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OA
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
目的 评价不同稀释基质对奥森多VITROS 4600全自动生化分析仪检测血清酶(ALT、AST、ALP、LDH、CK、CK-MB、AMY、LIPA)最大稀释倍数的影响,旨在确定最适宜的稀释基质,并制定基质特异性临床可报告范围(CRR).方法 依据中国合格评定国家认可委员会(CNAS)-GL037:2019《临床化学定量检验程序性能验证指南》,验证ALT、AST、ALP、LDH、CK、CK-MB、AMY和LIPA的分析测量范围(AMR).选取去离子水、生理盐水、7g/dl小牛血清白蛋白(BSA)及加工人血清作为稀释基质,分别进行最大稀释倍数验证,建立不同稀释基质下的临床可报告范围.结果 ALT的线性范围为10～697 U/L,r2=0.999,去离子水稀释时最大稀释倍数最高为20倍;AST的线性范围为12～716 U/L,r2=0.995,7g/dl BSA稀释时最大稀释倍数最高为20倍;ALP的线性范围为22～1 204 U/L,r2=0.998,7g/dl BSA稀释时最大稀释倍数最高为10倍;LDH的线性范围为137～946 U/L,r2=0.999,7g/dl BSA稀释时最大稀释倍数最高为10倍;CK的线性范围为24～1 489U/L,r2=0.998,四种基质稀释后的偏倚均大于行业规定;CK-MB的线性范围为4.7～283.1U/L,r2=0.999,加工人血清稀释时最大稀释倍数最高为20倍;AMY的线性范围为45～1 162 U/L,r2=0.999,去离子水稀释时最大稀释倍数最高为15倍;LIPA的线性范围为23～1 793U/L,r2=0.999,加工人血清稀释时最大稀释倍数最高为20倍.结论 不同血清酶项目在不同稀释基质中的稀释结果存在差异,需要建立基质特异性临床可报告范围.
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.
庞欢;尹倩雯;王晓岩;阮竞雄;王晓琴
西安交通大学第一附属医院检验科,西安 710061西安交通大学第一附属医院检验科,西安 710061西安交通大学第一附属医院检验科,西安 710061西安交通大学第一附属医院检验科,西安 710061西安交通大学第一附属医院检验科,西安 710061
医药卫生
血清酶稀释基质干化学临床可报告范围最大稀释度
serum enzyme dilution matrixdry chemical methodclinical reportable rangethe maximum dilution
《现代检验医学杂志》 2026 (3)
28-33,6
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