RAPID DIAGNOSTICS

A multi-centre evaluation of nine rapid, point-of-care syphilis tests using archived sera

A J Herring¹, R C Ballard², V Pope², R A Adegbola³, J Changalucha⁴, D W Fitzgerald⁵, E W Hook, III⁶, A Kubanova⁷, S Mananwatte⁸, J W Pape⁵, A W Sturm⁹, B West³, Y P Yin¹⁰ and R W Peeling¹¹

¹ Sexually Transmitted Bacteria Reference Laboratory, Health Protection Agency Laboratory, Bristol, UK
² Division of AIDS, STD and TB Laboratory Research, Centers for Disease Control and Prevention, Atlanta, Georgia, USA
³ MRC Laboratories, Fajara, The Gambia
⁴ National Institute for Medical Research, Mwanza, Tanzania
⁵ Les Centres GHESKIO (Groupe Haitien d’Etude du Sarcome de Kaposi et des Infections Opportunistes), Port au Prince, Haiti
⁶ University of Alabama, Alabama, USA
⁷ Central Institute for Skin and Venereal Diseases, Moscow, Russian Federation
⁸ National STD/AIDS Control Programme, Columbo, Sri Lanka
⁹ University of Natal, Durban, South Africa
¹⁰ National Center for STD, Nanjing, China
¹¹ Sexually Transmitted Diseases Diagnostics Initiative (SDI), WHO/TDR/PRD, Geneva, Switzerland

Correspondence to:
Correspondence to:
Dr Rosanna W Peeling
Sexually Transmitted Diseases Diagnostics Initiative (SDI), WHO/TDR, 20, Avenue Appia, 1211, Geneva 27, Switzerland; peelingr{at}who.int

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 T 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 84.5–97.7% and specificities from 84.5–98%. 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.

Abbreviations: SDI, Sexually Transmitted Diseases Diagnostics Initiative; STD, sexually transmitted diseases; RPR, rapid plasma reagin; SOP, standard operating procedures; TPHA, Treponema pallidum haemagglutination assay; TPPA, Treponema pallidum particle agglutination assay; WHO, World Health Organization

Keywords: rapid tests; syphilis

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