Evaluation of the Vitros® Anti-T. cruzi assay for its incorporation into the Trypanosoma cruzi infection diagnostic algorithm
Miriam Campos-Ruiz,
Jun Hao Wang-Wang,
Belén Rivaya,
Beatriz Rodriguez-Ponga,
Noelia López,
Victoria González,
Pere-Joan Cardona,
Gema Fernández-Rivas
Affiliations
Miriam Campos-Ruiz
Microbiology Department, Clinical Laboratory North Metropolitan Area, Germans Trias I Pujol University Hospital, 08916 Badalona, Spain; Department of Genetics and Microbiology, Autonomous University of Barcelona, 08916 Badalona, Spain
Jun Hao Wang-Wang
Microbiology Department, Clinical Laboratory North Metropolitan Area, Germans Trias I Pujol University Hospital, 08916 Badalona, Spain; Department of Genetics and Microbiology, Autonomous University of Barcelona, 08916 Badalona, Spain
Belén Rivaya
Microbiology Department, Clinical Laboratory North Metropolitan Area, Germans Trias I Pujol University Hospital, 08916 Badalona, Spain; Department of Genetics and Microbiology, Autonomous University of Barcelona, 08916 Badalona, Spain
Beatriz Rodriguez-Ponga
Microbiology Department, Clinical Laboratory North Metropolitan Area, Germans Trias I Pujol University Hospital, 08916 Badalona, Spain
Noelia López
Microbiology Department, Clinical Laboratory North Metropolitan Area, Germans Trias I Pujol University Hospital, 08916 Badalona, Spain
Victoria González
Microbiology Department, Clinical Laboratory North Metropolitan Area, Germans Trias I Pujol University Hospital, 08916 Badalona, Spain; Department of Genetics and Microbiology, Autonomous University of Barcelona, 08916 Badalona, Spain; Center for Epidemiological Studies on HIV/AIDS and STI of Catalonia (CEEISCAT), Generalitat de Catalunya, Ctra, Del Canyet, S/N, 08916 Badalona, Spain
Pere-Joan Cardona
Microbiology Department, Clinical Laboratory North Metropolitan Area, Germans Trias I Pujol University Hospital, 08916 Badalona, Spain; Department of Genetics and Microbiology, Autonomous University of Barcelona, 08916 Badalona, Spain
Gema Fernández-Rivas
Microbiology Department, Clinical Laboratory North Metropolitan Area, Germans Trias I Pujol University Hospital, 08916 Badalona, Spain; Department of Genetics and Microbiology, Autonomous University of Barcelona, 08916 Badalona, Spain; Corresponding author. Microbiology Department, Clinical Laboratory North Metropolitan Area, Germans Trias i Pujol University Hospital, 08916 Badalona, Spain.
Background and objective: Serological screening for Chagas disease (CD) in Latin American adults living in Europe is a cost-effective strategy for transmission prevention. The World Health Organization recommends two different serological tests including native and recombinant antigens for IgG detection. In Spain, most commercialized native tests require manual processing. We aimed to evaluate the sensitivity and specificity of the automated Vitros® Anti-T. cruzi native antigen-based test. Methods: A total of 556 serum samples were tested using two different tests: 1) our reference assay, a chemiluminescence immunoassay employing a recombinant multi-antigen protein (Liaison® XL Murex Chagas); 2) a chemiluminescence immunoassay with native antigen (Vitros® Anti-T. cruzi assay). Additionally, 180 samples were also processed by a manual indirect immunofluorescent assay (Chagas IFA). Sensibility, specificity and kappa index were calculated. Results: Vitros® showed a kappa index of 0.94 (IC 95 %: 0.86–1.03) compared to Liaison® XL with a sensitivity of 93.6 % and specificity of 99.5 %. Compared to IFA, Vitros® showed a kappa index of 0.61 (IC 95 %: 0.47–0.76), sensitivity of 97.5 % and specificity of 70.37 %. Discrepant results were obtained mainly in treated patients. Conclusions: The Vitros® Anti-T. cruzi assay showed potential for implementation as an automated serological screening test, enhancing the diagnostic process in high-throughput microbiology laboratories.
