SD Biosensor's HIV-syphilis dual test

In November 2021, we partnered with CHAI to execute a four-year volume guarantee agreement with SD Biosensor (SDB) to catalyse access to a dual HIV-syphilis rapid diagnostic test (Dual RDT). This will support the integration of syphilis testing into HIV testing programs in antenatal care settings which will help to close the testing gap between HIV and syphilis, and increase syphilis diagnosis and linkage to care among pregnant women.

The partnership

  • MedAccess has provided a volume guarantee to SD Biosensor, meaning we will make up any shortfall in sales.
  • SD Biosensor will continue to produce and supply the HIV-syphilis dual RDT, increasing availability and access to the product in low-and-middle-income countries.
  • CHAI helped facilitate the volume guarantee agreement and support country adoption of the dual test.

Through this partnership, SD Biosensor has agreed to reduce the price of its test by 32% to below $1 for public purchasers in low- and middle-income countries. This is a 21% price reduction per test when compared to the weighted average market price for all public procurers.

A mother smiling holding a baby

Development impact

Pregnant women with untreated syphilis are 52% more likely to experience adverse birth outcomes including stillbirths, low birth weight babies, and babies born with syphilis. HIV testing in pregnancy has increased to high coverage levels in many low-and middle-income countries. However, far fewer pregnant women are tested for syphilis.

By bringing the dual HIV-syphilis rapid diagnostic test closer in price to HIV rapid diagnostic tests already in use, this transaction will enable National Programs to introduce the dual test in antenatal care settings and leverage established HIV testing systems. This will increase syphilis testing among pregnant women and help to close the syphilis testing gap.

Over the course of this four-year volume guarantee, an additional 4.4 million pregnant women are expected to be tested for syphilis, contributing to:

  • 105,100 additional pregnant women with syphilis identified
  • 90,300 additional women receiving treatment
  • 19,000 stillbirths/miscarriage avoided
  • 14,000 fewer babies born with congenital syphilis

The transaction will also lead to a projected 21% reduction in the average market price of dual RDTs and direct savings of over $3.1 million over the volume guarantee period. SDB will be offering the lowest price on the market, encouraging more competitive pricing across the market.

How we calculate the impact of this guarantee

Lives changed: Estimations for additional women receiving access to syphilis testing are based on 2020 antenatal testing coverage for syphilis in African countries. Downstream patient outcomes were estimated based on 2020 seroprevalence and treatment rates in African countries, and a meta-analysis of risk for adverse outcomes of pregnancy by Gomez et. al.

Money saved: Impact is based on comparing the negotiated price to the expected weighted average market price of dual RDTs, taking into account expected distributor mark-up where relevant.

Markets shaped: We work with partners, including donors, procurers and ministries of health, to track changes in health markets where our investments are supporting access to products. We monitor for changes to policy, procurement practices and supplier movement, all of which affect markets and contribute to the long-term sustainability of impact.

A person getting a finger prick blood test

The product

The dual test is a point-of-care rapid diagnostic test which simultaneously detects antibodies to both Treponemal pallidum (“TP”, the cause of syphilis infection) and HIV in under 20 minutes from a single finger-prick sample.

Why we acted

Mother-to-child-transmission of syphilis contributes to serious negative outcomes in babies. Pregnant women with untreated syphilis are 52% more likely to suffer adverse birth outcomes such as stillbirth, neonatal death, premature birth, or low birth weight. Worldwide, 8% of stillbirths are because of syphilis.

Currently, between 70-100% of pregnant women are screened for HIV, but only 40-60% are screened for syphilis. By lowering the price of the HIV-syphilis dual RDT through this volume guarantee, HIV programmes can replace the single HIV RDT used in antenatal care settings with the dual RDT, thereby increasing the number of women tested for syphilis.