Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or...
Reexamination Certificate
2001-10-12
2004-11-30
Nguyen, Bao-Thuy L. (Department: 1641)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
C435S005000, C435S187000, C435S287700, C435S970000, C435S975000, C436S514000, C436S518000, C436S507000, C436S530000, C436S807000, C436S821000, C436S810000, C422S051000, C422S051000, C422S051000
Reexamination Certificate
active
06824975
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention discloses a method and composition for detecting the presence of antibodies in human or animal bodily fluids (blood, serum, plasma, urine, colostrum, milk, tears, or saliva) to analytes such as bacteria, Chlamydiae, Rickettsiae, protozoa, allergens, autoimmune antigens, viral proteins, and carbohydrates by lateral flow techniques.
2. Description of the Prior Art
Over the years, numerous patents have been issued involving immuno-chromatographic devices. The standard features of these devices comprise the following:
a) A plastic or paper housing allowing the viewing of a reaction area on a bibulous (lateral flow) strip;
b) An opening at one end of the housing allowing for the addition of sample (urine, blood, plasma, serum or bacteria in a media base);
c) Bibulous material (the lateral flow strip) having immobilized specific binding members (analytes) capable of reacting with antigens or antibodies.
d) A pad of absorbent bibulous material (the absorbent pad) enclosed at the end opposite the sample well and used to absorb transversely flowing sample, buffers and colloids;
e) A strip of bibulous material used in the sample well end to initially absorb the sample being applied;
f) A strip of bibulous material in contact with the sample well material and the lateral flow strip and containing a dried colored solid phase reagent, the solid phase coated with proteins or haptens.
Two types of chromatographic immunoassays are commonly described. In the one, proteins or small molecule analytes contained in human fluids (urine, blood, plasma, serum, and saliva) are detected. The analytes include hCG, FSH, LH, CKMB, TSH, troponins, myoglobulin, cancer proteins, viral/bacterial proteins, haptens, therapeutic drugs, and drugs of abuse.
In the other chromatographic immunoassay, the analyte being detected is human antibody specifically reactive with agents such as viral/bacterial proteins (HIV, Hepatitis A and C,
H. pylori
, EBV, Rubella, CMV, HSV, Dengue fever, Lyme, Chagas, TB, Toxoplasma, autoimmune antigens, etc.) or allergens (pollens, molds, dust/mites, foods, animal epithelia, etc.). The various analytes are abbreviated VB for simplified use below. When it comes to detecting antibody, three formats are typically used:
1) The colored solid phase [SP] is coated with proteins or lectins [protein A, protein G, lentil lectin, jacalin, concanavilin A, mannan binding protein, wheat germ lectin, peanut lectin and avidchrom] that react with human IgG antibodies. The solid phase may be coated with anti-immunoglobulins that specifically react with IgG, IgM, IgA, or IgE. The bibulous strip would in this case contain the analyte (VB) of interest to which the specific antibody contained in the sample reacts.
2) The colored solid phase contains the analyte (VB) to which the human immunoglobulins react. The bibulous strip would in this case also contain the analyte (VB) of interest to which the specific antibody contained in the sample reacts.
3) The colored solid phase contains the analyte (VB) to which immunoglobulins react. The bibulous strip contains proteins directed against human IgG or total immunoglobulins (protein A, protein G, lectins, lentil lectin, jacalin, concanavilin A, mannan binding protein, wheat germ lectin, peanut lectin and avidchrom or a mix of antibody to immunoglobulin classes IgG, IgA, IgM and IgE).
U.S. Pat. No. 5,459,041 (Blaser et al.) discloses antigenic compositions for use in diagnostic kits and the like for detecting the presence of antibodies specific for
Campylobacter pylori
, Samples of bodily fluids, for instance, may be contacted with immobilized antigen on a solid phase which is then washed and tested for the occurrence of significant levels of antigen/antibody complex. Levels exceeding a predetermined positive threshold are indicative of antibodies to
Campylobacter pylori
in the sample tested. Kits employing the antigenic compositions of the invention preferably include means for detecting the antigen/antibody complex such as materials and reagents for conducting an enzyme-linked immunosorbent assay, Western blot technique, ELISA, liposome-based assay or other known detection tests. The Western blot and ELISA tests used here are for the detection of IgA and IgG antibodies.
U.S. Pat. No. 5,567,594 (Calenoff) discloses a library of isolated and purified antigens specific for a microorganism is a set of individual molecules. The library forms antigen-antibody complexes useful in the context of diagnosing and treating conditions associated with a specific microorganism such as
H. pylori
-induced gastro-duodenal disease. For the antigen-antibody complexes the antibody in question is an immunoglobulin, which is IgE if the antigens are allergens. Antigen-antibody complexes with IgA, IgG and IgM are also useful if the antigen is a bacteria. By this multivariate approach, a specific condition is diagnosed with high sensitivity and specificity by determining whether complexes form between a specific antigen library and a biological sample which contains immunoglobulins from an individual. Such libraries also are useful for immunotherapy. Western blot is used to detect IgE antibodies. The method requires enzyme conjugates and enzyme substrates and two wash steps to detect antibodies.
U.S. Pat. No. 5,420,014 (Cripps et al.) discloses a method for detecting a current infection by
H. pylori
in a mammal. The method comprises contacting a mucous secretion [saliva] from said mammal with an immobilized antigen component from
H. pylori
for a time and under conditions sufficient for an IgG antibody in said mucous secretion specific to a antigen component to form a complex therewith and then subjecting said complex to a detecting means which involves an enzyme conjugate and specific substrate.
U.S. Pat. No. 6,068,985 (Cripps) discloses a method which uses saliva to detect IgG in both the Western Blot and ELISA tests. This detection method requires the use of an enzyme conjugate and enzyme substrate and two wash steps to detect the antibody.
U.S. Pat. No. 5,846,751 (Pronovost et al.) discloses a sensitive and specific antigen preparation for the detection of
Helicobacter pylori
in biological samples. The preparation uses a range of antigens derived from size exclusion chromatography of detergent-solubilized
H. pylori
cells and the purified antigen preparation is coated on the solid phase. Serological assays such as ELISA, latex agglutination, and rapid EIA assays are used to detect antibodies to
H. pylori
. The invention also uses a lateral flow device to detect total immunoglobulins to
H. pylori
. In this case, the
H. Pylori
antigen is striped on the membrane reaction area and also coated to the colored solid phase. The antibody in the sample reacts first with
H. pylori
gold coated conjugate, and then travels to the membrane reaction area where it reacts with striped
H. pylori.
U.S. Pat. No. 5,200,344 (Blaser et al) uses a purified p28kd protein from
H. pylori
to detect IgA, IgM and IgG antibody in ELISA and Western Blot. The test requires conjugate and enzyme substrate and two wash steps to detect the antibody.
U.S. Pat. Nos. 6,060,326 and 5,945,294 (Frank et al.) discloses methods to detect canine IgE using a canine Fc epsilon receptor to detect canine IgE antibodies in a biological sample from a canine.
U.S. Pat. No. 5,547,833 (Dorval et al.) discloses a radial flow assay delivery device, and methods of use.
None of these patents teach or disclose a fast and effective lateral flow assay test for the testing of multiple-class specific antibodies. More specifically, no chromatographic immunoassay is able to distinguish between reactive antibody contained in the classes of human antibody (IgG, IgA, IgM, IgD and IgE). All devices to date detect either total immunoglobulins or IgG. The problem of separating reactivities of antibody class lies in the 10 to 15 fold excess of IgG class specific antibodies over IgA, IgM, and IgE class specific antibodies reactive
Ford Glen M
Hubscher Thomas T.
Ruppenthal Teri M
Dexall Biomedical Labs, Inc
Grant Jonathan
Grant Patent Services
Nguyen Bao-Thuy L.
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