First quarter 2025. The Lab Medicine Update is a collaboration between the UVA Medical Laboratories and the UVA Medical Laboratory Committee. Feedback on the LMU? Contact Jim Harrison (james.harrison@virginia.edu).
Core Myeloid NGS DuoSeq panel now available in-house ↑
On March 18, next generation sequencing (NGS)-based testing for hematological malignancies became available again in-house. The UVA Clinical Genomics Laboratory has validated the Core Myeloid NGS DuoSeq panel, a 50-gene NGS-based assay designed to aid in the diagnosis and management of patients with acute myeloid leukemia, myelodysplastic syndrome, and myeloproliferative neoplasms.
This test is orderable in EPIC as: Core Myeloid NGS DuoSeq Panel LAB6695
Acceptable samples: Bone marrow aspirate or peripheral blood in a lavender tube (EDTA), or FFPE tissue
Genes tested include ASXL1, BCOR, BRAF, BTK, CALR, CBL, CD79B, CDK12, CDKN2A, CEBPA, CSF1R, CSF3R, CXCR4, DDX41, DNMT3A, EGFR, EZH2, FGFR3, FLT3, GATA2, IDH1, IDH2, IKZF1, IKZF3, JAK2, JAK3, KIT, KRAS, MAP2K1, MAP2K2, MPL, MYD88, NPM1, NRAS, PDGFRA, PIK3CA, PLCG2, RHOA, RUNX1, SETBP1, SF3B1, SH2B3, SRSF2, STAG2, STAT3, TET2, TP53, U2AF1, WT1, and ZRSR2.
New method for qualitative CMV testing, March 20 ↑
The platform currently used for qualitative CMV testing (samples other than blood) in the UVA Clinical Microbiology Laboratory is being discontinued. The discontinued platform allowed us to test urine, buccal swabs, and respiratory samples from patients of all ages for qualitative CMV. As the majority of this testing is for congenital CMV, we are moving to a FDA-approved test performed on buccal swabs and urine from patients that are 21 days old or less. This testing will begin on March 20, 2025. Urine and buccal samples from infants and children >21 days old, and respiratory samples from any age group will be performed at reference laboratories (details below). Note that there is no change to quantitative CMV (viral load) testing on blood.
- Acceptable samples for in-house testing are urine and buccal swabs from infants ≤21 days old
- Please order LAB 6155: Congenital CMV PCR
- Urine specimen stability:
- Samples should be collected and placed on ice
immediately for delivery to the laboratory - Do not send urine samples to the laboratory at room temperature
- Stability of refrigerated urine is 8 hours; frozen urine is stable for 3 days
- Urine samples for CMV testing of infants ≤21 days old will be frozen upon receipt in the laboratory to ensure stability until testing is performed
- Samples should be collected and placed on ice
- Buccal swab sample stability:
- Buccal swab samples are stable at room temperature for 48 hours
- These samples are stable for 7 days refrigerated or frozen
- This testing will be performed 7 days/week at least once daily, dependent upon staffing
- Turnaround times will vary based on staffing; please plan for a 24-36 hour TAT
- Buccal or urine samples on infants >21 days old and <6 months old can be sent to the state public health laboratory for testing
- Please order LAB 4535: Virginia State Congenital CMV
- Urine samples must still be sent on ice/refrigerated
- Buccal samples may be sent at room temperature
- Samples should arrive in the laboratory by 4pm to be sent to the state laboratory the same day
- Plan for a 2-5 day turnaround time, as testing may not be available on weekends
- Testing available as a send-out to Mayo medical Laboratories:
- Lower respiratory samples (bronchial washing, bronchoalveolar lavage, fluid/washings from lung, sputum, tracheal scretions, tracheal aspirates)
- Please order LAB 6696: Cytomegalovirus (CMV) Molecular Detection, Lower Respiratory (CMVLR)
- Other sample types available at Mayo Medical Laboratories include urine or buccal swab (patients >6 months old), upper respiratory tract fluid, body fluid, tissue, bone marrow (any age)
- Please order LAB 6564: Cytomegalovirus (CMV) Molecular Detection, Varies (CMVPV)
- Samples should arrive in the laboratory by 2pm M-F and 10am on Saturday, to be sent out the same day
- Please plan for a 2-4 day turnaround time, as courier transport is unlikely to be available between 10am Saturday and 2pm Monday
- Lower respiratory samples (bronchial washing, bronchoalveolar lavage, fluid/washings from lung, sputum, tracheal scretions, tracheal aspirates)
Please contact Melinda Poulter (PIC 3677, 434-924-5667), Medical Director of the Clinical Microbiology Laboratory with questions or concerns. The Microbiology director on call can be reached 24/7 at PIC 1221.
New method for qualitative HSV testing on respiratory samples, March 20 ↑
The platform currently used for qualitative HSV testing in the UVA Clinical Microbiology laboratory is being discontinued. The discontinued platform allowed us to test vesicle fluid/swabs, CSF, and respiratory samples. We are moving to a FDA-approved method performed on vesicle fluid/swabs and CSF only, beginning March 20, 2025. Testing for HSV on respiratory samples is available through Mayo Medical Laboratories by ordering LAB 3626: Miscellaneous Send-Out (Non-Genetic, Mayo) test. In the “Test requested” field, please state HSVPV (Mayo test code).
- Samples should arrive in the laboratory by 2pm M-F and 10am on Saturday, to be sent out the same day
- Please plan for a 2-4 day turnaround time, as courier transport is unlikely to be available between 10am Saturday and 2pm Monday
Sample types accepted for HSVPV (Mayo Medical Laboratories)
- Respiratory (bronchial washing, bronchoalveolar lavage, nasopharyngeal aspirate or washing, sputum, or tracheal aspirate)
- Body fluid (pleural, peritoneal, ascites, pericardial, amniotic, or ocular)
- Fresh tissue (formalin-fixed samples are not accepted)
- Urine (<1-month old infant)
Please contact Melinda Poulter (PIC 3677, 434-924-5667), Medical Director of the Clinical Microbiology Laboratory with questions or concerns. The Microbiology director on call can be reached 24/7 at PIC 1221.
Change in reporting of flow cytometry on brochoalveolar lavage (LAB 6433) ↑
The reporting of results for this assay changed on March 4th. The laboratory now reports only the CD4 : CD8 ratio. There is not an established reference interval at UVA. If the BAL specimen has a lymphocyte percent <15 the test will be cancelled due to low cellularity. Results of BAL fluid examination should be interpreted in the context of the patient’s clinical history.
In-house reptilase and alpha-2-antiplasmin testing to be discontinued ↑
Because of low test order volumes, these tests will no longer be performed by the UVA Special Coagulation lab after February 28th, 2025. Beginning March 1, the tests should be ordered as miscellaneous send-outs to Mayo:
- Reptilase, Mayo code RTSC
- Alpha-2-antiplasmin, Mayo code A2PI
Prostate-specific Antigen (PSA) reference interval update ↑
In collaboration with the Urology Department, the PSA Screen and PSA Diagnostic reference intervals were removed from Epic and there will be no abnormal flagging. This change was made as the threshold is more complex (see below) and to be consistent with NCCN guidelines, which are updated frequently and the best place to check the threshold each year. NCCN guidelines are available at https://www.nccn.org/guidelines (free account required).
Note: PROSD-2A, -2B, and -3 are sections of the NCCN Prostate Cancer guideline.
Chemistry reference interval updates ↑
A number of assays have been updated in the Clinical Chemistry Laboratory and have associated reference interval changes. In accordance with the FDA, below are the new reference intervals updated on December 12, 2024.
Albumin, plasma
| Age | Range (g/dL) |
|---|---|
| 0 – 4 days | 2.8 – 4.4 |
| 4 days – 14 years | 3.8 – 5.4 |
| 14 years – 60 years | 3.5 – 5.0 |
| 60 years – 90 years | 3.2 – 4.6 |
| > 90 years | 2.9 – 4.5 |
Phosphorus, plasma
| Age | Range (mg/dL) |
|---|---|
| 0 – 18 years | 4.0 – 7.0 |
| > 18 years | 2.5 – 4.5 |
Uric acid, plasma
| Age | Range (mg/dL) |
|---|---|
| 0 – 14 days | 2.8 – 12.7 |
| 15 days – < 1 year | 1.6 – 6.3 |
| 1 year – < 3 years | 1.8 – 4.9 |
| 3 years – < 5 years | 2.0 – 4.9 |
| 5 years – 8 years | 1.9 – 5.0 |
| 9 years – 10 years | 2.4 – 5.5 |
| 11 years – 12 years | 2.6 – 5.8 |
| 13 years – 79 years (female) | 2.5 – 6.2 |
| 13 years – 79 years (male) | 3.7 – 7.7 |
The following reference intervals were updated February 18, 2025:
Total bilirubin, plasma
| Age | Range (mg/dL) |
|---|---|
| 0 – 1 day* | < 8.0 |
| 1 day – 2 days* | < 12.0 |
| 3 days – 5 days* | < 16.0 |
| 0 – 1 day | 2.0 – 6.0 |
| 1 day – 2 days | 6.0 – 10.0 |
| 3 days – 5 days | 1.5 – 12.0 |
| > 5 days | 0.3 – 12.0 |
| *For premature infants. Age ranges not otherwise marked are for full term infants. Premature infants have an adjusted range that will appear as a result comment in patients with the associated age ranges, but will flag according to the full-term intervals. | |
Abbott Afinion 2 Hemoglobin A1c Analyzer is live ↑
On January 22nd the UVA Medical Labs transitioned from the Siemens DCA Vantage analyzer to the Abbott Afinion 2 analyzer for Hemoglobin A1c (HbA1c) at the point-of-care. The Abbott Afinion 2, which uses boronate affinity chromatography methodology, has demonstrated better overall measurement precision, better accuracy, and better alignment with the capillary electrophoresis reference method performed at the UVA Core Laboratory than the Siemens DCA Vantage analyzer. There are no changes in test ordering, sample type requirements, reference interval, and no changes to how the results are reported in Epic.
TruSight Myeloid Next Generation Sequence Assay replaced ↑
Reagents for the in-house NGS-based assay for hematological malignancies, TruSight Myeloid (aka TSM, NGS myeloid panel), have been discontinued by the vendor. As of January 17 the assay is no longer available.
For routine NGS testing, please order: MayoComplete Myeloid Neoplasms, Comprehensive Oncoheme Next-Generation Sequencing, Varies [JNGSHM; LAB6684] in Epic as a send-out test to Mayo. This assay is largely similar to the discontinued TruSight Myeloid assay. The complete gene list for the new assay can be found here: https://www.mayocliniclabs.com/test-catalog/overview/63367.
We anticipate this send out process will be necessary for a relatively short period of time. We will provide updates on development of a new in-house assay as they become available. We apologize for this abrupt change in service. Please don’t hesitate to reach out to the lab with any questions or concerns.
Alert to negative bias on prior heparin Levels ↑
The UVA Medical Labs have received a notification from the vendor of our Heparin Level assay that prior calibrators had a negative bias that may have impacted patient results. Our internal investigation at UVA showed a 10% bias with the impacted calibrator. The Lab has transitioned away from these calibrators as of February 12, 2025. There is no action needed at this time