Hepatitis B Virus (HBV) DNA Detection and Quantification by Real-Time PCR, Serum

Casandra

Casandra Test Code MC48188Version 1 (DRAFT)

Performing Lab

Lab Mayo Clinic LabLab Test ID HBVQNCPT Code 87517

Hepatitis B Virus (HBV) DNA Detection and Quantification by Real-Time PCR, Serum

Clinical Use

Use

This test is useful for the detection and quantification of hepatitis B virus (HBV) DNA in the serum of patients with chronic HBV infection, particularly those who are hepatitis B surface antigen-positive. It is used to monitor disease progression in chronic HBV infection and to evaluate the patient's response to anti-HBV therapy. The presence of HBV DNA in serum is a reliable marker of active HBV replication, which is crucial for differentiating between active and inactive disease states in chronic HBV infections.

Special Instructions

Specimens must be shipped frozen on dry ice. If the shipment will be delayed for more than 24 hours, freeze the serum at -20 to -80 degrees Celsius prior to shipment on dry ice. If not ordering electronically, complete and send the Gastroenterology and Hepatology Test Request or the Microbiology Test Request form with the specimen. It is recommended to use the same HBV DNA quantification assay for serial monitoring to ensure consistency in results.

Limitations

This test is not licensed by the FDA as a screening test for HBV infections. HBV serologic testing should be performed to initiate HBV infection status evaluation. The diagnosis of chronic HBV infection should not be based solely on a single serum specimen with detectable or quantifiable HBV DNA. An undetected HBV DNA test result does not exclude the possibility of a resolved infection, especially in cases with positive anti-HBV antibody status. Retesting in 1 to 2 months may be necessary to distinguish between resolved and chronic infections with episodic replication.

Test Details

FDA Approved