Purpose:
To inform all physicians and clinics that UCI Department of Pathology and Laboratory Medicine will introduce the Beckman Access TSH (3rd IS) assay on Feb. 7, 2018. The assay will replace the Access HYPERsensitive and Fast hTSH assays. The individual test code for the new assay is TSHHS and it will be integrated into the existing Thyroid Function Panel TFP).
The new TSH (3rd IS) calibrators are standardized to the World Health Organization 3rd International Standard (NIBSC Code 81/565). Re-baselining is not necessary. The new assay is a 3rd generation TSH assay with manufacturer specified functional sensitivity of 0.01 microIU/mL (imprecision of < 20% coefficient of variation for concentrations < 0.02 microIU/mL). The assay is not validated for testing neonatal serum hTSH levels.
The non-pregnant, adult reference interval for the assay is 0.45 – 4.12 microIU/mL. This reference interval was verified in 37 adult blood donors. (Hollowell JG et al. J Clin Endrocrinol Metab 87:489-499, 2002. Garber JR et al. Thyroid 12:1200-1235, 2012).
For any questions or concerns, please contact the UC Irvine Medical Center Laboratory.
Sincerely,
Bridgit Crews, PhD
Director, Clinical Chemistry and Toxicology
Edwin Monuki, MD, PhD
Chair, Department of Pathology and Laboratory Medicine
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