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Application of Biochip Microfluidic Technology to Detect Serum Allergen-specific Immunoglobulin E sIgE
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Allergy diagnostic performance of FastCheckPOC 20 Atopy.

Hannes Nösslinger1, Ewald Mair2, Gertie J Oostingh3

  • 1Department of Nutrition and Dietetics, Hospital of Merano (SABES-ASDAA), Teaching Hospital of Paracelsus Medical University, Merano-Meran, Italy.

Frontiers in Allergy
|November 10, 2025
PubMed
Summary

The FastCheckPOC 20 Atopy (FCP20) test shows high specificity for allergy diagnosis, making it useful for ruling out sensitization. However, its low sensitivity means it is not ideal as a general screening tool for allergic diseases.

Keywords:
IgEallergy and immunologyatopylateral flow testmolecular diagnosticspoint-of-care testprimary care

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Area of Science:

  • Allergy diagnostics
  • Point-of-care testing
  • Immunology

Background:

  • Allergic diseases are increasing, posing a healthcare challenge.
  • Accurate point-of-care tests are needed for primary care settings.
  • This study evaluates a new test against a established method.

Purpose of the Study:

  • To assess the diagnostic accuracy of the FastCheckPOC 20 Atopy (FCP20) test.
  • To compare FCP20 performance against the Allergy Explorer 2 (ALEX2) multiplex assay.
  • To determine the utility of FCP20 in primary healthcare for allergy screening.

Main Methods:

  • A cross-sectional study involving 215 participants from South Tyrol, Italy.
  • Serum samples analyzed using both FCP20 and ALEX2 assays.
  • Sensitivity and specificity calculated using dichotomous data compared to ALEX2.

Main Results:

  • Overall FCP20 sensitivity was 43.3% (95% CI: 40.3%-46.2%) and specificity was 92.1% (95% CI: 91.1%-93.0%).
  • Inhalation allergens showed higher sensitivity than food allergens; grass pollen (gx17) had 79.8% sensitivity.
  • Sensitivity exceeded 83% in patients with severe allergic symptoms, asthma, or eczema.

Conclusions:

  • FCP20 exhibits high specificity, useful for excluding specific allergen sensitization.
  • The low sensitivity of FCP20 restricts its use as a broad screening tool.
  • Further evaluation needed for FCP20's role in specific clinical scenarios.