【摘要】 目的对循环酶法同型半胱氨酸测定试剂盒进行临床应用评价,以确定其分析性能是否符合临床实验室应用的要求。方法依据美国国家临床实验室标准化委员会(NCCLS)颁布的EP5A,EP6A,EP7A分别对九强公司生产的循环酶法同型半胱氨酸测定试剂盒进行了精密度评价、线性评价和抗干扰实验。结果高、低浓度水平的批内精密度CV分别为1.23%和3.87%,总精密度CV分别为2.60%和4.03%。线性范围:在0～50.0mol/L范围内,测定结果为线性。结合胆红素在20mg/dl、乳糜在1.2%、抗坏血酸在30mg/dl以内,对试验无明显的干扰,干扰相对偏差<4%。血红蛋白在13.3g/L内,干扰偏差不大于7%。结论北京九强公司生产的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。更多还原

【Abstract】 Objective To evaluate the kit developed for the in vitro quantitative determination of Homocystteine in serum or plasma on basis of precision, linearity and interference testing.Methods Performance characteristics such as precision, linearity,interference testing of the kit were evaluated respectively according to EP5-A, EP6-A, EP7-A issued by the National Committee on Clinical Laboratory Standards (NCCLS).Results The CVs of within-run and total precisions at low concentration level (Hcy 7.0 mol/L) are 3.87% and 4.03% respectively, CVs of within-run and total precisions at high concentration level(Hcy 29.0 mol/L) are 1.23% and 2.60% respectively. The linear range is 0-50.0 μmol/L.When the concentration of conjugated bilirubin is at 20 mg/dl or chyle at 1.2% or ascorbic acid at 30 mg/dl, produced interference deviation is less than 4%.And the 13.3% of hemoglobin concentration produced less than 7% interference deviation.Conclusion Performance of precision, linearity and interference testing of the homocysteine assay kit produced by JiuQiang Company can fulfill the requirements of clinical laboratory.更多还原