Study on the performance evaluation of ARCHITECT i2000 automatic chemiluminescence immunoassay analyzer

Objective To evaluate the performance of ARCHITECT i2000 automatic chemiluminescence immunoassay analyzer. Methods With refer to the YY/T 1155-2009 automatic chemiluminescence immunoassay analyzer and related regulations published by the State Administration of Quality Supervision, Inspection and Quarantine, the protocols for accuracy, reproducibility, linear range, cross-contamination and so on were described in detail. Results Accuracy:the bias was 6pmol/L for 197pmol/L insulin sample and 2 pmol/L for 20 pmol/Linsulin sanple. Reproducibility: the standard deviation was 2% for 6 times analyses of 20 pmol/Linsulin sample. Stability: the relative bias was 3% and 4%, respectively, after 4 and 8 hours from power on. Linear range: the linear coefficient factor was 0.997 from 20 to 197pmol/L of insulin. cross-contamination: 1% from low level to high level and 0.2% from high level to low level. Conclusion The proposed protocols can be used for routine performance evaluation of automatic chemiluminescence immunoassay analyzer and can benefit the accuracy and comparability of clinical diagnostic results.