Identification of SARS-CoV-2 in a Proficiency Testing Program
Identification of SARS-CoV-2 in a Proficiency Testing Program
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DOI：
10.1093/ajcp/aqaa128
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发表时间：
2020-10-01
影响因子：
3.5
通讯作者：
Downes, Frances P.
中科院分区：
文献类型：
--
作者：
Edson, Daniel C.;Casey, Danielle L.;Downes, Frances P.
目的：在严重急性呼吸系统综合征冠状病毒2（SARS-CoV-2）在美国大流行开始时，检测仅限于疾病控制和预防中心开发的逆转录聚合酶链反应检测。对检测的迫切和大量需求促使检测SARS-CoV-2的方法迅速发展。本研究的目的是评估这些新开发的tests.Methods的准确性：美国能力研究所发送2个测试样本346临床实验室，以评估SARS-CoV-2检测的准确性。阳性样本含有5，175个病毒拷贝/mL，可以用SARS-CoV-2病毒衣壳蛋白和RNA完全提取。结果：在提交检测结果的实验室中，97.4%（302/310）的实验室正确检测出病毒，98.3%（296/301）的实验室正确检测出病毒。在本熟练度挑战报告的不正确结果中，76.9%（10/13）可能与笔误有关。这占所有报告结果的1.6%（10/611）Conclusions：在这个SARS-CoV-2 RNA检测挑战的总体性能是优秀的，提供了信心，这些新的分子测试的结果和保证的临床和公共卫生决策的基础上，这些测试结果。
Objectives: At the onset of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic in the United States, testing was limited to the Centers for Disease Control and Prevention-developed reverse transcription polymerase chain reaction assay. The urgent and massive demand for testing prompted swift development of assays to detect SARS-CoV-2. The objective of this study was to assess the accuracy of these newly developed tests.Methods: The American Proficiency Institute sent 2 test samples to 346 clinical laboratories in order to assess the accuracy of SARS-CoV-2 assays. The positive sample, containing 5,175 viral copies/mL, was fully extractable with SARS-CoV-2 viral capsid protein and RNA. The negative sample, with 3,951 viral copies/mL, contained recombinant virus particles with sequences for targeting human RNAase P gene sequences.Results: Of the laboratories submitting results, 97.4% (302/310) correctly detected the virus when present and 98.3% (296/301) correctly indicated when the virus was not present. Among incorrect results reported in this proficiency challenge, 76.9% (10/13) were likely related to clerical error. This accounts for 1.6% (10/611) of all reported results.Conclusions: Overall performance in this SARS-CoV-2 RNA detection challenge was excellent, providing confidence in the results of these new molecular tests and assurance for the clinical and public health decisions based on these test results.