A negative test result for this test means that novel antibodies specific to SARS-CoV-2 was not present in the specimen. A negative result may be caused by low concentrations of the IgM or IgG antibody in the sample and therefore cannot completely rule out the possibility of COVID-19. Therefore, negative results 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 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 by healthcare providers in consultation with public health authorities.
Risks to a patient of a false negative include: delayed or lack of supportive treatment, lack of monitoring 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.