Bio Drive Apparatus, and Assay Method Using the Same

• US 20090163367A1
• Filed: 06/28/2006
• Published: 06/25/2009
• Est. Priority Date: 06/28/2005
• Status: Active Grant

• Current Assignee: Precision Biosensor Inc.
• Original Assignee: Samsung Electronics Co. Ltd.
• Inventors: Yoo, Jae Chern
• Granted Patent: US 9,279,818 B2
• Time in Patent Office: Days
• US Class Current: 506/7
• 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
• CPC Class Codes: G16B 99/00 Subject matter not provided for in other groups of this subclass
• CPC Class Codes: G16C 20/10 Analysis or design of chemical reactions, syntheses or processes

Abstract

A non-optical bio-disc, a bio-disc device including the non-optical bio-disc and/or optical disc, a bio-driver apparatus in which a controller disc including a controller for the bio-disc is installed, and an assay method using the same, which are suitable for labs-on-a-chips for various diagnostic assays, nucleic acid hybridization assays, and immunoassays, are provided. The bio-driver apparatus is compatible with general optical discs, including audio, CD-ROMs, DVD players, etc. Thus, the bio-driver apparatus and the assay method offer and economical and convenient alternative to existing products. In addition, the bio-driver apparatus can be readily and easily applied in connection with a computer for remote diagnosis via the internet.

Claims

1. A bio driver apparatus comprising:

a controller for controlling driving of a general optical disc or a bio disc;

a strip insert slot into which a test strip for measuring bio sample is inserted; and

a bio sensor for assaying the test strip.

2. The bio driver apparatus according to claim 1, wherein the bio disc includes:

chambers which reserve a buffer or reaction solution;

an assay site where bio materials specifically reacting with the bio sample are fixed and arrayed on a substrate;

channels through which fluid flows between the chambers and the assay site;

holes which connect the channels; and

,

valves which are used to opens and close the holes.

3. The bio driver apparatus according to claim 2, wherein the valve includes:

a micro beads disposed in a hole;

a permanent magnet disposed above the micro bead; and

a movable permanent magnet disposed under the micro bead.

4. The bio driver apparatus according to claim 3, further comprising:

a turntable on which the bio disc or the general optical disc is mounted;

a spindle motor which rotates the bio disc or the general optical disc;

a slider which includes a detector device for detecting an assay site in the bio disc and a permanent magnet for controlling opening and closing of the valves in the bio disc;

a slide motor which controls moving of the slider;

a central control unit which controls whole components of the bio driver;

and a body which supports the bio driver.

5. The bio driver apparatus according to claim 4, wherein the slider is provided with a bio optical pickup module (BOPM) device where an optical sensor, an image sensor, or a fluorescent image sensor for detecting the assay site or product ID and a general optical pickup device (CD or DVD disk reader) are integrated as a module.

6. The bio driver apparatus according to claim 1, wherein the bio sensor assays a coloring-method test strip and/or an electrode-method test strip.

7. The bio driver apparatus according to claim 6, wherein the bio sensor for assaying the coloring-method test strip includes:

a light emitting device and a sensing device for measuring a change in color according to a reaction of a reagent on the coloring-method test strip and the bio sample;

a A/D converter for converting a result of measurement into a digital value; and

a central control unit which reads a digital signal output from the A/D converter.

8. The bio driver apparatus according to claim 6, wherein the bio sensor for assaying the electrode-method test strip includes:

an A/D converter for converting a predetermined current generated from a working electrode according to a reaction of a reagent on the electrode-method test is strip and the bio sample into a digital value; and

a central control unit which reads a digital signal output from the A/D converter.

9. The bio driver apparatus according to claim 6, wherein the bio sensor is provided with a mount portion where the coloring-method test strip and the electrode-method test strip are mounted.

10. The bio driver apparatus according to claim 1, wherein the bio sensor or the mounting portion further includes strip ID reading means for determining when the test strip is inserted into the strip insert slot and/or for reading strip ID.

11. The bio driver apparatus according to claim 10, wherein the strip 4, ID reading means is constructed with an image sensor.

12. The bio driver apparatus according to claim 11, wherein the image sensor includes a line image sensor and a light exposure means disposed in the vicinity of the line image sensor.

13. The bio driver apparatus according to claim 10, wherein the strip ID is a bar code pattern printed on the test strip.

14. The bio driver apparatus according to claim 10, wherein the strip ID reading means further includes a central control unit which recognizes information such is as a correction code number of the test strip, a type of the strip, and a type of an assayed material by using the strip ID.

15. The bio driver apparatus according to claim 14, wherein the central control unit controls and drives the bio sensor according to a protocol associated with the correction code number of the test strip, the type of the strip, and the type of the assayed material.

16. The bio driver apparatus according to claim 5, wherein the controller or the bio optical pickup module (BOPM) device further includes product ID reading means for determining whether the bio disc is loaded or for identifying the product ID of the loaded bio disc.

17. The bio driver apparatus according to claim 16, wherein the product ID is a bar code pattern printed on the bio disc.

18. The bio driver apparatus according to claim 16, wherein the product ID reading means further includes a central control unit which recognizes information such as a control protocol for the bio disc, an assay algorithm, a standard control value for reading the assay site, positional information on the assay site, and array information of the assay site by using the product ID.

19. The bio driver apparatus according to claim 10, further comprising is an input output device for providing the product ID or the strip ID to a computer and receiving a control command associated with the product ID or the strip ID from the computer.

20. The bio driver apparatus according to claim 19, wherein the input output device is a USB (Universal Serial Bus) device or a device according to IEEE1394, ATAPI, or Internet communication standard.

21. The bio driver apparatus according to claim 19, wherein the computer provides a control command associated with the product ID or the strip ID to the central control unit or a user interface (graphic user interface).

22. The bio driver apparatus according to claim 21, wherein the control command includes information such as control protocol for the bio disc, an assay protocol and algorithm for the test strip, a standard control value for reading the assay site, positional information on the assay site, and array information of the assay site.

23. The bio driver apparatus according to claim 21, wherein the user interface includes information on the assay algorithm, information on self diagnosis, device driver software, educational information for patients on clinical assays, and web sites and links enabling a patient to communicate with a doctor or hospital at a remote location based on his/her diagnosis result, or encrypted personal information.

24. The bio driver apparatus according to claim 19, wherein the computer is further includes a wire or wireless network for downloading or updating device driver software for the bio driver apparatus.

25. The bio driver apparatus according to claim 19, wherein the computer further includes a monitor (display device) for providing a graphic user interface which displays a status of progress of main processes and steps of the bio driver apparatus in percentage (%) or as a bar graph or a pie graph or providing a graphic user interface which displays a statistical result of diagnosis and assay and performs remote diagnosis.

26. The bio driver apparatus according to claim 21, wherein the graphic user interface further includes statistic software for manages a result of reading quantitative analysis of the assay site or the test strip and a history thereof and provides information on periodic diagnosis to a user.

27. The bio driver apparatus according to claim 26, wherein the statistic software for history management is driven by password registration and authentication at the time of diagnosis so as to perform the history management of the reading result for persons.

28. The bio driver apparatus according to claim 21, wherein the graphic user interface further includes software for measuring an intensity of a coloring light for the assay site of the bio disc and determining negative, positive or dangerous group, or calculating values thereof.

29. The bio driver apparatus according to claim 21, wherein the graphic user interface further includes software for determining negative, positive or dangerous group, or calculating values thereof based on the result of measurement obtained from the test strip.

30. The bio driver apparatus according to claim 21, wherein the graphic user interface further includes bio disc use history information providing means for performing history management of the product ID and providing information on how many times the currently loaded bio disc is used, information on a valid time, information on types of d disease which can be diagnosed, so that the information is provided to a user at the time of the bio disc being loaded.

31. The bio driver apparatus according to claim 30, wherein the graphic user interface provides the bio disc use history information through the input output device to a central server.

32. The bio driver apparatus according to claim 3, wherein the micro bead is a film-like cylindrical magnet.

33. The bio driver apparatus according to claim 32, wherein the valve is coated with a rubber cushion material or constructed by inserting a film-like rubber cushion material between the micro bead and the hole.

34. The bio driver apparatus according to claim 4, wherein the slider is connected to a slider motor with a worm gear so as to control a movement thereof.

35. The bio driver apparatus according to claim 4, further comprising disc type determining means for determining whether the disc loaded on the bio driver apparatus is a general optical disc or a bio disc.

36. The bio driver apparatus according to claim 5, wherein the bio optical pickup module (BOPM) device reads a groove pattern or a product ID pattern on a specific position of the bio disc so as to allow the central control unit to recognize that the disc currently loaded on the bio driver apparatus is the bio disc.

37. The bio driver apparatus according to claim 5,

wherein the central control unit determines whether the disc is a general optical disc or a bio disc, wherein, when the disc is the general optical disc, the central control unit transmits content of the optical disc from the optical pickup device to a storage unit of an output unit, transmits to-be-written content to the optical pickup device, or provides control signals for read and write to the components, and

wherein, when the disc is the bio disc, the central control unit transmits bio control command signals for controlling the bio disc to the bio optical pickup module (BOPM) device.

38. The bio driver apparatus according to claim 5, wherein the image sensor or the fluorescent image sensor is a line (one-dimensional) image sensor which senses light intensity in units of pixel.

39. The bio driver apparatus according to claim 38, wherein the line image sensor is a linear sensor array or a CIS (contact image sensor).

40. The bio driver apparatus according to claim 38, wherein the line image sensor further includes a light emitting diode (LED) for light exposure or fluorescence lighting and an optical lens which are disposed in the vicinity of the line image sensor, thereby constituting the bio optical pickup module (BOPM) device.

41. The bio driver apparatus according to claim 38, wherein the line (one-dimensional) image sensor is moved on the slider to obtain two-dimensional image information of the assay site

42. The bio driver apparatus according to claim 1, further comprising a light emitting diode (LED) for indicating that the bio disc is on operation.

43. The bio driver apparatus according to claim 4, wherein the body which supports the bio driver is constructed as a top loading type for the bio disc or a front loading type for the bio disc.

44. The bio driver apparatus according to claim 1, further comprising an eject button for ejecting the test strip from the inserted slot.

45. The bio driver apparatus according to claim 1, further comprising a liquid crystal display, so that the bio driver apparatus is used as a portable type.

46. The bio driver apparatus according to claim 45, further comprising a drawer for accommodating lancet tools.

47. An assay method using the bio driver apparatus according to claim 15, comprising steps of:

inserting the test strip into the strip insert slot;

reading the strip ID on the test strip;

performing diagnosis and assay of the bio sample on the strip according to the protocol corresponding to the read strip ID; and

displaying a result of the diagnosis and assay.

48. An assay method using the bio driver apparatus according to claim 18, comprising steps of:

loading the bio disc on the bio driver apparatus;

to reading the product ID on the bio disc;

driving the bio disc according to the control protocol corresponding to the read product ID;

analyzing the assay site by using the positional information of the assay site and the array information thereof according to the read product ID; and

display a result of the diagnosis and analysis of the assay site.

49. The assay method according to claim 47, further comprising a step of displaying a statistical result of the diagnosis and analysis.

50. The assay method according to claim 47, further comprising steps of:

transmitting the results to a doctor via a communication network; and

performing a remote diagnosis between the doctor and a patient through remote communication.

51. The assay method according to claim 48, further comprising a step of determining whether the disc loaded on the bio driver apparatus is a bio disc or a general optical disc.

52. The assay method according to claim 47, further comprising a step of providing information on a valid time bead on the strip ID or the product ID to a user or informing a user that a bio disc and strip is expired and cannot be diagnosed or used.

53. The assay method according to claim 49, wherein a statistical result of the diagnosis and analysis is displayed in a graph which represents a change in blood sugar, cholesterol, GOT, GPT, or cancer marker or a change in component of a urine test according to time, so that tracing management can be performed.

54. The assay method according to claim 47, further comprising a step of ring a buzzer when the strip ID of the test strip inserted into the strip insert slot is read.

55. The assay method according to claim 47, further comprising a step of mounting serum or plasma centrifugally separated by using the bio disc on the test strip.