THIS MONTH’S ISSUE

Read, save, and print articles from the current issue

ARTICLES

Chronological index
2013–2018

PRODUCT GUIDES

Compare all instruments
and software systems

DEPARTMENTS

Chronological index
2013–2018

WEBINARS

Register Now and
On Demand

Home » Top news

Aptima HBV Quant Assay gets PMA approval

Jan. 30, 2018Hologic announced the FDA has granted PMA approval for the Aptima HBV Quant Assay for quantitation of hepatitis B viral load on the Panther system.

The Aptima HBV Quant assay is the newest addition to the Panther system’s viral load menu, joining the previously approved Aptima HIV-1 Quant Assay and Aptima HCV Quant Dx Assay. The three assays use the company’s proprietary real-time transcription-mediated amplification, which provides highly sensitive and specific performance. The HBV Quant assay quantitates HBV DNA across all major genotypes A–H.

“This approval represents a milestone for Hologic’s growing virology assay menu,” Tom West, president of Hologic’s diagnostic solutions division, said in a statement. “We now have available on a single system the three major viral load assays that most laboratories are asked to run for patients.”

The Aptima HBV Quant assay offers a dual-target approach that aims to deliver accurate quantitation over a broad linear range and tolerates potential mutations in the HBV genome. The assay’s linear range is from 10 IU/mL to 1 billion IU/mL, which helps ensure precise quantitation for samples with the high viremia often associated with chronic HBV infection.

The Panther system can run viral load assays for HIV-1, HCV, and HBV in parallel or from a single patient sample. The Panther menu also includes tests for sexually transmitted infections including chlamydia, gonorrhea, trichomonas, human papillomavirus, and herpes simplex virus.

More top news

Print Friendly, PDF & Email
Tags:

X