摘要
目的:建立一种快速定量检测人体血清α-羟丁酸脱氢酶(α-HBDH)的干化学检测方法。方法:制备试纸,试纸由扩散层、试剂层、支持层组成,试纸和DC-101干式生化分析仪组成检测系统,参照CLSI提供的临床检验方法评价方案EP5-A2、EP15-A、EP6-A,对试纸的精密度、准确度、线性范围、稳定性、方法学比对等性能进行评价。结果:试纸测定朗道低、高值质控品的批内变异系数分别为4.1%和4.6%,小于1/4CLIA’88指标;对267U/L、465U/L两个浓度朗道校准品测定相对偏差分别为4.9%、5.3%,在1/2TEa范围内;线性范围在20～1 000U/L(r^2=0.992);试纸有效期12个月;Passing-Bablok回归方程的斜率为0.995,接近理论值1;Bland-Altman分析显示4.16%的点在一致性界限之外。结论:所制备的试纸可应用于α-HBDH的检测,能够满足临床需求。
Objective: To establish a rapid and quantitative dry chemistry method to detect α-hydroxybutyrate dehydrogenase (α-HBDH) in serum. Methods: Test strip was designed, the structure of test strip consisted of a spreading layer, a reagent layer and a supporting layer. Test strips and DC-101 dry biochemistry analyzer constitute a detection system. The precision, accuracy, linear range, stability of the test strips and methodological comparison were evaluated according to the clinical test method evaluation schemes EP5-A2, EP15-A, and EP6-A provided by CLSI. Results: The intra coefficient of variation of test strips for Randox low and high level quality controls were 4.1% and 5.8% respectively, which were lower than the standard of 1/4 CLIA’88. The relative bias of test were 4.9% and 5.3% respectively using 267 U/L and 465 U/L Randox calibrators within 1/2 TEa. The linear range was 20~1000 U/L (r 2=0.992). Test strips were valid for 12 months. The slope of Passing-Bablock regression equation was 0.995 which was close to the theoretical value 1. Bland-Altman analysis showed that 4.16% of the points were outside the consistency limit. Conclusion: Prepared test strips could be well applied to detect α-HBDH, which could meet the needs of clinical diagnosis.
作者
胡树昆
李玉宝
何翠云
朱世成
李文美
何小维
Hu Shukun;Li Yubao;He Cuiyun;Zhu Shicheng;Li Wenmei;He Xiaowei(College of Food Science and Engineering of South China University of Technology,Guangzhou 510640,China;Guangzhou Wondfo Biotech Co.Ltd,Guangzhou 510663,China)
出处
《广西医科大学学报》
CAS
2019年第4期654-658,共5页
Journal of Guangxi Medical University
基金
广东省省级科技计划课题资助项目(No.2017A020208014)
广州市科技计划项目课题资助(No.201802010030)
关键词
Α-羟丁酸脱氢酶
干化学方法
检测
α-hydroxybutyrate dehydrogenase
dry chemistry method
detection
