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Test Code SARS SARS Coronavirus 2 RNA Detection RAPID   

Important Note

Note:
SARS-CoV-2 testing performed by this method is limited to the following patient populations:

  1. Hospital inpatients with signs and symptoms of COVID-19 infection
  2. Emergency Room patients with signs and symptoms of COVID-19 infection
  3. Health Care Employees displaying signs and symptoms consistent with COVID-19 infection.

Fact sheets for this Emergency Use Authorization (EUA) assay can be found at the following links

For Healthcare Providers:

https://www.fda.gov/media/136313/download

 

Additional Codes

ALAB: SARS

Powerchart: Coronavirus (COVID-19/SARS-CoV-2) RAPID

MA Cerner: Not Available for Order at this time

Specimen Requirement

Nasopharyngeal swabs are the specimen of choice for this assay. 

  1. Collect the specimen using the COPAN FLOQ Swab in the Xpert Nasopharyngeal Sample Collection Kit for Viruses. Other acceptable sample collection materials include rayon or polyester tip swabs. These swabs can be substituted if Nasopharyngeal swabs are not available.
  2. Remove the cap from the Xpert Viral Transport Medium tube.
  3. Insert the swab into the tube.
  4. Break the swab shaft by bending it against the tube wall.
  5. Replace the cap and close tightly.
  6. Label with appropriate patient information.

Storage

  1. Specimens collected using Xpert Nasopharyngeal Sample Kit for Viruses:
    1. Specimens should be transported at 2-8°C.
    2. Specimens can be stored at room temperature for up to 24 hours.
    3. Specimens can be stored refrigerated at 2-8°C for up to seven days. 
  2. Nasal Collection Kit supplies are distributed by the hospital laboratory.

Reference Value

Negative

Critical Value: Positive, Presumptive positive, Indeterminant, Detected, Equivocal

Fact sheets for this Emergency Use Authorization (EUA) assay
can be found at the following links:
For Healthcare Providers: https://www.fda.gov/media/136313/download

For Patients: https://www.fda.gov/media/136312/download

CPT Code Information

87635 - Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique.

Useful For

The rapid detection SARS-CoV-2 in nasopharyngeal swabs collected from individuals suspected of COVID-19 by their healthcare provider.

Fact sheets for this Emergency Use Authorization (EUA) assay can be found at the following links:

For Healthcare Providers: https://www.fda.gov/media/136313/download

For Patients: https://www.fda.gov/media/136312/download

LOINC Code Information

94500-6

Method

Rapid Polymerase Chain Reaction (rPCR)

Performance

Testing is performed Monday through Sunday. Test performance is limited to the capacity of the instrument.

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