Monocyte activation test better able to detect non-endotoxin...

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...

Reexamination Certificate

Rate now

  [ 0.00 ] – not rated yet Voters 0   Comments 0

Details

C435S287200

Reexamination Certificate

active

07736863

ABSTRACT:
An improved monocyte activation test is described that is better able to detect non-endotoxin pyrogens in medical products, in which a sample is incubated with a monocyte-containing reagent in an assay system comprising at least one surface comprising polypropylene. The invention also concerns assay systems for use in these tests that include at least one microtiter well having at least one interior surface comprising polypropylene and having a shape such that monocyte-containing reagent is concentrated in the well to provide greater cell to cell contact. The invention also relates to a diagnostic kit that can be used to test for the presence of non-endotoxin pyrogens in a sample.

REFERENCES:
patent: 5281540 (1994-01-01), Merkh et al.
patent: 5891728 (1999-04-01), Wendel et al.
patent: 6696261 (2004-02-01), Patel et al.
patent: 2001/0034037 (2001-10-01), Patel et al.
Poole et al. J Immunol Meth. Mar. 1, 2003;274(1-2):209-220. Cited in Applicant's IDS of Jun. 7, 2007.
DeLay Ed. (Cytokine Protocols, Humana Press, Totowa, NJ. 2004, pp. 47 and 207.
Rose et al., Eds., (Manual of Clinical Laboratory Immunology, Sixth Edition. ASM Press. Washington, DC. 2002. pp. 323 and 326).
Gaines-Das et al., (J Immunol Meth. May 2004;288(1-2):165-177).
http://web.archive.org/web/2003101901343
uncbrand.com/page.asp?ID=298&lang=GB (NuncBrand FAQ for Immunology Products, published on the Internet at least since Jan. 2, 2004) (hereinafter “NuncBrand.com archive”), 7 pages.
Carlin, Gunnar, et al. (2003) In vitro Pyrogenicity of a Multivalent Vaccine: Infanrix, Pharmeuropa, vol. 15, No. 3, pp. 418-423.
Charles River Laboratories (Sep. 2004) Endosafe Times, vol. 2, No. 1.
Desch, Christopher E., et al. (1989) Production of Human Tumor Necrosis Factor from Whole Blood Ex Vivo, Lymphokine Research, vol. 8, No. 2, pp. 141-146.
Dinarello, Charles A., et al. (1984) Human Leukocytic Pyrogen Test for Detection of Pyrogenic Material in Growth Hormone Produced by RecombinantEscherichia coli, Journal of Clin. Microbiology, vol. 20, No. 3, pp. 323-329.
Duff, Gordon W., et al. (1982) The Detection of Endotoxin by in Vitro Production of Endogenous Pyrogen: Comparison with Limulus Amebocyte Lysate Gelation, Journal of Immunol. Methods, 52, pp. 323-331.
Eperon, Simone, et al. (1997) Human monocytoid cell lines as indicators of endotoxin: comparison with rabbit pyrogen and Limulus amoebocyte lysate assay, Journal of Immunol. Methods, 207, pp. 135-145.
Eperon, Simone, et al. (1996) The use of human monocytoid lines as indicators of endotoxin, Journal of Immunol. Methods, 194, pp. 121-129.
Fennrich, S., et al. (1999) Detection of Endotoxins and other Pyrogens Using Human Whole Blood, Dev. Biol Stand., vol. 101, pp. 131-139.
Fennrich, Stefan, et al. (1999) New Applications of the Human Whole Blood Pyrogen Assay (PyroCheck), ALTEX, 16, pp. 146-149.
Finch-Arietta, M. B., et al. (1991) Cytokine production in whole blood ex vivo, Agents and Actions, vol. 34, 1/2.
Fujiwara, Hiroshi, et al. (1990) Measurement of Endotoxin in Blood Products Using an Endotoxin-Specific Limulus Test Reagent and Its Relation to Pyrogenic Activities in Rabbit, Yakugaku Zasshi, vol. 110 (5), pp. 332-340.
Gaines Das, Rose E. et al. (2004) Monocyte activation test for pro-inflammatory and pyrogenic contaminants of parenteral drugs: test design and data analysis, 288 (1-2), pp. 165-177.
Hansen, E.W., et al. (1990) Comparison of Cultured Human Mononuclear Cells, Limulus Amebocyte Lysate and Rabbits in the Detection of Pyrogens, Journal of Clin. Pharmacy and Therapeutics, 15, pp. 425-433.
Harlan Sera-Lab, 2004 Catalogue.
Hartung, Thomas, et al. (1996) Detection of Pyrogens Using Human Whole Blood, In Vitro Toxicology, vol. 9, No. 4, pp. 353-359.
Hartung, Thomas, et al. (2001) Novel Pyrogen Tests Based on the Human Fever Reaction, Altern Lab Anim. 29, pp. 99-123.
Hoffmann, Sebastian, et al. (2005) International validation of novel pyrogen tests based on human monocytoid cells, Journal Immunol. Methods, 298, pp. 161-173.
Jahnke, M., et al. (2000) Comparative testing for pyrogens in parenteral drugs using the human whole blood pyrogen test, the rabbit in vivo pyrogen test and the LAL test, European Journal of Parenteral Science, 5 (2), pp. 39-44.
Martis, Leo, et al. (2005) Aseptic peritonitis due to peptidoglycan contamination of pharmacopoeia standard dialysis solution, Lancet, 365, pp. 588-594.
Mascoli, Carmine C., et al. (2003) Applications and advantages of the limulus amebocyte lysate (LAL) pyrogen test for parenteral injectable products, Prog. Clin. Biol. Res., 29, pp. 387-402.
Moesby, Lise, et al. (1999) A comparative study of Mono Mac 6 cells, isolated mononuclear cells and Limulus amoebocyte lysate assay in pyrogen testing, Internl. Journal of Pharmaceutics, 191, pp. 141-149.
Moesby, Lise, et al. (2000) Ultrasonication of pyrogenic microorganisms improves the detection of pyrogens in the Mono Mac 6 assay, European Journal of Pharmaceutical Sciences, 11, pp. 51-57.
Moltz, Howard (1993) Fever: Causes and Consequences, Neurosci. Biobehav. Rev., vol. 17, pp. 237-269.
Nakagawa, Yukari (2002) Evaluation of the In Vitro Pyrogen Test System Based on Proinflammatory Cytokine Release form Human Monocytes: Comparison with a Human Whole Blood Culture Test System and with the Rabbit Pyrogen Test, Clinical and Diagnostic Laboratory Immunol., vol. 9, No. 3, pp. 588-597.
Nerad, Judith L., et al. (1992) Interleukin-1β(IL-1β), IL-1 receptor antagonist, and TNFα production in whole blood, Journal of Leukocyte Biology, vol. 52, pp. 687-692.
Peterbauer, Anja, et al. (1999) Interferon-γ-primed monocytoid cell lines: optimizing their use for in vitro detection of bacterial pyrogens, Journal of Immunol. Methods, 8488.
Peterbauer, Anja, et al. (1999) Neopterin and Nitrite in Supernatants from Interferon-γ-treated Monocytoid Cell Lines: A Tool to Identify Bacterial Pyrogens, Pteridines, vol. 10, pp. 112-118.
Poole, Stephen, et al. (2003) A rapid ‘one-plate’ in vitro test for pyrogens, Journal of Immunol. Methods, 274, pp. 209-220.
Pool, Edmund, J., et al. (1998) The Detection of Pyrogens in Blood Products using an Ex Vivo Whole Blood Culture Assay, Journal of Immunoassay, 19 (2&3), pp. 95-111.
Roslansky, Priscilla F., et al. (1991) Sensitivity of Limulus Amebocyte Lysate (LAL) to LAL-Reactive Glucans, Journal of Clinical Microbiology, vol. 29, No. 11, pp. 2477-2483.
Rothwell, Nancy J. (1994) CNS Regulation of Thermogenesis, Critical Reviews in Neurobiology, 8 (1/2), pp. 1-10.
Taktak, Y.S., et al. (1991) Assay of Pyrogens by Interleukin-6 Release from Monocytic Cell Lines, J. Pharm. Pharmacol., 43, pp. 578-582.
Tilders, Fred J.H., et al. (1994) Activation of the Hypothalamus-Pituitary-Adrenal Axis by Bacterial Endotoxins: Routes and Intermediate Signals, Psychoneuroendocrinology, vol. 19, No. 2, pp. 209-232.
Tsuchiya, Shigeru, et al. (1980) Establishment and Characterization of a Human Acute Monocytic Leukemia Cell Line (THP-1), Int. J. Cancer, 26, pp. 171-176.
Yamamoto, Akihiko, et al. (2003) A Cell Line Assay System for Predicting the Response of Human Blood to Endotoxin, Jpn. J. Infect. Dis., 56 (3), pp. 93-100.
Zeisberger, Eugen, et al. (1993) Neurobiological Concepts of Fever Generation and Suppression, Neuropsychobiology, 28, pp. 106-109.
Ziegler-Heitbrock, H.W. Loms, et al. (1988) Establishment of a Human Cell Line (Mono Mac 6) with Characteristics of Mature Monocytes, Int. J. Cancer, 41, pp. 456-461.
Mascoli, Carmine C., et al. (1979) Limulus Amebocyte Lysate (LAL) Test for Detecting Pyrogens in Parenteral Injectable Products and Medical Devices: Advantages to Manufacturers and Regulatory Officials, J. Parenter Drug Assoc., vol. 33, No. 2, pp. 81-95.
Poole, Stephen, et al. (2001) Towards a ‘human pyrogen test’, European Journal of Parenteral Sciences, 6(2), pp. 63-64.

LandOfFree

Say what you really think

Search LandOfFree.com for the USA inventors and patents. Rate them and share your experience with other people.

Rating

Monocyte activation test better able to detect non-endotoxin... does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Monocyte activation test better able to detect non-endotoxin..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Monocyte activation test better able to detect non-endotoxin... will most certainly appreciate the feedback.

Rate now

     

Profile ID: LFUS-PAI-O-4195731

  Search
All data on this website is collected from public sources. Our data reflects the most accurate information available at the time of publication.