Technical Bulletins
The following technical bulletins are memos distributed to the UR Medicine Labs partners and affiliates. They are distributed via email and posted here for reference.
New POLE-POLD1 Assay Offering
Friday, April 10, 2026
Effective Date: May 6th, 2026
The Molecular Diagnostic Laboratory will begin offering a new POLE-POLD1 assay, effective May 6th, 2026. This test will be reflexively ordered for all newly diagnosed endometrial carcinomas by the assigned surgical pathologist and the corresponding results will be incorporated into the final surgical pathology report and/or available as a separate report in eRecord.
This assay is designed to qualitatively detect 17 specific point mutations in the POLE gene and one mutation in the POLD1 gene. This comprehensive detection capability allows us to identify 99% of the known pathogenic POLE and POLD1 mutations associated with endometrial cancer.
For any questions, please contact:
Allison Cox, Ph.D.
Interim Director of the Molecular Diagnostic Laboratory
UR Medicine Labs
Phone: (585) 758-0456
Email: Allison_Cox@URMC.Rochester.edu
Paige Elliott
Supervisor, Molecular Diagnostic Laboratory
UR Medicine Labs
Phone: (585) 275-2709
Email: Paige_Elliott@urmc.rochester.edu
Blood Culture Tube Fungi and Mycobacteria Change Memo
Monday, April 6, 2026
Effective immediately, due to supply chain issues, the collection container for collecting blood for culture of Fungi (Test Code: BIFUN) and Mycobacteria (Test Code: BIAFB) has changed to Green Top Vacutainer Tube containing sodium heparin as anticoagulant.
Specimen labels have been adjusted to account for this change. There is no change in how the test is ordered or resulted.
Please reach out to Dr. Hardy with any questions/concerns.
Dwight J. Hardy, Ph.D.
Director, Clinical Microbiology
UR Medicine Labs
Professor of Microbiology and Immunology,
Pathology and Laboratory Medicine
University of Rochester Medical Center
Phone: (585) 275-1408
Dwight_Hardy@urmc.rochester.edu
New JAK2 V617F (JAK2N) Control Ranges & Reporting Language in Molecular Diagnostics
Thursday, March 19, 2026
Effective Date: April 20th, 2026
The Molecular Diagnostic laboratory will be implementing new reference ranges and reporting language for JAK2 V617F testing (Soft order code JAK2N). This change is being made to align our reporting with the most current clinical data and best practices.
A high variant allele frequency (VAF) for JAK2 V617F has been associated with elevated platelet counts and, to a lesser extent, increased leukocyte numbers in patients, even in the absence of a diagnosed myeloproliferative neoplasm. To more accurately reflect this important clinical finding, we will be distinguishing between "Positive (0.5-10%)" and "Positive (>10%)" in our reports.
Also note that the limit of the detection for the assay has changed from 0.1 to 0.5%.
Current Reporting Ranges:
<0.1% variant allele frequency (VAF): Negative
0.1% to 0.5% VAF: Weak Positive
>0.5% VAF: Positive
New Reporting Ranges (Effective April 20, 2026):
<0.5% VAF: Negative
0.5% to 10% VAF: Positive (0.5-10%)
>10% VAF: Positive (>10%)
For any questions, please contact:
Allison Cox, Ph.D.
Interim Director of the Molecular Diagnostic Laboratory UR Medicine Labs
Phone: (585) 758-0456
Email: Allison_Cox@URMC.Rochester.edu
Paige Elliott
Supervisor, Molecular Diagnostic Laboratory
UR Medicine Labs
Phone: (585) 275-2709
Email: Paige_Elliott@urmc.rochester.edu
Discontinuation of Courtesy Printed PCP Lab Copy to Reports Notice
Thursday, March 5, 2026
Effective Date: April 1st, 2026
To: All Ordering Clinicians and Staff
From: UR Medicine Labs
SUBJECT: Notice of Service Change: Discontinuation of Courtesy Printed PCP Lab Copy to Reports
Effective April 1st, 2026, UR Medicine Labs will no longer provide printed courtesy copies of laboratory test reports to Primary Care Physicians (PCPs) who are not the direct ordering provider. (This does not apply to eRecord electronic reports)
Context for Change
For many years, we have provided these courtesy copies to assist with care coordination. However, as the healthcare landscape has transitioned from paper-based workflows to Electronic Health Records (EHR) and Electronic Laboratory Reporting (ELR), the need for manual distribution has significantly decreased. Modern digital systems now allow for more efficient, real-time data sharing that reduces the administrative burden of physical mail and manual faxing.
What This Means for You
- Direct Results: The clinician who orders the test will continue to receive the official report through existing electronic or paper channels. • Coordination of Care: We encourage providers to utilize different access Electronic Health Records (EHR) such as ePartner, eRecord, Rochester Regional Health Information Organization (RRHIO) or our Client Service Department to access patient records across different practices.
- Patient Requests: Patients remain entitled to receive copies of their own laboratory results, which they may share with any provider of their choice.
We appreciate your cooperation as we modernize our reporting processes to focus on more secure and efficient electronic delivery methods.
Toxoplasma gondii IgM/IgG, CMV IgM/IgG, and Helicobacter pylori IgG: Change to Assays and Test Codes
Monday, March 2, 2026
Effective Date: March 4th, 2026
A new instrument will be used to test for Toxoplasma IgM and IgG, Cytomegalovirus (CMV) IgM and IgG, and Helicobacter pylori IgG antibodies.
• Individual test codes will change; however, there is no change to the ordering process for eRecord users.
• For each test, the method will change to a qualitative chemiluminescence immunoassay (CLIA). The new method provides equivalent results for diagnostic accuracy compared to the prior method.
• For the Toxoplasma gondii IgG antibody test, reporting will change from semi-quantitative to qualitative (i.e., Positive, Equivocal, or Negative). All other tests will continue to be reported qualitatively.
• The existing group test panel codes and ordering process for Cytomegalovirus Antibodies, IgM & IgG (CMVP) and Toxoplasma gondii Antibodies, IgG & IgM (TOXOP) remain unchanged.
• There is no change to the specimen collection or handling process.
Performing Laboratory: Microbiology (Serology/Immunology)
Reporting: Qualitative (Positive,Equivocal, or Negative)
- Test Name: Toxoplasma gondii Antibody, IgM Test Code: TOXMG
- Test Name: Toxoplasma gondii Antibody, IgG Test Code: TOXGG
- Test Name: Cytomegalovirus Antibody, IgM Test Code: CMVMG
- Test Name: Cytomegalovirus Antibody, IgG Test Code: CMVGG
- Test Name: Helicobacter pylori Antibody, IgG Test Code: HELG
For questions or additional information, please contact Lindsay Ryan-Muntz, Serology/Immunology Supervisor.
From: Andrew Cameron, PhD D(ABMM)
Assistant Director, Microbiology, UR Medicine Labs
University of Rochester Medical Center
Phone: (585) 276-4674
E-mail: andrew_cameron@urmc.rochester.edu
Rivaroxaban (Xarelto), Anti-Xa Plasma: New Assay
Thursday, February 19, 2026
Effective Date: March 25th, 2026
UR Medicine Labs will perform rivaroxaban activity testing using a specific anti-Factor Xa assay. Routine clinical monitoring of rivaroxaban is not recommended. However, assessment of rivaroxaban activity may be helpful in certain clinical scenarios, including bleeding events, perioperative management, or suspected overdose.
Test name: Rivaroxaban
Test code: RVXBN
Sample type: Sodium citrate (blue top) plasma
Quantitative range: 20 ng/mL – 1000 ng/mL
Turn-around-time: Outpatient: Mondays, Wednesday, and Fridays
Inpatient and Emergency: 24/7
Stability: 24 hours at room temperature
This assay is specific for rivaroxaban. Separate anti-Factor Xa assays are available for unfractionated heparin (UNFH), low-molecular weight heparin (LMWH), and apixaban (APXBN).
If you have any questions please contact Geoffrey Harris, Lab Manager for Hematology & Chemistry Laboratories at Strong Memorial Hospital, at 275-2435 or Geoffrey_Harris@urmc.rochester.edu, or Dr. Refaai at any of the below methods listed.
From: Majed Refaai, M.D.
Professor of Pathology & Laboratory Medicine
Special Coagulation Laboratory Director
University of Rochester Medical Center
Phone: (585) 276-3927
Email: Majed_Refaai@urmc.rochester.edu
HSV-1/2 (Herpes Simplex Virus) NAAT: Change to Assay and Test Code
Tuesday, February 3, 2026
Effective Date: February 18th, 2026
A new nucleic acid amplification test (NAAT) for Herpes Simplex Virus types 1 and 2 (HSV-1/2) will be used for in-house testing of cutaneous and mucocutaneous swabs (i.e. lesion swabs). This testing will be performed under a new test code: ‘HSVQL’.
Test name: HSV-1/2 NAAT Test code: HSVQL
Specimen: Cutaneous and Mucocutaneous swabs (i.e. lesion swabs)
Collection device: BD Universal Viral Transport collection kit
Method: Nucleic acid amplification by PCR
Performing laboratory: Microbiology (Virology)
The new HSV-1/2 NAAT is a laboratory-developed test with improved sensitivity for the qualitative detection and differentiation of HSV-1 and HSV-2.
The existing test code (HSVRL) and ordering process will remain unchanged for testing of other non-blood sources (e.g. amniotic, respiratory, and ocular fluids). The existing test code (HSVQ) and ordering process for HSV-1/2 Quantitative NAAT (Blood) remains unchanged.
For questions or additional information, please contact Sarah Magri, Supervisor, Virology (sarah_magri@urmc.rochester.edu).
From: Andrew Cameron, PhD D(ABMM)
Assistant Director, Microbiology, UR Medicine Labs
University of Rochester Medical Center
Phone: (585) 276-4674
E-mail: andrew_cameron@urmc.rochester.edu
Immune Status Panel-MMR/V IgG Antibody: New Ordering Option
Tuesday, January 20, 2026
Effective Date: January 21, 2026
An Immune Status Panel which includes individual tests for IgG antibodies to Measles, Mumps, Rubella and Varicella-Zoster has been created to simplify test ordering and correct test selection. The Immune Status Panel for MMRV can be used to document the presence of IgG antibodies to these viral agents in individuals who have had natural infection or immunization. If desired, the tests can continue to be ordered individually.
Test Name: Immune Status Panel – MMR/V IgG Antibody
Test Code: MMRV
Note that these tests are not to be used for diagnosing acute infection. For diagnosing acute infection caused by one of these agents, specific IgM antibody test should be considered.
For questions or additional information, please contact Lindsay Ryan-Muntz, Serology/Immunology Supervisor.
Lindsay Ryan-Muntz
Serology/Immunology Supervisor
UR Medicine Labs
Pathology and Laboratory Medicine
University of Rochester Medical Center
Phone: (585) 275-8728
Lindsay_Ryan-Muntz@URMC.Rochester.edu
Dwight J. Hardy, Ph.D.
Director, Clinical Microbiology
UR Medicine Labs
Professor of Microbiology and Immunology,
Pathology and Laboratory Medicine
University of Rochester Medical Center
Phone: (585) 275-1408
Dwight_Hardy@urmc.rochester.edu