CMV UL97 and UL54 Drug Resistance Seq

General Information

Lab Name

CMV UL97 and UL54 Drug Resistance Seq

Lab Code

CMVDRS

Epic Name

CMV UL97 and UL54 Drug Resistance Seq

Description

CMV Drug Resistance: Ganciclovir, Cidofivir and Foscarnet (UL54 and UL97 genes).

Mutations leading to CMV drug resistance have been described in the UL97 gene (phosphotransferase encoding region) and UL54 gene (DNA polymerase encoding region) of the CMV genome.

Mutations associated with resistance to Ganciclovir have been described in the UL97 gene. Genotypic analysis is performed by Sanger sequencing two overlapping amplicons of about 350kB of the 3’ end of the UL97 gene.

Mutations associated with resistance to Ganciclovir, Cidofivir and Foscarnet have been described in the UL54 gene. Genotypic analysis is performed by Sanger sequencing a 1kB region of the UL54 gene.

The minimum viral load required to produce a sequenceable PCR amplicon is 400 IU/mL (2.6 Log₁₀ 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 UL56 CMV gene sequencing, see CMV Letermovir Resistance, UL56 [CMVDRL].

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

Synonyms

CMV Drug Resistance, CMV Sequencing, Foscarnet and Cidofovir Resistance Test, Ganciclovir, Maribavir, UL97 and UL54 Sequencing

Components

Code Name
CMVDST CMV UL97 UL54 Sample Type
CMVDRU UL97 and UL54 Result
UCIDOR CMV Cidofovir Sensitivity
UFOSCR CMV Foscarnet Sensitivity
UGANCR CMV Ganciclovir Sensitivity
UMARIR CMV Maribavir Sensitivity
CMVDRM CMV Drug Resistance Methodology

Interpretation

Method

Sequencing/Real-time Polymerase Chain Reaction

Reference Range

See individual components

Guidelines

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

Quantity

requested: 1 mL
minimum: 0.5 mL

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

Central Lab Virology (RVIR)

Performing Location(s)

CL Division of Infectious Disease Diagnostics (DIDD) - Virology

1601 Lind Ave SW
Renton, WA 98057

Phone: 206-685-6656 option 8
Hours of Operation:
Mon–Fri: 7:00 AM–7:00 PM
Sat: 9:00 AM–4:00 PM

Frequency

Once a week

Available STAT?

No

Billing & Coding

CPT codes

87910x2

LOINC

33632-1

Interfaced Order Code

UOW4568