Evaluation of Serological Tests for SARS-CoV-2: Implications for Serology Testing in a Low-Prevalence Setting
Evaluation of Serological Tests for SARS-CoV-2: Implications for Serology Testing in a Low-Prevalence Setting
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DOI：
10.1093/infdis/jiaa467
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发表时间：
2020-10-15
影响因子：
6.4
通讯作者：
Williamson, Deborah A.
中科院分区：
文献类型：
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作者：
Bond, Katherine;Nicholson, Suellen;Williamson, Deborah A.
背景稳健的血清学检测对COVID-19大流行的长期控制至关重要。许多最近发布的即时检测（PoCT）血清学检测方法几乎没有经过上市前验证。将在澳大利亚批准使用的5种PoCT侧向流装置的性能特征与商业酶免疫测定（ELISA）和最近描述的新型替代病毒中和试验（sVNT）进行比较。PoCT的灵敏度范围为51.8%（95%置信区间[CI]，43.1%-60.4%）至67.9%（95% CI，59.4%-75.6%），特异性范围为95.6%（95% CI，89.2%-98.8%）至100.0%（95% CI，96.1%-100.0%）。伊加或IgG检测的ELISA灵敏度为67.9%（95%CI，59.4%-75.6%），对于症状发作后>14天的样品增加至93.8%（95%CI，85.0%-98.3%）。sVNT的敏感性为60.9%（95%CI，53.2%~ 68.4%），发病后>14天的sVNT敏感性为91.2%（95%CI，81.8%~ 96.7%），特异性为94.4%（95%CI，89.2%~ 97.5%）。COVID-19血清学检测的性能特征通常低于制造商报告的性能特征。在报告COVID-19血清学检测的性能特征时，相对于疾病或感染发作的标本采集时间至关重要。实施COVID-19血清学检测的最佳算法仍有待确定，特别是在低流行率环境中。
Background. Robust serological assays are essential for long-term control of the COVID-19 pandemic. Many recently released point-of-care (PoCT) serological assays have been distributed with little premarket validation.Methods. Performance characteristics for 5 PoCT lateral flow devices approved for use in Australia were compared to a commercial enzyme immunoassay (ELISA) and a recently described novel surrogate virus neutralization test (sVNT).Results. Sensitivities for PoCT ranged from 51.8% (95% confidence interval [CI], 43.1%-60.4%) to 67.9% (95% CI, 59.4%-75.6%), and specificities from 95.6% (95% CI, 89.2%-98.8%) to 100.0% (95% CI, 96.1%-100.0%). ELISA sensitivity for IgA or IgG detection was 67.9% (95% CI, 59.4%-75.6%), increasing to 93.8% (95% CI, 85.0%-98.3%) for samples >14 days post symptom onset. sVNT sensitivity was 60.9% (95% CI, 53.2%-68.4%), rising to 91.2% (95% CI, 81.8%-96.7%) for samples >14 days post symptom onset, with specificity 94.4% (95% CI, 89.2%-97.5%).Conclusions. Performance characteristics for COVID-19 serological assays were generally lower than those reported by manufacturers. Timing of specimen collection relative to onset of illness or infection is crucial in reporting of performance characteristics for COVID-19 serological assays. The optimal algorithm for implementing serological testing for COVID-19 remains to be determined, particularly in low-prevalence settings.