Quality evaluation of TSH IRMA kit

The quality of TSH (IRMA) kit is estimated by experiment data obtained in 12 months. The essential results contain Bmin/T ≤ 0.3%, Bmax/Bmin > 190, the correlated coefficient of the standard curve ≥0.993 which have been processed by linear regression of IgD-lg(B/Bmax), ABCV ≤ 3.4%. Both CV of the curve slope and intercept are less than 5%. All determined values of QC serum are in reference limitation, the CV and bias of inter and intra are less than 10% and 15% respectively. The sensitivity of the method is 0.046 mIU/L, and the stability which is determined by stored the kit at 4 degree C is normal, except Bmin/T is less higher in two months. The samples are determined by TSH RIA and TSH produced by DPC in order to compare with TSH IRMA and the correlated coefficient of the results are 0.9494 and 0.9868 respectively