Pediatrics
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
Influenza prevalence fluctuates seasonally, and case numbers are currently increasing throughout West Michigan. The onset of “flu season” varies year-to-year though typically begins its upswing in the month of December. It is important for providers to have an awareness of influenza prevalence (in addition to other respiratory viruses) to help guide when influenza testing should be pursued.
The use of point of care (POC) antigen testing reduces both the cost to the patient and turn-around-time as compared to lab-based molecular methods. POC antigen tests are typically available for COVID-19, influenza A/B, and as a COVID-19/influenza A/B combination test. During warmer months when influenza prevalence is negligible yet COVID-19 may be circulating, a COVID-only antigen test may be helpful for diagnosis. As influenza increases into colder months, a COVID-19/Influenza A/B combo test would act as a screen for both viruses.
POC tests generally have high analytical specificity but lack the sensitivity of nucleic acid amplification methods (e.g. PCR). For this reason, PCR testing is still recommended for hospitalized patients and for outpatients with a negative POC result if influenza is still suspected and if the result will impact clinical decision making. Influenza PCR may be ordered as a standalone test (LAB3255) or as a part of a panel alongside COVID-19 and RSV (LAB1230746).
Test Information
- Influenza PCR Epic Code: LAB3255, Interface EMR Code: 11594, CPT Code 87502
- COVID-19, Influenza A/B, RSV PCR Epic Code: LAB1230746, Interface EMR Code: 1230746, CPT: 0241U
Contact/Resources
Local Infection Prevention Team
Michigan Department of Health and Human Services
- Resources: https://www.michigan.gov/flu/resources
- Surveillance information: https://www.michigan.gov/flu/surveillance
Effective Monday, September 16, 2024 all Corewell Health ambulatory offices will see an increase in Frequency Advance Beneficiary Notices (ABN) when ordering Lipids. This ensures compliance with Medicare requirements. ABNs serve as an indication to ordering physicians and APPs that the order has a stipulation for coverage and that Medicare may not reimburse for services; the patient will need to acknowledge potential financial responsibility. Having this completed ABN on file allows Corewell Health to provide and bill for services.
Specific to lipid frequency ABNs:
• Screening: Medicare covers testing once every 5 years. Per CMS, lipid testing in asymptomatic individuals is considered screening regardless of the presence of other risk factors such as family history, tobacco use, etc.
• Monitoring: Medicare covers testing once annually for monitoring the lifestyle and/or pharmaceutical treatment of lipid disorders. If more frequent testing is medically necessary after initiation of therapy, Medicare will cover up to six total cholesterol or LDL labs in the first year of therapy.
Lab will collect any ABNs needed if not collected prior to patient collection at our Patient Service Centers. If collection occurs in the office, be sure to follow the process: Ambulatory Clinical – Completing the Advance Beneficiary Notice (ABN) from the Epic Education Team SharePoint page. Any Medicare patient specimen submitted for lipid panel testing without an ABN will NOT be tested by the laboratory.
For more information on the CMS requirements for lipid testing, please review the NCD – Lipid Testing (190.23) (cms.gov)
New Test: HPV High Risk Screen with HPV Genotype Reflex
Effective August 26, 2024, Corewell Health Laboratories West will be updating their High-Risk HPV testing. The new assay will be performed on the Abbott Alinity m at Corewell Health Reference Laboratory West, Grand Rapids. Testing will now automatically include HPV Genotype results whenever HPV is detected. There will no longer be a separate charge to the patient for HPV Genotype testing.
There will also be an expanded number of High-Risk HPV Genotypes reported:
- HPV Genotype 16
- HPV Genotype 18
- HPV Genotype 45
- HPV Genotype 31/33/52/58
- HPV Genotype 35/39/51/56/59/66/68
The new assay is FDA approved for Primary screening in addition to co-testing.
Post hysterectomy vaginal specimens will still be a send out test (LAB1230722).
The following information was updated in the Lab Catalog.
All changes are for Corewell Health West Laboratories. For East and South locations, please visit: corewellhealth.org/labcatalog
The following information was updated in the Lab Catalog.
All changes are for Corewell Health West Laboratories.
For East and South locations, please visit: corewellhealth.org/labcatalog
The following information was updated in the Lab Catalog.
All changes are for Corewell Health Laboratories West.
The following information was updated in the Lab Catalog.
All changes are for Corewell Health Laboratories West.
This winter, West Michigan influenza infections peaked in February 2024 and significantly declined throughout March and April 2024. Now with a low prevalence of circulating influenza, using the most sensitive diagnostic test is recommended in order to obtain accurate and actionable results. Influenza antigen testing (e.g. Sofia instrument) is no longer appropriate at this time and Influenza PCR testing should be ordered when clinically indicated.
Low Influenza Prevalence |
High Influenza Prevalence |
|
Recommended Order | Influenza PCR (LAB3255) | Influenza antigen testing (e.g. Sofia instrument) or Influenza PCR (LAB3255) |
More detailed information can be found as published by the CDC: