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

Test Code: 4500

Cpt Code:

87799 (x1)

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-IBT'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 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.

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.

Turnaround Time

Same day (within 8 to 12 hours of receiving specimen), Monday through Saturday

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-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor-IBT Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086

Specimen Information

4509 BAL

NY approved. Assay Range: 25 IU/mL to 1.69x108 IU/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

4504 bone marrow

NY approved.  Assay Range: 213 IU/mL to 1.69x108 IU/mL. 2 mL collected in EDTA tube (minimum volume 0.2 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Do not centrifuge. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

4526 bronch wash

NY approved.  Assay Range: 25 IU/mL to 1.69x108 IU/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

4503 CSF

NY approved.  Assay Range: 52 IU/mL to 1.69x108 IU/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Store frozen and ship on dry ice for overnight deliver to Viracor-IBT.

4508 fecal

NY approved.  (CPT Code:87798 X 1). Assay Range: (Detected/Not Detected). Collect small amount of fecal material (size of pea, or 2 mL liquid stool) and place into screw top tube for shipment. Store frozen and ship on dry ice for overnight delivery to Viracor-IBT.

4501 plasma

NY approved. Assay Range: 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 (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

4510 serum

NY approved.  Assay Range: 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 (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

4505 tissue [Quant]

NY approved.  (CPT Code:87799 X 1). Assay Range: 7 IU/mg to 1.69x107 IU/mg. Place a minimum of 5 mg fresh tissue (appoximately 1/2 of a pencil eraser size) 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 to Viracor-IBT. Formalin fixed, paraffin embedded tissue will not be accepted.

4506 tissue [Qual]

NY approved.  (CPT Code:87798 X 1). Assay Range: (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 to Viracor-IBT. Formalin fixed, paraffin embedded tissue will not be accepted.

4519 trach asp

NY approved.  Assay Range: 25 IU/mL to 1.69x108 IU/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

4548 trach wash

NY approved.  Assay Range: 25 IU/mL to 1.69x108 IU/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

4516 whole blood

NY approved. Assay Range: 64 IU/mL to 1.69x108 IU/mL. 4-5 mL collected in EDTA (lavender top) tube (minimum volume 0.5 mL). Do not freeze; ship ambient. Specimen must be received within 96hrs of collection.

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 Viracor-IBT'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. Viracor-IBT 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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