COVID-19 Severe Disease Progression Risk Profile

For Interleukin-6, Serum [140916]: This test has not been FDA cleared or approved. This test has been authorized by FDA under and EUA for use by authorized laboratories. This test has been authorized only to assist in identifying severe inflammatory response, when used as an aid in determining the risk of intubation with mechanical ventilation in confirmed COVID-19 patients. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices under Section 564(b)(1) of the Act, 21 U.S.C. & 360bbb-3(b), unless the authorization is terminated or revoked sooner.

Further limitations include:

• For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings.

• Individual IL-6 levels need to be considered in combination with other clinical findings to mitigate the possible risks of false positive or false negative IL-6 results.

• In the event of a false positive result, risk to patients could include additional unnecessary intensive care admission, intubation with mechanical ventilation, and other unnecessary supportive therapy.

• Low IL-6 levels indicate that it is less likely that the patient suffers from a cytokine release syndrome and the risk for respiratory support is reduced. However, low levels if IL-6 do not preclude disease progression and future development of severe inflammatory response.

• A false negative result may occur if the test reports lower values than actual levels of IL-6 that are in the sample. When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient's clinical presentation and the presence of clinical signs and symptoms consistent with severe inflammatory response.

• Risk to a patient of a false negative result include: delayed or lack of supportive respiratory treatment, or other unintended adverse events.

• In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidinor ruthenium can occur. These effects are minimized by suitable test design.