新生牛血清血红蛋白含量测定能力的验证

Laboratory proficiency testing for determination of hemoglobin content of new born calf serum

目的验证各实验室检测新生牛血清血红蛋白含量的能力。方法采用纤维蛋白原析出法制备验证样品,并采用单因素方差考察样品的均匀性,t检验考察稳定性。组织24家实验室采用《中国药典》三部(2015版)规定的方法对验证样品进行检测,以各实验室结果的中位值作为样品血红蛋白的指定值,标准化四分位距(normalised interquartile range,NIQR)作为变动性度量值(目标标准偏差),计算Z比分数(Z值)。结果验证样品具有良好的均匀性及稳定性。24家实验室中,2家退出,20家检测结果为"满意"(|z|≤2),2家为"不满意"(|z|≥3)。结论参加验证的实验室满意率总体达89.5%,未取得满意结果的实验室可通过分析问题,找出原因并采取相应的整改措施。

Objective To evaluate the capacity of laboratories which participated in the proficiency testing for hemoglobin content of new born calf serum. Methods The test samples were prepared by fibrinogen precipitation,and evaluated for homogeneity by one-way ANOVA,and for stability by t test. The study was performed according to the requirements in Chinese Pharmacopoeia（Volume Ⅲ,2015 edition）by 24 laboratories. Z-scores were calculated serving the median values of test results by the laboratories as the specified values of test samples while the normalised interquartile range（NIQR）as variable metric value（target standard deviation）. Results All the test samples showed high homogeneity and stability.Two of the 24 laboratories withdrew the study. However,the test results by 20 of the other 22 laboratories were satisfactory（｜ z ｜ ≤ 2）while those by 2 laboratories were unsatisfactory（｜ z ｜ ≥ 3）. Conclusion Satisfactory results were obtained by 89. 5% of the laboratories participating the study. Measures should be taken in the laboratories by which unsatisfactory results were obtained to find the cause.