人降钙素原定量检测方法学评价

Quantitative Detection System Performance Evaluation of Human Procalcitonin

目的 评价深圳市晋百慧生物有限公司生产的人降钙素原（PCT）定量检测系统（简称晋百慧PCT定量检测系统）的检测性能.方法 以罗氏PCT检测系统为参比系统,晋百慧PCT定量检测系统为待评系统.在待评系统连续测定两浓度质控品（0.5 ng/ml,10 ng/ml）20次计算其变异系数（CV）评价其重复性,连续测定20个工作日计算其CV评价其天间不精密度;根据EP6-A文件配置不同标本浓度（0,0.5,1,2,5,10,20,50 ng/ml）计算其线性范围.收集200例患者血清标本,根据EP9-A3文件在待评系统与参比系统进行比对试验判断两者的可比性.结果 待评系统重复性为不同浓度质控品的CV分别为3.59％,1.57％,天间不精密度分别为7.02％,3.82％;在0～50 ng/ml范围为线性.比对试验线性决定系数R2 =0.968 6（Pearson相关分析α=0.05,P＜0.001）,在有医学意义浓度0.5 ng/ml处相对偏差为9％.结论 晋百慧PCT定量检测系统精密度好,检测范围宽,与参比系统具有可比性,能满足临床检测要求.

Objective To evaluate the quantitative detection system performance of human procalcitonin （PCT） produced by Gene Bio Health. Methods Roche pCT detection system was used as the reference system and Gene Bio Health PCT quanti- tative detection system was used as evaluated system. In evaluated system,the repeatability was evaluated by continuous de- termination two concentration quality control （0.5,10 ng/ml） 20 times to calculate the coefficient variation （CV）. Between day imprecision was evaluated by continuous determination 20 working days to calculate the CV. The linear range was calcu- lated according to the EP6-A file by determination different samples （0,0.5 ng/ml, concentration of 1,2,5,10,20 and 50 ng/ ml）. Comparability test was done according to EP9-A3 file by determination 200 patients serum samples between both sys- tems. Results The CV of repeatability was 3.59% and 1.57%, respectively. The CV of between days imprecision was 7.02 % and 3.82 % ,respectively. The linear was from 0 ng/ml to 50 ng/ml. Comparison test of determination R2=0. 968 6 （Pearson correlation analysis,α=0.05, P〈0. 001）. The relative deviation was 9 % in medical significance concentration of 0.5 ng/ml. Conclusion Compared with the Roche PCT, the Gene Bio Health PCT quantitative testing system had a good precision,a wide linear range,and a good comparability,which was enough to meet the clinical requirement.