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Improved Botulism, Botulinum Neurotoxin Type-E Diagnostics

CDC researchers have improved upon a prior, HHS patented mass spectrometry-based Endopep-MS assay that is able to rapidly detect and differentiate all seven botulinum neurotoxin (BoNT) types A to G. This current improvement comprises the addition of two optimized substrate peptides that increases the assay's sensitivity,relative to prior substrates, for botulinum neurotoxin type-E (BoNT/E) by greater than 100 fold. Currently, the primary method of detecting BoNT contamination entails mouse lethality bioassays. In addition to the sacrifice of numerous animals, these lethality assays are expensive and require several days to obtain results. During a suspected BoNT exposure, time is of the essence. The previously patented mass spectrometry approach can provide diagnostic results for all seven BoNT types in a matter of hours, at greater cost-efficiency and without animal toxicity studies. The specific innovation builds upon those earlier improvements by providing new substrates that allow for tremendous increases in the degree of sensitivity for BoNT/E-specific detection within clinical samples.
Patent Abstract: 
CDC researchers have improved upon a prior, HHS patented mass spectrometry-based Endopep-MS assay that is able to rapidly detect and differentiate all seven botulinum neurotoxin (BoNT) types A to G. This current improvement comprises the addition of two optimized substrate peptides that increases the assay's sensitivity,relative to prior substrates, for botulinum neurotoxin type-E (BoNT/E) by greater than 100 fold. Currently, the primary method of detecting BoNT contamination entails mouse lethality bioassays. In addition to the sacrifice of numerous animals, these lethality assays are expensive and require several days to obtain results. During a suspected BoNT exposure, time is of the essence. The previously patented mass spectrometry approach can provide diagnostic results for all seven BoNT types in a matter of hours, at greater cost-efficiency and without animal toxicity studies. The specific innovation builds upon those earlier improvements by providing new substrates that allow for tremendous increases in the degree of sensitivity for BoNT/E-specific detection within clinical samples.
Benefits 
More sensitive, greater cost-efficiency and provides results significantly faster than traditional BoNT/E mouse lethality assays -Builds upon a previously established and patented mass spectrometry-based Endopep-MS assay, adding optimized peptides that improve current BoNT/E detection sensitivity >100 fold
applications 
Inventors: 
Suzanne Kalb
Patent Number: 
PCT/US2013/073885
Internal Laboratory Ref #: 
E-528-2013/0
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