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Diagnostic manufacturers must ensure/document metrologically traceable assays. We report on a feasibility study of a split-sample comparison for that purpose. Processed, frozen single-donation sera, assigned target values by candidate reference measurement procedures (cRMPs), were used with immunoassays for total thyroxine (TT(4)) and triiodothyronine (TT(3)) as models.

clinical chemistry

Feasibility Study of the Use of Frozen Human Sera in Split-Sample Comparison of Immunoassays with Candidate Reference Measurement Procedures for Total Thyroxine and Total Triiodothyronine Measurements