CAJ | 학술논문

目的：对 BIO-RAD D-10高效液相色谱法检测糖化血红蛋白(HbA1c)的性能进行验证,评价其检测性能是否满足实验室质量及临床诊疗的要求。方法按 CLSI EP15A2文件的方法对糖化血红蛋白进行正确度、精密度的验证,采用线性回归分析方法对线性进行验证,按 WS/T 4022012的方法对参考区间进行验证。结果HbA1c 校准品水平1的标识值为5.3%,测定结果的验证限为1.63%~8.78%,校准品水平2的标识值为10.0%,测定结果的验证限为4.76%~13.64%,校准品的标识值均包含在测定值的95%置信区内,正确度验证通过。HbA1c 浓度为5.24%的实验室变异系数(CV)为1.01%,HbA1c 浓度为9.84%的 CV 为0.54%,均小于厂商声明的精密度,精密度验证通过。 HbA1c 线性校准品的实测值和目标值的线性回归方程为 Y =1.008X +0.023,相关系数指数 r 2为0.999,线性良好。20份健康成人标本的 HbA1c 检测结果均落在制造商提供的生物参考区间4.1%~6.2%范围内,参考区间验证通过。结论BIO-RAD D-10高效液相色谱法检测 HbA1c 的正确度、精密度、线性、参考区间均通过验证,能为临床提诊疗供准确可靠的检验结果,满足临床检测的要求,可用于临床标本的检测。
목적：대 BIO-RAD D-10고효액상색보법검측당화혈홍단백(HbA1c)적성능진행험증,평개기검측성능시부만족실험실질량급림상진료적요구。방법안 CLSI EP15A2문건적방법대당화혈홍단백진행정학도、정밀도적험증,채용선성회귀분석방법대선성진행험증,안 WS/T 4022012적방법대삼고구간진행험증。결과HbA1c 교준품수평1적표식치위5.3%,측정결과적험증한위1.63%~8.78%,교준품수평2적표식치위10.0%,측정결과적험증한위4.76%~13.64%,교준품적표식치균포함재측정치적95%치신구내,정학도험증통과。HbA1c 농도위5.24%적실험실변이계수(CV)위1.01%,HbA1c 농도위9.84%적 CV 위0.54%,균소우엄상성명적정밀도,정밀도험증통과。 HbA1c 선성교준품적실측치화목표치적선성회귀방정위 Y =1.008X +0.023,상관계수지수 r 2위0.999,선성량호。20빈건강성인표본적 HbA1c 검측결과균락재제조상제공적생물삼고구간4.1%~6.2%범위내,삼고구간험증통과。결론BIO-RAD D-10고효액상색보법검측 HbA1c 적정학도、정밀도、선성、삼고구간균통과험증,능위림상제진료공준학가고적검험결과,만족림상검측적요구,가용우림상표본적검측。
Objective To verify the detection performance of glycated hemoglobin (HbA1c)by using the BIO-RAD D-10 high performance liquid chromatography method,and to evaluate whether the detection performance can satisfy the requirements of the laboratory and clinical diagnosis and treatment.Methods The method of CLSI EP1 5A2 was used to verify the accuracy and preci-sion.The linear correlation and reference range were verified respectively by linear regression analysis and the method of the WS/T 402 2012.Results The calibration value of HbA1c calibrator level 1 was 5.3% and the validation limit of measured results was 1. 63%-8.78%.The calibration value of HbA1c calibrator Level 2 was 10.0%,and the validation limit of measured results was 4.76%-13.64%.Both calibration values were included in the 95% confidence range of measured values,so the accuracy verifica-tion passed.Laboratory variation coefficient (CV)for HbA1c with concentration of 5.24% was 1.01% and for 9.84% was 0. 54%,both less than the precision that the manufacturer declared,so the precision verification passed.The equation of linear regres-sion analysis for HbA1c linearity calibrator measured value and target value wasY =1.008X +0.023,with correlation coefficient in-dex r 2 of 0.999,so the linearity was good.The measured results of 20 healthy adults specimens were in the reference interval(4.1%-6.2%)that the manufacturer provided.Conclusion Accuracy,precision,linear correlation and reference range of HbA1c meas-ured by BIO-RAD D-10 HPLC detection method were verified.It can provide the accurate and credible measurement results for clin-ical diagnosis and treatment,and can be used in the detection of clinical specimens.