Endotoxin analysis

Details Endotoxin analysis Endotoxin analysis

2011-08-16

2011-08-16

Gitomer, Ralph (Department: 1657)

Chemistry: molecular biology and microbiology

Measuring or testing process involving enzymes or...

Involving hydrolase

C435S007910

Reexamination Certificate

active

07998697

ABSTRACT:
The present invention relates to a method for detecting the presence or non-presence of an endotoxin, characterized in that an OmpT protein is brought into contact with a sample suspected of containing an endotoxin and the protease activity of the OmpT protein is assayed. It also relates to a method for detecting early onset of septicaemia using the inventive method and a kit for performing the method.

REFERENCES:
patent: 2004087942 (2004-10-01), None
Chaby R. Lipopolysaccharide binding Molecules. CMLS Cellular and Molecular Life Sciences 61:1697-1713, 2004.
Kramer R. et al. Lipopolysaccharide Regions Involved in the Activation ofE. coliOuter Membrane Protease OmpT. European J Biochem 269:1746-1752, 2002.
Goh, Y. et al. A Novel Fluoresecent Protein Based Biosensor for Gram Negative Bacteria. Applied and Environmental Microbiology 68(12)6343-6352, Dec. 2002.
Handbook of Proteolytic Enzymes, Second Edition, vol. 1, Chapter 61, “Omptin”, Edited by Alan J. Barrett, Neil D. Rawlings and J. Fred Woessner, Elsevier Academic Press, 2004.
R. A. Kramer et al., Lipopolysaccharide regions involved in the activation ofEscherichia coliouter membrane protease OmpT, Eur. J. Biochem. 269, 1746-1752 (2002).
Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices, Dec. 1987, Prepared by Center for Drug Evaluation/Biological Evaluation and Research/Center for Devices and Radiological Health/Center for Veterinary Medicine.
R. Chaby, “Lipopolysaccharide-binding molecules: transporters, blockers and sensors”, CMLS Cellular and Molecular Life Sciences, 61(2004) 1697-1713.
R. A. Kramer et al., “In vitro folding, purification and characterization ofEscherichia coliouter membrane protease OmpT”, Eur. J. Biochem. 267(2000) 885-893.
R. A. Kramer, “Outer membrane protease OmpT ofEscherichia coli: functional and structural characterization”, Chapters 1-7 (Thesis), 2001, University of Utrecht, Utrecht Netherlands (ISBN 90-393-2791-2) Note: Scanned in two parts.
K. Brandenburg et al., “Investigation into the interaction of the bacterial protease OmpT with outer membrane lipids and biological activity of OmpT:lipopolysaccharide complexes”, Eur. Biophys. J. (2005)34: 28-41.
AAMI (Association for the Advancement of Medical Instrumentation), American National Standards Institute, Inc., “Bacterial endotoxins—Test methodologies, routine monitoring, and alternatives to batch testing”, ANSI/AAMI ST72:2002.
K. Sugimura et al., “Purification, Characterization, and Primary Structure ofEscherichia coliProtease VII with Specificity for Paired Basic Residues: Identity of Protease VII and OmpT”, J. of Bacteriology, vol. 170, No. 12, 5625-5632, Dec. 1988.

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