Browsing Tag

TPO

Compliance & Safety

Anti-TPO Assay Falsely Elevated Recovery

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

Education & Training, General Information, Test Utilization

Appropriate Thyroid Peroxidase Antibody Ordering

The most conclusive evidence for using thyroid peroxidase antibody (TPO) is predictive in nature when evaluating possible subclinical hypothyroidism. If this test is positive, hypothyroidism occurs at a rate of 4.3% per year versus 2.6% per year when the antibody is negative. While this scenario does not cover all clinical indications for ordering TPO, there is no definitive evidence that repeat TPO testing provides additional information.1

Based on this information the ordering of TPO within Spectrum Health is being modified. If the test is ordered more than once on a patient, a screen will appear in EPIC indicating the following: “This test should typically only be resulted once per lifetime. The duplicate checking indicates that this patient has already had this testing performed. Please see chart review for results.” This is not a “hard stop” but providers will need to click “Continue” to proceed with the order. Continue Reading