Geographic Variation in the Sensitivity of Recombinant Antigen-based Rapid Tests for Chronic Trypanosoma cruzi Infection

Jennifer R. Verani Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Jennifer R. Verani in
Current site
Google Scholar
PubMed
Close
,
Amy Seitz Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Amy Seitz in
Current site
Google Scholar
PubMed
Close
,
Robert H. Gilman Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Robert H. Gilman in
Current site
Google Scholar
PubMed
Close
,
Carlos LaFuente Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Carlos LaFuente in
Current site
Google Scholar
PubMed
Close
,
Gerson Galdos-Cardenas Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Gerson Galdos-Cardenas in
Current site
Google Scholar
PubMed
Close
,
Vivian Kawai Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Vivian Kawai in
Current site
Google Scholar
PubMed
Close
,
Elizabeth de LaFuente Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Elizabeth de LaFuente in
Current site
Google Scholar
PubMed
Close
,
Lisbeth Ferrufino Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Lisbeth Ferrufino in
Current site
Google Scholar
PubMed
Close
,
Natalie M. Bowman Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Natalie M. Bowman in
Current site
Google Scholar
PubMed
Close
,
Viviana Pinedo-Cancino Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Viviana Pinedo-Cancino in
Current site
Google Scholar
PubMed
Close
,
Michael Z. Levy Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Michael Z. Levy in
Current site
Google Scholar
PubMed
Close
,
Francis Steurer Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Francis Steurer in
Current site
Google Scholar
PubMed
Close
,
Charles W. Todd Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Charles W. Todd in
Current site
Google Scholar
PubMed
Close
,
Louis V. Kirchhoff Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Louis V. Kirchhoff in
Current site
Google Scholar
PubMed
Close
,
Lilia Cabrera Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Lilia Cabrera in
Current site
Google Scholar
PubMed
Close
,
Manuela Verastegui Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Manuela Verastegui in
Current site
Google Scholar
PubMed
Close
, and
Caryn Bern Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; Emory University, Atlanta, Georgia; Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland; Asociación Benéfica PRISMA, Lima, Peru; Universidad Peruana Cayetano Heredia, Lima, Peru; Hospital Unversitario Japonés, Santa Cruz, Bolivia; Fogarty International Center, National Institutes of Health, Bethesda, Maryland; Carver College of Medicine, University of Iowa, Iowa City, Iowa

Search for other papers by Caryn Bern in
Current site
Google Scholar
PubMed
Close
Restricted access

Chagas disease affects 8–11 million people throughout the Americas. Early detection is crucial for timely treatment and to prevent non-vectorial transmission. Recombinant antigen-based rapid tests had high sensitivity and specificity in laboratory evaluations, but no Peruvian specimens were included in previous studies. We evaluated Stat-Pak and Trypanosoma Detect rapid tests in specimens from Bolivia and Peru. Specimens positive by three conventional assays were confirmed positives; specimens negative by two or more assays were confirmed negatives. In Bolivian specimens, Stat-Pak and Trypanosoma Detect tests were 87.5% and 90.7% sensitive, respectively; both showed 100% specificity. Sensitivity in Peruvian specimens was much lower: 26.6–33.0% (Stat-Pak) and 54.3–55.2% (Trypanosoma Detect); both had specificities > 98%. Even in Bolivian specimens, these sensitivities are inadequate for stand-alone screening. The low sensitivity in Peru may be related to parasite strain differences. Chagas disease rapid tests should be field tested in each geographic site before widespread implementation for screening.

Author Notes

  • 1

    World Health Organization, 2002. Control of Chagas disease. World Health Organ Tech Rep Ser 905: i–vi, 1–109.

  • 2

    Organizacion Panamericana de la Salud, 2006. Estimación cuanti-tativa de la Enfermedad de Chagas en las Amèricas. OPS/OMS, ed. OPS/HDM/CD/425-06. Montevideo: OPS/OMS.

    • PubMed
    • Export Citation
  • 3

    Remme JHF, Feenstra P, Lever PR, Medici A, Morel C, Noma M, Ramaiah KD, Richards F, Seketelli A, Schmunis G, Brakel WH, Vassal A, 2006. Tropical diseases targeted for elimination: Chagas disease, lymphatic filariasis, onchocerciasis, and leprosy. Jamison DT, Breman JG, Measham AR, Alleyne G, Claeson M, Evans DB, Jha P, Mills A, Musgrove P, eds. Disease Control Priorities in Developing Countries. New York: The World Bank and Oxford University Press, 433–449.

    • PubMed
    • Export Citation
  • 4

    Maguire J, 2004. Trypanosoma. Gorbach SL BJ, Blacklow NR, eds. Infectious Diseases. Philadelphia: Lippincott, Williams and Wilkins, 2327–2334.

    • PubMed
    • Export Citation
  • 5

    de Andrade AL, Zicker F, de Oliveira RM, Almeida Silva S, Luquetti A, Travassos LR, Almeida IC, de Andrade SS, de Andrade JG, Martelli CM, 1996. Randomised trial of efficacy of benznidazole in treatment of early Trypanosoma cruzi infection. Lancet 348 :1407–1413.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 6

    Sosa Estani S, Segura EL, Ruiz AM, Velazquez E, Porcel BM, Yampotis C, 1998. Efficacy of chemotherapy with benznidazole in children in the indeterminate phase of Chagas’ disease. Am J Trop Med Hyg 59 :526–529.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 7

    Viotti R, Vigliano C, Lococo B, Bertocchi G, Petti M, Alvarez MG, Postan M, Armenti A, 2006. Long-term cardiac outcomes of treating chronic Chagas disease with benznidazole versus no treatment: a nonrandomized trial. Ann Intern Med 144 :724–734.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 8

    Caballero ZC, Sousa OE, Marques WP, Saez-Alquezar A, Umezawa ES, 2007. Evaluation of serological tests to identify Trypanosoma cruzi infection in humans and determine cross-reactivity with Trypanosoma rangeli and Leishmania spp. Clin Vaccine Immunol 14 :1045–1049.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 9

    Malchiodi EL, Chiaramonte MG, Taranto NJ, Zwirner NW, Margni RA, 1994. Cross-reactivity studies and differential serodiagnosis of human infections caused by Trypanosoma cruzi and Leishmania spp; use of immunoblotting and ELISA with a purified antigen (Ag163B6). Clin Exp Immunol 97 :417–423.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 10

    Luquetti AO, Ponce C, Ponce E, Esfandiari J, Schijman A, Revollo S, Anez N, Zingales B, Ramgel-Aldao R, Gonzalez A, Levin MJ, Umezawa ES, Franco da Silveira J, 2003. Chagas’ disease diagnosis: a multicentric evaluation of Chagas Stat-Pak, a rapid immunochromatographic assay with recombinant proteins of Trypanosoma cruzi.Diagn Microbiol Infect Dis 46 :265–271.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 11

    Ponce C, Ponce E, Vinelli E, Montoya A, de Aguilar V, Gonzalez A, Zingales B, Rangel-Aldao R, Levin MJ, Esfandiari J, Umezawa ES, Luquetti AO, da Silveira JF, 2005. Validation of a rapid and reliable test for diagnosis of Chagas’ disease by detection of Trypanosoma cruzi-specific antibodies in blood of donors and patients in Central America. J Clin Microbiol 43 :5065–5068.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 12

    Camargo ME, Rebonato C, 1969. Cross-reactivity in fluorescence tests for Trypanosoma and Leishmania antibodies. A simple inhibition procedure to ensure specific results. Am J Trop Med Hyg 18 :500–505.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 13

    Levy MZ, Bowman NM, Kawai V, Waller LA, Cornejo del Carpio JG, Cordova Benzaquen E, Gilman RH, Bern C, 2006. Periurban Trypanosoma cruzi-infected Triatoma infestans, Arequipa, Peru. Emerg Infect Dis 12 :1345–1352.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 14

    Levy MZ, Kawai V, Bowman NM, Waller LA, Cabrera L, Pinedo-Cancino VV, Seitz AE, Steurer FJ, Cornejo Del Carpio JG, Cordova-Benzaquen E, Maguire JH, Gilman RH, Bern C, 2007. Targeted screening strategies to detect Trypanosoma cruzi infection in children. PLoS Negl Trop Dis 1 :e103.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 15

    Bowman NM, Kawai V, Levy MZ, Cornejo del Carpio JG, Cabrera L, Delgado F, Malaga F, Cordova Benzaquin E, Pinedo VV, Steurer F, Seitz A, Gilman R, Bern C, 2008. Chagas disease transmission in peri-urban communities of Arequipa, Peru. Clin Infect Dis 46 :1822–1828.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 16

    Leiby DA, Wendel S, Takaoka DT, Fachini RM, Oliveira LC, Tibbals MA, 2000. Serologic testing for Trypanosoma cruzi: comparison of radioimmunoprecipitation assay with commercially available indirect immunofluorescence assay, indirect hemagglutination assay, and enzyme-linked immunosorbent assay kits. J Clin Microbiol 38 :639–642.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 17

    Kirchhoff LV, Gam AA, Gusmao RA, Goldsmith RS, Rezende JM, Rassi A, 1987. Increased specificity of serodiagnosis of Chagas’ disease by detection of antibody to the 72- and 90- kilodalton glycoproteins of Trypanosoma cruzi. J Infect Dis 155 :561–564.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 18

    Roddy P, Goiri J, Flevaud L, Palma PP, Morote S, Lima N, Villa L, Torrico F, Albajar-Vinas P, 2008. Field evaluation of a rapid immunochromatographic assay for detection of Trypanosoma cruzi infection by use of whole blood. J Clin Microbiol 46 :2022–2027.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 19

    Chippaux JP, Postigo JR, Santalla JA, Schneider D, Brutus L, 2008. Epidemiological evaluation of Chagas disease in a rural area of southern Bolivia. Trans R Soc Trop Med Hyg 102 :578–584.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 20

    Kirchhoff LV, Paredes P, Lomeli-Guerrero A, Paredes-Espinoza M, Ron-Guerrero CS, Delgado-Mejia M, Pena-Munoz JG, 2006. Transfusion-associated Chagas disease (American trypanosomiasis) in Mexico: implications for transfusion medicine in the United States. Transfusion 46 :298–304.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 21

    Umezawa ES, Bastos SF, Camargo ME, Yamauchi LM, Santos MR, Gonzalez A, Zingales B, Levin MJ, Sousa O, Rangel-Aldao R, da Silveira JF, 1999. Evaluation of recombinant antigens for serodiagnosis of Chagas’ disease in South and Central America. J Clin Microbiol 37 :1554–1560.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 22

    Umezawa ES, Luquetti AO, Levitus G, Ponce C, Ponce E, Henriquez D, Revollo S, Espinoza B, Sousa O, Khan B, da Silveira JF, 2004. Serodiagnosis of chronic and acute Chagas’ disease with Trypanosoma cruzi recombinant proteins: results of a collaborative study in six Latin American countries. J Clin Microbiol 42 :449–452.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 23

    Campbell DA, Westenberger SJ, Sturm NR, 2004. The determinants of Chagas disease: connecting parasite and host genetics. Curr Mol Med 4 :549–562.

  • 24

    Blanco SB, Segura EL, Cura EN, Chuit R, Tulian L, Flores I, Garbarino G, Villalonga JF, Gurtler RE, 2000. Congenital transmission of Trypanosoma cruzi: an operational outline for detecting and treating infected infants in north-western Argentina. Trop Med Int Health 5 :293–301.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 25

    Chippaux JP, Postigo JR, Santalla JA, Schneider D, Brutus L, 2008. Epidemiological evaluation of Chagas disease in a rural area of southern Bolivia. Trans R Soc Trop Med Hyg 102 :578–584.

    • PubMed
    • Search Google Scholar
    • Export Citation
Past two years Past Year Past 30 Days
Abstract Views 1577 1357 356
Full Text Views 427 11 3
PDF Downloads 145 10 2
 

 

 

 
 
Affiliate Membership Banner
 
 
Research for Health Information Banner
 
 
CLOCKSS
 
 
 
Society Publishers Coalition Banner
Save