Clinical Evaluation of 2 Point-of-Care Lateral Flow Tests for the Diagnosis of Syphilis

Sex Transm Dis. 2016 Oct;43(10):623-5. doi: 10.1097/OLQ.0000000000000498.

Abstract

A diagnostic performance study comparing the only Food and Drug Administration-approved, point-of-care (POC) treponemal test (Syphilis Health Check) and the World Health Organization pre-qualified SD Bioline POC treponemal test against a treponemal hemagglutination test (TPHA) and a sequential algorithm of nontreponemal rapid plasma reagin and TPHA found both POC tests had >85% sensitivity compared with the TPHA and >85% sensitivity and >95% specificity compared with the rapid plasma reagin and TPHA standards.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Adult
  • Algorithms
  • Antibodies, Bacterial / blood
  • Cross-Sectional Studies
  • Female
  • Hemagglutination Tests
  • Humans
  • Male
  • Point-of-Care Systems*
  • Reagins / blood
  • Sensitivity and Specificity
  • Syphilis / diagnosis*
  • Syphilis / microbiology
  • Syphilis Serodiagnosis
  • Treponema pallidum / immunology*
  • Treponema pallidum / isolation & purification
  • Young Adult

Substances

  • Antibodies, Bacterial
  • Reagins