Beta-lactams (BLCs) are the most frequently prescribed antibiotics worldwide. As consequence of their intake, hypersensitivity reactions can happen. Current figures show over 2.5 million (0.5%) people in Europe and more than 5.4 million (1.8%) north-Americans suffer from hypersensitivity to BLCs. These figures are increasing due to the misuse and consumption of these antibiotics. Moreover, allergy to BLCs is the most frequent cause (47%) of drug anaphylaxis, becoming an important public health problem with estimated additional hospitalization costs of 1750-4500 €/patient.
The correct diagnosis of BLCs allergic patients as well as the proper identification of patients who erroneously carry a label of BLCs allergy, leads to the improvement in the use of antibiotics, contributing to reduce the spread of multiple drug-resistant bacteria.
The diagnosis of drug hypersensitivity is difficult and underdiagnosed, there is a lack of standardization of the in vivo and in vitro test procedures to detect drug hypersensitivity reactions.
The most common methods for drug hypersensitivity allergic diagnosis are: clinical history, invasive skin test, in-vivo basophil test, in-vitro tests (quantification of IgEs), and drug provocation test (DPT). Among these methods, in-vitro test would be the preferred option as they are not invasive, but only a few in vitro diagnostic (IVD) methods are available in the market for the tertiary health services. These tests lack of sensitivity and selectivity (resulting in an inaccurate diagnosis), analyse few drugs allergens, are time consuming, and expensive.
COBIOPHAD project results provide an innovative IVD device for IgE-mediated drug allergies, we can highlight the following achievements:
• Different electronic and photonic modules, integrated in an optical reader for performing the assay and providing the readout of the results.
• Reagents and protein- determinant conjugates developed for nine BLCs.
• Detection platform: a microfluidic disc where to develop simultaneously six immunoassays able to determine up to nine different specific IgEs.
The results achieved in serum samples show high analytical sensitivity (<0.1 kUA/L), good clinical performances (sensitivity and selectivity 55% and 85%, respectively) and multiplexing capabilities (9 BLCs). This assay is developed in a fluidic disc capable to process simultaneously 6 different samples. On each sample the nine BLCs targeted are addressed and quantitative data about the content of specific IgE can be obtained. The assay time takes 60 minutes. The software processes the analytical results in 15 minutes storing them in the cloud and providing the report for supporting the diagnostics.
The cost of the disc reader and the consumables are very competitive, considering the components existing in the market.
