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 Dimech; Liza Cabuang; Christopher Barbara; Xiang-Sheng Chen; Maddalena Cordioli; Amina Hançali; Ting-Ting Jiang; Ranmini Kularatne; Stephanie Meli; Etienne Muller; Hicham Oumzil; Valeska Padovese; Angela Sandri; Silver Vargas; Graziella Zahra; Magnus Unemo; Karel Blondeel; Igor Toskin

doi:10.1186/s12879-024-09057-x

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

BMC Infect Dis. 2024 Feb 29;24(Suppl 1):203. doi: 10.1186/s12879-024-09057-x.

Authors

Mark Shephard¹, Susan Matthews², Kelly Andrewartha², Wayne Dimech³, Liza Cabuang³, Christopher Barbara⁴, Xiang-Sheng Chen⁵, Maddalena Cordioli⁶, Amina Hançali⁷, Ting-Ting Jiang⁵, Ranmini Kularatne⁸, Stephanie Meli⁹, Etienne Muller⁸, Hicham Oumzil¹⁰, Valeska Padovese¹¹, Angela Sandri¹², Silver Vargas¹³, Graziella Zahra¹⁴, Magnus Unemo¹⁵, Karel Blondeel^{16

17}, Igor Toskin¹⁶

Affiliations

¹ International Centre for Point-of-Care Testing, Flinders University, Bedford Park, South Australia, Australia. Mark.Shephard@flinders.edu.au.
² International Centre for Point-of-Care Testing, Flinders University, Bedford Park, South Australia, Australia.
³ National Serology Reference Laboratory, Australia, Fitzroy, Victoria, Australia.
⁴ Pathology Department, Mater Dei Hospital, Msida, Malta.
⁵ Chinese Academy of Medical Sciences and Peking Union Medical College Institute of Dermatology, National Center for STD Control, Nanjing, China.
⁶ Infectious Diseases Section, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
⁷ STIs Laboratory, Department of Bacteriology, Institut National d'Hygiene, Ministry of Health- Morocco, Rabat, Morocco.
⁸ Centre for HIV & STI, National Institute for Communicable Diseases, Sandringham, South Africa.
⁹ Point-of-Care Testing Committee, Department of Pathology, Mater Dei Hospital, Msida, Malta.
¹⁰ Pedagogy and Research Unit of Microbiology, Faculty of Medicine and Pharmacy, Mohammed V University -Rabat, Virology Department, Institut National d'Hygiène MoH, Rabat, Morocco.
¹¹ Genito-Urinary Clinic, Department of Dermatology and Venereology, Mater Dei Hospital, Msida, Malta.
¹² Department of Diagnosis and Public Health, Section of Microbiology, University of Verona, Verona, Italy.
¹³ Centro de Investigación Interdisciplinaria en Sexualidad SIDA y Sociedad, Universidad Peruana Cayetano Heredia, Lima, Peru.
¹⁴ Molecular Diagnostics Infectious Diseases, Department of Pathology, Mater Dei Hospital, Msida, Malta.
¹⁵ WHO Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
¹⁶ Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
¹⁷ Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.

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.

Keywords: Concordance; GeneXpert; Point-of-care testing; Quality; Sexually transmitted infections; Test errors; Training.

MeSH terms

Chlamydia Infections* / diagnosis
Chlamydia trachomatis / genetics
Gonorrhea* / diagnosis
Humans
Neisseria gonorrhoeae / genetics
Point-of-Care Testing
Sexually Transmitted Diseases* / diagnosis
Trichomonas vaginalis* / genetics

Grants and funding

001/WHO_/World Health Organization/International