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.

Mark Shephard, Susan Matthews, Ranmini Kularatne, Kelly Andrewartha, Karel Blondel, Christian Alvarez, Elsy Camey, Amina Hancali, Etienne Muller, Aurelie Haw, Hicham Oumzil, Daniel Golparian, Dorian E. Ramirez, James Kiarie, Firdavs Kurbonov, Massimo Mirandola, Rosanna W. Peeling, Ronaldo Silva, Soe Soe Thwin, Magnus UnemoIgor Toskin

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Abstract

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: 1383 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. 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 frst of its kind world-wide. Positive likelihood ratios, as well as specifcity 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.
Original languageEnglish
Article number277
Number of pages11
JournalBMC Infectious Diseases
Volume24
Issue numberSupplement 1
DOIs
Publication statusPublished - 4 Mar 2024

Keywords

  • GeneXpert
  • Multi-country
  • Point-of-care testing
  • Sensitivity
  • Sexually transmitted infections
  • Specificity

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