D3.85 - Evaluation of a new Multiplex Allergen Test Kit for the simultaneous detection of allergen specific IgE

The Identification of a specific allergen is essential for an accurate diagnosis and the determination of appropriate treatment options of allergic diseases. The diagnosis is made using an in vivo or in vitro test based on the patient's history and symptoms. The intradermal skin test (IDST) is primarily used for in vivo testing. For in vitro tests, methods like ImmunoCAP and the multiple allergen simultaneous test (MAST) are utilized. MAST has the advantage of detecting IgE for numerous allergens in a single test using a small serum sample. Component-resolved diagnostics (CRD) have recently enhanced the interpretation of IgE diagnostic results and are also useful in identifying cross-reactivity with other allergens.

We have developed a novel multi-allergy diagnostic product, PROTIA Allergy-Q 192D, which consists of 192 lines. This product measures specific IgE concentrations to various allergens in the blood using line blot immunoassay. Of the 192 lines on the test plate, 8 lines are standard lines that determine the positions of other lines, and 2 lines are used for calibration. One line calculates the total IgE concentration, and 175 lines test the specific IgE concentration for each allergen. The composition of allergens consists of 117 crude extract allergens, 48 component allergens, and 10 drug-related (β-lactam antibiotics) and occupational (chemical) allergens.

PROTIA Allergy-Q 192D enables comprehensive screening of various allergenic substances, including food, pollen, microorganisms, insects, dust mites, pet allergens, antibiotics, occupational chemicals, and their components for more precise investigation.

The objective of this study was to evaluate the properties of the newly developed PROTIA Allergy-Q 192D (PROTIA Inc.) in comparison with ImmunoCAP(Thermo Fisher).

To evaluate the performance of the PROTIA Allergy-Q 192D, we compared it with ImmunoCAP and the previous model, PROTIA Allergy-Q 128M(PROTIA Inc.) using 408 sera. The test results were analyzed using Cohen's kappa coefficient analysis and total agreement analysis for specific IgE, while total IgE was analyzed through regression analysis and difference analysis.

Total IgE was analyzed using difference analysis and regression analysis based on the total IgE measurement results of ImmunoCAP, confirming a difference within ±20% and an R² value of 0.9929 for the regression analysis. Based on the analysis of 10,104 diagnostic results for specific IgE using 408 samples, we found a total agreement rate of 93.5%, a kappa value of 0.87(indicating almost perfect agreement).

Our results suggest that the PROTIA Allergy-Q 192D demonstrated a strong correlation with the comparison products. It requires a relatively small sample volume considering the number of test allergens, allows simultaneous testing of suspected allergens, and enables comprehensive screening for allergens with potential risks.