Evaluation of the diagnostic performance and operational characteristics of four rapid immunochromatographic syphilis tests in Burkina Faso.

Fy Bocoum,A Kiba,Ro Traore,S Tiendrebeogo,H Ouedraogo,B Liestman,S Diagbouga,G Tarnagda,F Bationo,C Zarowsky,S Kouanda

doi:10.4314/ahs.v15i2.8

Abstract

Little information is available on the rapid diagnostic testing for syphilis in Burkina Faso. The objectives of the study were (i) to assess the sensitivity and specificity of four on site rapid tests in comparison with Treponema pallidum haemagglutination assay (TPHA) as a gold standard and (ii) to evaluate the operational characteristics of those tests among health workers in a maternity unit. Four rapid syphilis tests commercially available in Burkina Faso were evaluated using archived serum samples and Treponema pallidum hemagglutination assay (TPHA) as the gold standard. Blood samples were collected between November 2011 and June 2012 from blood donors at the Regional Blood Transfusion Center of Ouagadougou. The sensitivity and specificity of the tests were calculated. Evaluation of operational characteristics such as clarity of pamphlet, complexity of technique, duration, was conducted in a first-level healthcare center with health workers in maternity unit. Alere DetermineTM Syphilis was the most sensitive of the four rapid syphilis tests evaluated. It was followed by SD Bioline Syphilis 3.0, Cypress Diagnostics Syphilis Quick test and Accu-Tell ® Rapid Anti-TP, which was the least sensitive. The four tests demonstrated a good diagnostic specificity for syphilis (95-98%), and healthcare workers found them easy to use. The study allowed confirming the good performance of three of four rapid syphilis tests in Burkina Faso. More research will be conducted to assess the feasibility of introducing selected rapid tests for syphilis in antenatal care services.

Highlights

Syphilis in pregnant women remains a major public health problem
Study populations We evaluated rapid syphilis tests commercially available in Burkina Faso using archived serum samples and Treponema pallidum hemagglutination assay (TPHA) as the gold standard
Ease of result interpretation Moderately easy Very easy (n=16) 2 14 (n=16) 4 12 (n=16) 7 9 (n=16) 2 14. This is the first evaluation of the performance and the characteristics of commercially available rapid diagnostic syphilis tests for Burkina Faso, and it allows the identification of the test that is adapted to the context of the country

Summary

Introduction

Syphilis in pregnant women remains a major public health problem. The World Health Organization (WHO) estimates that 90% of syphilis cases occur in low-income countries[1]. In hospital laboratories (Medical Centers with Surgical Services (CMA), regional hospitals (CHR), national hospitals (CHU)), testing is conducted with a venereal diseases research laboratory (VDRL) test or with a Treponema pallidum hemagglutination assay (TPHA). These tests present certain advantages in that they allow for the differentiation between an old or treated syphilis infection and active syphilis, as well as an analysis of treatment adherence, their use requires qualified personnel, laboratory equipment, and a source of electricity, which limits their utility to peripheral clinics (CSPSs).

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