Publisher Information: Örebro universitet, Institutionen för medicinska vetenskaper Region Örebro län 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 International Centre for Point-of-Care Testing, Flinders University, Bedford Park, South Australia, Australia National Serology Reference Laboratory, Australia, Fitzroy, Victoria, Australia National Serology Reference Laboratory, Australia, Fitzroy, Victoria, Australia Pathology Department, Mater Dei Hospital, Msida, Malta Chinese Academy of Medical Sciences and Peking Union Medical College Institute of Dermatology, National Center for STD Control, Nanjing, China Infectious Diseases Section, Department of Diagnostics and Public Health, University of Verona, Verona, Italy STIs Laboratory, Department of Bacteriology, Institut National d'Hygiene, Ministry of Health- Morocco, Rabat, Morocco Chinese Academy of Medical Sciences and Peking Union Medical College Institute of Dermatology, National Center for STD Control, Nanjing, China Centre for HIV & STI, National Institute for Communicable Diseases, Sandringham, South Africa Point-of-Care Testing Committee, Department of Pathology, Mater Dei Hospital, Msida, Malta Centre for HIV & STI, National Institute for Communicable Diseases, Sandringham, South Africa Pedagogy and Research Unit of Microbiology, Faculty of Medicine and Pharmacy, Mohammed V University -Rabat, Virology Department, Institut National d'Hygiène MoH, Rabat, Morocco Genito-Urinary Clinic, Department of Dermatology and Venereology, Mater Dei Hospital, Msida, Malta Department of Diagnosis and Public Health, Section of Microbiology, University of Verona, Verona, Italy Centro de Investigación Interdisciplinaria en Sexualidad SIDA y Sociedad, Universidad Peruana Cayetano Heredia, Lima, Peru Molecular Diagnostics Infectious Diseases, Department of Pathology, Mater Dei Hospital, Msida, Malta WHO Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland; Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium Department of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland 2024
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 syst
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.
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