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评价七种用于混合临床标本 COVID-19 检测的商业 RT-PCR 试剂盒。

Evaluation of seven commercial RT-PCR kits for COVID-19 testing in pooled clinical specimens.

机构信息

Department of Microbiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, India.

出版信息

J Med Virol. 2021 Apr;93(4):2281-2286. doi: 10.1002/jmv.26691. Epub 2020 Dec 17.


DOI:10.1002/jmv.26691
PMID:33230819
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7753435/
Abstract

There are more than 350 real-time polymerase chain reaction (RT-PCR) coronavirus disease-2019 (COVID-19) testing kits commercially available but these kits have not been evaluated for pooled sample testing. Thus, this study was planned to compare and evaluate seven commercially available kits for pooled samples testing. Diagnostic accuracy of (1) TRUPCR SARS-CoV-2 Kit (Black Bio), (2) TaqPath RT-PCR COVID-19 Kit (Thermo Fisher Scientific), (3) Allplex 2019-nCOV Assay (Seegene), (4) Patho detect COVID-19 PCR kit (My Lab), (5) LabGun COVID-19 RT-PCR Kit (Lab Genomics, Korea), (6) Fosun COVID-19 RT-PCR detection kit (Fosun Ltd.), (7) Real-time Fluorescent RT-PCR kit for SARS CoV-2 (BGI) was evaluated on precharacterised 40 positive and 10 negative COVID-19 sample pools. All seven kits detected all sample pools with low C values (<30); while testing weak positive pooled samples with high C value (>30); the TRUPCR Kit, TaqPath Kit, Allplex Assay, and BGI RT-PCR kit showed 100% sensitivity, specificity, and accuracy. However, the Fosun kit, LabGun Kit, and Patho detect kit could detect only 90%, 85%, and 75% of weakly positive samples, respectively. We conclude that all seven commercially available RT-PCR kits included in this study can be used for routine molecular diagnosis of COVID-19. However, regarding performing pooled sample testing, it might be advisable to use those kits that performed best regarding positive identification in samples' pool, that is TRUPCR SARS-CoV-2 Kit, TaqPath RT-PCR COVID-19 Kit, Allplex 2019-nCOV Assay, and BGI Real-time RT-PCR kit for detecting SARS CoV-2.

摘要

有超过 350 种实时聚合酶链反应(RT-PCR)的 2019 年冠状病毒病(COVID-19)检测试剂盒在商业上可用,但这些试剂盒尚未经过用于混合样本检测的评估。因此,本研究旨在比较和评估七种市售的用于混合样本检测的试剂盒。(1)TRUPCR SARS-CoV-2 试剂盒(Black Bio)、(2)TaqPath RT-PCR COVID-19 试剂盒(Thermo Fisher Scientific)、(3)Allplex 2019-nCOV 检测试剂盒(Seegene)、(4)Patho detect COVID-19 PCR 试剂盒(My Lab)、(5)LabGun COVID-19 RT-PCR 试剂盒(Lab Genomics,韩国)、(6)复星 COVID-19 RT-PCR 检测试剂盒(复星有限公司)、(7)用于 SARS-CoV-2 的实时荧光 RT-PCR 试剂盒(BGI)在预先确定的 40 个阳性和 10 个阴性 COVID-19 样本池上进行了评估。所有七种试剂盒均能以低 C 值(<30)检测到所有样本池;而在检测高 C 值(>30)的弱阳性混合样本时,TRUPCR 试剂盒、TaqPath 试剂盒、Allplex 检测试剂盒和 BGI RT-PCR 试剂盒均显示出 100%的灵敏度、特异性和准确性。然而,福森试剂盒、LabGun 试剂盒和 Patho detect 试剂盒仅能检测到 90%、85%和 75%的弱阳性样本。我们的结论是,本研究中包含的七种市售 RT-PCR 试剂盒均可用于 COVID-19 的常规分子诊断。然而,关于进行混合样本检测,最好使用那些在样本池中阳性鉴定方面表现最好的试剂盒,即 TRUPCR SARS-CoV-2 试剂盒、TaqPath RT-PCR COVID-19 试剂盒、Allplex 2019-nCOV 检测试剂盒和 BGI 实时 RT-PCR 试剂盒用于检测 SARS-CoV-2。

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本文引用的文献

[1]
Evaluation of sample pooling for diagnosis of COVID-19 by real time-PCR: A resource-saving combat strategy.

J Med Virol. 2021-3

[2]
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J Clin Virol. 2020-8-2

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J Clin Virol. 2020-5-8

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Should RT-PCR be considered a gold standard in the diagnosis of COVID-19?

J Med Virol. 2020-11

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J Med Virol. 2020-11

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Clin Infect Dis. 2020-11-19

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Am J Clin Pathol. 2020-5-5

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Laboratory Diagnosis of COVID-19: Current Issues and Challenges.

J Clin Microbiol. 2020-5-26

[10]
Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR.

Euro Surveill. 2020-1

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