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

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.

Received June 20, 2008. Accepted for publication October 20, 2008.

Acknowledgments: The authors thank C. Espada, E. Hinojosa, R. J. Ledezma, N. Selum, and S. Quispe in Santa Cruz; A. Saman, E. Ramos, N. Figueroa, J. Calderon, P. Smith, C. Mendoza Gleny, R. Villazante, K. del Carpio, S. Quispe, JG. Cornejo del Carpio, E Cordova-B F Delgado, and J. Pastor in Arequipa; P. Maguiña, P. Herrera, and M. Meza at AB PRISMA; and C. Salazar at Johns Hopkins Bloomberg School of Public Health. Stat-Pak tests used in the Peru evaluation were donated by Chembio Diagnostic Systems; Stat-Pak tests for the Bolivian evaluation were donated by the Bolivian National Chagas Disease Control Program. Trypanosoma Detect tests for both evaluations were donated by InBios International.

Financial support: This work was supported by NIH P50 AI074285-01, NIH 1R21 AI072093-01, and NIH K01 AI079162-01.

Disclosure: Dr. Kirchoff serves as a consultant for Abbott Laboratories, receives payments through licensing agreements from the latter and from Quest Diagnostics, and owns an equity interest in Goldfinch Diagnostics. This statement is made in the interest of full disclosure and not because the authors consider this to be a conflict of interest.

^* Address correspondence to Jennifer R. Verani, 4770 Buford Highway MS F-22, Atlanta, GA 30341. E-mail: jverani{at}cdc.gov

Authors’ addresses: Jennifer R. Verani, Amy Seitz, Robert H. Gilman, Carlos LaFuente, Gerson Galdos-Cardenas, Vivian Kawai, Elizabeth de LaFuente, Lisbeth Ferrufino, Natalie M. Bowman, Viviana Pinedo-Cancino, Michael Z. Levy, Francis Steurer, Charles W. Todd, Louis V. Kirchhoff, Lilia Cabrera, Manuela Verastegui, and Caryn Bern, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS C-23, Atlanta, GA 30333.