Industry News

Alere’s First 4th Generation Rapid HIV Test Detects HIV Sooner

AlereHIV copyAccording to the latest federal guidelines and proposed algorithm from the Centers for Disease Control and Prevention (CDC), routine HIV testing with a 4th generation test can have a significant public health impact.

Alere Inc, Waltham, Mass, introduces in the United States its Alere Determineā„¢ HIV-1/2 Ag/Ab Combo test, the first FDA-approved rapid point-of-care test that detects 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 test is FDA-approved to be sold in the United States as a CLIA (Clinical Laboratory Improvement Amendments) moderately complex medical device.

According to the CDC, there are approximately 1.2 million Americans living with HIV, and an estimated 207,000 (18%) whose infections have not been diagnosed. In 2010, the CDC estimated that there were 47,500 newly infected people with the virus in the United States, indicating that HIV remains a serious health problem.

The 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. It can be used by trained professionals in healthcare settings to identify HIV-infected individuals.

The test is now available to all health facilities and labs that are licensed to conduct tests of moderate complexity under the CLIA program.

It is undergoing CLIA-waiver studies to demonstrate its ease of use, safety, and accuracy. In the fourth quarter of 2013, Alere anticipates submitting to the FDA its application to categorize Alere Determine HIV 1/2 Ag/Ab Combo as a CLIA-waived test, so it can be made widely available in physician offices and public health settings.

[Source: Alere]