2025 Laboratory Medicine Update
All Updates
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
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 an FDA-approved test performed on buccal swabs and urine samples from patients who 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
- Refrigerated urine is stable for 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
- 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 from 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 4 pm 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, and bone marrow (any age)
- Please order LAB 6564: Cytomegalovirus (CMV) Molecular Detection, Varies (CMVPV)
- Samples should arrive in the laboratory by 2 pm M-F and 10 am 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 10 am Saturday and 2 pm 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
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 an 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 2 pm M-F and 10 am 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 10 am Saturday and 2 pm 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 bronchoalveolar 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 no 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 on 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 the 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
Updated Chagas Disease testing algorithm
The UVA Clinical Microbiology Laboratory has updated its Chagas disease testing protocol in accordance with current CDC recommendations. Diagnosis of chronic Trypanosoma cruzi (Chagas) infection requires two serologic tests utilizing different methodologies. Due to the CDC no longer offering confirmatory testing, all testing now occurs at Mayo Clinic, which performs two distinct assays to meet CDC guidelines.
There is no change to the test order in Epic or the specimen requirements. Two test results will now be reported per specimen submission, with interpretive comments.
Key points:
- Testing must go through Mayo Clinic; CDC serologic testing is no longer available
- No change to the orderable test in Epic
- TRYPANOSOMA CRUZI (CHAGAS) ANTIBODY PANEL, SERUM [LAB6693]
- No change to the specimen requirements
- Preferred: 3 mL blood in gold top serum separator tube
For questions or if you encounter discordant results, please contact the Clinical Microbiology director on call at PIC 1221.
The Medical Laboratory Committee seeks new clinical members and a new clinical co-chair
The Medical Laboratory Committee is a cooperative group of clinicians and laboratorians who help manage the UVA Health Medical Laboratory Formulary and provide feedback to the Medical Laboratory and the Health System on laboratory issues. The Committee reviews requests for new sendout or local tests to add to the Lab Formulary, reviews laboratory-related policies and guidelines, and recommends updates when appropriate, analyzes laboratory performance data with the goal of optimizing laboratory support of clinical practice, and publishes the Laboratory Medicine Update.
If you are a physician or nurse with an interest in optimizing clinical use of the Medical Laboratory, fitting laboratory offerings to clinical need, improving laboratory ordering or results display, decision support for laboratory orders, or the use of artificial intelligence in laboratory result ordering and interpretation (which is definitely coming), we would love for you to join us. The Medical Laboratory Committee is attended by the overall laboratory director as well as the lab section directors and laboratory administration, and is an excellent forum for clinical communication directly to lab leadership.
Our clinical co-chair for many years, George Hoke, will be stepping down from that position in July, so in addition to regular committee members, we are interested in identifying a clinician to work with Jim Harrison, our laboratory co-chair, going forward.
The Medical Laboratory Committee schedules a one-hour monthly meeting online (by Zoom), and meets quarterly at a minimum and up to monthly depending on the pending agenda. Either George ([email protected]) or Jim ([email protected]) would be happy to respond to questions about committee operations and time commitments for membership and the co-chair position.
Introducing NT-proBNP testing
Clinical chemistry will transition from BNP to NT-proBNP testing on September 9th, 2025. NT-proBNP has become preferred over BNP for heart failure evaluation because while the two tests have similar clinical applications, NT-proBNP is more sensitive, is useful in a broader range of heart failure types, and is more reliable because it is not affected by heart failure therapy that may affect BNP.
Key information:
- The new test name and code will be NT proBNP [Lab6735]
- Go live date: September 9, 2025
- A light green top tube will be required
- The results for NT-proBNP and BNP are different and cannot be used interchangeably
- NT-proBNP has different reference ranges
Reference ranges for Female:
Age range (years) | Reference interval (pg/mL) |
18 to <50 | <104.8 |
50 to 75 | < 334.1 |
> 75 | < 956.1 |
Reference ranges for Male:
Age range (years) | Reference interval (pg/mL) |
18 to <50 | <180.3 |
50 to 75 | < 451.6 |
> 75 | < 683.0 |
Contact the Clinical Chemistry Director on call at PIC 1657 with any questions.
Anti-Microsomal Antibody test name change
On Tuesday, 8/26/25, the test name for Anti-Microsomal Antibody [LAB516] will change to Anti-TPO (Anti-Microsomal Antibody). The test code [in brackets] will stay the same, and there are no changes in the method or result reporting.
New CMV drug resistance testing is orderable in Epic
The UVA Clinical Microbiology Laboratory has made CMV Drug Resistance by NGS [LAB6728] available as a new Epic orderable. This test is performed at ARUP Laboratories and detects resistance-associated mutations in CMV genes.
Test information:
- Listing in Epic test menu: CMV DRUG RESISTANCE BY NGS [LAB6278]
- Covers resistance to 5 drugs: ganciclovir, foscarnet, cidofovir, maribavir, and letermovir
- Targets 4 CMV genes: UL97, UL54, UL27, UL56
- Requires CMV DNA viral load >2.6 log IU/mL for testing
- Specimen requirement: 3 ml plasma. Collect 2 full tubes of whole blood in lavender (EDTA) or 1 pink (EDTA) top tube.
Contact the Clinical Microbiology director on call (PIC 1221) with any questions.
New Hepatitis C Antibody with reflex to Hep C viral load
Effective Tuesday, August 12, HEPATITIS C ANTIBODY [LAB868] will no longer be available. It will be replaced by HEPATITIS C ANTIBODY WITH REFLEX TO HEPATITIS C VIRAL LOAD [LAB6729].
Any reactive or borderline Hepatitis C Antibody test will automatically reflex to a R EAP HEPATITIS C (HCV) VIRAL LOAD [LAB4059] (molecular test). Clinicians no longer need to place a separate order for R EAP HEPATITIS C (HCV) VIRAL LOAD [LAB4059] when the Hepatitis C Antibody is reactive or borderline.
The reflexive test will require an additional red-top tube at the time of initial collection. If there is no separate tube collected for the R EAP HEPATITIS C VIRAL (HCV) LOAD [LAB4059], the viral load test will be cancelled, and only the Hepatitis C Antibody will be performed.
The same reflexive testing will be in place for the following tests (note the LAB# changes):
- LAB8571 ACUTE HEPATITIS PANEL is now becoming LAB6731 ACUTE HEPATITIS PANEL (available in Community Health only)
- LAB2621 HEPATITIS PROFILE B, C is now becoming LAB6732 HEPATITIS PROFILE B, C
- LAB4512 CHILD HELP EXPOSURE PROFILE (no LAB# change)
- LAB2566 HEPATITIS SCREEN (EXP) (no LAB# change)
For existing order sets, R EAP HEPATITIS C ANTIBODY EIA [LAB868] will automatically be replaced with R EAP HEPATITIS C ANTIBODY WITH REFLEX TO HEPATITIS C VIRAL LOAD [LAB6729]. Clinicians will need to make this replacement in any personal preference lists, as these will not automatically update.
There are no changes to the availability of R EAP HEPATITIS C (HCV) VIRAL LOAD [LAB4059] as a stand-alone testing option.
For questions or concerns, please contact Melinda Poulter, medical director of Clinical Microbiology and Molecular Diagnostics at PIC 3677.
Update to the Lupus Anticoagulant Panel (LAB6001)
Effective July 21, 2025, the HexLA assay is replacing the Silica Clotting Time in the Lupus Anticoagulant Panel (LAB6001). The HexLA assay is an integrated (screen and confirm) silica-based APTT assay. The presence of a Lupus Anticoagulant in a plasma sample is confirmed by the correction of the aPTT clot time upon the addition of a reaction mixture containing hexagonal phase phospholipid. The test incorporates a pooled normal plasma (mixing test) and a heparin neutralizer.
The Lupus Anticoagulant Panel (LAB6001) now consists of the following elements:
- dRVVT
- HexLA, reference range: Delta < 13
- PT and PTT if not already ordered
- Lupus interpretation
Typenex bands are going away; new "Type and Screen" order
Typenex blood bands will no longer be used at UVA Health facilities effective July 15, 2025. Accurate labeling of blood products and patient identification will be accomplished by the combination of Electronic Positive Patient Identification (EPPID), the Epic Blood Product Administration Module (BPAM), and Transfusion Time-Outs, which are all currently standard work across UVA Health. The "Type and Hold" order will be retired from Epic and replaced with a new “Type and Screen” (TASN) order for pre-transfusion testing, and a streamlined “Prepare” order to request the number of units to be crossmatched for the patient. Starting July 15, Ambulatory clinics will need to replace active collected or signed “Type and Hold” orders that contain a red blood cell (RBC) order with the new “Type and Screen” order and a separate “Prepare RBC” order.
Toxicology STAT alcohol testing – New panel
The current practice at the UVA Toxicology Lab is to order alcohol testing for methanol, isopropanol, acetone, and ethylene glycol individually. As of July 24, 2025 there is a single test to order instead of individual components. For all alcohol testing in the Toxicology Laboratory, please order the Toxic Alcohol Panel (LAB6687). This panel will include Methanol, Isopropanol, Acetone, and Ethylene Glycol. Quantitative results will be reported, and the reference interval is < 10 mg/dL for all alcohol components.
Toxicology urine drug confirmation reflex process
Current practice at the UVA Toxicology Lab is for urine specimens that screen positive for any drug to automatically reflex for confirmation. There are situations when the more specific confirmation method will detect a drug that screened negative because the confirmation method is more sensitive than the screen. The Toxicology Lab will now reflex and report positive drug confirmation results, even if the screen is negative.
How to request new send-out or local laboratory tests
Clinicians who wish to request the addition of new send-out or local laboratory tests to the UVA Medical Laboratory test menu with ordering in Epic may submit a request online using the form. Requests are routed to the Sendout section of the Medical Laboratory and to the Medical Laboratory Committee. The Committee reviews the clinical validity and utility of the test in comparison with existing and potential alternatives, and recommends action to the Medical Laboratory. Requesters may participate in the review if desired.