自制新型冠状病毒抗体检测质控品及其临床应用评价  

Self-made SARS-CoV-2 Antibody Detection Quality Control Products andIts Evaluation for Clinical Use

作　　者：丁玮洁 夷峥 王雪亮 沈兴中[3] 黄维纲 DING Weijie;YI Zheng;WANG Xueliang;SHEN Xingzhong;HUANG Weigang(Shanghai Center for Clinical Laboratory,Shanghai 200126,China;Shanghai Academy of Experimental Medicine,Shanghai 200126,China;National Institute of Measurement and Testing Technology,Chengdu 610021,China)

机构地区：[1]上海市临床检验中心,上海200126 [2]上海市实验医学研究院,上海200126 [3]中国测试技术研究院,成都610021

出　　处：《现代检验医学杂志》2023年第6期178-184,共7页Journal of Modern Laboratory Medicine

基　　金：上海市卫生健康委员会/上海市医药卫生发展基金会资助项目(上海市“医苑新星”青年医学人才培养资助计划(青年医学人才类-临床检验项目))(沪卫人事[2021]99号)。

摘　　要：目的 制备新型冠状病毒(SARS-CoV-2)抗体检测质控品,并评价其在各检测系统中的性能指标和临床应用情况。方法 采用抗SARS-CoV-2核衣壳蛋白(nucleocapsid protein, NP)单克隆抗体和抗SARS-CoV-2刺突单克隆抗体的IgG或(和)IgM阳性质控物制备SARS-CoV-2抗体检测质控品,并对其适用性、均匀性和稳定性进行评价。稀释SARS-CoV-2抗体检测质控品制备SARS-CoV-2抗体检测调查品,并下发至各参评实验室,依据回报结果,对其临床应用进行评价。结果 SARS-CoV-2抗体检测质控品适用于17种国家药监局批准的SARS-CoV-2抗体检测系统,适用性良好。SARS-CoV-2抗体检测质控品在胶体金检测系统D的均匀性符合要求,在化学发光检测系统K,J和I检测系统中的检测结果(S/Co)分别为397.67±23.83(F=0.77,P=0.74),2.80±0.23(F=0.38,P=0.76)和36.09±0.50(F=0.55,P=0.91),均匀性符合要求。SARS-CoV-2抗体检测质控品开瓶14天内的t值范围在0.182~1.985之间,反复冻融15次的t值范围在0.022~1.44之间,长期储存至180天内的t值范围在0.024~1.950之间,与第0天(次)检出数据相比,均P>0.05,稳定性符合要求。共有95家参评实验室对SARS-CoV-2抗体检测调查结果进行回报,回报结果包含8个胶体金检测系统和11个化学发光系统。个别检测系统有“假阴性”的情况出现,主要与检测系统本身的灵敏度有关。结论自制SARS-CoV-2抗体检测质控品的适用性、均匀性和稳定性良好,可满足临床实验室质量控制的要求,可用于相关检测项目室内质量控制和室间质量评价。Obejctive To prepare SARS-CoV-2 antibody quality control products and assess their performance and clinical use on various detection systems.Methods SARS-CoV-2 antibody quality control products were prepared by using IgG or(and)IgM positive quality control substance of anti SARS CoV-2 nucleocapsid protein(NP)monoclonal antibody and SARS CoV-2spike monoclonal antibody.The self-made control products’applicability,homogeneity and stability were evaluated.SARSCoV-2 antibody survey samples were prepared by diluted SARS-CoV-2 antibody quality control products,and distributed to clinical laboratories.According to the results,the clinical use was assessed.Results SARS-CoV-2 antibody quality control products can be applied to 17 SARS-CoV-2 detection systems,their applicability were acceptable.SARS-CoV-2 antibody testing quality control products’homogeneity meet the requirement in colloidal gold detection system D,and their detection results(S/Co)in chemiluminescence detection system K,J and I were 397.67±23.83(F=0.77,P=0.74),2.80±0.23(F=0.38,P=0.76)and 36.09±0.50(F=0.55,P=0.91),and their homogeneity was acceptable.The t-value of 15 repeated freeze-thaw cycles was between 0.022 and 1.44,and the t-value of long-term storage for 6 months was between 0.024 and 1.950.Compared with the results of the 0 day(times),their P-value were all above 0.05,and their stability was acceptable.In this study,95 survey results were returned,which consisted of 8 colloidal gold systems and 11 chemiluminescence systems.The occurrence of“false negatives”in some detection systems was mainly related to the sensitivity of the detection system.Conclusion The self-made SARS-CoV-2 antibody detection quality control products’performance which including applicability,homogeneity and stability are acceptable.They can meet the requirements of clinical quality control and can be applied to indoor quality control and external quality assessment in SARS-CoV-2 antibody detection items.

关 键 词：新型冠状病毒抗体 血清质控品 实验室评价 

分 类 号：R446[医药卫生—诊断学]