You are here

Rapid HIV Diagnostic Test Now Available

New assay detects HIV earlier than antibody-only tests (October 29)

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.

Recent Headlines

Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Despite older, sicker patients, mortality rate fell by a third in 10 years
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs