HHV-6 Quantitative Real-time PCR

Test Code: 6500

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

Quantitative HHV-6 DNA PCR can be used for early detection of a primary infection, for tracking the course of infection, and for monitoring response to treatment. Quantitative HHV-6 DNA PCR does not differentiate HHV-6 viremia from patients with chromosomally integrated HHV-6, a relatively uncommon congenital occurrence that has not been conclusively related to a disease state. Treatment of HHV-6 in immunocompromised patients presents challenges, including drug toxicity, delayed onset of disease after discontinuing therapy, and emergence of mutations that may affect the ability of diagnostic assays to detect them efficiently.

About HHV-6

HHV-6 reactivation can cause fever, rash, hepatitis, encephalitis, pneumonitis, delay or suppression of bone marrow engraftment and/or increased risk of cytomegalovirus (CMV) infection in bone marrow or solid organ transplant patients. Bone marrow suppression due to HHV-6 infection is often confused with rejection in hematopoietic stem cell transplantation (HSCT) patients.

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.

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 6501 87533 Yes

2 mL (min. 0.5 mL)

188 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.
CSF 6503 87533 Yes

2 mL (min. 0.5 mL)

81 copies/mL to 1x108 copies/mL
  • Collect in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
bone marrow 6504 87533 Yes

2 mL (min. 0.5 mL)

183 copies/mL to 1x108 copies/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] 6505 87533 Yes 5 mg fresh tissue (approximately ½ of a pencil eraser size) 8 copies/mL to 1x108 copies/mL
  • 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] 6506 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.
fecal 6508 87532 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 6509 87533 Yes

2 mL (min. 0.5 mL)

78 copies/mL to 1x108 copies/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 6510 87533 Yes

2 mL (min. 0.5 mL)

188 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.
whole blood 6516 87533 Yes

2 mL (min. 0.5 mL)

79 copies/mL to 1x108 copies/mL
  • Collect in EDTA tube.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
trach asp 6519 87533 Yes

2 mL (min. 0.5 mL)

78 copies/mL to 1x108 copies/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 6526 87533 Yes

2 mL (min. 0.5 mL)

78 copies/mL to 1x108 copies/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 6548 87533 Yes

2 mL (min. 0.5 mL)

78 copies/mL to 1x108 copies/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.
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, 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.

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