Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Feb 20;13(4):810.
doi: 10.3390/diagnostics13040810.

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  1 , Luciano Chaves Franco Filho  1 , Herald Souza Dos Reis  1 , Yan Corrêa Rodrigues  1 , Felipe Bonfim Freitas  2 , Cintya de Oliveira Souza  1 , Giseli Nogueira Damacena  3 , Nazle Mendonça Collaço Véras  4 , Pamela Cristina Gaspar  4 , Adele Schwartz Benzaken  5   6 , Joana da Felicidade Ribeiro Favacho  1 , Olinda Macedo  2 , Maria Luiza Bazzo  7
Affiliations

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 et al. Diagnostics (Basel). .

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: Amazon; HIV; SD bioline duo assay; Syphilis; diagnosis; duo test; kappa coefficient; screening; sensitivity; specificity.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Key populations enrollment and testing procedures.
See this image and copyright information in PMC

References

    1. Ministério da Saúde . Protocolo Clínico e Diretrizes Terapêuticas para Prevenção da Transmissão Vertical de HIV, Sífilis e Hepatites Virais. Ministério da Saúde; Brasília, Brazil: 2020.
    1. Gaspar P.C., Bigolin Á., Alonso Neto J.B., Pereira E.D.D.S., Bazzo M.L. Brazilian Protocol for sexually transmitted infections 2020: Syphilis diagnostic tests. Rev. Soc. Bras. Med. Trop. 2021;54:e2020630. doi: 10.1590/0037-8682-630-2020. - DOI - PMC - PubMed
    1. Ministério da Saúde . Boletim Epidemiológico do HIV/Aids. Ministério da Saúde; Brasília, Brazil: 2021.
    1. Ministério da Saúde . Boletim Epidemiológico de Sífilis. Ministério da Saúde; Brasília, Brazil: 2021.
    1. World Health Organization WHO Information Note on the Use of Dual HIV/Syphilis Rapid Diagnostic Tests (RDT) 2017. [(accessed on 10 November 2022)]. Available online: https://apps.who.int/iris/bitstream/handle/10665/252849/WHO-RHR-17.01-en....

LinkOut - more resources