Test Information

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Enterovirus Quantitative Real-time RT-PCR

Test Code: 1400

Cpt Code:

87799 (x1)

Clinical Utility

The enteroviruses are well-known etiologic agents of viral meningitis, viral encephalitis, myocarditis, and respiratory tract disease as well as a wide variety of other clinical conditions. Quantitative PCR can be used to detect the presence of the virus as well as track the course of infection.

Procedure

Extraction of enterovirus nucleic acid from speciemen, followed by reverse transcription of viral RNA, then amplification and detection of cDNA 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-gene 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

Detects the entire spectrum of human enteroviruses, including coxsackie A viruses, coxsackie B viruses, echoviruses, polioviruses, and enteroviruses 68 through 71. The assay does not differentiate between serotypes. This assay is designed to specifically detect enteroviruses; however, rhinoviruses are a closely related and highly diverse group of pathogens. Low-level cross-reactivity has been observed with some strains of rhinovirus. Significant cross-reactivity was noted with rhinovirus serotype 51. Results should be used in conjunction with clinical findings and should not form the sole basis for a diagnosis or treatment decision.

Assay Range

  • 100 copies/mL to 1 x 108 copies/mL (all specimen types except fecal and tissue).
  • Fecal and tissue specimens report as qualitative (Detected/Not Detected).

Causes For Rejection

Whole blood frozen, specimens greater than 96 hrs old, 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 Type & Specimen Handling

1409 BAL - 2 mL collected in a sterile, screw top tube. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
1426 bronch wash - 2 mL collected in a sterile, screw top tube. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
1403 CSF - 2 mL collected in a sterile, screw top tube. Freeze and ship on dry ice Monday thru Friday. Specimen must be received within 96 hrs of collection.
1408 fecal - (CPT Code: 87498 X 1) 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.
1401 plasma - Collect 4-5 mL whole blood in EDTA or ACD tube, centrifuge and transfer 2 mL plasma to sterile, screw top tube. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
1410 serum - Collect 4-5 mL whole blood in red top tube, centrifuge and transfer 2 mL serum to sterile, screw top tube. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
1406 tissue [Qual] - (CPT Code: 87498 X 1)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.
1419 trach asp - 2 mL collected in a sterile, screw top tube. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
1448 trach wash - 2 mL collected in a sterile, screw top tube. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Type and Specimen Handling 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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