[1]李全双,许 靖,吴 燕,等.朗道血清质控品作为ELISA 法检测血清可溶性ST2 室内质控物的可行性探讨[J].现代检验医学杂志,2022,37(05):190-193.[doi:10.3969/j.issn.1671-7414.2022.05.038]
　LI Quan-shuang,XU Jing,WU Yan,et al.Feasibility Study on RANDOX Serum Quality Control Products as ELISA Method to Detect Serum Soluble ST2 Internal Quality Control Materials[J].Journal of Modern Laboratory Medicine,2022,37(05):190-193.[doi:10.3969/j.issn.1671-7414.2022.05.038]
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朗道血清质控品作为ELISA 法检测血清可溶性ST2 室内质控物的可行性探讨()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第37卷
期数:
2022年05期
页码:
190-193
栏目:
质量控制·实验室管理
出版日期:
2022-09-15

文章信息/Info

Title:
Feasibility Study on RANDOX Serum Quality Control Products as ELISA Method to Detect Serum Soluble ST2 Internal Quality Control Materials
文章编号:
1671-7414（2022）05-190-04
作者:
李全双; 许 靖; 吴 燕; 王书安; 杨艳君
徐州市中心医院/ 徐州市医学科学研究所，江苏徐州 221006
Author(s):
LI Quan-shuang;  XU Jing;  WU Yan;  WANG Shu-an;  YANG Yan-jun
Xuzhou Central Hospital/Xuzhou Institute of Medical Sciences, Jiangsu Xuzhou 221006, China
关键词:
可溶性生长刺激表达基因2 蛋白（sST2）; 质控品; 室内质控(IQC)
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2022.05.038
文献标志码:
A
摘要:
目的　探讨朗道血清质控品作为酶联免疫吸附（enzyme-linked immunosorbent assay, ELISA）法检测血清可溶性生长刺激表达基因2 蛋白（soluble growth stimulation expressed gene 2 protein, sST2）室内质控物的可行性。方法　连续性倍比稀释试剂盒中的sST2 标准品来确定标准值和空白。使用双抗体夹心ELISA 法检测sST2 浓度，结果用线性回归拟合，建立标准曲线并计算相关系数（r），确定线性范围。取朗道血清质控品中值Level 2 和高值Level3 进行纯水复溶，分别混合均匀后用无菌EP 管分装，-20℃冷冻保存。参照中国合格评定国家认可委员会发布的《CNAS-GL03 能力验证样品均匀性和稳定性评价指南》，首先进行均匀性验证，从分装的中值Level 2 质控品中随机抽取10 管，重复检测两次，用单因素方差分析比较两次测量值；然后进行稳定性验证，随机取中值Level 2 质控品6 管，每管重复检测两次，将所得均值作为初始均值，分别于第3，6，9 和12 个月随机抽取6 管，同样方法获得均值并分别与初始均值进行t 检验比较。高值Level 3 评价方法与Level 2 相同。结果　在3.125 ～ 200.0 ng/ml 范围区间，按标准品sST2 的结果建立标准曲线（r=0.99）。在均匀性检验中，中值Level 2 和高值Level3 中的 F 值分别为1.932，0.519，P 值分别为0.181，0.481，差异均无统计学意义（均P ＞ 0.05）。在中值Level 2 和高值Level 3 中sST2 的初始均值分别是20.03 ng/ml，22.01 ng/ml。在中值Level 2 中，第3，6，9 和12 个月的均值分别与初始均值进行t 检验(t =0.857， 0.506， 0.683，1.144；P =0.412，0.624，0.510，0.279)，差异均无统计学意义（均P ＞ 0.05）；同样在Level 3 中，t 值分别为0.260，0.639，0.660，1.372；P 值分别为0.800，0.537，0.524，0.200，差异均无统计学意义（均P ＞ 0.05）。结论　在朗道血清质控品中值Level 2 和高值Level 3 中，sST2 的浓度均较低且均匀性和稳定性好，因此二者均可以作为sST2 低值质控品。
Abstract:
Objective　To explore the feasibility of Randox serum quality control products as soluble growth stimulation expressed gene 2 protein（sST2） internal quality control materials. Methods　The standard values and blank were determined by diluting the sST2 standard in the kit by serial dilutions. Double-antibody sandwich enzyme-linked immuno sorbent assay （ELISA） was used to detect the concentration of sST2, the results were fitted with linear regression. The standard curve was established and the correlation coefficient (r) was calculated to determine the linear range. The median-value Level 2 and highvalue Level3 of RANDOX serum quality control products were reconstituted with pure water, mixed them evenly, sub pack them with sterile EP tube and freeze them at -20℃ . According to the “CNAS-GL03 Guidelines for the Evaluation of Homogeneity and Stability of Proficiency Testing Samples”issued by the China National Accreditation Service for Conformity Assessment, 10 tubes were randomly selected from the Level 2 quality control materials for homogeneity verification firstly, repeated the test twice, and used one-way analysis of variance for homogeneity test. Then 6 tubes of Level 2 quality control were randomly selected for stability verification, each tube was tested twice, and the average value obtained was used as the initial monthly average, and 6 tubes were randomly selected at the 3rd, 6th, 9th and 12th months. Finally, these average values were obtained by the same method and compared with the initial average value by t test. The evaluation method of Level 3 was the same as that of Level 2. Results　In the range of 3.125 ng/ml to 200.0 ng/ml, the standard curve established by the results of the standard sST2 （r=0.99）. In the homogeneity test, values of Level 2 and level 3 were 1.932，0.519 respectively，and the difference was not statistically significant ( P = 0.181，0.481，all P ＞ 0.05). The initial mean values of sST2 were 20.03 ng/ml and 22.01 ng/ml in Level 2 and Level 3, respectively. In the Level 2, the mean values of the 3rd, 6th, 9th, and 12th months were compared with the initial mean by t-test, the differences were not statistically significant ( t=0.857, 0.506, 0.683, 1.144; P =0.412, 0.624, 0.510, 0.279，all P ＞ 0.05). Also in Level 3, the t values were 0.260, 0.639, 0.660 and 1.372 respectively，and the differences were not statistically significant(P = 0.800, 0.537, 0.524, 0.200, all P ＞ 0.05). Conclusion　In the median-value Level 2 and highlevel Level 3 of RANDOX serum quality control products,the concentration of sST2 were low and the homogeneity and stability were good, so both of them can be used as the low-value quality control product of sST2.

参考文献/References:

[1] 宋丽颖, 袁慧. 可溶性ST2 在心血管相关疾病排除诊断和治疗监测的应用前景[J].中华检验医学杂志,2020, 43(3):239-244.
SONG Liying, YUAN Hui. Soluble ST2 is promising in the diagnosis of cardiovascular disease exclusion and therapy monitoring[J]. Chinese Journal of Laboratory Medicine ,2020,43(3):239-244.
[2] 贝雪艳, 李军, 曲忠慧, 等.血浆sST2 水平对老年心力衰竭患者死亡风险的评估价值[J]. 山东医药,2018, 58(1):51-53.
BEI Xueyan, LI Jun, QU Zhonghui, et al. Evaluation of the value of plasma sST2 level on the risk of death in elderly patients with heart failure[J].Shandong Medical Journal,2018,58(1):51-53.
[3] 罗年桑, 张海峰, 刘品明, 等.血清sST2 联合白细胞介素-33 对射血分数保留的心力衰竭辅助诊断价值的初探[J]. 中华心血管病杂志, 2017, 45（3）：198-203.
LUO Niansang, ZHANG Haifeng, LIU Pinming,et al.Diagnostic value of combining serum soluble ST2 and interleukin-33 for heart failure patients with preserved left ventricular ejection fraction [J]. Chinese Journal of Cardiology,2017,45(3):198-203.
[4] 何智余, 武锋超, 马兰虎, 等. H2S 和sST2 与射血分数降低的心力衰竭的相关性研究[J]. 临床心血管病杂志, 2020, 36(10):930-935.
HE Zhiyu, WU Fengchao, MA Lanhu,et al. Correlation between H2S,soluble ST2 and heart failure with reduced ejection fraction [J]. Journal of Clinical Cardiology,2020,36(10):930-935.
[5] 蒋玲丽, 黄中强, 王雪亮, 等.表皮生长因子受体（EGFR）基因突变检测质控品制备及应用[J]. 现代检验医学杂志, 2020, 35(2):145-147,152.
JIANG Lingli, HUANG Zhongqiang, WANG Xueliang,et al. Development and application of quality control materials for epidermal growth factor receptor (EGFR) mutation determination [J]. Journal of Modern Laboratory Medicine,2020,35(2):145-147,152.
[6] 王云平, 梁新妹, 郑笑荣, 等. 可溶性ST2 在心力衰竭合并心房颤动患者中的水平及临床意义[J]. 中华检验医学杂志, 2019, 42(11):933-941.
WANG Yunping, LIANG Xinmei, ZHENG Xiaorong, et al. The level and clinical significance of soluble ST2 in heart failure patients with atrial fibrillation [J]. Chinese Journal of Laboratory Medicine,2019,42(11):933-941.
[7] 闫福堂, 苏宝凤, 詹颉, 等. 血清sST2 与血BNP 在心力衰竭患者中的相关性研究[J]. 现代检验医学杂志, 2015, 30(6):78-79, 83.
YAN Futang, SU Baofeng, ZHAN Jie, et al. Correlation between serum soluble ST2 and BNP in patients with heart failure [J]. Journal of Modern Laboratory Medicine,2015,30(6):78-79,83.
[8] 胡晓飞, 许世佳, 孙红, 等.三种生物学标志物在心力衰竭患者诊断中的应用[J]. 中华老年心脑血管病杂志, 2018, 20(2):161-163.
HU Xiaofei, XU Shijia, SUN Hong, et al. Application of three biomarkers in diagnosis of heart failure[J].Chinese Journal of Geriatric Heart Brain and Vessel Diseases, 2018, 20(2):161-163.
[9] 冯仁丰. 临床检验质量管理技术基础[M].2 版. 上海：上海科学技术文献出版社, 2003:110-111, 229-238.
FENG Renfeng. The Quality Management Technique Bases in Clinical Laboratory[M].2th Ed.Shanghai:Shanghai Science and Technology Literature Press,2007:110-111, 229-238.
[10] 叶应妩, 王毓三, 申子瑜.全国临床检验操作规程[S].3 版.南京：东南大学出版社, 2006:47-99.
YE Yingwu, WANG Yusan, SHEN Ziyu. National guide to clinical laboratory procedures[S]. 3th Ed.Nanjing: Southeast University Press, 2006:47-99.
[11] 王运红, 周琼, 安涛, 等.中国社区人群可溶性ST2血浆水平的参考值范围及影响因素[J]. 中华心血管病杂志, 2015, 43(10):900-903.
WANG Yunhong, ZHOU Qiong, AN Tao, et al.Reference value and clinical correlates of soluble ST2 in healthy community-based Chinese population [J].Chinese Journal of Cardiology, 2015, 43(10): 900-903.

相似文献/References:

[1]蒋玲丽,黄中强,王雪亮,等.表皮生长因子受体（EGFR）基因突变检测质控品制备及应用[J].现代检验医学杂志,2020,35(02):145.[doi:10.3969/j.issn.1671-7414.2020.02.040]
　JIANG Ling-li,HUANG Zhong-qiang,WANG Xue-liang,et al.Development and Application of Quality Control Materials for EpidermalGrowth Factor Receptor （EGFR）Mutation Determination[J].Journal of Modern Laboratory Medicine,2020,35(05):145.[doi:10.3969/j.issn.1671-7414.2020.02.040]

备注/Memo

备注/Memo:
作者简介： 李全双（1982-），男，本科，医学学士，副主任技师，主要从事临床检验诊断工作，E-mail：182001824@qq.com。
许靖（1993-），女，硕士，检验技师，主要从事临床检验诊断工作，共同第一作者。
通讯作者：杨艳君，女，主任医师。
更新日期/Last Update: 2022-09-15