Performance of Treponema pallidum recombinant proteins in the serological diagnosis of syphilis

Silva, Ângelo Antônio Oliveira; Oliveira, Ueriton Dias de; Vasconcelos, Larissa de Carvalho Medrado; Foti, Leonardo; Leony, Leonardo Maia; Daltro, Ramona Tavares; Leitolis, Amanda; Lima, Fernanda Washington de Mendonça; Krieger, Marco Aurélio; Zanchin, Nilson Ivo Tonin; Santos, Fred Luciano Neves

doi:10.1371/journal.pone.0234043

Cited by 6 publications

(9 citation statements)

References 55 publications

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“…We followed the method previously described ( Silva et al, 2020 ) for recombinant protein synthesis. In brief, we acquired synthetic genes of the bacterium T. pallidum subspecies pallidum Nichols strain from a commercial supplier (GenScript, Piscataway-NJ, United States).…”

Section: Methodsmentioning

confidence: 99%

“…Standardization followed the checkerboard titration as previously described ( Silva et al, 2020 ) and was optimized for this study. In summary, 100 ng/well of TpN17 and 200 ng/well of TmpA, in coating buffer (0.05 M carbonate–bicarbonate, pH 9.6), were added to transparent flat-bottom polystyrene microplates (Microtest Plate 96 Well, F—Sarstedt, Germany).…”

Section: Methodsmentioning

confidence: 99%

“…Antigenic matrices can incorporate lysates of T. pallidum or recombinant antigens, either isolated or in combination ( Larsen et al, 1995 ). In a phase I study, TpN15, TpN17, TpN47, and TmpA recombinant proteins exhibited superior diagnostic performance ( Silva et al, 2020 ). TpN17 and TmpA showed the most promising results and advanced to a phase II study.…”

Section: Introductionmentioning

confidence: 99%

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Evaluating the diagnostic accuracy of TpN17 and TmpA recombinant proteins in syphilis detection: a phase II study

Silva,

Lima,

Vasconcelos

et al. 2024

Front. Microbiol.

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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.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Evaluating the diagnostic accuracy of TpN17 and TmpA recombinant proteins in syphilis detection: a phase II study

Silva,

Lima,

Vasconcelos

et al. 2024

Front. Microbiol.

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“…13 Moreover, new tests such as CIAs based on the recombinant antigens can distinguish between recent and previously treated syphilis infections. 25 In the past decades, with the elucidation of T. pallidum genome and application of bioinformatics and immunoproteomics, 21,22,26,27 many recombinant T. pallidum proteins, such as TpN15 (Tp0171), TpN17 (Tp0435), TpN44.5 (TmpA, Tp0768), TpN47 (Tp0574), Tp0453, Tp92 (Tp0326),TpF1 (Tp1038), Tp463, Tp0663, and Tp0821, have been evaluated for their diagnostic value, 18,[28][29][30][31][32][33][34] and some of them have been used as diagnostic antigens in commercial tests. 35,36 However, there is still no universally accepted serological test, and diagnosis of syphilis often relies on a combination of several assays.…”

Section: Direct Comparison Of the Agreement Between Clinical Syphilis...mentioning

confidence: 99%

Assessment of recombinant antigens Tp0100 and Tp1016 of Treponema pallidum for serological diagnosis of syphilis

Chen

Wang

et al. 2022

Clinical Laboratory Analysis

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Objective To discover novel serodiagnostic candidates for the serological diagnosis of syphilis. Methods Two recombinant Treponema pallidum proteins Tp0100 and Tp1016 were expressed, purified, and identified by Western Blotting. A total of 600 clinical serum samples were tested with the Tp0100‐based ELISA, the Tp1016‐based ELISA, and the commercial LICA Syphilis TP kit (ChIVD, Beijing, China). The sensitivities were determined by testing 340 samples from individuals with clinically diagnosed primary, secondary, latent, and tertiary syphilis. The specificities were determined by screening 260 samples from healthy controls and individuals with potentially cross‐reactive infections, including leptospirosis, Lyme disease, hepatitis B, tuberculosis, rheumatoid arthritis, systemic lupus erythematosus. Kappa ( κ ) values were applied to compare the agreement between clinical syphilis diagnosis and the Tp0100‐based ELISA, the Tp1016‐based ELISA, or the LICA Syphilis TP test. Results Using clinical syphilis diagnosis as the gold standard, Tp0100 exhibited an overall sensitivity of 95.6% and specificity of 98.1% for testing IgG antibody while Tp1016 demonstrated only an overall sensitivity of 75.0% and specificity of 79.6%. In contrast, the LICA Syphilis TP test revealed an overall sensitivity of 97.6% and specificity of 96.2%. In addition, the overall percent agreement and corresponding κ values were 96.7% (95% CI 95.6%–97.8%) and 0.93 for the Tp0100‐based ELISA, 77.0% (95% CI 74.3%–79.7%) and 0.54 for the Tp1016‐based ELISA, and 97.0% (95% CI 96.0%–98.0%) and 0.94 for the LICA Syphilis TP test, respectively. Conclusion The recombinant T. pallidum protein Tp0100 shows promise as a novel diagnostic antigen in the serological tests for syphilis.

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“…Anti-Treponema pallidum WESTERNBLOT (IgG)/(IgМ) забезпечує якісне визначення антитіл до різних антигенів T. pallidum і використовується для остаточного підтвердження позитивних скринінгових тестів на сифіліс. Застосування високоочищених рекомбінантних і пептидних антигенів мінімізує неспецифічну реактивність сироваток [20].…”

Section: лабораторна діагностика сифілісу під час вагітностіunclassified

Change of emphasis in the structure of prenatal infections, or what is SCORTCH? Literature review

Тутченко

Бурка

Коломієць

et al. 2020

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Prenatal infections (PI) remain an actual problem. Taking into account the epidemiological data on the increase in the incidence of syphilis in many countries, a review of modern algorithms for diagnosing this disease in pregnant women and newborns has been carried out. Universal screening for syphilis at the first prenatal examination is recommended by WHO and CDC, and is practiced in most countries. The article also presents the characteristics of modern laboratory methods of serological screening of pregnant women for syphilis and their combinations, one of which is primary screening using the treponemal test “total antibodies to syphilis” with confirmation of a positive result by immunoblotting.Given the controversial nature of approaches to the prevention of other PI and their consequences, this review provides current recommendations for countries that screen and actively manage infections such as cytomegalovirus (CMV) and toxoplasmosis (T). Despite the proven significance of CMV as a factor in PI, universal prenatal screening, similar to screening for syphilis is not practiced in any of the countries due to the absence of prenatal treatment with proven efficacy. According to the national protocol of Germany, serostatus (titers IgG, IgM) to CMV are determined in early pregnancy. Confirmation of congenital CMV infection (HCMVI) is a positive PCR result in the amniotic fluid after 20–21 weeks of gestation. The main method of laboratory diagnostics of HCMVI in a newborn is PCR for CMV in urine. The article also presents the main approaches to the prevention of congenital toxoplasmosis, which have been practiced in France since the 90s and demonstrate effectiveness.Thus, despite the fact that the use of effective prenatal treatment is not possible for all PI, their diagnosis using a complex of modern laboratory and instrumental methods is critical for the child’s health, since it allows the application of an appropriate algorithm for specific treatment and observation from birth

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Performance of Treponema pallidum recombinant proteins in the serological diagnosis of syphilis

Cited by 6 publications

References 55 publications

Evaluating the diagnostic accuracy of TpN17 and TmpA recombinant proteins in syphilis detection: a phase II study

Evaluating the diagnostic accuracy of TpN17 and TmpA recombinant proteins in syphilis detection: a phase II study

Assessment of recombinant antigens Tp0100 and Tp1016 of Treponema pallidum for serological diagnosis of syphilis

Change of emphasis in the structure of prenatal infections, or what is SCORTCH? Literature review

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