Circulation enzymatic homocysteine reagent performance verification / 国际检验医学杂志

ABSTRACT

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 ,batchCV2 .37 % (underval‐ued) ,3 .58% (high value) ,the total CV4 .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 .