The VaxArray Influenza potency assay is a multiplexed immunoassay for hemagglutinin (HA) quantification that utilizes a panel of subtype-specific, broadly reactive monoclonal capture antibodies printed in a microarray format.
The VaxArray assay is the first commercially available kit for rapid quantification of flu hemagglutinin protein, now delivering results in less than two hours.
The assay provides robust flu vaccine potency information critical to flu researchers and vaccine producers at all stages of vaccine research and development, including samples of crude extract through purification and concentration steps. If a secondary standard is available, quantification can be accomplished prior to the availability of seasonal reference antigens.
Improvements since the initial launch of product previously known as Flu-ToC include: longer reagent shelf-life, a semi-automation protocol for increased ease of use, less hands-on time, higher throughput and reduced assay time. In addition, VaxArray offers a streamlined automated data analysis package.
For influenza vaccines, typically HA quantification is performed using the single radial immunodiffusion assay (SRID). This method can be tedious and result in production delays. SRID is reliant on seasonal reference antisera and antigens as well as gels that must be prepared in-house.
Subsequently, analysis can be inconsistent between laboratories and scientists. SRID is also a singleplex method known to have limited dynamic range. The VaxArray Influenza potency assay has been recognized by the US Department of Health and Human Services as a promising alternative to SRID.
"Time to market in the vaccine industry is critical. With VaxArray customers save valuable time with an off-the-shelf potency assay that allows them to assess HA concentration and stability within hours rather than days, even during the early stages of development," said Kathy Rowlen, Chief Executive Officer of InDevR.
Development of the Flu-ToC/VaxArray Influenza product was supported in part by SBIR grants from the National Institute of Allergy and Infectious Diseases (NIAID).