Evaluation of SARS-CoV-2 serology assays reveals a range of test performance.
Evaluation of SARS-CoV-2 serology assays reveals a range of test performance.
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SARS-COV-2血清学测定法的评估显示了一系列测试性能。
DOI：
10.1038/s41587-020-0659-0
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发表时间：
2020-10
影响因子：
46.9
通讯作者：
Marson A
中科院分区：
文献类型：
--
作者：
Whitman JD;Hiatt J;Mowery CT;Shy BR;Yu R;Yamamoto TN;Rathore U;Goldgof GM;Whitty C;Woo JM;Gallman AE;Miller TE;Levine AG;Nguyen DN;Bapat SP;Balcerek J;Bylsma SA;Lyons AM;Li S;Wong AW;Gillis-Buck EM;Steinhart ZB;Lee Y;Apathy R;Lipke MJ;Smith JA;Zheng T;Boothby IC;Isaza E;Chan J;Acenas DD 2nd;Lee J;Macrae TA;Kyaw TS;Wu D;Ng DL;Gu W;York VA;Eskandarian HA;Callaway PC;Warrier L;Moreno ME;Levan J;Torres L;Farrington LA;Loudermilk RP;Koshal K;Zorn KC;Garcia-Beltran WF;Yang D;Astudillo MG;Bernstein BE;Gelfand JA;Ryan ET;Charles RC;Iafrate AJ;Lennerz JK;Miller S;Chiu CY;Stramer SL;Wilson MR;Manglik A;Ye CJ;Krogan NJ;Anderson MS;Cyster JG;Ernst JD;Wu AHB;Lynch KL;Bern C;Hsu PD;Marson A
正确使用和解释血清学检测来评估 SARS-CoV-2 暴露、感染和潜在免疫力需要准确的检测性能数据。我们对 10 种护理点 (POC) 式侧向层析测定 (LFA) 和两种基于实验室的酶联免疫吸附测定 (ELISA) 进行了头对头评估，以从症状出现起每隔 5 天的时间间隔检测抗 SARS-CoV-2 IgM 和 IgG 抗体，以及在 2019 年新型冠状病毒 (COVID-2019) 样本中每种测定的特异性。血清反应阳性个体的百分比随着时间的推移而增加，在最近测试的时间间隔（症状出现后 20 天以上）达到峰值。测试特异性具有异质性（范围为 84.3-100.0%），并且主要受 IgM 结果变异性的影响。通过将弱条带视为阴性可以提高 LFA 特异性，但这会减少 SARS-CoV-2 实时聚合酶链反应 (RT-PCR) 阳性病例子集中抗体的检测。我们的结果表明血清阳性阈值确定和读者培训对于可靠的 LFA 部署的重要性。血清学的知情使用需要对 SARS-CoV-2 感染的全谱进行评估，从无症状和轻度感染到严重疾病，再到后来的康复期。精心设计的研究阐明保护性免疫的机制和血清学相关性对于指导合理的临床和公共卫生政策至关重要。
Appropriate use and interpretation of serological tests for assessments of SARS-CoV-2 exposure, infection and potential immunity require accurate assay performance data. We conducted a head-to-head evaluation of 10 point-of-care (POC) style lateral flow assays (LFAs) and two laboratory-based enzyme-linked immunosorbent assays (ELISAs) to detect anti-SARS-CoV-2 IgM and IgG antibodies by 5-day time intervals from symptom onset and the specificity of each assay in pre-COVID-2019 specimens. The percent of seropositive individuals increased with time, peaking in the latest time interval tested (>20 days after symptom onset). Test specificity was heterogeneous (ranging from 84.3–100.0%) and was predominantly affected by variability in IgM results. LFA specificity could be increased by considering weak bands as negative, but this decreased detection of antibodies in a subset of SARS-CoV-2 real-time polymerase chain reaction (RT-PCR)-positive cases. Our results indicate the importance of seropositivity threshold determination and reader training for reliable LFA deployment. Informed use of serology will require evaluations covering the full spectrum of SARS-CoV-2 infections, from asymptomatic and mild infection to severe disease, and later convalescence. Well-designed studies to elucidate the mechanisms and serological correlates of protective immunity will be crucial to guide rational clinical and public health policies.
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作者：
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通讯作者：
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