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Reproductive Endocrinology

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
Chemistry, General Information, Immunochemistry

Test Update: Rubella IgG Antibody Testing

On January 24th, 2022 Rubella Antibody, IgG, Serum (LAB496) and Rubella IgG Antibody Quantitative (LAB3544) will be combined as LAB496 and moved to the Immunochemistry laboratory due to reagent constrains with the current vendor.

Testing will be available Monday-Friday with a turn-around-time of 1-3 days. Results will be reported qualitatively as Immune or Not Immune.  If quantitative results are needed, please fax Immunochemistry at 616-267-2771 or call 616-267-2770. Continue Reading

December 30, 2021 by
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

December 9, 2019 by
General Information, Immunochemistry

Test Update: Beta-2 Glycoprotein 1 Antibodies

Effective November 5th, testing for Beta-2 Glycoprotein 1 antibodies (IgG and IgM, serum) will change from a reference send out test to Mayo Medical Laboratories to an in-house test available at Spectrum Health Laboratories.  This testing is useful for evaluation of patients of suspected antiphospholipid antibody syndrome.

In addition, a new Antiphospholipid Antibody Syndrome Panel will be added which allows for appropriate and complete testing for antiphospholipid antibody syndrome. This panel includes:

Lupus Screen

Cardiolipin IgG and IgM Antibodies

Beta-2 Glycoprotein 1 IgG and IgM Antibodies

Continue Reading

November 4, 2019 by