BACKGROUND: Evaluation of commercially available test kits for Chagas disease for use in blood bank screening is difficult due to a lack of large and well-characterized specimen panels. This study presents a collaborative effort of Latin American blood centers and the World Health Organization (WHO) to establish such a panel. STUDY DESIGN: A total of 437 specimens, from 10 countries were collected and sent to the WHO Collaborating Center in São Paulo and used to evaluate 19 screening assays during 2001 through 2005. Specimens were assigned a positive or negative status based on concordant results in at least three of the four confirmatory assays (indirect immunofluorescence, Western blot, radioimmunoprecipitation assay, and recombinant immunoblot). RESULTS: Of the 437 specimens, 168 (39%) were characterized as positive, 262 (61%) were characterized as negative, and 7 (2%) were judged inconclusive and excluded from the analysis. Sensitivity and specificity varied considerably: 88 to 100 and 60 to 100 percent, respectively. Overall, enzyme immunoassays (EIAs) performed better than the other screening assays. Four EIAs had both parameters higher than 99 percent. Of the four confirmatory assays, only the RIPA gave a 100 percent agreement with the final serologic status of the specimens. CONCLUSION: The sensitivities and specificities of at least four of the commercially available EIAs for Chagas disease are probably high enough to justify their use for single-assay screening of blood donations. Our data suggest that the majority of commercially available indirect hemagglutination assays should not be used for blood donor screening and that the RIPA could be considered a gold standard for evaluating the performance of other assays.
BACKGROUND: Evaluation of commercially available test kits for Chagas disease for use in blood bank screening is difficult due to a lack of large and well-characterized specimen panels. This study presents a collaborative effort of Latin American blood centers and the World Health Organization (WHO) to establish such a panel. STUDY DESIGN: A total of 437 specimens, from 10 countries were collected and sent to the WHO Collaborating Center in São Paulo and used to evaluate 19 screening assays during 2001 through 2005. Specimens were assigned a positive or negative status based on concordant results in at least three of the four confirmatory assays (indirect immunofluorescence, Western blot, radioimmunoprecipitation assay, and recombinant immunoblot). RESULTS: Of the 437 specimens, 168 (39%) were characterized as positive, 262 (61%) were characterized as negative, and 7 (2%) were judged inconclusive and excluded from the analysis. Sensitivity and specificity varied considerably: 88 to 100 and 60 to 100 percent, respectively. Overall, enzyme immunoassays (EIAs) performed better than the other screening assays. Four EIAs had both parameters higher than 99 percent. Of the four confirmatory assays, only the RIPA gave a 100 percent agreement with the final serologic status of the specimens. CONCLUSION: The sensitivities and specificities of at least four of the commercially available EIAs for Chagas disease are probably high enough to justify their use for single-assay screening of blood donations. Our data suggest that the majority of commercially available indirect hemagglutination assays should not be used for blood donor screening and that the RIPA could be considered a gold standard for evaluating the performance of other assays.
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: Ester C Sabino; Nanci A Salles; Moussa Sarr; Angela M Barreto; Marcio Oikawa; Cláudia D Oliveira; Silvana C Leao; Anna B Carneiro-Proietti; Brian Custer; Michael P Busch Journal: Transfusion Date: 2010-12 Impact factor: 3.157
Authors: M Carmen Thomas; Ana Fernández-Villegas; Bartolomé Carrilero; Concepción Marañón; Daniel Saura; Oscar Noya; Manuel Segovia; Belkisyolé Alarcón de Noya; Carlos Alonso; Manuel Carlos López Journal: Clin Vaccine Immunol Date: 2011-12-07
Authors: Fred Luciano Neves Santos; Wayner Vieira de Souza; Michelle da Silva Barros; Mineo Nakazawa; Marco Aurélio Krieger; Yara de Miranda Gomes Journal: Am J Trop Med Hyg Date: 2016-03-14 Impact factor: 2.345
Authors: Ester C Sabino; Tzong-Hae Lee; Lani Montalvo; Megan L Nguyen; David A Leiby; Danielle M Carrick; Marcia M Otani; Elizabeth Vinelli; David Wright; Susan L Stramer; Michael Busch Journal: Transfusion Date: 2012-09-25 Impact factor: 3.157