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CMV Antiviral Resistance Sequencing

Test Code: 5600
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Clinical Utility

CMV infections are a major cause of morbidity and mortality among immunocompromised patients. Patient outcomes depend on rapid diagnosis and treatment with antiviral therapies, including ganciclovir, valganciclovir, foscarnet, and cidofovir. Unfortunately, the risk of developing an antiviral-resistant strain of CMV with continued antiviral use in either prophylaxis or preemptive therapy regimens is rising. Proper patient management requires rapid detection of resistance and immediate therapy modification. Laboratory testing should be used to confirm the occurrence of antiviral resistance, as treatment modification based solely on clinical suspicion may result in added toxicity and increased complexity in patient management. The use of gene sequencing offers distinct advantages over other methods, including a rapid turnaround time, a broader range of antiviral resistance information, and the ability to provide information concerning new drugs as they become available.

Procedure

Conventional PCR followed by gene sequencing. Sequencing analysis provides information on selected locations in two genes involved in CMV antiviral resistance: UL97 and UL54. Mutations in the UL97 phosphotransferase gene have been implicated in ganciclovir resistance. Mutations in the UL54 DNA polymerase gene may confer ganciclovir, foscarnet, and cidofovir resistance. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

2-4 business days from receipt of specimen

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
plasma 5601 87910 Yes 2 mL (min. 1000 IU/mL) Mutations in the UL97 and UL54 genes will be reported as Resistant/None Detected. Interpretation of gene mutations and association with antiviral resistance, including ganciclovir, foscarnet, and cidofovir, will be provided with the report. See CMV AVR Reportable Mutations in the test information navigation (right side of webpage).
  • Collect 4-5 mL whole blood in EDTA, ACD or PPT.
  • Centrifuge and transfer 2 mL plasma to a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor Eurofins test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 1001 NW Technology Dr, Lee's Summit, MO 64086

Causes for Rejection

CMV DNA concentrations too low to allow antiviral resistance testing, whole blood frozen, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Viracor Eurofins' interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

PCR tests are performed pursuant to a license agreement with Roche Molecular Systems, Inc.

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