Blejer J L, Saguier M C, Salamone H J
Transfusion Medicine Division and Clinical Research Department, Institute of Cardiology and Cardiovascular Surgery, Favaloro Foundation, Buenos Aires, Argentina.
Int J Infect Dis. 2001;5(2):89-93. doi: 10.1016/s1201-9712(01)90032-3.
The aim of this work was to study the prevalence of anti-Trypanosoma cruzi in the blood donor population in Buenos Aires, to compare the relative sensitivity and specificity of the two screening tests used and to confirm the results with a third assay.
Between May 1995 and July 1999, 64,887 blood donor consecutive samples were screened with the following commercial tests: indirect hemagglutination (IHA) (Polychaco, Buenos Aires, Argentina) and enzyme-linked immunosorbent assay (ELISA) (40,222 with Chagatek, Organon Teknika, Buenos Aires, Argentina, and 24,665 with Chagas EIA, Abbott, São Paulo, Brazil). Repeatedly reactive samples in one or both tests were analyzed with a third method: dot blot (Bio Chagas, Gador, Buenos Aires, Argentina) or particle agglutination (Serodia, Fujirebio, Tokyo, Japan). Sera that reacted in at least two tests were considered positive.
The seroprevalence was 2.66% (1744 samples were reactive for one or both screening tests), and 1.46% (949 samples) were confirmed positive. The ELISAs proved to be more sensitive (relative sensitivity: 99.67-99.71%) whereas 192 samples (0.47%) were IHA false-negatives (relative sensitivity: 79.77%). Relative specificity for EIA was 98.47--99.23% and for IHA 99.85%.
Results suggest the need of performing two screening tests for Chagas disease in blood banks from endemic areas and the importance of a third confirmatory assay to avoid unnecessary medical counseling.
本研究旨在调查布宜诺斯艾利斯献血人群中抗克氏锥虫的流行情况,比较两种筛查试验的相对敏感性和特异性,并通过第三种检测方法确认结果。
1995年5月至1999年7月期间,对64887份连续的献血者样本进行了以下商业检测:间接血凝试验(IHA)(阿根廷布宜诺斯艾利斯的Polychaco公司)和酶联免疫吸附试验(ELISA)(40222份样本使用阿根廷布宜诺斯艾利斯Organon Teknika公司的Chagatek试剂盒,24665份样本使用巴西圣保罗Abbott公司的Chagas EIA试剂盒)。对一项或两项检测中反复呈阳性的样本,采用第三种方法进行分析:斑点印迹法(阿根廷布宜诺斯艾利斯Gador公司的Bio Chagas试剂盒)或颗粒凝集试验(日本东京富士瑞必欧公司的Serodia试剂盒)。在至少两项检测中呈反应性的血清被视为阳性。
血清阳性率为2.66%(1744份样本在一项或两项筛查试验中呈反应性),经确认1.46%(949份样本)为阳性。ELISA检测结果显示更敏感(相对敏感性:99.67 - 99.71%),而192份样本(0.47%)为IHA假阴性(相对敏感性:79.77%)。EIA的相对特异性为98.47 - 99.23%,IHA的相对特异性为99.85%。
结果表明,在流行地区的血库中需要对恰加斯病进行两项筛查试验,并且第三种确认性检测对于避免不必要的医学咨询很重要。