Background:
The Department of Pathology & Laboratory Medicine will offer the Beckman Access Interleukin 6 (IL6). This assay has been authorized by the FDA under Emergency Use Authorization (EUA) to assist in identifying severe inflammatory response in patients with confirmed COVID-19 illness, to aid in determining risk of intubation with mechanical ventilation when used in conjunction with clinical findings and the results of other laboratory parameters. 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 95th percentile reference interval stated by the manufacturer is <6 pg/mL. This interval was verified in-house in 58 apparently healthy donors.
IL-6 values differ between assays due to selection of traceability and differences in the antibodies used in different assays. This assay has not been FDA cleared or approved. This test has been authorized by FDA under EUA for use by authorized laboratories. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use.
Effective date: Nov. 4, 2020
Specimen requirement and testing information:
Specimen: Collect 4.0 mL blood in a light green (lithium heparin), or gold, or red top tube. Spin down and separate plasma or serum from cells as soon as possible, and within 2 hours of sample collection.
Test methodology: Two-site immunoassay
Test code: IL6
Stability:
Plasma, or serum, after separation from cells:
Ambient: NA
Refrigerated: 48 hours
Frozen: 1 month; Thaw only once.
Turnaround time (TAT):
STAT: NA
Routine: 2-4 hours
Set Up Days: Daily
Specimen required: 2.0 mL plasma
Minimum volume: 0.5 mL plasma
Rejection criteria:
Specimens that exceed stated stability, unlabeled/mislabeled/mismatched specimens, specimens submitted in leaking containers, hemolyzed or lipemic specimens
References:
- Beckman Coulter. Access Interleukin-6 Instructions For Use. Accessed October 2020. https://www.beckmancoulter.com/download/file/phxA83733J-EN_US/A83733J?type=pdf
A summary of all tests offered by our laboratory services can be found here: http://www.pathology.uci.edu/services/index.asp
Sincerely,
Bridgit O. Crews, PhD, DABCC
Director
Clinical Chemistry & Toxicology
Edwin S. Monuki, MD, PhD
Chair
Department of Pathology & Laboratory Medicine |
