[Comparative study of immunochromatographic sets for rapid diagnosis of syphilis]

Klin Lab Diagn. 2008 Feb:(2):42-5.
[Article in Russian]

Abstract

The paper presents the results of the comparative study of 9 commercial kits made in foreign countries for the rapid diagnosis of syphilis, performed at the Central Research Institute of Dermatovenereological Infections, Russian Agency for Health Care, within the framework of the International Sexual Transmitted Diseases Diagnostic Initiative Program under the aegis of the World Health Organization during 2002-2005. The above diagnostic kits were assessed in the context of the availability of and statement simplicity in the instruction for use; the technological complexity in performing a study procedure and the simplicity in interpreting the findings; the necessity of employing additional laboratory equipment. The parameters of the clinical efficiency (sensitivity and specificity) were studied; a passive sensitized red blood cell agglutination test was used as a reference method. The comprehensive study showed that the "Determine Syphilis TP test system ("Abbot Lab", USA) yielded the best results with a total of 10 scores at 100% sensitivity and 100% sensitivity) while the "Bioline Syphilis anti-TP Test Card" ("Pacific Biotech Co.", Thailand) provided a total of 9 scores at 96% sensitivity and 98% specificity.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • English Abstract
  • Multicenter Study

MeSH terms

  • Antibodies, Bacterial / blood*
  • Chromatography, Paper / instrumentation
  • Chromatography, Paper / methods
  • Female
  • Humans
  • Immunoassay / instrumentation
  • Immunoassay / methods
  • Male
  • Reagent Strips* / standards
  • Sensitivity and Specificity
  • Syphilis / blood*
  • Syphilis / diagnosis
  • Syphilis Serodiagnosis / instrumentation*
  • Syphilis Serodiagnosis / methods*

Substances

  • Antibodies, Bacterial
  • Reagent Strips