Bock Sabine, Hoffmann Bernd, Beer Martin, Wernike Kerstin
Berlin-Brandenburg State Laboratory, 15236 Frankfurt, Germany.
Institute of Diagnostic Virology, Friedrich-Loeffler-Institut, 17493 Greifswald, Germany.
Diseases. 2021 Nov 15;9(4):84. doi: 10.3390/diseases9040084.
Since the beginning of 2020, the betacoronavirus SARS-CoV-2 is causing a global pandemic of an acute respiratory disease termed COVID-19. The diagnostics of the novel disease is primarily based on direct virus detection by RT-PCR; however, the availability of test kits may become a major bottleneck, when millions of tests are performed per week. To increase the flexibility of SARS-CoV-2 diagnostics, three real-time RT-PCR assays listed on the homepage of the World Health Organization were selected and investigated regarding their compatibility with three different RT-PCR kits. Furthermore, the reaction volume of the PCR chemistry was reduced up to half of the original protocol to make the individual reactions more cost- and resource-effective. When testing dilution series of culture-grown virus, nearly identical quantification cycle values (Cq) were obtained for all RT-PCR assay/chemistry combinations. Regarding the SARS-CoV-2 detection in clinical samples, agreeing results were obtained for all combinations for virus negative specimens and swabs containing high to medium viral genome loads. In cases of very low SARS-CoV-2 genome loads (Cq > 36), inconsistent results were observed, with some test runs scoring negative and some positive. However, no preference of a specific target within the viral genome (E, RdRp, or N) or of a certain chemistry was seen. In summary, a reduction of the reaction volume and the type of PCR chemistry did not influence the PCR sensitivity.
自2020年初以来,β冠状病毒严重急性呼吸综合征冠状病毒2(SARS-CoV-2)引发了一场名为COVID-19的急性呼吸道疾病全球大流行。这种新型疾病的诊断主要基于通过逆转录聚合酶链反应(RT-PCR)直接检测病毒;然而,当每周进行数百万次检测时,检测试剂盒的可用性可能成为一个主要瓶颈。为了提高SARS-CoV-2诊断的灵活性,我们选择了世界卫生组织主页上列出的三种实时RT-PCR检测方法,并研究了它们与三种不同RT-PCR试剂盒的兼容性。此外,将PCR反应体系的体积减少至原始方案的一半,以使单个反应更具成本效益和资源效益。在检测培养的病毒稀释系列时,所有RT-PCR检测方法/反应体系组合获得的定量循环值(Cq)几乎相同。对于临床样本中的SARS-CoV-2检测,所有组合对病毒阴性标本和含有高至中等病毒基因组载量的拭子均获得了一致结果。在SARS-CoV-2基因组载量非常低(Cq>36)的情况下,观察到结果不一致,一些检测结果为阴性,一些为阳性。然而,未发现对病毒基因组内特定靶标(E、RdRp或N)或特定反应体系有偏好。总之,反应体系体积的减少和PCR反应体系的类型不会影响PCR的灵敏度。