Allergy diagnostic performance of FastCheckPOC 20 Atopy

The increasing prevalence of allergic diseases, along with their diagnosis and treatment, presents 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 study aimed to investigate the accuracy of FastCheckPOC 20 Atopy (FCP20) in comparison with the multiplex assay Allergy Explorer 2 (ALEX²) system.

In this cross-sectional study, 215 participants were recruited from South Tyrol, Italy. Serum samples were analyzed using both FCP20 and ALEX². Dichotomous data were used to calculate sensitivity and specificity in comparison with the ALEX².

The overall sensitivity of the FCP20 was 43.3% (95% CI: 40.3%-46.2%), and the specificity was 92.1% (95% CI: 91.1%-93.0%). Inhalation allergens showed a higher sensitivity than food allergens; the grass pollen (gx17) exhibited the highest sensitivity at 79.8% (95% CI: 72.6%-85.7%). Among patients with severe allergic symptoms, bronchial asthma, or eczema, sensitivity increased to over 83%.

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.