Evaluation of the performance of the electrochemiluminescent immunoassay system of Elecsys 2010 / 生物医学工程学杂志

ABSTRACT

Performance of the electrochemiluminescent immunoassay system of Elecsys 2010 was evaluated by quantitative assay. The functional sensitivity of the TSH assay was 0.004 microU/ml. The extra-assay imprecision was RSD = 1.45%-4.65% in the range of TSH concentrations of 0.43-88.15 microU/ml. The intra-assay imprecision was RSD = 1.38%-3.14% in the range of TSH concentrations of 0.41-87.28 microU/ml. The recovery of TSH was in the range of 98.6%-104.4%. The correlation between theoretical values and obtained values of TSH was adequate(r = 0.999). We conclude that the Elecsys 2010 is provably satisfactory in sensitivity, precision, accuracy, reliability, practicability and rapidity.