Reagent Kit Advia Centaur® Immunoassay IL-6 For ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP Systems 100 Tests 50 µL Sample Volume

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests

This test has been authorized only for the quantitative measurement of IL-6

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for measurement of IL-6 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner

The ADVIA Centaur® Interleukin-6 (IL6) assay is for in vitro diagnostic use in the quantitative measurement of interleukin-6 (IL-6) in human serum or plasma (potassium EDTA and lithium heparin) using the ADVIA Centaur® XP, ADVIA Centaur XPT, and ADVIA Centaur CP systems

This assay is used to assist in identifying severe inflammatory response in patients with confirmed COVID-19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing

For use by health care providers

For prescription use only

For in vitro diagnostic use only

Normal IL-6 results do not preclude development of a severe inflammatory response, and IL-6 should not be used as the sole basis for patient management decisions

Results must be combined with clinical observations, patient history, other laboratory parameters, and epidemiological information

Kit contents: ReadyPack primary reagent, 1 vial of lyophilized low calibrator, 1 vial of lyophilized high calibrator, IL6 Master Curve card, IL6 Calibrator Assigned Value card