A multi-country comparative study of two treponemal tests for the serodiagnosis of syphilis amongst men who have sex with men (MSM): Chemo-luminescent assay vs Treponema pallidum particle agglutination assay.

Autor: Gios L; Infectious Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy. gios.lorenzo@gmail.com.; WHO Collaborating Centre for Sexual Health and Vulnerable Populations - Epidemiology Unit - Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy. gios.lorenzo@gmail.com.; Infectious Diseases Section, Department of Diagnostics and Public Health, University of Verona, Piazzale L. Scuro, 10, 37134, Verona, Italy. gios.lorenzo@gmail.com., Mirandola M; Infectious Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy.; WHO Collaborating Centre for Sexual Health and Vulnerable Populations - Epidemiology Unit - Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy.; School of Sport and Health Sciences, University of Brighton, Brighton, UK., Cordioli M; Infectious Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy.; WHO Collaborating Centre for Sexual Health and Vulnerable Populations - Epidemiology Unit - Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy., Zorzi A; WHO Collaborating Centre for Sexual Health and Vulnerable Populations - Epidemiology Unit - Division of Infectious Diseases, Department of Medicine, Verona University Hospital, Verona, Italy.; Virology and Microbiology Unit, Department of Pathology and Diagnostics, Verona University Hospital, Verona, Italy., Sherriff N; School of Sport and Health Sciences, University of Brighton, Brighton, UK., Vera J; Brighton & Sussex Medical School, University of Sussex and University of Brighton, Brighton, UK., Wlazly D; Brighton & Sussex Medical School, University of Sussex and University of Brighton, Brighton, UK., Hassan-Ibrahim MO; Department of Microbiology & Infection, Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust (Brighton & Haywards Heath Sites), Brighton, UK., Padovese V; Genitourinary Clinic, Department of Dermatology and Venereology, Mater Dei Hospital, Msida, Malta, L-Imsida, Malta., Anabel Darmanin; Genitourinary Clinic, Department of Dermatology and Venereology, Mater Dei Hospital, Msida, Malta, L-Imsida, Malta., Peeling RW; Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK.; Medical Microbiology Department, University of Manitoba, Winnipeg, MB, Canada., Unemo M; WHO Collaborating Centre for Gonorrhoea and Other STIs, Department of Laboratory Medicine, Örebro University, Örebro, Sweden.; Institute for Global Health, University College London (UCL), London, UK., Blondeel K; Department of Sexual and Reproductive Health and Research (includes the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction [HRP]), World Health Organization, Geneva, Switzerland.; Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium., Toskin I; Department of Sexual and Reproductive Health and Research (includes the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction [HRP]), World Health Organization, Geneva, Switzerland.
Jazyk: angličtina
Zdroj: BMC infectious diseases [BMC Infect Dis] 2024 Mar 14; Vol. 24 (Suppl 1), pp. 313. Date of Electronic Publication: 2024 Mar 14.
DOI: 10.1186/s12879-024-09100-x
Abstrakt: Introduction: International guidelines recommend routine screening for syphilis (aetiological agent: Treponema pallidum subspecies pallidum) amongst key populations and vulnerable populations using tests detecting treponemal and non-treponemal antibodies. Whilst treponemal tests have high sensitivities and specificities, they differ regarding subjective or objective interpretation, throughput and workload. Chemiluminescence immunoassays (CLIAs) are cost- and time-effective automated methods for detecting treponemal antibodies. The Treponema pallidum particle agglutination assay (TPPA) has been considered the "gold standard" treponemal assay, however, this includes a highly manual procedure, low throughput and subjective interpretation. The present multi-country study evaluated the ADVIA Centaur® Syphilis CLIA (Siemens Healthcare) assay compared to the reference SERODIA-TP·PA® (Fujirebio Diagnostics) for the serodiagnosis of syphilis amongst men who have sex with men (MSM).
Method: 1,485 MSM were enrolled in Brighton (UK), Malta, and Verona (Italy) as part of a larger WHO multi-country and multi-site ProSPeRo study. Ethical approval was obtained. Serum was tested with the ADVIA Centaur® Syphilis CLIA assay and SERODIA-TP·PA®, in accordance with the manufacturers' instructions, for a first round of validation. A second round of validation was carried out for discrepant results that were additionally tested with both Western Blot (Westernblot EUROIMMUN®) and an Immunoblot (INNO-LIA, Fujirebio Diagnostics). Sensitivity, specificity, positive and negative predictive value (PPV and NPV), likelihood ratios (positive/negative), and the Diagnostic Odds Ratio (DOR)/pre-post-test probability (Fagan's nomogram) were calculated.
Results: Out of 1,485 eligible samples analysed in the first phase, the SERODIA-TP·PA® identified 360 positive and 1,125 negative cases. The ADVIA Centaur® Syphilis CLIA assay (Siemens) identified 366 positives, missclassifying one TPPA-positive sample. In the second phase, the ADVIA Centaur® Syphilis CLIA resulted in 1 false negative and 4 false positive results. Considering the syphilis study prevalence of 24% (95% CI: 22-26.7), The sensitivity of the ADVIA Centaur® Syphilis CLIA assay was 99.7% (95% CI: 98.5-100), and the specificity was 99.4% (95% CI: 98.7-99.7). The ROC area values were 0.996 (95% CI: 0.992-0.999), and both the PPV and NPV values were above 98% (PPV 98.1%, 95% CI: 96.1-99.2; NPV 99.9%, 95% CI: 99.5-100).
Conclusions: The ADVIA Centaur® Syphilis CLIA assay showed similar performance compared to the SERODIA-TP·PA®. Considering the study is based on QUADAS principles and with a homogeneous population, results are also likely to be generalisable to MSM population but potentially not applicable to lower prevalence populations routinely screened for syphilis. The automated CLIA treponemal assay confirmed to be accurate and appropriate for routine initial syphilis screening, i.e. when the reverse testing algorithm is applied.
(© 2024. The Author(s).)
Databáze: MEDLINE
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