Cytokine Release Syndrome (12-test) Panel

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Justification

Diagnosing Cytokine Release Syndrome (CRS) immediately is vital. CRS can rapidly escalate into a life-threatening condition. CRS results from an excessive immune response, often triggered by immunotherapies like chimeric antigen receptor T cell therapy (CAR-T), bone marrow transplant or infections, leading to a massive release of pro-inflammatory cytokines. The degree of elevation often correlates with the severity of the clinical syndrome. For example, large elevations in IL-6 support the diagnosis of CRS. Design note: the tests included in this panel are based on the current (2024) recommendations from 25 physician key opinion leaders (KOLs) from major academic medical centers from across the US, including: CHOP, UCSF (2), Stanford, Children's Alabama (2), Kaiser SF, Valley Children's, CHOC (3), Phoenix Children's, Cook Children's, UC Davis, Stanford Children's, University of Michigan Health, Johns Hopkins, Hershey, St. Jude, NIH, St. Louis Children's, Loma Linda Children's, UCSD, and UC Davis.

STAT: < 24 hours (M-F)

Automated ELISA

Draw Tube: Purple Top

Sample Type: EDTA Plasma

Test Summary

Specimen Requirements

	Sample Type	Volume Required	Minimum Volume	Stability
PREFERRED	EDTA Plasma	3 aliquots of 1mL each	2 aliquots of 0.5mL each	Frozen (-20C): 72 hours Frozen (-80C): 6 months
ALTERNATIVE	-	-	-	-

REJECTION CRITERIA	Thawed in transit, refrozen, clotted sample
SPECIAL INSTRUCTIONS	Process and freeze samples within one hour of collection. Transport under dry ice.

General Information

METHODOLOGY	Automated ELISA
STAT TAT	< 24 hours (M-F)
STAT TAT Performance	> 90% of results released in 24 hours
ROUTINE TAT	< 5 days (M-F)
ALTERNATIVE NAMES	Cytokine Storm Panel, Cytokine Panel, CRS
DESCRIPTION	This panel includes the quantitative measurement of the following biomarkers: CXCL9, CXCL10, IL-1 beta, IL-4, IL-6, IL-10, IL-18, IFN-gamma, sIL-2RA, TNF-alpha, Fas ligand and sC5b-9. Please inquire about the upper limit of quantification (ULOQ); both CXCL9 and IL-18 have extended ranges that can measure above 100,000pg/mL.
LIMITATIONS	-
NORMAL RANGE	Interpretation
ASSOCIATED TESTING	HLH 3.0 Genetic Panel, Somatic Inborn Errors of Immunity (IEI) Genetic Panel
REFERENCES	1. Bakos et al., Eculizumab suppresses zymosan-induced release of inflammatory cytokines IL-1α, IL-1β, IFN-γ and IL-2 in autologous serum-substituted PBMC cultures: Relevance to cytokine storm in Covid-19. Biomedicine & Pharmacotherapy (2023) 166. 2. Fajgenbaum and June, Cytokine Storm. NEJM (2020) 383:2255. 3. Li et al., Signaling pathways in the regulation of cytokine release syndrome in human diseases and intervention therapy. Signal Transduction and Targeted Therapy (2021) 6:367.
SAMPLE REPORT	Upon request
NEW YORK STATE APPROVED	NY Restricted Laboratory Permit Required

Test Codes

ORDER CODE	P1238
CPT CODE	83520x10, 83529, 86160
LOINC CODE	-