Ordering Recommendation

Provides antiviral susceptibility information for ganciclovir, foscarnet, cidofovir, maribavir, and letermovir. Intended for patients with viral load >2.6 log IU/mL.

Mnemonic

CMVNGS5

Methodology

Massively Parallel Sequencing

Performed

Sunday-Saturday

Reported

3-9 days

New York DOH Approval Status

Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.

Specimen Required

Patient Preparation
Collect

Lavender (EDTA), pink (K2EDTA), or plasma preparation tube.

Specimen Preparation

Separate plasma from cells within 24 hours. Transfer 3 mL plasma to an ARUP Standard Transport Tube. (Min: 2.5 mL)

Storage/Transport Temperature

Frozen.

Unacceptable Conditions

Serum, heparinized specimens.

Remarks

If available, please submit the following: most recent viral load and test date; information on current or past drug therapy.

Stability

After separation from cells: Ambient: 8 hours; Refrigerated: 72 hours; Frozen: 1 month

Reference Interval

By report

Interpretive Data

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. Drug resistance is assigned using an ARUP-developed database of published resistance mutations. For a list of resistance mutations refer to https://ltd.aruplab.com/Tests/Pub/3004615.

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

This test was developed, and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration. This test was performed in a CLIA-certified laboratory and is intended for clinical purposes.

Compliance Category

Laboratory Developed Test (LDT)

Note

This test may be unsuccessful if the plasma CMV DNA viral load is less than 2.6 log IU/mL.

Hotline History

N/A

CPT Codes

87910; 87900

Components

Component Test Code* Component Chart Name LOINC
3004618 CMV Drug Resistance by NGS, 5 Drugs 48767-8
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • Cytomegalovirus (CMV) drug resistance, next generation sequencing
  • Cytomegalovirus (CMV) genotype
  • Cytomegalovirus antiviral drug resistance
Cytomegalovirus Drug Resistance by Next Generation Sequencing, Ganciclovir, Foscarnet, Cidofovir, Maribavir, and Letermovir