title: A laboratory-based evaluation of the BioStar Optical ImmunoAssay point-of-care test for diagnosing Neisseria gonorrhoeae infection.
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.
authors.affiliation: Department of Sexual Health and HIV, Caldecot Centre, King's College Hospital, Denmark Hill, London SE5 9RS, UK.
authors.forename: Amanda
authors.initials: A
authors.lastname: Samarawickrama
authors.affiliation: Sexually Transmitted Bacteria Reference Laboratory, Health Protection Agency, 61 Colindale Avenue, London NW9 5HT, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Alexander
authors.affiliation: Sexually Transmitted Bacteria Reference Laboratory, Health Protection Agency, 61 Colindale Avenue, London NW9 5HT, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Ison
mesh_terms: D001426:Bacterial Proteins / Q000276:immunology; D003429:Cross Reactions; D000939:Epitopes / Q000276:immunology; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008297:Male; D009344:Neisseria gonorrhoeae / Q000276:immunology / Q000302:isolation & purification*; D009345:Neisseria meningitidis / Q000276:immunology; D019095:Point-of-Care Systems; D012269:Ribosomal Proteins / Q000276:immunology; D012680:Sensitivity and Specificity
chemical_list: D001426:Bacterial Proteins; D000939:Epitopes; D012269:Ribosomal Proteins