Screening of at-risk blood donors for Chagas disease in non-endemic countries: Lessons from a 2-year experience in Tuscany, Italy

Background: Chagas disease (CD) is caused by the protozoan parasite Trypanosoma cruzi and is transmitted by blood-sucking triatomine insects in endemic areas of Latin America. Transmission can also occur via blood transfusion and is a major cause of CD in non-endemic areas. Objectives: The aim of the study was to assess the prevalence of anti-T. cruzi antibodies in blood donors at risk of infection in Tuscany, Italy, following the introduction of blood safety Italian legislation. Material and methods: Donors (N = 1985) were tested in 2016 to 2018 for anti-T. cruzi IgG using an immunochromatographic test (ICT). Chemiluminescent immunoassay (CLIA) was performed on ICT-positive donors to exclude CD, whereas enzyme-linked immunosorbent assay and Western blot were performed in case of discordant results. All assays were performed on CD patients (N = 10) for validation. Results: Ten blood donors had a positive ICT result, with a resulting T. cruzi seroprevalence of 0.5% but demonstrates negative results to CLIA, as well as to the other serological assays. The comparison of serological assays suggested a lower relative sensitivity of ICT. Conclusion: The results of this study confirm the significance of serological testing in the screening strategy for TT CD. However, they provide evidence for discontinuing the use of ICT as a screening test and suggest that a sensitive, specific and multi-sample format assay should be used at the national level for uniformity of results.