Laboratory Lab results are too important to go anywhere else.

Cytomegalovirus Antiviral Drug Resistance by Sequencing

CMV, CMV Resistance, UL54, UL97, UL27, UL56, next generation sequencing, CMV genotype, CMV antiviral drug resistance

Test Codes

EPIC: LAB7591, Beaker: XCMVRG, ARUP: 3004615

Department

Send Outs

Instructions

This test requires the Cytomegalovirus (CMV) DNA Quantitation by PCR to have a result of at least 1500 copies/mL.

Specimen Collection Criteria

Collect: Two Lavender-top EDTA tubes.

Physician Office/Draw Specimen Preparation

Centrifuge to separate plasma from cells within 8 hours of collection. Transfer plasma to a plastic transport tube and freeze (-20°C/-4°F or below).

Preparation for Courier Transport

Transport: 3.0 mL serum or plasma, frozen (-20°C/-4°F or below). (Minimum: 2.5 mL)

Rejection Criteria

• Serum
• Heparinized Specimen.
• Specimens not collected and processed as indicated.

In-Lab Processing

Centrifuge to separate plasma from cells within 8 hours of collection. Transfer plasma to a plastic transport tube and freeze (-20°C/-4°F or below).

Transport: 3.0 mL serum or plasma, frozen (-20°C/-4°F or below). (Minimum: 2.5 mL)

Storage

Specimen Stability for Testing:

Room Temperature (20-25°C or 68-77°F): 8 hours
Refrigerated (2-8°C or 36-46°F): 72 hours
Frozen (-20°C/-4°F or below): 30 days

Specimen Storage in Department Prior to Disposal:

Specimen retention time is determined by the policy of the reference laboratory. Contact the Send Outs Laboratory with any questions.

Laboratory

Sent to ARUP Laboratories, Salt Lake City, UT.

Performed

Sunday – Saturday.
Results available in 3-9 days.

Reference Range

By report.

Test Methodology

Massively Parallel Sequencing.

Interpretation

This assay assesses resistance to ganciclovir, foscarnet, cidofovir, maribavir, and letermovir. Resistance-associated mutations in the UL97, UL54, UL27, and  UL56 genes are sequenced using next generation sequencing.

This test detects populations down to 10% of the total population which may account for resistance interpretation differences between methods. Some insertions or deletions may be difficult to detect using this software.

Result interpretations are as follows:

• Sensitive indicates no evidence of drug resistance compared with a wild-type virus.
• Possible resistance indicates mutations were detected with borderline-level drug resistance or conflicting resistance status reported in the literature.
• Resistant indicates evidence of drug resistance compared with a wild-type virus.
• Not determined indicates incomplete sequence coverage across a given gene or genes.
• Additional mutations include variants that have not been associated with drug resistance.
• Uncalled mutation sites include drug resistance mutation positions with an inadequate number of sequencing reads.
• Inadequate sequence coverage indicates a low number of sequence reads at a given drug resistance site.

Drugs associated with each gene are as follows:

• UL97: ganciclovir, maribavir
• UL54: ganciclovir, foscarnet, cidofovir
• UL27: maribavir
• UL56: letermovir

CPT Codes

87910, 87900.

Contacts

Last Updated

9/12/2023