促甲状腺素免疫放射药盒的质量评价

Quality Evaluation of TSH IRMA Kit

对本所生产的 TSH(IRMA)药盒连续 12批的检测数据进行质量评价 ,基本质控内容 :Bmin/ T≤ 0 .3% ,Bmax/ Bmin>190 ,标准曲线经 lg D- lg(B/ Bmax)线性回归 ,r≥ 0 .993,平均批变异系数 (ABCV)≤ 3.4 %。斜率 (B)及截距 (A)的批间变异系数 CV<5 %。质控血清测定值均在参考范围内 ,批内、批间 CV<10 % ,批内、批间偏倚 <15 %。灵敏度为 0 .0 4 6 m IU/ L。药盒于 4℃存放 6 0天除 Bmin/ T略高于质控指标外 ,其它各项指标均正常 ,与 DPC公司 TSH固相包被法药盒测定样品的相关系数 (r)为 0 .986 8,与 TSH放射免疫法测定的 r为 0 .94

The quality of TSH (IRMA) kit is estimated by experiment data obtained in 12 months. The essential results contain B min / T ≤0.3%, B max / B min >190, the correlated coefficient of the standard curve≥ 0.993 which have been processed by linear regression of lg D lg( B/B max ),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℃ is normal, except B min /T is less higher in two months. The samples are determined byTSH RIA and TSH produced by DPC in order to compare with TSH IRMA and the correlated coefficient of the results are 0.949 4 and 0.986 8 respectively.