This clinical study was supported by Ortho-Clinical Diagnostics, which supplied the investigational product necessary for testing. Ortho-Clinical Diagnostics funded specimen acquisition, data management services, and labor costs to perform the testing. Dr Gorlin was retained as a paid consultant by Ortho-Clinical Diagnostics during the development of donor notification and counseling materials before the start of the study. Drs Gorlin, Rossmann, Robertson, Hirschler, Nguyen, Gilcher and Fernandes, and Mr Stallone received no compensation, either directly or indirectly, for oversight of the testing, data analysis, or manuscript development.
Evaluation of a new Trypanosoma cruzi antibody assay for blood donor screening
Article first published online: 7 DEC 2007
2008 American Association of Blood Banks
Volume 48, Issue 3, pages 531–540, March 2008
How to Cite
Gorlin, J., Rossmann, S., Robertson, G., Stallone, F., Hirschler, N., Nguyen, K.-A., Gilcher, R., Fernandes, H., Alvey, S., Ajongwen, P., Contestable, P. and Warren, H. (2008), Evaluation of a new Trypanosoma cruzi antibody assay for blood donor screening. Transfusion, 48: 531–540. doi: 10.1111/j.1537-2995.2007.01566.x
- Issue published online: 7 DEC 2007
- Article first published online: 7 DEC 2007
- Received for publication June 19, 2007; revision received September 7, 2007, and accepted September 9, 2007.
BACKGROUND: This multicenter prospective study was designed to evaluate the performance characteristics of a new commercially available enzyme-linked immunosorbent assay (ELISA) for the detection of antibodies to Trypanosoma cruzi in blood donors, the ORTHO T. cruzi ELISA Test System (Ortho-Clinical Diagnostics).
STUDY DESIGN AND METHODS: Assay specificity was evaluated among 40,665 serum and ethylenediaminetetraacetate (EDTA) plasma specimens from volunteer blood donors and 481 T. cruzi antibody–negative specimens from a high-risk population. Sensitivity was evaluated among 106 T. cruzi-infected subjects identified by parasite detection, among 93 radioimmunoprecipitation assay (RIPA)-positive specimens from high-risk subjects, and 662 specimens presumed positive for the presence of T. cruzi antibodies by serologic methods. Also assessed were the equivalence of serum and plasma as specimen sources, performance equivalence of automated and semiautomated processing methods, nonspecific reactivity in specimens from other disease states or clinical conditions, and assay precision.
RESULTS: Assay specificity was 99.998 percent in volunteer blood donors and 99.4 percent among high-risk subjects. Sensitivity was 100 percent among specimens positive by parasite detection, or by serologic methods, and 98.9 percent among RIPA-positive specimens from high-risk subjects. No differences were demonstrated between serum and plasma or between semiautomated and automated processing methods. Cross-reactivity was observed with known positive leishmaniasis specimens. Total inter- and intraassay variability was less than 10 percent with both the automated and the semiautomated methods.
CONCLUSION: The ORTHO T. cruzi ELISA Test System is an effective, qualitative assay for screening blood donors for immunoglobulin G antibodies to T. cruzi. The assay was licensed for donor screening by the FDA in December 2006.