2022 Volume 71 Issue 1 Pages 20-24
Chagas disease (CD) is a chronic infectious disease caused by the intracellular parasite Trypanosoma cruzi and originally prevalent in Latin American countries. It was estimated that about 25% of patients with CD develop chronic complications decades after infection. In this study, we evaluated the usefulness of the following two serological test kits available in Japan for CD: ARCHITECT Chagas Reagent Kit (Abbott, Chicago, IL) and Trypanosoma DetectTM Rapid Test Kit (InBios, Seattle, WA). A total of 192 serum samples were used in this study as follows: 20 from patients previously diagnosed as having CD in Japan, 72 from those previously diagnosed in Bolivia, and 100 from Japanese patients without CD in Saitama University Hospital. All patients were confirmed to have CD by ELISA and IFA in accordance with the previously reported protocol. Analysis using the ARCHITECT Chagas Reagent Kit demonstrated a 100% diagnostic concordance in all populations. The Trypanosoma DetectTM Rapid Test Kit, an immunochromatography test (ICT) kit, showed 99.4% sensitivity and 100% specificity. In this study, an automated immunoassay and ICT kits, which are also available in Japan, demonstrated good clinical performance for detecting antibodies against T. cruzi. However, the potential for false-negative results of serologic tests, especially those using the rapid ICT test kits, remained. Further research using a wider variety of clinical serum samples will be required to determine the usefulness of these test kits in Japan.
