New Assay for Thyroid-Stimulating Hormone

A new immunoassay for thyroid-stimulating hormone (TSH) is designed for the diagnosis of hyperthyroidism and hypothyroidism.

The ability to achieve third-generation sensitivity is essential for most TSH assays, since it yields information that is useful to clinicians referring patients with subnormal TSH concentrations, according to Olympus Life and Material Science Europa (Hamburg, Germany), which developed the assay.

The clinical benchmark for TSH is not its analytic sensitivity but its functional sensitivity. Functional sensitivity for TSH is normally defined as the lowest concentration at which the interassay coefficient of variation is ? 20%. This demonstrates the ability of the assay to discriminate euthyroid levels (0.4-4.0 µlU/ml) from the very low levels (< 0.01 µlU/ml) obtained in patients with thyrotoxicosis.

Olympus has announced that the latest performance verification of the assay on the new Olympus AU3000i immunoassay system delivered excellent functional sensitivity (fourth generation: ? 20% coefficient of variation (CV) @ 0.002 µlU/ml) and analytic sensitivity (< 0.001 µlU/ml). Based on this performance, the company concludes that the AU3000i TSH assay is a very sensitive and precise method for the detection of human TSH in both serum and plasma. These results would seem to justify the new assay as being regarded as fourth generation.



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