| Objective: To validate and explore a mode which is fit to evaluate the performance of the electrochemiluminescent immunoassay system of Elecsys 2010 by the guidance of evidence-based laboratory medicine. Meanwhile, to explore the comparability of results which are detected by 3 kinds of apparatuses.Methods: The analytical performance of the electrochemiluminescence immunoassay(ECLIA) system of Elecsys 2010 was validated by precision, analytical sensitivity, linear range, accuracy and reference range trials by detecting the sera specimens of different concentrations. The 60 sera specimens were detected by 3 kinds of apparatuses. The results were analyzed by statistical package for social science 10.0.Results: Imprecision studies yielded with-run CVs of 1.07%～3.73% and between-day CVs of 0.43%～2.12%; CVs for total imprecision were 1.81%～4.90%. Recoveries after dilution of high-concentration samples in assay diluent were within the range of 94%-110%. Analytical sensitivity was <0.1mIU/ml. The linear range was 0.1mlU/ral～9897.225mIU/ral. The comparison between theoretical values and obtained ones showed excellent correlation(r =0.999, P=0.000). The result of the comparision between ECLIA and radio immunoassay was not perfect(r =0.630, P =0.000). The reference range(8 w,12w,16w)for beta subunit human chorionic gonadotropin(β-HCG) was lower than that given by Roche(P<0.010, P<0.002, P<0.010). The relation between ECLIA and CLA was 0.72(P=0.000), the relation between ECLIA and RIA was 0.61 (P=0.000), the relation between RIA and CLA was 0.60 (P=0.000).Conclusion: ECLIA was improved precision, higher sensitivity, wider linear range, higher accurate and testing time than other conventional immunoassay methods. However, it is a problem to explore that whether to refer the reference range that given by the Roche, especially the ones of hormone. The comparability of detection results for 3 kinds of apparatuses was not very well.
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