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

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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 ~6.4×105 c.f.u. N. gonorrhoeae ml−1 and ~6.2×106 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.

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