Efficacy assessment of a new point-of-care test for confirmation of active syphilis in men who have sex with men

Syphilis, a curable sexually transmitted infection, is a re-emerging public health concern. Men who have sex with men (MSM) are driving recent syphilis epidemics. Diagnosis of active syphilis requires at least two visits to a health care provider where an initial screening test is performed followed by a confirmatory laboratory test. The laboratory test may not always available, leading to loss to follow up and delayed access to treatment.

The Burnet Institute is developing a novel rapid point of care test based on lateral flow technology for diagnosis of active syphilis in a single visit. Primary studies of an early prototype showed the test achieved >96% sensitivity and specificity in a low-risk population (pregnant women).

Objective 

This study aims to assess the efficacy of the next generation of the test detecting active syphilis at different stages of infection (primary, secondary, early latent syphilis), and HIV co-infection status in MSM.  

Timeline

2023–ongoing.

Approach

This study will use well-characterised, stored serum samples from a cohort of 200 MSM who had laboratory-confirmed and clinical diagnosis of active syphilis infection, participated in a previous syphilis study conducted at Melbourne Health Sexual Centre.

Community impact

The outcome of this study will determine the potential future clinical utility and health benefits of Burnet’s syphilis test for early diagnosis of active syphilis in high-risk populations. If proven effective, this study will accelerate the test’s progress to registration, implementation and heath impact.

The samples are accompanied by standard laboratory test results for syphilis and HIV, clinical data and diagnosis of active syphilis (number/episode and stage of syphilis infection). 

These samples will be tested with the second generation of the Burnet’s rapid point-of-care syphilis test by research staff in the Burnet Diagnostics Initiative.

Results will be compared with the accompanying data (standard of care laboratory test results, and clinical diagnosis/stage of syphilis infection) to determine the capacity of the test to identify active syphilis in MSM.