Standardised protocol for a prospective cross-sectional multicentre clinic-based evaluation of two dual point-of-care tests for the screening of HIV and syphilis in men who have sex with men, sex workers and pregnant women

IntroductionDual point-of-care tests (POCTs) for detecting antibodies to HIV and syphilis have been developed for use with venous whole blood, serum/plasma or finger-prick capillary whole blood. Several tests are commercially available showing encouraging performance compared with ‘gold-standard’ re...

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Vydáno v:BMJ open Ročník 10; číslo 11; s. e044479
Hlavní autoři: Cordioli, Maddalena, Gios, Lorenzo, Mirandola, Massimo, Zorzi, Antonella, Barbara, Christopher, Padovese, Valeska, Hançali, Amina, Oumzi, Hicham, Caceres, Carlos, Vargas, Silver, Kularatne, Ranmini, Mwima, Simon, Kyambadde, Peter, Huber, Jorg, Peeling, Rosanna, Sawyer, Alexandra, Sherriff, Nigel, Vera, Jaime, Ballard, Ronald, Blondeel, Karel, Kiarie, James, Thwin, Soe Soe, Toskin, Igor
Médium: Journal Article
Jazyk:angličtina
Vydáno: England British Medical Journal Publishing Group 26.11.2020
BMJ Publishing Group LTD
BMJ Publishing Group
Edice:Protocol
Témata:
Adolescent
Automation
Diagnostic tests
Enzymes
Female
Gays & lesbians
HIV
HIV & AIDS
HIV Infections - diagnosis
HIV Infections - epidemiology
Homosexuality, Male
Human immunodeficiency virus
Humans
Immunoassay
Infections
Infectious Diseases
Laboratories
Male
Medical research
Mens health
Point of care testing
Pregnancy
Pregnant Women
Prospective Studies
Public health
Serology
Sex industry
Sex Workers
Sexual and Gender Minorities
Sexual health
Syphilis
Syphilis - diagnosis
Syphilis - epidemiology
Womens health
HIV & AIDS
public health
infectious diseases
ISSN:2044-6055, 2044-6055
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Shrnutí:IntroductionDual point-of-care tests (POCTs) for detecting antibodies to HIV and syphilis have been developed for use with venous whole blood, serum/plasma or finger-prick capillary whole blood. Several tests are commercially available showing encouraging performance compared with ‘gold-standard’ reference tests in laboratory-based studies. However, data on their performance in the field are limited. This prospective cross-sectional study will conduct a clinic-based evaluation to assess the performance characteristics and acceptability to end-users of two dual HIV/syphilis POCTs for the screening of HIV and syphilis among men who have sex with men (MSM), sex workers (SWs) and pregnant women (PW). This master protocol outlines the overall research approach that will be used in seven countries.Method and analysisMSM, SWs and PW presenting at clinic evaluation sites in high, low and middle-income countries will be enrolled. The (WHO preapproved) POCTs to be evaluated are SD Bioline HIV/Syphilis Duo (Abbott) and Dual Path Platform HIV-Syphilis Assay (Chembio). Finger-prick blood will be collected to perform POCTs and compared with laboratory results (venepuncture blood). Procedures will be carried out by trained healthcare staff and tests performed according to the manufacturers’ directions. Sample size was calculated based on local prevalence of HIV and syphilis. The sensitivity, specificity, positive and negative predictive values for each POCT will be calculated. The study is ongoing with recruitment expected to be completed in all countries by mid to late 2021.Ethics and disseminationThis core protocol was independently peer reviewed and approved by the Research Project Review Panel (RP2) of the WHO Department of Sexual and Reproductive Health and Research and by the WHO Ethics Review Committee (ERC). The protocol has been adapted to individual countries and approved by RP2, ERC and institutional review boards at each site. Results will be disseminated through peer-reviewed journals and relevant conferences.
Bibliografie:Protocol
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SourceType-Scholarly Journals-1
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ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2020-044479