乳胶增强免疫比浊法测定髓过氧化物酶试剂盒性能验证评价

目的：评价血浆髓过氧化物酶（MPO）乳胶增强免疫比浊法试剂盒在AU2700全自动生化分析仪使用的性能验证。方法根据美国临床实验室标准化委员会（NCCLS）的评价方案对北京九强公司生产的乳胶增强免疫比浊法髓过氧化物酶测定试剂盒进行了回收试验、干扰试验、临床可报告范围及精密度验证。结果北京九强生产的MPO乳胶增强免疫比浊法试剂盒的两个浓度水平质控品的实验室精密度CV为8．9％；回收率95．7％～108．3％。线性评价的相关系数r＝0．997，线性回归方程为Y＝1．033X-25．092；干扰试验中不同程度的标本溶血均对测定MPO造成严重干扰。抗坏血酸6．3～100mg/L，三酰甘油小于7．8mmol/L内无明显干扰，相对偏差小于10％，三酰甘油浓度大于7．8mmol/L对试验有明显干扰，相对偏差为11．5％～11．9％。结论九强公司在国内首次推出的髓过氧化物酶（MPO）乳胶增强免疫比浊法试剂盒在抗干扰、线性、正确度及精密度等方面的性能达到临床需求，值得在临床心脑血管危险因子检测中推广应用。

Performance evaluation of detecting myeloperoxidase with immunoturbidimetry of latex-enhanced

Objective To evaluate the performance verification of method of detecting myeloperoxidase with immunoturbidimetry of latex-enhanced on the analyser OLYMPUS AU2700 .Methods According to evaluation scheme of National Committee for Clinical Laboratory Standards （NCCLS ） ,carried out recovery test ,interference test ,clinicalreportablerange and precision verification for myeloperoxidase with immunoturbidimetry of latex-enhanced determination kit ,which is produced by Beijing Strong Biotechnologies ,Inc .Results The coefficient of variation of two levels of quality control products produced by Beijing Strong Biotechnologies ,Inc is 8 .9 % ;percent recovery is between 95 .7% and 108 .3% .In the regression analysis ,correlation coefficient is 0 .997 ,equation of linear regression is Y=1 .033X -25 .092 .Different degrees of hemolysis caused serious interference in the test of MPO . When vitamin C is between6 .3 mg/L and 100 mg/L ,triglycerides is less than 7 .8 mmol/L ,no significant interference is found ,relative deviation is less than 10% .When triglycerides is more than 7 .8 mmol/L ,had serious interference , relative deviation is between 11 .5% and 11 .9% .Conclusion Myeloperoxidase with immunoturbidimetry of latex-enhanced determination kit produced by Beijing Strong Biotechnologies ,Inc is to achieve the clinical Standard in terms of anti-interference ,linearity ,accuracy and precision ,it is worthy of popularization and application in the detection of clinical cardiovascular risk factors .