Performance Characteristics of the Abbott Architect SARS-CoV-2 IgG Assay and Seroprevalence in Boise, Idaho
Performance Characteristics of the Abbott Architect SARS-CoV-2 IgG Assay and Seroprevalence in Boise, Idaho
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DOI：
10.1128/jcm.00941-20
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发表时间：
2020-08-01
影响因子：
9.4
通讯作者：
Greninger, Alexander L.
中科院分区：
文献类型：
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作者：
Bryan, Andrew;Pepper, Gregory;Greninger, Alexander L.
冠状病毒病2019(新冠肺炎)是由严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)引起的一种新型呼吸系统疾病，具有严重的发病率和死亡率。诊断检测在美国的推出速度很慢，导致许多病例在2020年2月和3月没有进行SARS-CoV-2检测，因此有必要使用血清学检测来确定过去的感染情况。在这里，我们通过检测3个不同的患者群体来评价雅培公司的SARS-CoV-2抗体检测试剂盒检测SARS-CoV-2抗体。我们检测了在美国SARS-CoV-2传播前收集的1020份血清样本，发现了一份假阳性，特异性为99.90%。对125例SARS-CoV-2逆转录-聚合酶链式反应(RT-PCR)阳性患者的689份超额血清标本进行检测，发现SARS-CoV-2阳性患者在发病第17天和PCR阳性后第13天的敏感性均达到100%。在这个队列中，阳性的替代指标值阈值导致了100%的敏感性和100%的特异性。我们测试了来自华盛顿州博伊西的4856个人的样本，这些人于2020年4月在一周内收集，作为粉碎曲线倡议的一部分，检测到87个阳性，阳性率为1.79%。这些数据证明了雅培SARS-CoV-2抗体检测的出色分析性能，以及病毒在美国西部的有限传播。我们预计，高质量血清学检测的可用性将成为抗击SARS-CoV-2的关键工具。
Coronavirus disease 2019 (COVID-19), the novel respiratory illness caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is associated with severe morbidity and mortality. The rollout of diagnostic testing in the United States was slow, leading to numerous cases that were not tested for SARS-CoV-2 in February and March 2020 and necessitating the use of serological testing to determine past infections. Here, we evaluated the Abbott SARS-CoV-2 IgG test for detection of anti-SARS-CoV-2 IgG antibodies by testing 3 distinct patient populations. We tested 1,020 serum specimens collected prior to SARS-CoV-2 circulation in the United States and found one false positive, indicating a specificity of 99.90%. We tested 125 patients who tested reverse transcription-PCR (RT-PCR) positive for SARS-CoV-2 for whom 689 excess serum specimens were available and found that sensitivity reached 100% at day 17 after symptom onset and day 13 after PCR positivity. Alternative index value thresholds for positivity resulted in 100% sensitivity and 100% specificity in this cohort. We tested specimens from 4,856 individuals from Boise, ID, collected over 1 week in April 2020 as part of the Crush the Curve initiative and detected 87 positives for a positivity rate of 1.79%. These data demonstrate excellent analytical performance of the Abbott SARS-CoV-2 IgG test as well as the limited circulation of the virus in the western United States. We expect that the availability of high-quality serological testing will be a key tool in the fight against SARS-CoV-2.