AusDiagnostics SARS-CoV-2 多重串联 PCR 检测试剂盒的临床评估。
Clinical evaluation of AusDiagnostics SARS-CoV-2 multiplex tandem PCR assay.
机构信息
Department of Microbiology, Monash Health, Clayton, VIC, Australia; Monash Infectious Diseases, Monash Health, Clayton, VIC, Australia.
Department of Microbiology, Monash Health, Clayton, VIC, Australia.
出版信息
J Clin Virol. 2020 Jul;128:104448. doi: 10.1016/j.jcv.2020.104448. Epub 2020 May 19.
BACKGROUND
In the context of the pandemic, the rapid emergency use authorisation of diagnostic assays for SARS-CoV-2 has meant there are few peer-reviewed published studies of clinical performance of commercial assays.
AIMS
To evaluate the clinical performance of AusDiagnostics respiratory multiplex tandem PCR assay including SARS-CoV-2.
METHODS
We reviewed the results following implementation of AusDiagnostics respiratory multiplex tandem PCR assay including SARS-CoV-2, and compared with an in-house RT-PCR assay at our State Reference Laboratory.
RESULTS
Initial validation using AusDiagnostics coronavirus multiplex tandem PCR assay including SARS-CoV-2 demonstrated good concordance with the State Reference Laboratory. After implementing the AusDiagnostics respiratory multiplex tandem PCR assay including SARS-CoV-2, we tested 7839 samples. 127 samples in which SARS-CoV-2 was detected using the AusDiagnostics assay were referred for testing at the State Reference Laboratory, with concordant results in 118/127 (92.9%) of samples. After resolution of discrepancies, 125/127 (98.4%) of AusDiagnostics results were determined to be true positive results. Out of 7839 samples tested for SARS-CoV-2 during this period, only 2 tests (0.02%) were indeterminate results.
CONCLUSION
The AusDiagnostics respiratory MT-PCR assay is a reliable assay for detection of SARS-CoV-2.
背景
在大流行背景下，针对 SARS-CoV-2 的诊断检测试剂快速获得紧急使用授权，这意味着针对商业检测试剂的临床性能，仅有少数经过同行评审的已发表研究。
目的
评估 AusDiagnostics 呼吸道多重串联 PCR 检测试剂（含 SARS-CoV-2）的临床性能。
方法
我们对 AusDiagnostics 呼吸道多重串联 PCR 检测试剂（含 SARS-CoV-2）实施后的结果进行了回顾，并与我们州立参考实验室的内部 RT-PCR 检测进行了比较。
结果
使用 AusDiagnostics 冠状病毒多重串联 PCR 检测试剂（含 SARS-CoV-2）进行初始验证，结果与州立参考实验室具有良好的一致性。在实施 AusDiagnostics 呼吸道多重串联 PCR 检测试剂（含 SARS-CoV-2）后，我们共检测了 7839 个样本。AusDiagnostics 检测到的 127 个 SARS-CoV-2 样本被送到州立参考实验室进行检测，其中 118/127（92.9%）的样本结果一致。在解决差异后，确定 125/127（98.4%）的 AusDiagnostics 结果为真阳性结果。在此期间，对 7839 个样本进行 SARS-CoV-2 检测，仅有 2 个（0.02%）结果为不确定。
结论
AusDiagnostics 呼吸道 MT-PCR 检测试剂是一种可靠的 SARS-CoV-2 检测方法。
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