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

• Autor(a) principal: Soares, Daniela Cristina
• Data de Publicação: 2023
• Outros Autores: Franco Filho, Luciano Chaves, Reis, Herald Souza dos, Rodrigues, Yan Corrêa, Freitas, Felipe Bonfim, Souza, Cintya de Oliveira, Damacena, Giseli Nogueira, Véras, Nazle Mendonça Collaço, Gaspar, Pamela Cristina, Benzaken, Adele Schwartz, Favacho, Joana da Felicidade Ribeiro, Macêdo, Olinda, Bazzo, Maria Luiza
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Repositório Digital do Instituto Evandro Chagas (Patuá)
• DOI: 10.3390/diagnostics13040810.
• Texto Completo: https://patua.iec.gov.br/handle/iec/6739
• topic: HIV / diagnóstico; Sífilis / diagnóstico; Teste de HIV; Testes Imediatos; Sensibilidade e Especificidade; SD Bioline HIV/Syphilis Duo; Região Amazônica (BR)

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: 82.35–100.0%) and 100.0% (95% CI: 99.28–100.0%), respectively. Sensitivity and specificity parameters found for TP antibody detection were 95.00% (95% CI: 87.69–98.62%) and 100.0% (95% CI: 98.18–100.0%), 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.