Verification of the analytical performance of thyroglobulin autoantibodies on ALINITY ci ® experience from the biochemistry laboratory of Mohammed VI University Hospital in Oujda

The objective of this study was to assess the analytical performance of thyroglobulin autoantibody determination using a two-step immunoassay based on microparticle chemiluminescence immunoassay (CMIA) technology. This evaluation was conducted in compliance with the Scope A criteria outlined in the guidelines for the verification and validation of medical biology methods.

We investigated the assay’s repeatability and intermediate precision. The results were highly satisfactory across three concentration levels (low, medium, and high). For intermediate precision, the coefficients of variation (CV) were:

 CV1 = 2.56 %, CV2 = 3.60 % and CV3= 2.70 %, respectively. For repeatability, the coefficients of variation were CV1 = 3.13 %, CV2 = 2.90 and CV3= 2.40 %, respectively. 

These findings confirm the method’s performance and its alignment with the analytical objectives set by the manufacturer and professional societies. This ensures compliance with both regulatory and normative requirements.