Point of care analytical processing system

• US 10,031,085 B2
• Filed: 07/23/2015
• Issued: 07/24/2018
• Est. Priority Date: 07/24/2014
• Status: Active Grant

• Current Assignee: Ortho-Clinical Diagnostics Incorporated (The Carlyle Group LP (Corporate Private Equity))
• Original Assignee: Ortho-Clinical Diagnostics Incorporated (The Carlyle Group LP (Corporate Private Equity))
• Inventors: Jakubowicz, Raymond F.
• Primary Examiner(s): WHITE, DENNIS MICHAEL
• Application Number:
  US14/807,212
• Publication Number:
  US 20160025639A1
• Time in Patent Office: 1,097 Days
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0864 comprising only one inlet and multiple receiving wells, e.g. for separation, splitting
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/086 using baffles or other fixed flow obstructions
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 9/52 Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips
• CPC Class Codes: B01L 9/527 for microfluidic devices, e.g. used for lab-on-a-chip
• CPC Class Codes: G01N 2021/752 Devices comprising reaction zones
• CPC Class Codes: G01N 2021/7759 Dipstick; Test strip
• CPC Class Codes: G01N 2035/00158 Elements containing microarrays, i.e. "biochip"
• CPC Class Codes: G01N 2035/00356 Holding samples at elevated temperature (incubation)
• CPC Class Codes: G01N 2035/0439 Rotary sample carriers, i.e. carousels
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 33/48707 by electrical means G01N33/49, G01N33/493 take precedence
• CPC Class Codes: G01N 33/49 Blood chemical methods for determining blood cell populations G01N33/5094; chemical analysis of blood groups or blood types G01N33/80
• CPC Class Codes: G01N 35/00029 provided with flat sample substrates, e.g. slides G01N35/028 takes precedence

Abstract

A point of care testing system includes a reader having an incubator disposed within a reader housing, the incubator having a rotor supported for rotation and having a plurality of circumferentially disposed slots. A drive mechanism is configured to rotate the rotor about a center axis A plurality of analytical test elements are sized for fitting in the slots of the incubator either manually or on demand. Each analytical test element commonly includes a support within a cartridge. The support retains at least one of a dry chemistry chip comprising a porous spreading layer disposed in stacked relation with at least one reagent layer or a lateral flow assay device wherein the plurality of test elements can assume a common form factor with multiplexed capability, and in which cartridges are preferably gated to enable random access processing.

Claims

1. A point of care analytical testing system comprising:

a point of care reader comprising;

a housing having an interior;

an incubator disposed in the housing interior and having a rotor configured for rotation, the incubator having a plurality of circumferentially disposed slots;

a drive mechanism for rotating the rotor about a center axis; and

at least one measurement device disposed within the housing, the at least one measurement device being movable along a defined scan path; and

a plurality of analytical test elements, each analytical test element being sized for fitting in a slot of the incubator and comprising;

a planar support; and

a cartridge sized for retaining the planar support, the cartridge comprising an upper cover portion and a lower cover portion that supports ends of the planar support and has an elongated axial cavity over which the planar support is supported, the upper cover portion including at least one port configured for applying a quantity of sample to the retained support and wherein the planar support retains at least one of a dry chemistry chip comprising a porous spreading layer disposed in stacked relation with at least one reagent layer or a lateral flow assay device, wherein the elongated axial cavity enables the at least one measurement device to measure the sample by movement along the defined scan path.

2. The system according to claim 1, in which at least one of the analytical test elements is configured to run a plurality of tests.

3. The system according to claim 1, wherein the at least one port of the cartridge is configured for applying a quantity of sample to a sample receiving zone of the support.

4. The system according to claim 3, wherein the at least one port is aligned with the sample receiving zone of the support and in which the sample receiving zone is common to each of the lateral flow assay device and the at least one dry chemistry chip.

5. The system according to claim 4, including a separation filter disposed between the at least one port and the sample receiving zone.

6. The system according to claim 1, wherein the cartridge further includes a sample retainer, the sample retainer being configured to selectively release retained sample to the planar support.

7. The system according to claim 6, in which the reader includes a sample metering station disposed in relation to the incubator.

8. The system according to claim 7, wherein the sample metering station includes a pump enabled to apply pressure to move sample from the sample retainer to a sample receiving zone of the test element.

9. The system according to claim 1, wherein the at least one measurement device includes at least one of a reflectometer, photometer, fluorimeter, potentiometer, an imager and an infrared sensor.

10. The system according to claim 1, wherein the reader further comprises a wash module.

11. The system according to claim 1, comprising a controller connected to a user interface and the reader, the controller being programmed to operate the reader in accordance with at least one stored set of instructions.

12. The system according to claim 11, wherein the reader further comprises a display, the display including the user interface.

13. The system according to claim 1, wherein the reader includes at least one input/exit port for loading and unloading the analytical test elements.

14. The system according to claim 13, wherein the reader includes a stacker port configured to automatically load at least one analytical test element into the reader.