Test Information

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HHV-6 Quantitative Real-time PCR

Test Code: 6500

Cpt Code:

87533 (x1)

Clinical Utility

HHV-6 reactivation can cause fever, rash, hepatitis, encephalitis, pneumonitis, and delay or suppression of bone marrow engraftment (HSCT) and/or increased risk of CMV infection (HSCT or SOT). Bone marrow suppression due to HHV-6 infection is often confused with rejection in an HSCT patient. Quantitative HHV-6 DNA PCR can be used for early detection of a primary infection, tracking the course of infection, and monitoring response to treatment; however, quantitative HHV-6 DNA PCR does not differentiate HHV-6 viremia from patients with chromosomally integrated HHV-6, a relatively uncommon congenital occurence that has not been conclusively related to a disease state.

Procedure

Extraction of HHV-6 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. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Specificity

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

Causes For Rejection

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

6509 BAL

NY approved.  Assay Range: 78 copies/mL to 1x108 copies/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.

6504 bone marrow

NY approved.  Assay Range: 183 copies/mL to 1x108 copies/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.

6526 bronch wash

NY approved.  Assay Range: 78 copies/mL to 1x108 copies/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.

6503 CSF

NY approved.  Assay Range: 81 copies/mL to 1x108 copies/mL. 2 mL collected in a sterile, screw top tube (minimum volume 0.5 mL). Store frozen and ship on dry ice for overnight delivery to Viracor-IBT.

6508 fecal

NY approved.  (CPT Code:87532 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.

6501 plasma

NY approved.  Assay Range: 188 copies/mL to 1x108 copies/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.

6510 serum

NY approved.  Assay Range: 188 copies/mL to 1x108 copies/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.

6506 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.

6505 tissue [Quant]

NY approved.  Assay Range: 8 copies/mg to 1x107 copies/mg. Place a minimum of 5 mg fresh tissue (approximately ½ 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.

6519 trach asp

NY approved.  Assay Range: 78 copies/mL to 1x108 copies/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.

6548 trach wash

NY approved.  Assay Range: 78 copies/mL to 1x108 copies/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.

6516 whole blood

NY approved. Assay Range: 79 copies/mL to 1x108 copies/mL. 4-5 mL collected in EDTA (lavender top) tube (minimum volume 0.5 mL). 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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