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Independent clinic-based evaluation of point-of-care testing for the screening of Chlamydia trachomatis, Neisseria gonorrhoea and Trichomonas vaginalis in women-at-risk in Australia, Guatemala, Morocco, and South Africa
International Centre for Point-of-Care Testing, Flinders University, Bedford Park, South Australia, Australia.
International Centre for Point-of-Care Testing, Flinders University, Bedford Park, South Australia, Australia.
Centre for HIV & STI, National Institute for Communicable Diseases, Johannesburg, South Africa.
International Centre for Point-of-Care Testing, Flinders University, Bedford Park, South Australia, Australia.
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2024 (English)In: BMC Infectious Diseases, E-ISSN 1471-2334, Vol. 24, no Suppl 1, article id 277Article in journal (Refereed) Published
Abstract [en]

BACKGROUND: In 2018, the World Health Organization commenced a multi-country validation study of the Cepheid GeneXpert for a range of molecular-based point-of-care (POC) tests in primary care settings. One study arm focused on the evaluation of POC tests for screening 'women at risk' for chlamydia (CT), gonorrhoea (NG) and trichomonas (TV) in four countries - Australia, Guatemala, Morocco and South Africa.

METHODS: Study participants completed a pre-test questionnaire which included demographics, clinical information and general questions on POC testing (POCT). Two vaginal swab samples (either self-collected or clinician collected) from each patient were tested on the GeneXpert at the POC and at a reference laboratory using quality-assured nucleic acid amplification tests (NAATs).

RESULTS: One thousand three hundred and eighty-three women were enrolled: 58.6% from South Africa, 29.2% from Morocco, 6.2% from Guatemala, and 6.0% from Australia. 1296 samples for CT/NG and 1380 samples for TV were tested by the GeneXpert and the reference NAAT. The rate of unsuccessful tests on the GeneXpert was 1.9% for CT, 1.5% for NG and 0.96% for TV. The prevalence of CT, NG and TV was 31%, 13% and 23%, respectively. 1.5% of samples were positive for all three infections; 7.8% were positive for CT and NG; 2.4% were positive for NG and TV; and 7.3% were positive for CT and TV. Compared to reference NAATs, pooled estimates of sensitivity for the GeneXpert tests were 83.7% (95% confidence intervals 69.2-92.1) for CT, 90.5% (85.1-94.1) for NG and 64.7% (58.1-70.7) for TV (although estimates varied considerably between countries). Estimates for specificity were ≥96% for all three tests both within- and between-countries. Pooled positive and negative likelihood ratios were: 32.7 ([CI] 21.2-50.5) and 0.17 (0.08-0.33) for CT; 95.3 (36.9-245.7) and 0.10 (0.06-0.15) for NG; and 56.5 (31.6-101.1) and 0.35 (0.27-0.47) for TV.

CONCLUSION: This multi-country evaluation is the first of its kind world-wide. Positive likelihood ratios, as well as specificity estimates, indicate the GeneXpert POC test results for CT, NG and TV were clinically acceptable for ruling in the presence of disease. However, negative likelihood ratios and variable sensitivity estimates from this study were poorer than expected for ruling out these infections, particularly for TV.

TRIAL REGISTRATION: Ethics approval to conduct the ProSPeRo study was granted by the WHO Ethics Review Committee, as well as local ethics committees from all participating countries.

Place, publisher, year, edition, pages
BioMed Central (BMC), 2024. Vol. 24, no Suppl 1, article id 277
Keywords [en]
GeneXpert, Multi-country, Point-of-care testing, Sensitivity, Sexually transmitted infections, Specificity
National Category
Infectious Medicine
Identifiers
URN: urn:nbn:se:oru:diva-112096DOI: 10.1186/s12879-024-09018-4ISI: 001179732400001PubMedID: 38438953Scopus ID: 2-s2.0-85186603810OAI: oai:DiVA.org:oru-112096DiVA, id: diva2:1842481
Note

This work was also funded by the UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored programme executed by the World Health Organization (WHO) and the Government of Canada.

Available from: 2024-03-05 Created: 2024-03-05 Last updated: 2024-04-24Bibliographically approved

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Golparian, DanielUnemo, Magnus

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