Evaluation of factors contributing to variability of qualitative and quantitative proficiency testing for SARS-CoV-2 nucleic acid detection  

作　　者：Yongzhuo Zhang Xia Wang Chunyan Niu Di Wang Qingfei Shen Yunhua Gao Haiwei Zhou Yujing Zhang Yan Zhang Lianhua Dong 

机构地区：[1]National Institute of Metrology,Beijing 100029,China [2]Division II of In Vitro Diagnostics for Infectious Diseases,Institute for In Vitro Diagnostics Control,National Institutes for Food and Drug Control,Beijing 100050,China

出　　处：《Biosafety and Health》2022年第5期321-329,共9页生物安全与健康（英文）

基　　金：NIM(National Institute of Metrology,China)(AKYZZ2126/AKYYJ2009).

摘　　要：The pandemic caused by severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)has led to unprecedented social and economic disruption.Many nucleic acid testing(NAT)laboratories in China have been established to control the epidemic better.This proficiency testing(PT)aims to evaluate the participants’performance in qualitative and quantitative SARS-CoV-2 NAT and to explore the factors that contribute to differences in detection capabilities.Two different concentrations of RNA samples(A,B)were used for quantitative PT.Pseudovirus samples D,E(different concentrations)and negative sample(F)were used for qualitative PT.50 data sets were reported for qualitative PT,of which 74.00%were entirely correct for all samples.Fortytwo laboratories participated in the quantitative PT.37 submitted all gene results,of which only 56.76%were satisfactory.For qualitative detection,it is suggested that laboratories should strengthen personnel training,select qualified detection kits,and reduce cross-contamination to improve detection accuracy.For quantitative detection,the results of the reverse transcription digital PCR(RT-dPCR)method were more comparable and reliable than those of reverse transcription quantitative PCR(RT-qPCR).The copy number concentration of ORF1ab and N in samples A and B scattered in 85,223,50,and 106 folds,respectively.The differences in the quantitative result of RT-qPCR was mainly caused by the non-standard use of reference materials and the lack of personnel operating skills.Comparing the satisfaction of participants participating in both quantitative and qualitative proficiency testing,95.65%of the laboratories with satisfactory quantitative results also judged the qualitative results correctly,while 85.71%of the laboratories with unsatisfactory quantitative results were also unsatisfied with their qualitative judgments.Therefore,the quantitative ability is the basis of qualitative judgment.Overall,participants from hospitals reported more satisfactory results than those from enterprises and universit

关 键 词：Proficiency testing SARS-CoV-2 Nucleic acid testing Reference material Quality assessment PSEUDOVIRUS 

分 类 号：R440[医药卫生—诊断学]