This test has not been FDA cleared or approved. This test has
been authorized by FDA under an 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)(1),
unless the authorization is terminated or
revoked sooner.
Interpretation
Based on the available clinical data,
PCR confirmed COVID 19 patients
with IL 6 concentrations > 35 pg/mL at presentation are at risk
for mechanical ventilation during their
hospitalization. IL 6 values should be used in
conjunction with clinical findings and the results of other
laboratory parameters. IL 6 values alone are not
indicative of the need for endotracheal intubation or
mechanical ventilation.