TEST MODULE WITH LOC HAVING ON-CHIP ELECTRONICS FOR MODULE CONTROL

• US 20110312603A1
• Filed: 06/01/2011
• Published: 12/22/2011
• Est. Priority Date: 06/17/2010
• Status: Abandoned Application

• Current Assignee: Geneasys Pty Ltd
• Original Assignee: Geneasys Pty Ltd
• Inventors: SILVERBROOK, KIA, AZIMI, MEHDI, WORSMAN, MATTHEW TAYLOR
• Application Number:
  US13/150,179
• Publication Number:
  US 20110312603A1
• Time in Patent Office: Days
• US Class Current: 506/16
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/023 Sending and receiving of information, e.g. using bluetooth
• 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 2300/0654 Lenses; Optical fibres
• CPC Class Codes: B01L 2300/0883 Serpentine channels
• CPC Class Codes: B01L 2300/10 Means to control humidity and/or other gases
• CPC Class Codes: B01L 2300/1827 using resistive heater
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0633 with moving parts
• CPC Class Codes: B01L 2400/0677 phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
• CPC Class Codes: B01L 2400/0688 surface tension valves, capillary stop, capillary break
• 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 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B01L 3/502738 characterised by integrated valves microvalves F16K99/0001
• CPC Class Codes: B01L 7/52 with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples amplification or hybridisation processes per se C12Q1/68; controlling sequential reactions for synthesis B01J19/0046
• CPC Class Codes: C12Q 1/68 involving nucleic acids
• CPC Class Codes: F16K 99/003 Valves for single use only
• CPC Class Codes: F16K 99/0036 operated by temperature variations
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
• CPC Class Codes: Y10T 137/0352 : Controlled by pressure
• CPC Class Codes: Y10T 137/0391 : Affecting flow by the addition of material or energy
• CPC Class Codes: Y10T 137/1044 : With other condition responsive valve control
• CPC Class Codes: Y10T 137/206 : Flow affected by fluid contact, energy field or coanda effect [e.g., pure fluid device or system]
• CPC Class Codes: Y10T 137/2076 : Utilizing diverse fluids
• CPC Class Codes: Y10T 137/2202 : By movable element
• CPC Class Codes: Y10T 436/107497 : Preparation composition [e.g., lysing or precipitation, etc.]
• CPC Class Codes: Y10T 436/11 : Automated chemical analysis
• CPC Class Codes: Y10T 436/143333 : Saccharide [e.g., DNA, etc.]
• CPC Class Codes: Y10T 436/145555 : Hetero-N
• CPC Class Codes: Y10T 436/173845 : Amine and quaternary ammonium
• CPC Class Codes: Y10T 436/203332 : Hydroxyl containing
• CPC Class Codes: Y10T 436/25 : including sample preparation
• CPC Class Codes: Y10T 436/25375 : Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

Abstract

A test module for analyzing a sample fluid, the test module having a receptacle for receiving the sample, functional sections for processing and analyzing the sample, a supporting substrate, and, CMOS circuitry on the supporting substrate for operative control of the functional sections during processing and analysis of the sample.

Claims

1. A test module for analyzing a sample fluid, the test module comprising:

a receptacle for receiving the sample;

functional sections for processing and analyzing the sample;

a supporting substrate; and

,

CMOS circuitry on the supporting substrate for operative control of the functional sections during processing and analysis of the sample.

2. The test module according to claim 1 further comprising a plurality of reagent reservoirs containing reagents for processing the sample wherein the CMOS circuitry has digital memory for storing data relating to the reagent identities.

3. The test module according to claim 2 wherein the data stored in the digital memory is a unique identifier for test module.

4. The test module according to claim 3 wherein the sample is a biological sample containing genetic material and one of the functional sections is a polymerase chain reaction (PCR) section for amplifying nucleic acid sequences in the sample, and the operational information stored in the digital memory relates to thermal cycle timing and duration.

5. The test module according to claim 4 wherein the functional sections include an incubation section upstream of the PCR section and one of the reagent reservoirs is a restriction enzyme reservoir, the incubation section having a heater for maintaining a mixture of the sample and restriction enzymes at an incubation temperature during restriction digestion of the nucleic acid sequences.

6. The test module according to claim 5 further comprising a temperature sensor wherein the CMOS circuitry uses the temperature sensor output for feedback control of the incubation section.

7. The test module according to claim 4 further comprising an array of probes for hybridization with target nucleic acid sequences in the amplicon from the PCR section.

8. The test module according to claim 7 wherein the data stored in the digital memory includes probe identity data identifying the probe at each site within the array of probes.

9. The test module according to claim 8 wherein each of the probes are configured to form a probe-target hybrid with a complementary target nucleic acid sequence contained in the amplicon, each of the probe-target hybrids being configured to emit photons in response to an input, and the CMOS circuitry incorporates a photosensor for sensing the photons emitted by the probe-target hybrids.

10. The test module according to claim 9 wherein the data stored in the digital memory includes hybridization data generated from the photosensor output.

11. The test module according to claim 10 further comprising a hybridization chamber array for containing the probes such that the probes within each hybridization chamber are configured to hybridize with one of the target nucleic acid sequences.

12. The test module according to claim 11 wherein the photosensor is an array of photodiodes positioned in registration with the hybridization chambers.

13. The test module according to claim 12 wherein the control circuitry has a data interface for transmission of the hybridization data to an external device.

14. The test module according to claim 13 wherein the sample is drawn from a patient and the control circuitry is configured to download patient data via the data interface and store the patient data in the digital memory.

15. The test module according to claim 13 wherein the PCR section has an active valve for retaining liquid in the PCR section during thermal cycling and allowing flow to the hybridization chambers in response to an activation signal from the control circuitry.

16. The test module according to claim 14 wherein the active valve is a boiling-initiated valve with a meniscus anchor configured to pin a meniscus that arrests capillary driven flow of the liquid, and a heater for boiling the liquid to unpin the meniscus from the meniscus anchor such that capillary driven flow resumes.

17. The test module according to claim 15 wherein the meniscus anchor is an aperture and the heater has an annular shape and is positioned near the aperture periphery.

18. The test module according to claim 2 further comprising a LOC device that incorporates the supporting substrate and the CMOS circuitry, and has a sample inlet in fluid communication with the receptacle, a microsystems technology (MST) layer that incorporates the functional sections and a cap wherein the cap overlies the MST layer and defines the reagent reservoirs.

19. The test module according to claim 18 wherein the reagent reservoirs each have a surface tension valve with a meniscus anchor for pinning a meniscus to retain the reagent therein, such that contact with a flow of the sample fluid removes the meniscus and the reagent combines with the sample.

20. The test module according to claim 4 wherein the PCR section is configured to complete a thermal cycle of the sample in less than 30 seconds.