Evaluate Performance of the Self-made Quality Control Products for C Peptide by Mixed Serums / 现代检验医学杂志

ABSTRACT

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.