Special Instructions

This test is specifically designed for screening or testing chronic hepatitis B in pregnant individuals. It should not be used for screening or confirmatory testing of blood donor specimens, nor is it suitable for diagnosing hepatitis B during the 'window period' of acute HBV infection. It is not intended for symptomatic individuals who may or may not have risk factors for hepatitis B virus infection. Consider alternative tests for nonpregnant or asymptomatic individuals.

Limitations

This assay is not licensed by the FDA for screening blood, plasma, and tissue donors. Results should be used in conjunction with a patient's medical history, clinical examination, and other findings. Positive HBsAg results due to recent hepatitis B vaccination may occur, and the test may not detect all infected individuals. A negative result does not exclude a possible hepatitis B infection entirely; it can occur if antigen concentration is below the detection threshold or no reaction occurs with the antibodies used in the assay. There is no established performance data for its use in newborns or with assays from other manufacturers.

Biomarkers

LOINC Codes

Result Turnaround Time

Related Documents

Stability Requirements