Verification of the analytical performance of the Human thyroid stimulating hormone assay on ALINITY ci ® Experience from the biochemistry laboratory of Mohammed VI University Hospital in Oujda

The aim of our work was to evaluate the analytical performance of the Human Thyroid Stimulating Hormone (TSH) determination by a two-step immunoassay using microparticle chemiluminescence immunoassay (CMIA) technology, in accordance with the Scope A criteria of the guide of the verification/validation of medical biology methods.

We evaluated the repeatability and the intermediate precision of the assay. The results obtained are very satisfactory for the three levels (low, medium and high), both for intermediate fidelity, with coefficients of variation (CV) of   5.38%, 4.16%, and 5.81%.  Respectively, and for repeatability, with coefficients of variation of CV1 = 2.17%, CV2 = 1.54%, CV3 = 1.98% respectively.

The results obtained made it possible to verify the method's performance and compare it with the analytical objectives set in order to meet the regulatory and normative requirements set by the supplier and learned societies.