自制C肽质控品及其性能评价  

Evaluate Performance of the Self-made Quality Control Products for C Peptide by Mixed Serums

作　　者：张培育 邓演超 李全双[2] 

机构地区：[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

出　　处：《现代检验医学杂志》2016年第3期156-157,161,共3页Journal of Modern Laboratory Medicine

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。Objective When detecting the blood C peptide by chemiluminescence method,used had confronted the lack of qual-ity 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 ser-um,preventing bacterial contamination,hepatitis B surface antigen,hepatitis C virus,human immunodeficiency virus indica-tors are negative;then these serum was mixed respectively,embalmed,packaged,-20 DEG preserved.The performance e-valuation 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 quality control in batch imprecision respectively were 4.46% and 4.15% respective-ly.Day not precision respectively were 6.00%,5.56%,-20 DEG saved stability for at least 6 months （P〉0.05）.Com-pared 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 of the C peptide in self-made preserved at -20 DEG can meet the requirements of internal quality control products.

关 键 词：C肽 化学发光法 混合血清 室内质控 

分 类 号：R446[医药卫生—诊断学]