Chemiluminescent third-generation assay (amerlite TSH-30) of thyroid-stimulating hormone in serum or plasma assessed

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Abstract

We assessed the laboratory performance and clinical util-ity of a new commercial third-generation assay of thyroid-stimulating hormone (TSH), Amerlite TSH-30. The interassay CV was 6% at TSH concentrations of ∼0.08 mlU/L, and the analytical and functional detection limits of the assay were 0.005 and 0.0125 mlU/L, respectively. Although the assay recovered ∼96% of TSH International Reference Preparation (TSH-IRP) 80/558 added to serum samples, the endogenous TSH concentrations in basal samples were significantly lower than those found by using two other TSH assays; bias data obtained from thyroliberin stimulation tests suggested that the negative bias found with TSH-30 may be due to the heterogeneity of TSH in basal samples. TSH-30 completely discriminated hyperthyroid and hypothyroid patients from euthyroid ambulatory patients but also detected TSH (>0.0125 mlU/L) in 3 of 46 untreated hyperthyroid patients. Compared with two second-generation assays, TSH-30 better discriminated between patients with subnormal TSH due to hyperthyroidism, thyroxine overreplacement, and nonthyroidal illness but there was still significant overlap between results for these groups.

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Wilkinson, E., Rae, P. W. H., Thomson, K. J. T., Toft, A. D., Spencer, C. A., & Beckett, G. J. (1993). Chemiluminescent third-generation assay (amerlite TSH-30) of thyroid-stimulating hormone in serum or plasma assessed. Clinical Chemistry, 39(10), 2166–2173. https://doi.org/10.1093/clinchem/39.10.2167

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