Assay device and method

• US 20050214827A1
• Filed: 01/19/2005
• Published: 09/29/2005
• Est. Priority Date: 07/08/1996
• Status: Abandoned Application

• Current Assignee: Burstein Technologies, Inc.
• Original Assignee: Burstein Technologies, Inc.
• Inventors: Virtanen, Jorma
• Application Number:
  US11/039,678
• Publication Number:
  US 20050214827A1
• Time in Patent Office: Days
• US Class Current: 435/6
• CPC Class Codes: B01J 2219/00536 in the shape of disks
• CPC Class Codes: B01J 2219/00605 the compounds being directly bound or immobilised to solid supports
• CPC Class Codes: B01J 2219/0061 The surface being organic
• CPC Class Codes: B01J 2219/00612 the surface being inorganic
• CPC Class Codes: B01J 2219/00619 using hydrophilic or hydrophobic regions
• CPC Class Codes: B01J 2219/00626 Covalent
• CPC Class Codes: B01J 2219/00635 by reactive plasma treatment
• CPC Class Codes: B01J 2219/00648 by the use of solid beads
• CPC Class Codes: B01J 2219/00689 using computers
• CPC Class Codes: B01J 2219/00704 integrated with the reactor apparatus
• CPC Class Codes: B01L 2300/024 Storing results with means integrated into the container
• CPC Class Codes: B01L 2300/0636 Integrated biosensor, microarrays
• CPC Class Codes: B01L 2300/0806 Standardised forms, e.g. compact disc [CD] format
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2300/087 Multiple sequential chambers
• CPC Class Codes: B01L 2400/0409 centrifugal forces
• CPC Class Codes: B01L 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/545 for laboratory containers
• CPC Class Codes: G01N 35/00069 whereby the sample substrate is of the bio-disk type, i.e. having the format of an optical disk

Abstract

A cleavable signal element for use in quantitative and qualitative assay devices and methods is described. Binding of the chosen analyte simultaneously to a first and a second analyte-specific side member of the cleavable signal element tethers the signal-responsive moiety to the signal element'"'"'s substrate-attaching end, despite subsequent cleavage at the cleavage site that lies intermediate the first and second side members. Assay devices comprising the cleavable signal elements are described, as are analytic methods adapted to their use. The analytic devices of the present invention may be adapted to detection using conventional CD-ROM and DVD readers.

Claims

1. An assay device comprising:

a laser readable disk;

one or more individual assay sectors including analyte binding cleavable signal elements within said disk to be scanned by an incident beam of a laser of a laser disc reader, wherein the signal elements provide an indication of the presence of an analyte by reflection of the incident beam;

a sample inlet port associated with each of said one or more assay sectors to be scanned by the incident beam of, and read by, a laser disk reader;

computer software encoded in said disk which is encoded in an annular area of an inner portion of said disk, which is spatially separate from said assay sectors to allow separate scanning of said software and said sectors; and

said sectors and software being provided in said disk for being read by the same laser disk reader.

2. The assay device of claim 1 wherein said elements are provided within said sectors within said disk in a predetermined spatially addressable manner.

3. The assay device of claim 1 wherein said software includes information selected from the group:

tracking information for tracking of an incident laser, assay interpretive algorithms, standard control values and self-diagnostics.

4. The assay device of claim 1 wherein said analyte binding cleavable signal elements comprise a cleavable spacer and a signal responsive moiety, and wherein said signal responsive moiety is adapted to reflect or scatter incident light.

5. The assay device of claim 3 wherein said software is capable of uploading diagnostic information to remote locations.

6. The assay device according to claim 4, wherein said signal responsive moiety is a metal microsphere.

7. The assay device according to claim 4, wherein said cleavable spacer includes a first side member and a second side member, said members including oligonucleotides.

8. The assay device according to claim 4, wherein said cleavable spacer includes a first side member having a first antibody, and a second side member having a second antibody.

9. The assay device according to claim 6, wherein said metal microsphere is essentially a metal selected from the group of gold, silver, nickel, platinum, chromium and copper.

10. The assay device according to claim 6, wherein said metal microsphere is ferromagnetic.

11. The assay device according to claim 7, wherein said first and second side member oligonucleotides are 5mers-20mers.

12. A laser light detector readable disk comprising:

a plurality of assay sectors individually segregated within said disk for individual detector inspection of a sample introduced into a respective sector by laser light;

a sample inlet port associated with each of said assay sectors;

laser light detectable software encoded in said disk in an area spatially distinct in a lateral direction of the disk from said assay sectors;

address information encoded in said disk spatially adjacent to said assay sectors to provide location information as to said assay sectors, and

wherein said assay sectors are positioned about said disk in radially extending spaced relation and said address information is encoded in or on said disk between said assay sectors.

13. The disk of claim 12 wherein said software is separately readable from said assay sectors.

14. The disk of claim 12 wherein analyte binding elements are provided within at least one of said sectors.

15. The disk of claim 14 wherein said analyte binding elements include oligonucleotides to bind an analyte within said sector for inspection by a laser light detector.

16. The disk of claim 14 wherein said analyte binding elements include cleavable signal elements having a cleavable spacer and a signal responsive moiety.

17. The disk of claim 16 wherein said cleavable spacer includes a first side member and a second side member, said members including oligonucleotides.

18. The disk of claim 16 wherein said signal responsive moiety is adapted to reflect or scatter incident light.

19. A method for conducting an inspection of an analyte preselected for detection through the use of a laser disk and laser disk reader having an incident laser which scans the disk under the control of an associated computer, comprising:

providing one or more analyte binding cleavable signal elements in a predetermined first location on or within a substrate of a laser readable disk,

introducing a sample, suspected of including an analyte which will bind to said one or more elements, to said predetermined first location,

reading software information, including incident laser tracking control information, encoded on or in said disk in a second location which is spaced separate and laterally relative said disc from said first location; and

scanning said incident laser under the control of a computer over said predetermined location to determine a presence or absence of an analyte at said location using said tracking control information and reflective properties of said signal elements, wherein a plurality of analyte binding cleavable signal elements are provided in a spatially addressable pattern.

20. The method of claim 19 wherein address information is encoded in said disc which is used in the scanning of said incident laser to address a location to be scanned.