Novel Pyrogen Tests Based on the Human Fever Reaction

3Biochemical Pharmacology, University of Konstanz, P.O. Box M 655, 78457 Konstanz, Germany; 4National Institute of Public Health (NIPH), Department of Vaccinology, P.O. Box 4404 Torshov, Geitmyrsveien 75, 0403 Oslo, Norway; 5Milenia-Biotec, Hohe Strasse 4–8, 61231 Bad Nauheim, Germany; 6Medical Products Agency, P.O. Box 26, Husargatan 8, 751 03 Uppsala, Sweden; 7European Directorate for the Quality of Medicines, Council of Europe, P.O. Box 907, 67029 Strasbourg Cedex 1, France; 8ECVAM, JRC Institute for Health and Consumer Protection, European Commission, 21020 Ispra (VA), Italy; 9Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51–59, 63225 Langen, Germany; 10National Institute for Public Health and the Environment (RIVM), LGM, P.O. Box 1, 3720 BA Bilthoven, The Netherlands; 11Analysis and Control Department, Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark; 12Pharma Hameln GmbH, Langes Feld 13, 31789 Hameln, Germany; 13Division of Endocrinology, National Institute for Biological Standards and Control (NIBSC), Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK; 14Office of Testing and Research, Center for Drug Evaluation and Research, Food and Drug Administration, FD-900, Parklawn Building, Room 13B-06, 5600 Fishers Lane, Rockville, MD 20857, USA; 15Institut fur Medizinische Chemie und Biochemie, Universitat Innsbruck, Fritz-Pregl-Strasse 3, 6020 Innsbruck, Austria ATLA 29, 99–123, 2001 99

[1]  A. Krieg,et al.  Bacterial DNA induces NK cells to produce IFN-gamma in vivo and increases the toxicity of lipopolysaccharides. , 1996, Journal of immunology.

[2]  J. Meer,et al.  Interleukin‐1 in the pathogenesis of fever , 1987, European journal of clinical investigation.

[3]  Horst Spielmann,et al.  [Reduction and replacement of animal tests required in standards for safety testing] , 1998, ALTEX.

[4]  C. Dinarello,et al.  The pyrogenicity of the synthetic adjuvant muramyl dipeptide and two structural analogues. , 1978, The Journal of infectious diseases.

[5]  Michael Balls,et al.  The Role of Prevalidation in the Development, Validation and Acceptance of Alternative Methods , 1995 .

[6]  G. Luheshi.  Cytokines and Fever: Mechanisms and Sites of Action , 1998, Annals of the New York Academy of Sciences.

[7]  J. Vallejo,et al.  Roles of the bacterial cell wall and capsule in induction of tumor necrosis factor alpha by type III group B streptococci , 1996, Infection and immunity.

[8]  M. Roggiani,et al.  Analysis of toxicity of streptococcal pyrogenic exotoxin A mutants , 1997, Infection and immunity.

[9]  F. Coceani,et al.  Pyrogen - prostaglandin coupling in the pathogenesis of fever: evidence against a role for nitric oxide. , 1995, Canadian journal of physiology and pharmacology.

[10]  R. Elin,et al.  Positive Limulus amoebocyte lysate reactions with polyriboinosinic acid x polyribocytidylic acid , 1980, Journal of clinical microbiology.

[11]  S. Roman-Roman,et al.  Mycoplasma membrane lipoproteins induced proinflammatory cytokines by a mechanism distinct from that of lipopolysaccharide , 1996, Infection and immunity.

[12]  P. Andrew,et al.  Pneumolysin stimulates production of tumor necrosis factor alpha and interleukin-1 beta by human mononuclear phagocytes , 1994, Infection and immunity.

[13]  M. Arvanitidou,et al.  Microbiological quality of water and dialysate in all haemodialysis centres of Greece. , 1998, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[14]  M. Matuszek,et al.  The Effect of N6‐Cyclohexyladenosine and 5′‐(N‐Cyclopropyl)‐Carboxamidoadenosine on Pyrogen Fever in Rabbits , 1997, Annals of the New York Academy of Sciences.

[15]  C. Sweet,et al.  Are known pyrogenic cytokines responsible for fever in influenza? , 1997, Journal of medical virology.

[16]  S. Wolff,et al.  Nonspecificity of the limulus amebocyte lysate test: positive reactions with polynucleotides and proteins. , 1973, The Journal of infectious diseases.

[17]  R. D. Myers,et al.  Fever of unknown origin: due toC. albicans or other fungi acting on the hypothalamus? , 1994, Brain Research.

[18]  M. Tsuchiya,et al.  Detection of peptidoglycan and endotoxin in dialysate, using silkworm larvae plasma and limulus amebocyte lysate methods. , 1997, Nephron.

[19]  B. Beutler,et al.  Tumor necrosis factor (cachectin) is an endogenous pyrogen and induces production of interleukin 1 , 1986, The Journal of experimental medicine.

[20]  Balls Michael,et al.  The Validation of Alternative Test Methods , 1996 .

[21]  S. Fennrich,et al.  Detection of endotoxins and other pyrogens using human whole blood. , 1999, Developments in biological standardization.

[22]  J. Wilson,et al.  Comparison of several control standard endotoxins to the National Reference Standard Endotoxin--an HIMA collaborative study , 1985, Applied and Environmental Microbiology.

[23]  R. Thorpe,et al.  Assay of pyrogenic contamination in pharmaceuticals by cytokine release from monocytes. , 1988, Developments in biological standardization.

[24]  F Bittinger,et al.  Current trends in biocompatibility testing , 1998, Proceedings of the Institution of Mechanical Engineers. Part H, Journal of engineering in medicine.

[25]  H. D. Hochstein,et al.  Comparative trial of influenza vaccines. II. Adverse reactions in children and adults. , 1976, American journal of epidemiology.

[26]  M. Kluger.  Fever: Role of Pyrogens and Cryogens , 1991, Physiological reviews.

[27]  G. Kupryszewski,et al.  Thermoregulatory activity of sodium nitroprusside and arginine vasopressin. , 1995, General pharmacology.

[28]  K. Heeg,et al.  Bacterial DNA causes septic shock , 1997, Nature.

[29]  L. Bland,et al.  Prevalence of nontuberculous mycobacteria in water supplies of hemodialysis centers , 1988, Applied and environmental microbiology.

[30]  C. Kirkpatrick,et al.  The cell and molecular biological approach to biomaterial research: a perspective , 1997, Journal of materials science. Materials in medicine.

[31]  D. Chang,et al.  Production of interleukin-1 (IL-1) and IL-1 inhibitor by human monocytes exposed to dengue virus. , 1994, The Journal of infectious diseases.

[32]  S. Poole,et al.  Second international standard for endotoxin: calibration in an international collaborative study , 1997 .

[33]  Margaret J. Flanigan,,et al.  Amitriptyline Attenuates the Febrile Response to a Pyrogen in Rabbits , 1992, Journal of basic and clinical physiology and pharmacology.

[34]  N. Rothwell,et al.  Fever and thermogenesis in response to bacterial endotoxin involve macrophage-dependent mechanisms in rats. , 1993, The American journal of physiology.

[35]  M. Kazatchkine,et al.  Induction of IL-1 during hemodialysis: transmembrane passage of intact endotoxins (LPS). , 1990, Kidney international.

[36]  M Balls,et al.  Progress toward the Validation of Alternative Tests , 1997, Alternatives to laboratory animals : ATLA.

[37]  G. Werner-Felmayer,et al.  Human monocytoid cell lines as indicators of endotoxin: comparison with rabbit pyrogen and Limulus amoebocyte lysate assay. , 1997, Journal of immunological methods.

[38]  C. Bird,et al.  Nature of the endogenous pyrogen (EP) induced by influenza viruses: lack of correlation between EP levels and content of the known pyrogenic cytokines, interleukin 1, interleukin 6 and tumour necrosis factor. , 1991, The Journal of general virology.

[39]  S. Hopkins,et al.  Sites of action of IL‐1 in the development of fever and cytokine responses to tissue inflammation in the rat , 1997, British journal of pharmacology.

[40]  V. Madison,et al.  The effect of endotoxin-contaminated medium on in vitro fertilization and development of bovine oocytes matured in vitro. , 1991, Reproduction, nutrition, development.

[41]  T. Hartung,et al.  Eine Methode unter Verwendung von menschlichem Vollblut zum Ersatz des Pyrogentests am Kaninchen , 1997 .

[42]  G. Duff,et al.  The detection of endotoxin by in vitro production of endogenous pyrogen: comparison with limulus amebocyte lysate gelation. , 1982, Journal of immunological methods.

[43]  C. W. Walter,et al.  Detection of endotoxin on sterile catheters used for cardiac catheterization , 1980, Journal of clinical microbiology.

[44]  C. Dinarello,et al.  Interleukin-6 as an endogenous pyrogen: induction of prostaglandin E2 in brain but not in peripheral blood mononuclear cells , 1991, Brain Research.

[45]  E. Vizi,et al.  α2 −, α2A −, α2B/2C-Adrenoceptor subtype antagonists prevent lipopolysaccharide-induced fever response in rabbits , 1995, Brain Research.

[46]  J. Coleman,et al.  The effects of selected drugs, including chlorpromazine and non-steroidal anti-inflammatory agents, on polyclonal IgG synthesis and interleukin 1 production by human peripheral blood mononuclear cells in vitro. , 1989, Clinical and experimental immunology.

[47]  U. Schmidt,et al.  Bakterielle Kontamination von Blutkomponenten , 1999, Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz.

[48]  J. Playfair,et al.  Soluble malarial antigens are toxic and induce the production of tumour necrosis factor in vivo. , 1989, Immunology.

[49]  T. Kirikae,et al.  Bacterial endotoxin: molecular relationships of structure to activity and function , 1994, FASEB journal : official publication of the Federation of American Societies for Experimental Biology.

[50]  H. Nariuchi,et al.  Analysis of endotoxin fever in rabbits by using a monoclonal antibody to tumor necrosis factor (cachectin) , 1989, Infection and immunity.

[51]  C. Dinarello.  Thermoregulation and the pathogenesis of fever. , 1996, Infectious disease clinics of North America.

[52]  J. Krueger,et al.  Macrophages produce somnogenic and pyrogenic muramyl peptides during digestion of staphylococci. , 1991, The American journal of physiology.

[53]  M. Lin,et al.  Staphylococcal enterotoxin A-induced fever is associated with increased circulating levels of cytokines in rabbits , 1997, Infection and immunity.

[54]  E. Werner,et al.  Neopterin and Nitrite in Supernatants from Interferon-γ-treated Monocytoid Cell Lines: A Tool to Identify Bacterial Pyrogens , 1999 .

[55]  S. Fennrich,et al.  New Applications of the Human Whole Blood Pyrogen Assay (PyroCheck). , 1999, ALTEX.

[56]  M. Arduino,et al.  Outbreak of pyrogenic reactions and gram-negative bacteremia in a hemodialysis center. , 1994, American journal of nephrology.

[57]  J. Beloeil,et al.  Synthesis and pyrogenic effect of 3α,7α-dihydroxy-5β-androstan-17-one and 3α-hydroxy-5β-androstane-7,17-dione , 1980, Steroids.

[58]  T. Bártfai,et al.  Interleukin‐1 System: Receptors, Ligands, and ICE in the Brain and Their Involvement in the Fever Response , 1998, Annals of the New York Academy of Sciences.

[59]  R. Hornick,et al.  Comparative Pyrogenic Reactivity of Rabbit and Man to Bacterial Endotoxin∗ , 1969, Proceedings of the Society for Experimental Biology and Medicine. Society for Experimental Biology and Medicine.

[60]  S. McAllister,et al.  The effects of endotoxin-contaminated dialysate and polysulfone or cellulosic membranes on the release of TNF alpha during simulated dialysis. , 1995, Artificial organs.

[61]  K. Knoernschild,et al.  Lipopolysaccharide affinity for titanium implant biomaterials. , 1997, The Journal of prosthetic dentistry.

[62]  Knight Pa,et al.  Studies on the toxicity of a variety of human vaccines as measured by laboratory tests. , 1977 .

[63]  Spielmann Horst,et al.  Practical Aspects of the Validation of Toxicity Test Procedures , 1995 .

[64]  W. Louis,et al.  Quantitative Limulus lysate assay for endotoxin and the effect of plasma. , 1991, Journal of clinical pathology.

[65]  C. Galanos,et al.  Bacterial lipopolysaccharides: structure, metabolism and mechanisms of action. , 1990, International reviews of immunology.

[66]  J. Chia,et al.  In vitro tumor necrosis factor induction assay for analysis of febrile toxicity associated with amphotericin B preparations , 1990, Antimicrobial Agents and Chemotherapy.

[67]  P. Bodel,et al.  Studies on steroid fever: I. Production of leukocyte pyrogen in vitro by etiocholanolone. , 1968, The Journal of clinical investigation.

[68]  T. Novitsky,et al.  Plastics, endotoxins, and the Limulus amebocyte lysate test. , 1991, Journal of parenteral science and technology : a publication of the Parenteral Drug Association.

[69]  M. Kazatchkine,et al.  Dissociation between the interleukin 1-inducing capacity and Limulus reactivity of lipopolysaccharides from gram-negative bacteria. , 1990, Cytokine.

[70]  D. Gemsa,et al.  Influenza A virus infection of macrophages. Enhanced tumor necrosis factor-alpha (TNF-alpha) gene expression and lipopolysaccharide-triggered TNF-alpha release. , 1991, Journal of immunology.

[71]  E. Klein,et al.  Microbial and endotoxin contamination in water and dialysate in the central United States. , 2008, Artificial organs.

[72]  C. Booth.  The limulus amoebocyte lysate (LAL) assay--a replacement for the rabbit pyrogen test. , 1986, Developments in biological standardization.

[73]  E. Werner,et al.  Detection of bacterial pyrogens on the basis of their effects on gamma interferon-mediated formation of neopterin or nitrite in cultured monocyte cell lines , 1995, Clinical and diagnostic laboratory immunology.

[74]  H. D. Hochstein,et al.  Uridine‐induced hyperthermia in the rabbit , 1986, The Journal of pharmacy and pharmacology.

[75]  V. Poli,et al.  Interleukin (IL)-6 gene expression in the central nervous system is necessary for fever response to lipopolysaccharide or IL-1 beta: a study on IL-6-deficient mice , 1996, The Journal of experimental medicine.

[76]  S. Lapierre,et al.  Quality of hemodialysis water: a 7-year multicenter study. , 1995, American journal of kidney diseases : the official journal of the National Kidney Foundation.

[77]  Z. Szreder.  Do Cardiovascular Mechanisms Participate in Thermoregulatory Activity of α2‐Adrenoceptor Agonists and Antagonists in Rabbits? a , 1997 .

[78]  T. Jungi,et al.  The use of human monocytoid lines as indicators of endotoxin. , 1996, Journal of immunological methods.

[79]  T. Murai,et al.  Potentiation of lethal endotoxin shock by streptococcal pyrogenic exotoxin in rabbits: possible relevance of hyperreactivity of macrophages to endotoxin. , 1996, FEMS immunology and medical microbiology.

[80]  Cooper Jf,et al.  The Limulus test for endotoxin (Pyrogen) in radiopharmaceuticals and biologicals. , 1972 .

[81]  C. Sweet,et al.  Role of surface glycoproteins in influenza virus pyrogenicity. , 1994, The Journal of general virology.

[82]  M Liebsch,et al.  The Principles of Good Laboratory Practice: Application to In Vitro Toxicology Studies , 1999, Alternatives to laboratory animals : ATLA.

[83]  C. Dinarello,et al.  Human leukocytic pyrogen test for detection of pyrogenic material in growth hormone produced by recombinant Escherichia coli , 1984, Journal of clinical microbiology.

[84]  S. Poole,et al.  The International Standard for Endotoxin: evaluation in an international collaborative study. , 1989, Journal of biological standardization.

[85]  R. Lucken,et al.  Studies on the toxicity of a variety of human vaccines as measured by laboratory tests. , 1977, Developments in biological standardization.

[86]  T. Hollon.  Researchers and regulators reflect on first gene therapy death. , 2000, Nature medicine.

[87]  池邨 勝美.  False-positive result in limulus test caused by limulus amebocyte lysate-reactive material in immunoglobulin products , 1992 .

[88]  C. Saper,et al.  Endogenous pyrogens in the CNS: role in the febrile response. , 1992, Progress in brain research.

[89]  F. Jordan,et al.  The impact of non-endotoxin LAL-reactive materials on Limulus amebocyte lysate analyses. , 1997, PDA journal of pharmaceutical science and technology.

[90]  I. Pastan,et al.  Pseudomonas Exotoxin and Recombinant Immunotoxins Derived from It , 1993, Annals of the New York Academy of Sciences.

[91]  H. Moltz.  Fever: Causes and consequences , 1993, Neuroscience & Biobehavioral Reviews.

[92]  Patrick Deboyser,et al.  ECVAM News & Views , 1999 .

[93]  M. Coleman,et al.  Dapsone toxicity: some current perspectives. , 1995, General pharmacology.

[94]  A. Gardi,et al.  Improved microtechnique for endotoxin assay by the Limulus amebocyte lysate test. , 1980, Analytical biochemistry.

[95]  M. Kurokawa,et al.  Cascade of fever production in mice infected with influenza virus , 1996, Journal of medical virology.

[96]  J. Cooper.  Acceptance of the Limulus test as an alternative pyrogen test for radiopharmaceutical and intrathecal drugs. , 1979, Progress in clinical and biological research.

[97]  C. Dinarello.  Interleukin-1 and interleukin-1 receptor antagonist production during haemodialysis: which cytokine is a surrogate marker for dialysis-related complications? , 1995, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.

[98]  M Balls.  Statement on the scientific validity of the 3T3 NRU PT test (an in vitro test for phototoxic potential) , 1998 .

[99]  M. Tsuchiya,et al.  Detection of peptidoglycan and beta-glucan with silkworm larvae plasma test. , 1996, FEMS immunology and medical microbiology.

[100]  J. Oppenheim,et al.  Isolation, characterization, and biological properties of an endotoxin-like material from the gram-positive organism Listeria monocytogenes , 1979, Infection and immunity.

[101]  D. Hull,et al.  Age-related changes in endotoxin sensitivity and the febrile response of newborn rabbits. , 1993, Biology of the neonate.

[102]  D. Benoliel,et al.  Effects of weight and sex of rabbits on the results of the testing of chorionic gonadoptrophin injection according to the European Pharmacopoeia , 1982, The Journal of pharmacy and pharmacology.

[103]  R. Thorpe,et al.  DETECTION OF PYROGEN BY CYTOKINE RELEASE , 1988, The Lancet.

[104]  P. Mackowiak,et al.  Concepts of fever. , 1998, Archives of internal medicine.

[105]  T. Bártfai,et al.  Delineation of the Proinflammatory Cytokine Cascade in Fever Induction a , 1998, Annals of the New York Academy of Sciences.

[106]  Thomas Hartung,et al.  [Detection of Pyrogens using human whole blood] , 1996, ALTEX.

[107]  C. Ball,et al.  Assay of Pyrogens by Interleukin‐6 Release from Monocytic Cell Lines , 1991, The Journal of pharmacy and pharmacology.

[108]  J. A. Majde.  Microbial cell-wall contaminants in peptides: A potential source of physiological artifacts , 1993, Peptides.

[109]  M. Lin,et al.  Mechanisms and sites of pyrogenic action exerted by staphylococcal enterotoxin A in rabbits , 1997, Neuroscience Letters.

[110]  D. Stevens,et al.  Streptococcal toxic shock syndrome: synthesis of tumor necrosis factor and interleukin-1 by monocytes stimulated with pyrogenic exotoxin A and streptolysin O. , 1992, The Journal of infectious diseases.

[111]  C. Frasch,et al.  Measurements of lipopolysaccharide (endotoxin) in meningococcal protein and polysaccharide preparations for vaccine usage. , 1989, Journal of biological standardization.

[112]  L. Leon,et al.  Cytokines and fever. , 1995, Neuroimmunomodulation.

[113]  H. Loppnow,et al.  Cytokine production by mononuclear cells following stimulation with a peptide-containing, endotoxin-free Escherichia coli extract. , 1995, Arzneimittel-Forschung.

[114]  S. McAllister,et al.  Pyrogenic reactions in patients receiving conventional, high-efficiency, or high-flux hemodialysis treatments with bicarbonate dialysate containing high concentrations of bacteria and endotoxin. , 1992, Journal of the American Society of Nephrology : JASN.

[115]  S. Becker,et al.  Cytokine (tumor necrosis factor, IL-6, and IL-8) production by respiratory syncytial virus-infected human alveolar macrophages. , 1991, Journal of immunology.

[116]  A. Espinel-Ingroff,et al.  Exoantigen test for differentiation of Exophiala jeanselmei and Wangiella dermatitidis isolates from other dematiaceous fungi , 1984, Journal of clinical microbiology.

[117]  M. Böhnke,et al.  Bacterial lipopolysaccharides in sterile corneal organ-culture media. , 1999, Cornea.

[118]  L. Sommese,et al.  Biological activities--lethality, Shwartzman reaction and pyrogenicity--of Salmonella typhimurium porins. , 1994, Microbial pathogenesis.

[119]  F. Galdiero,et al.  Inflammatory effects of Salmonella typhimurium porins , 1990, Infection and immunity.

[120]  C. Dinarello,et al.  Picogram concentrations of endotoxin stimulate synthesis of IL-1 beta and TNF alpha by human peripheral blood mononuclear cells exposed to recombinant human C5a. , 1991, European cytokine network.

[121]  R R Schumann,et al.  Bacterial endotoxin: Chemical constitution, biological recognition, host response, and immunological detoxification. , 1996, Current topics in microbiology and immunology.

[122]  C. Nimsky,et al.  [Endotoxin contents of phytopharmaceuticals: correlation with clinically observed side effects]. , 1988, Deutsche medizinische Wochenschrift.

[123]  N. Naidu,et al.  Effect of some penicillins on the sensitivity of limulus amoebocyte lysate test , 1989, The Journal of pharmacy and pharmacology.

[124]  R. Benz.  Structure and function of porins from gram-negative bacteria. , 1988, Annual review of microbiology.

[125]  E. W. Hansen,et al.  COMPARISON OF CULTURED HUMAN MONONUCLEAR CELLS, LIMULUS AMEBOCYTE LYSATE and RABBITS IN THE DETECTION OF PYROGENS , 1990, Journal of clinical pharmacy and therapeutics.

[126]  J. Schmidt-Gengenbach,et al.  Factors affecting recovery of endotoxin adsorbed to container surfaces. , 1986, Journal of parenteral science and technology : a publication of the Parenteral Drug Association.

[127]  J. Anderson,et al.  Human monocyte/macrophage activation and interleukin 1 generation by biomedical polymers. , 1988, Journal of biomedical materials research.

[128]  S. McAllister,et al.  An outbreak of pyrogenic reactions in chronic hemodialysis patients associated with hemodialyzer reuse. , 1995, Artificial organs.

[129]  P. Friberger.  The design of a reliable endotoxin test. , 1985, Progress in clinical and biological research.

[130]  E. Werner,et al.  Interferon-gamma-primed monocytoid cell lines: optimizing their use for in vitro detection of bacterial pyrogens. , 2000, Journal of immunological methods.

[131]  P. Bouic,et al.  The detection of pyrogens in blood products using an ex vivo whole blood culture assay. , 1998, Journal of immunoassay.

[132]  Cooper Jf.  Acceptance of the Limulus test as an alternative pyrogen test for radiopharmaceutical and intrathecal drugs. , 1979 .

[133]  H. Flad,et al.  Biochemistry and cell biology of bacterial endotoxins. , 1996, FEMS immunology and medical microbiology.