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Clinical Chemistry 34: 2087-2090, 1988;
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Clinical Chemistry, Vol 34, 2087-2090, Copyright © 1988 by American Association for Clinical Chemistry

A laboratory and clinical evaluation of an immunochemiluminometric assay of thyrotropin in serum

DJ Berry, PM Clark and CP Price
Department of Clinical Biochemistry, Addenbrooke's Hospital, Cambridge, U.K.

We evaluated an immunochemiluminometric assay for human thyrotropin. A chemiluminescent acridinium ester is used as a label, with magnetic- particle separation. The lower limit of detection of the assay (mean + 3 SD of the zero standard) was 0.07 milli-int. unit/L, with a working range of 0.5 to greater than 60.0 milli-int. units/L. Assay accuracy was good as judged from analytical recovery, analysis of external quality-assessment samples, and comparison with an enzyme-amplified immunoassay. There were no significant interferences or cross- reactivities. Twenty-four samples assayed showed aggregation of the magnetic particles. On re-assay, four of these samples showed a significant increase in the measured TSH by the luminescence assay. Assay time for 60 tubes was approximately 3.5 h with the use of a semi- automated luminometer. The reference interval, determined from data on 144 healthy euthyroid subjects, was 0.3-4.0 milli-int. units/L. Sixteen of 19 thyrotoxic patients showed clearly suppressed concentrations of thyrotropin in serum.




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Copyright © 1988 by the American Association for Clinical Chemistry.