Method and device for metering of fluid samples and detection of analytes therein

• US 5,234,813 A
• Filed: 08/26/1991
• Issued: 08/10/1993
• Est. Priority Date: 05/17/1989
• Status: Expired due to Fees

• Current Assignee: ActiMed Laboratories, Inc.
• Original Assignee: ActiMed Laboratories, Inc.
• Inventors: McGeehan, John K., Ertingshausen, Gerhard
• Primary Examiner(s): Saunders, David
• Assistant Examiner(s): Chin, Christopher L.
• Application Number:
  US07/749,521
• Time in Patent Office: 715 Days
• Field of Search: 435/7.9, 435/7.92, 435/970, 436/164, 436/169, 436/518, 436/805, 436/807-810, 422/56-58, 422/61, 422/55, 422/101
• US Class Current: 435/7.9
• CPC Class Codes: B01L 2200/027 for microfluidic devices
• CPC Class Codes: B01L 2300/044 pierceable, e.g. films, membranes
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• 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 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/502746 characterised by the means for controlling flow resistance, e.g. flow controllers, baffles B01L3/502738 takes precedence
• 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: C12Q 1/00 Measuring or testing processes involving enzymes, nucleic acids or microorganisms measuring or testing apparatus with condition measuring or sensing means, e.g. colony counters, C12M1/34; Compositions therefor; Processes of preparing such compositions
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/809 : Multifield plates or multicontainer arrays
• CPC Class Codes: Y10S 436/81 : Tube, bottle, or dipstick

Abstract

An analytical device for fluid samples includes a fluid sample well means connected to a sample initiation area in such a fashion that the assay will not commence unless sufficient sample is introduced into the sample well means to conduct the assay. Once sufficient sample has been deposited into the sample well means, the sample flows into an initiation area and the assay commences.

Claims

1. A measuring device for detecting an analyte in a fluid sample comprising:

a sample well means for measuring the amount of fluid sample applied to said measuring device;

an assay initiation area located above the level of said fluid sample well;

a siphon means connecting said sample well to said assay initiation area, whereby fluid sample will not contact and fill said assay initiation area unless a predetermined minimum amount of fluid sample is deposited in said fluid sample well, and a measurement channel in fluid communication with said assay initiation area, said measurement channel including a carrier on which is absorbed at least one indicator means for detecting the analyte of interest.

2. A device for detecting analyte in a fluid sample comprising:

a measuring device according to claim 1 wherein said assay initiation area is connected to a reservoir means through measurement channel.

3. The device according to claim 1 wherein said carrier is a membrane.

4. The device according to claim 1 wherein said channel includes obstacles therein which cause frequent changes in the direction of flow of said fluid sample.

5. The device according to claim 4 wherein said obstacles are in the form of a knurled surface in said channel.

6. The device according to claim 4 wherein said obstacles are in the form of a mesh.

7. The device according to claim 6 wherein said mesh is impregnated with a chromatic chemical indicator.

8. The device according to claim 2 wherein said assay initiation area includes a filter means to filter solid particles from said fluid sample.

9. The device according to claim 2 wherein said assay initiation area comprises at least one absorbent pad.

10. The device according to claim 2 wherein said assay initiation area and said reservoir means each comprise at least one absorbent pad.

11. The device according to claim 1 wherein said sample well is constructed of or coated with a hydrophilic material.

12. The device according to claim 1 wherein said siphon means is constructed of or coated with a hydrophilic material.

13. In a strip assay device for quantifying the amount of analyte in a fluid sample, said device comprising a detection zone containing a reagent that reacts with analyte in the fluid sample to provide a visual indication of the presence of the analyte, the improvement comprising preventing initiation of an assay in the device if there is insufficient sample present to conduct a reliable assay, by providing on said device;

a fluid sample well means;

an assay initiation area located above the level of said fluid sample well; and

siphon means connecting said sample well to said assay initiation area, whereby fluid sample will not contact said assay initiation area unless a predetermined minimum amount of fluid sample is deposited in said fluid sample well.

14. A process for ensuring that sufficient fluid sample is present to conduct an assay comprising:

introducing said fluid sample into a sample well means located below an assay initiation area, and which sample well means is connected to said assay initiation area by a siphon means, whereby if sufficient sample is present to initiate an assay, the sample will flow up the siphon means from the sample well means to the assay initiation area; and

noting if sample flows up the siphon means from the sample well.

15. A process for detecting an analyte in a fluid sample comprising:

introducing said fluid sample into a sample well means which is located below an assay initiation area, and which sample well means is connected to said assay initiation area by a siphon means, whereby if sufficient sample is present to initiate an assay, the sample will flow up the siphon means from the sample well means to the assay initiation area; and

, if there is sufficient sample present to initiate an assay,

permitting the fluid sample to flow through the assay initiation area into a measurement channel;

permitting the fluid sample to flow through a measurement channel having a carrier on which is absorbed at least one indicator means for detecting the analyte of interest, said measurement channel being connected to a reservoir means whereby said reservoir means draws fluid sample through said measurement channel; and

detecting the amount of analyte by reading the indicator means.

16. The process according to claim 15 further including obstacles in said measurement channel whereby said fluid sample changes flow direction while flowing through said measurement channel.

17. The process according to claim 16 wherein said obstacles are in the form of a knurled surface in said measurement channel.