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https://www.arca.fiocruz.br/handle/icict/58038
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
Diagnosis
Duo test
HIV
Kappa coefficient
Screening
SD bioline duo assay
Sensitivity
Specificity
Syphilis
Author
Soares, Daniela Cristina
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
Macedo, Olinda
Bazzo, Maria Luiza
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
Macedo, Olinda
Bazzo, Maria Luiza
Affilliation
Evandro Chagas Institute. Bacteriology and Mycology Section. Laboratory of Sexually Transmitted Infections. Ananindeua, PA, Brazil.
Evandro Chagas Institute. Bacteriology and Mycology Section. Laboratory of Sexually Transmitted Infections. Ananindeua, PA, Brazil.
Evandro Chagas Institute. Bacteriology and Mycology Section. Laboratory of Sexually Transmitted Infections. Ananindeua, PA, Brazil.
Evandro Chagas Institute. Bacteriology and Mycology Section. Laboratory of Sexually Transmitted Infections. Ananindeua, PA, Brazil.
Evandro Chagas Institute. Virology Section. Retrovirus Laboratory. Ananindeua. PA, Brazil.
Evandro Chagas Institute. Bacteriology and Mycology Section. Laboratory of Sexually Transmitted Infections. Ananindeua, PA, Brazil.
Oswaldo Cruz Foundation. Institute of Scientific and Technological Communication and Information in Health. Rio de Janeiro, RJ, Brazil.
Ministry of Health. Department of Diseases of Chronic Condition and Sexually Transmitted Infections. Brasília, DF, Brazil.
Ministry of Health. Department of Diseases of Chronic Condition and Sexually Transmitted Infections. Brasília, DF, Brazil.
Oswaldo Cruz Foundation. Institute of Maria Leônidas e Maria Deane. Manaus, AM, Brazil / AIDS Healthcare Foudation. Los Angeles, CA, USA.
Evandro Chagas Institute. Bacteriology and Mycology Section. Laboratory of Sexually Transmitted Infections. Ananindeua, PA, Brazil.
Evandro Chagas Institute. Virology Section. Retrovirus Laboratory. Ananindeua. PA, Brazil.
Federal University of Santa Catarina. Center for Health Sciences. Graduate Program in Pharmacy. Florianópolis, SC, Brazil.
Evandro Chagas Institute. Bacteriology and Mycology Section. Laboratory of Sexually Transmitted Infections. Ananindeua, PA, Brazil.
Evandro Chagas Institute. Bacteriology and Mycology Section. Laboratory of Sexually Transmitted Infections. Ananindeua, PA, Brazil.
Evandro Chagas Institute. Bacteriology and Mycology Section. Laboratory of Sexually Transmitted Infections. Ananindeua, PA, Brazil.
Evandro Chagas Institute. Virology Section. Retrovirus Laboratory. Ananindeua. PA, Brazil.
Evandro Chagas Institute. Bacteriology and Mycology Section. Laboratory of Sexually Transmitted Infections. Ananindeua, PA, Brazil.
Oswaldo Cruz Foundation. Institute of Scientific and Technological Communication and Information in Health. Rio de Janeiro, RJ, Brazil.
Ministry of Health. Department of Diseases of Chronic Condition and Sexually Transmitted Infections. Brasília, DF, Brazil.
Ministry of Health. Department of Diseases of Chronic Condition and Sexually Transmitted Infections. Brasília, DF, Brazil.
Oswaldo Cruz Foundation. Institute of Maria Leônidas e Maria Deane. Manaus, AM, Brazil / AIDS Healthcare Foudation. Los Angeles, CA, USA.
Evandro Chagas Institute. Bacteriology and Mycology Section. Laboratory of Sexually Transmitted Infections. Ananindeua, PA, Brazil.
Evandro Chagas Institute. Virology Section. Retrovirus Laboratory. Ananindeua. PA, Brazil.
Federal University of Santa Catarina. Center for Health Sciences. Graduate Program in Pharmacy. Florianópolis, SC, Brazil.
Abstract
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.
Keywords
AmazonDiagnosis
Duo test
HIV
Kappa coefficient
Screening
SD bioline duo assay
Sensitivity
Specificity
Syphilis
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