Accuracy of a Rapid Diagnostic Test (Cypress Chagas Quick Test®) for the Diagnosis of Chronic Chagas Disease in a Nonendemic Area: A Retrospective Longitudinal Study

Andrea Angheben Centro per le Malattie Tropicali, Ospedale Classificato Equiparato Sacro Cuore, Negrar, Verona, Italy;

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Silvia Staffolani Centro per le Malattie Tropicali, Ospedale Classificato Equiparato Sacro Cuore, Negrar, Verona, Italy;
Dipartimento di Scienze Biomediche e Salute Pubblica, Clinica di Malattie Infettive, Università Politecnica delle Marche, Ancona, Italy;

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Mariella Anselmi Centro de Epidemiologia Comunitaria y Medicina Tropical (CECOMET), Esmeraldas, Ecuador;

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Stefano Tais Servizio di Epidemiologia e Laboratorio per le Malattie Tropicali, Ospedale Classificato Equiparato Sacro Cuore, Negrar, Verona, Italy

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Monica Degani Servizio di Epidemiologia e Laboratorio per le Malattie Tropicali, Ospedale Classificato Equiparato Sacro Cuore, Negrar, Verona, Italy

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Federico Gobbi Centro per le Malattie Tropicali, Ospedale Classificato Equiparato Sacro Cuore, Negrar, Verona, Italy;

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Dora Buonfrate Centro per le Malattie Tropicali, Ospedale Classificato Equiparato Sacro Cuore, Negrar, Verona, Italy;

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Maria Gobbo Servizio di Epidemiologia e Laboratorio per le Malattie Tropicali, Ospedale Classificato Equiparato Sacro Cuore, Negrar, Verona, Italy

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Zeno Bisoffi Centro per le Malattie Tropicali, Ospedale Classificato Equiparato Sacro Cuore, Negrar, Verona, Italy;

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We analyzed the accuracy of Chagas Quick Test®, a rapid diagnostic test, for the diagnosis of chronic Chagas disease through a retrospective study on a cohort of 669 patients consecutively examined at a single reference center in Italy, during a 7-year period. We observed high concordance with serological reference standard but low accuracy for screening purposes (sensitivity/specificity: 82.8%/98.7%) at least in our nonendemic context.

Author Notes

Address correspondence to Andrea Angheben, Centro per le Malattie Tropicali, Ospedale Classificato Equiparato Sacro Cuore, Via Don Sempreboni 5, 37024 Negrar, Verona, Italy. E-mail: andrea.angheben@sacrocuore.it

These authors contributed equally to this work.

Financial support: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

Authors’ addresses: Andrea Angheben, Federico Gobbi, Dora Buonfrate, and Zeno Bisoffi, Centro per le Malattie Tropicali, Ospedale Classificato Equiparato Sacro Cuore, Negrar, Verona, Italy, E-mails: andrea.angheben@sacrocuore.it, federico.gobbi@sacrocuore.it, dora.buonfrate@sacrocuore.it, and zeno.bisoffi@sacrocuore.it. Silvia Staffolani, Dipartimento di Scienze Biomediche e Salute Pubblica, Clinica di Malattie Infettive, Università Politecnica delle Marche, Ancona, Italy, E-mail: silvia.staffolani@gmail.com. Mariella Anselmi, Centro de Epidemiologia Comunitaria y Medicina Tropical (CECOMET), Las Palmas, Esmeraldas, Ecuador, E-mail: mariella.anselmi@alice.it. Stefano Tais, Monica Degani, and Maria Gobbo, Servizio di Epidemiologia e Laboratorio per le Malattie Tropicali, Ospedale Classificato Equiparato Sacro Cuore, Negrar, Verona, Italy, E-mails: stefano.tais@sacrocuore.it, monica.degani@sacrocuore.it, and maria.gobbo@sacrocuore.it.

  • 1.

    Rassi A Jr, Rassi A, Marcondes de Rezende J, 2012. American trypanosomiasis (Chagas disease). Infect Dis Clin North Am 26: 275291.

  • 2.

    World Health Organization, 2007. WHO Consultation on International Biological Reference. Preparation for Chagas Diagnostic Tests. Available at: http://www.who.int/bloodproducts/ref_materials/WHO_Report_1st_Chagas_BRP_consultation_7-2007_final.pdf. Accessed March 13, 2017.

    • PubMed
    • Export Citation
  • 3.

    World Health Organization, 2002. WHO Expert Committee on the Control of Chagas Disease (2000: Brasilia). Control of Chagas Disease: Second Report of the WHO Expert Committee. Available at: http://apps.who.int/iris/bitstream/10665/42443/1/WHO_TRS_905.pdf. Accessed March 13, 2017.

    • PubMed
    • Export Citation
  • 4.

    Brasil PE, De Castro L, Hasslocher Moreno AM, Sangenis LH, Braga JU, 2010. ELISA versus PCR for diagnosis of chronic Chagas disease: systematic review and meta-analysis. BMC Infect Dis 10: 337.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 5.

    Sánchez-Camargo CL et al. 2014. Comparative evaluation of 11 commercialized rapid diagnostic tests for detecting Trypanosoma cruzi antibodies in serum banks in areas of endemicity and non endemicity. J Clin Microbiol 52: 25062512.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 6.

    Chappuis F, Mauris A, Holst M, Albajar-Viñas P, Jannin J, Luquetti AO, Jackson Y, 2010. Validation of a rapid immunochromatographic assay for diagnosis of Trypanosoma cruzi infection among Latin American migrants in Geneva, Switzerland. J Clin Microbiol 48: 29482952.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 7.

    Flores-Chavez M, Cruz I, Nieto J, Gárate T, Navarro M, Pérez-Ayala A, López-Vélez R, Cañavate C, 2012. Sensitivity and specificity of an operon immunochromatographic test in serum and whole blood samples for the diagnosis of Trypanosoma cruzi infection in Spain, an area of non endemicity. Clin Vaccine Immunol 19: 13531359.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 8.

    Reithinger R, Grijalva MJ, Chiriboga RF, de Noya BA, Torres JR, Pavia-Ruz N, Manrique-Saide P, Cardinal MV, Gürtler RE, 2010. Rapid detection of Trypanosoma cruzi in human serum by use of an immunochromatographic dipstick test. J Clin Microbiol 48: 30033007.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 9.

    Cypress Diagnostics, 2013. Chagas Quick Test leaflet. Available at: http://www.genius-diagnostics.al/pdf/Chagas.pdf. Accessed March 13, 2017.

    • PubMed
    • Export Citation
  • 10.

    Carley S, Dosman S, Jones SR, Harrison M, 2005. Simple nomograms to calculate sample size in diagnostic studies. Emerg Med J 22: 180181.

  • 11.

    Leeflang MM, 2014. Systematic reviews and meta-analyses of diagnostic test accuracy. Clin Microbiol Infect 20: 105113.

  • 12.

    López-Chejade P, Roca C, Posada E, Pinazo MJ, Gascon J, Portús M, 2010. Utility of an immunochromatographic test for Chagas disease screening in primary healthcare. Enferm Infecc Microbiol Clin 28: 169171.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 13.

    Navarro M, Perez-Ayala A, Guionnet A, Perez-Molina JA, Navaza B, Estevez L, Norman F, Flores-Chavez M, Lopez-Velez R, 2011. Targeted screening and health education for Chagas disease tailored to at-risk migrants in Spain, 2007 to 2010. Euro Surveill 16: 19973.

    • PubMed
    • Search Google Scholar
    • Export Citation
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