Quality Assessment of Radioimmunoassay Kits
The Immunodiagnostics Lab has been authorized by the National Organization for Medicines to perform the Quality Control of all radioimmunoassay kits on the Greek market, either imported or produced in the country. The kits tested include diagnostic reagents for the determination of cancer markers, cardiac markers, peptide and steroid hormones, thyroid and pituitary hormones, autoantibodies, vitamins, drugs, etc.
The Quality Control performed includes determination of the following parameters:
- Analytical and clinical sensitivity
- Working range
- Accuracy (recovery and linearity study)
- Intra- and inter-assay repeatability
- Normal levels and cut-off values (where applicable)
All tests are performed in accordance with the European Pharmacopoeia and the Package Leaflets for each radioimmunoassay kit.