Blood immune analysis for precision diagnosis of medication allergy

Allergic responses to medication can be life-threatening and require future
avoidance. As this can involve important, common drugs, such as antibiotics,
Nonsteroidal anti-inflammatory drugs (NSAIDs), and contrast material for
radiology images, this posed an increasing challenge in health care.
Importantly, less than 10% of reported adverse events constitute a true
allergic response, and the majority of patients with a presumed allergy
unnecessarily avoid medications. This is due to a lack of precision diagnostics
for drug allergy sensitization that does not require a challenge test.

The primary objective of this study is to determine if medication allergy
sensitization can be accurately determined through a laboratory test with a
patients* blood sample. The secondary objective is to develop a laboratory
assay that can be applied to perform differential diagnosis, e.g. to
investigate cross-allergy between multiple beta-lactam antibiotics to inform
whether the patients can tolerate one class or has to avoid all.

This is an observations study into which adults are recruited with a proven
allergic response to medication, such as antibiotics, contrast reagents,
anesthetics, NSAIDs, lidocaine, biologicals and peri-operative drugs. All
recruits will be asked to donate 50mL of venous blood for laboratory analysis.
In addition, they will be asked to share basic demographics (age, sex, medical
history); details of allergic responses and current medication use will be
obtained from their medical records.

There is no perceived risk to the participants, investigators or institution.
Participants are having an additional 50 mL of blood sample taken along with
routine care. All blood sampling will follow Good Clinical Practice.
This research will not provide a direct therapeutic benefit to the participant,
as they will continue to receive standard treatment of care. However, we hope
it will contribute to improving treatment and monitoring of allergy in the
future.
This research will aid in identifying potential biomarkers of allergy and its
treatment. This will have positive impacts in the field of Allergy by
potentially improving patient diagnosis and treatment.