Evaluation of a prototype Trypanosoma cruzi antibody assay with recombinant antigens on a fully automated chemiluminescence analyzer for blood donor screening.

Abstract:

BACKGROUND:Chagas disease is caused by Trypanosoma cruzi, a protozoan parasite that can be transmitted by transfusion. The diagnosis of chronic T. cruzi infection is generally made by detecting specific antibodies that bind to parasite antigens. The aim of this study was to assess the sensitivity and specificity of a new serologic assay for antibodies to T. cruzi on a fully automated analyzer (PRISM, Abbott Laboratories). STUDY DESIGN AND METHODS:A prototype chemiluminescent immunoassay based on chimeric recombinant antigens and run on the automated PRISM system was developed for detecting antibodies to T. cruzi in human serum and plasma. Assay specificity was evaluated by testing samples from random blood donors and from a diverse group of specimens from persons with diseases or conditions often associated with false-positive reactions in T. cruzi assays. Sensitivity was determined by testing 377 geographically diverse T. cruzi antibody-positive specimens. RESULTS:Six of 7911 samples (0.08%) from random donors were repeatedly reactive in the prototype PRISM Chagas assay. One of these was reactive in three other tests, including the radioimmune precipitation assay and was presumed to be a true positive. Hence, the specificity was 99.94 percent (7905/7910) in the negative donor group studied. All 377 T. cruzi antibody-positive specimens were positive in the prototype assay and thus the sensitivity was 100 percent. CONCLUSION:The results obtained to date, in terms of sensitivity as well as specificity, strongly suggest that the PRISM Chagas assay should function well as a tool for screening blood for serologic evidence of T. cruzi infection.

journal_name

Transfusion

journal_title

Transfusion

authors

Chang CD,Cheng KY,Jiang LX,Salbilla VA,Haller AS,Yem AW,Bryant JD,Kirchhoff LV,Leiby DA,Schochetman G,Shah DO

doi

10.1111/j.1537-2995.2006.00965.x

subject

Has Abstract

pub_date

2006-10-01 00:00:00

pages

1737-44

issue

10

eissn

0041-1132

issn

1537-2995

pii

TRF00965

journal_volume

46

pub_type

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