LABHORIZONS. New Procedures A NEWSLETTER FOR CLIENTS

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1 LABHORIZONS A NEWSLETTER FOR CLIENTS Volume XVIII, No. 3 March 2018 New Procedures Adalimumab Concentration and Anti-Adalimumab Antibody CPT 80299; Synonyms Anti-TNF-alpha Drug; Humira Use Monitor anti-adalimumab therapy for individuals with Crohn s disease, inflammatory bowel disease, ulcerative colitis, rheumatoid arthritis, or other autoimmune conditions. This test provides adalimumab drug concentration levels as well as the level of anti-adalimumab antibodies. In the absence of anti-adalimumab antibodies, the adalimumab drug level typically reflects the total adalimumab concentration in serum. In the presence if anti-adalimumab antibodies, the adalimumab level typically reflects the antibody-unbound fraction of adalimumab concentration in serum. This assay provides clinically valid antibody results at drug levels well above treatment targets (>30 ug/ml). Failure of adalimumab therapy may not always be due to the presence of anti-adalimumab antibodies. In addition, the absence of anti-adalimumab antibodies does not guarantee positive response to treatment. Methodology Electrochemiluminescence Immunoassay (ECLIA) Specimen Serum Volume 2 ml Minimum Volume 1 ml (Note: This volume does not allow for repeat testing). Container Red-top tube or gel-barrier tube Collection Serum must be separated from cells within 45 minutes of venipuncture. Send serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple test on frozen samples, please submit separate frozen specimens for each test requested. Storage Instructions Refrigerate or freeze Stability Temperature Room temperature Refrigerated Frozen Period 7 days 7 days 7 days Causes for Rejection Plasma specimen received Buprenorphine Medication Assisted Treatment Monitoring 2, Urine CPT Synonyms MAT Drug Screen Use Detect and confirm presence of prescribed and illicit drugs for monitoring Suboxone /buprenorphine medication assisted treatment (MAT). Please note: This testing is designed specifically for monitoring patients who are on Suboxone /buprenorphine only. This testing should not be used for monitoring chronic pain patients (medical drug monitoring) or methadone medication assisted treatment. Limitations Some components of this panel were developed, and performance characteristics determined, by LabCorp (EtG, Carisoprodol, Fentanyl, Tapentadol, and Gabapentin). They have not been cleared or approved by the US Food and Drug Administration (FDA). Methodology Initial presumptive testing by immunoassay at the following testing thresholds: buprenorphine, 5 ng/ml; alcohol biomarkers (EtG, EtS), 500 ng/ml; amphetamines, 500 ng/ml; barbiturates, 200 ng/ml; benzodiazepines, 200 ng/ml; cocaine metabolite, 150 ng/ml; phencyclidine, 25 ng/ml; cannabinoids (THC), 20 ng/ml; heroin metabolite (6-AM), 10 ng/ml; opiates, 300 ng/ml; oxycodones, 100 ng/ml; tapentadol, 200 ng/ml; fentanyl, 2.0 ng/ml; methadone, 300 ng/ml; propoxyphene, 300 ng/ml; tramadol, 200 ng/ml; carisoprodol, 100 ng/ml; gabapentin, 1.5 μg/ml. Presumptive positives are confirmed by definitive mass spectrometry (LC/MS-MS or GC/MS). Additional Information Testing referred to MEDTOX Laboratories, Inc. Specimen Urine Volume 30 ml Minimum Volume 15 ml Collection Random Urine Storage Instructions Ambient Stability Room Temperature: 5 days Causes for Rejection Insufficient volume; no ID on container; urine from preservative tube Red Blood Cell (RBC) Antigen Typing: k (Cellano) CPT Use Typing paternal RBCs for antigens that correspond to maternal antibody may aid in the prediction of hemolytic disease of the fetus and newborn. Red cell antigen typing may also be indicated for bone marrow, tissue, organ, or blood donors prior to donation. Testing a prenatal patient for red cell antigens is generally not indicated. The occurrence of the little k antigen is 99.8% in Caucasians and 100% in Blacks. Anti-K can cause mild to severe (rare) hemolytic disease of the fetus and newborn. Limitations Presence of potent cold agglutinins, positive direct antiglobulin test, and (in some cases) bacteremia may interfere with test interpretation. Methodology Hemagglutination Specimen Whole blood Volume 1 ml Minimum Volume 0.5 ml Container Lavender-top (EDTA) tube Storage Instructions Specimens should be tested as soon as possible or within 72 hours of collection. Samples that cannot be tested immediately should be stored at 2 C to 8 C. Do not freeze red cells. Causes for Rejection Gross hemolysis; bacterial or other contamination Special Instructions This test does not include big K (Kell). To order big K These new/revised publications are now available: Assays To Support HIV Treatment Decisions brochure (L9609) IntelliGEN Myeloid physician brochure (L18341) Antinuclear Antibodies Testing Options flyer (L16721) Please ask your LabCorp service representative for these titles.

2 typing, refer to test References Fung MK, Grossman JB, Hillyer CD, Westoff CM, eds. AABB Technical Manual. 18th ed. Bethesda, Md: American Association of Blood Banks; Reid ME, Lomas-Frances CG, Olsson ML, eds. Blood Group Antigen Facts Book. 3rd ed. London, England: Academic Press; Ustekinumab and Anti-Ustekinumab Antibody CPT 80299; Synonyms Anti-interleukin antibody drug, Anti-IL12, IL23 inhibitor; Biologic monitoring, therapeutic drug monitoring (TDM); Immunogenicity testing, anti-drug antibody; Stelara Use Provides ustekinumab drug concentration and anti ustekinumab antibodies in order to optimize treatment and facilitate clinical decisionmaking. This assay may be helpful in any patients on ustekinumab therapy for Crohn s disease, psoriasis, or other autoimmune conditions. Limitations Drug concentration should be interpreted with confirmation of specimen collection timing. Non trough concentrations may be misleading. Trough blood collection (just before or within 24 hrs. of next dose) is suitable because target ranges and therapeutic cut offs have been established in clinical studies using trough concentration. The drug half life should be taken into consideration when interpreting results from non perfect trough collections. Some primary non responders have inadequate clinical response despite adequate trough levels. As with other biologics, the optimal ustekinumab concentration depends upon patient specific factors including co morbidities, disease and desired therapeutic endpoint. Positive anti ustekinumab antibodies should be interpreted in the context of the concomitant free ustekinumab drug level. Methodology Electrochemiluminescence immunoassay (ECLIA) Reference Interval Ustekinumab drug level: <0.1 μg/ml Result 0.1 μg/ml indicates detection of ustekinumab In the presence of anti-ustekinumab antibodies, the ustekinumab drug level reflects the free, antibody-unbound fraction of ustekinumab in serum. Anti-ustekinumab antibody: <40 ng/ml Result 40ng/mL indicates detection of anti-ustekinumab antibodies. Additional Information Drug Assay: The ustekinumab drug level typically reflects the antibody-unbound (the free fraction) of ustekinumab when serum anti-ustekinumab antibodies are present. In the absence of anti-infliximab antibodies, the ustekinumab drug level typically reflects the total ustekinumab concentration in serum. Anti-drug Antibody Assay: This anti-ustekinumab antibody assay is drug-tolerant, that is, the presence of serum ustekinumab does not impede the detection and quantitation of antiustekinumab antibodies. This anti-ustekinumab antibody assay is specific; antibodies against other biologic drugs do not cross-react with this assay. All positive antiustekinumab antibody results are verified by a confirmatory test. Both drug and anti-drug antibody assays have been developed and validated in accordance with FDA Guidance for Industry documents: Bioanalytical Method Validation (2013) and Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products (2016). Specimen Serum Volume 3 ml Minimum Volume 1 ml (Note: This volume does not allow for repeat testing.) Collection Allow a minimum clotting time of 30 to 60 minutes with serum separation within 2 hours of collection. Send serum in a plastic transport tube. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. Storage Instructions Frozen (preferred) or refrigerated Stability Temperature Period Room temperature Refrigerated Frozen Freeze/thaw cycles Stable x6 References Adedokun O, et al. P-007 Exposure-Response to SC Ustekinumab in Moderate Severe Crohn s Disease: Results From the IM-UNITI Maintenance Study. Advances in IBD meeting, Orlando, FL, abstract. Oct Adedokun OJ, et al. Pharmacokinetics and Exposure-Response Relationships of Ustekinumab during IV Induction and SC Maintenance Treatment of Patients with Crohn s Disease with UNITI-1, UNITI-2, and IM-UNITI Studies. Gastroenterology. 2016;150(4):S408. Battat R, Kopylov U, Bessissow T, et al. Association Between Ustekinumab Trough Concentrations and Clinical, Biomarker, and Endoscopic Outcomes: Results in Patients with Crohn s Disease. Clin Gastroenterol Hepatol Sep;15(9): e2. PubMed Chiu H, Chu TW, Cheng YP, Tsai TF. The Association Between Clinical Response to Ustekinumab and Immunogenicity to Ustekinumab and Prior Adalimumab. PLoS One. doi:10:1371/journal.pone PubMed Menting SP, van den Reek JM, Baerveldt EM, et al. The correlation of clinical efficacy, serum trough levels and antidrug antibodies in ustekinumab-treated patients with psoriasis in a clinical-practice setting. Br J Dermatol Sep;173(3): PubMed

3 Updates to the Directory of Services and Interpretive Guide (DoS) Test Name Test No. Field/Change (Only fields that change are included here.) BCR-ABL1 Transcript Detection for Chronic Myelogenous Leukemia (CML) and Acute Lymphocytic Leukemia (ALL), Quantitative Use This assay can detect three different types of BCR-ABL1 fusion transcripts associated with CML, ALL, and AML:e13a2 (previously b2a2) and e14a2 (previously b3a2) (major breakpoint, p210), as well as e1a2 (minor breakpoint, p190). The e13a2 and e14a2 transcript values are titrated to the current International Scale (IS). The standardized baseline is 100% BCR-ABL1 (IS) and major molecular response (MMR) is equivalent to 0.1% BCR-ABL1 (IS) corresponding to a 3-log reduction. Results should be correlated with appropriate clinical and laboratory information as indicated. Limitations In vitro studies have indicated that this assay has an analytical detection sensitivity of 4.5 log below the standard baseline. A negative result does not rule out the presence of low levels of BCR-ABL1 transcript below the level of detection of this assay, or the presence of rare BCR-ABL1 transcripts not detected by the assay. This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). Methodology Total RNA is isolated from the sample and subject to a real-time, reverse transcriptase polymerase chain reaction (RT-PCR). The PCR primers and probes are specific for BCR-ABL1 e13a2, e14a2 and e1a2 fusion transcripts. The ABL1 transcript is amplified as the control for cdna quantity and quality. Serial dilutions of a validated positive control RNA with known t(9;22) BCR-ABL1 are used as reference for quantification of BCR- ABL1 relative to ABL1. The numeric BCR-ABL1 level is reported as % BCR-ABL1/ABL1 and the detection sensitivity is 4.5 log below the standard baseline. Causes for Rejection Specimen does not meet collection criteria; frozen whole blood or marrow; leaking tube; clotted blood or marrow; grossly hemolyzed; otherwise visibly degraded; contamination by another specimen; containing suspicious foreign material References (added) NCCN Clinical Practice Guidelines in Oncology: Chronic Myelogenous Leukemia. Version Bone-specific Alkaline Phosphatase (BAP) Collection Separate serum from cells within 45 minutes of collection. If a red-top tube is used, transfer separated serum to a plastic transport tube. Storage Instructions Maintain specimen at room temperature. Stability Brucella Antibody, IgG, EIA Limitations This test was developed, and its performance characteristics determined, by LabCorp. It has not Brucella Antibody, IgM, EIA been cleared or approved by the US Food and Drug Administration (FDA). Enterovirus Antibodies Profile Minimum Volume 0.7 ml Febrile Antibody Profile Limitations This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). Epstein-Barr Virus (EBV) Acute Infection Antibodies Profile Epstein-Barr Virus (EBV) Antibodies to Early Antigen, IgG Epstein-Barr Virus (EBV) Antibodies to Viral Capsid Antigen (VCA), IgG Temperature Room temperature Refrigerated Frozen Freeze/thaw cycles Limitations The results from this panel are not by themselves diagnostic and should be considered in association not indicative of the amount of antibodies present Limitations The results for this test are not by themselves diagnostic and should be considered in association not indicative of the amount of EBV-EA antibody Limitations The results for this test are not by themselves diagnostic and should be considered in association not indicative of the amount of EBV-VCA antibody. Note: Please consult the online Directory of Services and Interpretive Guide at for the most current test information. Period Stable x3 3

4 Test Name Test No. Field/Change (Only fields that change are included here.) Epstein-Barr Virus (EBV) Antibodies to Viral Capsid Antigen (VCA), IgM Epstein-Barr Virus (EBV) Nuclear Antigen Antibodies, IgG Epstein-Barr Virus (EBV) Profile, Chronic, Active Infection Epstein-Barr Virus (EBV) (Viral Capsid Antigen [VCA] and Early Antigen [EA]), IgG Antibody Profile Limitations Weakly positive results require cautious interpretation. The results for this test are not by themselves diagnostic and should be considered in association with other clinical data and patient symptoms. not indicative of the amount of EBV-VCA antibody Limitations The results for this test are not by themselves diagnostic and should be considered in association not indicative of the amount of EBNA antibody Limitations The results for this test are not by themselves diagnostic and should be considered in association not indicative of the amount of EBV antibodies Limitations The results for this test are not by themselves diagnostic and should be considered in association not indicative of the amount of EBV-EA or EBV-VCA antibodies. Folate, RBC Storage Instructions Freeze whole blood transport tube; store whole blood specimen at room temperature. Collection Transfer 4 ml from one whole blood tube into a plastic transport tube and freeze. Second whole blood tube should be at room temperature. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested. Causes for Rejection No frozen whole blood; transport tubes with whole blood for the hematocrit portion Helicobacter pylori Antibodies, IgG Volume 1 ml Minimum Volume 0.5 ml Herpes Simplex Virus (HSV) Type 1-Specific Antibodies, IgG Human Immunodeficiency Virus 1/O/2 (HIV- 1/O/2) Antigen/Antibody (Fourth Generation) Preliminary Test With Cascade Reflex to Supplementary Testing Immunofixation, Daratumumab-Specific, Serum Synonyms (added) Darzalex Use Qualititative detection of IgG antibodies specific to HSV type 1 infection; confirm or rule out possible infection with herpes simplex type 1 virus in prenatal patients. In a patient with no history of lesion disease, a positive result for this test may be indicative that the primary infection was asymptomatic. Once infected by HSV, it is possible for a patient to shed virus without the development of lesions (asymptomatic shedding). This test does not indicate the site of HSV infection. The magnitude of the Index Value is not indicative of the amount of antibody present in the patient sample. Additional Information (added) Test is set up and reported Monday through Friday. References (updated entry) Centers for Disease Control and Prevention. Sexually-transmitted disease treatment guidelines, MMWR. 2015;64(3). PubMed Test Includes Enzyme immunoassay (EIA) for antigen/antibody screen for HIV with reflex to supplementary differentiation assay for HIV-1 or HIV-2. The antigen/antibody assay detects antibodies to HIV-1 and HIV-2 as well as HIV-1 p24 antigen. Specimens positive by the screening assay but negative by the supplementary antibody typing assay will reflex to qualitative nucleic acid amplification (NAA). Use The fourth-generation HIV antigen-antibody assay is acknowledged to detect acute HIV infection 4 to 12 days earlier than third-generation assays. Coupled with supplemental tests and clinical information, this cascade can help decrease the spread of HIV infection. According to the CLSI guideline, anyone testing positive by a fourth-generation screening assay and supplemental tests (either antibody or RNA detection) should initiate care and follow-up tests for clinical staging. 1 Methodology (1) HIV antigen/antibody enzyme immunoassay (EIA) screen for antibodies to HIV-1 and HIV-2 and HIV-1 p24 antigen: Reflex to supplementary differentiation assay; (2) Screen positive with negative antibody typing: Reflex to qualitative nucleic acid amplification (NAA) Immunoglobulins, Quantitative, IgA, IgE, IgG, IgM Methodology IgG, IgA, IgM: Immunologic; IgE: Thermo Fisher ImmunoCAP IntelliGEN Myeloid Special Instructions (added) Please provide a clinical indication or related ICD10 code on the requisition. Test will be delayed if the clinical indication is not received. Please direct any questions regarding this test to customer service at Methylmalonic Acid, Serum or Plasma Limitations This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). NRAS Gene Mutation Analysis, Extended Special Instructions Removed sentence about needing New York state approval. Note: Please consult the online Directory of Services and Interpretive Guide at for the most current test information. 4

5 Test Name Test No. Field/Change (Only fields that change are included here.) Oxcarbazepine, Serum or Plasma Container Red-top tube or plastic transport tube. Do not use a gel-barrier tube. The use of gel-barrier tubes is not recommended due to slow absorption of the drug by the gel. Depending on the specimen volume and storage time, the decrease in drug level due to absorption may be clinically significant. Red Blood Cell (RBC) Antigen Typing: K (Kell) Special Instructions This test does not include little k (cellano). To order little k typing, refer to test Thyroid-stimulating Immunoglobulin (TSI) Synonyms Removed Thyretain Urinalysis, Complete With Microscopic Examination Urinalysis, Routine With Microscopic Examination on Positives Urinalysis, Complete With Microscopic Examination With Reflex to Urine Culture, Routine Urinalysis, Complete With Microscopic Examination With Reflex to Urine Culture, Comprehensive Container BD urine transport tube (preferred) or urine cup (STAT/DAY lab setting) Storage Instructions BD urine transport tube: Refrigerated or room temperature for up to 72 hours. Urine cup: Room temperature up to 2 hours and refrigerated up to 48 hours Causes for Rejection Quantity not sufficient for analysis; improper labeling; tubes with boric acid or tartaric acid (eg, BD gray-top C&S tube); LabCorp red-top C&S tube; Boricon, Bortiex, or Boricult yellow-top C&S tubes; specimen received in BD urine transport tube more than 72 hours old; specimen received in urine cup stored at room temperature greater than 2 hours old; specimen received in urine cup refrigerated more than 48 hours old; frozen specimens Container BD urine transport tube (preferred) and Vacutainer gray-top urine culture transport tube with preservative or sterile cup for both assays Storage Instructions BD urine transport tube: Refrigerated or room temperature for up to 72 hours. Urine cup: Room temperature up to 2 hours and refrigerated up to 48 hours. Vacutainer gray-top urine culture transport tube: Maintain at room temperature. Causes for Rejection Urinalysis ONLY: Quantity not sufficient for analysis; improper labeling; tubes with boric acid or tartaric acid (eg, BD gray-top C&S tube); LabCorp red-top C&S tube; Boricon, Bortiex, or Boricult yellowtop C&S tubes, specimen received in BD urine transport tube more than 72 hours old; specimen received in urine cup stored at room temperature greater than 2 hours old; specimen received in urine cup refrigerated more than 48 hours old; frozen specimens Culture ONLY: Quantity not sufficient for analysis; improper labeling; specimen received in urine cup stored at room temperature greater than 2 hours old; specimen received in urine cup refrigerated more than 48 hours old, frozen specimens Volume Urinalysis: 10 ml; Culture: To fill line on Vacutainer gray-top culture transport tube Container BD urine transport tube (preferred) and Vacutainer gray-top urine culture transport tube with preservative or sterile cup for both assays Storage Instructions BD urine transport tube: Refrigerated or room temperature for up to 72 hours. Urine cup: Room temperature up to 2 hours and refrigerated up to 48 hours. Vacutainer gray-top urine culture transport tube: Maintain at room temperature. Causes for Rejection Urinalysis ONLY: Quantity not sufficient for analysis; improper labeling; tubes with boric acid or tartaric acid (eg, BD gray-top C&S tube); LabCorp red-top C&S tube; Boricon, Bortiex, or Boricult yellowtop C&S tubes, specimen received in BD urine transport tube more than 72 hours old; specimen received in urine cup stored at room temperature greater than 2 hours old; specimen received in urine cup refrigerated more than 48 hours old; frozen specimens Culture ONLY: Quantity not sufficient for analysis; improper labeling; specimen received in urine cup stored at room temperature greater than 2 hours old; specimen received in urine cup refrigerated more than 48 hours old, frozen specimens Note: Please consult the online Directory of Services and Interpretive Guide at for the most current test information. 5

6 CPT Code Updates Test Name Test No. CPT(s) Microarray-Products of Conception (POC) Reveal FFPE Microarray-Products of Conception (POC) Reveal FFPE, Data Transfer Microarray-Tumor Reveal FFPE Deleted Procedures Deleted Tests Test No. LabCorp Offers Test No. Bardet-Biedl Syndrome (BBS): BBS1 (Full Gene Sequencing) Inheritest Gene-specific Sequencing, NGS Bardet-Biedl Syndrome (BBS): BBS1 (Known Mutation) Mutation-specific Sequencing, Whole Blood Bardet-Biedl Syndrome (BBS): BBS2 (Full Gene Sequencing) Inheritest Gene-specific Sequencing, NGS Bardet-Biedl Syndrome (BBS): BBS2 (Known Mutation) Mutation-specific Sequencing, Whole Blood Bardet-Biedl Syndrome (BBS): Two-gene Profile (BBS1, BBS2) (Full Gene Sequencing) Congenital Bilateral Absence of the Vas Deferens (CBAVD): CFTR (Full Gene Sequencing) Congenital Bilateral Absence of the Vas Deferens (CBAVD): CFTR (Known Mutation) Inheritest Gene-specific Sequencing, NGS Inheritest Gene-specific Sequencing, NGS Mutation-specific Sequencing, Whole Blood Cystic Fibrosis (CF): CFTR (Full Gene Sequencing) Inheritest Gene-specific Sequencing, NGS Cystic Fibrosis (CF): CFTR (Full Gene Sequencing) With Reflex to Deletion/ Duplication Analysis Inheritest Gene-specific Sequencing, NGS Cystic Fibrosis (CF): CFTR (Known Mutation) Mutation-specific Sequencing, Whole Blood Cystic Fibrosis (CF): CFTR Prenatal Test (Full Sequencing) Inheritest Gene-specific Sequencing, NGS Cystic Fibrosis (CF): CFTR Prenatal Test (Known Mutation) Mutation-specific Sequencing, Whole Blood Familial Mediterranean Fever: MEFV (Full Gene Sequencing) Inheritest Gene-specific Sequencing, NGS Familial Mediterranean Fever: MEFV (Known Mutation) Mutation-specific Sequencing, Whole Blood Galactosemia: GALT (Full Gene Sequencing) Inheritest Gene-specific Sequencing, NGS Galactosemia: GALT (Known Mutation) Mutation-specific Sequencing, Whole Blood Pancreatitis: CFTR (Full Gene Sequencing) Inheritest Gene-specific Sequencing, NGS Pancreatitis: CFTR (Known Mutation) Mutation-specific Sequencing, Whole Blood Paternity Studies Parentage/Relationship Testing Salivary Testosterone, LC/MS-MS (Endocrine Sciences) Please contact your LabCorp representative for testing options. Wilson Disease: ATP7B (Full Gene Sequencing) Inheritest Gene-specific Sequencing, NGS Wilson Disease: ATP7B (Known Mutation) Mutation-specific Sequencing, Whole Blood 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