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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Veröffentlicht in:	BMJ open Jg. 10; H. 11; S. e044479
Hauptverfasser:	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
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	England British Medical Journal Publishing Group 26.11.2020 BMJ Publishing Group LTD BMJ Publishing Group
Schriftenreihe:	Protocol
Schlagworte:	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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Abstract	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.
AbstractList	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. Introduction 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 ‘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 analysis 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’ 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 dissemination 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. 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 '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. 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' 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. 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. 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 '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.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.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' 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.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.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.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.
Author	Sherriff, Nigel Cordioli, Maddalena Toskin, Igor Oumzi, Hicham Vargas, Silver Padovese, Valeska Kularatne, Ranmini Hançali, Amina Mwima, Simon Gios, Lorenzo Sawyer, Alexandra Mirandola, Massimo Blondeel, Karel Thwin, Soe Soe Ballard, Ronald Caceres, Carlos Peeling, Rosanna Kiarie, James Zorzi, Antonella Barbara, Christopher Huber, Jorg Vera, Jaime Kyambadde, Peter
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Contributor	Sherriff, Nigel Cordioli, Maddalena Toskin, Igor Oumzi, Hicham Vargas, Silver Padovese, Valeska Kularatne, Ranmini Hançali, Amina Mwima, Simon Gios, Lorenzo Sawyer, Alexandra Mirandola, Massimo Blondeel, Karel Thwin, Soe Soe Ballard, Ronald Caceres, Carlos Peeling, Rosanna Kiarie, James Zorzi, Antonella Barbara, Christopher Huber, Jorg Vera, Jaime Kyambadde, Peter
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Publisher	British Medical Journal Publishing Group BMJ Publishing Group LTD BMJ Publishing Group
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References	Bristow, Leon, Huang (R10) 2016; 92 Zorzi, Cordioli, Gios (R11) 2017; 93 Cristillo, Bristow, Peeling (R2) 2017; 44 Van Den Heuvel, Smet, Prat (R8) 2019; 19 Dunseth, Ford, Krasowski (R1) 2017; 8 Peeling, Holmes, Mabey (R20) 2006; 82 Bristow, Adu-Sarkodie, Ondondo (R9) 2014; 1 Jacobsson, Boiko, Golparian (R12) 2018; 126 Fleming, Oremo, O'Connor (R5) 2013; 2013 Toskin, Blondeel, Peeling (R7) 2017; 93 Banoo, Bell, Bossuyt (R19) 2006; 4 Toskin, Govender, Blondeel (R3) 2020; 96 Dinh, Kamb, Msimang (R6) 2013; 40 Whiting, Rutjes, Westwood (R17) 2011; 155 Land, Boeras, Chen (R21) 2019; 4 Land, Boeras, Chen 2019; 4 Bristow, Leon, Huang 2016; 92 Dunseth, Ford, Krasowski 2017; 8 Toskin, Govender, Blondeel 2020; 96 Fleming, Oremo, O'Connor 2013; 2013 Jacobsson, Boiko, Golparian 2018; 126 Van Den Heuvel, Smet, Prat 2019; 19 Peeling, Holmes, Mabey 2006; 82 Zorzi, Cordioli, Gios 2017; 93 Toskin, Blondeel, Peeling 2017; 93 Banoo, Bell, Bossuyt 2006; 4 Cristillo, Bristow, Peeling 2017; 44 Bristow, Adu-Sarkodie, Ondondo 2014; 1 Dinh, Kamb, Msimang 2013; 40 Whiting, Rutjes, Westwood 2011; 155 Bristow (2025101814343709000_10.11.e044479.9) 2014; 1 2025101814343709000_10.11.e044479.20 Cristillo (2025101814343709000_10.11.e044479.2) 2017; 44 2025101814343709000_10.11.e044479.14 2025101814343709000_10.11.e044479.15 2025101814343709000_10.11.e044479.16 2025101814343709000_10.11.e044479.17 2025101814343709000_10.11.e044479.10 Jacobsson (2025101814343709000_10.11.e044479.12) 2018; 126 2025101814343709000_10.11.e044479.11 2025101814343709000_10.11.e044479.13 2025101814343709000_10.11.e044479.1 2025101814343709000_10.11.e044479.4 2025101814343709000_10.11.e044479.3 2025101814343709000_10.11.e044479.6 2025101814343709000_10.11.e044479.18 2025101814343709000_10.11.e044479.5 2025101814343709000_10.11.e044479.19 Van Den Heuvel (2025101814343709000_10.11.e044479.8) 2019; 19 2025101814343709000_10.11.e044479.7 Land (2025101814343709000_10.11.e044479.21) 2019; 4
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10.1097/OLQ.0000000000000042 – volume: 155 start-page: 529 year: 2011 article-title: QUADAS-2: a revised tool for the quality assessment of diagnostic accuracy studies publication-title: Ann Intern Med doi: 10.7326/0003-4819-155-8-201110180-00009 – volume: 19 year: 2019 article-title: Laboratory evaluation of four HIV/syphilis rapid diagnostic tests publication-title: BMC Infect Dis doi: 10.1186/s12879-018-3567-x – volume: 93 start-page: S51 year: 2017 article-title: Field evaluation of two point-of-care tests for syphilis among men who have sex with men, Verona, Italy publication-title: Sex Transm Infect doi: 10.1136/sextrans-2016-053065 – volume: 2013 start-page: 1 year: 2013 article-title: The impact of integration of rapid syphilis testing during routine antenatal services in rural Kenya publication-title: J Sex Transm Dis doi: 10.1155/2013/674584 – volume: 92 start-page: 182 year: 2016 article-title: Field evaluation of a dual rapid diagnostic test for HIV infection and syphilis in Lima, Peru publication-title: Sex Transm Infect doi: 10.1136/sextrans-2015-052326 – volume: 126 start-page: 907 year: 2018 article-title: WHO laboratory validation of Xpert ® CT/NG and Xpert ® TV on the GeneXpert system verifies high performances publication-title: APMIS doi: 10.1111/apm.12902 – volume: 1 year: 2014 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 publication-title: Open Forum Infect Dis doi: 10.1093/ofid/ofu015 – volume: 82 start-page: v1 year: 2006 article-title: Rapid tests for sexually transmitted infections (STIs): the way forward publication-title: Sex Transm Infect doi: 10.1136/sti.2006.024265 – volume: 8 start-page: 52 year: 2017 article-title: Traditional versus reverse syphilis algorithms: a comparison at a large academic medical center publication-title: Pract Lab Med doi: 10.1016/j.plabm.2017.04.007 – volume: 96 start-page: 342 year: 2020 article-title: Call to action for health systems integration of point-of-care testing to mitigate the transmission and burden of sexually transmitted infections publication-title: Sex Transm Infect doi: 10.1136/sextrans-2019-054358 – volume: 4 start-page: 46 year: 2019 article-title: REASSURED diagnostics to inform disease control strategies, strengthen health systems and improve patient outcomes publication-title: Nat Microbiol doi: 10.1038/s41564-018-0295-3 – volume: 44 start-page: 211 year: 2017 article-title: Point-of-care sexually transmitted infection diagnostics publication-title: Sex Transm Dis doi: 10.1097/OLQ.0000000000000572 – volume: 93 start-page: S81 year: 2017 article-title: Advancing point of care diagnostics for the control and prevention of STIs: the way forward publication-title: Sex Transm Infect doi: 10.1136/sextrans-2016-053073 – volume: 19 year: 2019 ident: 2025101814343709000_10.11.e044479.8 article-title: Laboratory evaluation of four 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the GeneXpert system verifies high performances publication-title: APMIS doi: 10.1111/apm.12902 – ident: 2025101814343709000_10.11.e044479.5 doi: 10.1155/2013/174506 – ident: 2025101814343709000_10.11.e044479.7 doi: 10.1136/sextrans-2016-053073
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Snippet	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... 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... Introduction 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...
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SubjectTerms	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
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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
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