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在筛查项目中,用干血替代血浆或血清用于检测克氏锥虫IgG。

Dried blood as an alternative to plasma or serum for Trypanosoma cruzi IgG detection in screening programs.

作者信息

Holguín Africa, Norman Francesca, Martín Leticia, Mateos María Luisa, Chacón Jesús, López-Vélez Rogelio, Pérez-Molina José A

机构信息

HIV-1 Molecular Epidemiology Laboratory, Microbiology Department, IRYCIS-Hospital Ramón y Cajal and CIBER-ESP, Madrid, Spain.

出版信息

Clin Vaccine Immunol. 2013 Aug;20(8):1197-202. doi: 10.1128/CVI.00221-13. Epub 2013 Jun 5.

Abstract

Trypanosoma cruzi serological screening is recommended for people potentially exposed to this parasite in countries where Trypanosoma cruzi is endemic and those where it is not endemic. Blood samples on filter paper may be a practical alternative to plasma/serum for antibody detection. Using the Architect Chagas assay, we detected the presence of IgG against T. cruzi in matched serum and dried blood spots (DBS) collected from 147 patients residing in Madrid, Spain, who had potential previous exposure to T. cruzi. The κ statistic for the DBS/serum proportion of agreement for the detection of antibodies against T. cruzi was 0.803, considering an S/CO (assay result unit; chemiluminescent signal from the sample [S] divided by the mean chemiluminescent signal for the three calibrators used in the test [CO]) cutoff value of ≥1.00. The relative sensitivity of the Architect test using DBS increased from 95.2% to 98.8% when the cutoff was lowered from ≥1.00 to ≥0.88, while the relative specificity decreased from 84.1% to 71.6%. Overall, the median S/CO values for DBS were significantly lower than those for serum (2.6 versus 6.5; P < 0.001). Discrepancies that occurred with the use of DBS included 10 false positives (with low S/CO values in 9 cases [median, 2.13]) and 4 false negatives, with mean S/CO values of 0.905 (gray zone). Using DBS plus a highly sensitive and specific enzyme-linked immunosorbent assay (ELISA) may be a simple and reliable method for detecting IgG against T. cruzi when blood sampling by venipuncture is not feasible. This method may also reduce the false-negative rates observed with some rapid diagnostic tests. The lower relative sensitivity compared to the reference method may be increased by lowering the optical density threshold.

摘要

对于在克氏锥虫流行国家以及非流行国家中可能接触过这种寄生虫的人群,建议进行克氏锥虫血清学筛查。滤纸血样对于抗体检测而言,可能是血浆/血清的一种实用替代物。我们使用Architect查加斯检测法,在从西班牙马德里147名曾有潜在克氏锥虫接触史的患者中收集的配对血清和干血斑(DBS)中,检测了抗克氏锥虫IgG的存在。考虑到检测抗克氏锥虫抗体的DBS/血清一致性比例的κ统计量为0.803,检测结果单位(S/CO)(样本的化学发光信号[S]除以检测中使用的三个校准物的平均化学发光信号[CO])的截断值≥1.00。当截断值从≥1.00降至≥0.88时,使用DBS的Architect检测法的相对灵敏度从95.2%提高到98.8%,而相对特异性从84.1%降至71.6%。总体而言,DBS的S/CO中位数显著低于血清(2.6对6.5;P < 0.001)。使用DBS时出现的差异包括10例假阳性(9例S/CO值较低[中位数,2.13])和4例假阴性,平均S/CO值为0.905(灰色区域)。当静脉穿刺采血不可行时,使用DBS加上一种高灵敏度和特异性的酶联免疫吸附测定(ELISA)可能是检测抗克氏锥虫IgG的一种简单可靠的方法。该方法还可能降低一些快速诊断检测中观察到的假阴性率。通过降低光密度阈值,与参考方法相比相对较低的相对灵敏度可能会提高。

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[ARCHITECT Chagas(®): a new diagnostic tool in Chagas disease].[ARCHITECT 恰加斯病检测系统(®):恰加斯病的一种新型诊断工具]
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