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Summary: Background: The identification of the primary sensitizing pollen is difficult in Southern European patients with Seasonal Allergic Rhinitis (SAR) if sensitized to various pollen sources with overlapping seasonality. A more precise diagnosis is obtained by IgE assays to allergen molecules, currently available as singleplex or microarrays. Objectives: To test the analytical performance of a multi‐parameter immunoblot molecular "Pollen Test" specifically designed to test IgE antibodies to pollen extracts and molecules clinically relevant in Southern Europe. Methods: Sera were obtained from 101 children and 98 adults with SAR and tested with a customized multiplex immunoblot assay (EUROLINE Southern European Pollen Profile [ESEP]; EUROIMMUN AG, Luebeck, Germany) containing a comprehensive panel of allergen extracts and molecules. ESEP's outcomes were then compared in selected sera (ESEP positive to negative = 2:1) with those of singleplex IgE assays (ImmunoCAP; ThermoFisher Scientific, Uppsala, Sweden). For each of the examined reagents, qualitative (sensitivity, specificity, accuracy), semi‐quantitative (classes) and quantitative (Spearman's rank correlation, Bland‐Altmann plots) comparisons were performed. Results: Compared to ImmunoCAP, cumulative ESEP's sensitivity and specificity were 87% (95% CI 84%‐90%) and 88% (83%‐93%) for extracts and 99% (98%‐100%) and 87% (83%‐91%) for molecules. Cohen's kappa coefficients (κC) ranged for extracts from 0.18 (Pellitory) to 0.50 (Cypress) and for molecules from 0.21 (Ole e 1) to 0.68 (Phl p 7). The quantitative outcomes of the two diagnostic tests were highly correlated, with Spearman's rank correlation coefficients always exceeding 0.80. Bland‐Altmann plots showed a tendency of ESEP to overestimate serum specific IgE levels, when compared to ImmunoCAP. Conclusions and clinical relevance: Sensitivity and specificity of ESEP in testing serum IgE antibodies against pollen allergen extracts and molecules, in Italian patients with SAR, both exceeded 85%. The advantages and limitations of a multiplex customized immunoblot assay, in the routine clinical use of molecular diagnostics in Southern European pollen allergic patients, deserve to be tested. [ABSTRACT FROM AUTHOR]

Background: Patient‐generated symptom and medication scores are essential for diagnostic and therapeutic decisions in seasonal allergic rhinitis (SAR). Previous studies have shown solid consistencies between different scores at population level in real‐life data and trials. For clinicians, the evaluation of individual data quality over time is essential to decide whether to rely on these data in clinical decision‐making. Objective: To analyze the consistency of different symptom (SS) and symptom medication scores (SMSs) at individual level in two study cohorts with different characteristics and explore individual patient trajectories over time. Methods: Within the pilot phase of the @IT.2020 project on diagnostic synergy of mobile health and molecular IgE assessment in patients with SAR, we analyzed data of 101 children and 93 adults with SAR and instructed them to record their symptoms and medication intake daily via the mobile app AllergyMonitor®. We then assessed the correlation between different SMS and a visual analogue scale (VAS) on the impact of allergy symptoms on daily life at population and individual level. Results: At population level, the Rhinoconjunctivitis total symptom score (RTSS) correlated better with VAS than the combined symptom and medication score (CSMS). At individual level, consistency among RTSS and VAS was highly heterogeneous and unrelated to disease severity or adherence to recording. Similar heterogeneity was observed for CSMS and VAS. Conclusions: The correlation of clinical information provided by different disease severity scores based on data collected via electronic diaries (e‐diaries), is sufficient at population level, but broadly heterogeneous for individual patients. Consistency of the recorded data must be examined for each patient before remotely collected information is used for clinical decision making. [ABSTRACT FROM AUTHOR]

Background: There is growing interest both in testing IgE in nasal secretions (NS) and in molecular diagnosis of seasonal allergic rhinitis (SAR). Yet, the reliability of nasal IgE detection with the newest molecular assays has never been assessed in a large cohort of pollen allergic patients. Objective: To investigate with microarray technology and compare the repertoires of specific IgE (sIgE) antibodies in NS and sera of a large population of children and adults with SAR. Methods: Nasal secretions were collected with an absorbent device (Merocel 2000®, Medtronic) and a minimal dilution procedure from 90 children and 71 adults with SAR. Total IgE (tIgE) (ImmunoCAP, Thermo Fisher Scientific (TFS)) and sIgE antibodies against 112 allergen molecules (ISAC‐112, TFS) were measured in NS and serum. Results: Nasal sIgE was detectable in 68.3% of the patients. The detected nasal sIgE antibodies recognized airborne (88%), vegetable (10%), and animal food or other (<1%) allergen molecules. The prevalence and average levels of sIgE in NS and serum were highly interrelated at population level. A positive nasal sIgE antibody to a given molecule predicted the detection of the same antibody in the patient's serum with a specificity of 99.7% and a sensitivity of 40%. Conclusions: The concentration of sIgE is much lower in nasal secretions than in the serum. sIgE assays with very high analytical sensitivity and sampling methods with minimal dilution will be therefore needed to validate nasal secretions as alternative to serum in testing the sIgE repertoire. [ABSTRACT FROM AUTHOR]