酶转换法测定同型半胱氨酸的方法学评价

Evaluation of the Enzyme Conversion Method to Detect Hcy

目的对酶转换法测定同型半胱氨酸(Hcy)进行方法学评价,以确定其分析性能是否符合临床实验室使用的要求。方法根据NCCLS文件和已建立的方法对酶转换法测定Hcy的精密度、线性、方法学比较、干扰试验、回收率、试剂稳定性等进行评价和比较。结果酶转换法测定Hcy的精密度(批内、批间、日间、总CV均<5.0%)较高;Hcy浓度在0～40μmol/L内,呈线性关系;酶转换法和循环酶法测定Hcy结果两者相关性良好(r2=0.924,n=60),测定结果的可靠性是相同的(t=0.08,P>0.05);血红蛋白(Hb)<2g/L、甘油三酯(TG)<72mmol/L,总胆红素(Tbil)<340μmol/L,维生素C(VitC)<10.0g/L时,酶转换法测定Hcy干扰相对偏差<10.0%;回收率为101.25%;试剂稳定性较好。结论酶转换法测定Hcy具有较高的精密度、较宽的线性、较强的抗干扰能力,结果准确可靠,适合在临床实验室使用。

Objective To evaluate the enzyme conversion detection method in Hcy in order to determines that the analysis perform ance can meet the clinical lab requirement or not. Methods It evaluated the enzyme conversion method to detect Hcy precision, linearity, method comparison, interference, recovery and stability by the NCCLS and the established method. Results Precision of enzyme conversion method is higher, the CV of intra- batch, inter- batch and between- run individual was less than 5% ,the consistencies of Hey were within 0 -40μmol/L and shows a linearity relation. The Hey were detected by the enzymatic cycling assay or the enzyme conver- sion were better correlation （ r2 = 0. 924, n = 60 ） and consistency （ t = 0.08, P 〉 0.05 ）. Enzyme conversion detection, The interference relative bias was 〈 10.0% and the recovery was 101.25% by the enzyme conversion method to detect Hey when Hb was less than 2g/L,TG was less than 72 mmol/L, Tbil was less than 340μmol/L and VitC was less than 10. 0g/L. However, it showed excellent stability.. Conclusion The enzyme conversion detection of Hcy with better precision,wider working range,better anti - Interference and reliable re- suits is a suitable method to be used in lab.