{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T10:18:29Z","timestamp":1783678709800,"version":"3.55.0"},"reference-count":28,"publisher":"MDPI AG","issue":"14","license":[{"start":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T00:00:00Z","timestamp":1783641600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background\/Objectives: CHORUS CLIA \u201cAllergy Components\u201d is a novel line of fully automated assays designed to detect specific IgE directed against allergenic molecular components. Methods: Six singleplex assays\u2014here collectively named as CHORUS CLIA \u201cAllergy Components\u201d\u2014were developed against molecular components of birch (Bet v 1, Bet v 2), timothy grass (Phl p 1, Phl p 5b, Phl p 7), and wall pellitory (Par J 2) and validated on the CHORUS EVO instrument using serum from patients with suspected IgE-mediated sensitization. Limits of detection (LoD) and quantitation (LoQ) were determined according to current guidelines. Comparative analyses of CHORUS CLIA \u201cAllergy Components\u201d with ImmunoCAP ISAC and ImmunoCAP Specific IgE were performed to assess diagnostic accuracy. Spearman\u2019s correlation, Passing\u2013Bablok regression, and Bland\u2013Altman analysis were used to evaluate correlation between methods. Results: The LoD was 0.029 kU\/L and the analytical interval, 0.10\u201350.0 kU\/L, was validated by LoQ analyses. CHORUS CLIA \u201cAllergy Components\u201d showed high sensitivity (92.0\u2013100.0%) and specificity (96.0\u2013100.0%) versus ImmunoCAP ISAC. Furthermore, diagnostic accuracy was confirmed against ImmunoCAP Specific IgE (Cohen\u2019s kappa: 0.840\u20131.000). The Spearman coefficient ranged from 0.907 to 0.970 between CHORUS CLIA \u201cAllergy Components\u201d and ImmunoCAP ISAC, and from 0.903 to 0.989 versus ImmunoCAP Specific IgE. The Passing\u2013Bablok analysis showed no differences, and the Bland\u2013Altman analysis revealed outliers only among high-positive samples, without affecting the clinical interpretation. Conclusions: The six assays of the CHORUS CLIA \u201cAllergy Components\u201d panel can detect IgE directed against major allergens from Betula verrucosa (birch), Phleum pratense (timothy grass), and Parietaria judaica (wall pellitory). These assays resulted accurate, reproducible, and specific, and showed substantial agreement with both ImmunoCAP ISAC and ImmunoCAP Specific IgE.<\/jats:p>","DOI":"10.3390\/diagnostics16142158","type":"journal-article","created":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T09:46:47Z","timestamp":1783676807000},"page":"2158","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Fully Automated Chemiluminescent Immunoassay for Component-Resolved Diagnosis of Pollen Allergy: Validation of Six CHORUS CLIA Assays"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3424-7725","authenticated-orcid":false,"given":"Helena","family":"Cerutti","sequence":"first","affiliation":[{"name":"DIESSE Diagnostica Senese S.p.A Societ\u00e0 Benefit, 53035 Monteriggioni, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simone","family":"Bianciardi","sequence":"additional","affiliation":[{"name":"DIESSE Diagnostica Senese S.p.A Societ\u00e0 Benefit, 53035 Monteriggioni, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulia","family":"Barberini","sequence":"additional","affiliation":[{"name":"DIESSE Diagnostica Senese S.p.A Societ\u00e0 Benefit, 53035 Monteriggioni, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Soldatini","sequence":"additional","affiliation":[{"name":"DIESSE Diagnostica Senese S.p.A Societ\u00e0 Benefit, 53035 Monteriggioni, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1818-6275","authenticated-orcid":false,"given":"Alessandra","family":"Cartocci","sequence":"additional","affiliation":[{"name":"Department of Molecular and Developmental Medicine, University of Siena, 53100 Siena, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9356-3325","authenticated-orcid":false,"given":"Tommaso","family":"Bandini","sequence":"additional","affiliation":[{"name":"DIESSE Diagnostica Senese S.p.A Societ\u00e0 Benefit, 53035 Monteriggioni, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulia","family":"Tesi","sequence":"additional","affiliation":[{"name":"DIESSE Diagnostica Senese S.p.A Societ\u00e0 Benefit, 53035 Monteriggioni, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Brogi","sequence":"additional","affiliation":[{"name":"DIESSE Diagnostica Senese S.p.A Societ\u00e0 Benefit, 53035 Monteriggioni, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,7,10]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Torres-Borrego, J., and S\u00e1nchez-Sol\u00eds, M. 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