IPC분류정보
| 국가/구분 |
United States(US) Patent
등록
|
| 국제특허분류(IPC7판) |
|
| 출원번호 |
US-0794061
(2001-02-28)
|
| 우선권정보 |
GB-198709873 (1987-04-27); GB-8725457 (1988-10-30) |
|
발명자
/ 주소 |
- May, Keith
- Prior, Michael Evans
- Richards, Ian
|
| 출원인 / 주소 |
- Inverness Medical Switzerland GmbH
|
| 대리인 / 주소 |
|
| 인용정보 |
피인용 횟수 :
53 인용 특허 :
149 |
초록
▼
An analytical test device useful for example in pregnancy testing, comprises a hollow casing ( 500 ) constructed of moisture-impervious solid material, such as; plastics materials, containing a dry porous carrier ( 510 ) which communicates indirectly with the exterior of the casing via a bibulous sa
An analytical test device useful for example in pregnancy testing, comprises a hollow casing ( 500 ) constructed of moisture-impervious solid material, such as; plastics materials, containing a dry porous carrier ( 510 ) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member ( 506 ) which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the two zones being arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone, and the device incorporating means, such as an aperture ( 508 ) in the casing, enabling the extent (if any) to which the labelled reagent becomes bound in the second zone to be observed. Preferably the device includes a removable cap for the protruding bibulous member.
대표청구항
▼
1. An analytical test device for detecting an analyte suspected of being present in a liquid biological sample and requiring solely the application thereto of said liquid biological sample to enable a test to be performed and a test result to be provided, said device comprising:a hollow casing const
1. An analytical test device for detecting an analyte suspected of being present in a liquid biological sample and requiring solely the application thereto of said liquid biological sample to enable a test to be performed and a test result to be provided, said device comprising:a hollow casing constructed of moisture impervious solid material;a test strip comprising a dry porous earner disposed in said casing, said dry porous carrier comprising a test result zone and a control zone; anda labeled reagent capable of specifically binding with said analyte to form a first complex of said labeled reagent and said analyte, said labeled reagent comprising a particulate direct label and being positioned within said casing as part of said test strip prior to use,said casing including sample application aperture through which liquid biological sample can be supplied directly or indirectly to said carrier, said labeled reagent being located upstream from said test result zone prior to use and being released into mobile form by contact with said liquid biological sample,said carrier including, immobilized in said test result zone, a second reagent for specifically binding said first complex, wherein migration of said liquid biological sample through said dry porous carrier by capillarity conveying said first complex to said test result zone where said second reagent binds to said first complex thereby to form a second complex and to thereby indicate the presence of said analyte in said liquid biological sample,said casing further comprising a test result observation aperture spaced apart from said sample application aperture, said test result zone being visible through said test result observation aperture, wherein the test result observation aperture is substantially shielded to prevent accidental application of sample liquid directly to a portion of said test strip downstream from the location of said labeled reagent through the test result observation aperture, andsaid control zone includes a material for indicating that said liquid biological sample has been conveyed thereto by capillarity along said carder irrespective of the presence or absence of said analyte in said liquid biological sample. 2. The test device according to claim 1, wherein the porous carrier communicates with the exterior of the device via a bibulous sample receiving member which protrudes from the casing and which can act as a reservoir to receive the liquid sample and release it into the porous carrier. 3. The test device according to claim 2, which incorporates a removable and replaceable moisture-impervious cover for the protruding bibulous sample receiving member. 4. The test device according to claim 1, wherein the casing, and cover if present, is moulded from plastics material. 5. The test device according to claim 1, wherein the porous carrier comprises a strip or sheet of porous material backed with a layer of transparent moisture-impervious material, the transparent layer being in contact with the inside of the casing adjacent the test result observation aperture to inhibit ingress of moisture or sample. 6. The test device according to claim 4, wherein the porous carrier material is nitrocellulose. 7. The test device according to claim 6, wherein the nitrocellulose has a pore size of greater than about 1 micron. 8. The test device according to claim 1, wherein the label comprises coloured latex particles having a maximum dimension of not greater about 0.5 micron. 9. The test device according to claim 1, wherein the analyte is hCG. 10. The test device according to claim 1, wherein the analyte is LH. 11. A pregnancy testing device comprising a hollow enlongated casing containing a dry porous nitrocellulose carrier which communicates indirectly with the exterior of the casing via a bibulous urine receiving member which protrudes from the casing and which can act as a reservoir from which urine is released into the porous carrier, the carrier containing in a first zone an anti-hCG antibody bearing a coloured direct label, the labelled antibody being freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone an unlabelled anti-hCG antibody which is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the labelled and unlabelled antibodies having specificities for different hCG epitopes, the two zones being arranged such that a urine sample applied to the porous carrier can permeate via the first zone into the second zone, and the casing being constructed of opaque or translucent material incorporating at least one aperture through which the analytical result may be observed, together with a removable and replaceable cover for the protruding bibulous urine receiving member. 12. A pregnancy testing device for detecting human chorionic gonadotrophin (hCG) suspected of being present in a urine sample and requiring solely the application thereto of said urine sample to enable a test to be performed and a test result to be provided, said device comprising:a hollow casing constructed of moisture impervious solid material;a test strip, comprising a dry porous carrier disposed in said casing, said dry porous carrier having a detection zone and a control zone; andlabeled reagent comprising an anti-hCG antibody bearing a particulate direct label, said anti-hCG antibody being capable of specifically binding with said hCG to form a first complex of said labeled anti-hCG antibody and said hCG,said casing comprising a sample application aperture through which urine can be applied directly or indirectly to said carrier, said labeled anti-hCG antibody being located upstream from said detection zone prior to use and being released into mobile form by contact with said urine sample,said carrier comprising, immobilized in said detection zone, a reagent for selectively binding said first complex, and wherein migration of said applied urine sample through said dry porous carrier conveys by capillarity said first complex of labeled anti-hCG antibody and said hCG to said detection zone of said dry porous carrier, where said reagent binds said first complex to form a second complex and thereby indicate the presence of said hCG in said urine sample,said casing further comprising a test result observation aperture spaced apart from said sample application aperture, said detection zone being visible through said test result observation aperture, wherein the test result observation aperture is substantially shielded from to prevent accidental application of urine directly to a portion of said test strip downstream from the location of said labeled anti-hCG antibody through the test result observation aperture, andsaid control zone comprises a reagent for indicating that said urine sample has been conveyed thereto by capillarity along said carrier irrespective of the presence or absence of hCG in said urine sample. 13. A fertile period prediction device comprising a hollow elongated casing containing a dry porous nitrocellulose carrier which communicates indirectly with the exterior of the casing via a bibulous urine receiving member which protrudes from the casing and which can act as a reservoir from which urine is released into the porous carrier, the carrier containing in a first zone a highly-specific anti-LH antibody bearing a coloured “direct” label, the labelled antibody being freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone an highly-specific unlabelled anti-LH antibody which is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the labelled and unlabelled antibodies having specificities for different LH epitopes, the two zones being arranged such that a urine sample applied to the porous carrier can permeate via the first zone, and the casing being constructed of opaque or translucent material incorporating at least one aperture through which the analytical result may be observed, together with a removable and replaceable cover for the protruding bibulous urine receiving member. 14. A fertile period prediction kit suitable for home use, comprising a plurality of devices according to claim 13 individually wrapped in moisture-impervious wrapping and packaged together with appropriate instructions to the user.
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