CAJ | 학술논문

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。
목적：평개혈장수과양화물매（MPO）유효증강면역비탁법시제합재AU2700전자동생화분석의사용적성능험증。방법근거미국림상실험실표준화위원회（NCCLS）적평개방안대북경구강공사생산적유효증강면역비탁법수과양화물매측정시제합진행료회수시험、간우시험、림상가보고범위급정밀도험증。결과북경구강생산적MPO유효증강면역비탁법시제합적량개농도수평질공품적실험실정밀도CV위8．9％；회수솔95．7％～108．3％。선성평개적상관계수r＝0．997，선성회귀방정위Y＝1．033X-25．092；간우시험중불동정도적표본용혈균대측정MPO조성엄중간우。항배혈산6．3～100mg/L，삼선감유소우7．8mmol/L내무명현간우，상대편차소우10％，삼선감유농도대우7．8mmol/L대시험유명현간우，상대편차위11．5％～11．9％。결론구강공사재국내수차추출적수과양화물매（MPO）유효증강면역비탁법시제합재항간우、선성、정학도급정밀도등방면적성능체도림상수구，치득재림상심뇌혈관위험인자검측중추엄응용。
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-en-hanced determination kit ,which is produced by Beijing Strong Biotechnologies ,Inc .Results The coefficient of varia-tion of two levels of quality control products produced by Beijing Strong Biotechnologies ,Inc is 8 .9 % ;percent re-covery 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-en-hanced 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 .