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
General Information, Referral/Sendouts

Collection Device Update: Referral STI Testing for Pediatric Patients

Effective March 12, 2025, Corewell Health Laboratories will update the STI testing process for patients under 14 years old. These tests will now be sent to Children’s of Wisconsin Laboratory, aligning with the current in-house testing methods for patients 14 years and older using the Alinity m multi collection tube. Previously, these tests were sent to Quest Diagnostics Laboratory using the Aptima® collection device. Please discontinue use of Aptima® collection devices on March 12, 2025. Continue Reading

February 28, 2025 by
Compliance & Safety, General Information, Referral/Sendouts

Weather Impact on Send Out Testing

We want to inform you about an important update regarding T-Spot test collections and deliveries. Due to severe weather conditions expected to affect parts of the United States, we have been advised by our reference laboratory to suspend the collection and sending of this test on Monday, February 17 after 3 p.m. through Tuesday, February 18. Testing collection will begin again on Wednesday, February 19th, unless the request is extended.

This precaution is necessary to ensure the safety and integrity of the specimens, as well as to avoid any potential delays or issues that could arise from the adverse weather. We appreciate your understanding and cooperation during this time.

February 17, 2025 by
General Information

Reminders: COVID Collection

Corewell Health Laboratories no longer offers Covid collection observations or collections at any of our draw sites/laboratories.

If your patient is experiencing symptoms and requires a Covid test, please choose one of the options below:

Collect the specimen in your office and send the specimen to any Corewell Health Laboratory or with your Corewell Health Courier, if available.

• Please be sure to place a collected order in Epic or your EMR, or include a paper order with the specimen.

• Please make sure the specimen is labeled with 2 patient identifiers, date and time of collection, and source (nasopharyngeal or nares)

For all other options please visit: Corewell Health COVID-19 screening and testing

NOTE: Walk-in COVID-19 testing is not available at any of our sites, including emergency departments, urgent care locations or walk-in clinics. Testing is available to registered patients who are seeking medical treatment.

February 4, 2025 by
Advanced Technology Laboratory

Human Papillomavirus (HPV) Testing Update

Corewell Health South and Corewell Health West Laboratories 

Effective Date: February 3, 2025 

Human Papillomavirus (HPV) Genotypic testing will be updated to expand acceptable sources and collection methods. The following HPV test will be available, and the corresponding testing algorithm will be driven by the clinician specified specimen source and collection method/device.  

New Test: Self-Collect HPV High-Risk Screen with HPV Genotype Reflex (LAB1231853)  

  • Testing Restricted to HPV only –Co-testing Not Available: PAP or STI (CT, NG, TV)  
  • Detection of 14 HR HPV genotypes:  
    • HPV Genotype 16  
    • HPV Genotype 18
    • Other HR  HPV – includes 31,33,35,39,45,51,52,56,58,59,66,68  
  • Collection Information:  
    • Acceptable Source: Patient Self-collected vaginal  
    • Collection Device: Rovers® Evalyn® Brush  (ITM-1303902)
    • Collection Instructions: Patients must use the Evalyn Brush in a healthcare setting (i.e. physician office or clinic) to self-collect a vaginal specimen following the Evalyn Brush collection instructions. (Spanish instructions) 
    • A trained healthcare staff member must immediately suspend the Evalyn Brush into a vial of ThinPrep PreservCyt solution following transport instructions. The ThinPrep PreservCyt vial can then be transported to the lab at 2 to 30°C.  
    • This may not be collected at home or in an outpatient draw site. 

Corewell Health Southwest: Effective February 3, 2025, PAP and HPV results will once again be bundled for all orders placed from that date onward. 

Continue Reading

January 28, 2025 by
Advanced Technology Laboratory, General Information

Chromosome Analysis Update

Chromosome Analysis Prenatal and Chromosome Analysis Prenatal Limited orders will now include cryopreservation of prenatal specimens (amniotic fluid and chorionic villi), excluding those found to have straightforward abnormalities (i.e. whole chromosome copy gain).

 

TEST INFORMATION

  • Array Comparative Genomic Hybridization (ACGH), Direct Prenatal with Limited Chromosome Analysis LAB1231125
  • Chromosome Analysis, Prenatal TEST LAB2111376
January 21, 2025 by
Chemistry, General Information

Discontinuation of CKMB

Effective Wednesday, January 1, 2025, the in-house test, Research Creatine Kinase MB Fraction (CK-MB) (LAB2111534) will be made inactive. Recommended alternative testing is CK-MB (CK-2) (TC:17581) which is referred to Quest Diagnostics.

For questions or additional information, please use the Contact Us link above.

January 13, 2025 by