{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T06:54:24Z","timestamp":1773298464224,"version":"3.50.1"},"reference-count":21,"publisher":"BMJ","issue":"11","license":[{"start":{"date-parts":[[2020,11,26]],"date-time":"2020-11-26T00:00:00Z","timestamp":1606348800000},"content-version":"unspecified","delay-in-days":25,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,10,15]]},"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Dual 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 \u2018gold-standard\u2019 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Method and analysis<\/jats:title>\n                  <jats:p>MSM, 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\u2019 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>This 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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2020-044479","type":"journal-article","created":{"date-parts":[[2020,11,26]],"date-time":"2020-11-26T15:38:49Z","timestamp":1606405129000},"page":"e044479","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":9,"title":["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"],"prefix":"10.1136","volume":"10","author":[{"name":"The ProSPeRo Network","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2020,11,26]]},"reference":[{"key":"2025101814343709000_10.11.e044479.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.plabm.2017.04.007"},{"key":"2025101814343709000_10.11.e044479.2","doi-asserted-by":"crossref","first-page":"211","DOI":"10.1097\/OLQ.0000000000000572","article-title":"Point-of-care sexually transmitted infection diagnostics","volume":"44","author":"Cristillo","year":"2017","journal-title":"Sex Transm Dis"},{"key":"2025101814343709000_10.11.e044479.3","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2019-054358"},{"key":"2025101814343709000_10.11.e044479.4","unstructured":"WHO . WHO information note on the use of dual HIV\/Syphilis rapid diagnostic tests (RDT). Geneva: World Health Organization, 2017. https:\/\/www.who.int\/reproductivehealth\/publications\/rtis\/dual-hiv-syphilis-diagnostic-tests\/en\/"},{"key":"2025101814343709000_10.11.e044479.5","doi-asserted-by":"publisher","DOI":"10.1155\/2013\/174506"},{"key":"2025101814343709000_10.11.e044479.6","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0000000000000042"},{"key":"2025101814343709000_10.11.e044479.7","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2016-053073"},{"key":"2025101814343709000_10.11.e044479.8","doi-asserted-by":"crossref","DOI":"10.1186\/s12879-018-3567-x","article-title":"Laboratory evaluation of four HIV\/syphilis rapid diagnostic tests","volume":"19","author":"Van Den Heuvel","year":"2019","journal-title":"BMC Infect Dis"},{"key":"2025101814343709000_10.11.e044479.9","doi-asserted-by":"crossref","DOI":"10.1093\/ofid\/ofu015","article-title":"Multisite laboratory evaluation of a dual human immunodeficiency virus (HIV)\/syphilis point-of-care rapid test for simultaneous detection of HIV and syphilis infection","volume":"1","author":"Bristow","year":"2014","journal-title":"Open Forum Infect Dis"},{"key":"2025101814343709000_10.11.e044479.10","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2015-052326"},{"key":"2025101814343709000_10.11.e044479.11","doi-asserted-by":"publisher","DOI":"10.1136\/sextrans-2016-053065"},{"key":"2025101814343709000_10.11.e044479.12","doi-asserted-by":"crossref","first-page":"907","DOI":"10.1111\/apm.12902","article-title":"WHO laboratory validation of Xpert \u00ae CT\/NG and Xpert \u00ae TV on the GeneXpert system verifies high performances","volume":"126","author":"Jacobsson","year":"2018","journal-title":"APMIS"},{"key":"2025101814343709000_10.11.e044479.13","unstructured":"WHO . Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2nd edn. Geneva: World Health Organization, 2016. https:\/\/www.who.int\/hiv\/pub\/arv\/arv-2016\/en\/"},{"key":"2025101814343709000_10.11.e044479.14","unstructured":"European Centre for Disease Prevention and Control . HIV infection and AIDS. In: ECDC. annual epidemiological report for 2017. Stockholm: European Centre for Disease Prevention and Control, 2019. https:\/\/www.ecdc.europa.eu\/en\/publications-data\/hiv-infection-and-aids-annual-epidemiological-report-2017"},{"key":"2025101814343709000_10.11.e044479.15","unstructured":"Centers for Disease Control and Prevention . Sexually transmitted disease surveillance 2018.: centers for disease control and prevention, 2019. Available: https:\/\/www.cdc.gov\/std\/stats18\/default.htm"},{"key":"2025101814343709000_10.11.e044479.16","unstructured":"WHO . Global guidance on criteria and processes for validation: elimination of mother-to-child transmission of HIV and syphilis. Geneva: World Health Organization, 2014. http:\/\/apps.who.int\/iris\/handle\/10665\/112858"},{"key":"2025101814343709000_10.11.e044479.17","doi-asserted-by":"publisher","DOI":"10.1059\/0003-4819-155-8-201110180-00009"},{"key":"2025101814343709000_10.11.e044479.18","unstructured":"WHO . Prequalification of in vitro diagnostics programme, public report. Geneva: World Health Organization, 2017. https:\/\/www.who.int\/diagnostics_laboratory\/evaluations\/151028_final_report_0179-012-00_sd_bioline_hiv_syphilis2.pdf?ua=1"},{"key":"2025101814343709000_10.11.e044479.19","doi-asserted-by":"publisher","DOI":"10.1038\/nrmicro1570"},{"key":"2025101814343709000_10.11.e044479.20","doi-asserted-by":"publisher","DOI":"10.1136\/sti.2006.024265"},{"key":"2025101814343709000_10.11.e044479.21","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1038\/s41564-018-0295-3","article-title":"REASSURED diagnostics to inform disease control strategies, strengthen health systems and improve patient outcomes","volume":"4","author":"Land","year":"2019","journal-title":"Nat Microbiol"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2020-044479","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T21:34:45Z","timestamp":1760823285000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2020-044479"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,11]]},"references-count":21,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2020,11,26]]},"published-print":{"date-parts":[[2020,11]]}},"alternative-id":["10.1136\/bmjopen-2020-044479"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2020-044479","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,11]]}}}