COVID - 19 Direct Access, PCR, Direct Access, 24 hours

Last Modified: 1/31/2022 11:19:20 AM


Medical Necessity Documentation:  
Client Notes:  
Patient Preparation: Link to https://www.parkview.com/services-specialties/lab-diagnostic-imaging/direct-access-testing
Specimen Requirements:  
Collection Instructions:  XPERT Nasopharyngeal Swab Specimen Collection Kit (Red Top/Pink Fluid)
Transport & Storage: Temperature/Stability:  Nasopharyngeal Swab placed in an M4RT Vial, Nasopharyngeal Swab placed in UTM, Nasopharyngeal Swab placed in saline, Nasal Swab placed in UTM, Nasal Swab placed in M4RT, Nasal
Rejection Criteria: Wood shaft swab; calcium alginate swab; cotton-tipped swab
Reference Range:  
Critical Ranges: Negative
Test Comments: Testing performed by real-time PCR using the Cepheid SARS CoV-2 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) on March 20, 2020.  This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens,  until the emergency use authorization is terminated or revoked.
Methodology: Real-Time PCR
Clinical Significance:  
Custom Panel: No

PRODUCTION SCHEDULE

Turn Around Time: 24 hours
Days Performed: Sunday, Monday, Tuesday, Wednesday, Thursday, Friday, Saturday
Sites Performed: Parkview Regional Medical Center
PHL Test Code: COV24
Alternate Test Names: Covid 19; COVID-19, PCR, Direct Access; COVID-19, PCR, Direct Access, 24 hours
Included Tests:  
CPT Coding: .

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