| Author | Silva, Ângelo Antônio Oliveira | |
| Author | Lima, Ayla Araújo | |
| Author | Vasconcelos, Larissa Carvalho Medrado | |
| Author | Almeida, Rosângela Andrade | |
| Author | Freitas, Natália Erdens Maron | |
| Author | Oliva, Talita Andrade | |
| Author | Silva, Miralba Freire de Carvalho Ribeiro da | |
| Author | Marchini, Fabricio Klerynton | |
| Author | Zanchin, Nilson Ivo Tonin | |
| Author | Siqueira, Isadora Cristina de | |
| Author | Santos, Fred Luciano Neves | |
| Access date | 2024-04-19T19:28:14Z | |
| Available date | 2024-04-19T19:28:14Z | |
| Document date | 2024 | |
| Citation | SILVA, Ângelo Antônio Oliveira et al. Evaluating the diagnostic accuracy of TpN17 and TmpA recombinant proteins in syphilis detection: a phase II study. Frontiers in Microbiology, v. 15, n. 1348437, p. 1-11, 2024. | en_US |
| ISSN | 1664-302X | en_US |
| URI | https://www.arca.fiocruz.br/handle/icict/63606 | |
| Language | por | en_US |
| Publisher | Frontiers Media | en_US |
| Rights | open access | en_US |
| Title | Evaluating the diagnostic accuracy of TpN17 and TmpA recombinant proteins in syphilis detection: a phase II study | en_US |
| Type | Article | |
| DOI | 10.3389/fmicb.2024.1348437 | |
| Abstract | Syphilis is a sexually transmitted infection (STI) caused by the spiral bacterium Treponema pallidum. Diagnosis is based on epidemiology, clinical and serology, but serodiagnosis is challenging because distinct clinical forms of the infection may influence serological performance. Several recombinant Treponema pallidum-proteins have already been tested for syphilis diagnosis and they are critical to achieve high accuracy in serological testing. A total of 647 samples were included in the study: 180 T. pallidum-positive samples, 191 T. pallidum-negative samples and 276 sera from individuals infected with unrelated diseases. The diagnostic potential was validated by analysis of ROC curves. For the indirect ELISA, TpN17 (100%) and TmpA (99%) showed excellent AUC values. Sensitivity values were 97.2% for TpN17 and 90.6% for TmpA, while specificity was 100% for both molecules. According to the clinical phase, TmpA ranged from 84% to 97%, with the highest value for secondary syphilis. TpN17 was 100% sensitive for the primary and secondary stages and 93.2% for recent latent syphilis. All clinical phases achieved 100% specificity. Accuracy values showed that TmpA (> 95%) and TpN17 (> 98%) presented high diagnostic accuracy for all clinical stages of syphilis. Cross-reactivity was only observed in one sample positive for Chagas disease (1.5%), when TpN17 was evaluated. On the other hand, TmpA showed reactivity for two samples positive for Chagas disease (3.1%), one sample positive for HBV (1.25%), two samples positive for HIV (9.5%) and one sample positive for HTLV (1.6%). The TmpA antigen’s performance was evaluated in multiple studies for syphilis diagnosis, corroborating our findings. However, TpN17 sensitivity values have ranged in other studies. According to clinical stages of the infection, our findings obtained close performance values. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Laboratório de Saúde Pública Avançada. Salvador, BA, Brasil / Universidade Salvador. Salvador, BA, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Laboratório de Saúde Pública Avançada. Salvador, BA, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Laboratório de Saúde Pública Avançada. Salvador, BA, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Laboratório de Saúde Pública Avançada. Salvador, BA, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Laboratório de Saúde Pública Avançada. Salvador, BA, Brasil. | en_US |
| Affilliation | Centro Especializado em Diagnóstico. Assistência e Pesquisa. Salvador, BA, Brasil. | en_US |
| Affilliation | Centro Especializado em Diagnóstico. Assistência e Pesquisa. Salvador, BA, Brasil. | en_US |
| Affilliation | Instituto de Biologia Molecular do Paraná. Curitiba, PR, Brasil / Fundação Oswaldo Cruz. Instituto Carlos Chagas. Laboratório de Ciências e Tecnologias Aplicadas em Saúde. Curitiba, PR, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Carlos Chagas. Laboratório de Biologia Estrutural e Engenharia de Proteínas. Curitiba, PR, Brasil / Fundação Oswaldo Cruz. Presidência. Vice-Presidência de Pesquisa e Coleções Biológicas. Programa Translacional Integrado de Doença de Chagas da Fiocruz (Fio-Chagas). Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Programa Translacional Integrado de Doença de Chagas da Fiocruz (Fio-Chagas). Rio de Janeiro, RJ, Brasil / Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Laboratório de Investigação em Saúde Global e Doenças Negligenciadas. Salvador, BA, Brasil. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto Gonçalo Moniz. Laboratório de Saúde Pública Avançada. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Presidência. Vice-Presidência de Pesquisa e Coleções Biológicas. Programa Translacional Integrado de Doença de Chagas da Fiocruz (Fio-Chagas). Rio de Janeiro, RJ, Brasil. | en_US |
| Subject | Syphilis | en_US |
| Subject | Recombinant Proteins | en_US |
| Subject | Immunodiagnosis | en_US |
| Subject | TpN17 protein | en_US |
| Subject | TmpA protein | en_US |
| Subject | Enzyme-Linked Immunosorbent Assay | en_US |
| Subject | Treponemal test | en_US |
| Subject | ELISA | |
| Subject in Spanish | Sífilis | en_US |
| Subject in Spanish | Proteínas Recombinantes | en_US |
| Subject in Spanish | Pruebas Inmunológicas | en_US |
| Subject in Spanish | Ensayo de Inmunoadsorción Enzimática | en_US |
| Subject in French | Syphilis | en_US |
| Subject in French | Protéines recombinantes | en_US |
| Subject in French | Tests immunologiques | en_US |
| Subject in French | Test ELISA | en_US |
| DeCS | Sífilis | en_US |
| DeCS | Proteínas Recombinantes | en_US |
| DeCS | Imunodiagnóstico | en_US |
| DeCS | Ensaio de Imunoadsorção Enzimática | en_US |
| DeCS | Teste de Absorção do Anticorpo Treponêmico | en_US |
