At-home HIV Test Coming?

These studies are part of a group of research and development protocols known as "stress" or "flex" studies that are designed to demonstrate the robustness of the OraQuick(R) test for home use. Specifically, the studies are designed to determine the impact of environmental and common household factors on the performance of OraQuick(R). Several of these studies were recently commenced and several more are expected to be started in the near future. These studies are in addition to those the Company previously performed when it obtained a CLIA (Clinical Laboratory Improvements Amendments Act of 1988) waiver for the OraQuick(R) test in 2005...

OraQuick ADVANCE(R) is the first and only FDA-approved and CLIA-waived rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in 20 minutes, using oral fluid, finger-stick or venipuncture whole blood or plasma specimens. The Centers for Disease Control and Prevention and the Substance Abuse and Mental Health Services Administration have deployed over one million OraQuick(R) tests in various public health, drug treatment and outreach settings throughout the United States. The OraQuick(R) test is also used by hospitals, state departments of health, clinics...

OraSure Technologies, Inc., the maker of OraQuick ADVANCE ® Rapid HIV-1/2 Antibody Test, has initiated several studies to try to obtain an FDA approval of its HIV testing technology for home use. Here's what the Bethlehem, PA-based company says about its technology and about these ongoing studies:

Via medgadget.com