方法学评价的设计及对葡萄糖试剂盒的评价

Design of Method Evaluation Study and Evaluation of a GLU Determination System

目的 对由希森美康（sysmex）生产的葡萄糖测定试剂盒、校准品、日立7170A组成的葡萄糖测定系统进行了精密度、线性、方法学对比以及干扰实验的研究.方法 分别根据美国临床实验室标准化协会（CLSI）标准文件EP5-A,EP6-A,EP9-A2对系统进行精密度评价、线性评价、方法学对比实验,并选取临床常见的五种干扰物质对试剂盒进行干扰实验.结果 精密度：批内不精密度〈1.0%,总不精密度〈1.2%;线性范围：在0～60 mmol/L,r2=0.998 9;方法学对比：与Roche葡萄糖试剂盒/ROCHE校准品/日立7170A系统测定结果的相关系数r=0.998 3.在选定的医学决定水平,相对偏差小于3%;干扰试验：游离胆红素在20 mg/dl以内、结合胆红素在20 mg/dl以内、乳糜在3 000度以内、抗坏血酸在50 mg/dl以内,血红蛋白在500 mg/dl以内对实验结果无明显影响（偏差在3%以内）.结论 该系统精密度好,线性达到说明书的规定指标,和比对系统间的偏差较小;常见干扰物对其无明显干扰.

Objective To evaluate the GLU determination system composed of Sysmex Kit/calibrator and Hitachi 7170A automatic analyzer ,by studying its precision ,linear range ,interfere factors and method comparison. Methods According to the standard procedures described by CLSI ：EP5-A,EP6-A and EP9-A2,the precision,linear range and method comparison were evaluated. Five clinically common interfere substances were chosen to be used in the study of interfere factors. Results Precision：CVs of between-run were less than 1.0% ,total CVs were less than 1.2%;The linear range was 0- 60retool/L （r^2=0.998 9）;Method comparison： the correlation between evaluation system and Roche GLU kit/callbrator/Hitachi 7170A automatic analyzer was 0. 998 3,the bias was no more than 3% at the chosen concentrations ;Interfere factors ：substance such as free bilirubin ,conjugated bilirubin ,ehyle ,ascorbic ,hemoglobin at the respective concentrations of 20 mg/dl, 20 mg/dl, 3 000 degrees, 50 mg/dl, 500 mg/dl had no significant influence on the assay （bias（3%）. Conclusion GLU determination system composed of Sysmex Kit/calibrator and Hitachi 7170A automatic analyzer has good precision and its linear range is consistent with the specification on instruction sheet. The bias between this system and comparison system is negligible. Clinically common interfere substance has no significant compact on the assay