Research on electrochemical luminescence analyzer test anemia indicators of performance verification methodology
10.3969/J.ISSN.1672-8270.2016.01.023
- VernacularTitle:电化学发光分析仪检测贫血指标的方法学性能验证
- Author:
Wei YAO
;
Aisheng LIU
;
Duzhi FANG
- Publication Type:Journal Article
- Keywords:
Electrochemical luminescence immunity analyzer;
Folic acid;
Ferritin;
Vitamin B12;
Performance evaluation
- From:
China Medical Equipment
2016;13(1):74-77
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To detect anaemia parameter methodology performance for validation of Roche Cobas E601 automatic electrochemical luminescence immunity analyzer.Methods:Recommended by the American association of clinical laboratory standardization (CLSI) method was developed for the determination of folic acid, iron, protein, and this precision, accuracy, linear range, sensitivity, biological reference range and carry pollution index, and validated.Results: Cohas E601 determination of folic acid, iron, protein and precision, the daytime in this batch variation coefficient were 3.03%~4.27% and 3.51%~4.68%. Relative bias must lean on(%) between -3.54%~4.46%. The scope of determination of linear range and the manufacturer to provide similar. Folic acid, iron, protein and numerical value with the determination of this instrument manufacturers provide reference interval coincidence rate were 90.0%, 85.0% and 90.0% respectivel. Instrument to detect carry pollution rate is 0.04%~0.16%. CohasE601 detection sensitivity were 0.23 ng/ml, 0.21 ng/ml and 0.19 pg/ml.Conclusion: Cobas E601 detect folic acid, iron, protein and good performance of this methodology, but manufacturers provide biological reference range is not suitable for the local crowd, should establish the corresponding normal reference range.
