The application of latent class analysis for diagnostic test validation of chronic Trypanosoma cruzi infection in blood donors.

The main strategy to prevent transfusion-associated Chagas disease is the identification of T. cruzi-infected blood donors by serological screening tests, however there is no perfect serological gold standard. We evaluated an enzyme immunoassay (EIA), an indirect hemaglutination (IHA), and an indirect immunofluorescence (IIF) test for detecting T. cruzi antibodies in Brazilian blood donors. The results were submitted to latent class analysis, and a radioimmunopreciptation (RIPA) test was performed on repeatedly positive samples. Among 1951 donors, 11 (0.56%) were positive by EIA, 6 (0.31%) by IHA and 16 (0.82%) by IIF. Six samples were positive with all tests, while 4 reacted with EIA and IIF. The RIPA was positive in 6 (75.0%), 7 (66.6%), and 4 (54.0%) samples reacting by the EIA, IHA and IIF tests, respectively. The latent class model detected a high sensitivity rate (100%) for the EIA and IIF, and a specificity rate of 99.95% and 99.69% for the EIA and IIF tests, respectively. The probability of being case according to the model was 99.92% when both EIA and IIF were positive, and 100% for the association of EIA, IIF, and IHA.

The application of latent class analysis for diagnostic test validation of chronic Trypanosoma cruzi infection in blood donors

The main strategy to prevent transfusion-associated Chagas disease is the identification of T. cruzi-infected blood donors by serological screening tests, however there is no perfect serological gold standard. We evaluated an enzyme immunoassay (EIA), an indirect hemaglutination (IHA), and an indirect immunofluorescence (IIF) test for detecting T. cruzi antibodies in Brazilian blood donors. The results were submitted to latent class analysis, and a radioimmunopreciptation (RIPA) test was performed on repeatedly positive samples. Among 1951 donors, 11 (0.56) were positive by EIA, 6 (0.31) by IHA and 16 (0.82) by IIF. Six samples were positive with all tests, while 4 reacted with EIA and IIF. The RIPA was positive in 6 (75.0), 7 (66.6), and 4 (54.0) samples reacting by the EIA, IHA and IIF tests, respectively. The latent class model detected a high sensitivity rate (100) for the EIA and IIF, and a specificity rate of 99.95 and 99.69 for the EIA and IIF tests, respectively. The probability of being case according to the model was 99.92 when both EIA and IIF were positive, and 100 for the association of EIA, IIF, and IHA.

Trypanosoma cruzi in Los Angeles and Miami blood donors: impact of evolving donor demographics on seroprevalence and implications for transfusion transmission.

BACKGROUND: Trypanosoma cruzi, the agent of Chagas' disease, continues to be a concern for blood safety, as demonstrated by recent transfusion-transmitted cases in the United States and Canada. The chronic nature of Chagas', coupled with increasing numbers of immigrants from T. cruzi-endemic countries, suggests that Chagas' is a long-term public health problem. Herein, we report on a multiyear epidemiologic study of T. cruzi in Los Angeles and Miami blood donors. STUDY DESIGN AND METHODS: From May 1994 to September 1998, blood donors in Los Angeles and Miami were queried regarding birth or time spent in an endemic country. Donations of "yes" respondents were tested by EIA, confirmed by radioimmunoprecipitation assay, and if confirmed as seropositive, enrolled in look-back investigations. RESULTS: A total of 1,104,030 Los Angeles and 181,139 Miami donors were queried regarding risk; 7.3 and 14.3 percent, respectively, responded yes. Seropositive rates were 1 in 7,500 Los Angeles and 1 in 9,000 Miami donors. In Los Angeles, seroprevalence rates increased significantly from 1996 to 1998 and were significantly higher for directed donors than nondirected donors. Look back identified 18 recipients, all of whom were seronegative for T. cruzi. CONCLUSION: Significant numbers of T. cruzi-seropositive donors contribute to the U.S. blood supply. The incidence of seropositivity is enhanced by minority recruitment efforts necessitated by donor demographic shifts. Similarly, high rates among directed donations in Los Angeles are attributable to a disproportionate number of at-risk directed donors. Current look-back data likely underestimate the frequency of transfusion- transmitted T. cruzi. These results indicate that continued evaluation of transfusion as a mode of T. cruzi transmission in the United States is needed.