Alere Inc., the world's leading provider of point-of- care rapid diagnostic and health information solutions, today announced the immediate U.S. availability of the Alere Determine™ HIV-1/2 Ag/Ab Combo test, the first U.S. Food and Drug Administration (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.
"We're excited to announce the availability of the only fourth generation rapid test that can identify HIV infections in individuals earlier than ever before at the point of care by detecting the free HIV-1 p24 antigen," said Joe Medeiros, Director of Marketing, North America Virology Solutions at Alere. "The availability of the Alere Determine Combo test will contribute measurably to public health by helping HIV-positive individuals to become aware of their HIV status earlier, thereby potentially reducing HIV transmission. Earlier diagnosis can also allow effective treatment to be started without delay."
The Alere Determine HIV-1/2 Ag/Ab Combo test is FDA-approved to be sold in the United States as a CLIA (Clinical Laboratory Improvement Amendments) moderately complex medical device. 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. The test can be used by trained professionals in healthcare 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 CLIA program. Alere Determine HIV 1/2 Ag/Ab Combo test is currently 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.
According to the Centers of Disease Control and Prevention (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. HIV testing is essential for healthcare and social services to improve the quality of life and survival for persons who have HIV.
"We're excited to announce the availability of the only fourth generation rapid test that can identify HIV infections in individuals earlier than ever before at the point of care by detecting the free HIV-1 p24 antigen," said Joe Medeiros, Director of Marketing, North America Virology Solutions at Alere. "The availability of the Alere Determine Combo test will contribute measurably to public health by helping HIV-positive individuals to become aware of their HIV status earlier, thereby potentially reducing HIV transmission. Earlier diagnosis can also allow effective treatment to be started without delay."
The Alere Determine HIV-1/2 Ag/Ab Combo test is FDA-approved to be sold in the United States as a CLIA (Clinical Laboratory Improvement Amendments) moderately complex medical device. 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. The test can be used by trained professionals in healthcare 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 CLIA program. Alere Determine HIV 1/2 Ag/Ab Combo test is currently 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.
According to the Centers of Disease Control and Prevention (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. HIV testing is essential for healthcare and social services to improve the quality of life and survival for persons who have HIV.