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Immunology & Allergy

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
Immunochemistry, Main lab

Update in Testing Platform – Immunochemistry

As of January 26, 2024, for the following tests, the testing platform has changed from EliA Fluorescence Enzyme Immunoassay (FEIA) from Thermofisher to Multiplex Flow Immunoassay from Biorad. Please review the lab catalog for any changes to collection information or reference ranges.

• Anti-dsDNA Antibody
• Cyclic Citrullinated Peptide (CCP) Antibody
• Celiac Antibody Cascade
• Tissue Transglutaminase Antibody
• Gliadin Antibodies Continue Reading

January 26, 2024 by
Chemistry

Updates: Chemistry Reference Ranges

Effective August 2, 2022, reference ranges for the below tests will be updated to better align with the vendor’s recommendation and with Spectrum Health Lakeland Laboratory. Please click on the links below and scroll to the Reference Range field to see the updated ranges.

• Lithium Level [LAB29]

• PTH Intact [LAB108]

• IgM Level [LAB72]

• IgA Level [LAB73]

• CA 125 Level [LAB155]

• C4 Complement Level [LAB151]

• C3 Complement Level [LAB152]

• Albumin Level [LAB45]

• Transferrin Level [LAB133]

Questions or inquiries may be directed to the “Contact Us” link above.

August 2, 2022 by
General Information, Immunochemistry, Test Spotlight

New Insect Allergen Component Testing

Effective December 9, 2020, the following insect allergen components will be available:

◊ Allergen Honey Bee Component Panel – EPIC #LAB1230747, Interface #1230747, CPT 86008

◊ Allergen Common Wasp (Yellow Jacket) Component Panel – EPIC #LAB1230752, Interface #1230752, CPT 86008

◊ Allergen Paper Wasp Component rPol d 5 – EPIC #LAB1230754, Interface #1230754, CPT 86008

◊ Cross-reactive Carbohydrate Determinant (CCD) – EPIC #LAB1230755, Interface #1230755, CPT 86008 Continue Reading

December 11, 2020 by
Compliance & Safety, General Information, Immunochemistry, Main lab

Serum Kappa/Lambda Free Light Chain Assay Update

Effective September 28th, 2020, a new generation of the serum kappa/lambda free light chain assay has been implemented.

With the implementation of the new generation of the assay there is an approximately 20% negative bias for kappa free light chains in serum containing >20 mg/dL kappa free light chain.  This may affect the trending for patient who are serially monitored by this assay. Continue Reading

September 24, 2020 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