两种方法测定胆红素结果对比及偏差评估

Comparison between two methods for determination of bilirubin and bias estimation

目的在全自动生化分析仪上使用国产康特和日本OLYMPUS公司试剂共同检测临床患者血清总胆红素与结合胆红素。对比国产试剂(氧化酶法)与原装配套试剂(重氮法)的准确性和可靠性。方法依据美国临床实验室标准化委员(NCCLS)EP9-A文件要求,每天按要求抽取临床样本8份,分别用两种试剂共同测定5 d,以康特试剂为实验方法,日本OLYMPUS公司试剂为对比方法,共测定40份新鲜血清总胆红素与结合胆红素,然后对结果进行分析。结果两种试剂测定的血清总胆红素与直接胆红素结果的相关系数分别为0.995和0.983,无方法间的离群点,测定结果的偏差在允许误差范围内。结论经过方法对比及偏差评估发现,国产试剂检测总胆红素与结合胆红素结果符合相关实验要求,可以用国产试剂替代进口试剂进行胆红素测定,从而降低成本。

Objective To compare the accuracy and reliability between the domestic reagents provided by the ComTech company and the original matching reagents provided by the Japan Olympus company for detecting serum total bilirubin and direct bilirubin with the fully automatic biochemical analyzer. Methods Based on the requirement of the National Committee for Clinical Laboratory Standards（NCCLS） EPg, 8 clinical samples per day were collected as required and detected by using the two kinds of reagents for 5 d, respectively. The ComTech reagents were used as the experimental method and the Japan Olympus reagents as the control method. 40 fresh serum samples were detected total bilirubin and direct bilirubin respectively.Then the de- tected results were analyzed. Results The statistical analysis showed that the correlation coefficients in the results of total biliru- bin and direct bilirubin detected by using two kind of reagents were 0.995 and 0.983 ,respectively. There was no outlier between the methods ,the deviations of the test results were within the allowable ranges. Conclusion The method comparison and the bias estimation find that the various indicators of total bilirubin and direct bilirubin detected by using domestic reagents all con- form with the relevant test requirement,the domestic enzyme reagents can be used to replace the imported diazonium reagent for the bilirubin determination, thereby the cost of reagents is reduced.