COVID - 19 Direct Access, PCR 24 hours (Direct Access Testing)

Client Notes:

Cepheid Factsheet for Healthcare Providers

Patient Preparation

Cepheid Factsheet for Patients

Specimen Requirements

  XPERT Nasopharyngeal Swab Specimen Collection Kit (Red Top/Pink Fluid)

Alternate Specimen

Nasopharyngeal Swab placed in an M4 Vial

Nasopharyngeal Swab placed in Universal Transport Media (UTM)

Nasopharyngeal Swab placed in saline

Nasal Swab placed in Universal Transport Media (UTM)

Nasal Swab placed in M4, Nasal

TransportAndStorage

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

Collection Instructions

Nasopharyngeal Collection Instructions

Minimum Volume

Neonatal Volumne

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 Polymerase Chain Reaction

CPT Coding

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