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JC Virus (JCV) Quantitative Real-time PCR

Test Code: 3500
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Clinical and Procedure
Clinical Utility

JCV is the etiologic agent of progressive multifocal leukoencephalopathy (PML) which is mainly seen in HIV patients, organ transplant patients, and other immunodeficient syndromes. In addition to PML, JCV also causes nephropathy in the renal transplant setting, although with considerably less frequency than BKV. JCV should always be considered in an immunocompromised patient with progressively deteriorating CNS function. Quantitative JCV DNA PCR can be used to detect JCV in CSF in the setting of CNS disease, and blood and urine in the setting of renal dysfunction. Quantitative DNA PCR can be used to track the course of infection as well as monitor response to treatment.

Procedure

Extraction of JCV 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. 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 all known JCV strains based on similarity search algorithms. Additionally, no cross reactivity was detected when tested against adenoviruses, BKV, CMV, EBV, HSV-1, HSV-2, HHV-6 variant A, HHV-6 variant B, HHV-7, HHV-8, parvo B19, SV-40, and VZV.

Turnaround Time

Same day (within 8 - 12 hours from receipt of specimen), Monday through Saturday.

Specimen Information
Specimen Type Test Code CPT Code NY Approved Volume Assay Range Special Instructions
plasma 3501 87799 Yes

2 mL (min. 0.5 mL)

40 copies/mL to 1x108 copies/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 3502 87799 Yes

2 mL (min. 0.5 mL)

151 copies/mL to 1x108 copies/mL

  • Collect in a sterile urinalysis container then transfer to sterile, screw top tube for shipment
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
CSF 3503 87799 Yes

2 mL (min. 0.5 mL)

72 copies/mL to 1x108 copies/mL

  • Collect in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
serum 3510 87799 Yes

2 mL (min. 0.5 mL)

40 copies/mL to 1x108 copies/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.
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

Specimens beyond their acceptable length of time from collection as listed in the specimen handling, grossly hemolyzed plasma/serum specimens, 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 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.

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