CMV Drug Resistance, Rapid UL54

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General Information

Lab Name
CMV Drug Resist,Rapid UL54
Lab Code
CMVU54
Epic Ordering
CMV Drug Resistance w/ Rapid UL54 Seq
Description

CMV Drug Resistance: Ganciclovir, Cidofivir and Foscarnet (UL54 gene).

Mutations leading to drug resistance have been described in both the UL97 gene (phosphotransferase encoding region), and the UL54 gene (DNA polymerase encoding region) of the CMV genome. Mutations associated with resistance to Ganciclovir have been described in the UL97 gene. Mutations associated with resistance to Ganciclovir, Cidofivir and Foscarnet have been described in the UL54 gene.

Genotypic analysis is performed by direct Sanger sequencing a 1kB region of the UL54 gene. For UL54 and UL97 CMV gene sequencing, see CMV Drug Resistance UL97 and UL54 [CMVDR].

The minimum virus level that gives a sequencable PCR amplicon in 95% of replicates is 240 IU/mL (2.4 log IU/mL).

Specimens with undetectable CMV viral load are rejected.

This test was developed and its performance characteristics determined by the University of Washington Department of Laboratory Medicine and Pathology. It has not been cleared or approved by the US Food and Drug Administration.

For UL97 (Ganciclovir resistance) CMV gene sequencing, see CMV Drug Resistance, Rapid UL97 [CMVU97].

For UL54, UL97 and UL56 (Letermovir resistance) CMV gene sequencing, see CMV Drug Resistance, Rapid UL97, UL54 and UL56 [CMVULR].

For UL56 CMV gene sequencing, see CMV Letermovir Resistance, UL56 [CMVDRL].

Synonyms
CMV Sequencing, Foscarnet and Cidofivir Resistance Test, UL54 Sequencing
Components

Interpretation

Method

Sequencing/Real-time Polymerase Chain Reaction

Reference Range
See individual components

Ordering & Collection

Specimen Type
Blood, CSF, or Clear non-cellular fluid
Collection

Blood: 3 mL blood in EDTA (LAVENDER TOP), RED, SST, or PPT tube.

CSF or Clear non-cellular fluid: 1 mL of CSF in sterile container.

Unacceptable samples: Plasma collected in sodium or lithium Heparin. NO URINE SAMPLES.

Minimum sample requirement: 0.5 mL

.

Handling Instructions
Quantity
requested: 1 mL
minimum: 0.5 mL

Processing

Processing

Blood: Separate plasma/serum from whole blood within 24 hours of collection. Freeze at -10°C or colder and ship on dry ice. If freezer and/or dry ice is not available, ship immediately at 2-8°C (ice pack). Sample may be stored at 2-8°C (ice pack) for up to 48 hours of collection. Samples stored at 2-8°C greater than 48 hours old may be rejected. Do not freeze/thaw.

CSF or Clear non-cellular fluid: If CSF has cellular material, centrifuge & aliquot clear CSF. Freeze at -10°C or colder and ship on dry ice. If freezer and/or dry ice is not available, ship immediately at 2-8°C (ice pack). Sample may be stored at 2-8°C (ice pack) for up to 48 hours of collection. Samples stored at 2-8°C greater than 48 hours old may be rejected. Do not freeze/thaw.

Outside Laboratory: Freeze at -10°C or colder and ship on dry ice. If freezer and/or dry ice is not available, ship immediately at 2-8°C (ice pack). Sample may be stored at 2-8°C (ice pack) for up to 48 hours of collection. Shipment time must not exceed 48 hours from collection if stored at 2-8°C. Samples stored at 2-8°C greater than 48 hours old may be rejected. Do not freeze/thaw.

Performance

LIS Dept Code
Virology - OLD (VIRO)
Performing Location(s)
Other Virology, Molecular
206-685-6656

Virology Laboratory, Ste 320
1616 Eastlake Ave E.
Seattle, WA 98102
Frequency
Once a week.
Available STAT?
No

Billing & Coding

CPT codes
LOINC
33631-3
Interfaced Order Code
UOW2584