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<p>Nasal allergen challenge (NAC) confirms clinically relevant allergy but has been under-used in India, and EAACI criteria have not been locally validated for Dermatophagoides farinae. To evaluate the diagnostic performance of EAACI-based NAC with D. farinae in differentiating true clinical allergy from asymptomatic sensitization, and to identify local allergic rhinitis (LAR). Prospective single-centre cohort (n = 100) stratified by skin prick testing (SPT): Group A: SPT + (n = 50) and Group B: SPT − (n = 50). TNSS, PNIF and acoustic rhinometry (TNV, MCA) were measured at baseline and post-NAC. Intra and intergroup changes were tested with paired/independent non-parametric statistics. ROC analyses (pooled A + B) estimated AUC, 95% CIs, Youden’s cut-offs, and sensitivity/specificity. Exploratory logistic models combined TNSS with single objective measures. Group A showed pronounced post-NAC responses in all parameters (all <i>p</i> &lt; 0.0001), whereas Group B changes were minimal; a small PNIF decline in B was not clinically relevant. NAC was positive in 44/50 (88%) SPT+ and 4/50 (8%) SPT– patients, the latter consistent with LAR. ROC (single parameters) demonstrated excellent accuracy: TNSS AUC 0.932 (cut-off ≥ 3; sensitivity 87.5%, specificity 96.2%), TNV % reduction AUC 0.972 (cut-off ≥ 15.65%), MCA % reduction AUC 0.984 (cut-off ≥ 28.12%), and PNIF % reduction AUC 0.801 (cut-off ≥ 18.18%). Combined models further improved discrimination: TNSS + MCA AUC 1.000, TNSS + TNV 0.994, TNSS + PNIF 0.949. Among SPT + NAC + patients, 38.6%, 18.2% and 43.2% reacted at 1:100, 1:50 and 1:10, respectively; all SPT − NAC+ cases reacted at 1:10. No systemic adverse events occurred. EAACI based NAC with D. farinae reliably distinguishes clinical allergy from asymptomatic sensitization in Indian subjects and identifies LAR. While optimal cut-offs in this cohort were lower than guideline thresholds, overall accuracy was high, and combined subjective-objective models provided near-perfect discrimination. Findings support integrating NAC into routine diagnostics and warrant multicentre validation across allergens and regions.</p>

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Real-World Validation of Nasal Allergen Challenge to Differentiate Clinically Relevant Dermatophagoides farinae Allergy from Asymptomatic Sensitization: An Indian Clinical Cohort Study

  • 期刊论文

  • 发表日期：

    2025年12月12日

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  • Rohil Kunnathummal,
  • Nagendra Prasad Komarla,
  • Paranjothy Kanni,
  • Sujatha Ramesh,
  • Anita Leishangthem

摘要

Nasal allergen challenge (NAC) confirms clinically relevant allergy but has been under-used in India, and EAACI criteria have not been locally validated for Dermatophagoides farinae. To evaluate the diagnostic performance of EAACI-based NAC with D. farinae in differentiating true clinical allergy from asymptomatic sensitization, and to identify local allergic rhinitis (LAR). Prospective single-centre cohort (n = 100) stratified by skin prick testing (SPT): Group A: SPT + (n = 50) and Group B: SPT − (n = 50). TNSS, PNIF and acoustic rhinometry (TNV, MCA) were measured at baseline and post-NAC. Intra and intergroup changes were tested with paired/independent non-parametric statistics. ROC analyses (pooled A + B) estimated AUC, 95% CIs, Youden’s cut-offs, and sensitivity/specificity. Exploratory logistic models combined TNSS with single objective measures. Group A showed pronounced post-NAC responses in all parameters (all p < 0.0001), whereas Group B changes were minimal; a small PNIF decline in B was not clinically relevant. NAC was positive in 44/50 (88%) SPT+ and 4/50 (8%) SPT– patients, the latter consistent with LAR. ROC (single parameters) demonstrated excellent accuracy: TNSS AUC 0.932 (cut-off ≥ 3; sensitivity 87.5%, specificity 96.2%), TNV % reduction AUC 0.972 (cut-off ≥ 15.65%), MCA % reduction AUC 0.984 (cut-off ≥ 28.12%), and PNIF % reduction AUC 0.801 (cut-off ≥ 18.18%). Combined models further improved discrimination: TNSS + MCA AUC 1.000, TNSS + TNV 0.994, TNSS + PNIF 0.949. Among SPT + NAC + patients, 38.6%, 18.2% and 43.2% reacted at 1:100, 1:50 and 1:10, respectively; all SPT − NAC+ cases reacted at 1:10. No systemic adverse events occurred. EAACI based NAC with D. farinae reliably distinguishes clinical allergy from asymptomatic sensitization in Indian subjects and identifies LAR. While optimal cut-offs in this cohort were lower than guideline thresholds, overall accuracy was high, and combined subjective-objective models provided near-perfect discrimination. Findings support integrating NAC into routine diagnostics and warrant multicentre validation across allergens and regions.