To evaluate the lymphocyte transformation test (LTT) in supporting the Spanish Pharmacovigilance System (SPS) causality algorithm for identifying culprit drugs in pediatric ADRs, emphasizing the critical need for reliable in vitro methods, and to estimate the diagnostic accuracy of various diagnostic tools.
Key Findings:
LTT demonstrated 100% sensitivity (95% CI: 51.0-100%) and 100% negative predictive value (NPV) (95% CI: 89.3-100%) with 78% specificity (95% CI: 12.6-57.6%).
Significant associations between LTT positivity and SPS scores ≥4 (p<0.001) and between LTT and DPT outcomes (p=0.008).
Common ADRs included cutaneous and hepatic reactions, with amoxicillin and paracetamol being frequent culprit drugs.
Interpretation:
LTT is a valuable, non-invasive tool for evaluating T-cell–mediated reactions in children, particularly when DPT is risky or contraindicated, highlighting its potential role in clinical practice.
Limitations:
Retrospective design may introduce bias affecting results.
Limited sample size may affect generalizability.
LTT remains largely restricted to research contexts due to inconsistent sensitivity.
Conclusion:
LTT correlates significantly with high causality scores and DPT outcomes, supporting its use in diagnosing drug hypersensitivity in pediatric patients and emphasizing its importance in clinical practice.
by Olga Rogozina, Susana Martín-López, Fiorela Cinthia Dueñas López, Zoraida del Solar Moreno, Larry Leiva Castrejon, Daniela Aguilar-Concepción, María Jiménez-González, Ana Martínez Feito, Miguel González-Muñoz, Elena Ramírez
