Evidence map›Paper›PMID 38418947›Full record

ArticleBMC infectious diseases2024

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 and 11 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.1field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 12 institutions in 10 countries.

Mark ShephardInternational Centre for Point-of-Care Testing, Flinders University, Bedford Park, South Australia, Australia. Mark.Shephard@flinders.edu.au.ORCID http://orcid.org/0000-0002-9181-1874
Susan MatthewsInternational Centre for Point-of-Care Testing, Flinders University, Bedford Park, South Australia, Australia.
Kelly AndrewarthaInternational Centre for Point-of-Care Testing, Flinders University, Bedford Park, South Australia, Australia.
Wayne DimechNational Serology Reference Laboratory, Australia, Fitzroy, Victoria, Australia.
Liza CabuangNational Serology Reference Laboratory, Australia, Fitzroy, Victoria, Australia.
Christopher BarbaraPathology Department, Mater Dei Hospital, Msida, Malta.
Xiang-Sheng ChenChinese Academy of Medical Sciences and Peking Union Medical College Institute of Dermatology, National Center for STD Control, Nanjing, China.
Maddalena CordioliInfectious Diseases Section, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
Amina HançaliSTIs Laboratory, Department of Bacteriology, Institut National d'Hygiene, Ministry of Health- Morocco, Rabat, Morocco.
Ting-Ting JiangChinese Academy of Medical Sciences and Peking Union Medical College Institute of Dermatology, National Center for STD Control, Nanjing, China.
Ranmini KularatneCentre for HIV & STI, National Institute for Communicable Diseases, Sandringham, South Africa.
Stephanie MeliPoint-of-Care Testing Committee, Department of Pathology, Mater Dei Hospital, Msida, Malta.
Etienne MullerCentre for HIV & STI, National Institute for Communicable Diseases, Sandringham, South Africa.
Hicham OumzilPedagogy and Research Unit of Microbiology, Faculty of Medicine and Pharmacy, Mohammed V University -Rabat, Virology Department, Institut National d'Hygiène MoH, Rabat, Morocco.
Valeska PadoveseGenito-Urinary Clinic, Department of Dermatology and Venereology, Mater Dei Hospital, Msida, Malta.
Angela SandriDepartment of Diagnosis and Public Health, Section of Microbiology, University of Verona, Verona, Italy.
Silver VargasCentro de Investigación Interdisciplinaria en Sexualidad SIDA y Sociedad, Universidad Peruana Cayetano Heredia, Lima, Peru.
Graziella ZahraMolecular Diagnostics Infectious Diseases, Department of Pathology, Mater Dei Hospital, Msida, Malta.
Magnus UnemoWHO Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Karel BlondeelDepartment of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
Igor ToskinDepartment of Sexual and Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
Mater Dei Hospital · MTFlinders University · AUChinese Academy of Medical Sciences & Peking Union Medical College · CNRespiratory and Meningeal Pathogens Research Unit · ZAUniversity of Verona · ITVictorian Infectious Diseases Reference Laboratory · AUGhent University · BEInstitut National d'Hygiène du Maroc · MAMohammed V University · MAÖrebro University · SEUniversidad Peruana Cayetano Heredia · PEWorld Health Organization · CH

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundSexually 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.

methodsA 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.

resultsFor 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'.

conclusionsThe 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 registrationEthics approval to conduct the ProSPeRo study was granted by the WHO Ethics Review Committee.

Indexed as

Chlamydia InfectionsGonorrheaSexually Transmitted DiseasesTrichomonas vaginalisChlamydia trachomatisHumansNeisseria gonorrhoeaePoint-of-Care TestingConcordanceGeneXpertPoint-of-care testingQualitySexually transmitted infectionsTest errorsTraining

Identifiers

PMID38418947
PMCPMC10902926
OpenAlexW4392770404

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.