Methodological evaluation of a new chemiluminescence immunoassay for thyrotropin using acridinium ester-labelled antibody

✍ Scribed by Zucchelli, G. C. ;Pilo, A. ;Masini, S. ;Chiesa, M. R. ;Masi, A.

• Publisher: John Wiley and Sons
• Year: 1989
• Weight: 395 KB
• Volume: 4
• Category: Article
• ISSN: 0884-3996
• DOI: 10.1002/bio.1170040182

✦ Synopsis

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 t w o 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 >12,000 RLU (corresponding t o a concentration interval 0.7-113pIU/ml) and worsened in the lower range (up t o 10% CV); the sensitivity, computed from the mean within-assay precision profile, was 0.028 plU/ml; the betweenassay precision ranged from 4.6 t o 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 3 0 plU/ml) gave y = -0.003 + 0 . 9 8 ~ 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 (< 1 plU/ml) against the IRMA Boots Celltech (x) on 80 patient samples ( y = 0.04 + 1.04~).