A reagent bulletin from Roche has informed us that the recovery of the Anti-TPO assay has been falsely elevated for a reagent lot that was in use at Corewell Health Grand Rapids from September 2024 until March, 3, 2025. Based on the product evaluation, and in conjunction with a product and safety risk assessment, the remaining risk of false positive results with the Elecsys Anti-TPO assay is in the acceptable range.
We apologize for the inconvenience. Please reach out with any concerns or questions.
Best,
Dr. Alvarez
Yasel Alvarez, Ph.D.
Clinical Chemistry and Immunology
Corewell Health Reference Laboratory, West Michigan
Test Information
Thyroid Peroxidase Antibody, Blood Level [LAB516]
Clinical Implications
The risk of false positive results with the Elecsys anti-TPO assay is generally acceptable with respect to the given discrepancy.
Resources
Roche Customer Bulletin TP-02316
No Comments