Hepatitis B Virus (HBV) Prenatal Screen With Reflex to HBV DNA

TEST: 144523
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CPT: 87340; if reflex test is performed, additional CPT code(s) may apply.
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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

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

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Specimen Requirements

Specimen

Serum or EDTA plasma

Volume

6 mL

Minimum Volume

2.2 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: 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: Room temperature up to 14 days. Refrigerated up to 14 days. Frozen up to 7 days.

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

Causes for Rejection

Non-EDTA plasma specimen; PST gel-barrier tube

Test Details

Use

Screening of pregnant women for hepatitis B virus (HBV) infection to identify neonates who are at risk of acquiring hepatitis B during the perinatal period. A positive HBsAg test will reflex to HBV quantitative DNA.

Limitations

Patients who are negative for HBsAg may still have acute type B viral hepatitis. A nonreactive/negative result in individuals with prior exposure to hepatitis B may be due to antigen levels below the detection limit of the assay or lack of antigen reactivity to the antibodies in the assay used. In cases with strong clinical suspicion of viral hepatitis, testing should not be limited to detecting HBsAg, but should include a battery of tests to evaluate different stages of acute and convalescent hepatitis, including detection of antibodies hepatitis B core antigen (anti-HBc) and HBVDNA.

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

Methodology

Immunochemiluminometric assay (ICMA)

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.

Refer to https://www.cdc.gov/hepatitis/hbv/pdfs/PrenatalHBsAgTesting.pdf for additional information on HBV testing recommendations in pregnant women.

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.
Centers for Disease Control and Prevention; The American Colllege of Obstetrics and Gynecologists. Screening Pregnant Women for Hepatitis B Virus (HBV) Infection and Screening and Referral Algorithm for Hepatitis B Virus (HBV) Infection Among Pregnant Women. CDC web site: https://www.cdc.gov/hepatitis/hbv/pdfs/PrenatalHBsAgTesting.pdf. Accessed June 2021.
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

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
144523 HBV Prenatal Screen w/ rfx 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
Reflex Table for HBsAg Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 551610 HBV Real-Time PCR, Quant 551629 HBV IU/mL IU/mL 42595-9
Reflex 2 551595 HBV Real-Time PCR, Quant 551628 HBV IU/mL IU/mL 42595-9
Reflex Table for HBsAg Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 551610 HBV Real-Time PCR, Quant 551629 HBV IU/mL IU/mL 42595-9
Reflex 2 551595 HBV Real-Time PCR, Quant 551596 log10 HBV IU/mL log10 IU/mL 48398-2
Reflex Table for HBsAg Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 551610 HBV Real-Time PCR, Quant 551597 log10 HBV IU/mL log10 IU/mL 48398-2
Reflex Table for HBsAg Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 551610 HBV Real-Time PCR, Quant 551724 Test Information: 19147-8
Reflex Table for HBsAg Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 144405 HBsAg Confirmation 016105 HBsAg Confirmation 7905-3
Reflex 2 551610 HBV Real-Time PCR, Quant 551629 HBV IU/mL IU/mL 42595-9
Reflex 3 551595 HBV Real-Time PCR, Quant 551628 HBV IU/mL IU/mL 42595-9
Reflex Table for HBsAg Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 144405 HBsAg Confirmation 016105 HBsAg Confirmation 7905-3
Reflex 2 551610 HBV Real-Time PCR, Quant 551629 HBV IU/mL IU/mL 42595-9
Reflex 3 551595 HBV Real-Time PCR, Quant 551596 log10 HBV IU/mL log10 IU/mL 48398-2
Reflex Table for HBsAg Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 144405 HBsAg Confirmation 016105 HBsAg Confirmation 7905-3
Reflex 2 551610 HBV Real-Time PCR, Quant 551597 log10 HBV IU/mL log10 IU/mL 48398-2
Reflex Table for HBsAg Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 144405 HBsAg Confirmation 016105 HBsAg Confirmation 7905-3
Reflex Table for HBsAg Screen
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 144405 HBsAg Confirmation 016105 HBsAg Confirmation 7905-3
Reflex 2 551610 HBV Real-Time PCR, Quant 551724 Test Information: 19147-8

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