PR NEWSWIRE- Laboratory Evaluation of Hepatitis B Rapid Tests for Use in Screening Walking Blood bank Donors: A Walter Reed Evaluation Concluded That The FirstVue(TM) HBSAG Test is Preferred Over Other Rapid Tests...
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.”
(PR WIRE WORLDWIDE)--Sept. 2008—FirstVue(TM) a marketing leader in rapid diagnostic tests, today announced that an evaluation by the Walter Reed Army Institute of Research of the FirstVue(TM) HBSAG Test, currently in development by, was recently 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 evaluation.
Blood that is donated to commercial or hospital blood banks is subjected to extensive testing for blood-borne pathogens before it is released to be used in transfusions. However, emergency battlefield conditions sometimes dictate that an available soldier, or Walking Blood Bank, donate without this normal lab-based testing being available. A rapid assay such as the FirstVue(TM) HBSAG test can add a measure of safety against this important blood borne virus.
Out of 40 manufactures, Six rapid tests were initially selected from the rapid HBSAG tests available worldwide, based on an evaluation of published claims and sensitivity testing using HBSAG positive samples. The 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 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 and approximately sixteen days earlier than the next most sensitive rapid HBSAG test. Early detection of seroconversion is an important measure of the sensitivity of a test and means that hepatitis B infection can be identified even with relatively recent exposure.
"We are very pleased with the results of the Walter Reed evaluation, its just another confirmation of the quality of our full product line of rapid tests" said Jonathan Barash President of FirstVue(TM) . "We are eager to complete our technical paperwork for the FirstVue(TM) HBSAG test and submit our applications for both FDA approval and CE registration for this product. Based on the performance data generated to date, we believe this test will play an important future role in identifying new HBSAG infections and enabling infected individuals to receive the care and treatment they need."
The 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. Conference information may be obtained at https://www.usaccc.org/ATACCC/index.htm
The FirstVue(TM) HBSAG rapid test is currently not currently available for commercial sale in the United States by the U.S. Food and Drug Administration ("FDA"). AT First Diagnostic is in a final process of collecting all the technical data together in order to obtain FDA approval for the test utilizing multiple specimen types, finger-stick, venous, whole blood, plasma and serum. The studies are nearing completion and a pre-market application is in progress for submission to the FDA.
Hepatitis B is a potentially life-threatening liver infection caused by the hepatitis B virus. It is a major global health problem 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 about 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) caused by the chronic infection. The 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. Identification of occult infections could significantly reduce future morbidity and mortality associated with HBSAG infection.
A vaccine against hepatitis B has been available since 1982. Hepatitis B vaccine is 95% effective in preventing HBV infection and its chronic consequences, and is the first vaccine against a major human cancer.
About FirstVue(TM)
FirstVue(TM) brand develops, contract manufactures and markets rapid test devices using proprietary technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities. For more information on the Company, please go to http://firstvue.com/company.html
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 militarily relevant issues, including naturally occurring infectious diseases, combat casualty care, operational health hazards, and medical defense against biological and chemical weapons. 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 HIV vaccine development, prevention, disease surveillance and care and treatment for HIV. This program builds on the strength of the U.S. military medical research community, and addresses specific HIV research requirements to meet its mission: prevention of HIV-1 disease in the active force and, by extension, the global community at risk of infection. 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. USMHRP information may be found at http://www.hivresearch.org/index.html
By Robert J. O’Connell1,3, Robert G. Gates2, Michelle Imbach3, Christian T. Bautista3, Stephen G. Beardsley4, Richard Gonzales5, Francisco Rentas6, Victor W. MacDonald7, Lisa J. Cardo7,David T. Reiber8, Susan Stramer9, Michael Busch10, Nelson L. Michael1,3, and Sheila A. Peel1,3
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