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HBV Baseline Evaluation, HCV Direct-acting Antivirals

CPT: 86704; 86706; 87340. If reflex testing is performed, concomitant CPT codes/charges will apply.

Synonyms

  • Hepatitis

Test Includes

Hepatitis B Surface Antigen (HBsAg) Screen [006510]; Hepatitis B Surface Antibody (anti-HBs) [006395]; Hepatitis B Core Antibody, Total (anti-HBc) [006718].

Reflex of HBsAg + to: HBV quant DNA [551610].


Special Instructions

If reflex test is performed, additional charges/CPT codes may apply.

This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.


Expected Turnaround Time

1 - 5 days


Related Documents


Specimen Requirements


Specimen

Serum or EDTA plasma


Volume

7.5 mL


Minimum Volume

2.9 mL (Note: This volume does not allow for repeat testing.)


Container

Gel-barrier tube, red top tube, or lavender-top (EDTA) tube


Collection

Two samples must be submitted.

HBsAg, anti-HBs, anti-HBc Total: If tube other than a gel-barrier tube is used, transfer separated serum or plasma to a plastic transport tube.

HBV DNA: Centrifuge sample within 24 hours of collection. Transfer serum/plasma to a screw-cap polypropylene transport tube. Ship frozen (preferred). Plasma from a PPT can be frozen in situ.

To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit a separate frozen specimen for each test requested.


Storage Instructions

HBsAg, anti-HBs, anti-HBc Total: Room temperature (preferred) up to 14 days. Refrigerated up to 14 days. Frozen up to 14 days.

HBV DNA: Frozen (preferred) up to 12 weeks. Refrigerated up to 6 days. Room temperature up to 24 hours.


Causes for Rejection

Heat-inactivated specimens; cord blood; cadaveric specimens; or body fluid other than serum or EDTA plasma; gross hemolysis; excessive lipemia; improper labeling


Test Details


Use

Risk assessment and management of HBV infection status in patients prior to initiation of HCV treatment with direct-acting antiviral agents.


Limitations

The HBV quantitative real-time PCR assay has a quantitative range of 10 to 1,000,000,000 IU/mL.


Methodology

Immunochemiluminometric assay (ICMA)


References

US Food and Drug Administration. FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C. FDA web site: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-about-risk-hepatitis-b-reactivating-some-patients-treated. Published Oct. 4, 2016. Accessed April 7, 2017.
Whitsett M, Feldman DM, Pan CQ. Risk assessment and management of hepatitis B reactivation from direct-acting antivirals for hepatitis C. Liver Research. 2019 Jun;3(2):75-79. doi.org/10.1016/j.livres.2019.03.002

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The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf