Valentina D Mangano1,2, Marco Prato3, Antonella Marvelli4, Giovanna Moscato5, Fabrizio Bruschi1,6. 1. Department of Translational Research, N.T.M.S., Università di Pisa, Pisa, Italy. 2. Department of Laboratory Medicine, Unit of Microbiology, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy. 3. Postgraduate School of Microbiology and Virology, Università di Pisa, Pisa, Italy. 4. Postgraduate School of Clinical Pathology and Biochemistry, Università di Pisa, Pisa, Italy. 5. Department of Laboratory Medicine, Unit of Clinical Chemistry Analyses, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy. 6. Department of Laboratory Medicine, Programme of Parasitic Disease monitoring, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy.
Abstract
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 demonstrated 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 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.
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 demonstrated 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 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.
Authors: Andrea Angheben; Lucia Boix; Dora Buonfrate; Federico Gobbi; Zeno Bisoffi; Simonetta Pupella; Giorgio Gandini; Giuseppe Aprili Journal: Blood Transfus Date: 2015-10 Impact factor: 3.443
Authors: David A Leiby; Sheila F O'Brien; Silvano Wendel; Megan L Nguyen; Gilles Delage; Sushil G Devare; Anthony Hardiman; Hira L Nakhasi; Silvia Sauleda; Evan M Bloch Journal: Vox Sang Date: 2018-12-06 Impact factor: 2.144