Technical Research on Calibration of Fully Automated ELISA Analyzers
KANG Juan1,WU Li-qing2,YAN Zhen-yu1,WANG Jun1,SUN Jing-sheng1
1.Beijing Institute of Medical Device Testing & Beijing Key Lab of Medical Device Testing & Safety Evaluation, Beijing 101111, China
2. Division of Medical and Biological Measurement, National Institute of Metrology, Beijing 100029, China
Abstract：A calibration technique has been established to evaluate the testing performance of fully automated ELISA analyzers. The technique tests the accuracy and precision of adding module, the temperature of incubation module, the washing residue rate and cross contamination of washing module, and the absorbance stability, accuracy, precision and channel difference of reading module separately around the constituent modules of the system. 3 fully automated ELISA analyzers from different manufactures were chosen to validate the technique applicability. Results showed that the maximum adding bias and CV were -7.4% and 8.0% respectively, the incubation temperature bias was within ±0.5 ℃, the maximum washing residue rate was 0.8% and maximum cross contamination was 0.1%, the maximum absorbance fluctuation was 0.003 within ten minutes, the maximum absorbance bias and CV were 0.019 and 0.2% respectively for tested wavelengths and absorbance,the maximum channel difference was 0.005. The calibration technique was testified to be scientific and practical, and expected to be used to evaluate the fully automated ELISA analyzers effectively.
2017, Vol. 38 
