Zucchelli G C, Pilo A, Masini S, Chiesa M R, Masi A
C. N. R. Institute of Clinical Physiology, Pisa, Italy.
J Biolumin Chemilumin. 1989 Jul;4(1):620-6. doi: 10.1002/bio.1170040182.
A recently available immunochemiluminometric assay (ICMA) for TSH developed by Ciba Corning Corp. has been evaluated. This system (Magic Lite) uses an acridinium-ester-labelled antibody and magnetizable particle for bound-free separation. In each assay only two calibrators are carried out and used to re-scale a manufacturer-generated curve stored in the memory of the luminometer. The precision of the response (RLU) estimated by all duplicates of 14 runs was about 4% for responses greater than 12,000 RLU (corresponding to a concentration interval 0.7-113 microIU/ml) and worsened in the lower range (up to 10% CV); the sensitivity, computed from the mean within-assay precision profile, was 0.028 microIU/ml; the between-assay precision ranged from 4.6 to 13.1 CV%. Regression analysis of ICMA results (y) against consensus values of Behring IRMA (x) on 15 QC sera assayed in an inter-laboratory survey (concentration range 1-30 microIU/ml) gave y = -0.003 + 0.98x indicating a good agreement of the two techniques. Similar conclusions have been derived from the comparison of the ICMA results (y) in the low TSH concentration range (less than 1 microIU/ml) against the IRMA Boots Celltech (x) on 80 patient samples (y = 0.04 + 1.04x).
已对由汽巴康宁公司开发的一种最近可用的促甲状腺激素免疫化学发光测定法（ICMA）进行了评估。该系统（Magic Lite）使用吖啶酯标记的抗体和可磁化颗粒进行结合-游离分离。每次测定仅进行两个校准，并用于重新校准存储在发光计内存中的制造商生成的曲线。14次运行的所有重复测定估计的响应精度（相对光单位，RLU）对于大于12,000 RLU的响应（对应于浓度区间0.7 - 113微国际单位/毫升）约为4%，在较低范围内变差（变异系数高达10%）；根据测定内精度曲线计算的灵敏度为0.028微国际单位/毫升；测定间精度范围为4.6%至13.1%变异系数。在一项实验室间调查中对15份质量控制血清（浓度范围1 - 30微国际单位/毫升）进行的ICMA结果（y）与拜耳免疫放射测定法（IRMA）的一致值（x）的回归分析得出y = -0.003 + 0.98x，表明两种技术具有良好的一致性。从对80份患者样本在低促甲状腺激素浓度范围（小于1微国际单位/毫升）的ICMA结果（y）与IRMA Boots Celltech（x）的比较中也得出了类似结论（y = 0.04 + 1.04x）。
