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
Daniela Cristina Soares,
Luciano Chaves Franco Filho,
Herald Souza dos Reis,
Yan Corrêa Rodrigues,
Felipe Bonfim Freitas,
Cintya de Oliveira Souza,
Giseli Nogueira Damacena,
Nazle Mendonça Collaço Véras,
Pamela Cristina Gaspar,
Adele Schwartz Benzaken,
Joana da Felicidade Ribeiro Favacho,
Olinda Macedo,
Maria Luiza Bazzo
Affiliations
Daniela Cristina Soares
Laboratory of Sexually Transmitted Infections, Bacteriology and Mycology Section, Evandro Chagas Institute (IEC), Ananindeua 67030-000, Brazil
Luciano Chaves Franco Filho
Laboratory of Sexually Transmitted Infections, Bacteriology and Mycology Section, Evandro Chagas Institute (IEC), Ananindeua 67030-000, Brazil
Herald Souza dos Reis
Laboratory of Sexually Transmitted Infections, Bacteriology and Mycology Section, Evandro Chagas Institute (IEC), Ananindeua 67030-000, Brazil
Yan Corrêa Rodrigues
Laboratory of Sexually Transmitted Infections, Bacteriology and Mycology Section, Evandro Chagas Institute (IEC), Ananindeua 67030-000, Brazil
Felipe Bonfim Freitas
Retrovirus Laboratory, Virology Section, Evandro Chagas Institute (IEC), Ananindeua 67030-000, Brazil
Cintya de Oliveira Souza
Laboratory of Sexually Transmitted Infections, Bacteriology and Mycology Section, Evandro Chagas Institute (IEC), Ananindeua 67030-000, Brazil
Giseli Nogueira Damacena
Institute of Scientific and Technological Communication and Information in Health, Oswaldo Cruz Foundation, Rio de Janeiro 21045-360, Brazil
Nazle Mendonça Collaço Véras
Department of Diseases of Chronic Condition and Sexually Transmitted Infections, Ministry of Health, Brasilia 70723-040, Brazil
Pamela Cristina Gaspar
Department of Diseases of Chronic Condition and Sexually Transmitted Infections, Ministry of Health, Brasilia 70723-040, Brazil
Adele Schwartz Benzaken
Fiocruz Amazônia, Manaus 69057-070, Brazil
Joana da Felicidade Ribeiro Favacho
Laboratory of Sexually Transmitted Infections, Bacteriology and Mycology Section, Evandro Chagas Institute (IEC), Ananindeua 67030-000, Brazil
Olinda Macedo
Retrovirus Laboratory, Virology Section, Evandro Chagas Institute (IEC), Ananindeua 67030-000, Brazil
Maria Luiza Bazzo
Graduate Program in Pharmacy, Center for Health Sciences, Federal University of Santa Catarina, Florianópolis 88040-900, Brazil
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.
