Introduction

Bacterial sexually transmitted infections (STI) syphilis, chlamydia and gonorrhoea impose a disproportionate disease burden on women and children in the developing world. Diagnostic testing is particularly critical for the detection of STI, as most infected individuals have few or no symptoms. Genital chlamydial and gonococcal infections in women can lead to chronic pelvic pain, ectopic pregnancy or tubal infertility. Syphilis in pregnancy can result in stillbirth, spontaneous abortion or babies with congenital syphilis, 50% of whom may die in the first year of life. Bacterial STI are curable and treatment is affordable, but sensitive diagnostic tests are required for early detection to guide treatment to prevent the development of reproductive sequelae and adverse outcomes of pregnancy, and to interrupt onward transmission.

In resource-poor settings, laboratory services for STI are either not available, or where limited services are available, patients may not be able to pay for or physically access these services. In sub-Saharan Africa, only 30% of pregnant women with syphilis are screened and treated, even though universal screening of pregnant women for syphilis is the recommended policy in many countries. The major obstacle is the lack of access to laboratories that can offer screening as women often have to travel long distances to reach a hospital or clinic with such services. Many women also fail to return for test results and treatment after the initial visit. In recent years, rapid tests have made it possible to increase access to STI testing to all levels of the healthcare system. A mathematical model estimated that a test for syphilis that requires no laboratory infrastructure could save more than 201 000 lives and avert 215 000 stillbirths per year worldwide. A similar test could save approximately four million disability-adjusted life-years, avert more than 16.5 million incident gonorrhoea and chlamydial infections and prevent more than …