[1]丁玮洁,夷 峥,王雪亮,等.自制新型冠状病毒抗体检测质控品及其临床应用评价[J].现代检验医学杂志,2023,38(06):178-184.[doi:10.3969/j.issn.1671-7414.2023.06.033]
　DING Weijie,YI Zheng,WANG Xueliang,et al.Self-made SARS-CoV-2 Antibody Detection Quality Control Products and Its Evaluation for Clinical Use[J].Journal of Modern Laboratory Medicine,2023,38(06):178-184.[doi:10.3969/j.issn.1671-7414.2023.06.033]
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自制新型冠状病毒抗体检测质控品及其临床应用评价()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第38卷
期数:
2023年06期
页码:
178-184
栏目:
质量控制·实验室管理
出版日期:
2023-11-15

文章信息/Info

Title:
Self-made SARS-CoV-2 Antibody Detection Quality Control Products and Its Evaluation for Clinical Use
文章编号:
1671-7414（2023）06-178-07
作者:
丁玮洁1; 2; 夷 峥1; 2; 王雪亮1; 2; 沈兴中3; 黄维纲1; 2
（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）
Author(s):
DING Weijie1; 2;  YI Zheng1; 2;  WANG Xueliang1; 2;  SHEN Xingzhong3;  HUANG Weigang1; 2
（1.Shanghai Center for Clinical Laboratory, Shanghai 200126, China; 2. Shanghai Academy of Experimental Medicine, Shanghai 200126, China; 3.National Institute of Measurement and Testing Technology, Chengdu 610021, China）
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
DOI:
10.3969/j.issn.1671-7414.2023.06.033
文献标志码:
A
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。
Abstract:
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.

参考文献/References:

[1] 李家俊, 郑潇, 盛杰, 等. 新型冠状病毒及其临床检测方法研究进展[J]. 生物技术通报, 2021, 37(4):282-292. LI Jiajun, ZHENG Xiao, SHENG Jie, et al. Novel coronavirus and research progress of related clinical detection methods[J]. Biotechnology Bulletin, 2021,37(4): 282-292.
[2] 王越珉, 雷喜梅, 邬丽, 等. 新型冠状病毒及其检测方法研究进展[J]. 中国计量大学学报, 2020, 31(1):1-7. WANG Yuemin, LEI Ximei, WU Li, et al. A review of severe acute respiratory syndrome coronavirus 2 and its detecting methods[J]. Journal of China University of Metrology, 2020, 31(1): 1-7.
[3] 邹明园, 吴国球. 抗原交叉反应对新型冠状病毒血清特异性抗体检测的影响[J]. 临床检验杂志, 2020,38(3): 161-163. ZOU Mingyuan, WU Guoqiu. Effect of antigen cross reaction on detection of serum specific antibodies against novel coronavirus[J]. Chinese Journal of Clinical Laboratory Science, 2020, 38(3): 161-163.
[4] 罗雪莲, 闫梅英, 吴媛, 等. 新型冠状病毒血清学抗体检测试剂盒现状分析[J]. 疾病监测, 2021, 36(1):29-36. LUO Xuelian, YAN Meiying, WU Yuan, et al. Current status of antibody detection kits for SARS-CoV-2[J].Disease Surveillance, 2021, 36(1): 29-36.
[5] 中国合格评定国家认可委员会. CNAS-GL003:2018《能力验证样品均匀性和稳定性评价指南》 [S]. 北京：中国标准出版社, 2018. China National Accreditation Service for Conformity Assessment . CNAS-GL003:2018 Guidance on Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing[S].Beijing：China Standards Press, 2018.
[6] 张赛, 向乐, 李林海, 等. 新型冠状病毒(2019-nCoV)IgM/IgG 抗体检测试剂的研制及性能评价[J]. 中国生物工程杂志, 2020, 40(8): 1-9. ZHANG Sai, XIANG Le, LI Linhai, et al. Development and performance evaluation of a rapid IgM-IgG combined antibody test for 2019 novel coonavirus infection[J]. China Biotechnology, 2020, 40(8): 1-9.
[7] 唐鹏, 赵自武, 刘颖娟, 等. 化学发光和胶体金法检测新型冠状病毒特异性抗体比较及其临床意义[J].武汉大学学报( 医学版）, 2020, 41(4): 517-520. TANG Peng, ZHAO Ziwu, LIU Yingjuan, et al. Comparison between chemiluminescence and colloidal gold method in the detection of 2019 novel coronavirus specific antibodies and the value in COVID-19 diagnosis and treatment[J]. Medical Journal of Wuhan University,2020, 41(4): 517-520.
[8] 刘国才, 刘智强, 张江, 等. 新型冠状病毒感染后特异性IgM 和IgG 抗体变化规律的初步探索[J]. 实用医学杂志, 2020, 36(13): 1724-1728. LIU Guocai, LIU Zhiqiang, ZHANG Jiang, et al. A preliminary study on the changes of specific IgM and IgG antibody after SARS-CoV-2 infection[J]. The Journal of Practical Medicine, 2020, 36(13): 1724-1728.
[9] 国家卫生健康委员会办公厅, 国家中医药管理局办公室. 国卫办医函〔2020〕184 号: 关于印发新型冠状病毒感染的肺炎诊疗方案( 试行第七版）的通知[EB/OL].(2020-03-04). http://www.nhc.gov.cn/xcs/zhengcwj/202003/46c9294a7dfe4cef80dc7f5912eb1989. shtml.General Office for National Health Commission, National Administration of Traditional Chinese Medicine. Medical Letter of the State Health Office [2020] No.184: Notification on the issuance of COVID-19 medical program (trial seventh edition) [EB/OL].(2020-03-04). http://www.nhc.gov.cn/xcs/zhengcwj/202003/46c9294a7dfe4cef80dc7f5912eb1989.shtml.
[10] 李齐光, 徐令清, 钟国权. 荧光免疫层析法检测2019-nCoV 特异性抗体用于新冠病毒感染筛查价值探讨[J]. 当代医学, 2021, 27(7): 145-146. LI Qiguang, XU Lingqing, ZHONG Guoquan. Fluorescence immunochromatography method to detect 2019-nCoV specific antibodies for the value of new coronavirus infection screening[J]. Contemporary Medicine,2021, 27(7): 145-146.
[11] 王玉珀, 任丽萍, 张明霞. 新型冠状病毒IgM 和IgG抗体检测结果分析及抗体数值变化监测[J]. 中国药物与临床, 2021, 21(6): 1021-1022. WANG Yupo, REN Liping, ZHANG Mingxia. Analysis of novel coronavirus IgM and IgG antibody detection results and monitoring of antibody number[J]. Chinese Remedies & Clinics, 2021, 21(6): 1021-1022.
[12] LI Zhengtu, YI Yongxiang, LUO Xiaomei, et al. Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis[J]. Journal of Medical Virology, 2020, 92(9):1518-1524.
[13] 闫琦, 吴伟祥, 王文强. 两种常用新型冠状病毒抗体检测方法一致性分析[J]. 标记免疫分析与临床,2022, 29(1): 158-160. YAN Qi, WU Weixiang, WANG Wenqiang. A consistency analysis of two commonly used SARS-CoV-2 antibody detection methods[J]. Labeled Immunoassays and Clinical Medicine, 2022, 29(1): 158-160.
[14] LIU Wanbing, LIU Lei, KOU Guomei, et al. Evaluation of nucleocapsid and spike protein-based enzyme-linked immunosorbent assays for detecting antibodies against SARS-CoV-2[J]. Journal of Clinical Microbiology,2020, 58(6): e00461-20.
[15] 上海市医学会检验医学专科分会. 新型冠状病毒核酸和抗体检测临床应用专家共识[J], 国际检验医学杂志, 2020,41(14): 1665-1669. Laboratory Medicine Branch of Shanghai Medical Association. Expert consensus on clinical application of novel coronavirus nucleic acid and antibody detection[J]. International Journal of Laboratory Medicine,2020,41(14): 1665-1669.
[16] 宁明哲, 陶月, 陈雨欣, 等. 新型冠状病毒血清特异性抗体检测的假性问题分析和对策探讨[J]. 现代检验医学杂志, 2020, 35(6): 129-131. NING Mingzhe, TAO Yue, CHEN Yuxin, et al. SARSCoV-2 serological antibody testing: problems of false detections and the solutions[J]. Journal of Modern Laboratory Medicine, 2020, 35(6): 129-131.
[17] 胡纪文, 王恩运, 阚丽娟, 等. 三种化学发光法检测新型冠状病毒(SARS-CoV-2) 抗体试剂盒的临床应用评价[J]. 现代检验医学杂志, 2020, 35(4): 100-105. HU Jiwen, WANG Enyun, KAN Lijuan, et al. Evaluation of clinical application of three chemiluminescence detection kits for detection of novel coronavirus(SARS-CoV-2) antibody[J]. Journal of Modern Laboratory Medicine, 2020, 35(4): 100-105.
[18] 张华, 耿亚松, 王倩, 等. 三种新型冠状病毒抗体检测系统一致性评价[J]. 山东医药, 2021, 61(14): 33-36. ZHANG Hua, GENG Yasong, WANG Qian, et al. Consistency evaluation of three detection systems for anti-SARS-CoV-2 antibodies[J]. Shandong Medical Journal,2021, 61(14): 33-36.
[19] 樊璐. 某血液质控实验室参加CITIC 血液成分细菌检测室间质评结果分析[J]. 实验与检验医学, 2021,39(6): 1402-1406. FAN Lu. Analysis of the results of a certain blood quality control laboratory participating in the CITIC blood composition bacterial testing room quality assessment[J]. Experimental and Laboratory Medicine, 2021,39(6): 1402-1406.
[20] 李虎金, 卢楠, 孙继云, 等. 同型半胱氨酸室内质控物的研制及性能评价[J]. 北京医学, 2020, 42(5):463-464, 467. LI Hujin, LU Nan, SUN Jiyun, et al. Development and performance evaluation of homocysteine indoor quality control products[J]. Beijing Medical Journal, 2020,42(5): 463-464, 467.

备注/Memo

备注/Memo:
基金项目： 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）。
作者简介：丁玮洁（1985-），女，硕士，主管技师，研究方向：质控品的研发和评价，E-mail：dingweijie@sccl.org.cn。
夷峥（1972-），女，大专，经济师，研究方向：质控品的管理，E-mail：yizheng@sccl.org.cn。并列第一作者。
通讯作者： 沈兴中（1984-），男，硕士，副研究员，研究方向：生物计量与检测技术，E-mail: best-196@163.com。
黄维纲（1970-），男，本科，主任技师，研究方向：质控品的管理，E-mail：huangweigang@sccl.org.cn。并列通讯作者。
更新日期/Last Update: 2023-11-15