Clinical chemistry-specific protein IVDs

Intended purpose

The Allergy Explorer² (ALEX²) test system is a quantitative in vitro diagnostic test for the measurement of allergen specific IgE (sIgE) and a semi-quantitative in vitro diagnostic test for the measurement of total IgE (tIgE) in human serum or plasma (exception EDTA-plasma). It is to be used by clinical chemistry laboratories, trained laboratory personnel and medical professionals for the purpose of supporting the clinical diagnosis of IgE mediated diseases, in conjunction with other clinical findings or diagnostic test results.