Ma Liang, Fan Yanyan, Kong Xiaomu, Jiang Yongwei, Huang Hong, Zhao Meimei, Liu Yi, Gao Peng, Cui Yong, Cao Yongtong
Department of Clinical Laboratory, China-Japan Friendship Hospital, Beijing 100029, China.
Department of Pulmonary & Critical Care Medicine, Laboratory of Clinical Microbiology & Infectious Diseases, China-Japan Friendship Hospital, Beijing 100029, China.
Int J Anal Chem. 2023 Jan 20;2023:8053524. doi: 10.1155/2023/8053524. eCollection 2023.
To establish and evaluate the analytical and clinical performance of the Flash20 SARS-CoV-2 nucleic acid rapid detection system free of RNA extraction.
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.
The LoD of the Flash20 SARS-CoV-2 detection system is 250 copies/mL with a positive rate ≥90% ( = 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.
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.
建立并评估免RNA提取的Flash20 SARS-CoV-2核酸快速检测系统的分析性能和临床性能。
使用添加不同浓度SARS-CoV-2病毒的阴性鼻咽拭子基质来确定检测限（LoD）；共使用来自GenBank的734,337条病毒基因组参考序列进行电子分析，以评估该检测方法的包容性。通过检测27种医学相关生物体来评估该系统的特异性。总共收集了115份临床标本，并在Flash20 SARS-CoV-2检测系统上进行检测，同时与FDA批准的对照检测进行比较，以评估该系统的临床性能。
Flash20 SARS-CoV-2检测系统的LoD为250拷贝/毫升，阳性率≥90%（=20）；比对结果显示，Flash20 SARS-CoV-2核酸快速检测系统的引物和探针与可用的SARS-CoV-2序列的同一性超过99%；奥密克戎样本检测结果100%为阳性。27种生物体中没有一种与Flash20 SARS-CoV-2核酸快速检测系统显示交叉反应。在所有215份临床样本中，Flash20 SARS-CoV-2核酸快速检测系统表现出99.24%（131/132）的高灵敏度和100%（83/83）的特异性。
该核酸快速检测系统可在免RNA提取的情况下对SARS-CoV-2进行灵敏且准确的检测。高灵敏度和约35分钟的短出结果时间可能会对早期感染控制和疾病管理产生影响。
