Sample metering device and assay device with integrated sample dilution

• US 10,126,294 B2
• Filed: 05/14/2015
• Issued: 11/13/2018
• Est. Priority Date: 12/03/2010
• Status: Expired due to Fees

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories)
• Inventors: Miller, Cary James
• Primary Examiner(s): Brown, Melanie Yu
• Application Number:
  US14/712,335
• Publication Number:
  US 20150247840A1
• Time in Patent Office: 1,279 Days
• 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 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/045 whereby the whole cover is slidable
• CPC Class Codes: B01L 2300/0672 Integrated piercing tool
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0867 Multiple inlets and one sample wells, e.g. mixing, dilution
• CPC Class Codes: B01L 2300/126 Paper
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• 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 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/502753 characterised by bulk separation arrangements on lab-on-a-chip devices, e.g. for filtration or centrifugation separation in general B01D; microapparatus for analysis using electrophoresis G01N27/44791; sample preparation G01N1/28
• CPC Class Codes: G01N 1/38 Diluting, dispersing or mixing samples
• CPC Class Codes: G01N 2333/4737 C-reactive protein
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: Y10T 436/25625 Dilution

Abstract

In one embodiment, the invention is to a sample metering device, comprising a sample holding chamber oriented between a sample entry port and a sample isolation unit and having a diluent introduction port disposed therebetween for introduction of a diluent into the sample holding chamber. The volume within the sample holding chamber between the diluent introduction port and the sample isolation unit defines a metered volume of a sample for analysis. In another embodiment, the invention is to an apparatus and method for rapid determination of analytes in liquid samples by various assays including immunoassays incorporating a sample dilution feature, preferably suitable for low range sample dilution, and preferably capable of being used in the point-of-care diagnostic field.

Claims

1. A sample metering device, comprising a diluent, a sample holding chamber oriented between a sample entry port and a sample isolation unit and having a diluent introduction port disposed therebetween for introduction of the diluent into the sample holding chamber, a diluent conduit configured for transporting the diluent to the diluent introduction port, a closure member that can be secured over the sample entry port, wherein the volume within the sample holding chamber between the diluent introduction port and the sample isolation unit defines a metered volume of a sample for analysis.

2. The device of claim 1, further comprising a dilution chamber for mixing said diluent with the metered volume of sample to form a diluted sample.

3. The device of claim 2, wherein said volume within the sample holding chamber between the diluent introduction port and the sample isolation unit defines said dilution chamber, and wherein a lysing agent is disposed within said dilution chamber.

4. The device of claim 3, wherein said lysing agent comprises sodium deoxycholate.

5. The device of claim 3, wherein said lysing agent comprises saponin.

6. The device of claim 1, wherein the sample is selected from the group consisting of blood, plasma, serum, urine, interstitial fluid and cerebrospinal fluid.

7. The device of claim 1, wherein the sample isolation unit comprises a capillary stop.

8. The device of claim 1, wherein said sample isolation unit comprises a porous hydrophilic material.

9. The device of claim 1, wherein said sample isolation unit comprises a cellulose material.

10. The device of claim 1, wherein said sample isolation unit comprises nitrocellulose.

11. The device of claim 1, wherein said sample isolation unit comprises cotton fiber.

12. The device of claim 1, wherein said sample isolation unit comprises paper.

13. The device of claim 1, wherein said sample isolation unit comprises glass-filled paper.