摘要
目的在临床开展新项目血清胃蛋白酶原Ⅰ和II前，用实验评价血清胃蛋白酶原Ⅰ和Ⅱ检测系统的性能，评估是否能满足临床使用要求。方法使用厂家配套的正常值质控品和异常值质控品测定胃蛋白酶原Ⅰ和Ⅱ检测系统的批内精密度、批间精密度和准确度，利用厂家提供的样品和方法进行线性、前带和检出限评价。结果待评胃蛋白酶原Ⅰ检测系统正常值质控、异常值质控批内CV分别为1．38％和o．29Yo，批间CV分别为1．98％和1．25％。待评胃蛋白酶原Ⅱ检测系统正常值质控、异常值质控批内CV分别为0．58％和0．30％，批间Cy分别为1．12％和o．96％。待评检测系统批内精密度和批问精密度都达到了规定要求。胃蛋白酶原Ⅰ和Ⅱ检测系统所测样品结果都在靶值土20％范围内，准确度达到了规定要求。胃蛋白酶原I线性回归方程和相关系数分别为y=1．026X-2．4，R2=0．9996；胃蛋白酶原Ⅱ线性回归方程和相关系数分别为y=o．989X-0．24，R2=0．9995。胃蛋白酶原Ⅰ和Ⅱ检测系统线性与说明书相符。胃蛋白酶原I和Ⅱ检测系统浓度达到线性范围5倍时也不会出现前带现象。胃蛋白酶原Ⅰ和Ⅱ检出限分别为2／μg／L和1pg／L。结论血清胃蛋白酶原Ⅰ和Ⅱ检测系统的性能较好，能满足临床使用要求。
Objective To evaluate the performance of pepsinogen Ⅰ/Ⅱ （PG I/Ⅱ） detecting system,and additionally to discuss its application feasibility in clinic. Methods Quality control materials for both normal value and abnormal value were utilized to measure the within-run precision,between-run precision and the accuracy of the PG Ⅰ and PG Ⅱ detecting system. And the samples and methods of the linear regression,frontal zone phenomenon and detection limit were provided by the manu- facturer. Results In PG Ⅰ detection system, the within-run CV of normal value and abnormal value were 1.38%and 0.29 respectively,and the between-run CV of that were 1. 98% and 1.25%. In terms of PG Ⅱ detecting system, the within-run CV of normal value and abnormal value were 0. 58 %and 0.30 G respectively, and the between-run CV of that were 1.12 % and 0.96%. Both the within-run and between-run precision met the requirement of the manufacturer. Inaddition,detected by PG Ⅰ and PG Ⅱ detecting system,the accuracy of samptesranged within±20% of the target value,which met the demand of clinical application. The linearity of PG I and PG Ⅱ detecting system results were coincided with the instructions as the linear regression and coefficient were Y= 1.02 6X-2.4,R2 = 0. 999 6 and Y= 0. 989X-0.24,R2 = 0.9 99 5 respectively. Ad- ditionally,there was no presence of frontal zone phenomenon when the concentration of PG Ⅰ and PG Ⅱ detecting system accelerated to five-folds of linear range. The detecrion limit were 2 μg/L for PG I detecting system and Ⅰ μg/L in terms of PG Ⅱ detecting system. Conclusion The serum PG Ⅰ and serum PG Ⅱ detection system has a good performance,which meets the requirements for clinical use.
出处
《现代检验医学杂志》
CAS
2012年第6期110-112,共3页
Journal of Modern Laboratory Medicine
