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Performance and operational characteristics of point-of-care tests for the diagnosis of urogenital gonococcal infections
The Kirby Institute, University of New South Wales, Sydney, Australia.
The Kirby Institute, University of New South Wales, Sydney, Australia.
Department of Global Health, University of California, San Francisco, USA.
WHO Collaborating Centre for Gonorrhoea and other STIs, Örebro University Hospital, Örebro, Sweden.ORCID iD: 0000-0003-1710-2081
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2017 (English)In: Sexually Transmitted Infections, ISSN 1368-4973, E-ISSN 1472-3263, Vol. 93, no Suppl. 4, p. S16-S21Article, review/survey (Refereed) Published
Abstract [en]

Background: In 2012, there was an estimated 78 million new cases of gonorrhoea globally. Untreated infection may lead to reproductive and neonatal morbidity and facilitate HIV transmission. Diagnosis and treatment are a priority for control and prevention, yet use of point-of-care tests (POCTs) for Neisseria gonorrhoeae (NG) is limited.

Objectives: To review the performance and operational characteristics of NG POCTs for diagnosis of urogenital gonorrhoea.

Methods: We compiled and synthesised findings from two separate systematic reviews which included evaluations published until August 2015.

Results: Six tests were included: five were immunochromatographic tests (ICTs) or optical immunoassay (OIAs) based on antigen detection; with 5-7 steps and results in 25-40 min, and one (GeneXpert CT/NG) was a 'near-patient test' based on nucleic acid amplification technique (NAAT); with three steps, electricity required, and results in 90 min. When compared with laboratory-based NAATs as the reference tests, sensitivities of ICT and OIA-based POCTs ranged from 12.5% to 70% when cervical/vaginal swabs were tested. Specificities ranged from 89% to 99.8%. The near-patient NAAT had sensitivities of >95% and specificities of >99.8% consistently across all specimen types (urine, cervical and vaginal swabs).

Conclusions: Based on a limited number of evaluations, antigen detection POCTs for NG lacked sufficient sensitivity to be used for screening. A near-patient NAAT has acceptable performance, only involved a few steps, but needs electricity, a temperature-controlled environment and has a 90 min run time. To achieve wider scale up of NG POCTs, we need strong evidence of cost-effectiveness, which should inform guidelines and ultimately increase test development, demand and reduce costs.

Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2017. Vol. 93, no Suppl. 4, p. S16-S21
National Category
Infectious Medicine Dermatology and Venereal Diseases
Identifiers
URN: urn:nbn:se:oru:diva-65036DOI: 10.1136/sextrans-2017-053192ISI: 000424009900003PubMedID: 29223959OAI: oai:DiVA.org:oru-65036DiVA, id: diva2:1183274
Available from: 2018-02-16 Created: 2018-02-16 Last updated: 2018-08-14Bibliographically approved

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