Analytical Variation Between Two Different TSH Reagents from the Same Manufacturer

Thyroid stimulating hormone (TSH) immunoassays are known for giving varying results based on the platform of testing and the generation of kit used. It is generally expected that the results should not vary to affect clinical diagnosis and management. We aimed to perform method comparison study between two TSH assays by the same manufacturer Siemens Healthineers. Results show that there is a large proportional error between the assays with a bias of -3.71mIu/L indicating that TSH assay gives higher values for TSH for the same patient as measured against the TSH3-Ultra kit. This can affect interpretation of results leading to false increase in patients categorized under hypothyroidism and subclinical hypothyroidism. We strongly suggest, to prevent errors in clinical evaluation of a patient with thyroid dysfunction, validation of the performance of the assay and method comparison should be performed in-house.