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US5182191A Expired / Lapsed US ⏱️ 0.0 years remaining

Occult blood sampling device and assay

Assignee: Quidel Corp
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Filing: 1989-09-21
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Granted: 1993-01-26
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Expires: 2009-09-21
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Abstract

Abstract The invention provides a disposable device for collecting, transporting and storing semi-solid or liquid specimens prior to analysis. A sample of the collected specimen is removed from the device for analysis by means of a detachable transferring stick, one area of which is the sample collecting portion of the device and another area of which is an integral handle. The device also provides for the collection of a liquid sample drained from a defined volume of a semi-solid specimen through porous screen and collected on the detachable transferring stick. A sample of the specimen or liquid from it may be flushed from the stick for a qualitative or quantitative determination of analyte. The device is useful in collecting fecal specimens and detecting occult blood therein by a determination of hemoglobin in the specimen itself or in a liquid sample drained therefrom.

Inventors

  • 👤 Eugene Fan
  • 👤 Fon-Chiu M. Chen
  • 👤 Michael W. Milner
  • 👤 Leslie J. Rehg

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-07 02:01
CPC Classifications
B; B01; B01L; B01L3/00; B01L3/50; B01L3/505; A; A61; A61B; A61B10/00; A61B10/0038; B01L3/5055; G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/72; G01N33/721; G01N33/726; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S435/81; Y10S436/00; Y10S436/807; Y10S436/808; Y10S436/81

Claims Analysis

Total Claims: 32
Claim 1
Independent Claim 169 words
A sampling folder for use in the collection of a specimen, comprising: a front panel, a back panel, a sample collecting panel at least partially covered by said front panel and having a specimen application area thereon, and a specimen receiving panel covered by said sample collecting panel, all of said panels being in overlying relationship, said front panel being openable to permit application of a specimen to said specimen application area; said specimen receiving panel comprising, at least in part, a detachable sample transferring stick having a handle portion and a sample collecting portion, said sample transferring stick positioned such that the sample collecting portion of said sample transferring stick is located underneath said specimen application area of said sample collecting panel and said handle portion is located under a part of said specimen receiving panel other than said specimen application area, and wherein said back panel includes an opening therein through which said handle portion of said stick can be grasped and said stick can be removed.
Claim 2
Dependent Claim 169 words
A sampling folder for use in the collection of a specimen, comprising: a front panel, a back panel, a sample collecting panel at least partially covered by said front panel and having a specimen application area thereon, and a specimen receiving panel covered by said sample collecting panel, all of said panels being in overlying relationship, said front panel being openable to permit application of a specimen to said specimen application area; said specimen receiving panel comprising, at least in part, a detachable sample transferring stick having a handle portion and a sample collecting portion, said sample transferring stick positioned such that the sample collecting portion of said sample transferring stick is located underneath said specimen application area of said sample collecting panel and said handle portion is located under a part of said specimen receiving panel other than said specimen application area, and wherein said back panel includes an opening therein through which said handle portion of said stick can be grasped and said stick can be removed.
Claim 3
Dependent Claim 19 words
The folder of claim 1, wherein said sample transferring stick is attached to the inside of said back panel.
Claim 4
Dependent Claim 20 words
The folder of claim 1, wherein said specimen receiving panel comprises a central leaflet between said front and back panels.
Claim 5
Dependent Claim 19 words
The system of claim 3, wherein said sample transferring stick is attached to the back of said central leaflet.
Claim 6
Dependent Claim 44 words
The folder of claim 1 or claim 3 further comprising a sheet of porous material in front of said specimen receiving panel, wherein said porous material is adapted to permit said specimen to be transferred through said porous material onto said specimen receiving panel.
Claim 7
Dependent Claim 20 words
The folder of claim 5 wherein said specimen application area is adapted to retain a defined volume of said specimen.
Claim 8
Dependent Claim 27 words
The folder of claim 5, wherein said porous material is coated with a release agent to prevent the porous material from sticking to said specimen receiving panel.
Claim 9
Dependent Claim 14 words
The folder of claim 7, wherein said release agent comprises a poly hydroxy compound.
Claim 10
Dependent Claim 12 words
The folder of claim 7, wherein said release agent comprises a sugar.
Claim 11
Dependent Claim 12 words
The folder of claim 7, wherein said release agent comprises polyethylene glycol.
Claim 12
Dependent Claim 11 words
The folder of claim 7, wherein said release agent comprises polyvinylpyrrolidone.
Claim 13
Dependent Claim 27 words
The folder of claim 1, additionally comprising indicia imprinted on said specimen application area, wherein said indicia are obscured when an adequate amount of sample is applied.
Claim 14
Dependent Claim 22 words
The folder of claim 1, wherein said back panel includes an opening therein through which said sample transferring stick can be removed.
Claim 15
Dependent Claim 17 words
The folder of claim 1, wherein said panels and said transferring stick are formed from cellulosic material.
Claim 16
Dependent Claim 21 words
The folder of claim 1, further comprising a layer of absorbent material on the sample collecting portion of said transferring stick.
Claim 17
Dependent Claim 17 words
The folder of claim 1, wherein said sample transferring stick is capable of transferring a semi-solid specimen.
Claim 18
Dependent Claim 12 words
The folder of claim 1 wherein said sample transferring stick is non-absorbent.
Claim 19
Dependent Claim 65 words
An assay system for determining the presence or quantity of an analyte, said system being in the form of a kit, said system comprising: the folder of claim 1; a mixing cup; a liquid for use in said mixing cup to extract sample from said sample collecting portion; and an assay device for determining the presence or quantity of an analyte in said extracted sample.
Claim 20
Dependent Claim 17 words
The system of claim 18, wherein said specimen is a stool sample and said analyte is hemoglobin.
Claim 21
Dependent Claim 13 words
The system of claim 18, wherein said assay device comprises an enzyme immunoassay.
Claim 22
Independent Claim 128 words
A method for collecting a clinical specimen, using a sample collecting folder having a front panel, a back panel, a specimen receiving portion, and a detachable sample transferring stick, comprising the following steps in order: opening the sample collecting folder by lifting the front panel to expose a specimen receiving area; applying a clinical specimen which contains an analyte to said receiving area; transferring said specimen to a sample collecting portion of said sample transferring stick; closing said sample collecting folder by lowering said front panel; and removing a sample transferring stick of said folder by grasping the handle portion thereof, said transferring stick containing a portion of said applied specimen adhering thereto, so that contact between a user and the specimen is avoided during the removal step.
Claim 23
Independent Claim 128 words
A method for collecting a clinical specimen, using a sample collecting folder having a front panel, a back panel, a specimen receiving portion, and a detachable sample transferring stick, comprising the following steps in order: opening the sample collecting folder by lifting the front panel to expose a specimen receiving area; applying a clinical specimen which contains an analyte to said receiving area; transferring said specimen to a sample collecting portion of said sample transferring stick; closing said sample collecting folder by lowering said front panel; and removing a sample transferring stick of said folder by grasping the handle portion thereof, said transferring stick containing a portion of said applied specimen adhering thereto, so that contact between a user and the specimen is avoided during the removal step.
Claim 24
Dependent Claim 12 words
The method of claim 21 where said specimen is a biological specimen.
Claim 25
Dependent Claim 17 words
The method of claim 21, wherein said specimen is a stool sample and said analyte is hemoglobin.
Claim 26
Dependent Claim 55 words
The method of claim 21, wherein said folder further comprises a sheet of porous material in front of said specimen collecting portion to which said specimen can be applied, wherein said porous material is adapted to permit only a portion of said specimen to be transferred through said porous material onto said specimen collecting portion.
Claim 27
Dependent Claim 29 words
The method of claim 21 further comprising analyzing the specimen adhering to said sample collecting portion of said sample transferring stick for the presence or quantity of an analyte.
Claim 28
Dependent Claim 12 words
The method of claim 25, wherein said analyzing step comprises an immunoassay.
Claim 29
Dependent Claim 11 words
The method of claim 21, wherein the said specimen is semi-solid.
Claim 30
Dependent Claim 155 words
A sampling folder for use in the collection of a specimen, comprising: a front panel; a back panel; a sample collecting panel at least partially covered by said front panel and having a specimen application area thereon; and a specimen receiving panel covered by said sample collecting panel; all of said panels being in overlying relationship, said front panel being openable to permit application of a specimen to said specimen application area, said specimen receiving panel comprising a detachable sample transferring stick having a handle portion and a sample collecting portion, said sample collecting portion being of a material that does not absorb substantial amounts of fluid, said sample transferring stick positioned such that the sample collecting portion of said sample transferring stick is located underneath said specimen application area of said specimen receiving panel and said handle portion is located under a portion of said specimen receiving panel other than said specimen application area.
Claim 31
Dependent Claim 155 words
A sampling folder for use in the collection of a specimen, comprising: a front panel; a back panel; a sample collecting panel at least partially covered by said front panel and having a specimen application area thereon; and a specimen receiving panel covered by said sample collecting panel; all of said panels being in overlying relationship, said front panel being openable to permit application of a specimen to said specimen application area, said specimen receiving panel comprising a detachable sample transferring stick having a handle portion and a sample collecting portion, said sample collecting portion being of a material that does not absorb substantial amounts of fluid, said sample transferring stick positioned such that the sample collecting portion of said sample transferring stick is located underneath said specimen application area of said specimen receiving panel and said handle portion is located under a portion of said specimen receiving panel other than said specimen application area.
Claim 32
Dependent Claim 23 words
The folder of claim 28 wherein said sample transferring stick additionally comprises an absorbent material, said absorbent material overlaying said sample collection portion.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1996-01-26 1996-07-27 1997-01-26 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2000-01-26 2000-07-27 2001-01-26 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2004-01-26 2004-07-27 2005-01-26 $7700.00 Window Closed / Lapsed

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