School of Medicine, University of California, San Francisco, San Francisco, California, USA.
Department of Pharmaceutical Chemistry, University of California, San Francisco, San Francisco, California, USA.
J Clin Microbiol. 2021 May 19;59(6). doi: 10.1128/JCM.00158-21.
Confirmed diagnosis of chronic Chagas disease (CD) requires positive results by two different IgG serology tests. Variable sensitivity has been reported among tests and in different geographic regions. Inadequate specificity presents a particular challenge in low-prevalence settings such as the United States. This study provides a direct comparison of the latest-generation IgG serology assays with four previously assessed FDA-cleared tests. Seven hundred ten blood donor plasma specimens were evaluated by Wiener Lisado and Wiener v.4.0 enzyme-linked immunosorbent assays (ELISAs) and Abbott PRISM Chagas chemiluminescent assay (ChLIA). Sensitivity and specificity were assessed relative to infection status as determined by the original blood donation testing algorithm. All three latest-generation assays demonstrated 100% specificity (95% confidence interval [CI], 98.6 to 100.0). Wiener Lisado, Wiener v.4.0, and Abbott PRISM had sensitivities of 97.1% (95% CI, 95.1 to 98.4), 98.9% (95% CI, 97.4 to 99.6), and 95.5% (95% CI, 93.2 to 97.3), respectively. As with previously evaluated FDA-cleared tests, all three assays had the highest reactivity and sensitivity in samples from donors born in South America and lowest reactivity and sensitivity in specimens from those born in Mexico, with intermediate results in specimens from Central American donors. Wiener v.4.0 had the highest diagnostic sensitivity in all comparisons. Our findings suggest that the latest-generation CD serology tests could improve diagnostic sensitivity without affecting specificity.
慢性恰加斯病（Chagas disease，CD）的确诊需要两项不同 IgG 血清学检测均呈阳性。不同检测方法和不同地理区域的报道其敏感性存在差异。在低流行地区（如美国），特异性不足是一个特别的挑战。本研究对最新一代 IgG 血清学检测与之前评估的四项经美国食品药品监督管理局（FDA）批准的检测进行了直接比较。710 份献血者血浆标本经 Wiener Lisado 和 Wiener v.4.0 酶联免疫吸附试验（ELISA）以及 Abbott PRISM 查加斯化学发光免疫分析（ChLIA）检测。根据最初的献血检测算法确定的感染状态评估了敏感性和特异性。三种最新一代检测方法的特异性均为 100%（95%置信区间[CI]，98.6%至 100.0%）。Wiener Lisado、Wiener v.4.0 和 Abbott PRISM 的敏感性分别为 97.1%（95%CI，95.1%至 98.4%）、98.9%（95%CI，97.4%至 99.6%）和 95.5%（95%CI，93.2%至 97.3%）。与之前评估的经 FDA 批准的检测方法一样，所有三种检测方法在来自南美的献血者样本中反应性和敏感性最高，在来自墨西哥的样本中反应性和敏感性最低，在来自中美洲的献血者样本中结果居中。Wiener v.4.0 在所有比较中均具有最高的诊断敏感性。我们的研究结果表明，最新一代的 CD 血清学检测可能在不影响特异性的情况下提高诊断敏感性。
