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Rapid HIV Diagnostic Test Now Available
A new diagnostic test for human immunodeficiency virus (HIV) infection, the Alere Determine HIV-1/2 Ag/Ab Combo test, is now available in the U.S. It is the first FDA-approved rapid point-of-care test that can detect both HIV-1/2 antibodies and the HIV-1 p24 antigen, which can appear days after infection and prior to HIV-1/2 antibodies.
The combo test simultaneously detects free HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole-blood specimens. The test can be used by trained professionals in health care settings to identify HIV-infected individuals.
Alere Determine HIV 1/2 Ag/Ab Combo is currently available to all health facilities and laboratories that are licensed to conduct tests of moderate complexity under the Clinical Laboratory Improvement Amendments (CLIA) program. The test is currently undergoing CLIA-waiver studies to determine its ease of use, safety, and accuracy.
In the fourth quarter of 2013, the test’s manufacturer (Alere, Inc.) anticipates submitting to the FDA its application to categorize Alere Determine HIV 1/2 Ag/Ab Combo as a CLIA-waived test, so that it can be made widely available in physician offices and public health settings.
Source: PR Newswire; October 29, 2013.