Alere, a global leader in rapid diagnostics, announced that its Alere SD Bioline HIV/Syphilis Duo test has been awarded World Health Organization (WHO) prequalification, making it the first dual HIV/syphilis point-of-care test available for public sector procurement in resource-limited countries.
With WHO prequalification, global health organisations such as PEPFAR, UNAIDS and the Global Fund to Fight AIDS, Tuberculosis and Malaria can now deploy the HIV/Syphilis Duo test in national screening programmes targeting those in greatest need. Utilization of the test will be focused on screening pregnant women for HIV and syphilis and linking those infected to care, in support of WHO's goal of eliminating mother-to-child transmission (EMTCT) of these serious diseases.
"Alere is committed to making our infectious disease diagnostics widely available to support prevention of mother-to-child transmission programmes in resource-limited countries, and the WHO prequalification of HIV/Syphilis Duo test significantly advances this goal," said Avi Pelossof, Alere global president of infectious disease. "With this broadened access, the full potential of the HIV/Syphilis Duo test in helping meet EMTCT goals can now be unlocked."
Dr. Nana Lordina Dramani Mahama, first lady of the Republic of Ghana and president of the Organisation of African First Ladies Against HIV/AIDS, said, "Alere has already provided test kits to help us screen 200,000 people for HIV and syphilis infections, and we are delighted that this productive relationship continues to grow and thrive."
Globally, 1.4 million pregnant women have active syphilis and almost 1.5 million pregnant women are HIV infected. Both HIV and syphilis can be transmitted during pregnancy to the fetus. Additionally, syphilis infection during pregnancy increases the risk of mother-to-child HIV transmission by 180 per ceny. In sub-Saharan Africa, 260,000 African children are infected with HIV each year. Mother-to-child transmission occurs through pregnancy, labor, delivery and breast feeding. In fact, breast-feeding alone increases the risk of MTCT by 12 per cent-43 per cent. Maternal syphilis infection can cause stillbirth, neonatal death, prematurity, low birth weight or congenital syphilis. The impact of maternal syphilis can be prevented by testing early in pregnancy, treating seropositive pregnant women, and preventing re-infection.
Forty per cent of pregnant women living with HIV have not received anti-retrovirals to reduce mother-to-child transmission during pregnancy. Without any intervention, up to 45 per cent of infants born to mothers living with HIV will become infected.
In 2014, WHO and key partners published guidance on and recommendations for the dual elimination of mother-to-child transmission of syphilis and HIV, and a framework for countries to monitor progress and validate success.
The Alere SD Bioline HIV/Syphilis Duo offers a simple, easy-to-use rapid diagnostic test for simultaneous detection of HIV and Syphilis. By enabling early detection of HIV, Syphilis or both in mothers, the Alere SD BIOLINE HIV/Syphilis Duo helps bridge the health equity gap and get patients onto treatment pathways faster. The test uses a solid-phase immunochromatographic assay for simultaneously qualitative detection of HIV-specific antigens (HIV-1 gp41, sub O, HIV-2 gp36) and recombinant Treponema pallidum antigen (17 kDa) in human serum, plasma, or whole blood.
Prior to WHO prequalification, the product received CE certification on July 1, 2015.