评估一种无需 RNA 提取即可用于临床样本的商业实时 PCR 检测 SARS-CoV-2 的方法。

Evaluation of a commercial Real Time PCR for clinical samples without RNA extraction for detection of SARS-CoV-2.

机构信息

Department of Microbiology, Armed Forces Medical College Pune, 411040, India.

出版信息

Diagn Microbiol Infect Dis. 2024 Nov;110(3):116441. doi: 10.1016/j.diagmicrobio.2024.116441. Epub 2024 Jul 25.

DOI:10.1016/j.diagmicrobio.2024.116441

Abstract

RT-PCR is the gold standard for diagnosis of COVID-19. All RT-PCR kits are based on RNA extraction from the clinical sample. There was a sudden increase in demand of these kits, both RNA extraction and COVID-19 RT-PCR kits during the pandemic. This sudden spurt in global demand created a situation of shortage of consumables, especially the RNA extraction kits. Hence, this study was carried out to evaluate and compare COVID-19 RT-PCR without RNA extraction step using buffer R3. Sensitivity, specificity and accuracy of RT-PCR kit without RNA extraction were 89.16 %, 100% and 89.6% respectively. This approach saved more than 50 % time compared to the RT-PCR kit with RNA extraction approach allowing enhanced daily sample processing capability. RT-PCR kit without RNA extraction help in managing a greater number of samples, reduces cost and turnaround time.

摘要

实时逆转录聚合酶链反应（RT-PCR）是诊断 COVID-19 的金标准。所有的 RT-PCR 试剂盒都是基于从临床样本中提取 RNA。在大流行期间，这些试剂盒（包括 RNA 提取试剂盒和 COVID-19 RT-PCR 试剂盒）的需求突然增加。这种急剧增长的全球需求导致了耗材短缺的情况，尤其是 RNA 提取试剂盒。因此，本研究旨在评估和比较使用缓冲液 R3 进行无 RNA 提取步骤的 COVID-19 RT-PCR。无 RNA 提取的 RT-PCR 试剂盒的灵敏度、特异性和准确性分别为 89.16%、100%和 89.6%。与使用 RNA 提取方法的 RT-PCR 试剂盒相比，这种方法节省了超过 50%的时间，允许增强每日样本处理能力。无 RNA 提取的 RT-PCR 试剂盒有助于处理更多的样本，降低成本和周转时间。