新鲜混合血清用于乙型肝炎病毒DNA检测室内质量控制的效果评价

The effectiveness evaluation on fresh pooled serum in internal quality control of HBV DNA detection

目的对自制新鲜混合血清用于乙型肝炎病毒(HBV)DNA定量检测室内质控的使用效果作出初步评价。方法收集HBV DNA定量检测值在107copy/mL左右的阳性新鲜血清,分装-70℃保存,初定靶值后用于日常室内质控,并统计出恒定靶值,绘制室内质控图,观察精密度和使用情况。结果首批20个样本测定的均值(x)及批内精密度(OCV)%分别为7.44和1.62%;第1月、第1～2月、第1～3月的检测x及精密度(CV)%分别为7.46和2.93%、7.43和3.10%、7.47和3.09%,精密度均小于2OCV,稳定性良好;统计自制混合血清使用半年在Levey-Jennings质控图上的落点,在控率为92.50%(74/80),警告率为7.50%(6/80),失控率为0%(0/80),使用效果良好。结论自制混合血清可作为室内质控品用于HBV DNA定量检测的质量控制。

Objective To perform preliminary assessment on self-made fresh pooled serum in internal quality control of HBV DNA detection. Methods The positive fresh serum was collected and stored at --70 ℃ which HBV DNA level was about 107 copies/mL. After the initial target value was measured, the fresh pooled serum was used for the daily internal quality control, and the constant target value was calculated. The internal quality control chart was drawn and the precision and effectiveness were assessed. Results As for the 20 samples in the first batch,the mean was 7.44, and the within-run precision was 1. 62%. The mean and detection precision was respectively 7. 46 and 2.93% within the first month,7.43 and 3.10% within the first two months,as well as 7.47 and 3.09% within the first three months. The stability of the detection precisions was satisfactory. By means of counting the points on the Levey-Jennings quality control chart after half a year’s use of the self-made pooled serum,we acquired the following results：the rate of in control 92. 5% （74/80） ; the warning rate 7. 5% （6/80） ; and the out-of-control rate 0% （0/ 80）. Conclusion The self-made pooled serum can be used as preparation for internal quality control for HBV DNA quantitative detection.