Fast and Sensitive Detection of SARS-CoV-2 Nucleic Acid Using a Rapid Detection System Free of RNA Extraction.

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2023-01-01 DOI:10.1155/2023/8053524

Liang Ma, Yanyan Fan, Xiaomu Kong, Yongwei Jiang, Hong Huang, Meimei Zhao, Yi Liu, Peng Gao, Yong Cui, Yongtong Cao

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引用次数: 3

Abstract

Objectives: To establish and evaluate the analytical and clinical performance of the Flash20 SARS-CoV-2 nucleic acid rapid detection system free of RNA extraction.

Methods: The limit of detection (LoD) was determined using a negative nasopharyngeal swab matrix spiked with different concentrations of SARS-CoV-2 virus; a total of 734,337 reference sequences of viral genomes from GenBank were used for the in-silico analysis to assess the inclusivity of the assay. The specificity of the system was evaluated by testing 27 medically relevant organisms. A total of 115 clinical specimens were collected and tested on the Flash20 SARS-CoV-2 detection system and with an FDA-approved comparator test to assess the clinical performance of the system.

Results: The LoD of the Flash20 SARS-CoV-2 detection system is 250 copies/mL with a positive rate ≥90% (n = 20); alignments results showed that over 99% identity of the primer and probe of the Flash20 SARS-CoV-2 nucleic acid rapid detection system to the available SARS-CoV-2 sequences; the omicron samples tested 100% positive. None of the 27 organisms showed cross-reactivity with the Flash20 SARS-CoV-2 nucleic acid rapid detection system. Among all the 215 clinical samples, the Flash20 SARS-CoV-2 nucleic acid rapid detection system exhibits a high sensitivity of 99.24% (131/132) and 100% (83/83) specificity.

Conclusion: The nucleic acid rapid detection system provides sensitive and accurate detection of SARS-CoV-2 free of RNA extraction. The high sensitivity and short time to results of approximately 35 minutes may impact earlier infection control and disease management.

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非RNA提取快速检测系统对SARS-CoV-2核酸的快速灵敏检测

目的:建立并评价Flash20不含RNA提取的SARS-CoV-2核酸快速检测系统的分析和临床性能。方法:采用添加不同浓度SARS-CoV-2病毒的阴性鼻咽拭子基质测定检测限(LoD);共使用来自GenBank的734,337个病毒基因组参考序列进行计算机分析，以评估该方法的包容性。通过检测27种医学相关生物来评估该系统的特异性。共收集115例临床标本，采用Flash20 SARS-CoV-2检测系统和fda批准的比较试验评估该系统的临床性能。结果:Flash20 SARS-CoV-2检测系统LoD为250拷贝/mL，阳性率≥90% (n = 20);比对结果表明，Flash20核酸快速检测系统引物和探针与现有SARS-CoV-2序列的一致性超过99%;组粒样本100%呈阳性。27种生物与Flash20 SARS-CoV-2核酸快速检测系统均无交叉反应性。在215份临床样本中，Flash20 SARS-CoV-2核酸快速检测系统的灵敏度为99.24%(131/132)，特异性为100%(83/83)。结论:该核酸快速检测系统可灵敏、准确地检测SARS-CoV-2，无需提取RNA。高灵敏度和大约35分钟的短时间检测结果可能影响早期感染控制和疾病管理。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.