Cytomegalovirus (CMV) Quantitative PCR

Test Code: 5500

CMV Cytomegalovirus cells banner

Some specimen types for this assay are reported as qualitative results; please see our Specimen Information section below for more information.

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Clinical and Procedure
Clinical Utility

Cytomegalovirus (CMV) is an important pathogen in the transplant setting causing pneumonitis, colitis, hepatitis, CNS disease, neutropenia, and disseminated disease. Prior to the availability of rapid and sensitive DNA PCR, CMV was a leading cause of morbidity and mortality in the transplant population. Quantitative CMV DNA PCR can be used for early detection of CMV reactivation, primary infections, and monitoring response to treatment.

About Cytomegalovirus

Clinically significant Cytomegalovirus infection frequently develops in immunocompromised patient populations (e.g. hematopoietic stem cell transplantation, solid organ transplant and HIV).  A frequent complication after transplantation, CMV infection may cause a series of direct and indirect effects that lead to increased incidence of graft rejection, opportunistic infections, and decreased allograft and patient survival.1,2  Symptomatic CMV disease in immunocompromised individuals can affect almost every organ of the body, resulting in fever, pneumonia, hepatitis, encephalitis, myelitis, colitis, uveitis, retinitis, and neuropathy.

Procedure

Extraction of CMV DNA from specimen followed by amplification and detection using real-time, quantitative PCR. An internal control is added to ensure the extraction was performed correctly and the PCR reaction was not inhibited. Eurofins Viracor's assay design includes multiple targets to account for viral mutations, which significantly reduces the chance of false negative results. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

The primers and probes used in this assay are specific for known CMV strains based on similarity search algorithms. Additionally, no cross reactivity was detected when tested against adenoviruses, BKV, EBV, HSV-1, HSV-2, HHV-6 variant A, HHV-6 variant B, HHV-7, HHV-8, JCV, parvovirus B19, SV-40, and VZV.

Turnaround Time

Same day (within 8 - 12 hours from receipt of specimen), Monday through Saturday, with the exception of Tissue and Bone Marrow specimens. Tissue and Bone Marrow specimens are expected to report within 18-24 hours from receipt of specimen, Monday-Saturday.

Specimen Information
Specimen Type Test Code CPT Code NY Approved Volume Assay Range Special Instructions
plasma 5501 87497 Yes

2 mL (min. 0.8 mL)

96 IU/mL to 1.88x108 IU/mL
  • Collect 4-5 mL whole blood in EDTA or ACD tube.
  • Avoid using gel separator tubes; samples collected in gel separator tubes have increased rate of PCR inhibition.
  • Centrifuge and transfer 2 mL plasma to 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.
urine 5502 87497 Yes

2 mL (min. 0.8 mL)

475 IU/mL to 1.88x108 IU/mL
  • Collect in a sterile urinalysis container then transfer to sterile, screw top tube for shipment
  • Can be shipped Monday through Friday.
  • Ambient: Not Stable
    Refrigerated: 3 days
    Frozen -80C: 30 days
    Shipping conditions: Store frozen and ship on dry ice for overnight delivery.
CSF 5503 87497 Yes

2 mL (min. 0.5 mL)

142 IU/mL to 1.88x108 IU/mL
  • Collect in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
bone marrow 5504 87497 Yes

2 mL (min. 0.5 mL)

1,039 IU/mL to 1.88x108 IU/mL
  • Collect in EDTA tube.
  • Do not centrifuge.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
Fresh Frozen Tissue [Quant] 5505 87497 Yes

5 mg fresh tissue (approximately ½ of a pencil eraser size)

37 IU/mg to 1.88x107 IU/mg
  • Place fresh tissue in a sterile, screw top container.
  • Do not add water, saline or other fluid media to container.
  • Store frozen and ship on dry ice for overnight delivery.
  • Formalin fixed, paraffin embedded tissue will not be accepted.
Fresh Frozen Tissue [Qual] 5506 87496 Yes 5 mg fresh tissue (approximately ½ of a pencil eraser size) Detected/Not Detected
  • Place fresh tissue in a sterile, screw top container.
  • The preferred handling is to not add water, saline or other fluid media to the tissue container; however, fluid media filled containers will be accepted for qualitative results.
  • Store frozen and ship on dry ice for overnight delivery.
  • Formalin fixed, paraffin embedded tissue will not be accepted.
amniotic fluid 5507 87497 Yes

2 mL (min. 0.5 mL)

104 IU/mL to 1.88x108 IU/mL
  • Collect 2 mL in sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped ambient temperature must be received within 96 hours of collection
fecal 5508 87496 Yes Size of pea, or 2 mL liquid stool Detected/Not Detected
  • Collect and place in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
BAL 5509 87497 Yes

2 mL (min. 0.5 mL)

79 IU/mL to 1.88x108 IU/mL
  • Collect in 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.
serum 5510 87497 Yes

2 mL (min. 0.8 mL)

96 IU/mL to 1.88x108 IU/mL
  • Collect 4-5 mL whole blood in red top tube.
  • Avoid using gel separator tubes; samples collected in gel separator tubes have increased rate of PCR inhibition.
  • Centrifuge and transfer 2 mL serum to 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.
pleural fluid 5511 87497 Yes

2 mL (min. 0.5 mL)

104 IU/mL to 1.88x108 IU/mL
  • Collect in 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.
pericardial fluid 5512 87497 Yes

2 mL (min. 0.5 mL)

104 IU/mL to 1.88x108 IU/mL
  • Collect in 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.
vitreous fluid 5514 87497 Yes

0.25 mL (min. 0.05 mL)

1,423 IU/mL to 1.88x108 IU/mL
  • Transfer collected amount to sterile, screw top tube for shipment.
  • Do not add water, saline or other fluid media to container.
  • Do not ship specimen in syringe.
  • Store frozen and ship on dry ice for overnight delivery.
trach asp 5519 87497 Yes

2 mL (min. 0.5 mL)

79 IU/mL to 1.88x108 IU/mL
  • Collect in 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.
bronch wash 5526 87497 Yes

2 mL (min. 0.5 mL)

79 IU/mL to 1.88x108 IU/mL
  • Collect in 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.
eye swab 5527 87496 Yes

2 mL

Detected/Not Detected
  • Place sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube.
  • Do not use calcium alginate swab or wood shafted swab.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
aqueous fluid 5545 87497 Yes

0.25 mL (min. 0.05 mL)

1,423 IU/mL to 1.88x108 IU/mL
  • Transfer collected amount to sterile, screw top tube for shipment.
  • Do not add water, saline or other fluid media to container.
  • Do not ship specimen in syringe.
  • Store frozen and ship on dry ice.
trach wash 5548 87497 Yes

2 mL (min. 0.5 mL)

79 IU/mL to 1.88x108 IU/mL
  • Collect in 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.
saliva 5571 87496 Yes

1 mL

Detected/Not Detected
  • Place swab in the mouth until saturated with saliva. Wait 90-120 minutes following breast feeding to collect the sample.
  • Transfer swab to tube containing 1 to 3 mL of Universal Transport Media (UTM).
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 48 hrs. of collection.
    (If a dry swab is shipped at ambient temperature, must be received within 24 hrs. of collection.)
  • Samples are stable refrigerated or frozen for 7 days.
  • Do not use calcium alginate swab or wood shafted swab.
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 Eurofins Viracor test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Eurofins Viracor, 18000 W 99th St. Ste, #10, Lenexa, KS 66219

Causes for Rejection

Whole blood frozen, grossly hemolyzed plasma/serum specimens, specimens beyond their acceptable length of time from collection as listed in the specimen handling, specimens received in trap containers, or specimen types other than those listed.

Disclaimer

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

The CPT codes provided are based on Eurofins Viracor's 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. Eurofins Viracor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

References

1 Kotton CN, Kumar D, Caliendo AM, et al. International consensus guidelines on the management of cytomegalovirus in solid organ transplantation. Transplantation. Apr 15 2010;89(7):779-95.

2 Boeckh M, Ljungman P. How we treat cytomegalovirus in hematopoietic cell transplant recipients. Blood. 2009;113(23):5711-9.

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