Developing novel test for allergy diagnostics: using today’s biochemical techniques

Abstract Background The key to moving beyond “bucket chemistry” in allergy testing is to tightly control the sourcing, analysis, and performance testing of the extracts used. It is imperative that each allergen extract be scrutinized using today’s biochemical techniques as an active part of the qualification process rather than the ones developed almost 30 years ago for the technologies of the 1990s. Characterization of allergens demystifies the source material and provides results in the clinical lab that are less ambiguous and are more closely related with the clinical status of the patient. Methods and results This article delivers a technical overview that outlines the requisite steps for diagnostic companies to characterize, analyze, and qualify allergen extracts, mixtures, and components integrated into their platforms. It also evaluates diverse technologies employed in both singleplex and multiplex diagnostics, highlighting the incorporation of more precisely defined biochemical materials in their product offerings. Conclusion The primary goal of this review is to provide laboratory professionals and clinicians with a systematic approach to ensure that extracts meet stringent performance requirements crucial for dependable allergen-specific IgE testing.