Chagas disease: Performance analysis of immunodiagnostic tests anti-Trypanosoma cruzi in blood donors with inconclusive screening results

Abstract

Background The screening of Trypanosoma cruzi -infected blood donors using two serological techniques frequently leads to conflicting results. This fact prompted us to evaluate the diagnostic performance of four “in-house” immunodiagnostic tests and two commercially available enzyme-linked immunosorbent assays (ELISAs). Material and Methods One hundred and seventy-nine blood donors, whose screening for Chagas disease was doubtful, underwent three in-house ELISAs, one in-house immunoblotting test (TESA-blot), and two commercial ELISAs (bioMérieux and Wiener) in an attempt to define the presence or absence of infection. Simultaneously, 29 donors with previous positive results from three conventional serological tests and 30 donors with constant negative results were evaluated. Results The ELISA-Wiener showed the highest rate in sensitivity (98.92%) and the ELISA-bioMérieux, the highest specificity (99.45%), followed by the TESA-blot, which showed superior performance, with lower false-negative (2.18%) and false-positive (1.12%) rates. In series, the combination composed of the TESA-blot and ELISA-bioMérieux showed slightly superior performance, with trifunctional protein deficiency (TFP) = 0.01%. Conclusion Our study confirms the high sensitivity and specificity of commercial kits. To confirm the presence or absence of T. cruzi infection, the combination of TESA-blot and ELISA-bioMérieux may be suggested as the best alternative. Individually, the TESA-blot performed the closest to the gold standard; however, it is not commercially available.

In vitro diagnostic methods of Chagas disease in the clinical laboratory: a scoping review

“…Out of 85, 72 studies (84.7%) explored a single test type while 13 studies (15.3%) explored more than a single type. Stratified by testing method, 62 studies (72.94%) covered serological methods ( Carvalho et al, 1993 ; Brashear et al, 1995 ; Almeida et al, 1997 ; Hamerschlak et al, 1997 ; Oelemann et al, 1998 ; Reiche et al, 1998 ; Leiby et al, 2000 ; Ferreira et al, 2001 ; Ponce et al, 2005 ; Tobler et al, 2007 ; Gorlin et al, 2008 ; Otani et al, 2009 ; Chappuis et al, 2010 ; Reithinger et al, 2010 ; Barfield et al, 2011 ; Frade et al, 2011 ; Gamboa-León et al, 2011 ; Praast et al, 2011 ; Flores-Chavez et al, 2012 ; Longhi et al, 2012 ; Araújo and Berne, 2013 ; Holguín et al, 2013 ; Llano et al, 2013 ; Reis-Cunha et al, 2014 ; Sánchez-Camargo et al, 2014 ; Shah et al, 2014 ; Abras et al, 2016 ; Santos et al, 2016 ; Valdez et al, 2016 ; Angheben et al, 2017 ; Egüez et al, 2017 ; Mucci et al, 2017 ; Cortes-Serra et al, 2018 ; Flores-Chavez et al, 2018 ; Mita-Mendoza et al, 2018 ; Pérez-Ayala et al, 2018 ; Santos et al, 2018 ; Kim et al, 2019 ; Lozano et al, 2019 ; Mendicino et al, 2019 ; Whitman et al, 2019 ; de Oliveira et al, 2020 ; Brossas et al, 2021 ; Ferreira-Silva et al, 2021 ; Hernández et al, 2021 ; Kelly et al, 2021 ; Peverengo et al, 2021 ; Santos et al, 2021 ; Silgado et al, 2021 ; Torcoroma-García et al, 2021 ; Castro-Sesquen et al, 2021a , ...…”

Prevalence of Trypanosoma cruzi infection in a cohort of people living with HIV/AIDS from an urban area

“…ELISA EAE associated with TESA Blot seems to substantially increase the reliability of our results, as test sensitivity is important in HIV-infected patients due to immunosuppression as well as excluding any possibility of cross-reactivity with leishmaniasis [ 17 ]. TESA Blot has been already in use for confirmation of immunodiagnosis of CD [ 25 – 31 ]. Here, for the first time we used TESA Blot to measure the prevalence of T. cruzi /HIV co-infection.…”

Recognition and screening for Chagas disease in the USA

“…73 As transfusional transmission has been an important source of infection in endemic countries and in the setting of high prevalence rates in blood donors in the USA (1:7500 in LA, 1:9000 Miami), the Food and Drug Administration (FDA) has mandated screening of all first-time blood donors in the USA for CD. 74 , 75 Universal CD screening in blood banks has been effective in controlling transmission through transfusion. 76 , 77 The general challenges to screening for CD include costs, discordance in test results, and risk/benefit ratio regarding treatment.…”