摘要
目的 评估基于微流控芯片的微型生化分析仪与全自动生化分析仪检测结果的可比性。方法 使用质控血清并按照临床和实验室标准协会(CLSI)操作规程对微型生化分析仪进行精密度验证;收集天津中医药大学第一附属医院与天津市人民医院的274例标本为试验样本,将两家医院日常使用的全自动生化分析仪作为对照,采用配对t检验、组间相关系数、Passing-Bablok回归分析、Bland-Altman散点图统计分析进行检测结果的相关性及一致性检验。结果 微型生化分析仪低值质控血清批内精密度的变异系数(CV)为0.51%~1.51%,日间精密度的CV为2.29%~5.20%;高值质控血清批内精密度的CV为0.65%~2.25%,日间精密度的CV为1.49%~3.74%。全自动生化分析仪与微型生化分析仪的血浆检测结果比较,以及微型生化分析仪的血浆、全血检测结果比较,差异均无统计学意义(P>0.05);各项指标检测结果的组间相关系数ri均>0.9;但尿素(UREA)、丙氨酸氨基转移酶(ALT)、γ-谷氨酰胺转肽酶(GGT)和白蛋白(ALB)4个指标的检测结果偏倚均存在系统误差或随机误差,且UREA的误差范围超出临床要求的误差范围。结论 基于微流控芯片的微型生化分析仪具有低样本消耗量(100μl)、快速(10 min)、低成本、操作简单、微型化、便携化等诸多优点,且与全自动生化分析仪检测结果的相关性及一致性较高,可相互替代;但微型生化分析仪存在需要手工进样、芯片不可重复使用等不足。
Objective The comparability of the test results of the micro biochemical analyzer based on the microfluidic chip and the automatic biochemical analyzer was evaluated.Methods The precision of the micro-biochemical analyzer was verified by using quality control serum and following Clinical and Laboratory Standards Institute(CLSI)operating procedures.With collection of 274 samples from the The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine and Tianjin People's Hospital as test samples,and use of the automatic biochemical analyzers used daily by the two hospitals as controls,paired t-test,inter-group correlation coefficient,Passing-Bablock regression analysis,and Bland-Altman scatter plot statistical analysis were used to test the correlation and consistency of the test results.Results The coefficient of variation(CV)of the intra-batch precision of the low value quality control serum of the micro biochemical analyzer was 0.51%-1.51%,and the CV of the intraday precision was 2.29%-5.20%;The CV of intra-batch precision of high value quality control serum was 0.65%-2.25%,and the CV of intra-day precision was 1.49%-3.74%.There was no statistically significant difference between the plasma test results of automatic biochemical analyzer and micro biochemical analyzer(P>0.05);There was no statistically significant difference between the results of plasma and whole blood of the micro-biochemical analyzer(P>0.05);The inter-group correlation coefficient ri of the test results of each index is greater than 0.9;However,urea(UREA),alanine aminotransferase(ALT),γ-glutamine transpeptienzyme(GGT)and albumin(ALB)had systematic or random error in the test result bias,and the error range of urea was beyond the clinical requirement.Conclusion Micro-biochemical analyzer based on microfluidic chip has low sample consumption(100μL),fast(10 min),low cost,simple operation,miniaturization,portability and other advantages,and high correlation and consistency with the detection results of automatic biochemical an
作者
贺鑫
李莎
李桐
王丹
龚菁菁
张鑫
杜晶辉
He Xin;Li Sha;Li Tong;Wang Dan;Gong Jingjing;Zhang Xin;Du Jinghui(The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,National Clinical Research Center of Acupuncture and Moxibustion of Traditional Chinese Medicine,Tianjin 300193,China)
出处
《医疗装备》
2023年第7期8-13,共6页
Medical Equipment
关键词
微流控芯片
临床生物化学
生化分析仪
方法比较
Microfluidic chip
Clinical biochemistry
Biochemical analyzer
Method comparison
