新型冠状病毒英国变异株的核酸检测试剂有效性和敏感性评估

Validity and sensitivity evaluation of real-time RT-PCR kits for the diagnosis of SARS-CoV-2 B.1.1.7 variant strain

目的:评估三种商用试剂盒对新型冠状病毒英国B.1.1.7变异株的检测效果。方法:收集2021年1月北京市某区新冠肺炎聚集性疫情期间的10份鉴定为B.1.1.7变异株的咽拭子、鼻咽拭子样本,同时收集2020年6—12月北京市监测发现的10份鉴定为非变异株的咽拭子、鼻咽拭子样本做为对照。用三种可检测该变异株的商业化试剂盒分别进行检测,分析比较检测结果。结果:三种试剂盒中,以B试剂盒的检测效果最差,C试剂盒的综合效果最好,其检测灵敏度可达1000 copy/mL。结论:部分检测试剂盒在灵敏度、稳定性等方面还有待进一步提高。为保证检测结果的质量,需要及时评估检测试剂对变异株的有效性,以使新冠病毒的检测更迅速,检测结果更可靠。

Objective To evaluate the detection efficiency of three real-time PCR kits for SARS-CoV-2 B.1.1.7 variant.Methods Ten confirmed throat swab and nasopharyngeal swab samples of SARS-CoV-2 B.1.1.7 variant strain from clustered cases of coronavirus 2019(COVID-19)in one district of Beijing in January 2021 were selected.Ten confirmed throat swab and nasopharyngeal swab samples of non-variant SARS-CoV-2 strain were used as controls.The samples were tested by three commercially available realtime PCR kit,and the results were compared.Results Among the three kits,the detection efficiency of kit B was the worst while the integrated performance of kit C was the best with the detection limit of 1000 copy/ml.Conclusions The sensitivity and stability of certain kits need to be improved.In order to maintain quality of detection for SARS-CoV-2,evaluation for the detection efficiency of the variant strains should be timely carried out to ensure more rapid detection of SARS-CoV-2 and more reliable testing results.