ORIGINAL RESEARCH article
Front. Allergy
Sec. Allergy Diagnosis
Volume 6 - 2025 | doi: 10.3389/falgy.2025.1669268
This article is part of the Research TopicNovel and Promising Laboratory Biomarkers for Allergic Disease Diagnosis and Prognosis: Clinical ApplicabilityView all 7 articles
Allergy Diagnostic Performance of FastCheckPOC 20 Atopy
Provisionally accepted
Hannes Nösslinger1,2*
Ewald Mair2
Gertie Janneke Oostingh3
Verena Ahlgrimm-Sieds4
Anna Ringauf5Roland Lang4- 1Ospedale di Merano, Merano, Italy
- 2Azienda Sanitaria dell'Alto Adige, Bolzano, Italy
- 3Fachhochschule Salzburg GmbH, Salzburg, Austria
- 4Landeskrankenhaus Salzburg - Universitatsklinikum der Paracelsus Medizinischen Privatuniversitat, Salzburg, Austria
- 5MacroArray Diagnostics GmbH, Vienna, Austria
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Background: The increasing prevalence of allergic diseases, their diagnosis and treatment are a growing challenge in health care. To reduce this burden, a highly sensitive and specific point-of-care test for detecting sensitization could be implemented in a primary health care setting. The aim of the study was to investigate the accuracy of FastCheckPOC 20 Atopy (FCP20) in comparison to the multiplex assay Allergy Explorer 2 (ALEX2) system. Methods: For this cross-sectional study, 215 participants were recruited from South Tyrol (Italy). Serum samples were used for the analysis by both FCP20 and ALEX2. Dichotomous data were used to calculate sensitivity and specificity in comparison to the ALEX2. Results: The overall sensitivity of the FCP20 was 43.3% (95% CI 40.3% to 46.2%), the specificity was 92.1% (95% CI 91.1% to 93.0%). Inhalation allergens showed a higher sensitivity than food allergens, the grass pollen (gx17) had the highest sensitivity at 79.8% (95% CI 72.6% to 85.7%) and in patients with severe allergic symptoms, bronchial asthma or eczema, sensitivity increased to over 83%. Conclusions: Due to its low overall sensitivity, the FCP20 cannot be recommended as a screening instrument for allergies, except for grass pollen. However, it is well suited to ruling out sensitization in patients. FCP20 demonstrates high specificity and may be considered for the exclusion of sensitization to selected allergens, but its low sensitivity limits its utility as a general screening tool.
Keywords: Allergy and Immunology, Atopy, IgE, Lateral flow test, Molecular diagnostics, point-of-care-test, Primary Care
Received: 19 Jul 2025; Accepted: 29 Sep 2025.
Copyright: © 2025 Nösslinger, Mair, Oostingh, Ahlgrimm-Sieds, Ringauf and Lang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Hannes Nösslinger, hannes@med-noesslinger.com
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