Effective October 10, 2025, Corewell Health Reference Laboratory West will implement an updated protocol for the Lupus Screen (LAB478). This change is designed to improve diagnostic accuracy for patients undergoing anticoagulant therapy, where false-positive or false-negative results can complicate clinical decision-making.
Rheumatology
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
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
Effective December 20, 2023, Rheumatoid Factor, IgM, Quantitative will be replaced with Rheumatoid Factor.
Monoclonal gammopathies are characterized by the secretion of a monoclonal protein or M-protein. A wide variety of conditions can produce an M-protein, and the initial screening and monitoring of these patients require an array of tests. Herein we described best practices for protein electrophoresis ordering at Corewell Health.
Microalbumin/Creatinine, Random Urine Result Comment Update
Effective January 4, 2023, the process for reporting the Microalbumin/Creatinine ratio was changed for situations where one of the results, microalbumin and/or creatinine, is below or above the assay’s analytical measuring range (AMR).
After consultation with our clinical partners, Spectrum Health West Michigan Laboratory will be adjusting the pediatric reference ranges for our new ALT and AST reagents in an effort to better serve our population. Numerous academic studies were reviewed, and the values listed below were adopted on August 3, 2022:
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.
Effective immediately, Thyroglobulin Antibody will be performed at Spectrum Health Reference Laboratory (SHRL, Grand Rapids, MI) and will no longer be a sendout to Mayo Clinical Laboratories. Collection instructions and other information may have changed, please visit the lab catalog for more information.
Thyroglobulin Tumor Marker will continue to be a sendout. If a Thyroglobulin Antibody is ordered with a Thyroglobulin Tumor Marker, then the Thyroglobulin Antibody will automatically be canceled as Mayo Clinic Laboratories will perform the Thyroglobulin Antibody as well as the Tumor Marker.
For questions and inquiries, please use the “Contact Us” link above.
TEST INFORMATION
New test: Thyroglobulin Antibody [LAB1230840]
Former test: Thyroglobulin Antibody, Serum [LAB1230457]
Mentioned Test: Thyroglobulin, Tumor Marker, Serum [LAB864]