LAB3245
ENTPCRPLS

UCHealth University of Colorado Hospital Clinical Laboratory - Molecular Diagnostics

Effective January 16^th, 2023: Enterovirus PCR Plasma testing will be sent to ARUP Labs until further notice.

Preferred: 6 mL Pink (K2 EDTA)
Acceptable: 4 mL Purple (EDTA)
Minimum volume: 0.5 mL plasma.

2.0 mL Pink top (K2EDTA) BD Microtainer.
Minimum volume: 0.5 mL whole blood (0.3 mL plasma).

• Blood collected in containers other than EDTA.
• Plasma from green tops (LiHep or NaHep).
• Frozen whole blood.
• 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

Day shift: Monday–Friday

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

Day shift: Monday–Friday

Qualitative Real-time PCR

1–3 days

LAB3245
ENTPCRPLS

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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