Claims for Patent: 7,875,435

Summary for Patent: 7,875,435

Title:	Diagnostic testing process
Abstract:	A method and apparatus for use in a flow through assay process is disclosed. The method is characterized by a \"pre-incubation step\" in which the sample which is to be analysed (typically for the presence of a particular protein), and a detection analyte (typically one or more antibodies bound to colloidal gold or a fluorescent tag) which is known to bind to the particular protein may bind together for a desired period of time. This pre-incubation step occurs before the mixture of sample and detection analyte come into contact with a capture analyte bound to a membrane. The provision of the pre-incubation step has the effect of both improving the sensitivity of the assay and reducing the volume of sample required for an assay. An apparatus for carrying out the method is disclosed defining a pre-incubation chamber for receiving the sample and detection analyte having a base defined by a membrane and a second membrane to which a capture analyte is bound. In one version the pre-incubation chamber is supported above the second membrane in one position but can be pushed into contact with the membrane carrying the capture analyte thus permitting fluid transfer from the incubation chamber through the capture membrane. In another version the membrane at the base of the incubation chamber is hydrophobic and its underside contacts the capture membrane and when a wetting agent is applied to the contents of the pre-incubation chamber fluid transfer occurs.
Inventor(s):	Marlborough; David Ian (Balgowlah, AU), Sloane; Andrew John (Balmain, AU), Cole; Robert Alan (Greenwich, AU), Hunter; William Samuel (Jan Juc, AU)
Assignee:	Proteome Systems Ltd (North Ryde, AU)
Application Number:	10/497,925
Patent Claims:	1. A method for assaying for the presence of at least one reagent in a liquid sample of microbial extracts, said method comprising: a) providing a first porous membrane to which a plurality of capture analytes have been bound wherein each capture analyte of said plurality binds to a reagent in the sample, if present; b) placing a liquid sample of microbial extracts comprising particulate and non-particulate material to be assayed and a multi-detection analyte in a chamber having a base defined by a second porous membrane through which membrane the particulate material cannot pass, wherein said multi-detection analyte comprises a plurality of detection compounds bound to a detectable element; c) allowing a sufficient period of time to pass for the plurality of detection compounds of the multi-detection analyte to bind to one or more reagents in the sample, if present, by virtue of an affinity of a detection compound for a reagent, thereby forming a complex between a reagent and the multi-detection analyte; d) contacting the base of the chamber with the first porous membrane; e) causing non-particulate material in the microbial extract to flow through the first and second porous membranes, thereby separating and removing particulate material from non-particulate material by filtration through the second porous membrane and permitting non-particulate material to flow through to the first porous membrane, under conditions sufficient for the complex at (c) to bind to a capture analyte on the first porous membrane, thereby forming a complex between the multi-detection analyte and at least one reagent in the sample and a capture analyte; and f) detecting the detectable element in the complex formed at (e) wherein the presence of said detectable element indicates the presence of at least one reagent in the sample. 2. The method as claimed in claim 1 further comprising: removing the chamber and washing the first porous membrane with a buffer prior to detecting the detectable element. 3. The method as claimed in claim 2 further comprising: washing the first porous membrane with a buffer by addition of said buffer to the chamber before removing said chamber and detecting said detectable element. 4. The method as claimed in claim 1 further comprising removing or neutralizing unwanted analytes in the sample to be tested that may interfere with the binding of the reagent with the reagent on the first membrane in the chamber. 5. The method as claimed in claim 4, wherein the unwanted analytes are removed or neutralized by contacting the antibodies or other ligands that bind to said unwanted analytes with the unwanted analytes and wherein said antibodies or other ligands are bound to the walls or the base of the chamber. 6. The method as claimed in claim 1 further comprising swirling an absorbent swab having the sample to be tested absorbed thereto in an extraction solution in the chamber. 7. The method as claimed in claim 1 wherein the multi-detection analyte comprises a detection compound selected from the group consisting of an antibody, a ligand and an antigen. 8. The method as claimed in claim 7, wherein the antibody is an immunoglobulin G. 9. The method as claimed in claim 7 wherein the detection compound is an antibody. 10. The method as claimed in claim 7 wherein the detection compound is a ligand. 11. The method as claimed in claim 7 wherein the detection compound is an antigen. 12. The method as claimed in claim 1, wherein the multi-detection analyte comprises detection compounds consisting of two or more antibodies. 13. The method as claimed in claim 12 wherein at least one of the two or more antibodies is a control antibody. 14. The method as claimed in claim 1, wherein the multi-detection analyte comprises detection compounds consisting of three or more antibodies. 15. The method as claimed in claim 1, wherein the multi-detection analyte comprises a detectable element selected from the group consisting of colloidal gold particle, latex bead, coloured dye and colloidal carbon. 16. The method as claimed in claim 15, wherein the detectable element is a colloidal gold particle. 17. The method as claimed in claim 15, wherein the detectable element is a latex bead linked to a coloured dye. 18. The method as claimed in claim 15, wherein the detectable element is colloidal carbon. 19. The method as claimed in claim 1, wherein the multi-detection analyte consists of two or more antibodies conjugated to a colloidal gold particle. 20. The method as claimed in claim 1 wherein the second membrane is a hydrophobic membrane.

Details for Patent 7,875,435

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668	12/12/2018		2021-12-12