In-Home HIV Test Empowers Patients
In-Home HIV Test Empowers Patients
Abstract & Commentary
By Dean L. Winslow, MD, FACP, FIDSA
Chairman, Department of Medicine, Santa Clara Valley, Medical Center; Clinical Professor, Stanford University School of Medicine
Dr. Winslow is a consultant for Siemens Diagnostic. This article originally appeared in the August issue of Infectious Disease Alert.
Synopsis: The OraQuick in-home HIV-1/2 antibody test was granted market clearance by the FDA on May 15, 2012. Data presented included a < 0.1% false-positive rate and 91.7% sensitivity to correctly detect HIV infection compared to conventional ELISA performed on blood.
Source: OraSure Technologies, Inc. OraQuick in-home HIV test package insert. Available at http://ow.ly/ckHuF.
ON MAY 15, THE FDA CENTER FOR BIOLOGICS EVALUATION and Research/Office of Blood Research and Review (CBER/OBRR) granted market clearance to the OraQuick in-home HIV-1/2 antibody test based on the recommendation of the Blood Products Advisory Committee. The in-home assay is a rapid, CLIA-waived immunoassay using synthetic peptides as antigens formatted in a test strip format to be used on saliva. The in-home assay is similar to the OraQuick assay previously approved by FDA for rapid HIV testing of venous or fingerstick whole blood or plasma. Data submitted to the FDA included a study of 4999 individuals of unknown HIV status. Results obtained with OraQuick were compared to “gold standard” testing with a laboratory-based ELISA performed on serum or plasma.
Bottom-line results from this performance trial showed that 4902/4903 HIV-negative patients were correctly identified (i.e., one false-positive was seen). Of ELISA-positive patients, 88/96 (91.7%) were correctly identified (i.e., eight false negatives were seen). A total of 56/5055 (1.1%) failed to obtain a test result.
Commentary
The FDA market clearance of this in-home, rapid assay to detect HIV-1/2 antibodies demonstrated fairly robust performance and seemed easy to use by most patients. The assay as performed by untrained personnel on saliva does appear to be somewhat less sensitive than the comparator laboratory-based serum or plasma HIV antibody assay. The product package insert is careful to point out the limitations of the test in laymen’s terms and emphasizes that individuals should wait at least 3 months after a suspected exposure event to test themselves with OraQuick.
The impact of confidential in-home testing may or may not be significant in interrupting transmission of HIV on a large scale in the United States or Western Europe. However, it is hard for me to imagine a scenario (other than acute HIV infection where the test may be negative, yet the patient highly contagious) where harm could be done. I am a firm believer in empowering patients to take responsibility for their health and for transmission of sexually-transmitted infections to others. This is a step in the right direction and will be a useful development even if only a few new cases of HIV are prevented each year in North America and Western Europe. Hopefully, the OraQuick test will be priced low enough in the developing world where its impact could potentially be very large.
The OraQuick in-home HIV-1/2 antibody test was granted market clearance by the FDA on May 15, 2012. Data presented included a < 0.1% false-positive rate and 91.7% sensitivity to correctly detect HIV infection compared to conventional ELISA performed on blood.Subscribe Now for Access
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