Chemistry: analytical and immunological testing – Including sample preparation – Liberation or purification of sample or separation of...
Reexamination Certificate
2009-03-25
2011-12-27
Gabel, Gail R (Department: 1641)
Chemistry: analytical and immunological testing
Including sample preparation
Liberation or purification of sample or separation of...
C436S506000, C436S512000, C436S513000, C436S166000, C436S175000, C435S007100, C435S007200, C435S007920, C435S287200, C435S287900, C422S527000
Reexamination Certificate
active
08084272
ABSTRACT:
The invention is directed to methods and devices for reducing interference from heterophile antibodies in an analyte immunoassay. In one embodiment, the invention is to a method comprising the steps of (a) amending a biological sample such as a whole blood sample with non-human IgM or fragments thereof by dissolving into said sample a dry reagent to yield a non-human IgM concentration of at least about 20 μg/mL or equivalent fragment concentration; and (b) performing an electrochemical immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG or fragments thereof in addition to the IgM of fragments thereof.
REFERENCES:
patent: 5063081 (1991-11-01), Cozzette et al.
patent: 5096669 (1992-03-01), Lauks et al.
patent: 5112455 (1992-05-01), Cozzette et al.
patent: 5200051 (1993-04-01), Cozzette et al.
patent: 5447440 (1995-09-01), Davis et al.
patent: 5628961 (1997-05-01), Davis et al.
patent: 5656504 (1997-08-01), Johansson et al.
patent: 6030827 (2000-02-01), Davis et al.
patent: 6106778 (2000-08-01), Oku et al.
patent: 6106779 (2000-08-01), Buechler et al.
patent: 6379883 (2002-04-01), Davis et al.
patent: 7419821 (2008-09-01), Davis et al.
patent: 7723099 (2010-05-01), Miller et al.
patent: 2003/0059954 (2003-03-01), Vikholm et al.
patent: 2004/0018556 (2004-01-01), Cantor
patent: 2004/0018577 (2004-01-01), Campbell et al.
patent: 2005/0054078 (2005-03-01), Miller et al.
patent: 2006/0121626 (2006-06-01), Imrich
patent: 2006/0160164 (2006-07-01), Miller et al.
patent: 2008/0261242 (2008-10-01), Goix et al.
Miller, Immunoassay Reliability, CLI Apr. 2004; pp. 1-3.
Bjerner et al. Human heterophilic antibodies display specificity for murine IgG subclasses, Clinical Biochemistry 38: 465-472 (2005).
Boscato et al., Heterophile antibodies: A problem for all immunoassays, Clin Chem 34, 27-33, 1988.
Kricka, “Human Anti-Animal Antibody Interferences in Immunological Assays,” Clinical Chemistry 45:7 at 942-956 (1999).
Laurell et al., “Electroimmunoassay”, Methods in Enzymology, vol. 73, Academic Press, New York, 339, 340, 346-348 (1981).
Green, “Electrochemical Immunoassays”, Phil. Trans. R. Soc. Lond. 316:135-142. 1987.
Nicholson et al., Immunoglobulin inhibiting reagent (IIR): Evaluation of a new method for eliminating spurious elevation in CA125 cuased by HAMA, Intl J Biol Markers 11, 46-49, 1996.
Clinical and Laboratory Standards Institute (CLSI) Immunoassay Interference by Endogenous Antibodies; Approved Guideline. CLSI document I/LA30-P (ISBN 1-56238-633-6) Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2007.
Bjerner, Johan, et al., “Human heterophilic antibodies display specificity for murine IgG subclasses”, Clinical Biochemistry, May 2005, vol. 38, No. 5, pp. 465-472.
International Search Report and Written Opinion for PCT/ US2010/028491 mailed on Jun. 18, 2010.
Campbell John Lewis Emerson
Omakor John Emegbero
Abbott Point of Care Inc.
Gabel Gail R
Roberts Mlotkowski Safran & Cole P.C.
LandOfFree
Amelioration of heterophile antibody immunosensor interference does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Amelioration of heterophile antibody immunosensor interference, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Amelioration of heterophile antibody immunosensor interference will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-4298207