Diagnostics testing devices and processes

• US 4,385,115 A
• Filed: 10/22/1980
• Issued: 05/24/1983
• Est. Priority Date: 10/22/1980
• Status: Expired due to Term

• Current Assignee: Hoffmann-La Roche Incorporated (Roche Holding AG)
• Original Assignee: Hoffmann-La Roche Incorporated (Roche Holding AG)
• Inventors: de Zabala, Edward F., Savard, Edward V., Taylor, Doris B.
• Primary Examiner(s): Warden, Robert J.
• Application Number:
  US06/199,399
• Time in Patent Office: 944 Days
• Field of Search: 435/32, 435/33, 435/299, 435/300, 435/301, 222/485, 222/486, 222/565
• US Class Current: 435/33
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/0684 Venting, avoiding backpressure, avoid gas bubbles
• CPC Class Codes: B01L 2300/0803 Disc shape
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2400/0409 centrifugal forces
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: C12M 41/34 of gas
• CPC Class Codes: C12M 41/36 of biomass, e.g. colony counters or by turbidity measurements electrooptical investigation of individual particles G01N15/14, flow cytometers G01N15/1404
• CPC Class Codes: C12Q 1/04 Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor C12Q1/6897 takes precedence
• CPC Class Codes: G01N 2021/0325 Cells for testing reactions, e.g. containing reagents
• CPC Class Codes: G01N 2021/0328 Arrangement of two or more cells having different functions for the measurement of reactions
• CPC Class Codes: G01N 21/03 Cuvette constructions
• CPC Class Codes: G01N 21/253 for batch operation, i.e. multisample apparatus analytical automats G01N35/00
• CPC Class Codes: G01N 21/78 producing a change of colour

Abstract

A convenient, self-contained, disposable device suitable for the rapid identification of microorganisms, having capability for simultaneously carrying out a multiplicity of analytical determinations. The device comprises a disc-shaped arrangement defining a multiplicity of satellite testing chambers each of which is connected to a centrally defined chamber. The central chamber is provided with a movable sleeve or piston arrangement. Liquid sample is received in the central chamber and the sleeve is manipulated to provide samples uniformly and simultaneously to each of the satellite testing chambers without resorting to external means, such as positive or a negative pressurization or centrifugal force. Also disclosed are unique disc-shaped optically transparent support films which are coated on one or both sides with analytical substrates or reagents which are predispensed to the satellite testing chambers.

Claims

1. A diagnostic device having a first chamber for receiving a sample and a multiplicity of separate analysis chambers in controlled communication only with the first chamber, wherein the improvement comprises the combination of:

(a) at least one diagnostically useful substance predispensed in solid form to each of the individually viewable, optically transparent analysis chambers;

(b) optically transparent and flat cover seal means being disposed above each of the analysis chambers to render each analysis chamber individually viewable in a vertical orientation from above said analysis chamber;

(c) self-contained means for controlling communication between the first source chamber and the optically transparent analysis chambers, and for dispensing sample from the first chamber simultaneously and in uniform amount to each of the analysis chambers concurrently with venting said first chamber said means being adjustably interdisposed between said first chamber and said analysis chambers; and

(d) analysis chambers circumferentially arranged relative to the first chamber, each of said analysis chambers sharing in common a wall with the immediately adjacent analysis chambers.

2. A device according to claim 1 wherein said diagnostically useful substance is disposed apart from a wall defining said analysis chamber.

3. A device according to claim 1 or 2 wherein said at least one diagnostically useful substance comprises a pair of such substances which are normally incompatible.

4. A device according to claim 1 or 2 wherein said diagnostically useful substance is coated onto at least one surface of an optically transparent support.

5. A device according to claim 4 wherein at least one diagnostically useful substance is coated onto each side of said support, and at least one of said substances on the one side of said support is normally incompatible with at least one of said substances on the other side of said support.

6. A device according to claim 5 wherein each substance coated onto said support has a property for microorganism identification.

7. A device according to claim 5 wherein said analysis locations are provided with means for supporting a side of said optically transparent support thereby enabling simultaneous access of the sample to all surfaces of said predispensed substances.

8. A device according to claim 1 wherein the optically transparent analysis chambers are circumferentially arranged relative to the first chamber and share in common an optically transparent cover seal means.

9. A device according to claim 1 wherein said self-contained accessing means is adjustably interdisposed between said source and analysis locations and is structured for a reversible linear vertical movement relative to source and analysis locations whereby communication between said source and analysis locations and venting above said source location is concurrently controlled.

10. A device according to claim 9 wherein said self-contained accessing means is a substantially cylindrical sleeve disposed adjacent to and surrounding said source location and structured to provide a vertical displacement.

11. A device according to claim 1 wherein said self-contained accessing means is adjustably interdisposed between said source and analysis locations and is structured for a reversible rotary movement relative to source and analysis locations whereby communication between said source and analysis locations and venting above said source location is concurrently controlled.

12. A device according to claim 11 wherein said self-contained accessing means is a substantially cylindrical sleeve disposed adjacent to and surrounding said source location and structured to provide a horizontal rotary movement.

13. A device according to claim 1 wherein said self-contained accessing means is adjustably interdisposed between said source and analysis locations and is structured for a reversible screw movement whereby communication between said source and analysis locations and venting above said source location is concurrently controlled.

14. A device according to any of claims 13 wherein said self-contained accessing means provides means for simultaneously closing the vent means above the first chamber and blocking communication between the source and analysis locations thereby sealing the dispensed sample at each of the analysis locations.

15. A device according to any of claims 9, 13 or 14 wherein said self-contained accessing means comprises a substantially cylindrical sleeve disposed adjacent to and surrounding said source location.

16. A device according to claim 15 wherein said source location comprises a first chamber and said analysis locations comprise a multiplicity of separate, optically transparent analysis chambers circumferentially spaced about the substantially cylindrical sleeve and source chamber.

17. A device according to claim 16 further comprising a multiplicity of passageway means for facilitating transfer of sample from the first chamber to the optically transparent analysis chambers when said sleeve is moved, said multiplicity of passageway means being formed on the wall defining the first chamber and radiating out to the analysis chambers from said first chamber and each said passageway means being in communication with a an optically transparent, separate analysis chamber.

18. A device according to claim 16 wherein each of the analysis locations includes a venting arrangement above the analysis locations.

19. A device according to claim 18 wherein said venting arrangement includes a venting chamber.

20. A device according to claim 19 wherein said venting arrangement further includes means for enabling the venting chamber to communicate with the respective analysis chamber and the atmosphere.

21. A device according to claim 20 wherein said enabling means is structured to pass gaseous matter and block passage of liquid and solid matter.

22. A device according to claim 19 wherein said venting chamber is disposed above the analysis chamber.

23. A device according to claim 19 wherein said venting chamber is provided with at least one predispensed substance useful in sample identification.

24. A device according to claim 1 wherein said self-contained accessing means comprises a piston arrangement adjustably disposed at the source location for pressurizing the first chamber whereby communication between the source and analysis locations is controlled.

25. A device according to claim 24 wherein said self-contained accessing means further comprises a screw movement adjustable, threaded piston arrangement.

26. A device according to claim 1 further including a multiplicity of inclined passageway means in controlled communication with the source location and the analysis locations for facilitating the dispensing of sample to the analysis locations.

27. A device according to claim 1 wherein a plurality of said substances is predispensed in at least one analysis location.

28. A device according to any one of claims 1, and 27 wherein said substances are in solid form.

29. A device according to claim 28 wherein said substances are coated on opposite sides of a support material which is optically transparent.

30. A device according to claim 29 wherein at least one analysis location is provided with a plurality of said coated supports.

31. Diagnostic method comprising:

(a) predepositing in solid form at least one selected substance useful in the identification of at least a part of a sample, into each of a series of separate, optically transparent analysis chambers;

(b) depositing a sample in a single source chamber;

(c) providing a portion of said sample simultaneously to each of the separate analysis chambers and while maintaining the orientation of the device concurrently venting said source chamber, such that a substantially uniform amount of sample is received therein; and

(d) individually measuring the nature and extent of reactions between the sample portion and substance useful in its identification in each optically transparent, separate analysis chamber whereby the nature and extent of said reactions are indicative of identifying characteristics of said sample.

32. A method according to claim 31 wherein said sample identification comprises identifying microorganisms.

33. A method according to claim 32 wherein said microorganism identification includes measuring the endogenous respiration.