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.
Specimens
Whole Blood: 3 to 5 ml 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: 3 to 5 ml separated from whole blood collected in EDTA (lavender top) tube; ship ambient.
Amniotic Fluid: 1 ml minimum submitted in sterile, screw-top tube; ship ambient.
Bone Marrow: 2 ml minimum, collected in an EDTA (lavender top) tube. Do not freeze; ship ambient.
Bronchial Lavage/Bronchial Wash: 1 to 3 ml, collected in sterile, screw-cap tube; ship ambient.
Conjunctival Swab: Swab conjunctiva with sterile, preferably flocked swab. Place into 1-2 ml sterile saline, M4 or viral transport media in sterile, screw-cap tube. Do not use calcium alginate swab or wood shafted swab; ship ambient.
CSF: 1 ml minimum, submitted in sterile, screw-cap tube; ship on dry ice.
Pericardial Fluid: 1 ml minimum, submitted in a sterile, screw-top tube; ship ambient.
Pleural Fluid: 1 ml submitted in a sterile, screw-top tube; ship ambient.
Skin Swab: Sterile swab placed in 1 to 2 ml sterile saline, M4, or viral transport media in a sterile, screw-cap tube; ship ambient. Do not use calcium alginate swab or wood shafted swab.
Sputum: 1-2 ml submitted in a sterile, screw-top tube; ship ambient
Throat Gargle: Instruct patient to gargle with 2-3ml sterile saline. Expectorate into sterile cup, then transfer contents to sterile, screw-cap tube for shipment; ship ambient.
Tissue: Place in a sterile, screw-cap tube, add a small amount of saline to keep moist. Prefer 1 mm x 1 mm specimen. Prefer fresh over formalin fixed for maximum sensitivity; ship ambient. Results for tissue testing will be qualitative.
Upper respiratory aspirate (NP aspirate, nasal aspirate, tracheal aspirate, etc.): Instill 1 to 2 ml sterile saline into desired location and gently aspirate contents. Place collected fluid into sterile, screw-cap tube; ship ambient.
Upper respiratory swab (NP swab, throat swab): Swab desired location with sterile, flexible shaft swab, preferably a flocked swab. Place swab into 1 to 2 ml sterile saline, M4, or viral transport media in sterile, screw-cap tube. Do not use calcium alginate swab or wood shafted swab; ship ambient.
Urine: 1 to 2 ml sample collected in a sterile urinalysis container. Transfer to a 15 ml sterile, screw-cap tube; ship ambient.
Vitreous Fluid: Place collected vitreous fluid into small, sterile, screw-cap tube; ship ambient.
Other specimens may be accepted for testing; however 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." Call ViraCor for further information.
Causes for rejection
Whole blood frozen. Call ViraCor 800-305-5198 if specimen is greater than 96 hours old.
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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