for its new Multispot HIV-1/HIV-2 Rapid Test. This highly sensitive test kit will soon be available in the United States and will significantly aid in the diagnosis of HIV-1/HIV-2 (Human Immunodeficiency Virus, Types 1 and 2), the viruses that cause AIDS (Acquired Immunodeficiency Syndrome).
"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 percent) and
specificity (>99.9 percent). 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 Centers for Disease Control and Prevention (CDC) recently
reported that there are between 850,000 and 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.
Source: Bio-Rad Laboratories, Inc.