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Hepatitis B Surface Antigen (HBsAg) Screen, Qualitative

CPT: 87340
Updated on 09/22/2020
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Synonyms

  • HBsAg
  • HBV
  • Hepatitis-associated Antigen
  • Qualitative HBV surface antigen
  • Hepatitis-associated Antigen
  • HBsAg
  • HBV
  • Hepatitis-associated Antigen
  • Qualitative HBV surface antigen

Test Includes

Confirmation of positive results is performed as indicated, by a neutralization assay at no additional charge.

• Samples with an index value greater than an established threshold and with positive results for other hepatitis B markers are considered positive for Hepatitis B Surface Antigen without further testing (neutralization testing is not performed).

• Samples with an index value greater than an established threshold but with no other positive results for hepatitis B markers, or with an index value less than an established threshold but above the cutoff for positivity, are confirmed by neutralization.


Special Instructions

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 - 2 days


Related Documents


Specimen Requirements


Specimen

Serum or plasma


Volume

3.5 mL


Minimum Volume

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


Container

Red-top tube, gel-barrier 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


Causes for Rejection

Non-EDTA plasma specimen; PST gel-barrier tube


Test Details


Use

This assay can be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis B infection. This assay may also be used to screen for hepatitis B infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period.

Test blood donors (HBsAg positive individuals are rejected). Hepatitis B surface antigen is the earliest indicator of the presence of acute infection. Also indicative of chronic infection. Test is useful in the differential diagnosis of hepatitis.

This assay can be used in conjunction with other serological and clinical information to diagnose individuals with acute or chronic hepatitis B infection. This assay may also be used to screen for hepatitis B infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during the perinatal period.


Limitations

Patients who are negative for HBsAg may still have acute type B viral hepatitis. There is sometimes a “core window” stage when HBsAg has become negative and the patient has not yet developed the antibody (anti-HBs). On such occasions, both tests for anti-HBc are usually positive and anti-HBc, IgM is the only specific marker for the diagnosis of acute infection with hepatitis B. In cases with strong clinical suspicion of viral hepatitis, serologic testing should not be limited to detecting HBsAg, but should include a battery of tests to evaluate different stages of acute and convalescent hepatitis.


Methodology

Immunochemiluminometric assay (ICMA)


Reference Interval

Negative


Additional Information

Hepatitis B surface antigen (HBsAg) is a distinctive serological marker of acute or chronic hepatitis B infection. HBsAg is the first antigen to appear following infection with HBV and is generally detected 1-10 weeks after the onset of clinical symptoms. HBsAg assays are routinely used to diagnose suspected HBV infection and monitor the status of infected individuals to determine whether the infection has resolved or the patient has become a chronic carrier of the virus. In patients that recover from HBV infection, HBsAg is undetectable 3-5 months after the onset of infection. In patients with chronic HBV infection, HBsAg remains detectable for life. Prenatal HBsAg screening has been recommended so that newborns from HBV carrier mothers may obtain prophylactic treatment. Persistence of HBsAg, without anti-HBs, with combinations of positivity of anti-HBc, HBeAg, or anti-HBe indicates infectivity and need for investigation for chronic persistent or chronic aggressive hepatitis.


References

Abara WE, Qaseem A, Schillie S, et al. Hepatitis B Vaccination, Screening, and Likage to Care: Best Practice Advice from 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. Screening Pregnant Women for Hepatitis B Virus (HBV) Infection and Acreening and Referral Algorithm for hepatitis B Virus (HBV) Infection among Pregnant Women. CDC Web site. https://www.cdc.gov/hepatitis/hbv/perinatalxmtn.htm#section1. Accessed August 2020.
Schillie S, Vellozzi C, Reingold A, et al. Prevention of Hepatitis B Virus Infection in the United States. Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2018 Jan 12;67(1):1-31.29939980
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
Workowski KA, Bolan GA, Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines. MMWR Recomm Rep. 2015 Jun 5;64(RR-03):1-137.26042815
Edwards MS. Hepatitis B serology-Help in interpretation. Pediatr Clin North Am. 1988 Jun; 35(3):503-515 (review). 3287312
Favero MS, Maynard JE, Leger RT, Graham DR, Dixon RE. Guidelines for the care of patients hospitalized with viral hepatitis. Ann Intern Med. 1979 Dec; 91(6):872-876. 517890
Lee HS, Vyas GN. Diagnosis of viral hepatitis. Clin Lab Med. 1987 Dec; 7(4):741-757 (review). 3319367
Mushahwar IK, Dienstag JL, Polesky HF, McGrath LC, Decker RH, Overby LR. Interpretation of various serological profiles of hepatitis B virus infection. Am J Clin Pathol. 1981 Dec; 76(6):773-777. 7315794
Abara WE, Qaseem A, Schillie S, et al. Hepatitis B Vaccination, Screening, and Likage to Care: Best Practice Advice from 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. Screening Pregnant Women for Hepatitis B Virus (HBV) Infection and Acreening and Referral Algorithm for hepatitis B Virus (HBV) Infection among Pregnant Women. CDC Web site. https://www.cdc.gov/hepatitis/hbv/perinatalxmtn.htm#section1. Accessed August 2020.
Schillie S, Vellozzi C, Reingold A, et al. Prevention of Hepatitis B Virus Infection in the United States. Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2018 Jan 12;67(1):1-31.29939980
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
Workowski KA, Bolan GA, Centers for Disease Control and Prevention. Sexually Transmitted Diseases Treatment Guidelines. MMWR Recomm Rep. 2015 Jun 5;64(RR-03):1-137.26042815

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
006510 HBsAg Screen 5196-1 006510 HBsAg Screen 5196-1
Reflex Table for HBsAg Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 016105 HBsAg Confirmation 016105 HBsAg Confirmation 7905-3

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