RALI-Dx™ IL-6 Severity Triage Test is an in vitro diagnostic test for the quantitative measurement of IL-6 (Interleukin 6) in human plasma (potassium EDTA). RALI-Dx™ IL-6 Severity Triage Test is a fluorescent immunoassay and is intended for use on the sqidlite® instrument.
Acute Respiratory Distress
RALI-Dx™ IL-6 Severity Triage Test is used to assist in identifying severe inflammatory response in patients (age ≥18 years) with confirmed COVID-19 illness by a healthcare provider and to aid in determining the risk of intubation with mechanical ventilation. 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.
The RALI-Dx™ IL-6 Severity Triage Test is only for use under Health Canada’s Interim Order, for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, for use by health care providers, for prescription use only, and for in vitro diagnostic use only.
*Not cleared by FDA or licensed by Health Canada.
TRIAGE RESPIRATORY DISTRESS
Under development for point of care (POC). Not cleared by FDA or licensed by Health Canada.
RALI-fast (15-Minute POC Test)