Evaluation of rapid syphilis tests in KwaZulu-Natal

J Clin Lab Anal. 2014 Jan;28(1):77-81. doi: 10.1002/jcla.21647. Epub 2014 Jan 2.


Background: Despite the considerable decrease in the seroprevalence of syphilis in South Africa, with an estimated prevalence of 1.5% in 2010, the disease remains a threat particularly to pregnant women, hence there is a need for a rapid, reliable, and affordable screening and diagnostic test. A laboratory evaluation study was conducted in response to a call by the KwaZulu-Natal (KZN) Provincial Department of Health that is considering using rapid point-of-care syphilis tests.

Methods: The performances of the Hexagon and the SD Bioline syphilis tests were compared with the Treponema pallidum hemagglutination assay (TPHA) reference test using 297 (142 positive and 155 negative) serum specimens.

Results: Both assays demonstrated good performance with negative and positive concordance of 97 and 94% for the Hexagon assay and 98 and 90% for SD Bioline assay, respectively, when compared to the TPHA. The Hexagon test was quicker and easier to read than the SD Bioline test.

Conclusion: Although the rapid syphilis tests performed favorably, a number of issues need to be considered prior to their use for syphilis screening in the public sector of South Africa.

Keywords: rapid; screening; syphilis; testing; treponemal.

Publication types

  • Evaluation Study

MeSH terms

  • False Negative Reactions
  • Female
  • Hemagglutination Tests / methods*
  • Humans
  • Pregnancy
  • Reagins / blood
  • Reference Standards
  • South Africa
  • Syphilis / blood*
  • Syphilis / diagnosis
  • Syphilis / microbiology
  • Treponema pallidum / isolation & purification


  • Reagins