Evaluation Protocol for SARS-CoV-2 Serological Assays.
Evaluation Protocol for SARS-CoV-2 Serological Assays.
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SARS-CoV-2 血清学检测评估方案。
DOI：
10.1007/978-1-0716-2395-4_23
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发表时间：
2022
期刊：
影响因子：
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通讯作者：
Mayne,ElizabethS
中科院分区：
文献类型：
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作者：
Gededzha,MaemuP;Jugwanth,Sarika;Mampeule,Nakampe;Zwane,Nontobeko;David,Anura;Scott,Lesley;Stevens,Wendy;Mayne,ElizabethS
严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 已被确定为 COVID-19 的病原体。准确检测 SARS-CoV-2 感染不仅对于感染者的管理很重要，而且对于打破传播链也很重要。尽管聚合酶链反应 (PCR) 是诊断急性 SARS-CoV-2 感染的金标准，但这些检测方法存在许多局限性，其中包括无法检测过去的感染情况以及症状出现 14 天后敏感性下降。目前已开发出多种用于检测 SARS-CoV-2 抗体的血清学测试，包括高通量血清学平台和侧流免疫测定。应评估这些测试的性能以满足当地法规的验收标准。为了优化 SARS-CoV-2 的诊断算法，该协议描述了使用各种自动化血清学平台和侧流免疫分析对血清学抗体测试进行评估。该方案在血清和血浆样本中进行了评估。描述了样品制备、程序和数据分析。该方案可适用于任何血清学测试。
Severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) has been identified as the causative agent of COVID-19. Accurate detection of SARS-CoV-2 infection is not only important for management of infected individuals but also to break the chain of transmission. Although the polymerase chain reaction (PCR) is the gold standard for diagnosis of acute SARS-CoV-2 infection, there are a number of limitations of these assays, which include the inability to detect past infection and decline in sensitivity 14 days post-symptom onset. There are several serology tests developed for the detection of SARS-CoV-2 antibodies including high-throughput serology platforms and lateral flow immunoassays. These tests should be evaluated for their performance to meet local regulations acceptance criteria. To optimize the diagnostic algorithm for SARS-CoV-2, this protocol describes the evaluation of serological antibody testing using various automated serology platforms and lateral flow immunoassays. This protocol was evaluated in both serum and plasma samples. The sample preparation, procedure, and data analysis are described. The protocol can be adapted for any serological testing.