Project Details

E.W. "Al" Thrasher

Status: Funded - Closed

Improved diagnosis of active syphilis at point-of-care for the elimination of congenital syphilis

David Anderson, PhD


BACKGROUND: Congenital syphilis affects more newborns than any other single infection including HIV or tetanus; without effective antibiotic treatment it causes significant developmental, neurological and musculoskeletal disability in children, and many infected infants will die within the first year of life. Every year over 650,000 perinatal deaths are attributable to maternal syphilis infection, and maternal syphilis has been estimated to contribute to a quarter of all stillbirths and 11-14% of all neonatal deaths in some parts of the world.

GAP: Treatment of syphilis is simple, effective and inexpensive, however diagnosis according to existing policies and methods is complex and requires venous blood collection, laboratory equipment, highly trained staff, and storage and transport of samples, making it difficult to implement in many settings. Existing POC tests cannot differentiate between active syphilis and past or treated syphilis because antibody to syphilis lasts for life, even after treatment or clearance of infection. Similarly, the babies of women who have had past syphilis infections also appear to be infected when using the current tests, severely limiting the impact of POC tests particularly in high-prevalence settings and resulting in pregnant women and neonates not receiving appropriate treatment.

HYPOTHESIS: This project will develop, optimize and validate an innovative, specific and sensitive POC test, which, for the first time, will rapidly and accurately diagnose active syphilis and allow for immediate treatment at the point-of-care.

METHODS: Test development, optimization and initial laboratory evaluation of the POC test for active syphilis will take place in Australia. Following the laboratory-based test optimization, initial performance will be evaluated in a “blinded” study in China and Zimbabwe using an independent panel of stored plasma samples (n=450, National Centre for Sexually Transmitted Disease Control, China; n=300, Organization for Public Health Interventions and Development, Zimbabwe).

RESULTS: Pending

IMPACT: Our POC test could result in immediate access to diagnosis and significantly increased syphilis treatment uptake, thereby improving maternal and neonatal health outcomes and reducing stillbirths. Screening and treatment of 90% of pregnant women for syphilis would avert over 121,000 stillbirths worldwide and greatly reduce the burden of congenital syphilis.

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Bacteria, Congenital, Diagnosis, Human, In Vitro