Cytomegalovirus Drug Resistance


Abbrev Code:CMVDR   
Order Code:LAB8303Order Name:Cytomegalovirus Drug Resistance
Methodology:Massively Parallel Sequencing
CPT Codes: 87900 x1, 87910 x1
Test Includes:Susceptibility information for ganciclovir, foscarnet, cidofovir, maribavir, and letermovir.
Turnaround Time:Specimens sent to reference laboratory Mon-Sat; results reported within 4-10 days.
Special Instructions:If available, please submit the following: most recent viral load and test date; information on current or past drug therapy.
Compliance:

ARUP Laboratory Developed Test (LDT): For tests developed and validated by ARUP (previously referred to as Compliance Statement B, C or D). This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.



Collection Instructions

Specimen:Blood
Optimal Volume:10 mL
Minimum\Peds Volume:5.2 mL
Container:
Alternate Containers: Purple (EDTA)
Causes for Rejection:Serum, heparinized specimens.


Processing and Shipping

Specimen Processing:Separate plasma from cells within 24 hours. Aliquot 3 mL, 2.5 minimum, plasma. Store in freezer.
Shipping Instructions:Ship frozen.
Stability:After separation of cells, 8 hours at room temperature; 72 hours refrigerated; 1 month frozen.
Test Performed at or Referral Lab Lab Sendouts  (ARUP)
Referral Lab number:3004615


Interpretive

Reference Range:By report.

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


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