"This
unique rapid test is the only single use assay to be approved
by the FDA for the detection and differentiation of HIV-1 and
HIV-2 antibodies," said John Goetz, Bio-Rad Vice President
and Group Manager of Clinical Diagnostics. "We are pleased
to receive FDA approval and look forward to providing the product
to our U.S. customers in January 2005.”
“The
Multispot HIV-1/HIV-2 Rapid Test is an important addition to the
company's HIV product line, which now includes a full range of
kits for screening, confirmation and differentiation of HIV-1
and HIV-2 antibodies.
“The
new single use qualitative enzyme immunoassay can be used on both
fresh and frozen serum and plasma samples; it is easy to use,
producing results in approximately 10 minutes; and it will provide
clinical laboratories with a significant improvement to existing
diagnostics for HIV.
“Clinical
studies on a large number of HIV-1 and HIV-2 antibody positive
and negative samples have shown that the test provides the highest
levels of sensitivity (100%) and specificity (>99.9%). The
assay is also suitable for use in multi-test algorithms designed
for statistical validation of rapid HIV test results. The test
is moderately complex and approved for use in CLIA-certified laboratories
(Clinical Laboratory Improvement Amendments of 1988).
“The
U.S. Centers for Disease Control and Prevention (CDC) recently
reported that there are between 850,000 - 950,000 people living
with HIV/AIDS in the U.S. alone.
“Due
to the disproportionate number of cases of people who do not know
they are infected (people who are tested, but do not return for
results), the CDC and other World Health Organization (WHO) affiliates
are showing increased support for the implementation of rapid
HIV testing programs that will provide patients with faster test
results.
“According
to WHO, testing and counseling is the key entry point to prevention
services in populations at risk for HIV/AIDS and can lead to the
reduction of infections transmitted sexually and/or by intravenous
drug use.”
