This article is more than 5 years old. Information may no longer be current.

FDA approves Aptima HBV Quant assay

The FDA announced the approval of the Aptima HBV quant assay, designed to measure the amount of hepatitis B DNA in plasma or serum from patients with HBV, according to a release from the organization.

Clinicians can use the assay test to measure HBV DNA levels both at baseline and during treatment to assess the patient’s response to therapy.

According to the FDA, the assay should not be used unless ordered by a physician and is not approved as a screening or diagnostic test.

Based on preclinical and clinical studies, the Aptima HBV Quant assay (Hologic) demonstrated significant efficacy and no observed adverse effects on health.

When used according to provided directions and in conjunction with other laboratory results and clinical information, the Aptima HBV Quant assay should be safe and pose minimal risk to the patient due to incorrect test results.

Reference: www.fda.gov