-- 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
Source: AT First Diagnostic LLC
CONTACT: Jonathan Barash of AT First Diagnostic LLC,
Web site: http://www.firstdiagnostic.com/