循环酶法同型半胱氨酸试剂的分析性能验证

Circulation enzymatic homocysteine reagent performance verification

目的对应用于全自动生化分析仪的同型半胱氨酸(Hcy)试剂进行分析性能验证,并应用于临床。方法在日本Olympus AU-640全自动生化分析仪上对四川新成公司生产的循环酶法测定Hcy试剂进行性能验证,参考CLSI EP6-A、EP15-A、EP-7方案对检测方法的精密度、线性范围、干扰因素(胆红素、血红蛋白、乳糜)进行评估,与传统的高效液湘色谱法(HPLC)进行了比对,并对分析前质量控制影响因素进行实验分析。结果精密度实验为批内:CV2.37%(低值)、3.58%(高值),总CV:4.52%(低值)、4.85%(高值);该法与HPLC法相关性良好(r2=0.996,P>0.05);线性范围为2.0~50.0μmol/L,线性相关良好;试验浓度内的3种干扰物(胆红素小于或等于20mg/dL,三酰甘油小于或等于1 000mg/dL,Hb≤150mg/dL)对试剂无显著干扰;采血体位对结果有影响;全血标本1h内分离血清,血清4℃12h内及-20℃15d内结果无明显变化;EDTA与肝素防凝血结果无差异。Hcy水平与心脑血管病发生呈正相关,其阳性检出率高于传统的血脂指标。结论应用于全自动生化分析仪的循环酶法Hcy试剂具有较高的精密度和灵敏度,与HPLC测定相关良好,可满足临床测试要求,适合血清(浆)Hcy的常规和自动化分析。

Objective To do performance verification for full automatic biochemical analyzer of homocysteine reagent analysis and applied in the clinic .Methods In Japan to push around AU‐640 fully automatic biochemical analyzer in sichuan new into the company′s production cycle enzymatic determination of homocysteine (Hcy ) reagent for performance verification ,reference CLSI EP6‐A ,EP15‐A ,EP‐7 scheme for the precision of the detection method ,linear range ,interference factors (bilirubin ,hemoglobin , chyle) assessed ,and the traditional ,the high efficiency liquid chromatography (HPLC) had carried on the comparison ,and the qual‐ity control before the influencing factors of experiment analysis .Results In precision experiments ,batch :CV2 .37 % (underval‐ued) ,3 .58% (high value) ,the total CV :4 .52% (low ) ,4 .85% (high value);In good correlation with HPLC method (r2 =0 .996 ,P>0 .996);The linear range of 2 .0-50 .0 μmol/L ,good linear correlation ;Test concentration within the three distractors (bilirubin 20 mg/dL or less ,triglycerides 1 000 mg/dL or less ,Hb 150 mg/dL or less) no significant interference of reagent ;In pursuance of postures have an impact on the results ;Whole blood specimens of 1 hour separation serum ,serum 4 ℃ for 15 days and 12 hours -20 ℃ results have no obvious change ;EDTA with heparin anti‐clotting results no difference .Hcy levels were positively correlated with cardio‐cerebrovascular disease ,the positive detection rate higher than that of the traditional blood fat index .Conclusion Through out the cycle of automatic biochemical analyzer enzymatic homocysteine reagent has high precision and sensitivity ,and tra‐ditional ,the high efficiency liquid chromatography (HPLC) determination of the related good ,can meet the requirements of clinical test ,is suitable for the normal serum (plasma Hcy) and automated analysis .