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分析和临床评估“AccuPower SARS-CoV-2 多重 RT-PCR 试剂盒(韩国 Bioneer)”和“Allplex 2019-nCoV 检测试剂盒(韩国 Seegene)”用于 SARS-CoV-2 RT-PCR 诊断:韩国 CDC EUA 作为发展中国家的质量控制代理。

Analytical and Clinical Evaluation of "AccuPower SARS-CoV-2 Multiplex RT-PCR kit (Bioneer, South Korea)" and "Allplex 2019-nCoV Assay (Seegene, South Korea)" for SARS-CoV-2 RT-PCR Diagnosis: Korean CDC EUA as a Quality Control Proxy for Developing Countries.

机构信息

One Health Research Group, Universidad de Las Americas, Quito, Ecuador.

出版信息

Front Cell Infect Microbiol. 2021 Jun 10;11:630552. doi: 10.3389/fcimb.2021.630552. eCollection 2021.


DOI:10.3389/fcimb.2021.630552
PMID:34178716
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8223252/
Abstract

BACKGROUND: Multiple RT-qPCR kits are available in the market for SARS-CoV-2 diagnosis, some of them with Emergency Use Authorization (EUA) by FDA or their country of origin agency, but many of them lack of proper clinical evaluation. OBJECTIVE: We evaluated the clinical performance of two Korean SARS-CoV-2 RT-PCR kits available in South America, AccuPower SARS-CoV-2 Multiplex RT-PCR kit (Bioneer, South Korea) and Allplex 2019-nCoV Assay (Seegene, South Korea), for RT-qPCR SARS-CoV-2 diagnosis using the CDC protocol as a gold standard. RESULTS: We found strong differences among both kits clinical performance and analytical sensitivity; while the Allplex 2019-nCoV Assay has sensitivity of 96.5% and an estimated limit of detection of 4,000 copies/ml, the AccuPower SARS-CoV-2 Multiplex RT-PCR kit has a sensitivity of 75.5% and limit of detection estimated to be bigger than 20,000 copies/ml. CONCLUSIONS: AccuPower SARS-CoV-2 Multiplex RT-PCR kit and Allplex 2019-nCoV Assay are both made in South Korea but EUA by Korean CDC was only granted to the later. Our results support that Korean CDC EUA should be considered as a quality control proxy for Korean SARS-CoV-2 RT-PCR kits prior to importation by developing countries to guarantee high sensitivity diagnosis.

摘要

背景:市场上有多种用于 SARS-CoV-2 诊断的实时 RT-qPCR 试剂盒,其中一些获得了 FDA 或原产国机构的紧急使用授权(EUA),但其中许多试剂盒缺乏适当的临床评估。

目的:我们评估了两种在南美可用的韩国 SARS-CoV-2 RT-PCR 试剂盒的临床性能,AccuPower SARS-CoV-2 多重 RT-PCR 试剂盒(Bioneer,韩国)和 Allplex 2019-nCoV 检测试剂盒(Seegene,韩国),使用 CDC 方案作为金标准进行 RT-qPCR SARS-CoV-2 诊断。

结果:我们发现这两种试剂盒的临床性能和分析灵敏度存在很大差异;虽然 Allplex 2019-nCoV 检测试剂盒的灵敏度为 96.5%,估计检测限为 4,000 拷贝/ml,但 AccuPower SARS-CoV-2 多重 RT-PCR 试剂盒的灵敏度为 75.5%,估计检测限大于 20,000 拷贝/ml。

结论:AccuPower SARS-CoV-2 多重 RT-PCR 试剂盒和 Allplex 2019-nCoV 检测试剂盒均在韩国制造,但韩国 CDC 仅对后者授予了 EUA。我们的结果支持在发展中国家进口之前,应将韩国 CDC EUA 视为韩国 SARS-CoV-2 RT-PCR 试剂盒的质量控制代理,以保证高灵敏度诊断。

相似文献

[1]
Analytical and Clinical Evaluation of "AccuPower SARS-CoV-2 Multiplex RT-PCR kit (Bioneer, South Korea)" and "Allplex 2019-nCoV Assay (Seegene, South Korea)" for SARS-CoV-2 RT-PCR Diagnosis: Korean CDC EUA as a Quality Control Proxy for Developing Countries.

Front Cell Infect Microbiol. 2021

[2]
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[4]
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[2]
Optimization of the STARlet workflow for semi-automatic SARS-CoV-2 screening of swabs and deep respiratory materials using the RealAccurate Quadruplex SARS-CoV-2 PCR kit and Allplex SARS-CoV-2 PCR kit.

Microbiol Spectr. 2024-2-6

[3]
The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing (December 2023).

Clin Infect Dis. 2024-6-27

[4]
Humoral and T cell responses to SARS-CoV-2 reveal insights into immunity during the early pandemic period in Pakistan.

BMC Infect Dis. 2023-12-1

[5]
Environmental surface surveillance during a COVID-19 outbreak in a school community: implications for controlling indirect transmission.

Braz J Microbiol. 2024-3

[6]
The Diagnostic Performance of Various Clinical Specimens for the Detection of COVID-19: A Meta-Analysis of RT-PCR Studies.

Diagnostics (Basel). 2023-9-26

[7]
Simple Point-of-Care Nucleic Acid Amplification Test for Rapid SARS-CoV-2 Infection Diagnosis.

Diagnostics (Basel). 2023-9-20

[8]
In response to: "Diagnostic evaluation of nCoV-QS, nCoV-QM-N, and nCoV-OM detection kits based on rRT-PCR for detection of SARS-CoV-2 in Ecuador".

Heliyon. 2023-8-26

[9]
Inactivated SARS-CoV-2 vaccine candidate immunization on non-human primate animal model: B-cell and T-cell responses immune evaluation.

Heliyon. 2023-7-7

[10]
The quality of commercial SARS-CoV-2 nucleic acid tests in Ecuador: lessons from COVID-19 pandemic for advancing social equity through microbiology.

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本文引用的文献

[1]
High prevalence of SARS-CoV-2 infection among food delivery riders. A case study from Quito, Ecuador.

Sci Total Environ. 2021-5-20

[2]
Low clinical performance of the Isopollo COVID-19 detection kit (M Monitor, South Korea) for RT-LAMP SARS-CoV-2 diagnosis: A call for action against low quality products for developing countries.

Int J Infect Dis. 2021-3

[3]
Analytical and clinical comparison of Viasure (CerTest Biotec) and 2019-nCoV CDC (IDT) RT-qPCR kits for SARS-CoV2 diagnosis.

Virology. 2021-1-15

[4]
Poor sensitivity of "AccuPower SARS-CoV-2 real time RT-PCR kit (Bioneer, South Korea)".

Virol J. 2020-11-14

[5]
Analytical sensitivity and clinical performance of a triplex RT-qPCR assay using CDC N1, N2, and RP targets for SARS-CoV-2 diagnosis.

Int J Infect Dis. 2021-1

[6]
"One health" inspired SARS-CoV-2 surveillance: The Galapagos Islands experience.

One Health. 2020-12-20

[7]
"Sample pooling of RNA extracts to speed up SARS-CoV-2 diagnosis using CDC FDA EUA RT-qPCR kit".

Virus Res. 2020-9-24

[8]
SARS-CoV-2 viral load assessment in respiratory samples.

J Clin Virol. 2020-5-19

[9]
Cotton-Tipped Plastic Swabs for SARS-CoV-2 RT-qPCR Diagnosis to Prevent Supply Shortages.

Front Cell Infect Microbiol. 2020-6-23

[10]
Suppression of a SARS-CoV-2 outbreak in the Italian municipality of Vo'.

Nature. 2020-6-30

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