Reference Range

Reference Range:  Negative

Interpretive data: 

This is a culture independent diagnostic test consisting of individual PCR assays. 
The test can detect SARS-CoV-2, Influenza A, Influenza B, and/or Respiratory Syncytial Virus. However, it does not differentiate viable from non-viable/non-infectious microorganisms. Negative results do not exclude target nucleic acids which are present in the specimen but below the limits of detection for each virus. All results should be correlated with patient’s clinical history and symptoms.

SARS-CoV-2: This test has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.  Additional "Fact Sheets" for healthcare providers are available at: https://www.fda.gov/media/152162/download and for patients at: https://www.fda.gov/media/152166/download
In addition, optimum specimen type and timing for peak viral levels during infection caused by SARS-CoV-2 has not been determined.  The possibility of a false negative result should be considered if the patient's recent exposure or clinical presentation suggests COVID-19 and diagnostic tests for other causes of respiratory illness are not detected. 

Influenza:  Recent administration of nasal influenza vaccines (e.g. FluMist) prior to specimen collection could lead to accurate detection of the viruses contained in the vaccine but would not represent infection by those agents. 

For healthcare providers:  https://www.fda.gov/media/152162/download

For patients:  https://www.fda.gov/media/152166/download