Evidence map›Paper›PMID 38418989›Full record

ArticleBMC infectious diseases2024

External quality assessment to support the WHO ProSPeRo study for the evaluation of two dual HIV/syphilis point-of-care tests in seven countries.

Weiping Cao, Yetunde F Fakile, Mayur R Shukla, Kevin Pettus, Kathryn Lupoli, Jaeyoung Hong, Allan Pillay, Ranmini Kularatne, Hicham Oumzil, Valeska Padovese and 7 more

Open access · goldAbstract read
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, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 21% 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, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Review
  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

17 authors at 10 institutions in 10 countries.

Weiping Cao *Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA. jgz9@cdc.gov.ORCID http://orcid.org/0000-0002-5794-9685
Yetunde F Fakile *Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA.
Mayur R Shukla *Division of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA.
Kevin PettusDivision of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA.
Kathryn LupoliDivision of Global HIV &TB, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Jaeyoung HongDivision of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA.
Allan PillayDivision of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA.
Ranmini KularatneCentre for HIV & STI, National Institute for Communicable Diseases, Johannesburg, South Africa.
Hicham OumzilNational Reference Laboratory for HIV, Virology Department, National Institute of Hygiene, and Pedagogy and Research Unit of Microbiology, School of Medicine and Pharmacy, Mohammed V University in Rabat, Rabat, Morocco.
Valeska PadoveseGenitourinary Clinic, Department of Dermatology and Venereology, Mater Dei Hospital, Msida, 2090, Malta.
Nigel SherriffSchool of Sport and Health Sciences, University of Brighton, Brighton, UK.
Isaac SSewanyanaCentral Public Health Laboratories, Ministry of Health, Plot 1062, 106 Old Butabika Rd, Kampala, Uganda.
Silver K VargasCenter for Interdisciplinary Research in Sexuality, AIDS and Society, Universidad Peruana Cayetano Heredia, Lima, Peru.
Antonella ZorziVirology and Microbiology Unit, Department of Pathology and Diagnostics, Verona University Hospital, Verona, Italy.
Karel BlondeelDepartment of Sexual and Reproductive Health and Research, UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), World Health Organization, Geneva, Switzerland.
Igor ToskinDepartment of Sexual and Reproductive Health and Research, UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), World Health Organization, Geneva, Switzerland.
Ellen N KershDivision of STD Prevention, Centers for Disease Control and Prevention, Atlanta, GA, 30329, USA. egk6@cdc.gov.
Centers for Disease Control and Prevention · USGhent University · BEMater Dei Hospital · MTMinistry of Health · UGMohammed V University · MANational Institute for Communicable DiseasesUniversidad Peruana Cayetano Heredia · PEUniversity of Brighton · GBUniversity of Verona · ITWorld Health Organization · CH

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundSexually transmitted infections (STIs) such as syphilis and HIV remain to be a significant public health issue worldwide. Dual rapid point-of-care tests (POCTs) have shown promise for detecting antibodies to HIV and syphilis but have not been fully evaluated in the field. Our study supported the WHO ProSPeRo study on Sexually Transmitted Infection Point-of-Care Testing (STI POCT) by providing external quality assessment (EQA) for HIV and syphilis testing in reference laboratories and their associated clinical sites in seven countries.

methodsHIV/syphilis serum liquid and dried tube specimen (DTS) panels were prepared by CDC. Liquid panels were distributed to the reference laboratories for three rounds of testing using commercially and locally available laboratory-based serological tests. DTS panels were sent to the clinical testing sites for 8 rounds of POC testing using the Abbott SD BIOLINE HIV/Syphilis Duo test (hereafter referred to as SD BIOLINE) and the Chembio Dual Path Platform (DPP) HIV-Syphilis assay. EQA panels were tested at CDC using the Rapid Plasma Reagin (RPR) test and the Treponema pallidum Particle Agglutination assay (TP-PA) for syphilis antibodies. Genetic Systems HIV-1/HIV-2 Plus O EIA, Geenius HIV Supplemental Assay and the Oraquick Advance HIV test were used to detect HIV antibodies in the EQA panels. Results from the reference laboratories and POCT sites were compared to those obtained at the CDC and a percentage agreement was calculated.

resultsQualitative RPR and TP-PA performed at the reference laboratories demonstrated 95.4-100% agreement with CDC results while quantitative RPR and TP-PA tests demonstrated 87.7% and 89.2% agreement, respectively. A 93.8% concordance rate was observed for qualitative HIV testing in laboratories. EQA testing at clinical sites using dual tests showed 98.7% and 99.1% agreement for detection of HIV antibodies and eight out of 10 sites had > 95.8% agreement for syphilis testing. However, two clinical sites showed only 65.0-66.7% agreement for SD BIOLINE and 84.0-86.7% for DPP, respectively, for syphilis testing.

conclusionsOverall, laboratories demonstrated high EQA performance in this study. Both HIV/syphilis POCTs gave expected results in the clinic-based evaluations using DTS. However, testing errors were identified in a few testing sites suggesting the necessity for continuous training and monitoring the quality of POC testing.

Indexed as

HIV-1HIV InfectionsSyphilisAntibodies, BacterialHIV-2HIV AntibodiesHumansPoint-of-Care SystemsPoint-of-Care TestingSensitivity and SpecificitySyphilis SerodiagnosisTreponema pallidumWorld Health OrganizationAntibodies, BacterialHIV AntibodiesDried tube specimens (DTS)Dual HIV/syphilis assayExternal Quality Assurance (EQA)Point-of-care diagnostic tests (POCTs)Sexually transmitted infections (STIs)

Identifiers

PMID38418989
PMCPMC10902925
OpenAlexW4392770409

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.