Routine Clinical Adoption of Immunoassay Multiplexing, Whether Microarray or Cytometric Bead Array, Is Still Several Years Away Due to Operational Entrenchment

IN Discussion Topics, Uncategorized

An objective look at immunoassay multiplexing, where it stands today and contrasted to the standard ELISA was authored recently by Dr. Lucy Fairclough et al. The discussion argued the efficacy of multiplexing as well as the pros and cons of present methods available.Commercial availability of multiplex immunoassays for life science discovery research is rapidly expanding and here the authors point out some hurdles for widespread adoption into clinical applications. Overall, an optimistic future was described in which multiplexed immunoassays could be used in “cheap point-of-care assay” with microfluidics in the use of screening and near patient testing. The discussion highlights many advantages for multiplex immunoassays such as large replicate and internal control features for improved quality assessment as well as increased throughput and costing economies for small valuable sample volumes. Additionally, the authors highlight the technical facets of multiplex microarray assays which contribute to the unique performance characteristics such as the beneficial dynamics of miniaturization, advantages from mixing, and co-localization as a method to mitigate cross reactivity. The authors go on to summarize several facets of the current validation status of multiplex applications for discovery and clinical applications, manufacturing, quality control, and data analysis. As discussed here, standardization, robust automation, and assay cross reactants are hurdles that need to be overcome before broader clinical acceptance can take place. My observation is the obstacles addressed in this paper have solutions in practice or are readily available. Pursuant to these solutions, it is likely that further clinical adoption is 2 years out. My opinion is lack of adoption by direct clinical consumers is likely due to the lack of awareness and the lack of robust and widely available offerings by clinical IVD manufacturers and suppliers.

 

Full text can be found here:

 

ELISA in the Multiplex Era; Potential and Pitfalls

 

PMID: 25644123