Evaluation of a new Trypanosoma cruzi antibody assay for blood donor screening
Evaluation of a new Trypanosoma cruzi antibody assay for blood donor screening
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DOI：
10.1111/j.1537-2995.2007.01566.x
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发表时间：
2008-03-01
期刊：
影响因子：
2.9
通讯作者：
Warren, Harold
中科院分区：
文献类型：
--
作者：
Gorlin, Jed;Rossmann, Susan;Warren, Harold
背景技术背景：这项多中心前瞻性研究旨在评价一种用于检测献血者体内克氏锥虫抗体的新型市售酶联免疫吸附试验（ELISA）ORTHO T的性能特征。研究设计和方法：在来自志愿献血者的40，665份血清和乙二胺四乙酸盐（EDTA）血浆样品和来自481份T.来自高危人群的克氏抗体阴性标本。对106例T.在93份放射免疫沉淀试验（RIPA）阳性的高危受试者标本和662份假定T.血清学方法测定克氏抗体。还评估了血清和血浆作为标本来源的等效性，自动化和半自动化处理方法的性能等效性，从其他疾病状态或临床条件的标本中的非特异性反应，和测定precision.RESULTS：测定特异性为99.998%，在志愿献血者和99.4%之间的高危受试者。寄生虫检测或血清学方法阳性标本的敏感性为100%，高危受试者RIPA阳性标本的敏感性为98.9%。血清和血浆之间或半自动化和自动化处理方法之间没有差异。与已知阳性利什曼病标本观察到交叉反应性。总的批间和批内变异性均小于10%的自动化和半自动化方法。cruzi ELISA检测系统是一种有效的定性检测方法，用于筛查献血员的T免疫球蛋白G抗体。克鲁兹该检测试剂盒于2006年12月获得FDA批准用于供体筛选。
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.