Method Profile
Two human 2H4 reporter-cell assays combine activation-related IL-2 signaling with information about antimitotic effects.
Contribute in vitro evidence about potential immunosuppression in drug and chemical safety evaluation, alongside other tests.
The same Jurkat-derived 2H4 human T-cell reporter line is used in IL-2 Luc and IL-2 Luc LTT.
Interpret the two assay results separately, then classify the combination as positive if either assay indicates immunosuppression.
Human cell system
2H4 reporter cells derived from the Jurkat T-cell line.
Measured functions
IL-2 activation-related luciferase signal and an assay reflecting antimitotic/cell-proliferation effects.
Reference substances
Extended guideline evaluation of 83 substances, including 46 pharmaceutical drugs and 37 other chemicals.
Keep reproducibility and reference-classification performance separate. The reported combined performance is not a drug-only or clinical-risk estimate.
protocol_reported_benchmark
OECD guideline synthesis of validation and extended reference-classification data.
Lead and three independent laboratories; 83 substances in the extended set, with combined classification analyses of 79 and 76 substances under different domain conditions.
Reference immunosuppression categories and within-/between-laboratory repeat classifications.
Combined sensitivity 88.7% (47/53) and specificity 53.8% (14/26) for 79 substances; after domain considerations, 90.0% (45/50) and 53.8% (14/26) for 76 substances.
OECD's IL-2 Luc and IL-2 Luc LTT assays examine T-cell activation-related signaling and antimitotic effects in the same human reporter cell line. The guideline's evaluation includes medicines, but its overall performance figures combine drugs and other chemicals.
