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Updated: Mar 11, 2026
Quantitative Analyses of all Influenza Type A Viral Hemagglutinins and Neuraminidases using Universal Antibodies in Simple Slot Blot Assays
Published on: April 4, 2011
A semi-universal assay platform to quantitate vaccines with potential applications for biotherapeutics
Jeanette Roman1, Silikhone Bouaraphan1, Thorsten Verch1
1Merck & Co., Inc., 770 Sumneytown Pike, PO Box 4, West Point, PA 19486, USA.
Aim:
Biologics development often requires multiple immunoassays to evaluate both assay reagents and potential drug candidates resulting in extensive analytical development.
Methodology:
We developed a semi-universal, 5-layer platform assay on Gyrolab using secondary antispecies or anti-isotype-specific capture and detection antibodies. We applied the assay to several multivalent vaccines.
Results:
Method performance exhibited a median accuracy of 110%, reproducibility of 9% CV and intermediate precision of 11% CV. System suitability criteria were met for 92.5% of the samples and only one out of 31 replicate samples exhibited a %CV greater than 20%.
Conclusion:
The semi-universal Gyrolab assay allowed assay development without reagent labeling. The format could also be translated into a plate-based assay.
