A laboratory-based evaluation of the BioStar Optical ImmunoAssay point-of-care test for diagnosing Neisseria gonorrhoeae infection

J Med Microbiol. 2011 Dec;60(Pt 12):1779-1781. doi: 10.1099/jmm.0.034116-0. Epub 2011 Aug 11.

Abstract

The development of gonococcal point-of-care tests (POCTs) has been challenging due to the relatively monomorphic nature of the Neisseria genus. The BioStar Optical ImmunoAssay (OIA) POCT for diagnosing Neisseria gonorrhoeae infection detects a specific epitope on the L7/L12 ribosomal protein, which reduces cross-reactivity with other neisseriae, and produces a highly specific test. A laboratory-based evaluation of this POCT was performed to determine its analytical sensitivity and specificity. A panel of N. gonorrhoeae (n=158) and non-gonococcal Neisseria (n=62) isolates were examined. The OIA GC POCT positively reacted with 99.4% of N. gonorrhoeae isolates and produced no reaction with 88.7% of non-gonococcal Neisseria isolates. It cross-reacted with six strains of N. meningitidis and one non-speciated Neisseria sp., but failed to produce a positive result with one isolate of N. gonorrhoeae. The OIA GC POCT required a bacterial suspension of ~6.4×10(5) c.f.u. N. gonorrhoeae ml(-1) and ~6.2×10(6) c.f.u. N. meningitidis ml(-1) to produce a reactive result. The OIA POCT detected the majority of N. gonorrhoeae (99.4%) isolates examined.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bacterial Proteins / immunology
  • Cross Reactions
  • Epitopes / immunology
  • Female
  • Gonorrhea / diagnosis*
  • Humans
  • Immunoassay / methods*
  • Male
  • Neisseria gonorrhoeae / immunology
  • Neisseria gonorrhoeae / isolation & purification*
  • Neisseria meningitidis / immunology
  • Point-of-Care Systems
  • Ribosomal Proteins / immunology
  • Sensitivity and Specificity

Substances

  • Bacterial Proteins
  • Epitopes
  • Ribosomal Proteins