InDevR Cypher One™ Collaborative Study With FDA Published
InDevR, FDA Study, “Automated interpretation of influenza hemagglutination inhibition (HAI) assays” published in PLOS ONE
InDevR, Inc., an innovative life science company dedicated to improving biopharmaceutical and vaccine manufacturing, announced study results and a joint publication with the U.S. Food and Drug Administration (FDA) of “Automated interpretation of influenza hemagglutination inhibition (HAI) assays: is plate tilting necessary?” in the scientific journal PLOS ONE.
Serological screening is an important step in influenza monitoring and vaccine development. The hemagglutination inhibition assay (HAI) is widely used to evaluate vaccine-induced antibody responses as well as to antigenically characterize influenza viruses. HAI results are based on an endpoint titration where the titers are typically manually interpreted and recorded by a trained expert. For serological applications, the lack of a standardized endpoint interpretation and presence of interfering non-specific inhibitors can translate into a high degree of variability in the results. This variability along with the lack of a digital record limits is a recognized weakness of the assay.
In the study, a side-by-side comparison of titer calls for more than 2,200 serum samples was made by the Cypher One automated hemagglutination analyzer without tilting and by an expert human reader with tilting. The HAI analysis was performed by FDA as part of its biannual human serological testing of influenza viruses.
Despite prevalent non-specific inhibition, high overall agreement (95%) and good correlation were observed between the results from an expert human reader and the Cypher One system. Even in the presence of challenging samples where the endpoint was non-existent or not obvious, the Cypher One system did not require tilting for accurate interpretation.
The Cypher One Hemagglutination Analyzer is a commercially available instrument for rapid automated analysis, standardization and digital record creation for the interpretation of HA and HAI assays. The Cypher One analyzer reduces subjectivity and enhances data integrity.
“This study supports the impact that Cypher One can have on standardization and interpretation of HAI assays where historically plate tilting was needed to make an accurate titer call,” said Erica Dawson, Chief Technology Officer of InDevR. “At 95.6% agreement, Cypher One offers the scientist a tool to reduce manual call subjectivity and provides an auditable record to meet current data integrity needs of the industry.”
Development of the Cypher One product was supported in part by Phase 1 and 2 Small Business Innovation Research (SBIR) grants from the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID).
Cypher One Analyzer is commercially available. More information is available at: https://www.indevr.com/products/cypher-one/
About the Study:
Wilson G, Ye Z, Xie H, Vahl S, Dawson E, et al. (2017) Automated interpretation of influenza hemagglutination inhibition (HAI) assays: Is plate tilting necessary?. PLOS ONE 12(6): e0179939. https://doi.org/10.1371/journal.pone.0179939
About InDevR:
InDevR has a demonstrated commitment to innovative solutions for the life science industry. With focus on enhancing bioprocessing for vaccines and other biotherapeutics, InDevR has emerged as a leader in progressive new analytical technologies that enable accelerated development and manufacturing of these life-saving products. For more information about the company and products, please visit www.indevr.com or call 303-402-9100.
About PLOS ONE:
PLOS ONE is the world’s first multidisciplinary open access journal, accepting scientifically rigorous original research across a variety of scientific and medical disciplines. PLOS ONE is published by the non-profit Public Library of Science, created to serve the interest of scientists and the public good.
As PLOS ONE is an open access journal, copies of the publication are freely available for viewing and download.
FDA is not responsible for the contents of this release. The statements contained in this release do not constitute endorsement or recommendation by the U.S. Government or FDA.
