LAB3246
ENTPCR

UCHealth University of Colorado Hospital Clinical Laboratory - Molecular Diagnostics

 Effective Jan 16^th, 2023, this test can only be performed in-house on the following sources:

• CSF
• Stool

• Sources other than those listed cannot be performed in-house.
• eSwabs.
• Wooden-shafted or cotton swabs.
• Sample not properly identified, incorrect container, insufficient volume, past stability, or leaking container.
• Lab Note: Samples processed in lab using non-sterile technique—including samples previously tested with a “common needle” on an instrument—are unacceptable.

Internal: Ambient
Offsite: Refrigerated or frozen

Daily, upon receipt

Room Temp: Unacceptable
Refrigerated: 3 days
Frozen: 6 months

Daily, upon receipt

Qualitative Real-time PCR using Cepheid^® GeneXpert^®

Same day

LAB3246
ENTPCR

Interpretation: 
Not detected = Negative, no virus detected. 
Detected = Positive, virus detected. 

Methodology: 
This test employs PCR amplification of an Enterovirus-specific conserved genetic target. Some cross-reactivity was noted during validation with suspected Rhinovirus positive samples. A positive result should be coupled with clinical indicators for diagnosis.  A "Not detected" result for this assay does not exclude Enterovirus involvement in a disease process. This test has been approved by the U.S. Food and Drug Administration for CSF sample testing.  Other sample types are not FDA-approved but were validated by the UCH Molecular Diagnostics Laboratory.This test is used for clinical purposes.  It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendment of 1988 ("CLIA") as qualified to perform high complexity clinical testing.

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