CAJ | 학술논문

目的对3种应用于自动生化分析仪的胶乳增强免疫比浊法检测血肌红蛋白(Mb)试剂进行分析性能验证，并初步应用于临床。方法在OLYMPUS2700全自动生化分析仪上对四川迈克、太原川至和宁波美康生产的胶乳增强免疫比浊法Mb试剂(标为A、B、C)进行性能验证，对3种方法的精密度、线性范围、干扰因素进行评估，并与美国贝克曼库尔特公司生产的化学发光免疫分析仪ACCESS2及配套试剂进行比对。结果试剂A、B、C的批内CV均小于试剂盒声明不精密度；试剂A、B、C的定量测定下限基本满足检测要求；线性范围相关均良好。干扰物深度不同对试剂的干扰程度各不相同；试剂A、B、C与贝克曼库尔特化学发光免疫分析仪异常的一致率试剂B最高。结论应用于自动生化分析仪的3种胶乳增强免疫比浊法测定Mb试剂盒，具有较高的精密度和灵敏度，与贝克曼库尔特公司的化学发光免疫分析仪结果相关良好；可满足临床测试要求。但抗干扰能力存在差异，部分试剂参考范围也有待进一步验证。
목적대3충응용우자동생화분석의적효유증강면역비탁법검측혈기홍단백(Mb)시제진행분석성능험증，병초보응용우림상。방법재OLYMPUS2700전자동생화분석의상대사천매극、태원천지화저파미강생산적효유증강면역비탁법Mb시제(표위A、B、C)진행성능험증，대3충방법적정밀도、선성범위、간우인소진행평고，병여미국패극만고이특공사생산적화학발광면역분석의ACCESS2급배투시제진행비대。결과시제A、B、C적비내CV균소우시제합성명불정밀도；시제A、B、C적정량측정하한기본만족검측요구；선성범위상관균량호。간우물심도불동대시제적간우정도각불상동；시제A、B、C여패극만고이특화학발광면역분석의이상적일치솔시제B최고。결론응용우자동생화분석의적3충효유증강면역비탁법측정Mb시제합，구유교고적정밀도화령민도，여패극만고이특공사적화학발광면역분석의결과상관량호；가만족림상측시요구。단항간우능력존재차이，부분시제삼고범위야유대진일보험증。
Objective Immune turbidimetry detect blood myoglobin (Mb) reagents used in automatic biochemical analyzer latex enhanced analytical performance validation and preliminary clinical application. Mike Sichuan, Taiyuan chuanzhi and Ningbo Diamicron the OLYMPUS2700 automatic biochemical analyzer produced latex enhanced performance verification immune turbidimetry Mb reagents (labeled A, B, C), the precision of the three methods the linear range, interference factors to assess, and Beckman Coulter chemiluminescence immunoassay the instrument ACCESS2 and ancillary reagents compared.Results Reagents A, B, C batch CV were less than the kits statement imprecision; quantitative determination of the lower limit of the reagents A, B, C, basically meet the testing requirements; linear range were good. Reagent interference disruptors depth varies; the concordance rate Reagent B Reagent A, B, C, and Beckman Coulter chemiluminescence immunoassay analyzer exception highest. Conclusion Applies to automatic biochemical analyzer latex enhanced immune turbidimetric method Mb kit, with high precision and sensitivity, and Beckman Coulter chemiluminescence immunoassay analyzer results correlated well; meet the clinical testing requirements. Anti-interference ability differences, part of the reagent reference range needs to be validated.