摘要
目的验证Anytest 2000 TRF时间分辨荧光免疫分析仪检测乙肝两对半(HBsAg、HBsAb、HBeAg、HBeAb、HBcAb)的性能。方法对该仪器精密度、正确度、线性范围、生物参考区间及分析的灵敏度进行评估,并与厂家提供参考标准进行比较。结果该仪器HBsAg、HBsAb精密度CV均<15%;HBeAg、HBeAb、HBcAb精密度CV均<20%;检测HBsAg、HBsAb、HBeAg、HBeAb、HBcAb标准品低值和高值的在厂家提供标准品范围内,正确度验证通过;HBsAg、HBsAb、HBeAg、HBeAb、HBcAb线性范围a值均在1±0.05范围内,相关系数r均≥0.975;检测我室所选20个参考个体HBsAg值均为0ng/ml,HBeAg值均为0PEIU/ml,HBsAb<10m IU/ml,HBeAb<0.2PEIU/ml,HBcAb<0.9PEIU/ml;HBsAg、HBsAb、HBeAg、HBeAb、HBcAb分析的灵敏度(检测低限)值分别小于0.2ng/ml、5m IU/ml、0.5PEIU/ml、0.1PEIU/ml、0.5PEIU/ml。结论 Anytest2000TRF五个性能参数符合标准,满足临床需要。
Objective To validate the basic analytical performance of Anytest 2000 TRF time resolved immunofluorescence system in the detection of 5 markers of hepatitis B(HBsAg,HBsAb,HBeAg,HBeAb,HBcAb). Methods The precision,accuracy,linearity range,reference interval and sensibility were validated,the results were compared with manufacturer's claims and acceptable quality standards. Results The results of precision,HBsAg,HBsAb,coefficient of variability(CV)<15%,HBeAg,HBeAb and HBcAb CV<20%. The standard substance C and standard substance E of 5 markers of hepatitis B were detected;the were within the area of the manufacturer's standard substance;accuracy were acceptable quality standards. The linear range of HBsAg,HBsAb,HBeAg,HBeAb and HBcAb were assessed and the result of a value were within 1 ±0.05,The correlation coefficient(r) were more than 0.975. Twenty reference samples were detected include HBsAg,HBsAb,HBeAg,HBeAb,HBcAb,the mean value was0 ng/ml,<10 m IU/ml,0 PEIU/ml,<0.2 PEIU/ml,<0.9 PEIU/ml within the area of the manufacturer's standard substance respectively.Sensibility of HBsAg,HBsAb,HBeAg,HBeAb and HBcAb were less than 0.2 ng/ml,5 m IU/ml,0.5 PEIU/ml,0.1 PEIU/ml and 0.5 PEIU/ml,respectively. Conclusion Five performance parameters of ANYTEST 2000 TRF system were acceptable and conduced to clinical diagnosis.
出处
《实验与检验医学》
CAS
2017年第6期847-850,共4页
Experimental and Laboratory Medicine
基金
国家自然科学基金项目(编号:81601043)
关键词
乙肝两对半
精密度
正确度
线性范围
生物参考区间
灵敏度
5 markers of hepatitis B
Precision
Accuracy
Linearity range
Reference interval
Sensibility
