Description

This test can aid in the detection of the virus that causes COVID-19 using a technique known as polymerase chain reaction (PCR). This test requires an upper respiratory nasal swab which is then tested using PCR looking for COVID-19 causative viral material, specifically the SARS-CoV-2 coronavirus.

A positive COVID-19 PCR Viral test result indicates that RNA from SARS-CoV-2 was detected, and the patient is infected with the virus and presumed to be contagious. Patient management should follow current CDC guidelines. The cobas® SARS-CoV-2 test has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects.

A negative COVID-19 PCR Viral test result indicates that RNA from SARS-CoV-2 was not detected above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions. A negative result does not exclude the possibility of COVID-19. When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. The possibility of a false negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that COVID- 19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative. If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing should be considered in consultation with public health authorities. Risks to a patient of a false negative include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events.