CAJ | 학술논문

目的验证罗氏 Modular全自动生化分析仪酶学指标丙氨酸氨基转移酶(ALT)和天门冬氨酸氨基转移酶(AST)分析性能.方法根据美国临床实验室标准化研究所(CLSI)系列文件(EP5-A2、EP15-A2、EP6-A2、EP7-A2、C28-A2)和其他相关文献的实验方案,对罗氏 Modular全自动生化分析仪检测ALT、AST的精密度、准确度、线性、临床可报告范围、干扰和生物参考区间6大性能进行验证,并与厂商声明的性能或公认的质量标准进行比较.结果精密度均符合罗氏性能标准;对卫生部5份室间质控品检测结果与靶值的相对偏倚(SE%)在-3.94%～-9.09%之间,变异指数得分(VIS)均<50,室内质控(IQC)结果与罗氏全球质控系统(QCS)结果相对SE%在-3.70%～5.85%之间;ALT、AST检测均呈一次线性(r=0.999,P<0.05), 线性范围分别为 4～1 332 U/L、4～1 031 U/L;ALT、AST的临床可报告范围分别为0～133 200 U/L和0～206 200 U/L;血红蛋白(Hb)对AST检测有正干扰,Hb ≤ 6.025 g/L的干扰效应剂量曲线呈一次线性(P<0.05); ALT、AST生物参考区间验证结果均在本实验室给出的参考区间内.结论罗氏 Modular 生化分析仪ALT、AST检测的主要分析性能符合质量目标要求,CLSI实验评价方案具有可操作性和实用性.
목적 험증라씨 Modular전자동생화분석의매학지표병안산안기전이매(ALT)화천문동안산안기전이매(AST)분석성능.방법 근거미국림상실험실표준화연구소(CLSI)계렬문건(EP5-A2、EP15-A2、EP6-A2、EP7-A2、C28-A2)화기타상관문헌적실험방안,대라씨 Modular전자동생화분석의검측ALT、AST적정밀도、준학도、선성、림상가보고범위、간우화생물삼고구간6대성능진행험증,병여엄상성명적성능혹공인적질량표준진행비교.결과 정밀도균부합라씨성능표준;대위생부5빈실간질공품검측결과여파치적상대편의(SE%)재-3.94%～-9.09%지간,변이지수득분(VIS)균<50,실내질공(IQC)결과여라씨전구질공계통(QCS)결과상대SE%재-3.70%～5.85%지간;ALT、AST검측균정일차선성(r=0.999,P<0.05), 선성범위분별위 4～1 332 U/L、4～1 031 U/L;ALT、AST적림상가보고범위분별위0～133 200 U/L화0～206 200 U/L;혈홍단백(Hb)대AST검측유정간우,Hb ≤ 6.025 g/L적간우효응제량곡선정일차선성(P<0.05); ALT、AST생물삼고구간험증결과균재본실험실급출적삼고구간내.결론 라씨 Modular 생화분석의ALT、AST검측적주요분석성능부합질량목표요구,CLSI실험평개방안구유가조작성화실용성.
Objective To validate the analytic characteristic of alanine aminotransferase(ALT)and aspartate aminotransferase(AST)measurement by Roche Modular automatic biochemical analyzer. Methods The precision, accuracy, linearity, clinical reportable range , interference and biotic reference interval of ALT and AST were validated according to Clinical and Laboratory Standards Institute (CLSI) documents (EP5-A2, EP15-A2, EP6-A2, EP7-A2 and C28-A2) and other experimental procedures. The results were compared with manufacturer′s claims and acceptable quality standards. Results The precisions were in line with the Roche performance standard. The system error (SE%) of five external quality assessment control samples was -3.94%--9.09% and the variance index scores (VIS) were <50. The SE% of internal quality control(IQC)and quality control service (QCS) was -3.70% - 5.85%. ALT and AST showed good linearity (r=0.999,P<0.05) and linearity range (4-1 332 U/L and 4-1 031 U/L), and the clinical reportable ranges were 0-133 200 U/L and 0-206 200 U/L respectively. As for AST, hemoglobin(Hb)showed positive interference. As Hb ≤ 6.025 g / L, the interference dose-response series showed linear relationship (P<0.05). The validation results of biotic reference interval of ALT and AST were in line with our laboratory reference interval. Conclusions The main analytic characteristic of ALT and AST measurement by Roche biochemical autoanalyzers is consistent with acceptable quality standards, and the experimental evaluation project of CLSI shows maneuverability and practicability.