{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,28]],"date-time":"2026-01-28T20:36:12Z","timestamp":1769632572109,"version":"3.49.0"},"reference-count":24,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2023,2,20]],"date-time":"2023-02-20T00:00:00Z","timestamp":1676851200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100011893","name":"Pan American Health Organization (PAHO\/WHO)","doi-asserted-by":"publisher","award":["TC 66\u2013SCON2019-00400"],"award-info":[{"award-number":["TC 66\u2013SCON2019-00400"]}],"id":[{"id":"10.13039\/100011893","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100011893","name":"Pan American Health Organization (PAHO\/WHO)","doi-asserted-by":"publisher","award":["TC 66\u2013SCON2019-00400"],"award-info":[{"award-number":["TC 66\u2013SCON2019-00400"]}],"id":[{"id":"10.13039\/100011893","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100011893","name":"Department of Chronic Diseases and Sexually Transmitted Infections\u2014DCCI\/SVS\/MS","doi-asserted-by":"publisher","award":["TC 66\u2013SCON2019-00400"],"award-info":[{"award-number":["TC 66\u2013SCON2019-00400"]}],"id":[{"id":"10.13039\/100011893","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100011893","name":"Department of Chronic Diseases and Sexually Transmitted Infections\u2014DCCI\/SVS\/MS","doi-asserted-by":"publisher","award":["TC 66\u2013SCON2019-00400"],"award-info":[{"award-number":["TC 66\u2013SCON2019-00400"]}],"id":[{"id":"10.13039\/100011893","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>We field-assessed the accuracy, acceptability, and feasibility of the SD BIOLINE HIV\/Syphilis Duo rapid diagnostic test in three groups: pregnant women, female sex workers (FSW), and men who have sex with men (MSM). Venous blood samples collected in the field were compared with the respective gold standard methods: SD BIOLINE HIV\/Syphilis Duo Treponemal Test versus FTA-abs (Wama brand) treponemal laboratory test for syphilis, and SD BIOLINE HIV\/Syphilis Duo Test versus the fourth generation Genscreen Ultra HIV Ag-Ag (Bio-Rad brand) laboratory test for HIV. From a total of 529 participants, 397 (75.1%) were pregnant women, 76 (14.3%) FSW and 56 (10.6%) MSM. Sensitivity and specificity parameters of HIV were 100.0% (95% CI: 82.35\u2013100.0%) and 100.0% (95% CI: 99.28\u2013100.0%), respectively. Sensitivity and specificity parameters found for TP antibody detection were 95.00% (95% CI: 87.69\u201398.62%) and 100.0% (95% CI: 98.18\u2013100.0%), respectively. The SD BIOLINE HIV\/Syphilis Duo Test showed high acceptability among participants (85.87%) and health professionals (85.51%), as well as easy usability by professionals (91.06%). The usability of the SD BIOLINE HIV\/Syphilis Duo Test kit would not be a barrier to accessing rapid testing, if the product were incorporated into the list of health service supplies.<\/jats:p>","DOI":"10.3390\/diagnostics13040810","type":"journal-article","created":{"date-parts":[[2023,2,21]],"date-time":"2023-02-21T02:30:35Z","timestamp":1676946635000},"page":"810","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Assessment of the Accuracy, Usability and Acceptability of a Rapid Test for the Simultaneous Diagnosis of Syphilis and HIV Infection in a Real-Life Scenario in the Amazon Region, Brazil"],"prefix":"10.3390","volume":"13","author":[{"given":"Daniela Cristina","family":"Soares","sequence":"first","affiliation":[{"name":"Laboratory of Sexually Transmitted Infections, Bacteriology and Mycology Section, Evandro Chagas Institute (IEC), Ananindeua 67030-000, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5648-4118","authenticated-orcid":false,"given":"Luciano Chaves Franco","family":"Filho","sequence":"additional","affiliation":[{"name":"Laboratory of Sexually Transmitted Infections, Bacteriology and Mycology Section, Evandro Chagas Institute (IEC), Ananindeua 67030-000, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6513-3937","authenticated-orcid":false,"given":"Herald","family":"Souza dos Reis","sequence":"additional","affiliation":[{"name":"Laboratory of Sexually Transmitted Infections, Bacteriology and Mycology Section, Evandro Chagas Institute (IEC), Ananindeua 67030-000, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9922-4797","authenticated-orcid":false,"given":"Yan Corr\u00eaa","family":"Rodrigues","sequence":"additional","affiliation":[{"name":"Laboratory of Sexually Transmitted Infections, Bacteriology and Mycology Section, Evandro Chagas Institute (IEC), Ananindeua 67030-000, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Felipe Bonfim","family":"Freitas","sequence":"additional","affiliation":[{"name":"Retrovirus Laboratory, Virology Section, Evandro Chagas Institute (IEC), Ananindeua 67030-000, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5496-3713","authenticated-orcid":false,"given":"Cintya","family":"de Oliveira Souza","sequence":"additional","affiliation":[{"name":"Laboratory of Sexually Transmitted Infections, Bacteriology and Mycology Section, Evandro Chagas Institute (IEC), Ananindeua 67030-000, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Giseli Nogueira","family":"Damacena","sequence":"additional","affiliation":[{"name":"Institute of Scientific and Technological Communication and Information in Health, Oswaldo Cruz Foundation, Rio de Janeiro 21045-360, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nazle Mendon\u00e7a Colla\u00e7o","family":"V\u00e9ras","sequence":"additional","affiliation":[{"name":"Department of Diseases of Chronic Condition and Sexually Transmitted Infections, Ministry of Health, Brasilia 70723-040, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pamela Cristina","family":"Gaspar","sequence":"additional","affiliation":[{"name":"Department of Diseases of Chronic Condition and Sexually Transmitted Infections, Ministry of Health, Brasilia 70723-040, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adele Schwartz","family":"Benzaken","sequence":"additional","affiliation":[{"name":"Fiocruz Amaz\u00f4nia, Manaus 69057-070, Brazil"},{"name":"AIDS Healthcare Foudation (AHF), Los Angeles, CA 90028, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7926-7952","authenticated-orcid":false,"given":"Joana","family":"da Felicidade Ribeiro Favacho","sequence":"additional","affiliation":[{"name":"Laboratory of Sexually Transmitted Infections, Bacteriology and Mycology Section, Evandro Chagas Institute (IEC), Ananindeua 67030-000, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Olinda","family":"Macedo","sequence":"additional","affiliation":[{"name":"Retrovirus Laboratory, Virology Section, Evandro Chagas Institute (IEC), Ananindeua 67030-000, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1292-0974","authenticated-orcid":false,"given":"Maria Luiza","family":"Bazzo","sequence":"additional","affiliation":[{"name":"Graduate Program in Pharmacy, Center for Health Sciences, Federal University of Santa Catarina, Florian\u00f3polis 88040-900, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2023,2,20]]},"reference":[{"key":"ref_1","unstructured":"Minist\u00e9rio da Sa\u00fade (2020). Protocolo Cl\u00ednico e Diretrizes Terap\u00eauticas para Preven\u00e7\u00e3o da Transmiss\u00e3o Vertical de HIV, S\u00edfilis e Hepatites Virais."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"e2020630","DOI":"10.1590\/0037-8682-630-2020","article-title":"Brazilian Protocol for sexually transmitted infections 2020: Syphilis diagnostic tests","volume":"54","author":"Gaspar","year":"2021","journal-title":"Rev. Soc. Bras. Med. Trop."},{"key":"ref_3","unstructured":"Minist\u00e9rio da Sa\u00fade (2021). Boletim Epidemiol\u00f3gico do HIV\/Aids."},{"key":"ref_4","unstructured":"Minist\u00e9rio da Sa\u00fade (2021). Boletim Epidemiol\u00f3gico de S\u00edfilis."},{"key":"ref_5","unstructured":"World Health Organization (2022, November 10). WHO Information Note on the Use of Dual HIV\/Syphilis Rapid Diagnostic Tests (RDT). Available online: https:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/252849\/WHO-RHR-17.01-eng.pdf?sequence=1."},{"key":"ref_6","unstructured":"World Health Organization (2022). Product: SD Bioline HIV\/Syphilis Duo. Number PQDx 0179-012-00. 28 October 2015, World Health Organization. WHO Prequalification of In Vitro Diagnostics Programmes Public Report."},{"key":"ref_7","unstructured":"Minist\u00e9rio da Sa\u00fade, Secretaria de Vigil\u00e2ncia em Sa\u00fade, and Departamento de Vigil\u00e2ncia, Preven\u00e7\u00e3o e Controle das Doen\u00e7as Sexualmente Transmiss\u00edveis, Aids e Hepatites Virais (2022, November 17). Manual T\u00e9cnico para Diagn\u00f3stico da S\u00edfilis, Available online: http:\/\/www.aids.gov.br\/pt-br\/pub\/2016\/manual-tecnico-para-diagnostico-da-sifilis."},{"key":"ref_8","doi-asserted-by":"crossref","unstructured":"ProSPeRo Network (2020). 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. BMJ Open, 10.","DOI":"10.1136\/bmjopen-2020-044479"},{"key":"ref_9","first-page":"393","article-title":"Barreiras de acesso para Homens que fazem Sexo com Homens \u00e0 testagem e tratamento do HIV no munic\u00edpio de Curitiba (PR)","volume":"45","author":"Cota","year":"2021","journal-title":"Sa\u00fade Debate"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"490","DOI":"10.1080\/09540120802270284","article-title":"Emergency department patient perceptions and preferences on opt-in rapid HIV screening program components","volume":"21","author":"Merchant","year":"2009","journal-title":"AIDS Care"},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"501","DOI":"10.1177\/0956462420979852","article-title":"Acceptability of dual HIV\/syphilis rapid test in community-and home-based testing strategy among transgender women in Buenos Aires, Argentina","volume":"32","author":"Zalazar","year":"2021","journal-title":"Int. J. STD AIDS"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"723","DOI":"10.1177\/0956462414552696","article-title":"Operations research study to implement HIV and syphilis point-of-care tests and assess client perceptions in a marginalised area of Lima, Peru","volume":"26","author":"Flores","year":"2015","journal-title":"Int. J. STD AIDS"},{"key":"ref_13","doi-asserted-by":"crossref","unstructured":"Olugbenga, I., Taiwo, O., Laverty, M., Ngige, E., Anyaike, C., Bakare, R., Ogunleye, V., Maddox, B.L.P., Newman, D.R., and Gliddon, H.D. (2018). Clinic-based evaluation study of the diagnostic accuracy of a dual rapid test for the screening of HIV and syphilis in pregnant women in Nigeria. PLoS ONE, 13.","DOI":"10.1371\/journal.pone.0198698"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"182","DOI":"10.1136\/sextrans-2015-052326","article-title":"Field evaluation of a dual rapid diagnostic test for HIV infection and syphilis in Lima, Peru","volume":"92","author":"Bristow","year":"2016","journal-title":"Sex. Transm. Infect."},{"key":"ref_15","doi-asserted-by":"crossref","unstructured":"Bristow, C.C., Severe, L., Pape, J.W., Javanbakht, M., Lee, S.-J., Comulada, W.S., and Klausner, J.D. (2016). Dual rapid lateral flow immunoassay fingerstick wholeblood testing for syphilis and HIV infections is acceptable and accurate, Port-au-Prince, Haiti. BMC Infect. Dis., 16.","DOI":"10.1186\/s12879-016-1574-3"},{"key":"ref_16","doi-asserted-by":"crossref","unstructured":"Van Den Heuvel, A., Smet, H., Prat, I., Sands, A., Urassa, W., Fransen, K., and Crucitti, T. (2019). Laboratory evaluation of four HIV\/syphilis rapid diagnostic tests. BMC Infect. Dis., 19.","DOI":"10.1186\/s12879-018-3567-x"},{"key":"ref_17","unstructured":"Minist\u00e9rio da Sa\u00fade, Secretaria de Vigil\u00e2ncia em Sa\u00fade, and Preven\u00e7\u00e3o e Controle das Infec\u00e7\u00f5es Sexualmente Transmiss\u00edveis, do HIV\/Aids e das Hepatites Virais (2017). Manual T\u00e9cnico para o Diagn\u00f3stico da Infec\u00e7\u00e3o pelo HIV em Adultos e Crian\u00e7as."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"495","DOI":"10.1136\/sextrans-2015-052474","article-title":"Field evaluation of Standard Diagnostics\u2019 Bioline HIV\/Syphilis Duo test among female sex workers in Johannesburg, South Africa","volume":"92","author":"Black","year":"2016","journal-title":"Sex. Transm. Infect."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"323","DOI":"10.1177\/0956462418800872","article-title":"Field performance evaluation of dual rapid HIV and syphilis tests in three antenatal care clinics in Zambia","volume":"30","author":"Kasaro","year":"2019","journal-title":"Int. J. STD AIDS"},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"173","DOI":"10.1177\/0956462418802685","article-title":"A field evaluation of a rapid dual immunoassay for human immunodeficiency virus and syphilis antibodies, Hanoi, Vietnam","volume":"30","author":"Withers","year":"2019","journal-title":"Int. J. STD AIDS"},{"key":"ref_21","doi-asserted-by":"crossref","unstructured":"Lodiongo, D.K., Bior, B.K., Dumo, G.W., Katoro, J.S., Mogga, J.J.H., Lokore, M.L., Abias, A.G., Carter, J.Y., and Deng, L.L. (2018). Field evaluation of SD BIOLINE HIV\/Syphilis Duo assay among pregnant women attending routine antenatal care in Juba, South Sudan. PLoS ONE, 13.","DOI":"10.1371\/journal.pone.0205383"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1177\/0956462417717649","article-title":"An evaluation of the SD Bioline HIV\/syphilis duo test","volume":"29","author":"Holden","year":"2018","journal-title":"Int. J. STD AIDS"},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"584","DOI":"10.1097\/OLQ.0000000000001022","article-title":"Performance of a Dual Human Immunodeficiency Virus\/Syphilis Rapid Test Compared with Conventional Serological Testing for Syphilis and Human Immunodeficiency Virus in a Laboratory Setting: Results From the Zimbabwe STI Etiology Study","volume":"46","author":"Rietmeijer","year":"2019","journal-title":"Sex. Transm. Dis."},{"key":"ref_24","doi-asserted-by":"crossref","unstructured":"Taremwa, I.M., Twelwanike, A., Mwambi, B., and Atuhairwe, C. (2019). Laboratory assessment of SD Bioline HIV\/Syphilis Duo Kit among pregnant women attending antenatal clinic Mayuge Health Center III, East central Uganda. BMC Res. Notes, 12.","DOI":"10.1186\/s13104-019-4272-6"}],"container-title":["Diagnostics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2075-4418\/13\/4\/810\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T18:37:33Z","timestamp":1760121453000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2075-4418\/13\/4\/810"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,2,20]]},"references-count":24,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2023,2]]}},"alternative-id":["diagnostics13040810"],"URL":"https:\/\/doi.org\/10.3390\/diagnostics13040810","relation":{},"ISSN":["2075-4418"],"issn-type":[{"value":"2075-4418","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2,20]]}}}