PDF(Pubmed)
Abstract：
We report on sample IS/17575 since it generated highly divergent results in the Belgian SARS-CoV-2 serology external quality assessment scheme. Sample IS/17575 was serum originating from a 30 years old male patient. 124 diagnostic laboratories analysed this sample. A total of 168 results was returned (including 5 doubles). Overall, 38 were positive. All tests against S1 were positive except the Euroimmun IgG ELISA and the Ortho clinical Diagnostics VITROS IgG CLIA. All tests against S1/S2 (Liaison, Diasorin) resulted in a signal above cutoff. Assays against RBD, mostly generate a negative result. An exception are the Wantai SARS-CoV-2 ELISA\'s. All tests targeting N protein were negative. The survey shows, when >6 months post-infection, assays targeting at least S1, and preferably S1 combined with S2, are the most sensitive. This finding accentuates the necessity of external quality assessment schedules and importance of antigenic composition of serologic SARS-CoV-2 assays.
摘要：
我们报告了样品IS/17575，因为它在比利时SARS-CoV-2血清学外部质量评估方案中产生了高度不同的结果。样品IS/17575是来源于30岁男性患者的血清。124个诊断实验室分析了这个样本。总共返回了168个结果（包括5个双打）。总的来说,38是积极的。除EuroimmunIgGELISA和Ortho临床诊断VITROSIgGCLIA外，所有针对S1的测试均为阳性。针对S1/S2的所有测试(联络，Diasorin）导致信号高于截止值。针对RBD的测定，主要产生负面结果。万泰SARS-CoV-2ELISA是一个例外。所有针对N蛋白的测试均为阴性。调查显示,当感染后>6个月，靶向至少S1,优选S1与S2组合的测定是最敏感的。这一发现强调了外部质量评估时间表的必要性以及血清SARS-CoV-2测定的抗原组成的重要性。
