雅培ARCHITECT i2000检测B-型脑尿钠肽性能验证

Performance verification of Abbott ARCHITECT i2000 in detecting B type natriuretic peptide

目的验证雅培ARCHITECT i2000检测B型脑尿钠肽（BNP）的分析性能,确保检测方法的性能满足实验室及临床诊疗的质量要求。方法按CLSI EP15-A2文件的方法进行了正确度和精密度验证,按CLSI EP6-A文件的方法进行可报告范围进行验证。结果低值、高值样品BNP测定的实验室变异系数（CVl）分别为3.43%和2.89%,均小于厂商声明的精密度6.7%和4.1%;测定由制造商提供的浓度为75 pg/ml和2500 pg/ml的BNP校准品,校准品的指定值均包含在测定值的95%置信区内;卫生部临床检验中心5份室间质控品的检测结果与靶值的相对偏倚为-10.89%~3.86%,均在允许误差范围内。BNP分析测量范围为10.23~4382.67 pg/ml,与厂商提供的线性范围10~5 000 pg/ml基本一致;最高可稀释5倍,与仪器自动稀释倍数相一致,其可报告范围为10.23~21913.35 pg/ml。结论雅培ARCHITECT i2000检测BNP的正确度、精密度、可报告范围均通过验证,分析性能满足临床实验室和临床诊疗质量要求。

Objective To verify the analysis performance of the Abbott ARCHITECT i2000 system in the detection of B type brain natriuretic peptide（ BNP）,to ensure that the performance of the measure method could satisfy the quality requirements of laboratory and clinical diagnosis and treatment. Methods According to the method of CLSI EP15-A2 file to verify the trueness and precision,and the reportable range was verified according to the method of CLSI EP6-A file. Results Laboratory variation coefficients（ CVl） of low and high values BNP were 3. 43% and 2. 89%,both were lower than the precision of 6. 7% and 4. 1% that manufacturers declared. The calibration value 75 pg / ml and 2500 pg / ml of BNP calibrator provided by manufacturer were included in the 95% confidence region of measured value. The relative biases between measured results and target values of 5 external quality assessment（ EQA） samples provided by national center clinical laboratories（ NCCL）were between-10. 89% and 3. 86%,all biases were in the allowable error range. The BNP analytical measurement range was from 10. 23 to 4382. 67 pg / ml,basically consistent with the linear range of 10 to 5000 pg /ml provided by the manufacturers,the maximum dilution was 5 times,which consistent with dilution ratio of the instrument,the reportable range was 10. 23-21913. 35 pg / ml. Conclusions Trueness,precision and reportable range of BNP measured by Abbott ARCHITECT i2000 were verified,the analysis performance is satisfied the quality requirements of clinical laboratory and clinical diagnosis and treatment.