Bio-Rad receives FDA approval for new HIV rapid test

Jan 4 2005

Bio-Rad Laboratories announced today that it recently received approval from the U.S. Food and Drug Administration (FDA) 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%) 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.