First US-licenced blood screening and diagnostic test to detect HIV Group O variant
Bio-Rad Laboratories has received a license from the FDA (Food and Drug Administration) for its HIV-1/HIV-2 Plus O EIA test kit used for diagnostic testing and the screening of blood and blood products.
The test simultaneously detects both HIV-1 (Groups M and O) and HIV-2 antibodies.
This test is significantly more sensitive than the currently licensed HIV-1/HIV-2 Peptide EIA test kit.
The new test, which incorporates a specific sequence designed to detect the Group O variant of HIV-1, has detected 100% of the HIV-1 Group M, HIV-1 Group O and HIV-2 samples tested.
"We are pleased to be able to provide the first combination HIV-1/HIV-2/HIV-O blood screening and diagnostic test to our customers in the U.S.," said John Goetz, vice president of Bio-Rad's clinical diagnostics group.
"HIV testing is an important way to ensure the safety of the blood supply, and it is our goal to provide the highest quality test kits to diagnostic and blood screening laboratories throughout the world." Nearly one million people in the United States are infected with HIV (Human Immunodeficiency Virus), which has become a significant public health problem worldwide.
The virus can be transmitted through the use of contaminated donor blood and plasma and is especially prevalent in countries where routine HIV screening has not been implemented.
Effective diagnostic testing and blood screening are critical tools used in the prevention of new infections.
HIV-1 Group O viruses, which are genetic 'outliers' of HIV-1, were first reported in individuals from central Africa in the early 1990s.
Subsequently, evidence of Group O infection was also reported in Europe among patients of west and central African origin, along with a single case reported of a French national patient infected with the Group O virus.
The Centers for Disease Control and Prevention (CDC) published the first US case of HIV-1 Group O infection discovered in Los Angeles, California in a Morbidity and Mortality Weekly Report (MMWR) in 1996.
In 1996 and 1997, the US FDA Center for Biologics Evaluation and Research (CBER) notified licensed test manufacturers that they should incorporate a Group O-derived antigen in their HIV test kits to enhance detection of this HIV variant.
Variants of HIV-1 may elude detection by tests that lack a Group O-derived specific sequence.
Bio-Rad has incorporated a synthetic polypeptide mimicking an artificial (ie, encoded by no existing virus) HIV-1 Group O-specific epitope into the HIV-1/HIV-2 Plus O EIA test kit, which utilizes a third generation assay format.
The new kit detected all 77 Group O serum samples obtained from Africa, France and the United States, as well as 100% of the HIV-1 Group M and HIV-2 serum samples tested.
Bio-Rad's Clinical Diagnostics Group manufactures a variety of diagnostic test kits used for HIV-1 and HIV-2, Hepatitis A, B, C, Syphilis, Aspergillus, and autoimmune diseases, as well as tests used for the detection of genetic disorders and food-borne pathogens.
