Assay Sheet
Test ID Code
1400 Enterovirus RealTime RT-qPCR
CPT Code
87799
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 CSF, 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’s assay design includes multiple-gene targets to account for viral mutations, which exponentially reduces the chance of false negative results.
Specimen type & specimen handling
Whole Blood: 4-5 mls collected in EDTA (lavender top) tube. Do not freeze; ship ambient. Testing will be performed on plasma separated from the submitted whole blood specimen. Whole blood specimens are accepted as a matter of convenience for the originating laboratory.
Plasma: Collect 4-5 mls whole blood in EDTA or ACD tube, centrifuge and transfer 2 mls plasma to sterile, screw top tube. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
Amniotic Fluid: 2 mls collected in a sterile, screw top tube. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
Bone Marrow: 2 mls collected in EDTA tube. Ship at ambient temperature Monday thru Friday. Do not centrifuge or freeze. Specimen must be received within 96 hrs of collection.
Bronchial Lavage/Bronchial Wash: 2 mls collected in a sterile, screw top tube. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
Conjunctival Swab: 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. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
CSF: 2 mls 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.
Fecal: Collect small amount of fecal material (size of pea, or 2 mls liquid stool) and place into screw top tube for shipment. Ship at ambient temperature Monday thru Friday. Specimen must arrive within 96 hrs of collection. Note: Specimen may also be stored at 2 to 8°C or frozen in a non-self-defrosting freezer and shipped with frozen gel packs or dry ice for overnight delivery at Viracor-IBT.
Pericardial Fluid: 2 mls collected in a sterile, screw top tube. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
Pleural Fluid: 2 mls collected in a sterile, screw top tube. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
Skin Swab: 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. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
Sputum: 2 mls collected in a sterile container, then transferred to sterile, screw top tube for shipment. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
Throat Gargle: 2 mls collected in a sterile container then transferred to sterile, screw top tube for shipment. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
Tissue: Place in sterile, screw top container; add small amount of sterile saline to keep moist. Paraffin embedded tissue is acceptable. Ship at ambient temperature Monday thru Friday. Fresh tissue must arrive within 96 hrs of collection.
Upper respiratory aspirate (NP aspirate, nasal aspirate/wash, tracheal aspirate, etc.): 2 mls collected in a sterile, screw top tube. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
Upper respiratory swab (NP swab, throat swab): 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. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
Urine: 2 mls sample collected in a sterile urinalysis container then transferred to sterile, screw top tube for shipment. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
Vitreous Fluid: Small volumes are acceptable. Transfer collected amount to sterile, screw top tube for shipment. Do not ship specimen in syringe. Ship at ambient temperature Monday thru Friday. Specimen must be received within 96 hrs of collection.
Call ViraCor for authorization prior to sending any specimen type other than those listed above.
If another specimen type has received authorization for testing the following comment will appear in the final report: "The clinical utility of this result has not yet been demonstrated in the peer reviewed literature and is therefore unknown."
Causes for rejection
Whole blood frozen
Call ViraCor 800-305-5198 if specimen is greater than 96 hours old
Specimen types other than those listed above that were sent without prior authorization
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 1010 copies/ml
Tissue biopsy results will be qualitative.
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 test requisition form must accompany each specimen.
Ship specimens FedEx Priority Overnight® to:
ViraCor Laboratories, 1001 NW Technology Dr., Lee’s Summit MO, 64086
The CPT codes provided are based on 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. ViraCor 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. This assay was developed and the performance characteristics were determined at ViraCor Laboratories. This test is performed in a CLIA certified laboratory. FDA approval is not required for the performance of this test.
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