Evaluation of a prototype Trypanosoma cruzi antibody assay with recombinant antigens on a fully automated chemiluminescence analyzer for blood donor screening
Evaluation of a prototype Trypanosoma cruzi antibody assay with recombinant antigens on a fully automated chemiluminescence analyzer for blood donor screening
复制标题
DOI：
10.1111/j.1537-2995.2006.00965.x
复制
发表时间：
2006-10-01
期刊：
影响因子：
2.9
通讯作者：
Shah, Dinesh O.
中科院分区：
文献类型：
--
作者：
Chang, Chi-Deu;Cheng, Kevin Y.;Shah, Dinesh O.
恰加斯病是由克氏锥虫引起的，克氏锥虫是一种可以通过输血传播的原生寄生虫。慢性克氏锥虫感染的诊断通常是通过检测与寄生虫抗原结合的特异性抗体来完成的。本研究的目的是评估在全自动分析仪（PRISM，雅培实验室）上检测克氏锥虫抗体的一种新的血清学检测方法的敏感性和特异性。建立了一种基于嵌合重组抗原的化学发光免疫分析法的原型，并在自动PRISM系统上运行，用于检测人血清和血浆中的克氏锥虫抗体。通过对随机献血者和患有克氏t型病毒检测中常伴有假阳性反应的疾病或病症患者的不同组标本进行检测，来评估检测的特异性。通过检测377个地理位置不同的克氏体抗体阳性标本来确定敏感性。来自随机供者的7911份样品中有6份（0.08%）在原型PRISM查加斯试验中重复反应。其中一种在包括放射免疫沉淀试验在内的其他三种试验中均有反应，并被推定为真阳性。因此，阴性供体组特异性为99.94%（7905/7910）。所有377例克氏t型抗体阳性标本在原型试验中均为阳性，因此灵敏度为100%。迄今为止获得的结果，就敏感性和特异性而言，强烈表明PRISM查加斯测定法应作为筛查血液中克鲁氏锥虫感染血清学证据的工具。
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).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.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.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.