FirstVue(TM) HBSAG Test Found to Have Higher Sensitivity and Specificity than Other Rapid HBSAG Tests and FirstVue(TM) '...and was the preferred
test in all phases of this evaluation'
CORAL SPRINGS, Fla., Oct. 13 /PRNewswire/ -- AT First Diagnostic LLC an emerging worldwide marketing leader in rapid diagnostic test kits, today announced that a recent evaluation conducted by the Walter Reed Army Institute of Research of the FirstVue(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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 U.S. 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 U.S. Food and Drug Administration ("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.
Hepatitis B is a potentially life-threatening liver infection caused by the Hepatitis B virus. It is a major global health issue and the most serious type of viral hepatitis. It can cause chronic liver disease and puts people at high risk of death from cirrhosis of the liver and liver cancer.
Approximately 2 billion people worldwide have been infected with the virus and about 350 million live with chronic infection. About 25% of adults who become chronically infected during childhood later die from liver cancer or cirrhosis (scarring of the liver). Hepatitis B virus is 50 to 100 times more infectious than HIV. Most people who develop chronic Hepatitis B infection are not aware that they have the disease.
About AT First Diagnostic LLC
AT First Diagnostic LLC, Coral Springs, FL USA (Privately Held) markets, develops, and contract manufactures rapid medical devices using proprietary technologies under their brands FirstVue(TM) & inSTIcheck(TM); products include a wide range of various infectious disease tests for Chlamydia, Gonorrhea, Syphilis, etc... These tests are sold in the United States and internationally to clinical laboratories, hospitals, clinics, community organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities. For more information please go to http://www.firstdiagnostic.com .
About the Walter Reed Army Institute of Research
Walter Reed Army Institute of Research (WRAIR) is the largest, most diverse and oldest laboratory in the US Army Medical Research and Material Command. It conducts research on a range of military relevant issues, including naturally occurring infectious diseases, combat casualty care operational health hazards. WRAIR is the Department of Defense's lead agency for infectious disease research and a crucial source of research support for medical product development.
About the United States Military HIV Research Program
The U.S. Military HIV Research Program (USMHRP) is dedicated to, prevention, disease surveillance and care and treatment for HIV. USMHRP's extensive diagnostics expertise including familiarity with HIV rapid tests led the U.S. Army Blood Program to engage with USMHRP for this HBSAG rapid test evaluation.
This press release contains certain forward-looking statements, including with respect to products, product performance, clinical studies, and regulatory submissions and approvals. Although forward-looking statements help to provide complete information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. The forward-looking statements are made as of the date of this press release and AT First Diagnostic undertakes no duty to update these statements.
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