Alere, a global leader in rapid diagnostics, announced that its Alere HIV Combo, a rapid point-of-care fourth-generation test that detects both HIV-1/2 antibodies and the HIV-1 p24 antigen, has been awarded World Health Organization (WHO) prequalification, making it available for public sector procurement in resource-limited countries.

Conventional second- and third-generation HIV rapid tests can only detect antibodies against HIV which may not appear until three weeks after infection. Alere HIV Combo detects not only these antibodies but can also detect free HIV-1 p24 antigen which can appear up to 7.7 days earlier. For global HIV programmes this means the potential to increase case finding particularly in key high risk populations that have been disproportionally affected by HIV.

"WHO's prequalification of the Alere HIV Combo reflects our commitment to making high-quality point-of-care HIV diagnostics available in areas with the greatest burden of HIV infection," said Avi Pelossof, Alere global president of Infectious Disease. "The first step in eradicating AIDS is identifying as many individuals as possible infected with HIV and linking them to care. Now, even more healthcare workers will be able to accomplish this with a new 4th generation HIV point-of-care test available today."

"We can't meet UNAIDS' 90-90-90 target unless we achieve the first goal of ensuring that people with HIV know their status, and this requires helping healthcare workers in developing countries make every testing opportunity count," said Collins Odhiambo, Ph.D., who evaluated the Alere HIV Combo at the Kenya Medical Research Institute (KEMRI). "The Alere HIV Combo brings point-of-care diagnosis directly to people at greatest risk for infection – including those in remote areas – and makes screenings as impactful as possible by enabling healthcare workers to identify highly infectious individuals, and link them to treatment."

In 2014, the Joint United Nations Programme on HIV/AIDS (UNAIDS) established an ambitious target designed to drive progress towards ending the AIDS epidemic: by 2020, 90 percent of all people living with HIV will know their HIV status, 90 percent of all people with diagnosed HIV infection will receive sustained antiretroviral therapy, and 90 percent of all people receiving antiretroviral therapy will have viral suppression. Alere supports these important goals with a portfolio of diagnostic solutions for the complete cascade of HIV care from initial screening and diagnosis to staging and ongoing monitoring.

Prior to WHO prequalification, the product received CE certification on January 29, 2015.

The Alere HIV Combo is a new 4th generation HIV point-of-care test that detects both free HIV 1-p24 antigen and HIV 1/2 antibodies in 20 minutes. HIV-1 p24 can appear up to 7.7 days before the appearance of antibodies and can help further reduce the window period. By detecting HIV infection earlier, the Alere HIV Combo enables increased case finding at a time when individuals are up to 10 times more likely to transmit HIV than individuals with established infection.

The Alere HIV Combo is not approved for sale in the US. Alere Determine HIV-1/2 Ag/Ab Combo is CLIA-waived and available in the US.