Abbott Laboratories and OraSure Technologies introduce Oraquick Rapid HIV-1 antibody test
Test provides result in approximately 20 minutes using a finger-stick blood sample
Abbott Laboratories and OraSure Technologies, Inc. announced the availability of the recently approved rapid HIV-1 antibody test, OraQuick®, to hospitals, physician offices and other health care facilities in the United States.
OraQuick is the first rapid, point-of-care test approved by the U.S. Food and Drug Administration (FDA) designed to detect antibodies to HIV-1 in finger-stick whole blood within approximately 20 minutes. The test was approved by the FDA on November 7, 2002. Based on clinical data submitted by OraSure Technologies, the OraQuick test has been shown to have sensitivity and specificity comparable to laboratory-based tests. Sensitivity is the ability to correctly identify those who have the disease and specificity is the ability to correctly identify those who do not have the disease.
"Based on 14 years of experience with rapid diagnostics for HIV, it is encouraging to see that technology has evolved to the point where an accurate, reliable test can be performed quickly and simply," said Niel Constantine, Ph.D., professor of pathology and director of the Clinical Immunology Laboratory, University of Maryland Medical System. "With a rapid test, more people will have the ability to learn their HIV status and, if necessary, seek earlier treatment intervention. Knowledge about HIV status is also a critical factor in stemming the spread of the virus."
According to the Centers for Disease Control, more than one-third of the 2.2 million Americans tested for HIV at public health clinics each year do not return to learn their test results. In fact, as many as 11,000 individuals who test positive for HIV each year do not return for their results. Of the approximately 900,000 people in the United States currently living with HIV, it is estimated that one-fourth may not know they are infected.
"OraQuick is an important tool to assist in the rapid detection of HIV and represents our continuing commitment to improve diagnostic testing and medical care for people living with HIV and AIDS," said James Koziarz, Ph.D., vice president, hepatitis/retrovirus research and development and assay technical support, Abbott Laboratories. "We are committed to making OraQuick widely available to the health care professionals and patients who need it."
Abbott and OraSure entered into an agreement in June 2002 for the co- exclusive distribution of OraQuick. Abbott is the market leader for the distribution of infectious disease testing products.
"OraQuick is a major breakthrough in testing for HIV and the fight against AIDS," said Sam Niedbala, Ph.D., executive vice president and chief science officer, OraSure Technologies. "Our development teams worked for several years to make this device simple and easy. Looking forward, our commitment is to expand the availability of OraQuick while maintaining uncompromising quality of performance and reliability."
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