CoVid 19

Last Modified: 8/25/2021 12:15:01 PM

Medical Necessity Documentation:  
Client Notes:  
Patient Preparation:  
Specimen Requirements:  XPERT Nasopharyngeal Swab Specimen Collection Kit (Red Top/Pink Fluid)
Collection Instructions:  
Transport & Storage: Temperature/Stability:  48 hours refrigerated
Rejection Criteria: Wood shaft, calcium alginate, or cotton-tipped swab
Reference Range: Negative
Critical Ranges:  
Test Comments:  Testing performed by real-time PCR using the Cepheid SARS-CoV-2/Flu/RSV assay on the GeneXpert Infinity.  This test has not been FDA cleared or approved.  This test has been authorized by the FDA under an Emergency Use Authorization (EUA).  This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, Influenza A, Influenza B, and RSV, not for any other viruses or pathogens.  This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or the EUA is revoked.
Methodology: Real-Time PCR
Clinical Significance:  
Documentation: Influenza A/B and/or RSV Testing may be added on to this Covid-19 collection by contacting the lab client response center at 260-266-1500 Option 1
Custom Panel: No


Days Performed: Sunday, Monday, Tuesday, Wednesday, Thursday, Friday, Saturday
Sites Performed: Parkview Regional Medical Center
PHL Test Code: CAB3
EPIC Test Code: LAB14098
Alternate Test Names: SARS-COV-2 RNA
Included Tests:  
CPT Coding: 87635

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