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目的:采用假病毒对三种新型冠状病毒(severe acute respiratory syndrome coronavirus 2,SARS-CoV-2)核酸血液筛查试剂的检测性能进行比较和分析,为SARS-CoV-2核酸血液筛查的试剂选择提供依据。方法:使用慢病毒包装系统构建包含SARS-CoV-2基因组片段的假病毒。使用A、B、C三个单位的SARS-CoV-2核酸血液筛查系统进行RNA提取和扩增,根据各试剂检测结果计算其检测限(limit of detection, LoD)、特异度和精密度。结果:A、B、C三个单位N区段的单检LoD分别为3.46、8.73、23.87 copies/mL,混检LoD分别为13.65、78.92、159.14 copies/mL。ORF1ab区段的单检LoD分别为6.32、12.22、24.05 copies/mL,混检LoD分别为26.94、67.97、94.80 copies/mL。各试剂检测SARS-CoV-2阴性血浆的特异度均为100%,检测2LoD和较高浓度假病毒的批内和批间变异系数均小于5%。结论:A公司的SARS-CoV-2核酸血筛系统灵敏度最高。三种试剂均有良好的特异度和精密度。“,”Objective:To compare and analyze the performance of three nucleic acid blood screening reagents for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using pseudoviruses, so as to provide references for choosing suitable reagents for SARS-CoV-2 blood screening.Methods:PCDH-based pseudovirus containing fragments of SARS-CoV-2 genome was used as reference material. SARS-CoV-2 nucleic acid blood screening reagents from three companies (A, B and C) were used for RNA extraction and amplification. The results were used to calculate limit of detection (LoD), specificity and precision of the reagents.Results:For N region, LoDs of company A, B and C were 3.46, 8.73 and 23.87 copies/mL for individual testing, and 13.65, 78.92 and 159.14 copies/mL for pooling testing respectively. For ORF1ab region, LoD of A, B, C was 6.32, 12.22 and 24.05 copies/mL for individual testing, and 26.94, 67.97 and 94.80 copies/mL for pooling testing, respectively. The specificity of each reagent in detecting SARS-CoV-2 negative plasma was 100%. The intra-batch and inter-batch coefficient of variation for detecting 2LoD and higher concentration of pseudoviruses were less than 5%.Conclusions:The kit of company A had higher sensitivity than those from company B and C. All the kits showed good specificity and precision.