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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 specimen, 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 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, 87 and 91. Results should be used in conjunction with clinical findings and should not form the sole basis for a diagnosis or treatment decision.

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

1409 BAL

NY approved. Assay Range: 209 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.

1426 bronch wash

NY approved. Assay Range: 209 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.

1403 CSF

NY approved. Assay Range: 195 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.

1408 fecal

(CPT Code: 87498 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.

1431 nasal asp

NY approved. Assay Range: 95 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.

1430 nasal swab

NY approved. (CPT Code:87498 X 1) Assay Range: (Detected/Not Detected). Sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube. Do not use calcium alginate swab or wood shafted swab. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

1413 nasal wash

NY approved. Assay Range: 95 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.

1424 NP aspirate

NY approved. Assay Range: 95 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.

1425 NP swab

NY approved. (CPT Code:87498 X 1) Assay Range: (Detected/Not Detected). Sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube. Do not use calcium alginate swab or wood shafted swab. Can be shipped at ambient or frozen temperature Monday through Friday. Specimens shipped at ambient temperature must be received within 96 hrs of collection.

1447 NP wash

NY approved. Assay Range: 95 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.

1401 plasma

NY approved. Assay Range: 290 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.

1410 serum

NY approved. Assay Range: 290 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.

1423 throat gargle

NY approved. Assay Range: 95 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.

1405 tissue [Qual]

(CPT Code: 87498 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.

1419 trach asp

NY approved. Assay Range: 209 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.

1448 trach wash

NY approved. Assay Range: 209 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.

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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