Objectives We undertook a prospective evaluation of the Qualpro Syphicheck-WB rapid syphilis test to measure its diagnostic performance and utility as a point-of-care (POC) screening test among female sex workers (FSWs) in Bangalore, India.
Methods From August 2008 to May 2009, FSWs without a laboratory-confirmed history of syphilis attending STI clinics in Bangalore underwent POC syphilis screening using finger-prick whole blood, with onsite treatment if indicated. Serum samples were collected for local laboratory offsite rapid plasma reagin (RPR) testing and reference laboratory RPR, Treponema pallidum haemagglutination assay (TPHA), and rapid syphilis testing. FSWs who participated in standard offsite RPR screening from August 2007 to May 2008 in the same clinics formed the comparison group for treatment coverage.
Results Of the 1617 women who underwent POC syphilis testing, 7.4% had laboratory evidence of active syphilis with reactive RPR and TPHA, and 3.7% had an RPR titre ≥1:8. Compared with the reference RPR and TPHA, the sensitivity and specificity of the POC syphilis test were 70.8% (95% CI 62.7 to 79.0) and 97.8% (95% CI 97.1 to 98.5). Because of the low rate of women returning for their test results after offsite RPR screening, the proportion of women with active syphilis who were appropriately treated rose from 44.8% to 68.3% with the use of POC syphilis screening (p=0.003).
Conclusion The Syphicheck-WB test utilising finger-prick whole blood has a relatively low sensitivity in detecting active syphilis. However, among hard-to-reach populations who may not return for follow-up treatment, POC screening with this assay could still confer an advantage over offsite RPR testing with respect to treatment coverage.
- point of care systems
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Funding This research was funded by the Bill & Melinda Gates Foundation. The views expressed herein are those of the authors and do not necessarily reflect the official policy or position of the Bill & Melinda Gates Foundation. S. Mishra was supported by a Royal College of Physicians and Surgeons of Canada International Travelling Fellowship.
Competing interests None.
Patient consent Obtained.
Ethics approval Ethics approval was provided by the Institutional Ethics Review Board, St John's Medical College, Bangalore, India.
Provenance and peer review Not commissioned; externally peer reviewed.