Antigen preparation for detecting H. pylori
AssigneeQuidel Corporation
InventorsAllan David Pronovost, Jan Waclaw Pawlak, Kristy S. Condon
Life of this patent
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Abstract
A sensitive and specific antigen preparation for the detection of Helicobacter pylori in biological samples is disclosed. The preparation uses a range of antigens derived from size exclusion chromatography of detergent-solubilized H. pylori cells. Serological assays such as ELISA, latex agglutination, and rapid EIA assays utilizing the improved antigen preparation, and a kit for use in these serological assays are also disclosed.
Claims2
A composition comprising Helicobacter pylori-derived proteins useful to detect the presence of H. pylori antibodies
- wherein said H. pylori-derived proteins are obtainable by extracting intact H. pylori cells with n-octyl-.beta.-D-glycopyranoside (BOG) to obtain an extract;
- subjecting said extract to sizing column chromatography to obtain fractions;
- and recovering urease-depleted fractions having a molecular weight of less than about 200 kD as determined by said sizing column chromatography;
- wherein said composition has a urease-specific activity of less than 0.34 OD.sub.550 /A.sub.280 in a urease-catalyzed urease hydrolysis assay;
- and
- wherein the H. pylori-derived proteins in said composition, when denatured and reduced, are characterized by SDS PAGE to consist of antigens specific to H. pylori of molecular weights 120 kD;
- 66 kD;
- 62 kD;
- 59 kD;
- 52 kD;
- and 31 kD and common antigens of molecular weights 89 kD;
- 73 kD;
- 56 kD;
- 45 kD;
- 42 kD;
- 29 kD;
- 25 kD;
- 21 kD;
- and 16 kD;
- and
- wherein the amounts of antigens of 66 kD and of 56 kD are greater than the amounts of any of the remaining individual antigens set forth above.
A composition comprising H. pylori-derived proteins useful to detect the presence of H. pylori antibodies;
- wherein said composition has a urease-specific activity of less than 0.34 OD.sub.550 /A.sub.280 in a urease-catalyzed assay, and the H. pylori-derived proteins in said composition, when denatured and reduced, are characterized by SDS PAGE to consist of antigens specific to H. pylori of molecular weights 120 kD;
- 66 kD;
- 62 kD;
- 59 kD;
- 52 kD;
- and 31 kD and common antigens of molecular weights 89 kD;
- 73 kD;
- 56 kD;
- 45 kD;
- 42 kD;
- 29 kD;
- 25 kD;
- 21 kD;
- and 16 kD;
- and wherein the amounts of antigens of 66 kD and 56 kD are greater than the amounts of any of the remaining individual antigens set forth above.
Dependencies are inferred from the claim text.