糖化血红蛋白两种床旁检测方法性能的比较

摘要

目的 比较两种H bA1c床旁检测方法的性能.方法 通过对已发表的两种HbA1c床旁检测方法(POC A,POC B)与两种中心实验室仪器(Central X,Central Y)验证试验的数据分析得到两种HbA1c床旁检测仪器与中心实验室仪器相比的不精密度(CV％)、偏倚(Bias％),并将其与质量要求进行比较.结果 POC A测定HbA1c在6.0％和10.4％浓度水平时的变异系数(CV)分别为3.8％、3.7％,与中心实验室仪器(Central X)比对测得的偏倚分别为10.33％、13.58％,与中心实验室仪器(Central Y)比对得到的偏倚分别为7.83％、10.44％；POCB测定HbA1 c在5.5％和11.9％浓度水平时的CV分别为3.4％、7.3％,与CentralX比对测得的偏倚分别为0.45％、11.08％,与CentralY比对得到的偏倚分别为3.73％、9.57％.结论 两种HbA1c床旁检测方法的性能不能满足目前对HbA1 c检测的质量要求.%Objective To evaluate the performance of two point-of-care testing (POCT) methods for HbA1c testing. Methods Using published data from a study, the two POCT HbA1c devices with two central laboratory instruments for HbA1c measurement were compared. The imprecision bias for the two methods of POC A and POC B was determined by verification tests with two central laboratory instruments of Central X and Central Y, from the published data, and then was compared with the requirement of quality. Results At HbA, c level 6. 0% and 10. 4%, the total CV of POC A was 3. 8% and 3. 7% respectively and when comparing with Central X, the bias of POC A was 10. 33% and 13. 58%. Comparing with Central Y, the bias was 7. 83% and 10. 44%. At A,C level 5. 5% and 11. 9% the total CV of POC B was 3. 4%, 7. 3% respectively, and when comparing with Central X, the bias was 0. 45% and 11. 08%. Comparing with Central Y, the bias was 3. 73% and 9. 57%respectively. Conclusions The performance of the two methods for HbA1c testing cannot meet the current quality requirements for the HbA1c testing .