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  1. Device Approvals, Denials and Clearances

Aptima HBV Quant assay - P170025

Aptima HBV Quant assay - P170025

Image of Aptima HBV Quant assay - P170025

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Aptima HBV Quant assay
PMA Applicant: Hologic, Inc.
Address: 10210 Genetic Center Drive, San Diego, CA 92121
Approval Date: January 23, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170025A.pdf

What is it? The Aptima HBV Quant assay is a laboratory test designed to measure the amount of Hepatitis B Virus (HBV) DNA (deoxyribonucleic acid) in plasma or serum from patients with an HBV infection. Viral DNA is the genetic material from HBV.

Hepatitis B is a liver infection caused by HBV. Hepatitis B is transmitted when blood, semen, or another body fluid from a person infected with the Hepatitis B virus enters the body of someone who is not infected. This can happen through sexual contact; sharing needles, syringes, or other drug-injection equipment; or from mother to baby at birth. For some people, hepatitis B is an acute, or short-term, illness but for others, it can become a long-term, chronic infection. Risk for chronic infection is related to age at infection: approximately 90% of infected infants become chronically infected, compared with 2%–6% of adults. Chronic Hepatitis B infection can lead to serious health issues, like cirrhosis or liver cancer.

How does it work? A physician orders the test, and a sample of the patient's blood is obtained and sent to a clinical laboratory. Nucleic Acid (DNA) is automatically separated from serum or plasma using Hologic's Panther system (an automated system that separates the viral DNA from the serum or plasma and viral proteins). The assay reagents are automatically mixed with the separated DNA. The Panther system calculates the amount of HBV DNA in the patient's blood based on the fluorescent signal measured by the analyzer during transcription-mediated nucleic acid amplification (TMA). Physicians can use the measurement of the amount of HBV DNA in the blood, along with clinical presentation and other laboratory findings, to help determine an individual's response to treatment.

When is it used? This test is used together with other laboratory results and clinical information to aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The test can be used to measure HBV DNA levels at baseline and during treatment to assess the patient's response to treatment.

What will it accomplish? This test, when used with other laboratory results and clinical information, helps physicians assess if the virus is responding to treatment, and manage patients with chronic HBV infection who are undergoing anti-viral therapy.

When should it not be used? The Aptima HBV Quant assay should not be used if it is not ordered by a physician. It should not be used to screen blood or blood products for transfusion. The assay should not be used to determine if a person is infected with the hepatitis B virus or to determine the state of HBV infection.

Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data and labeling are available online: