Objective To evaluate the performance of common inhalant allergen specific IgE antibodies (sIgE) measurement using capture enzyme-linked immunosorbent assay (ELISA), Fooke™ system. Methods The performance of Fooke™ system was evaluated according to the CLSI EP documents. Specific IgE to 6 common inhalant allergens, Dermatophagoides pteronyssinus (d1), Dermatophagoides farina (d2), cat epithelium and dander (e1), dog epithelium and dander (e5), Alternaria Alternata (m6) and mugwort pollen (w6), were measured by Fooke™ system. The precision, sensitivity, and linearity range were assessed. The results were compared with ImmunoCAP® system, collecting the compared samples from clinical patient serum from 25 May 2016 to 30 June 2016. Results The within run CVs of the 6 allergens were 3.60%-6.53%, and total CVs were 3.57%-7.46%, lower than the stated. Limit of quantitative determination was <0.35 KU/L, lower than the sensitivity stated. The linearity range of d1 and m6 was 0.37-94.30 KU/L (R2=0.999, P<0.001) and 0.35-89.80 KU/L (R2=0.998, P<0.001), which demonstrated a sound linear correlation.In the method comparison tests, the quantitative results between Fooke™ and ImmunoCAP® system had obvious linear correlation, R2 of d1, d2, e1, e5, m6 and w6 was 0.356, 0.473, 0.847, 0.478, 0.254 and 0.355, respectively, P<0.001. The negative, positive and overall agreement ratio of qualitative results was 99.2% (944/952), 82.1% (528/643) and 92.3% (1 472/1 595), with high level of agreement (Kappa=0.835, P<0.001). The ranked agreement ratio was 91.5% (1 459/1 595). Conclusions Fooke™ system (Capture ELISA) is domestically produced, automated and quantitative allergen sIgE detecting system, which showed high precision and sensitivity, and sound correlation with ImmunoCAP® system, meeting the testing requirement. Fooke™ system has practical value, which is a new option for clinical application.(Chin J Lab Med, 2016, 39: 824-828) Key words: Allergens; Immunoglobulin E; Enzyme-linked immunosorbent assay; Immunoenzyme techniques
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