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

Amanda Samarawickrama, Sarah Alexander, Catherine Ison

Research output: Contribution to journalArticlepeer-review

9 Citations (Scopus)

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 (n5158) and non-gonococcal Neisseria (n562) 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.

Original languageEnglish
Pages (from-to)1779-1781
Number of pages3
JournalJournal of Medical Microbiology
Volume60
Issue number12
DOIs
Publication statusPublished - Dec 2011

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