The sensitivity of our Home Allergy test is qualified by a ‘limit of detection,’ which means the lowest levels of allergens that the test needs to measure and detect allergens. This has been determined in accordance with CLSI guideline EP17-A (Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures Approved Guidelines) for representative allergen components and is below 0.3 kU/L for all allergen components and all allergen extracts.
This means to the range all the way down to 0.3 kU/L, the method will be able to detect a positive sample. For negative results below 0.3 kU/L, sensitisation is unlikely but cannot be ruled out for some allergens.
Furthermore, from examination of analytical specificity, there is no detectable cross-reactivity with other human Immunoglobulins (IgA, IgG1, IgG2, IgG3, IgG4 and IgM) at normal physiological concentrations. So other antibodies are not interfering with the test result.