Device for determining an analyte in a liquid sample

• US 7,459,125 B1
• Filed: 06/10/1999
• Issued: 12/02/2008
• Est. Priority Date: 06/30/1998
• Status: Expired due to Fees

• Current Assignee: Vedalab Co.
• Original Assignee: Vedalab Co.
• Inventors: Donati, Raphael, Stankov, Milovan
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): Hyun; Paul S
• Application Number:
  US09/720,862
• Time in Patent Office: 3,463 Days
• Field of Search: 422/50, 422/55, 422/56, 422/57, 422/58, 422/61, 422/68.1, 436/65, 436/510, 435/806
• US Class Current: 422/412
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/065 sliding valves
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: Y10S 435/806 Fertility tests

Abstract

The invention concerns a device for determining an analyte in a liquid sample, comprising: a) a gripping support (1); b) first capillary diffusing means (2) integral with the gripping support (1) comprising a downstream zone (2a) accessible to external observation; c) a set of predetermined reagents for detecting and/or quantifying the analyte; d) a member for collecting (4) the liquid sample mounted on the support (1). The invention is characterized in that the member for collecting (4) the liquid sample is mounted mobile or fixed on the support; second capillary diffusion means (41) extends from a zone collecting (41a) said sample, to a zone transferring (41b) the latter; and an upstream zone (2b) of said first capillary diffusion means (2) is arranged to be urged temporarily to constitute continuous capillary flow with the second diffusion means (41) transferring zone (41b), when the collecting member (4) is in the retracted position.

Claims

1. A device for determination of an analyte in a liquid sample, comprising:

a) an elongated support to be gripped extending along a reference direction having a proximate gripping zone and a distal portion away from said gripping zone;

b) a first means for capillary diffusion in said reference direction, integral with the support to be gripped, comprising a downstream zone which is accessible to external observation, and an upstream zone opposite to said downstream zone along said reference direction;

c) a movable member movably mounted inside said support along said reference direction, for taking up the liquid sample, comprising a second means for capillary diffusion extending in said reference direction having a distal collection zone for collecting said sample, and a proximal transfer zone opposite to said distal collection zone along said reference direction, said movable member being mounted on said support so that it can move between a protruding position and a retracted position, wherein;

in the protruding position, the distal collection zone of the second means for capillary diffusion protrudes from the distal portion across an opening of said support to be brought into direct contact with said sample at said distal portion of said support, and in which the transfer zone of the second means for capillary diffusion remains inside said support and is in capillary flow discontinuity with, and away from, the upstream zone of the first means for capillary diffusion,

and in the retracted position, the transfer zone of the second means for capillary diffusion is in capillary flow continuity, inside said support, with the first means for capillary diffusion, and in which the collection zone of the second means for capillary diffusion is contained in said distal portion of said support, leaving said opening across said support free of said second means for capillary diffusion;

d) means for opening and closing said opening in said support, respectively in the protruding and retracted positions of said movable member;

e) a set of predetermined reagents for at least one of detection and quantitative analysis of the analyte, comprising

a first reagent comprising a marker, being arranged in the free state on any one of the first and the second capillary means for capillary diffusion in a functional location upstream of the downstream zone of the first means for capillary diffusion, and

a second reagent, fixed in the downstream zone of the first means for capillary diffusion, for direct or indirect capture of the first reagent.

2. The device as claimed in claim 1, wherein the first reagent is deposited on the second means for capillary diffusion downstream of the collection zone.

3. The device as claimed in claim 1, wherein the first reagent is deposited on the first means for capillary diffusion downstream of said upstream zone.

4. The device as claimed in claim 1, wherein the support to be gripped is in the form of a kit which, at one end, comprises an opening for the movable member to pass through into the protruding position, and on the opposite side from said end, a window registered with at least the downstream zone of the first means for capillary diffusion.

5. The device as claimed in claim 1, wherein the support to be gripped includes a slideway whose shape is adapted to the path along which the movable member moves, and said movable member includes a manual control component passing through said slideway.

6. The device as claimed in claim 1, wherein the movable member can be moved and be translated relative to the support to be gripped, and said movable member and said support are elongated in the translation direction.

7. The device as claimed in claim 1, wherein the first means for capillary diffusion includes two separate sections, in permanent capillary flow continuity, including a first section of relativity high porosity, designed to come removably into capillary flow continuity with the transfer zone of the second means for capillary diffusion, and a second section of relatively low porosity, including said downstream zone.

8. The device as claimed in claim 4, wherein the movable member comprises a carriage for supporting the second means for capillary diffusion, the kit and the carriage includes means for guiding said carriage as it moves, and the kit incorporates a means for actuating said carriage, with manual control.

9. The device as claimed in claim 8, wherein the second means for capillary diffusion is in the form of a stick, and the carriage includes a rear stop relative to the direction of movement, and a component for holding said stick in position.

10. The device as claimed in claim 8, wherein the actuation means comprises a hairpin-shaped semirigid band, one branch of which has a component to be gripped on its outer face, and the other branch of which has an end joined to the carriage, and wherein the kit comprises, on the one hand, a path which is intended for pulling the band and is also shaped as a hairpin, and on the other hand a window which is designed for the passage of the component to be gripped, and whose length is adapted to the displacement travel of the movable member.

11. The device as claimed in claim 4, wherein the first means for capillary diffusion is clamped and held inside the kit, between ribs extending parallel to the direction of the capillary flow.