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商业逆转录酶-聚合酶链反应试剂盒检测严重急性呼吸综合征冠状病毒 2 感染效率的比较研究。

A comparative study on the efficiency of commercial reverse transcriptase-Polymerase chain reaction kits for the detection of severe acute respiratory syndrome coronavirus 2 infections.

机构信息

Scientist B, Department of Microbiology Govt Theni Medical College Theni, Tamil Nadu, India.

Assistant Professor, Department of Microbiology Govt Theni Medical College Theni, Tamil Nadu, India.

出版信息

Indian J Public Health. 2022 Jul-Sep;66(3):276-281. doi: 10.4103/ijph.ijph_2042_21.

DOI:10.4103/ijph.ijph_2042_21
PMID:36149104
Abstract

BACKGROUND

Real-time reverse transcriptase-polymerase chain reaction (RT-PCR) kits have been reliably employed for the diagnosis of coronavirus disease 2019 (COVID-19) by the detection of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA since the beginning of the disease outbreak. In consideration of reliable diagnosis, apart from RT-PCR, the isothermal nucleic acid amplification-based point-of-care automated kits have also been tagged as a simpler and rapid alternative to the conventional techniques. Currently, the availability of a better diagnostic method for COVID-19 when compared to RT-PCR is nil. The most important step in the detection of SARS-CoV-2 in a RT-PCR diagnostic laboratory is to identify and employ RT-PCR kits with higher sensitivity as well as specificity.

OBJECTIVES

This study aimed to study commercially available RT-PCR kits for the detection of SARS-CoV-2 infections.

METHODS

The performance of seven different RT-PCR kits from different manufacturers used for diagnosis of COVID-19 in Govt Theni Medical College and Hospital, Theni, Tamil Nadu were analysed. Nasopharyngeal and oropharyngeal swabs were collected from patients and subjected to RT-PCR using these kits.

RESULTS AND CONCLUSION

The sensitivities and batch effects of the assessed kits were slightly different for different targets, for SARS-CoV-2 detection in nasopharyngeal swab specimens. Examination of COVID-19 kits should be done using currently employed kits in routine diagnosis for better efficiency.

摘要

背景

自疾病爆发以来,通过检测严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)RNA,实时逆转录-聚合酶链反应(RT-PCR)试剂盒已可靠地用于 2019 年冠状病毒病(COVID-19)的诊断。为了确保可靠的诊断,除 RT-PCR 外,等温核酸扩增的即时检测自动化试剂盒也被标记为比传统技术更简单、更快速的替代方法。目前,与 RT-PCR 相比,COVID-19 更好的诊断方法还不存在。在 RT-PCR 诊断实验室中检测 SARS-CoV-2 的最重要步骤是识别和使用具有更高灵敏度和特异性的 RT-PCR 试剂盒。

目的

本研究旨在研究可用于检测 SARS-CoV-2 感染的市售 RT-PCR 试剂盒。

方法

分析了来自不同制造商的 7 种不同 RT-PCR 试剂盒在泰米尔纳德邦蒂尼政府医学院和医院用于 COVID-19 诊断的性能。从患者中采集鼻咽和口咽拭子,并使用这些试剂盒进行 RT-PCR。

结果和结论

对于不同的靶标,评估试剂盒对鼻咽拭子标本中 SARS-CoV-2 的检测灵敏度和批次效应略有不同。为了提高效率,应使用目前常规诊断中使用的试剂盒对 COVID-19 试剂盒进行检查。

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