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Yasel Alvarez

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

March 7, 2025 by
Education & Training, General Information, Test Utilization

Thyroid Disease Awareness Month

Written by Yasel Fleitas Alvarez, Ph.D., Chemistry Clinical Advisor, Corewell Health Reference Laboratory West, Michigan Pathology Specialists.

This January we are celebrating the National Thyroid Awareness Month. In United States of America, it is estimated that approximately 20 million people have thyroid disease and most importantly, according to the American Thyroid Association (ATA) as many as 60% of people suffering from a thyroid disorder are not aware they have it.The thyroid is a butterfly shaped-gland located at the front of the neck that produces and release thyroid hormones (See Figure 1).

Figure 1. Thyroid Gland Anatomy and Histology

 

It regulates important physiological functions as:

    • Breathing
    • Heart rate
    • Energy production
    • Muscle strength
    • Body temperature
    • Weight
    • Mood

Thyroid disease can present in two main forms:

  1. Hypothyroidism (under functioning thyroid)
  2. Hyperthyroidism (over functioning thyroid)

Confirmation or exclusion of thyroid disease requires a clinical examination combined with biochemical determination of thyroid hormones (TH) and thyrotropin (TSH)concentrations.

In this blog we discuss the best practices for ordering thyroid function tests for the initial screening of thyroid disease at Corewell Health.
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January 24, 2024 by