循环酶法测定同型半胱氨酸的临床研究

目的对循环酶法测定同型半胱氨酸方法进行临床评价。方法依据美国临床实验室标准化委员会(NCCLS)评价方案对循环酶法同型半胱氨酸测定方法进行了精密度、线性和抗干扰试验评价。结果批内精密度CV小于3.45%,总精密度小于3.78%。线性范围:在0~50.0 mol/L范围内呈线性。胆红素在700μmol/L、TG在8.0 mmol/L、抗坏血酸在30 mg/dL以内,对试验无明显的干扰,干扰相对偏差小于4%。血红蛋白在150 g/L内,干扰偏差小于5.2%。结论循环酶法同型半胱氨酸检测试剂盒在测定精密度、线性范围、抗干扰等方面的性能可以满足临床检测的需要。

Clinical research of enzymatic cycling assay for detecting homocysteine

Objective To perform the clinical evaluation on the enzymatic cycling assay for detecting homocysteine（Hcy）.Methods The performance characteristics such as precision,linearity,interference testing of the kit were evaluated respectively according to the evaluating scheme issued by the National Committee on Clinical Laboratory Standards（NCCLS）.Results CV of within-run was less than 3.45% and the total CV was less than 3.78%.The linear range was 0-50.0 μmol/L.When the concentration of conjugated bilirubin was within 700 μmol/L,TG within 8.0 mmol/L and ascorbic acid within 30 mg/dL,there was no obvious interference to test.The relative deviation of interference was less than 4%.And the hemoglobin concentration of 150 g/L produced less than 5.2% interference deviation.Conclusion The performance of precision,linearity and interference testing of the homocysteine enzymatic cycling assay kit can fulfill the requirements of clinical laboratory.