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A Multi-centre Evaluation of Nine Rapid Point of Care Syphilis Tests Using Archived Sera
  1. Alan J Herring (alanherring{at}yahoo.co.uk)
  1. Bristol University, United Kingdom
    1. Ron C Ballard (rballard{at}cdc.gov)
    1. Centres for Disease Control and Prevention, United States
      1. Victoria Pope (vpope{at}cdc.gov)
      1. Centres for Disease Control and Prevention, United States
        1. Richard A Adegbola (radegbola{at}mrc.gm)
        1. Medical Research Council, Gambia
          1. John Changlaucha (jchangalucha{at}yahoo.com)
          1. National Institute for Medcial Research, Tanzania, United Republic of
            1. Dan W Fitzgerald (dfitzgerald{at}gheskio.org)
            1. Les Centres GHESKIO, Haiti
              1. Edward W Hook III (ehook{at}uab.edu)
              1. University of Alabama, United States
                1. Anna Kubanova (koubanova{at}cnikvi.ru)
                1. Central Institute for Skin and Vnereal Diseases, Russian Federation
                  1. Sujatha Mananwatte (smanan{at}itmin.com)
                  1. National STD/AIDS Control Programme, Sri Lanka
                    1. Jean W Pape (jwpape{at}gheskio.org)
                    1. Les Centres GHESKIO, Haiti
                      1. Wim Sturm (sturm{at}ukzn.ac.za)
                      1. University of Natal, South Africa
                        1. Beryl West (beryl_west{at}hotmail.com)
                        1. MRC Laboratories, Gambia
                          1. Yueping Yin (ypyin{at}vip.163.com)
                          1. National Center for STD, China
                            1. Rosanna W Peeling (peelingr{at}who.int)
                            1. World Health Organization, Switzerland

                              Abstract

                              Objectives: To evaluate nine rapid syphilis tests at eight geographically diverse laboratory sites for their performance and operational characteristics.

                              Methods: Tests were compared 'head to head' using locally assembled panels of 100 archived (50 positive and 50 negative) sera at each site using as reference standards the Treponema pallidum Haemagglutination or the Treponema pallidum Particle agglutination test. In addition inter-site variation, result stability, test reproducibility and test operational characteristics were assessed.

                              Results: All nine tests gave good performance relative to the reference standard with sensitivities ranging from 84.5% to 97.7% and specificities from 84.5% to 98%. Result stability was variable if result reading was delayed past the recommended period. All the tests were found to be easy to use, especially the lateral flow tests.

                              Conclusions: All the tests evaluated have acceptable performance characteristics and could make an impact on the control of syphilis. Tests that can use whole blood and do not require refrigeration were selected for further evaluation in field settings.

                              • evaluation
                              • rapid tests
                              • syphilis

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