Preparation and Application Evaluation of Weak Positive Quality Control Products by Chemiluminescence Method
Objective To explore the feasibility of self-made weak positive quality control materials in the application of internal quality control.Methods The serum of patients with positive four infectious indicators[hepatitis B surface antigen(HBsAg),hepatitis C antibody(HCV-Ab),treponema pallidum specific antibody(TP-Ab),human immunodeficiency virus antigen antibody(HIV-Ag/Ab)]in Aier Eye Hospital,Wuhan University was collected.The above positive serum was diluted to about 3 times the critical value with the serum of negative patients as self-made weak positive quality control products,stored in the refrigerator at-20℃ after subpackaging,evaluated its uniformity,stability at thaw 4 ℃ and stability at-20 ℃ storage for 4 months,the 30-day test value of self-made weak positive quality control product was compared with that of original Abbott quality control product.Results The results of HBsAg,HCV-Ab,TP-Ab and HIV-Ag/Ab weakly positive quality control products were compared between the two groups[(0.153±0.009)IU/mL vs.(0.154±0.008)IU/mL,(3.48±0.23)S/CO vs.(3.50±0.19)S/CO,(4.27±0.22)S/CO vs.(4.24±0.18)S/CO,(3.02±0.15)S/CO vs.(3.04±0.16)S/CO],there were no statistical significances(P>0.05),and the homogeneity evaluation was passed.The 30 d test results of the self-made weak positive quality control products are basically consistent with the original quality control products[(0.152±0.007)IU/mL vs.(0.154±0.008)IU/mL,(3.56±0.17)S/CO vs.(3.53±0.21)S/CO,(4.42±0.17)S/CO vs.(4.21±0.20)S/CO,(3.04±0.15)S/CO vs.(2.99±0.15)S/CO],there were no statistical significances(P>0.05).The self-made weakly positive quality control products after remelting were stored in a refrigerator at 4 ℃,and the coefficient of variation(CV)of each index quality control product was<15%(6.58%,5.95%,5.91%,5.92%)for continuous determination for 20 days.There was no statistical significance in the results of self-made weakly positive quality control products(P>0.05).Conclusion Our self-made weakly positive infectious quality control products have good uniformity and stability.When stored at-20 ℃,they can be stable for at least 4 months.During the stable period,they can replace imported quality control products for indoor quality control.
chemiluminescenceinfectious indicatorsself-made quality control productsinternal quality controlhomogeneitystability
万方数据
维普
