International Medical Research Frontier

Objective To verify and evaluate the analytical performance of the electrochemiluminescence (ECLIA) human calcitonin (CT) detection kit. Methods According to the international standards for medical laboratories, performance verification is required for newly launched projects. The ROCHE electrochemiluminescence instrument was used to quantitatively detect human calcitonin in serum in vitro by electrochemiluminescence to verify the accuracy, precision, quantitative detection limit, linear range, reference interval and other performance indicators of this method. Results In terms of precision: The intra-batch coefficient of variation (CV) of serum calcitonin specimens at high and low concentration levels was 3.080% and 4.014% respectively, and the inter-batch coefficient of variation (CV) was 6.6% and 6.0% respectively, both less than 15%. In terms of accuracy: The bias calculation results of the reference material samples at levels one and two are 4.43% and 2.58% respectively, both within the allowable range. The quantitative detection limit is 1 pg/ml. In terms of linear range: The correlation coefficient r between the expected values and the measured values of high and low concentration mixed serum samples is 0.991, and the regression equation is y=0.9962x-25.705. In terms of the biological reference range: The serum calcitonin detection values of 20 healthy men and women of similar age were as follows: 4.9-8.7pg/ml for men and 3.5-5.7pg/ml for women. Conclusion The precision, accuracy, quantitative detection limit, linear range, and biological reference interval of the electrochemiluminescence calcitonin kit all meet the requirements of clinical trials. The verification results of all performance indicators can provide references for relevant laboratories.

Calcitonin; Electrochemiluminescence method; Performance verification; ECLIA