Background:
The Microbiology Division will switch the current molecular platform Focus Diagnostics to the Abbott m2000 RealTime System for BK virus viral load testing. This test is used to monitor BK viral load in renal transplant patients at risk of developing BK virus-associated nephropathy, as well as monitoring bone marrow transplant patients at risk for hemorrhagic cystitis.
Effective date:
Jan. 15, 2019
Methodology and reporting:
The Real-Time BK virus test is an in vitro polymerase chain reaction (PCR) assay for the detection and quantitation of BK virus DNA. This assay has been validated at UCI Health to determine BK viral load in urine and plasma specimens. For a period of 30 days (Jan. 15, 2019 to Feb. 15, 2019), the laboratory will have both assays available to re-baseline your patient’s viral load.
- Analytical measurement range: 628 copies/mL - 62,800,000 copies/mL (2.8 - 7.8 log copies/mL)
- Lower limit of quantification (LoQ): 628 copies/mL (2.8 log copies/mL)
- Lower limit of detection (LoD): 312 copies/mL (2.5 log copies/mL)
Clinical validation data:
- Plasma samples covered a range of 3.05 - 5.66 log copies/mL. The Abbott m2000 RealTime System showed a mean bias of -0.54 log copies/mL (-0.96 log copies/mL to -0.26 log copies/mL)
- Urine samples covered a range of 2.98 to 7.59 log copies/mL. The Abbott m2000 RealTime System showed a mean bias of -0.21 log copies/mL (-1.34 log copies/mL to 0.47 log copies/mL)
- Please take this into consideration when reviewing patient’s results
Test codes:
SBKQTB: BK Virus DNA by PCR Quantitative, Blood
SBKQTU: BK Virus DNA by PCR Quantitative, Urine
Specimen required:
- Blood: Collect 10.0 mL whole blood in PPT (pearl-top EDTA tubes) or 2.0 mL in lavender EDTA tubes. Separate plasma from cells within 6 hours of collection. Transfer 2.0 mL plasma to a sterile, plastic, transport tube and store refrigerated or frozen. Collect separate tubes dedicated for use on this test only
- Urine: 1.0 - 10.0 mL in a screw-capped, sterile container
Stability:
Plasma (after separation from cells) and urine: Ambient: 24h; Refrigerated: 5 days; Frozen: 3 months
Turnaround time (TAT):
2 - 10 days
Rejection criteria:
Specimens that exceed stated stability, unlabeled/mislabeled/mismatched specimens, specimens submitted in leaking containers, non-sterile containers, heparinized specimens. Any blood specimens shared with other test requests.
A summary of all tests offered by our laboratory services can be found here: http://www.pathology.uci.edu/services/index.asp
Sincerely,
Cassiana Bittencourt, MD
Director
Division of Clinical Microbiology
Edwin S. Monuki, MD, PhD
Chair
Department of Pathology & Laboratory Medicine |
