WHO 'pre-qualifies' new HIV/syphilis combo test

HIV positive test
HIV positive test

Alere, a global leader in rapid diagnostics, announced that Alere SD BIOLINE HIV/Syphilis Duo test has been awarded World Health Organisation (WHO) pre-qualification, making it the first dual HIV/syphilis point-of-care test available for public sector procurement in resource-limited countries.

Eliminating mother-to-child transmission

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. Utilisation 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.

Read: Global HIV funding for SA is waning

“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.” 

Her Excellency, 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.” 

Transmission of HIV and syphilis 

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 foetus.

Additionally, syphilis infection during pregnancy increases the risk of mother-to-child HIV transmission by 180%. In sub-Saharan Africa, 260,000 African children are infected with HIV each year.

Read: WHO guidelines recommend early ARVs for all with HIV

Mother-to-child transmission occurs through pregnancy, labour, delivery and breast feeding. In fact, breast-feeding alone increases the risk of MTCT by 12% to 43%.

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 percent 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% 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. 

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