Lateral flow test device

• US 6,372,516 B1
• Filed: 09/07/2000
• Issued: 04/16/2002
• Est. Priority Date: 09/07/2000
• Status: Expired due to Term

• Current Assignee: Sun Biomedical, Ltd.
• Original Assignee: Sun Biomedical Laboratories Incorporated (Dimerix Ltd.)
• Inventors: Sun, Ming
• Primary Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US09/656,781
• Time in Patent Office: 586 Days
• Field of Search: 422/56, 422/58, 422/99, 422/59, 422/60, 422/104, 435/7.1, 435/7.93, 435/7.94, 435/287.7, 435/287.9, 435/288.7, 435/970, 436/518, 436/524, 436/530, 436/541, 436/807
• US Class Current: 436/518
• CPC Class Codes: B01D 15/3804 Affinity chromatography
• CPC Class Codes: B01L 2300/045 whereby the whole cover is slidable
• CPC Class Codes: B01L 2300/046 Function or devices integrated in the closure
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 30/02 Column chromatography
• CPC Class Codes: G01N 30/90 Plate chromatography, e.g. thin layer or paper chromatography
• 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 436/807 Apparatus included in process claim, e.g. physical support structures

Abstract

A immunochromatographical test device including a cap, an absorbent pad, a membrane, a test strip, a holder, and a housing is disclosed. The housing contains the membrane and the test strip which contains immunoreagents. Secured to the holder is the absorbent pad which contains the sample to be tested. The cap fits over the holder and the holder fits within the housing. When the absorbent pad contacts the membrane, the membrane indicates that a proper amount of the sample has been collected. When the absorbent pad contacts the test strip, a reaction, if any, can be observed via a window formed within the housing.

Claims

1. A test device comprising:

a housing;

a test strip contained within said housing, said test strip having immunoreagents therein;

a membrane contained within said housing for indicating the saturation of a sample to be tested;

means for retaining said test strip within said housing;

means for retaining said membrane within said housing;

a holder secured to said housing for containing the sample to be tested, said holder having an absorbent material for holding the sample wherein said absorbent material and said holder extend outwardly from said housing; and

a cap releasably attached to said holder wherein said cap moves said holder within said housing so that said absorbent material is contacted with said membrane and said test strip after the sample has been collected.

2. The test device of claim 1 further including means for facilitating said absorbent material to contact said membrane.

3. The test device of claim 1 wherein said housing includes a top half and a bottom half.

4. The test device of claim 3 wherein said top half of said housing include said means for retaining said test strip and said means for retaining said membrane therein.

5. The test device of claim 1 further including means for locking said holder to said housing after the sample has been collected.

6. The test device of claim 5 wherein said locking means includes a locking member and said housing includes a slot through which said locking member extends.