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Cytomegalovirus (CMV) is the major opportunistic virus encountered after organ transplantation, and resistant variants can make antiviral treatment challenging. ARUP is introducing three new tests to detect CMV drug resistance using next generation sequencing (NGS). These tests will detect variants present in the CMV viral genes UL27, UL97, UL54, and UL56.
Specific variants present in these genes are associated with antiviral resistance. Increasing or stable viral loads in a patient receiving antiviral therapy may indicate the presence of drug-resistant viral populations.1 NGS technology allows a deeper discrimination of the emergence and persistence of a drug-resistance mutation.
Indications for Testing
Two classes of molecular CMV tests are key to the successful management of CMV. The first is the quantitative molecular test that identifies concentrations of CMV virus due to active infections. The second class includes the sequencing tests used to identify antiviral drug-associated resistance variants that, when present even at low concentrations, may continue to evolve and ultimately lead to treatment failure. The detection and identification of drug-resistant virus populations is essential for informing optimal therapy.
- Viral load testing should be performed before ordering these tests. To ensure a high-quality sequencing result, the current CMV DNA viral load must be >2.6 log IU/mL.
- Please include the patient’s most recent CMV DNA viral load and antiviral drug history with test orders.
- See Cytomegalovirus by Quantitative NAAT, Plasma 3005895.
Choosing a Test
ARUP offers multiple tests that determine CMV drug resistance depending on the drug(s) of interest. Effective November 7, 2022, the following tests will be available:
| Test Name | ARUP Test Code |
Sequencing |
Genes Sequenced |
Antiviral Drug Resistance Reported | Limit of Detection |
|---|---|---|---|---|---|
|
Cytomegalovirus Drug Resistance by Next Generation Sequencing, Ganciclovir, Foscarnet, Cidofovir, and Maribavir |
NGS |
UL97 |
Ganciclovir |
Mutations <10% of total population may not be detected |
|
|
Cytomegalovirus Drug Resistance by Next Generation Sequencing, Letermovir |
NGS |
UL56 |
Letermovir |
Mutations <10% of total population may not be detected |
|
|
Cytomegalovirus Drug Resistance by Next Generation Sequencing, Ganciclovir, Foscarnet,Cidofovir, Maribavir and Letermovir |
NGS |
UL97 |
Sequencing, Ganciclovir, Foscarnet, Cidofovir, Maribavir, and Letermovir |
Mutations <10% of total population may not be detected |
|
|
Cytomegalovirus Antiviral Drug Resistance by Sequencing |
Polymerase Chain Reaction/Sequencing |
UL97 |
Ganciclovir |
Mutations <20% of total population may not be detected |
Why Use ARUP Laboratories?
ARUP’s NGS testing offers the following:
- The NGS testing has high sensitivity and can detect viral populations as low as 10% of the total viral population. The NGS testing is more sensitive than ARUP’s current test, Cytomegalovirus Antiviral Drug Resistance by Sequencing 2004760, with a limit of detection that is lower than some competitor’s assays.
- ARUP’s testing can determine resistance-associated variants in multiple genes (UL97, UL54, UL27, and UL56). More genes are sequenced compared to some competitor’s assays.
- ARUP offers multiple testing options that determine CMV drug resistance depending on the drug(s) of interest.
- Drug resistance is determined using a database of published resistance mutations.
|
Cytomegalovirus Drug Resistance by Next Generation Sequencing, Ganciclovir, Foscarnet, Cidofovir, and Maribavir |
|
|
Cytomegalovirus Drug Resistance by Next Generation Sequencing, Letermovir |
|
|
Cytomegalovirus Drug Resistance by Next Generation Sequencing, Ganciclovir, Foscarnet, Cidofovir, Maribavir, and Letermovir |
Additional Resources/Information
Cytomegalovirus Antiviral Drug Resistance by Sequencing, 2004760, is New York approved.
The CMV drug resistance by NGS testing is not currently New York approved. Please call ARUP Client Services for current status.
For more information on testing options, visit the ARUP Consult Cytomegalovirus - CMV topic.
References
- Kotton CN, et al. The Third International Consensus Guidelines on the management of cytomegalovirus in solid-organ transplantation. Transplantation. 2018;102(6):900-931.
