Abstract
A collaborative study, initiated under the auspices of the Health Industry Manufacturers Association (HIMA), was designed to establish the relationship of Escherichia coli O55:B5 endotoxin (the control standard endotoxin of HIMA and the Food and Drug Administration's Office of Medical Devices) to the U.S. National Reference Standard Endotoxin and to two internationally used control standard endotoxins. By using two Limulus amoebocyte lysate test systems, it was established that the E. coli O55:B5 endotoxin lot originally used by HIMA and the Office of Medical Devices to establish Limulus amoebocyte lysate release test criteria for pyrogen testing of medical devices contains approximately 4.5 endotoxin units (EU) per ng. Thus, the 1.0-ng/kg endotoxin dose limit currently established for medical devices is approximately the same as the 5.0-EU/kg endotoxin limit (on an activity basis) established by several other Food and Drug Administration agencies for human and animal parenteral drugs and biological products.
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- DAVIES D. A., MORGAN W. T., MOSIMANN W. Studies in immunochemistry. 13. Preparation and properties of the 'O' somatic antigen of Shigella dysenteriae (Shiga). Biochem J. 1954 Apr;56(4):572–581. doi: 10.1042/bj0560572. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Dabbah R., Ferry E., Jr, Gunther D. A., Hahn R., Mazur P., Neely M., Nicholas P., Pierce J. S., Slade J., Watson S. Pyrogenicity of E. coli 055:b5 endotoxin by the USP rabbit test--a HIMA collaborative study. J Parenter Drug Assoc. 1980 May-Jun;34(3):212–216. [PubMed] [Google Scholar]
- Elin R. J., Wolff S. M., McAdam K. P., Chedid L., Audibert F., Bernard C., Oberling F. Properties of reference Escherichia coli endotoxin and its phthalylated derivative in humans. J Infect Dis. 1981 Oct;144(4):329–336. doi: 10.1093/infdis/144.4.329. [DOI] [PubMed] [Google Scholar]
- Galanos C., Lüderitz O., Westphal O. Preparation and properties of a standardized lipopolysaccharide from salmonella abortus equi (Novo-Pyrexal). Zentralbl Bakteriol Orig A. 1979 Apr;243(2-3):226–244. [PubMed] [Google Scholar]
- Hochstein H. D., Mills D. F., Outschoorn A. S., Rastogi S. C. The processing and collaborative assay of a reference endotoxin. J Biol Stand. 1983 Oct;11(4):251–260. doi: 10.1016/s0092-1157(83)80013-4. [DOI] [PubMed] [Google Scholar]
- Rudbach J. A., Akiya F. I., Elin R. J., Hochstein H. D., Luoma M. K., Milner E. C., Milner K. C., Thomas K. R. Preparation and properties of a national reference endotoxin. J Clin Microbiol. 1976 Jan;3(1):21–25. doi: 10.1128/jcm.3.1.21-25.1976. [DOI] [PMC free article] [PubMed] [Google Scholar]