AT First Diagnostic LLC has announced that a recent evaluation conducted by the Walter Reed Army Institute of Research of the FirstVue™ HBSAG Test, was released at the Advanced Technology Applications for Combat Casualty Care meeting, sponsored by the Department of Defense.
The purpose of the evaluation, entitled "Laboratory Evaluation of Hepatitis B Rapid Test for Use in Screening Walking Blood Bank Donors," was to determine the best rapid HBSAG test to use for screening blood donors for Hepatitis B ("HBSAG") in the theater of war. The FirstVue HBSAG test was selected as the preferred test based on all facets of the study evaluation.
Out of all manufactures in the rapid diagnostic industry, six rapid tests were initially selected based on an evaluation of published claims and sensitivity testing using HBSAG positive samples. Those tests were then compared in a comprehensive evaluation of test performance using plasma and blood specimens. The study indicated that the FirstVue HBSAG test had the highest sensitivity (95.4%) and the highest specificity (99.7%) among all the tests evaluated.
In addition, the evaluation indicated that the FirstVue HBSAG test detected HBSAG antibodies approximately three days sooner than available laboratory-based enzyme immunoassays. Early detection of seroconversion is an important measure of the sensitivity of a test and means that Hepatitis B infection can now be identified even with relatively recent exposure.
"We are very pleased with the results of the Walter Reed evaluation, it’s just another confirmation of the quality of our product line and of the HBSAG rapid test we are providing the military," said Jonathan Barash President of AT First Diagnostic. "We are eager to complete our paperwork for the FirstVue HBSAG test and submit our findings and applications for both FDA and CE registrations on this product. Based on the performance data generated to date, we believe this test will play an important role in identifying HBSAG infections in the future and will enable infected individuals to receive the proper care and treatment they need."
This extensive study was conducted at The Walter Reed Army Institute of Research and involved investigators from the Walter Reed Army Institute of Research Division of Retrovirology, The US Military HIV Research Program, Walter Reed Army Institute of Research Division of Military Casualty Research, the U.S. Army Blood Program, the Army Medical Department Center and School, the Robertson Blood Center and the American Red Cross.
Rapid Hepatitis "B" or "C" tests are not currently available for commercial sale in the United States by the US FDA. AT First Diagnostic is in the process of collecting all the technical data together in order to obtain FDA guidance and approvals for this HBSAG test utilizing multiple specimen types, whole blood, plasma and serum. The data stage is nearing completion and a pre-market application will be in progress for submission to the FDA soon.