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Hepatitis B Virus (HBV) Screening and Diagnosis

CPT: 86704; 86706; 87340

Test Includes

Hepatitis B surface Antigen (HBsAg) Screen; Hepatitis B Surface Antibody (anti-HBs); Hepatitis B Core Antibody, Total (anti-HBc); and reflexes to Hepatitis B Core Antibody, IgM (IgM anti-Hbc) when indicated.

Reflex criteria: If 006718 Hep B Core Ab, Tot is Positive and 006395 Hep B Surface Ab is Non-Reactive (NR), reflexes to 016881 Hep B Core Ab, IgM.


Special Instructions

If reflex test is performed, additional charges/CPT code(s) 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 - 3 days


Related Documents


Specimen Requirements


Specimen

Serum or EDTA plasma


Volume

5 mL


Minimum Volume

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


Container

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


Collection

If tube other than a gel-barrier tube is used, transfer separated serum or plasma to a plastic transport tube.


Storage Instructions

Room temperature


Stability Requirements

Temperature

Period

Room temperature

14 days

Refrigerated

14 days

Frozen

14 days

Freeze/thaw cycles

Stable x3


Patient Preparation

No special preparation required.


Causes for Rejection

Specimens other than serum or EDTA plasma; PST gel-barrier tube; specimens with visible gross microbial contamination


Test Details


Use

Screen for and diagnose Hepatitis B Virus (HBV) infection


Limitations

The performance of the assays included in this panel has not been established with cadaveric specimens, heat-inactivated specimens or body fluids other than serum and EDTA plasma.


Methodology

Immunochemiluminometric assay (ICMA)


Additional Information

Hepatitis B surface antigen (HBsAg) is a protein on the surface of hepatitis B virus that can be detected in high levels in serum during acute or chronic hepatitis B virus infection. The presence of HBsAg indicates that the person is infectious. HBsAg can typically be detected in an infected person's blood an average of 4 weeks (range: 1-9 weeks) after exposure to the virus. Persistence of HBsAg, without anti-HBs, with combinations of positivity of anti-HBc, HbeAg, or anti-HBe indicates infectivity and the need for investigation for chronic persistent or chronic aggressive hepatitis.

The presence of Hepatitis B surface antibody (anti-HBs) is generally interpreted as indicating recovery and immunity from hepatitis B virus infection. Anti-HBs also develops in a person who has been successfully vaccinated against hepatitis B.

Total hepatitis B core antibody (anti-HBc) appears at the onset of symptoms in acute hepatitis B and persists for life. The presence of anti-HBc indicates previous or ongoing infection with hepatitis B virus in an undefined time frame. IgM antibody to hepatitis B core antigen (IgM anti-HBc) positivity indicates recent infection with hepatitis B virus (< 6 months) and its presence is consistent with acute infection.

HBV Serology Interpretation: Key: Analyte present: + Analyte absent: - Test not indicated: TNI

Interpretation

HBsAg

anti-HBs

anti-HBc

IgM anti-HBc

* Multiple possibilities: resolved infection (most common); false-positive anti-HBc (susceptible); "low-level" chronic infection; resolving acute infection.

Susceptible/no evidence of infection

-

-

-

TNI

Immune due to natural resolved infection

-

+

+

TNI

Immune due to vaccination

-

+

-

TNI

Acute infection

+

-

+

+

Chronic infection

+

-

+

-

Intrepretation unclear*

-

-

+

±


References

Abara WE, Oaseem A, Schillie S. McMahon BJ, Harris AM, High Value Care Task Force of the American College of Physicians and the Centers for Disease Control and Prevention. Hepatitis B Vaccination, Screening, and Linkage to Care: Best Practice Advice from the American College of Physicians and the Centers for Disease Control and Prevention. Ann Intern Med. 2017 Dec 5;167(11):794-804.29159414
Centers for Disease Control and Prevention. Hepatitis B. CDC web site: www.cdc.gov/hepatitis/hbv/index.htm. Accessed May 2021.
Terrault NA, Lok ASF, McMahon BJ, et al. Update on Prevention, Diagnosis, and Treatment of Chronic Hepatitis B: AASLD 2018 Hepatitis B Guidance. Hepatology. 2018 Apr;67(4):1560-1599.29405329

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