CAJ | 학술논문

目的：评估顺磁性微粒子化学发光免疫分析法（ Chemiluminescence microparticle immunoassay，CMIA）检测血清维生素B12（ Vitamin B12，VitB12）的分析性能。方法：应用美国临床和实验室标准化协会（ CLSI） EP5-A2、EP15-A2、EP7-A2、EP6-A、C28-A3c方法评价CMIA检测VitB12的精密度、正确度、抗干扰性、分析测量范围（AMR）、临床可报告范围（CRR）、生物参考区间。采用美国国家标准技术研究所（ National Institute of Standards and Technology，NIST）有证参考物质SRM 1955、美国病理学家协会（CAP）发放的室间质评物（K-C）、校准验证/线性评价物（LN5-B）评估CMIA系统检测VitB12正确度。结果：VitB12在108.84～874.43 pmol/L时，批内、批间精密度均小于厂家声明的标准。正确度验证显示测定有证参考物质NIST SRM 1955，结果符合验证要求；检测CAP室间质评物（K-C）、校准验证/线性评价物（LN5-B）显示，结果均符合CAP校准验证/线性评价误差界限所规定的标准，VitB12浓度在89～1057 pmol/L范围内通过线性验证，95％验证区间也包含其指定均值，相对偏差均小于卫生部临床检验中心室间质量评价标准（ TEa：靶值±25％）。抗干扰性评估显示在TG≤20 mmol/L、Bil≤300μmol/L、Vit C≤1.5 g/L时对VitB12检测系统（CMIA）无显著干扰。 AMR验证判断最佳拟合方程为二元一次多项式，VitB12浓度在0～1107 pmol/L范围内存在线性关系。 CRR上限为110700 pmol/L，最大稀释倍数为100倍。生物参考区间验证显示本研究选择的参考个体VitB12水平符合厂家试剂说明书给定参考区间，女性略高于男性，但无显著差异。结论：CMIA检测血清VitB12的各项性能指标基本满足实验室要求，其可为实验室提供可靠的VitB12结果，为实验室评价人群VitB12营养状况提供信息。
목적：평고순자성미입자화학발광면역분석법（ Chemiluminescence microparticle immunoassay，CMIA）검측혈청유생소B12（ Vitamin B12，VitB12）적분석성능。방법：응용미국림상화실험실표준화협회（ CLSI） EP5-A2、EP15-A2、EP7-A2、EP6-A、C28-A3c방법평개CMIA검측VitB12적정밀도、정학도、항간우성、분석측량범위（AMR）、림상가보고범위（CRR）、생물삼고구간。채용미국국가표준기술연구소（ National Institute of Standards and Technology，NIST）유증삼고물질SRM 1955、미국병이학가협회（CAP）발방적실간질평물（K-C）、교준험증/선성평개물（LN5-B）평고CMIA계통검측VitB12정학도。결과：VitB12재108.84～874.43 pmol/L시，비내、비간정밀도균소우엄가성명적표준。정학도험증현시측정유증삼고물질NIST SRM 1955，결과부합험증요구；검측CAP실간질평물（K-C）、교준험증/선성평개물（LN5-B）현시，결과균부합CAP교준험증/선성평개오차계한소규정적표준，VitB12농도재89～1057 pmol/L범위내통과선성험증，95％험증구간야포함기지정균치，상대편차균소우위생부림상검험중심실간질량평개표준（ TEa：파치±25％）。항간우성평고현시재TG≤20 mmol/L、Bil≤300μmol/L、Vit C≤1.5 g/L시대VitB12검측계통（CMIA）무현저간우。 AMR험증판단최가의합방정위이원일차다항식，VitB12농도재0～1107 pmol/L범위내존재선성관계。 CRR상한위110700 pmol/L，최대희석배수위100배。생물삼고구간험증현시본연구선택적삼고개체VitB12수평부합엄가시제설명서급정삼고구간，녀성략고우남성，단무현저차이。결론：CMIA검측혈청VitB12적각항성능지표기본만족실험실요구，기가위실험실제공가고적VitB12결과，위실험실평개인군VitB12영양상황제공신식。
Objective:To evaluate the performance of paramagnetic particles chemiluminescence microparticle immunoassay ( CMIA) for detection of serum Vitamin B12 ( VitB12 ).Methods: Analysed CMIA system precision, accuracy, anti-interference, analytical measuring range( AMR) ,clinical reportable range ( CRR) and biological reference interval were evaluated,according to the clinical and laboratory standards institude ( CLSI) EP5-A2,EP15-A2,EP7-A2,EP6-A,C28-A3c guidelines.To assess the accuracy,we used the reference material SRM 1955 from national institute of standards and technology ( NIST ) and external quality assessment ( EQA) samples ( LN5-B and K-C) from CAP.Results:The precisions of within-run and between-run were less than standard of manu-facturer when the concentration of VitB12 was 108.84-874.43 pmol/L.The results of SRM1955 met the allowable range of the target val-ue.The results of EQA samples( K-C and LN5-B) also up to the CAP calibration and validation/linear evaluation error limits stipulated standards,and the results through linear verification when the concentration of VitB12 was 89-1 057 pmol/L.The 95% verification interval contains the specified value also.The relative deviation was less than external quality assessment standard from national center for clinical laboratory ( TEa:target value ±25%).Anti-interference evaluation showed without significant interferenc when TG ≤20 mmol/L,Bil ≤300 μmol/L VitC≤1.5 g/L to the VitB12 detection system ( CMIA).AMR validation showed determines the best fit equation was linear equation polynomial.There was the linear relationship when the concentration of VitB12 was 0-1 107 pmol/L.The upper limit of CRR was 110 700 pmol/L,the maximum dilution was 100 times.Biological reference interval validation showed that the overall level of VitB12 in this study reference individuals conform to the standard of manufacturer statement for the population,the overall level of VitB12 in female little higher than male,but no significant differences.Conclusion:Performance of CMIA for detection of serum VitB12 basically met needs of laboratory,which can provide reliable results of VitB12 for laboratory,provide information for the VitB12 status of population in the laboratory evaluation.