The poster illustrates the significant clinical diagnostic need for robust and accurate methods for determining thyroid hormone levels in general, and in particular for rT3.  rT3 was developed as a certified solution reference standard – a critical starting material in the production of calibrators.  The evaluation at Cerilliant and LabCorp demonstrated that the accuracy of the spiking solution impacts the accuracy of the calibrators and thus clinical results. In recent years there has been significant push to develop LC-MS/MS LDTs for quantitation of thyroid hormones with the potential for higher accuracy even on the low end, better specificity, and the ability to quantitate the different thyroid hormones separately.

Key conclusions include:

• Proper characterization and certification of reference materials is critical for use in clinical diagnostic applications. The comparison of materials from various sources demonstrates that unless complete certification is performed, it is not possible to fully evaluate whether a material is suitable for use as a calibrator.
• Insufficient characterization and /or use of low purity research grade materials can result in incorrect therapeutic reference ranges and negatively impact clinical outcomes.
• The calibrator for the LabCorp method was changed to the Cerilliant Certified Spiking Solution® and reference ranges were re-qualified.

The poster can be viewed at  Accurate Reference Standards for Accurate Quantitation of Thyroid Hormones: Impact on Clinical Reference Ranges.