US5145789A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Device and method for pregnancy detection
Assignee: Roche Diagnostics SpA
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Filing: 1989-10-05
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Granted: 1992-09-08
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Expires: 2009-10-05
Abstract
Abstract A device to determine human chorionic gonadotropin (hCG) in urine is described. It includes: a) a first area, consisting of a material able to draw urine by capillarity, on which an hCG bioselective colored agent is absorbed, an end of said first area, to be dipped in urine, while the other end contacts with the following b) area; b) a reading area which contacts the previous one and an area of a material able to assure the capillary flow of urine, on which there is bound: 1) a protein able to selectively bind hCG and possibly; 2( hCG (positive reagent control) and 3) an inert protein (negative reagent control) disposed so as to form, after the reaction with the bioselective colored reagent present in a), two different figures which can be visually detected according to the positivity of the analysis: c) a further area, an end of which contacts the previous one, of a material able to assure the capillary flow of urine towards the other end containing an indicator revealing the occurred passage of urine through the A device. According to the invention, pregnancy analysis becomes easier because the a device is dipped just once in the sample to be tested and because the results are simple to read.
Inventors
- 👤 Angelo Corti
- 👤 Paola Piro
- 👤 Emanuela Carta
- 👤 Cesare Rovelli
- 👤 Rosangela Bassi
- 👤 Sandro Lamponi
- 👤 Nicola Morgese
- 👤 Carlo Rurali
- 👤 Sergio Tognella
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-05 21:47
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; G01N33/54366; G01N33/54386; G01N33/74; G01N33/76; Y; Y10; Y10S; Y10S435/00; Y10S435/97; Y10S436/00; Y10S436/807; Y10S436/81; Y10S436/811; Y10S436/814; Y10S436/815; Y10S436/817; Y10S436/818
Claims Analysis
Total Claims: 11
Claim 1
Independent Claim
309 words
A device to detect human chorionic gonadotropin (hCG) in urine, comprising: a first longitudinal container having distal and proximal ends, said distal end of said first container containing a hydrophilic pore septum which covers an entrance in said distal end through which urine is capable of being drawn; a second longitudinal container having distal and proximal ends, said second container being telescopically housed within and capable of being removed from said first container; a first material contained within an area defined between said hydrophilic pore septum and said distal end of said second container, said first material capable of drawing urine by capillarity and on which a color labeled first protein capable of specifically binding to hCG is diffusively adsorbed; a second material comprising a reading area contained within the distal end of said second container and in contact with said first material to allow movement of urine from said first material through said second material and on which is bound (i) a second protein capable of specifically binding to hCG, wherein at least one of said first or second protein is an antibody, (ii) immobilized hCG and (iii) an inert protein, wherein (i), (ii), and (iii) are disposed on said second material so as to form, after reaction with said first color labeled protein, at least one of two figures which can be visually detected according to the positivity of the reaction when the second container is removed from the first container; a third material capable of drawing urine by capillarity contained within the proximal end of said second container and contacting said second material to allow movement of urine through said second material to said third material; and a flow indicator means contained within said third material at the proximal end of said second container, said means capable of indicating the passage of urine through said device.
Claim 2
Independent Claim
309 words
A device to detect human chorionic gonadotropin (hCG) in urine, comprising: a first longitudinal container having distal and proximal ends, said distal end of said first container containing a hydrophilic pore septum which covers an entrance in said distal end through which urine is capable of being drawn; a second longitudinal container having distal and proximal ends, said second container being telescopically housed within and capable of being removed from said first container; a first material contained within an area defined between said hydrophilic pore septum and said distal end of said second container, said first material capable of drawing urine by capillarity and on which a color labeled first protein capable of specifically binding to hCG is diffusively adsorbed; a second material comprising a reading area contained within the distal end of said second container and in contact with said first material to allow movement of urine from said first material through said second material and on which is bound (i) a second protein capable of specifically binding to hCG, wherein at least one of said first or second protein is an antibody, (ii) immobilized hCG and (iii) an inert protein, wherein (i), (ii), and (iii) are disposed on said second material so as to form, after reaction with said first color labeled protein, at least one of two figures which can be visually detected according to the positivity of the reaction when the second container is removed from the first container; a third material capable of drawing urine by capillarity contained within the proximal end of said second container and contacting said second material to allow movement of urine through said second material to said third material; and a flow indicator means contained within said third material at the proximal end of said second container, said means capable of indicating the passage of urine through said device.
Claim 3
Dependent Claim
20 words
The device according to claim 1, wherein said color labeled first protein is a monoclonal antibody labeled with colloidal gold.
Claim 4
Dependent Claim
20 words
The device according to claim 1, wherein said second protein capable of specifically binding to hCG is a monoclonal antibody.
Claim 5
Dependent Claim
14 words
The device according to claim 1, wherein said second material is a nitrocellulose filter.
Claim 6
Dependent Claim
16 words
The device according to claim 1, wherein said first material and said third material are cellulosic.
Claim 7
Dependent Claim
21 words
The device according to claim 1, wherein said flow indicator means is a compound which changes color upon contact with urine.
Claim 8
Dependent Claim
12 words
The device according to claim 6, wherein said compound is bromophenol blue.
Claim 9
Dependent Claim
36 words
The device according to claim 1, wherein said at least one of two figures which can be visually detected according to the positivity of the reaction is a plus (+) sign or a minus (-) sign.
Claim 10
Independent Claim
439 words
A method of detecting human chorionic gonadotropin (hCG) in urine, comprising the steps of: (a) providing a capillary device, wherein said capillary device contains therein: a first longitudinal container having distal and proximal ends, said distal end of said first container containing a hydrophilic pore septum which covers an entrance in said distal end through which urine is capable of being drawn; a second longitudinal container having distal and proximal ends, said second container being telescopically housed within and capable of being removed from said first container; a first material contained within an area defined between said hydrophilic pore septum and said distal end of said second container, said first material capable of drawing urine by capillarity and on which a color labeled first protein capable of specifically binding to hCG is diffusively adsorbed; a second material comprising a reading area contained within the distal end of said second container and in contact with said first material to allow movement of urine from said first material through said second material and on which is bound (i) a second protein capable of specifically binding to hCG, wherein at least one of said first or second protein is an antibody, (ii) immobilized hCG, and (iii) an inert protein, wherein (i), (ii), and (iii) are disposed on said second material so as to form, after reaction with said first color labeled protein, at least one of two figures which can be visually detected according to the positivity of the reaction when the second container is removed from the first container; a third material capable of drawing urine by capillarity contained within the proximal end of said container and contacting said second material to allow movement of urine through said second material to said third material; and a flow indicator means contained within said third material at the proximal end of said second container, said means capable of indicating the passage of urine through said device; (b) contacting the distal end of said capillary device with a urine sample suspected of containing hCG, and allowing said sample to migrate into said capillary device by capillary action, thereby subjecting any hCG present in said sample to immunoreaction with said color labeled first protein capable of specifically binding to hCG in said first material to form a labeled immunocomplex, followed by further migration of said immunocomplex onto said second material, wherein any immunocomplex is bound to said second protein capable of specifically binding to hCG; (c) removing said second container from said first container; and (d) visually detecting said at least one of two figures to determine if hCG is present in said urine sample.
Claim 11
Independent Claim
439 words
A method of detecting human chorionic gonadotropin (hCG) in urine, comprising the steps of: (a) providing a capillary device, wherein said capillary device contains therein: a first longitudinal container having distal and proximal ends, said distal end of said first container containing a hydrophilic pore septum which covers an entrance in said distal end through which urine is capable of being drawn; a second longitudinal container having distal and proximal ends, said second container being telescopically housed within and capable of being removed from said first container; a first material contained within an area defined between said hydrophilic pore septum and said distal end of said second container, said first material capable of drawing urine by capillarity and on which a color labeled first protein capable of specifically binding to hCG is diffusively adsorbed; a second material comprising a reading area contained within the distal end of said second container and in contact with said first material to allow movement of urine from said first material through said second material and on which is bound (i) a second protein capable of specifically binding to hCG, wherein at least one of said first or second protein is an antibody, (ii) immobilized hCG, and (iii) an inert protein, wherein (i), (ii), and (iii) are disposed on said second material so as to form, after reaction with said first color labeled protein, at least one of two figures which can be visually detected according to the positivity of the reaction when the second container is removed from the first container; a third material capable of drawing urine by capillarity contained within the proximal end of said container and contacting said second material to allow movement of urine through said second material to said third material; and a flow indicator means contained within said third material at the proximal end of said second container, said means capable of indicating the passage of urine through said device; (b) contacting the distal end of said capillary device with a urine sample suspected of containing hCG, and allowing said sample to migrate into said capillary device by capillary action, thereby subjecting any hCG present in said sample to immunoreaction with said color labeled first protein capable of specifically binding to hCG in said first material to form a labeled immunocomplex, followed by further migration of said immunocomplex onto said second material, wherein any immunocomplex is bound to said second protein capable of specifically binding to hCG; (c) removing said second container from said first container; and (d) visually detecting said at least one of two figures to determine if hCG is present in said urine sample.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1995-09-08 | 1996-03-09 | 1996-09-08 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1999-09-08 | 2000-03-09 | 2000-09-08 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2003-09-08 | 2004-03-09 | 2004-09-08 | $7700.00 | Window Closed / Lapsed |