Bogiel Tomasz, Rzepka Mateusz, Depka Dagmara
Microbiology Department, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Toruń, 9 Maria Skłodowska-Curie Street, 85-094 Bydgoszcz, Poland.
Diagnostics (Basel). 2021 Oct 5;11(10):1839. doi: 10.3390/diagnostics11101839.
SARS-CoV-2 is a new virus from the family and its rapid spread is now the most important medical problem worldwide. Currently used tests vary in the number and selection of SARS-CoV-2 target genes. Meanwhile, the choice of the appropriate target gene may be important in terms of a reliable detection of a viral RNA. As some researchers questioned the sensitivity of the monogenic VIASURE SARS-CoV-2 gene Real Time PCR Detection Kit (CerTest Biotec, Zaragoza, Spain) in mid-2020, the aim of the study was to evaluate the usefulness of this kit, used along with the BD MAX™ System (Becton Dickinson, East Rutherford, NJ, USA), and compare the results with two-gene Bosphore Novel Coronavirus (2019-nCoV) Detection Kit v1 (Anatolia Diagnostics and Biotechnology Products Inc., Istanbul, Turkey). Both tests were carried out on 306 nasopharyngeal/oropharyngeal swabs. The consistent results (72 positive and 225 negative results found simultaneously in both kits) were obtained for 297 (97.1%) samples altogether, while discrepancies between the results of the evaluated tests were observed for nine (2.9%) specimens. There were no statistically significant differences between the method used and the frequency of positive results. Both tests, targeted at detecting one and two genes, are effective in SARS-CoV-2 RNA detection.
严重急性呼吸综合征冠状病毒2(SARS-CoV-2)是一种来自该病毒家族的新型病毒,其迅速传播是目前全球最重要的医学问题。目前使用的检测方法在SARS-CoV-2靶基因的数量和选择上各不相同。同时,选择合适的靶基因对于可靠检测病毒RNA可能很重要。由于一些研究人员在2020年年中质疑了单基因VIASURE SARS-CoV-2基因实时荧光定量PCR检测试剂盒(CerTest Biotec公司,西班牙萨拉戈萨)的灵敏度,本研究的目的是评估该试剂盒与BD MAX™系统(美国新泽西州东卢瑟福的贝克顿·迪金森公司)一起使用的有效性,并将结果与双基因的博施福尔新型冠状病毒(2019-nCoV)检测试剂盒v1(土耳其伊斯坦布尔的安纳托利亚诊断和生物技术产品公司)进行比较。两项检测均在306份鼻咽/口咽拭子上进行。总共297份(97.1%)样本获得了一致的结果(两个试剂盒同时检测到72份阳性和225份阴性结果),而在9份(2.9%)标本中观察到评估检测结果之间存在差异。所使用的方法与阳性结果的频率之间没有统计学上的显著差异。针对检测一个和两个基因的两项检测在SARS-CoV-2 RNA检测中均有效。