Uses nucleic acid-amplification technology (e.g., PCR), which detects the genetic information and indicates active infection with the virus which causes COVID-19.

A negative test result for this test means that SARS-CoV-2 RNA was not detected in the specimen. However, a negative result does not completely rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions.  When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of any recent exposure and clinical signs or symptoms that may suggest COVID-19.  The possibility of a false negative result should especially be considered if COVID-19 is clinically likely and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative.  If COVID-19 is still suspected, re-testing should be considered by healthcare providers in consultation with public health authorities.

A positive test result indicates that SARS-CoV-2 RNA was detected, and the patient is presumably infected with the virus and presumably contagious.  Laboratory test results should be considered in the clinical and community context to establish a final diagnosis and care plan.  Positive results do not rule out simultaneous bacterial infection or co-infection with other viruses.  Patient management decisions should be made by a healthcare provider and should follow the current CDC guidelines.  The COVID-19 test has been designed to minimize the likelihood of false-positive test results, but it may not be possible to completely exclude a false positive.