[1]张培育,邓演超,李全双.自制C肽质控品及其性能评价[J].现代检验医学杂志,2016,31(03):156-157.[doi:10.3969/j.issn.1671-7414.2016.03.044]
　ZHANG Pei-yu,DENG Yan-chao,LI Quan-shuang.Evaluate Performance of the Self-made Quality Control Products for C Peptide by Mixed Serums[J].Journal of Modern Laboratory Medicine,2016,31(03):156-157.[doi:10.3969/j.issn.1671-7414.2016.03.044]
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自制C肽质控品及其性能评价()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第31卷
期数:
2016年03期
页码:
156-157
栏目:
质量控制·实验室管理
出版日期:
2016-06-15

文章信息/Info

Title:
Evaluate Performance of the Self-made Quality Control Products for C Peptide by Mixed Serums
作者:
张培育1; 邓演超2; 李全双2
1.新沂市人民医院检验科,江苏新沂 221400;
2.徐州市医学科学研究所,徐州市中心医院,徐州市糖尿病研究所,江苏徐州 221006
Author(s):
ZHANG Pei-yu1; DENG Yan-chao2; LI Quan-shuang2
1.Department of Clinical Laboratory,Xinyi People's Hospital,Jiangsu Xinyi 221400,China;
2.Xuzhou Institute of Medical Sciences Laboratory, Xuzhou Center Hospital,Xuzhou Diabetes Institute,Jiangsu Xuzhou 221006,China
关键词:
C肽;  化学发光法;  混合血清;  室内质控
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2016.03.044
文献标志码:
A
摘要:
目的 应用化学发光法检测血液C肽时,实验室缺乏相应的质控品。探讨自制C肽混合血清质控品作为该法测定C肽室内质控品的可行性。方法 从糖尿病患者和健康体检血清中分别收集C肽低值血清(浓度在1.20 ng/ml左右)和高值血清(浓度在12.00 ng/ml左右),排除溶血、黄疸及脂浊血清,防止细菌污染,乙型肝炎表面抗原、丙型肝炎病毒、人类免疫缺陷病毒指标均为阴性,然后分别进行混合、防腐、分装,-20℃保存。使用西门子公司化学发光C肽试剂盒进行测定,对自制C肽混合血清质控品进行性能评价。结果 低值、高值两个水平的血清C肽质控品的批内不精密度分别是4.46%和4.15%; 天间不精密度分别是6.00%,5.56%; -20℃保存稳定期至少6个月; 经单因素方差分析,每个月之间相比,低值和高值的F值分别是0.665,0.602,P值分别是0.471,0.568,均>0.05,差异无统计学意义; 瓶间无显著性差异。结论 -20℃保存的低值和高值两个水平自制C肽混合血清质控品能够符合室内质控品要求。
Abstract:
Objective When detecting the blood C peptide bychemiluminescence method,used had confronted the lack of quality control.This paper examines the feasibility of self-made C peptide quality control as indoor quality control products.Methods From the serum of diabetic patients and health examination,C peptide low values(concentration around the 1.20 ng/ml)and high value(concentration around the 12.0 ng/ml)were collected,excluding hemolysis,jaundice and tallow serum,preventing bacterial contamination,hepatitis B surface antigen,hepatitis C virus,human immunodeficiency virus indicators are negative; then these serum was mixed respectively,embalmed,packaged,-20 DEG preserved.The performance evaluation of the C peptide mixed serum was carried out using SIEMENS's C peptide reagent kit.Results Low value,high value of two levels of serum C peptide qualitycontrol in batch imprecision respectively were 4.46% and 4.15% respectively.Day not precision respectively were 6.00%,5.56%,-20 DEG saved stability for at least 6 months(P>0.05).Compared with six months by analysis of variance,F value of the low and high values were 0.665,0.602,P values were 0.471,0.568 and the difference was not statistically significant(P>0.05),but the difference among bottles was no significant.Conclusion Two levels value ofthe C peptide in self-made preserved at -20 DEG can meet the requirements of internal quality control products.

参考文献/References:

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备注/Memo

备注/Memo:
作者简介:张培育(1965-),男,本科,副主任技师,研究方向:生物化学及实验室质量控制,Tel:18952295228,E-mail:zhangpeiyu7828@163.com。 通讯作者:邓演超,男,主任技师,研究方向:生物化学及实验室质量控制管理,Tel:15105216123,E-mail:dengychao@126.com。
更新日期/Last Update: 2016-06-25