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Evaluation of the Performance of Ortho T. cruzi ELISA Test System for the Detection of Antibodies to Trypanosoma cruzi.
Rivera, Hilda N; McAuliffe, Isabel; Aderohunmu, TaLesa; Wiegand, Ryan E; Montgomery, Susan P; Bradbury, Richard S; Handali, Sukwan.
Affiliation
  • Rivera HN; Parasitic Diseases Branch, Division of Parasitic Diseases & Malaria, Center for Global Health, Centers for Disease Control & Prevention, Atlanta, Georgia, USA.
  • McAuliffe I; Parasitic Diseases Branch, Division of Parasitic Diseases & Malaria, Center for Global Health, Centers for Disease Control & Prevention, Atlanta, Georgia, USA.
  • Aderohunmu T; Parasitic Diseases Branch, Division of Parasitic Diseases & Malaria, Center for Global Health, Centers for Disease Control & Prevention, Atlanta, Georgia, USA.
  • Wiegand RE; IHRC, Atlanta, Georgia, USA.
  • Montgomery SP; Office of the Director, Division of Parasitic Diseases & Malaria, Center for Global Health, Centers for Disease Control & Prevention, Atlanta, Georgia, USA.
  • Bradbury RS; Parasitic Diseases Branch, Division of Parasitic Diseases & Malaria, Center for Global Health, Centers for Disease Control & Prevention, Atlanta, Georgia, USA.
  • Handali S; School of Science, Psychology and Sport, Federation University Australia, Berwick, Australia.
J Clin Microbiol ; 60(8): e0013422, 2022 08 17.
Article in En | MEDLINE | ID: mdl-35862752
ABSTRACT
The serologic diagnosis of chronic Chagas disease, caused by infection with the parasite Trypanosoma cruzi, is challenging and lacks a gold-standard assay. To overcome the problem, CDC uses an algorithm that uses two tests on different platforms and applies a third test as a tiebreaker. The Ortho T. cruzi ELISA Test System from Ortho Diagnostics was cleared by FDA for clinical diagnosis usage. We evaluated this test against the CDC algorithm for chronic Chagas disease. We tested several sets of serum specimens 104 specimens tested positive for T. cruzi specific antibody and 283 (including 30 specimens positive for antibody to Leishmania spp.) tested negative based on the current CDC chronic T. cruzi infection diagnostic testing algorithm. Concordance of the Ortho T. cruzi ELISA Test System with the CDC algorithm result was 90% (95% CI 87 to 93%) overall and 92% (95% CI 89 to 95%) when excluding Leishmania spp. antibody positive specimens. The cross-reactivity of the Ortho T. cruzi ELISA Test System was 37% to Leishmania spp. serologically positive specimens, 1% to specimens from patients diagnosed with other parasitic infections, and 0% against specimens from a US noninfected population. In conclusion, the Ortho T. cruzi ELISA Test System compares well against the CDC diagnostic algorithm for chronic Chagas disease. The availability of this FDA-cleared assay will improve the chronic Chagas disease diagnosis.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Trypanosoma cruzi / Chagas Disease / Leishmania Type of study: Diagnostic_studies Limits: Humans Language: En Journal: J Clin Microbiol Year: 2022 Document type: Article Affiliation country: United States

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Trypanosoma cruzi / Chagas Disease / Leishmania Type of study: Diagnostic_studies Limits: Humans Language: En Journal: J Clin Microbiol Year: 2022 Document type: Article Affiliation country: United States