Performance Evaluation of the Elecsys Syphilis Assay for the Detection of Total Antibodies to Treponema pallidum
| Autor: | Kriangsak Chaiwong, Andrea Hunjet, Wolfgang Mayer, Ajda Turhan, Vittorio Sambri, Rüçhan Sertöz, Martin Enders, Harald Schennach, Annelies Mühlbacher, Eva Wolf, Lan Lan Wang, Simona Semprini, Tasanee Sakuldamrongpanich, Chuanmin Tao, Michael Gleich, Roland Imdahl |
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| Přispěvatelé: | Ege Üniversitesi, Enders, M, Hunjet, A, Gleich, M, Imdahl, R, Mühlbacher, A, Schennach, H, Chaiwong, K, Sakuldamrongpanich, T, Turhan, A, Sertöz, R, Wolf, E, Mayer, W, Tao, C, Wang, Ll, Semprini, S, Sambri, V. |
| Jazyk: | angličtina |
| Rok vydání: | 2015 |
| Předmět: |
Syphilis
Laboratory Diagnosis Chemiluminescence assay Microbiology (medical) medicine.medical_specialty Clinical Biochemistry Immunology Sensitivity and Specificity Lyme disease Diagnostic Laboratory Immunology Internal medicine medicine Humans Immunology and Allergy Syphilis Treponema pallidum Letters to the Editor Immunoassay Treponema medicine.diagnostic_test biology Diagnostic Tests Routine business.industry Incidence (epidemiology) Gold standard (test) medicine.disease biology.organism_classification Antibodies Bacterial Multicenter study biology.protein Reagent Kits Diagnostic Antibody business |
| Popis: | WOS: 000348771800003 PubMed ID: 25355799 Syphilis is a health problem of increasing incidence in recent years that may have severe complications if not diagnosed and treated at an early stage. There are many diagnostic tests available for syphilis, but there is no gold standard, and diagnosis therefore usually relies upon a combination of tests. In this multicenter study, we evaluated the treponemal Elecsys syphilis assay for use in the diagnosis of syphilis in routine samples, i.e., when syphilis is suspected or during antenatal or blood donation screening. The sensitivity and specificity of the Elecsys syphilis assay were compared head to head with those of other treponemal assays used in routine clinical practice and were assessed in potentially cross-reactive samples from patients with Epstein-Barr virus, HIV, and Lyme disease. In a total of 8,063 syphilis-negative samples collected from routine diagnostic requests and blood donations, the Elecsys syphilis assay had a specificity of 99.88%. In 928 samples previously identified as syphilis positive, the sensitivity was 99.57 to 100% (the result is presented as a range depending on whether four initially indeterminate samples are included in the assessment). The specificity of the Elecsys syphilis assay in patients with other infections was 100%; no false-positive samples were identified. Roche Diagnostics GmbH (Penzberg, Germany); Roche Diagnostics GmbH; Novartis Diagnostics; Roche Diagnostics; DiaSorin; bioMerieux Funding for the study was provided by Roche Diagnostics GmbH (Penzberg, Germany). Rebecca Gardner (Elements Communications Ltd., Westerham, United Kingdom) provided medical writing assistance supported by Roche Diagnostics GmbH.; V. Sambri declares speaker's fees from Novartis Diagnostics and Roche Diagnostics. V. Sambri has received research funding from Roche Diagnostics, Novartis Diagnostics, DiaSorin, and bioMerieux. H. Schennach received travel fees for attendance at an advisory board for Roche Diagnostics. |
| Databáze: | OpenAIRE |
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