides SJ, Bykerk V, et al. Serum η is a novel marker that complements current serological measurements to enhance detection of patients with rheumatoid arthritis. J Rheumatol 2014;41(11): PubMed Lee DM, Schur PH. Clinical utility of the anti-ccp assay in patients with rheumatic diseases. Ann Rheum Dis 2003 Sep;62(9): PubMed Carrier N, Marotta A, de-brum-fernandes AJ, et al. Serum levels of η protein supplement C-reactive protein and rheumatoid arthritis-associated antibodies to predict clinical and radiographic outcomes in a prospective cohort of patients with recent-onset inflammatory polyarthritis. Arthritis Res Ther 2016 Feb 1;18:37. PubMed Dubucquoi S, Solau-Gervais E, Lefranc D, et al. Evaluation of anti-citrullinated filaggrin antibodies as hallmarks for the diagnosis of rheumatic diseases. Ann Rheum Dis 2004 Apr;63(4): PubMed American College of Rheumatology. The 2010 ACR-EULAR Classification Criteria for Rheumatoid Arthritis. ra_2010.asp. Accessed June 20, Amphetamines, Screen With Reflex Confirmation, Serum Synonyms Amphetamine; methamphetamine Test Includes Amphetamines Use Detect the presence of amphetamine class drugs Methodology Initial presumptive testing by immunoassay at a testing threshold of 50 ng/ml; presumptive positives confirmed to limit of quantitation by definitive chromatography mass spectrometry (GC/MS or LC/MS-MS). venipuncture. Submit serum in plastic transport tube. These new/revised publications are now available: Assessing Respiratory Symptoms brochure (L17045) LABUpdate: Testosterone Reference Interval Changes for Adult Males (L16726) Inflammatory Bowel Disease brochure (L16357) M3 Checklist flyer (L17072) eta Rheumatoid Arthritis service announcement (L16564) Please ask your LabCorp service representative for these titles.

2 Drug Screen 10 With Reflex Confirmation (AMP,BAR,BZO,COC, PCP,THC,OPI,OXY,MD,PPX), Serum Test Includes Amphetamines; barbiturates; benzodiazepines; cocaine metabolite; methadone; opiates; oxycodone; phencyclidine (PCP); propoxyphene; tetrahydrocannabinol (THC) (marijuana) metabolite Use Detect the presence of abused and prescribed drugs Methodology Initial presumptive testing by immunoassay at the following testing thresholds: amphetamines, 50 ng/ml; barbiturates, 0.1 μg/ml; benzodiazepines, 20 ng/ml; cocaine metabolite, 25 ng/ml; methadone, 25 ng/ml; opiates, 5 ng/ml; oxycodones, 5 ng/ml; phencyclidine (PCP), 8 ng/ml; propoxyphene, 50 ng/ml; tetrahydrocannabinol (THC), 5 ng/ ml. Presumptive positives confirmed to limit of quantitation by definitive chromatography mass spectrometry (GC/MS or LC/MS-MS). venipuncture. Submit serum in a plastic transport tube. Drug Screen 11 With Reflex Confirmation (ETOH,AMP,BAR, BZO,COC,PCP,THC,OPI,OXY,MD,PPX), Serum Synonyms Serum Drug Screen, 11 Panel Test Includes Amphetamines; barbiturates; benzodiazepines; cocaine metabolite; ethyl alcohol; methadone; opiates; oxycodone; phencyclidine (PCP); propoxyphene; tetrahydrocannabinol (THC) Use Detect the presence of abused and prescribed drugs Methodology Initial presumptive testing by immunoassay at the following testing thresholds: amphetamines, 50 ng/ml; barbiturates, 0.1 μg/ml; benzodiazepines, 20 ng/ml; cocaine metabolite, 25 ng/ml; methadone, 25 ng/ml; opiates, 5 ng/ml; oxycodones, 5 ng/ml; phencyclidine (PCP), 8 ng/ml; propoxyphene, 50 ng/ml; tetrahydrocannabinol (THC), 5 ng/ ml; presumptive positives confirmed to limit of quantitation by definitive chromatography mass spectrometry (GC/MS or LC/MS-MS). Initial presumptive testing for ethanol by enzymatic assay at a testing threshold of gm/dl; presumptive positives confirmed by gas chromatography (GC). venipuncture. Submit serum in a plastic transport tube. Drug Screen 13 with reflex Confirmation (AMP,BAR,BZO,COC, PCP,THC,OPI,OXY,MD,FEN,MEP,PPX,TRAM), Serum Synonyms Serum Drug Screen, 13 Panel Test Includes Amphetamines; barbiturates; benzodiazepines; cocaine metabolite; fentanyl; meperidine; methadone; opiates; oxycodones; phencyclidine (PCP); propoxyphene; tetrahydrocannabinol (THC); tramadol Use Detect the presence of abused and prescribed drugs Methodology Initial presumptive testing by immunoassay at the following testing thresholds: amphetamines, 50 ng/ml; barbiturates, 0.1 μg/ ml; benzodiazepines, 20 ng/ml; cocaine metabolite, 25 ng/ml; fentanyl, 1.0 ng/ml; methadone, 25 ng/ml; meperidine, 100 ng/ml; opiates, 5 ng/ ml; oxycodones, 5 ng/ml; phencyclidine (PCP), 8 ng/ml; propoxyphene, 50 ng/ml; tetrahydrocannabinol (THC), 5 ng/ml; tramadol, 50 ng/ml; presumptive positives confirmed to limit of quantitation by definitive chromatography mass spectrometry (GC/MS or LC/MS-MS). venipuncture. Submit serum in a plastic transport tube. Tetrahydrocannabinol (THC), Screen With Reflex Confirmation, Serum Test Includes THC (marijuana) metabolite Use Detect the presence of tetrahydrocannabinol (marijuana constituent) Methodology Initial presumptive testing by immunoassay at the following testing threshold: tetrahydrocannabinol (THC), 5.0 ng/ml. Presumptive positives confirmed to limit of quantitation by definitive chromatography mass spectrometry (GC/MS or LC/MS-MS). venipuncture. Submit serum in a plastic transport tube. 2

3 Special notice Revised CMS Advance Beneficiary Notice of Noncoverage (ABN) for Medicare Beneficiaries The latest version of the ABN released by the Centers for Medicare & Medicaid Services (CMS) went into effect on June 21, This version replaced the 03/11 version. LabCorp has transitioned to the latest ABN version with expiration date 03/2020. CMS announced in March 2017 that ABNs with the release date of 03/11 and issued on or after June 21, 2017, will be considered invalid. There were no changes to the form itself; however, the form now incorporates an expiration date of 03/2020 and language was added to inform beneficiaries of their rights to CMS nondiscrimination practices and how to request an ABN in an alternative format. LabCorp connectivity products have been updated to generate an ABN that reflects these revisions. For clients who do not use LabCorp s connectivity products, the latest version of the paper copy ABN has been printed and distributed through routine channels. For more information about ABN, visit the ABN section of the CMS website: Updates to the Directory of Services and Interpretive Guide (DoS) α-fetoprotein (AFP), Amniotic Fluid Patient Preparation The patient should have undergone ultrasound studies to verify fetal viability, detect multiple gestation, confirm gestational age, localize placenta, and detect fetal and uterine pathology. α-fetoprotein (AFP), Maternal Serum for Open Spina Bifida Synonyms AFP, Maternal Serum; Alpha-Fetoprotein (AFP), Maternal Serum for Open Spina Bifida; Maternal Serum α-fetoprotein; msafp Special Instructions This test screens for open spina bifida. This test does not screen for Down syndrome or trisomy 18. The following information must be provided: gestational age, date on which the patient was the stated gestational age, how gestational age was determined (LMP, EDD, US), patient s weight, patient s date of birth, patient s race (white, black, other), and insulin-dependent diabetic status. Also indicate relevant patient history, such as prior neural tube defects, ultrasound anomalies, or previous maternal serum screening during this pregnancy. Complete information is necessary to interpret the test. Patient information may be provided to the laboratory using the Maternal Prenatal Screening request form (0900). Specimens must be collected before amniocentesis. Open spina bifida screening is offered for gestational ages 15.0 to 23.9 weeks. The optimal gestational age for open spina bifida screening is 16.0 to 18.9 weeks. α 1 -Antitrypsin Phenotyping Storage Instructions Room temperature: stable for 14 days. Stable refrigerated or frozen for three days. Freeze/ thaw cycles: stable x2. Causes for Rejection (deleted field) GeneSeq : Cardio Noonan Syndrome and Related Conditions Profile Gestational Diabetes Screen (ACOG Recommendations) Use Confirm a clinical diagnosis of Noonan syndrome and identify presymptomatic family members, guiding prophylactic measures Specimen Whole blood Volume 10 ml, or 30 ml if ordering multiple tests Container Yellow-top (ACD) tube or lavender-top (EDTA) tube Special Instructions Test orders must include an attestation that the provider has the patient s informed consent for genetic testing. See sample physician office consent form: Consent for Genetic Testing. For family testing, please call customer service at before submitting specimens for family testing (ie, known mutations) Causes for Rejection Frozen gray-top tube (frozen plasma from gray-top is acceptable); stressed patient (surgery, infection, corticosteroids) should not have GTT; specimen not labeled with collection time intervals (i.e., one hour) 3

4 Gestational Glucose Tolerance Diagnostic Test (Three-hour, ACOG Recommendations) Gestational Glucose Tolerance Screening and Diagnostic Test (Two-hour, ADA Recommendations) Glucose 6-Phosphate Dehydrogenase (G6PD), Quantitative, Blood and Hemoglobin Homovanillic Acid (HVA), 24-Hour Urine Volume 4 ml aliquot Minimum Volume 1 ml aliquot Causes for Rejection Frozen gray-top tube (frozen plasma from gray-top is acceptable); stressed patient (surgery, infection, corticosteroids) should not have GTT; specimens not labeled with collection time intervals (i.e., fasting, one-hour, two-hour, and three-hour) Causes for Rejection Frozen gray-top tube (frozen plasma from gray-top is acceptable); stressed patient (surgery, infection, corticosteroids) should not have GTT; specimens not labeled with collection time intervals (i.e., fasting, one-hour, and two-hour) Storage Instructions Hemoglobin: Stable refrigerated for 72 hours. G6PD: Stable refrigerated for seven days. Immunoglobulin G, Subclass Reference Interval See table. Immunoglobulin G, Subclass 1 Age Cord Range (mg/dl) to 2 m to 5 m to 8 m to 35 m to 4 y to 6 y to 8 y to 10 y to 12 y to 14 y to 17 y to 19 y >19 y Immunoglobulin G, Subclass Reference Interval See table. Immunoglobulin G, Subclass 2 Age Cord Range (mg/dl) to 2 m to 5 m to 8 m to 35 m to 4 y to 6 y to 8 y to 10 y to 12 y to 14 y to 17 y to 19 y >19 y

5 Immunoglobulin G, Subclass Reference Interval See table. Immunoglobulin G, Subclass 3 Age Cord Range (mg/dl) to 2 m to 5 m to 8 m to 35 m to 4 y to 6 y to 8 y to 10 y to 12 y to 14 y to 17 y to 19 y >19 y Immunoglobulin G, Subclass Reference Interval See table. Immunoglobulin G, Subclass 4 Additional Information Measurement of serum IgG4 can aid in the diagnosis of IgG4-RD. According to two recent meta-analyses, the pooled sensitivity and specificity of a serum IgG4 135 mg/dl is % and %, respectively. 1,2 Although elevated serum IgG4 is consistent with the diagnosis of IgG4-RD, not all patients will have elevated concentrations. IgG4 related disease (IgG4-RD) encompasses a constellation of individual organ disorders that share particular pathologic, serologic, and clinical features. These disorders were previously thought to be unrelated. They are characterized by the infiltration of IgG4+ plasma cells and an elevated serum IgG4. 1 Common features of IgG4-RD include: 3 elevated serum IgG4 ( 135 mg/dl); clinical examination identifying swelling or masses in single or multiple organs; histopathological evidence of infiltrating IgG4+ plasma cells and fibrosis; imaging identifying narrowing of ducts and/or enlargement of organs. IgG4-RD includes disorders such as: 3 Type 1 (IgG4-related) autoimmune pancreatitis (AIP); salivary gland disease (Mikulicz s disease); nypophysitis; riedel thyroiditis; interstitial pneumonitis; nephritis; prostatitis; lymphadenopathy; retroperitoneal fibrosis; inflammatory aortic aneurysm Footnotes 1. Xu WL, Ling YC, Wang ZK, Deng F. Diagnostic performance of serum igg4 level for igg4-related disease: a meta-analysis. Sci. Rep Aug 25;6: PubMed Hao M, Liu M, Fan G, Yang X, Li J. Diagnostic value of serum igg4 for igg4-related disease: A prisma-compliant systematic review and meta-analysis. Medicine (Baltimore) May;95(21):e3785. PubMed Umehara H, Okazaki K, Masaki Y, et al. Comprehenisve diagnostic criteria for igg4-related disease (igg4-rd), Mod Rheumatol Feb;22(1): PubMed Immunoglobulin G, Subclasses (1-4) Volume 3 ml Minimum Volume 1.8 ml Age Cord Range (mg/dl) to 2 m to 5 m to 8 m to 35 m to 4 y to 6 y to 8 y to 10 y to 12 y to 14 y to 17 y to 19 y >19 y

6 MGMT (O 6 -Methylguanine-DNA Methyltransferase) Gene Methylation Assay Special Instructions This assay is not approved for New York State residents. Please provide a copy of the pathology report. Sample submission without a copy of the pathology report may delay testing. Please direct any questions regarding this test to customer service at Neuromyelitis Optica, IgG Autoantibodies Collection Separate serum from cells and transfer to a plastic transport tube. Storage Instructions Refrigerate. Causes for Rejection Gross hemolysis; gross lipemia; icteric specimen; improperly labeled specimen Ovarian Malignancy Risk (ROMA ) Volume 1.75 ml Minimum Volume 1 ml (Note: This volume does not allow for repeat testing.) PIK3CA Oncogene Mutation Detection Special Instructions This assay is not approved for New York State residents. Please provide a copy of the pathology report. Please direct any questions regarding this test to customer service at PIK3CA testing will be delayed if the pathology report is not received. Pregabalin, Urine Limitations This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the Food and Drug Administration (FDA). Volume 3 ml Testosterone Free, Profile I Limitations See individual test components. Reference Interval See table. 22 Age Male (pg/ml) Female (pg/ml) 0 to 1 y Not established Not established 2 to 5 y to 7 y y y y y y y y y y y to 30 y to 40 y to 50 y to 60 y to 70 y to 80 y to 100 y Container Red-top tube or gel-barrier tube Causes for Rejection See individual test components. Footnotes (Added) 22. Reference intervals for calculated free testosterone developed through LabCorp Internal Studies. 6

7 Testosterone Free, Profile II Reference Interval See table. 22 Age Male (pg/ml) Female (pg/ml) 0 to 1 y Not established Not established 2 to 5 y to 7 y y y y y y y y y y y to 30 y to 40 y to 50 y to 60 y to 70 y to 80 y to 100 y Container Red-top tube or gel-barrier tube Footnotes (Added) 22. Reference intervals for calculated free testosterone developed through LabCorp Internal Studies. Testosterone, Free, Direct With Total Testosterone, LC/MS-MS Thyroglobulin, Lymph Node Aspirate (Endocrine Sciences) Minimum Volume 1.3 ml (Note: This volume does not allow for repeat testing.) Storage Instructions Freeze. Vanillylmandelic Acid (VMA), 24-Hour Urine Volume 4 ml aliquot 5-Hydroxyindoleacetic Acid (HIAA), Quantitative, Hour Urine 7

8 CPT Code Updates Test Name Test No. CPT(s) Allergen Profile, Food IgE II With Component Reflexes (x19) PD-L1, IHC (Atezolizumab), Non-Small-cell Lung Cancer PD-L1, IHC (Atezolizumab), Urothelial Cancer PD-L1, IHC (Nivolumab) PD-L1, IHC (Nivolumab), Melanoma PD-L1, IHC (Pembrolizumab) Thiopurine Metabolites Thiopurine Methyltransferase (TPMT), Enzyme Activity, Erythrocytes The CPT codes listed are in accordance with the current edition of Current Procedural Terminology, a publication of the American Medical Association. CPT codes are provided for the convenience of our clients; however, correct coding often varies from one carrier to another. Consequently, the codes presented here are intended as general guidelines and should not be used without confirming with the applicable payer that their use is appropriate in each case. LOINC Map. The Logical Observation Identifiers Names and Codes (LOINC ) corresponding to the individual LabCorp published assays is updated on a regular basis at Laboratory Corporation of America Holdings All Rights Reserved. L