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Epstein-Barr Virus (EBV) Quantitative Real-time PCR

Test Code: 4500
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Clinical Utility

EBV is the etiologic agent of most post-transplant lymphoproliferative disorder (PTLD), which is an important cause of morbidity and mortality in both solid organ transplant recipients and HSCT patients. PTLD results from uncontrolled EBV-induced proliferation of B-cells in the immunocompromised setting. Quantitative EBV DNA PCR can be used to aid in the early diagnosis of PTLD, track the course of the disease, and monitor response to treatment.

Procedure

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

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

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
BAL 4509 87799 Yes

2 mL (min. 0.5 mL)

25 IU/mL to 1.69x108 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.
bone marrow 4504 87799 Yes 2 mL (min. 0.5 mL) 213 IU/mL to 1.69x108 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.
bronch wash 4526 87799 Yes

2 mL (min. 0.5 mL)

25 IU/mL to 1.69x108 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.
CSF 4503 87799 Yes 2 mL (min. 0.5 mL) 52 IU/mL to 1.69x108 IU/mL
  • Collect in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
fecal 4508 87798 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.
plasma 4501 87799 Yes

2 mL (min. 0.5 mL)

49 IU/mL to 1.69x108 IU/mL
  • Collect 4-5 mL whole blood in EDTA or ACD tube.
  • 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.
serum 4510 87799 Yes 2 mL (min. 0.5 mL) 49 IU/mL to 1.69x108 IU/mL
  • Collect 4-5 mL whole blood in red top tube.
  • 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.
tissue [Quant] 4505 87799 Yes 5 mg fresh tissue (approximately ½ of a pencil eraser size) 7 IU/mg to 1.69x107 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.
tissue [Qual] 4506 87798 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.
trach asp 4519 87799 Yes

2 mL (min. 0.5 mL)

25 IU/mL to 1.69x108 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.
trach wash 4548 87799 Yes

2 mL (min. 0.5 mL)

25 IU/mL to 1.69x108 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.
whole blood 4516 87799 Yes 2 mL (min. 0.5 mL) 64 IU/mL to 1.69x108 IU/mL
  • Collect in EDTA tube.
  • Ship at ambient 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

Whole blood frozen, 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.

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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