现代检验医学杂志2026，Vol.41Issue(3)：28-33,6.DOI:10.3969/j.issn.1671-7414.2026.03.005
奥森多VITROS 4600全自动生化分析仪检测血清酶类项目应用不同稀释基质对其临床可报告范围的影响评估
Evaluation of the Impact of Different Diluent Matrices on the Clinical Reportable Range of Serum Enzyme Items Detected by Ortho VITROS 4600 Automated Biochemical Analyzer
摘要
Abstract
Objective To evaluate the impact of different dilution matrices on the maximum dilution factors for the detection of serum enzymes(ALT,AST,ALP,LDH,CK,CK-MB,AMY,LIPA)using the Ortho VITROS 4600 fully automated biochemical analyzer,aiming to determine the most suitable dilution matrix and establish the matrix-specific clinical reportable ranges(CRR).Methods According to the China National Accreclitation Service for Conformity Assessment(CNAS)-GL037:2019"Guidance on the Verification of Quantitative Measurement Procedures used in the Clinical Chemistry",the analytical measurement ranges(AMR)for ALT,AST,ALP,LDH,CK,CK-MB,AMY and LIPA were validated.Deionized water,physiological saline,7g/dl bo-vine serum albumin(BSA),and processed human serum were selected as dilution matrices.Maximum dilution factor validation was performed for each matrix to establish CRR under different dilution conditions.Results The linear range for ALT was 10-697 U/L,with an r2 of 0.999.The maximum dilution factor was 20-fold when diluted with deionized water.For AST verification,the linear range was 12～716 U/L,with an r2 of 0.995.The maximum dilution factor was 20-fold when diluted with 7g/dl BSA.The linear range for ALP was 22～1 204 U/L,with an r2 of 0.998.The maximum dilution factor was 10-fold when diluted with 7g/dl BSA.LDH showed a linear range of 137～946 U/L,with an r2 of 0.999.The maximum dilution factor was 10-fold when di-luted with 7g/dl BSA.CK had a linear range of 24～1 489 U/L,with an r2 of 0.998,and the biases for all four diluted substrates exceeded industry standards.The linear range for CK-MB was 4.7～283.1 U/L,with an r2 of 0.999.The maximum dilution fac-tor was 20-fold when diluted with processed human serum.AMY showed a linear range of 45～1 162 U/L,with an r2 of 0.999.The maximum dilution factor was 15-fold when diluted in deionized water.LIPA had a linear range of 23～1 793 U/L,with an r2 of 0.999.The maximum dilution factor was 20-fold when diluted in processed human serum.Conclusions The dilution results vary across differ-ent serum enzyme assays in different dilution matrices,necessitating the establishment of matrix-specific CRR.关键词
血清酶/稀释基质/干化学/临床可报告范围/最大稀释度Key words
serum enzyme dilution matrix/dry chemical method/clinical reportable range/the maximum dilution分类
医药卫生引用本文复制引用
庞欢,尹倩雯,王晓岩,阮竞雄,王晓琴..奥森多VITROS 4600全自动生化分析仪检测血清酶类项目应用不同稀释基质对其临床可报告范围的影响评估[J].现代检验医学杂志,2026,41(3):28-33,6.基金项目
西安市重点产业链技术攻关集群项目(24LLRHZDZX0028). （24LLRHZDZX0028）
