title: Point-of-care tests for the diagnosis of Neisseria gonorrhoeae infection: a systematic review of operational and performance characteristics.
abstract: OBJECTIVE
  Systematic review of the performance and operational characteristics of point-of-care (POC) tests for the diagnosis of Neisseria gonorrhoeae.
  
  
  METHODS
  We searched PubMed and Embase until August 2010 using variations of the terms: 'rapid test', 'Neisseria gonorrhoeae' and 'evaluation'.
  
  
  RESULTS
  We identified 100 papers, 14 studies were included; nine evaluated leucocyte esterase (LE) dipsticks and three immunochromatographic strips, and two clinical audits of microscopy were identified. Of the field evaluations the gold standard was nucleic acid amplification technology in six studies and bacterial culture in the other six. In four studies, 50% or more of the patients were symptomatic. The median sensitivity of LE dipsticks was 71% (range 23-85%), median specificity was 70% (33-99%), median positive predictive value (PPV) was 19% (5-40%) and median negative predictive value (NPV) was 95% (56-99%). One LE study found a sensitivity of 23% overall, increasing to 75% in symptomatic women. LE dipsticks mostly involved three steps and took under 2 min. The median sensitivity of immunochromatographic tests (ICT) was 70% (60-94%), median specificity was 96% (89-97%), median PPV was 56% (55-97%) and median NPV was 93% (92-99%). Immunochromatic strips involved five to seven steps and took 15-30 min. Specificity of microscopy ranged from 38% to 89%.
  
  
  CONCLUSIONS
  ICT and LE tests had similar sensitivities, but sensitivity results may be overestimated as largely symptomatic patients were included in some studies. ICT had a higher specificity in women than LE tests. The findings highlight the need for improved POC tests for diagnosis of N gonorrhoeae and more standardised evaluations.
authors.affiliation: The Kirby Institute, University of New South Wales, Sydney, NSW 2052, Australia. lwatchirs-smith@kirby.unsw.edu.au
authors.forename: Lucy Alexandra
authors.initials: LA
authors.lastname: Watchirs Smith
authors.forename: Richard
authors.initials: R
authors.lastname: Hillman
authors.forename: James
authors.initials: J
authors.lastname: Ward
authors.forename: David M
authors.initials: DM
authors.lastname: Whiley
authors.forename: Louise
authors.initials: L
authors.lastname: Causer
authors.forename: Steven
authors.initials: S
authors.lastname: Skov
authors.forename: Basil
authors.initials: B
authors.lastname: Donovan
authors.forename: John
authors.initials: J
authors.lastname: Kaldor
authors.forename: Rebecca
authors.initials: R
authors.lastname: Guy
mesh_terms: D000293:Adolescent; D000328:Adult; D002265:Carboxylic Ester Hydrolases / Q000378:metabolism*; D002846:Chromatography, Affinity / Q000379:methods*; D005260:Female; D006069:Gonorrhea / Q000175:diagnosis*; D006801:Humans; D008297:Male; D009344:Neisseria gonorrhoeae / Q000201:enzymology / Q000235:genetics / Q000302:isolation & purification*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity
chemical_list: C021443:leukocyte esterase; D002265:Carboxylic Ester Hydrolases
keywords: Diagnosis; Gonorrhoea; Systematic Reviews; Testing