Quality control and external quality assessment for the independent clinic-based evaluation of point-of-care testing to detect Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis in eight countries.

Mark Shephard, Susan Matthews, Kelly Andrewartha, Wayne Dimich, Liza Cabuang, Christopher Barbara, Xiang-Sheng Chen, Maddalena Cordioli, Amina Hancali, Ting-Ting Jiang, Ranmini Kularatne, Stephanie Meli, Etienne Muller, Hicham Oumzil, Valeska Padovese, Angela Sandri, Silver Vargas, Graziella Zahra, Magnus Unemo, Karel BlondeelIgor Toskin

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Abstract

Background
Sexually transmitted infections caused by Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) remain significant global health problems. The World Health Organization (WHO) has recently conducted a multi- faceted, multi-country validation study (ProSPeRo), which included an evaluation of the Xpert CT/NG and Xpert TV assays on the GeneXpert system (Cepheid, Sunnyvale, Ca., USA) in clinic-based settings across eight countries. To support the study, a training and quality management system was implemented and evaluated.
Methods
A comprehensive training program for the study was developed. Quality control (QC) and external quality assessment (EQA) samples were provided by an accredited quality assurance provider. QC testing was conducted at 14 point-of-care testing (POCT) clinics, while EQA samples were tested by the POCT sites and a reference laboratory supporting each clinic.
Results
For QC testing, concordance with the expected results for CT and NG was >99% and rates of unsuccessful tests were <4%. For TV testing, concordance was similar (97%), but rates of ‘unsuccessful’ tests were high (18%), particularly in the ‘TV negative’ sample. For EQA testing initially conducted in 2018, concordance was 100% for CT and NG, and 90% for TV for the reference laboratory group (which used non- GeneXpert systems). Concordance for the POCT group was also high (>94%) for all analytes, but this cohort (which used GeneXpert systems) exhibited a high rate of ‘unsuccessful’ TV tests. All but one of these unsuccessful tests was subcategorised as ‘invalid’.
Conclusions
The high level of concordance for QC and EQA testing confirm that the trained operators at the POC clinical sites were competent to conduct POC testing and that the training and quality systems implemented for the ProSPeRo study were effective. The quality materials used were satisfactory for CT and NG but exhibited poor performance for TV testing on the GeneXpert system. The WHO should continue to work with industry and EQA providers to provide improved materials that are reliable, stable and cost effective for quality management, as it seeks to rollout molecular-based STI POCT in non-laboratory-based settings.
Trial registration
Ethics approval to conduct the ProSPeRo study was granted by the WHO Ethics Review Committee.


Original languageEnglish
Article number203
Number of pages10
JournalBMC Supplements
Volume24
Issue numberSupplement 1
DOIs
Publication statusPublished - 29 Feb 2024

Keywords

  • Point-of-care testing
  • sexually transmitted infection
  • women
  • quality assurance
  • Training
  • Concordance
  • Quality
  • GeneXpert
  • Test errors

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