2024 Laboratory Medicine Updates
All Updates
Chlamydia/Gonorrhea PCR 24 hr TAT for Labor & Delivery patients
Because of a shortage of erythromycin ointment used for neonates, the Clinical Microbiology laboratory has implemented a new PCR test for Chlamydia and Gonorrhea with a reduced turn-around time (24hrs). This testing is currently available ONLY for the Labor and Delivery unit, and requires a different collection device. The new testing and collection devices will be rolled out to other areas of UVA Health over the next 4 months.
New Mayo sendout test for CMV resistance
A new test for CMV resistance, "CMV Resistance: Ganciclovir, Foscarnet, Cidofovir," with the Mayo test code JFCMVR is available to order from the Epic menu and replaces the previous test "CMV Drug Resistance, Next Generation Sequencing." The new test is expected to improve turnaround times.
Clinical flow cytometry laboratory update
The clinical flow cytometry laboratory will transition to new flow cytometry instruments and panels for leukemia/lymphoma assays (Flow Cytometry Immunophenotyping, LAB2554) on Monday, February 26, 2024. This change will improve the efficiency of the clinical flow laboratory and will position us for future transition to more sophisticated flow cytometry analyses. You will see changes in the formatting of the flow cytometry summary section of the flow cytometry reports and minor changes in the panel of antigens evaluated. The test name/number and ordering process remain the same (specimen source and clinical history requested at time of order). Please reach out to Elizabeth Courville (Medical Director of the Clinical Flow Cytometry Laboratory) if you have questions or concerns.
Foundation Medicine tests now orderable in Epic
Tests from the Foundation Medicine referral laboratory have been integrated into the UVA Epic orderables list. The tests can be selected and ordered within Epic; a portal order is no longer required. Results will report into Epic when complete.
New online referral test request form available
An online form for submitting requests for review and approval of new "send-out" tests and reference laboratories is now available on the UVA Medical Laboratory Web site. UVA LIPs may use the form to request new reference testing or referral laboratories. The contents of the form are submitted to the Medical Laboratory and the Laboratory Stewardship Committee for review. This form should be used to request tests prior to use in patients. Questions related to the immediate or emergent use of non-approved tests for specific patients should not use this form and should be addressed to the Medical Laboratory leadership or on-call pathologists. The form is available under the "Laboratory Tests" tab, "Referral Lab Testing," "New Sendout Test or Referral Lab Request Form." It includes instructions for completion and submission.
Standardization of LDL-c calculation
On January 3rd, 2024, the calculation for low-density lipoprotein cholesterol (LDL-c) will be changed to standardize calculation across the UVA Health System. After this change, the calculation for LDL-c on lipid panels will match across UVA University Hospital and Prince William, Haymarket, and Culpeper hospitals. This change is part of the ongoing effort to standardize test results across the UVA Health System to provide the same care no matter where the patient engages with us. The LDL-c equation will match the most common equation used, the Friedewald equation, which calculates LDL-c as LDL-c = Total-c – HDL-c – Triglycerides/5.
Fentanyl added to urine drug screen testing
In consultation with the Medical Toxicology service and the department of Pathology, the Toxicology Laboratory is adding Fentanyl to the following urine drug screens:
- Drugs of Abuse Modified (LAB2020)
- Drugs of Abuse Full (LAB677)
- Urine Contract Med Screen (LAB3701)
The screening assay is calibrated to detect fentanyl when the quantitation is >1.0 ng/mL and should detect synthetic analogs of fentanyl. Any urine sample that screens positive for fentanyl will be reflexed to Fentanyl Confirmation (LAB6241) for an additional charge. Please contact Lindsay Bazydlo, Ph.D., director of the laboratory if you have any questions at [email protected].
Anti-Fungal Drug Testing Schedule Update
The Toxicology Laboratory will increase Anti-Fungal Drug testing (Itraconazole, Posaconazole, Voriconazole) to twice weekly on Monday and Thursday. Samples need to be in the laboratory by 9:00 am for same-day testing. Samples received after 9 am will be analyzed on the next day of testing.
Flow Cytometry Anti-CD20 Panel Reporting
The FLOW anti-CD20 panel was developed for monitoring patients on anti-CD20 immunotherapy such as Rituximab. The results reported from this assay are CD19+ lymphocytes and CD20+ lymphocytes as a percentage of total lymphocytes. Reference ranges are not provided. Percentages are reported to the nearest whole number. This assay is not designed to detect leukemia/lymphoma and no pathologist consultation is provided.
INTERCEPT® Fibrinogen Complex (IFC) for STAT Cryoprecipitate from the Blood Bank
INTERCEPT® Fibrinogen Complex (IFC) is a pathogen-reduced unit of cryoprecipitate (cryo) that is a replacement for a unit of regular cryo. It has the advantage of a thawed shelf life of 5 days (rather than 4 hrs for cryo), making it more readily available for emergencies that require cryo. Beginning August 19, the Blood Bank will have IFC thawed and ready to issue on an ongoing basis when cryo is ordered STAT. The Blood Bank will determine when it is appropriate to send IFC for a cryo order (IFC cannot be ordered specifically). There will be no changes to ordering cryo (Epic) or administering cryo/IFC (2-person time-out plus BPAM). A unit of IFC looks the same as a unit of cryo except for the component information as shown below.
Update to Miscellaneous Sendout Orders
Additional required fields have been added to the Miscellaneous Sendout Non-Mayo Genetic (LAB3923) and Misc Sendout Non-Mayo Non-Genetic (LAB3927) order panels. When ordering these tests LIPs should now enter the referral lab requested, the test requested, and the test code (see red exclamation signs in the image below). These data are needed to clearly indicate the specific test requested and lab to which the samples should be sent. These data will improve the efficiency and speed of handling sendout testing, and will decrease the number of callbacks to LIPs for clarification.
BioFire FilmArray Meningitis/Encephalitis (ME) Panel
Effective July 23, 2024 the UVA Microbiology and Molecular Diagnostics Laboratory will begin performing the BioFire FilmArray Meningitis/Encephalitis (ME) Panel (previously available only as a send out test). Due to the complexities and limitations of this assay, testing will only be performed with approval of the Microbiology Director on call. Please page PIC 1221 prior to submission of the specimen to prevent delays in testing.
The BioFire ME Panel is a qualitative multiplexed nucleic acid-based test for detection and identification of multiple bacterial and viral nucleic acid targets directly from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis. Testing from all other collection methods will be rejected.
The following organisms are identified using the BioFire ME Panel:
Bacteria | Viruses |
|---|---|
Escherichia coli K1 | Cytomegalovirus |
Haemophilus influenzae | Enterovirus |
Listeria monocytogenes | Herpes simplex virus 1 and 2 |
Neisseria meningitidis (encapsulated) | Human herpesvirus 6 |
Streptococcus agalactiae | Human parechovirus |
Streptococcus pneumoniae | Varicella zoster virus |
Limitations and/or Special notes regarding testing with the BioFire ME Panel:
- Results should be used in conjunction with other clinical, epidemiological, and laboratory data, and is not intended to be used as the sole basis for diagnosis, treatment, or other patient management decisions.
- Positive results do not rule out co-infection with organisms not included in the test. The agent detected may not be the definitive cause of disease. Negative results do not preclude central nervous system (CNS) infection. Not all agents of CNS infection are detected by this test and sensitivity in clinical use may vary.
- This test is not a replacement for CSF culture for at-risk patients. Testing for cryptococcal meningitis is not included. Order Cryptococcal Antigen [Lab927] for detection of Cryptococcus neoformans/gattii. Test results should be interpreted in the context of host factors and other laboratory information.
- Sensitivity of this test for HSV 1 and 2 is suboptimal. Testing by another molecular method (LAB6153) is recommended if clinical suspicion is high.
- Latent reactivation or shedding of herpesviruses (CMV, HHV-6, HSV-1, HSV-2, and VZV) in CSF may be detected with this test. Results should be interpreted in the appropriate clinical context.
- Non-K1 E. coli serotypes may be present in a specimen and will not be detected by this test.
- Non-encapsulated strains of Neisseria meningitidis are not detected by this test.
- This test cannot distinguish between latent and active CMV and HHV-6 infections. Detection of these viruses may indicate primary infection, secondary reactivation, or the presence of latent virus. Results should always be interpreted in conjunction with other clinical, laboratory, and epidemiological information.
- Viral shedding into the CSF often occurs in cases of zoster (shingles; caused by reactivation of VZV). Detection of VZV in CSF may not indicate the cause of CNS disease in these cases.
New Collection Device for Chlamydia/Gonorrhea Testing
The UVA Clinical Microbiology and Molecular Diagnostics laboratory has implemented a new method for molecular detection of Chlamydia and Gonorrhoeae, which requires a new collection device. Please ensure samples are collected using the BLUE “Alinity-m Multi-Collect Specimen Collection Kit” circled in the photograph below.
There is no change to the sample collection method. Only the collection device has changed.
- Only the orange shaft swab provided in the BLUE specimen collection kit should be used.
- Do NOT discard the media in the tube when inserting swab or filling with a urine sample.
- Acceptable specimens include:
- Clinician-collected vaginal, endocervical, oropharyngeal or rectal swab specimens
- Male or female urine samples
- Self-collected vaginal swabs (if collected in a healthcare setting)
- Samples collected with the previously used Abbott Multi-Collect specimen collection kit in WHITE packaging, will be batched and tested only once weekly, which may cause significant delays in result reporting.
- If the WHITE collection device is used and the extended turnaround time is unacceptable, the sample will need to be recollected with the BLUE collection device.
Per our Supply Chain colleagues, these new collection kits have been rolled out to all university hospital units and UVA Clinic locations. If you do not have the BLUE Alinity-m Multi-Collect Specimen Collection Kit, please contact Supply Chain to request this product immediately.
For questions or concerns, please contact the Clinical Microbiology director on call at PIC 1221.
Reporting Change for Flow Cytometry for Immunodeficiency (Non-HIV), LAB 4135
The Flow Cytometry Laboratory is modifying the results reported for primary immunodeficiency/severe combined immunodeficiency testing.
- The new report will include CD45RO and CD45RA as a percent (%) of CD3+CD4+ cells and not total lymphocytes.
- Current T and B cell percent and absolute values will continue to be reported.
- Sub-populations of CD8+ cells with CD45RO and CD45RA will no longer be reported.
- A pathologist interpretation will no longer be reported.
The new format will be updated in Epic on Tuesday, 12/24.
VEGF-D Send-out Testing Unavailable
Cincinnati Children's Hospital has been unable to perform VEGF-D testing since October 2024 and this will continue for an undetermined amount of time. We will post an update when we are notified of a timeline for the test to be offered. Currently there are no other clinical laboratories that offer this testing. For more information, see the Cincinnati Children's Test Directory.
Discontinuation of In-house Fragile X Testing
The UVA Clinical Genomics Laboratory will no longer offer in-house Fragile X testing. Fragile X testing can be performed by Mayo Medical Laboratories, using test code FXS, which is an orderable test in EPIC.
Addition to Benzodiazepine Confirmation Testing on Urine
The Toxicology Laboratory has added alpha-hydroxymidazolam, a midazolam metabolite, to the urine drug confirmation for benzodiazepines. Any result ≥ 25 ng/mL is considered positive and is reflective of midazolam use. This change was effective on September 26, 2024.
Change to Thyroglobulin Antibody Test Lower Reporting Limit
The Thyroglobulin Antibody test [LAB515] lower reporting limit changed from 10 IU/mL to 15 IU/mL on 10/25/24. This change is is occuring because of a reagent reformulation that will reduce the potential for biotin interference and yield more accurate test results in patients taking biotin supplements.
Serum Free Light Chains Update to Instructions For Use
Serum free light chains (kappa and lambda light chains) are measured in the UVA Medical Laboratory by turbidimetry. Turbidimetric methods may yield false low readings when there is substantial antigen excess (i.e., very high light chain levels; this is sometimes called a "high dose hook" effect). The method we use includes automatic checks for excess antigen levels and we have not seen an example of false low readings for this reason. However, no automated check will identify all cases of antigen excess and a very small percentage of samples with antigen excess may appear normal to the checks. The vendor of the method has updated the test instructions to include the following statement: “If these free light chain results do not agree with other clinical or laboratory findings, or if the sample is from a patient that has previously demonstrated antigen excess, the result must be checked by retesting at a higher sample dilution.” There is no change to the test itself. Patient results should always be interpreted in conjunction with other laboratory tests and clinical evidence; any anomalies should be discussed with the testing laboratory.
The Medical Laboratory Committee Seeks Clinician Members
The Medical Laboratory Committee (formerly the Laboratory Stewardship Subcommittee) advises the UVA Medical Laboratory and the UVA Health System on a variety of medical laboratory topics, including the orderable test menu, available send-out tests, laboratory-related policies, and laboratory operational issues. The committee is co-chaired by a clinician and a laboratorian, and its membership includes about half patient-care clinicians and half laboratorians. In addition to influencing policy and operations, the Committee provides a forum for cooperative communication, discussion, and prioritization of a variety of topics related to operation and use of the lab. The Committee and the UVA Medical Lab encourage clinicians with interests in the optimal organization and use of the lab to join the Committee and contribute your enthusiasm and expertise. Contact the co-chairs Jim Harrison ([email protected]) and/or George