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Volume 26, Number 10—October 2020
Research Letter

Eliminating Spiked Bovine Spongiform Encephalopathy Agent Activity from Heparin

Cyrus BettComments to Author , Omozusi Andrews, David M. Asher, Teresa Pilant, David Keire, and Luisa Gregori
Author affiliations: US Food and Drug Administration, Silver Spring, Maryland, USA (C. Bett, O. Andrews, D.M. Asher, T. Pilant, L. Gregori); US Food and Drug Administration, St. Louis, Missouri, USA (D. Keire)

Main Article


Reduction of BSE agent measured by animal infectivity bioassay and PrPTSE amplification with RT-QuIC*

Sample Animal bioassay
Samples with heparin
Samples after heparin removed
Samples after heparin removed
log10 ID50/g brain log10 removal
log10 ID50/g brain log10 removal
log10 SD50/g brain log10 removal
Step Total Step Total Step Total
BSE spike 8.0 NA NA 6.9 NA NA 9.0 ± 0.2 NA NA
NaOH treatment 6.3 1.7 1.7 5.4 1.5 1.5 6.6 ± 0.3 2.4 2.4
DE filtration <5.2 >1.1 >2.8 <4.0 >1.4 >2.9 5.3 ± 0.1 1.3 3.7
H2O2 bleaching ND NA NA <3.4 >0.6 >3.5 5.0 ± 0.4 0.3 4.0
Final product ND NA NA <2.6 >0.8 >4.3 5.0 ± 0.6 0.0 4.0

*Values are the number of animals with confirmed BSE divided by the number of animals inoculated. BSE, bovine spongiform encephalopathy; DE diatomaceous earth; H2O2, hydrogen peroxide; ID50, 50% infectious dose; NA, not applicable; NaOH, sodium hydroxide; ND, not detectable; NT, not tested; RT-QuIC, real-time quaking-induced conversion; SD50, 50% seeding dose; TSE, transmissible spongiform encephalopathies.

Main Article

Page created: July 16, 2020
Page updated: September 17, 2020
Page reviewed: September 17, 2020
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