Brashear R J, Winkler M A, Schur J D, Lee H, Burczak J D, Hall H J, Pan A A
Department of Diagnostic Biology Research, Abbott Laboratories, North Chicago, Illinois.
Transfusion. 1995 Mar;35(3):213-8. doi: 10.1046/j.1537-2995.1995.35395184277.x.
Chagas' disease or American trypanosomiasis, caused by infection with Trypanosoma cruzi, is a significant health problem in Latin America. In the United States, transfusions of T. cruzi-contaminated blood from Latin American immigrants may represent the major source of Chagas' disease.
A new enzyme immunoassay (EIA) for the detection of antibody to T. cruzi was evaluated in the sera of blood donors from the southwestern and western regions of the United States. Serum samples had been screened and were negative for all tests required. Specimens that were repeatedly reactive in the Chagas antibody EIA were analyzed for seroreactivity by a confirmatory EIA and by radioimmunoprecipitation assay.
Fourteen of the 13,309 donor samples (0.105%) were confirmed as being positive for antibody to T. cruzi. The Chagas antibody EIA showed improved sensitivity over the Chagas IgG enzyme-linked immunosorbent assay and two indirect hemagglutination assays. The Chagas antibody EIA had a specificity of 99.98 percent with negative samples. The sensitivity of the Chagas antibody EIA was 100 percent (80/80) in xenodiagnosed specimens and 100 percent (50/50) in specimens positive by consensus (i.e., reactive in EIA, indirect hemagglutination assay, and immunofluorescence assays).
This Chagas antibody EIA meets the need for accurate and rapid identification of seroreactive samples in low-prevalence or endemic populations.
恰加斯病或美洲锥虫病由克氏锥虫感染引起，是拉丁美洲一个重要的健康问题。在美国，来自拉丁美洲移民的受克氏锥虫污染的血液输血可能是恰加斯病的主要来源。
在美国西南部和西部地区献血者的血清中评估了一种用于检测克氏锥虫抗体的新型酶免疫测定（EIA）。血清样本已经过筛查，所有所需检测均为阴性。对在恰加斯抗体EIA中反复呈反应性的标本，通过确证性EIA和放射免疫沉淀测定分析其血清反应性。
13309份供体样本中有14份（0.105%）被确认为克氏锥虫抗体阳性。恰加斯抗体EIA比恰加斯IgG酶联免疫吸附测定和两种间接血凝测定具有更高的敏感性。恰加斯抗体EIA对阴性样本的特异性为99.98%。恰加斯抗体EIA在异种接种确诊的标本中的敏感性为100%（80/80），在经共识判定为阳性的标本中（即在EIA、间接血凝测定和免疫荧光测定中呈反应性）敏感性为100%（50/50）。
这种恰加斯抗体EIA满足了在低流行率或流行地区人群中准确快速鉴定血清反应性样本的需求。
