Evaluation of the Elecsys Chagas Assay for Detection of Trypanosoma cruzi-Specific Antibodies in a Multicenter Study in Europe and Latin America
| Autor: | Dieter Roessler, Alfredo Martinez, María Flores-Chávez, Tina Laengin, Fernando Aparicio Higuera-Escalante, Vittorio Sambri, Monica Chaves, Bernhard Fleischer, Volkmar Schottstedt |
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| Přispěvatelé: | Roche, Grifols (Spain), Abbott, Siemens, DiaSorin, Flores-Chavez, Maria Delmans, Sambri, Vittorio, Schottstedt, Volkmar, Higuera-Escalante, Fernando Aparicio, Roessler, Dieter, Chaves, Monica, Laengin, Tina, Martinez, Alfredo, Fleischer, Bernhard |
| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Microbiology (medical) Chagas disease Male Trypanosoma cruzi 030106 microbiology 030231 tropical medicine serology Antibodies Protozoan Sensitivity and Specificity Serology 03 medical and health sciences 0302 clinical medicine Antigen Pregnancy Medicine Humans Serologic Tests Immunoassays Immunoassay biology medicine.diagnostic_test business.industry biology.organism_classification medicine.disease Virology Europe Specific antibody Latin America Multicenter study electrochemiluminescence immunoassay biology.protein Female Antibody business Electrochemiluminescence immunoassay |
| Zdroj: | Repisalud Instituto de Salud Carlos III (ISCIII) Journal of Clinical Microbiology |
| Popis: | Serology is the preferred method to confirm a Chagas disease diagnosis and to screen blood donors. A battery of assays is often required due to the limited accuracy of single assays. The Elecsys Chagas assay is a newly developed, double-antigen sandwich assay for use on the Elecsys and cobas e immunoassay analyzers, intended to identify individuals infected with Trypanosoma cruzi, for diagnosis and screening. The performance of the Elecsys Chagas assay was evaluated in comparison with those of other widely used T. cruzi antibody assays, at multiple sites (Europe/Latin America). Relative sensitivity and specificity were assessed by using samples from blood donors, pregnant women, and hospitalized patients from regions where Chagas disease is endemic and from regions of nonendemicity. The Elecsys Chagas assay had an overall relative sensitivity of 100% (n = 674). Overall relative specificities were 99.90% (n = 14,681), 100% (n = 313), and 100% (n = 517) for samples from blood donors, pregnant women, and hospitalized patients, respectively. The analytical specificity was 99.83% (n = 594). The Elecsys Chagas assay detected T. cruzi antibodies in two World Health Organization (WHO) standard T. cruzi reference panels (panels 09/188 and 09/186) at a 1:512 dilution, corresponding to a cutoff sensitivity of approximately 1 mIU/ml. The Elecsys Chagas assay demonstrated robust performance under routine conditions at multiple sites in Europe and Latin America. In contrast to other available Chagas assays, the Elecsys assay uses a reduced number of recombinant T. cruzi antigens, resulting in a significantly smaller number of cross-reactions and improved analytical specificity while being highly sensitive. This study was funded by Roche Diagnostics (Penzberg, Germany). Medical writing assistance was provided by David Evans and Emma McConnell (Gardiner-Caldwell Communications, Macclesfield, UK) and was funded by Roche Diagnostics (Penzberg, Germany). We thank the Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET) and Miguel Vicco from the Universidad Nacional del Litoral (Santa Fe, Argentina) for the provision of Chagas-positive samples; DiaSorin SpA (Saluggia, Italy) for the free-ofcharge provision of DiaSorin Liaison XL Murex Chagas for measurements performed at the Greater Romagna Hub Laboratory in Pievesestina, Italy; and Sigrid Reichhuber, Verena Rauchberger, Stefanie Hornauer, Michaela Eibl, and Christian Schuster for perfect technical assistance. All authors fulfill International Committee of Medical Journal Editors authorship criteria. Maria Delmans Flores-Chavez received funds from Roche Diagnostics to perform this study and received a speaker fee from Roche Diagnostics. Vittorio Sambri received research grants from Grifols, Abbott Iridica, Siemens Diagnostics, and DiaSorin; speaker fees from Abbott Diagnostics, DiaSorin, and Beckman Coulter; and funds from Roche Diagnostics to perform this study. Volkmar Schottstedt received funds from Roche Diagnostics to perform this study. Fernando Aparicio Higuera-Escalante received funds from Roche Diagnostics to perform this study. Dieter Roessler is employed by Roche Diagnostics. Monica Chaves is employed by Roche Diagnostics. Tina Laengin is employed by Roche Diagnostics. Alfredo Martinez received funds from Roche Diagnostics to perform this study and received a speaker fee from Roche Diagnostics. Bernhard Fleischer received funds from Roche Diagnostics to perform this study and received a speaker fee from Roche Diagnostics. Sí |
| Databáze: | OpenAIRE |
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