血浆总同型半胱氨酸检测系统的方法学评价和量值溯源

Metrological traceability and methodological evaluation of unclosed detection system of total homocysteine

目的：评价自建血浆总同型半胱氨酸（total homocysteine,tHcy）开放系统的分析性能,探讨量值溯源的临床实际应用。方法：应用美国临床和实验室标准化协会系列文件,对AXIS-SHIELD公司tHcy试剂盒进行方法学评价,包括不精密度、分析测量范围、不准确度、抗干扰性及参考区间的验证。结果：tHcy在浓度为15.5μmol/L时,总不精密度为2.94%;分析测量范围为4.5~40.4μmol/L;相关结果与雅培公司Axsym免疫分析系统的结果显著相关（r=0.988,P〈0.05）,在医学决定水平下的系统误差小于1/2最适允许误差8.9%。三酰甘油〈14 mmol/L、血红蛋白〈10 g/L、总胆红素〈300 mg/L时,AXIS-SHIELD公司tHcy检测不受干扰;男、女各20例参考个体的检测结果均在厂商提供的参考区间内。结论：自建同型半胱氨酸开放系统的不精密度、分析测量范围、不准确度、抗干扰能力均符合临床要求;临床实验室需了解各个检测项目的溯源性以更好地保证检测结果的准确性和可靠性。

Objective： To evaluate the performance and metrological traceability of the unclosed detection system of tHcy. Methods： The precision, analytical range of measurement, interference, and accuracy of AXIS-SHIELD tHcy kit evaluated with CLSI and reference interval was determined. Results： As the concentration of tHcy was 15.5 μmol/L, total CV was only 2.94%, and analytical range of measurement was 4.5-40.4 μmol/L, and the assay data had significant correlation with that of the Axsym （r=0.988, P〈0.05） at the medical decide levels. When triglyceride〈14 mmol/L, haemoglobin〈10 g/L, bilirubin〈300 mg/L, the sample were not significantly interfered in the assay. The reference interval of tHcy provided by the manufacturer was confirmed in 20 healthy man and 20 healthy women. Conclusions： The main performance of the unclosed detection system of tHcy could meet the needs of clinical diagnosis and research. Clinical laboratory should pay attention on the importance of traceability of the detection system.