Performance Assessment of Treponemal and Nontreponemal Tests for the Diagnosis of Acquired Syphilis

Ângelo Antônio Oliveira Silva Advanced Public Health Laboratory, Institute Gonçalo Moniz, Foundation Oswaldo Cruz (FIOCRUZ-BA), Salvador, Brazil;
Salvador University (UNIFACS), Salvador, Brazil;

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Ayla Araújo Lima Advanced Public Health Laboratory, Institute Gonçalo Moniz, Foundation Oswaldo Cruz (FIOCRUZ-BA), Salvador, Brazil;

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Larissa de Carvalho Medrado Vasconcelos Advanced Public Health Laboratory, Institute Gonçalo Moniz, Foundation Oswaldo Cruz (FIOCRUZ-BA), Salvador, Brazil;

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Rosângela Andrade de Almeida Advanced Public Health Laboratory, Institute Gonçalo Moniz, Foundation Oswaldo Cruz (FIOCRUZ-BA), Salvador, Brazil;

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Natália Erdens Maron de Freitas Advanced Public Health Laboratory, Institute Gonçalo Moniz, Foundation Oswaldo Cruz (FIOCRUZ-BA), Salvador, Brazil;

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Fernanda Lopes Habib Advanced Public Health Laboratory, Institute Gonçalo Moniz, Foundation Oswaldo Cruz (FIOCRUZ-BA), Salvador, Brazil;

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Talita Andrade Oliva State Center Specializing in Diagnosis, Assistance, and Research (CEDAP), Salvador, Brazil;

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Miralba Freire de Carvalho Ribeiro da Silva State Center Specializing in Diagnosis, Assistance, and Research (CEDAP), Salvador, Brazil;

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Isadora Cristina de Siqueira Laboratory of Experimental Pathology, Institute Gonçalo Moniz, Foundation Oswaldo Cruz (FIOCRUZ-BA), Salvador, Brazil;

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Fred Luciano Neves Santos Advanced Public Health Laboratory, Institute Gonçalo Moniz, Foundation Oswaldo Cruz (FIOCRUZ-BA), Salvador, Brazil;
Integrated Translational Program in Chagas Disease from Fiocruz (Fio-Chagas), Rio de Janeiro, Brazil

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There are a variety of nontreponemal test (NTT) and treponemal test (TT) kits for the serologic diagnosis of syphilis. Because of the complexity of the infection (multiple clinical stages) and the different antigens used in these kits, a systematic evaluation of the accuracy of the currently available commercial tests is warranted. Our objective was to evaluate the performance of commercially available tests for the diagnosis of syphilis infection. In this study, we analyzed one NTT (Venereal Disease Research Laboratory [VDRL] test, Wiener Laboratories, Rosario, Argentina) and two TTs (fluorescent treponemal antibody absorption [FTA-ABS] test, Euroimmun, Lübeck, Germany, and syphilis recombinant ELISA v. 4.0 test [ELISA], Wiener Laboratories, Rosario, Argentina) using a panel of 187 samples, including serum samples from 31 individuals with primary syphilis, 77 with secondary syphilis, and 79 with latent syphilis. An additional 192 samples from uninfected individuals and 323 serum samples from individuals with other diseases were included. The sensitivities of the VDRL, ELISA, and FTA-ABS tests were 97.9%, 100%, and 96.3%, respectively. The VDRL and ELISA tests showed a specificity of 100%, and the FTA-ABS test showed a specificity of 99.5%. Accuracy was 98.9% for the VDRL test, 100% for the ELISA, and 97.9% for the FTA-ABS test. For primary, secondary, and latent syphilis, the ELISA achieved a diagnostic performance of 100%, whereas the sensitivity for the VDRL and FTA-ABS tests ranged from 96.8% to 98.7% and 93.7% to 98.7%, respectively. No difference was observed when the tests were used as traditional or reverse algorithms. In general, all three tests are able to discriminate positive and negative samples for syphilis, regardless of the diagnostic algorithm.

Author Notes

Financial support: This research was supported by the Coordination for the Improvement of Higher Education Personnel in Brazil (CAPES; finance code 001 award to F. L. N. Santos, award number 88887.637869/2021-00 to L. C. M. Vasconcelos, and award number 88887.637758/2021-00 to N. E. M. de Freitas), the Research Support Foundation of the State of Bahia (FAPESB; award number BOL0543/2020 to Â. A. O. Silva and award number BOL2173/2021 to A. A. Lima), and the National Council for Scientific and Technological Development-Brazil (CNPq; award number 128257/2021-0 to F. L. Habib). I. C. de Siqueira and F. L. N. Santos are CNPq research grantees (process numbers 316456/2021-7 and 309263/2020-4, respectively). The funders had no influence on the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Disclosure: The present research protocol was approved by the Institutional Research Board for Human Research at the Gonçalo Moniz Institute of the Oswaldo Cruz Foundation (IGM-FIOCRUZ), Salvador, Bahia, Brazil (CAAE number 42341121.0.0000.0040). All procedures were performed in accordance with the principles of the Declaration of Helsinki and its subsequent revisions.

Authors’ addresses: Ângelo Antônio Oliveira Silva, Advanced Public Health Laboratory, Institute Gonçalo Moniz, Foundation Oswaldo Cruz (FIOCRUZ-BA), Salvador, Brazil, and Salvador University (UNIFACS), Salvador, Brazil, E-mail: angelo.oliveira@fiocruz.br. Ayla Araújo Lima, Larissa de Carvalho Medrado Vasconcelos, Rosângela Andrade de Almeida, Natália Erdens Maron de Freitas, and Fernanda Lopes Habib, Advanced Public Health Laboratory, Institute Gonçalo Moniz, Foundation Oswaldo Cruz (FIOCRUZ-BA), Salvador, Brazil, E-mails: aylaaraujo00@gmail.com, larissa.vasconcelos@fiocruz.br, rosangelaandrade1@hotmail.com, natalia.erdens@fiocruz.br, and flopeshabib@gmail.com. Talita Andrade Oliva and Miralba Freire de Carvalho Ribeiro da Silva, State Center Specializing in Diagnosis, Assistance, and Research (CEDAP), Salvador, Brazil, E-mails: ta.andradeoliva@gmail.com and miralbafsilva@gmail.com. Isadora Cristina de Siqueira, Laboratory of Experimental Pathology, Institute Gonçalo Moniz, Foundation Oswaldo Cruz (FIOCRUZ-BA), Salvador, Brazil, E-mail: isadora.siqueira@fiocruz.br. Fred Luciano Neves Santos, Advanced Public Health Laboratory, Institute Gonçalo Moniz, Foundation Oswaldo Cruz (FIOCRUZ-BA), Salvador, Brazil, and Integrated Translational Program in Chagas Disease from Fiocruz (Fio-Chagas), Rio de Janeiro, Brazil, E-mail: fred.santos@fiocruz.br.

Address correspondence to Fred Luciano Neves Santos, Gonçalo Moniz Institute, Oswaldo Cruz Foundation, Waldemar Falcão St, 121, Candeal, Salvador, Bahia 40296-710, Brazil. E-mail: fred.santos@fiocruz.br
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