CA2257164A1 - Device and method for screening fecal occult blood specimens - Google Patents
Device and method for screening fecal occult blood specimens Download PDFInfo
- Publication number
- CA2257164A1 CA2257164A1 CA002257164A CA2257164A CA2257164A1 CA 2257164 A1 CA2257164 A1 CA 2257164A1 CA 002257164 A CA002257164 A CA 002257164A CA 2257164 A CA2257164 A CA 2257164A CA 2257164 A1 CA2257164 A1 CA 2257164A1
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- CA
- Canada
- Prior art keywords
- panel
- aperture
- cover
- sheet
- specimen
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0038—Devices for taking faeces samples; Faecal examination devices
Abstract
A specimen testing device, as illustrated in the figure, said testing device having a first (4) and a second panel and a reagent sheet (9) therebetween.
The first panel has a first aperture (10, 12, 14) with a first aperture cover (16, 18, 20). The sheet in the first apertures has first (40) and second (42) portions disposed on opposite sides of a longitudinal axis of the first panel, wherein a fecal speciment is smeared on the sheet in the first aperture of the first panel so as to cover the first and second portions.
The first panel has a first aperture (10, 12, 14) with a first aperture cover (16, 18, 20). The sheet in the first apertures has first (40) and second (42) portions disposed on opposite sides of a longitudinal axis of the first panel, wherein a fecal speciment is smeared on the sheet in the first aperture of the first panel so as to cover the first and second portions.
Description
W O 97146864 PCT~US97108612 DEVICE AND METHOD FOR SCREENING
FECAL O~CULT BLOOD SPECIMENS
The present invention relates to a device for determining the presence of occult blood in fecal matter, and to a method of testing using such a device.
BACKGROUND OF THE INVENTION
For many years it has been recoa~ni2ed that colorectal cancer and large polyps bleed into the stool. Use of guaiacum for the detection of blood was described in "The Scarlet Letter" by Sherlock Holmes as being sensitive but unreliable. The problem has been that 15 guaiacum detects oxidizing agents of which blood is only one, and red meat and other oxidi~ing agents also can test positive.
A typical form of f'ecal occult blood testing known as Haemoccult II utilizes a guaiac tTeated test sheet upon which a 20 specimen of f'ecal material is smeared. A developing solution is applied to the opposite side of the sheet ~Tielding a blue color which suggests that blood may be present in the fecal specimen. The drawback of this approach is that a high percentage of false positives is obtained f'rom patients w. ho in fact do not have a cancer or polyp. A
26 false positive result in the test often results in e~pensive testing of patients who in fact have simplv consumed a lot of meat just prior to the test.
.
CA 022~7164 1998-12-04 W O 97/46864 PCTrUS97/08612 One approach to overcome the high incidence of false positives has been to make the test paper sensitive enough to detect up to 2~o of blood but not sensitive enough to produce too many false positives.
A disadvantage of this compromise approach is that because of the 5 reduced sensitivity, a number of cancers and polyps are not detected.
In an effort to increase sensitivity, the Haemoccult Sensa system w as devised. However, this system results in a higher incidence of false positives r equiring unnecessary invasive tests.
Alternative approaches to cutting down on false positives have involved placing patients on specific diets designed to restrict intake of animal proteins and other sources of false positives. Despite these efforts, large numbers of false positives still occur. One reason for 16 this is the very long time it can take for food to pass through the bowel in certain patients.
A specific test f'or human hemoglobin has been devised. This test - the Haemselect test - theoretically registers only human 20 hemoglobin and not ~nim~l blood from meat or other agents and therefore theoretically does not require the patient to be on a special diet. Another possible advantage is that human blood from the upper gastrointestinal tract may be digested by the time it reaches the stool and the only human blood detected would be that from the distal 25 bowel. A serious drawback of the Haemselect test is that it is expensive for a screening test and requires specially trained individuals to perfoIm and read the test.
W O 97/46864 PCTrUS97/08612 A need therefore exists for an inexpensive and easy-to-use test which has a minimal incidence of false positives and can be readily used in a doctor's office. The invention of the present application meets that need.
SUMMARY OF THE INVENTION
In accordance with one aspect of the present invention, there is provided a testing device includin~ a first panel, a first aperture in 10 the first panel, a second panel and a second aperture in the second panel opposite the first aperture. A sheet is deposed between the first and second panels for recei~ing a specimen through the first aperture. The sheet has first and second portions disposed on opposite sides of a longitudinal a~xis of the first panel onto which the 1~ specimen is placed. A first aperture cover is mounted on the first panel and overlies the first aperture. A second aperture cover is mounted on the second panel and overlies the first portion of the sheet. A third aperture co~er is also mounted on the second panel and overlies the second portion of the sheet. The second and third 20 covers are movable independentl~v of each other to selectively expose the first and second portions of the sheet.
According to a preferred aspect, the first and second apertures are rectan~lar a~d extend transversely across the first and second 25 panels. The first co~ er is preferably hingedly mounted along a hinge line extending transversely of the first panel, and the second cover is preferably hingedly mounted along a hinge line extending longitudinally of the second panel. The thi~d cover is preferal: ly CA 022~7164 1998-12-04 W 097146864 PCTrUS97/08612 hingedly mounted along a hinge line extending longitudinally of the second panel~
The sheet may be a single piece of paper, typically filter paper, 5 with a hydrophobic dividing strip separating the first and second portions to prevent or minimi~e possible leakage of developing solution from the first portion to the second portion. Alternatively, the first and second portions may be comprised of two separate pieces of filter paper separated by a hydrophobic barrier. The paper sheet 10 may be impregnated with reagent (e.~,. guaiac) over the entire area thereof, or may be impregated with reagent (guaic) only on the first portion and plain unimpregnated filter paper for the second portion.
The hydrophobic material may be wax or other suitable solid organic material.
In another preferred aspect, the first and second portions are provided with indicating means for locating where specimen is to be placed on the sheet through the first aperture and where developing solution is to be placed on the first portion through the second 20 aperture. At least one of the indicating means, usually that in the second portion, is preferably comprised of a perforated zone which is removable from the sheet. Preferably, the third cover overlies the removable zone.
In accordance with a particularly preferred aspect of the invention, the first panel has three apertures extending transversely of the first panel and the second panel has two apertures opposite the three apertures which extend longitudinally of the second panel. A
. . .
CA 022F,7164 1998-12-04 support panel for the sheet is provided between the first and second panels with apertures corresponding to the apertures in the first panel. Each of the three apertures in the first panel has a respective cover hingedly mounted along a hinge line extending transversely of 5 the longitudinal axis of the panel and overlying a respective aperture and respective first and second portions of the sheet. A single second cover is hingedly mounted on the second panel along a hinge line extending longitudinally of the second panel and overlies the three first portions. A single third cover is hingedly mounted on the second 10 panel along a hinge line extending longitudinally of the second panel and overlies the three second portions. The second and third covers are selectively movable ~ith respect to each other to expose the first and second portions as desired According to another preferred feature, the device may carry printed matter on the first panel such as patient details and instructions for opening of the respective covers to revea~ the apertures on which the ;,pecimen is smeared. Printed matter may also be provided on the second panel, such as instructions to the 20 doctor for conducting tecting of specimens.
A further preferred feature of the device is that sticking of the cover to the specimen is prevented by providing the inside surfaces of the respective aperture co~ ers ~ith a non-stick coating~ such a ~,vax 25 layer.
According to yet another aspect of the invention, there is provided a method of analvzing a specimen using a specimen testing CA 022~7164 1998-12-04 W O 97/46864 PCTrUS97/08612 device according to the invention. The method includes the steps of obt~inin~ a specimen, for example a fecal specimen, opening an aperture cover on the first panel, smearing a portion of the specimen on the first and second portions of the sheet through the first 5 aperture, and closing the first aperture cover to overlie the aperture and the specimen on the sheet. A first analysis of the specimen is carried out by opening the aperture cover on the second panel to expose the first portion of the sheet carrying the specimen and applying a reagent to the exposed first portion through the second 10 panel. Depending on the outcome of the first analysis, the other aperture cover on the second panel is selectively opened to expose the second portion of the sheet carrying the specimen and filrther analysis is carried out, for example in a laboratory.
The presentinvention enjoys numerous advantages. In particular, the device is embodied in one card which readily facilitates transference between the doctor and the patient and between the doctor and another testing location, such as a laboratory.
The device is easy to use by the patient and is inexpensive to produce.
20 A particularly important advantage is that the device allows a first test to be carried out by the doctor and, in the event that a specimen is positive, subsequent testing can be carried out on the same specimen.
BRIEF DES(~RIPTION OF THE DRAWINGS
The invention will now be desclibed with reference to the accompanying drawings, in which:
_ CA 022=,7164 1998-12-04 W O 97/46864 PCTrUS97/08612 Figure 1 is a perspective view of the device of the invention showing one cover in the open position;
Figure 2 is a perspective view of the device of Fi,,~ure 1 as 5 viewed from the other side and showing one cover in the open position;
Figures 3a, 3b and 3c are an exploded view of the device of Figure 1 showing the outer panels and the support panel carrying the 10 sheet therebetween; and Fit~ures 4a, 4b and 4c ~how perspective views of alternative embodiments of the de~ice of the invention DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Referring to Figures 1-3. where like numbers refer to the same elements, a device of the in~-ention, ~enerally referenced 2, is shown 20 which includes first and second panels 4, 6 with a support panel 8 disposed between the first and second panels 4, 6 carrying a absorbent sheet 9 on which a specimen is placed. The first panel 4 has three rectangular apertures 10, 12, 14 extending transversely of a longitudinal axis L of the f~rst panel. Each aperture has a 25 respective cover 16, 18 and 20 hingedly mounted to the first panel along a hinge line 22, 24, 2t~i extending transversely of the lont,itudinal axis L. Each co~ er 16, 18. 20 is hinged~y movable independently of the other bet~veen a closed position as sho~,vn for CA 022~7l64 Isss-l2-04 W 097/46864 PCTrUS97/08612 covers 18 and 20 where the cover overlies the aperture, and an open position as shown for cover 16 where the aperture 10 and underlying sheet 9 are exposed.
5 The second panel 6 includes two rectangular apertures 28,30 extending longitudinally of the longitudinal axis L and positioned opposite the transversely extending apertures 10, 12,14 in the first panel 4. Aperture 28is provided with a cover 32 and aperture 30 is provided with a cover 34. Covers 32 and ~34 are each hingedly 10 mounted along a respective hinge line 36, 38, each of which extends parallel to longitudinally axis L of second panel. Each cover 32,34 is movable independently of each other between a closed position as shown for cover 34 where the cover overlies the aperture 30, and an open position as shown for cover 32 where the aperture 28 and 15 underlying sheet 9 are exposed.
The support panel 8 is positioned between the first and second panels 4, 6 and supports sheet 9. Sheet 9 is made of an absorbent material, and is typically filter paper impregnated with a reagent 20 which will react with hemoglobin components from blood and a peroxide solution to form a colored compound. Examples of suitable reagents are guaiac, tetramethyl benzidene, orthotoluidine and other similar chromogens. In the embodiment illustrated herein, the reagent impregnated in sheet is guaiac. The support panel 8 has 25 apertures 11 corresponding to the apertures in the first panel.
Referring to Figure 3, Fi~,ures 3a and 3c show- the first and second panels 4,~ with the respective first and second covers CA 022~7164 1998-12-04 overlying the apertures. In Fi~ure 3c, the second panel is oriented upwards for ease of viewing. Figure 3b shows sheet 8 disposed between panels 4 and 6. In the embodiment illustrated, the sheet 9 is a single piece of filter paper having first and second portions 40, 42 5 separated from each other by a dividing region 44, which may comprise a hydrophobic material, for example wax. The first portion 40 is impregnated with the reagent and the second portion 42 is not impregnated with reagent. It is possible however for both portion to be impregnated with reagent provided impregnation of the second 10 portion does not adversely affect any subsequent testing which might be conducted using the second portion. The first and second portions are visible through the apertures when the respective covers are in the open position. Each of the portions 40, 42 is provided with indicating means 46, 48, tvpic211y circular zones in dashed outline, in 16 order to assist the user in knowing where to smear sample on the sheet. Moreover, the zones 48 have perforations 50 to enable the zones 48 to be removed from the sheet 9 for further analysis (described in more detail below:).
The outer panels 4. 6 and the support panel 8 are preferably formed of paper or cardboard in which the apertures are die-cut along with perforations in the outer panels to form the covers. The panels could equally be made from other suitable materials such as a plastic material. A tab 52 is formed on each cover and is engageable with a 25 slit 54 to maintain the co~ er in the closed position. The slit 54 may be formed during the die-cutting operation mentioned above.
The sheet 9 is tvpicallv cut f~om a length of filter paper with a CA 022~7164 1998-12-04 ~ 10 repeating pattern of perforations 50 corresponding to the zones 48.
The sheet 9 may be formed from one piece of filter paper with the hydrophobic dividing region 44 separating the first and second portions. Alternatively, the first and second portions may be two 5 separate pieces of filter paper each constituting the first and second portions of the sheet, and separated by a hydrophobic region.
The device is assembled by overlying the panels 4 and t~ with the support panel 8 carrying the sheet 9 therebetween. The assembly 10 is held together with a suitable glue or adhesive. In order to minimi7:e sticking of the covers to the specimen, the panels 4 and 6 are provided on their inner surfaces 56, 58 with a layer of non-stick material, typically a wax layer. In this way, the perforated zones 48 carrying the specimen can be removed without them sticking to the 15 inner surfaces of the covers on the first and second panels.
The panels 4, 6 and support panel 8 are assembled such that the apertures in the first panel and the support panel are opposite the apertures in the second panel, and the first and second portions 20 on the sheet are aligned with the apertures in each panel. In this way, specimens placed on the sheet through the apertures in the first panel can be accessed and tested through the apertures in the second panel.
The first panel 4 may be provided with appropriate printed matter at the top and bottom to assist the user. For example, the patient'~ name, address and instructions on how to use the device may be printed at the top of the first panel in the region 60. Printed CA 022~7164 1998-12-04 matter may also be provided at the top and bottom of the second panel. For example instructions to the doctor as to how to carry out testing by opening respective covers on the second panel 6 may be provided at 62.
In use, where a fecal sample is to be analyzed, a cover on the first panel 4 of the device is opened and a fecal specimen is smeared through the aperture on the ~rst and second portions of the exposed sheet. The cover is then closed. A second fecal sample tak~n at a 10 different time as a result of a different bowel movement is then smeared onto the first and second portions of the sheet through the second aperture on the first panel and the cover is closed. The third specimen from yet a different bowel movement at a different time is smeared onto the first and second portions through the third aperture 16 on the first panel and the cover is closed. To conduct a first analysis, the cover on the seeond panel covering the first portions on which specimen has been applied is opened and developer solution is applied to the circular zone ~6 of each first portion. If a specimen tests positive, as evidenced, for example, by the development of a blue 20 color, the cover on the second panel covering the second portions is opened, and the respective perforated circular zone 48 of the second portion of the sheet carrving the positive specimen is removed from the sheet and subjected to further analysis (e.g. an immunochemical test).
Figures 4a and 4b show an alternative embodiment of the device of the invention includin~ a first panel 4' with one aperture 10' extending transversely of longitudinal axis L and ~ cover 1~' CA 022~7l64 l998-l2-04 W O 97t46864 PCTrUS97/08612 overlying the aperture 10', a second panel fi~vith two apertures 2 8', 3 O' each with an independently moveable cover 3 2', 3 4' hin gedly mounted along hinge lines 3 6', 3 8' extending parallel to axis L, and a support panel 8' positioned between the first and second panels with 5 a sheet 9' having first and second portions 40', 4 2' divided by a dividing region 44'. The covers on the first and second panels overlie the first and second portions 40', 42' of sheet 9'.
Figure 4c shows a structural variation of the device of Figures 10 4a and 4b where the second panel 6' has a single transversely extending aperture 2 8' opposite the single aperture in the first panel with two independently moveable covers 30', 32' hingedly mounted along hinge lines 3 6', 3 8' extending transversely of axis L. The device of Eigure 4a-4c is constructed and used in the same manner as for the 15 embodiment described with reference to Figures 1-~, and is adapted for situations where it is not necessary to collect and analyze a plurality of specimens.
Further modifications of the invention will be readily apparent 20 to those skilled in the art. For example, the invention has been described above with reference to the preferred embodiment where three transversely extending rectangular apertures are present in the first panel 4 and two longitudinally extending rectangular apertures are in the second panel fi. The invention, however, is not limited to 25 devices comprising three apertures in the first panel. Embodiments comprising fewer apertures in the first and second panels are described above. Other embodiments with more or less than three apertures in the first panel may be constructed and used as the W O 97/46864 PCT~US97/08612 analytical situation demands.
In the above description, the apertures are illustrated as rectangular. However, any desired shape may be used, for example 5 oval or circular.
The device has been described as including a support panel 8.
However, it is possible, depending on the dimensions of the device and the thickness of the filter paper, to dispense with the support 10 panel and place the sheet 9 directly between the first and second panels 4, t~
The invention has been described with reference to analysis of fecal samples for stool occult blood. However, the device may be used 1~ for screening and testin~ of other biological specimens, for example blood and AIDS tests, urine tests and pregnancy tests.
While the present invention has been described in considerable detail, the invention disclosed herein is not limited to the detailed 20 description, and is to be afforded the full scope of the appended claims and all equivalents thereto.
FECAL O~CULT BLOOD SPECIMENS
The present invention relates to a device for determining the presence of occult blood in fecal matter, and to a method of testing using such a device.
BACKGROUND OF THE INVENTION
For many years it has been recoa~ni2ed that colorectal cancer and large polyps bleed into the stool. Use of guaiacum for the detection of blood was described in "The Scarlet Letter" by Sherlock Holmes as being sensitive but unreliable. The problem has been that 15 guaiacum detects oxidizing agents of which blood is only one, and red meat and other oxidi~ing agents also can test positive.
A typical form of f'ecal occult blood testing known as Haemoccult II utilizes a guaiac tTeated test sheet upon which a 20 specimen of f'ecal material is smeared. A developing solution is applied to the opposite side of the sheet ~Tielding a blue color which suggests that blood may be present in the fecal specimen. The drawback of this approach is that a high percentage of false positives is obtained f'rom patients w. ho in fact do not have a cancer or polyp. A
26 false positive result in the test often results in e~pensive testing of patients who in fact have simplv consumed a lot of meat just prior to the test.
.
CA 022~7164 1998-12-04 W O 97/46864 PCTrUS97/08612 One approach to overcome the high incidence of false positives has been to make the test paper sensitive enough to detect up to 2~o of blood but not sensitive enough to produce too many false positives.
A disadvantage of this compromise approach is that because of the 5 reduced sensitivity, a number of cancers and polyps are not detected.
In an effort to increase sensitivity, the Haemoccult Sensa system w as devised. However, this system results in a higher incidence of false positives r equiring unnecessary invasive tests.
Alternative approaches to cutting down on false positives have involved placing patients on specific diets designed to restrict intake of animal proteins and other sources of false positives. Despite these efforts, large numbers of false positives still occur. One reason for 16 this is the very long time it can take for food to pass through the bowel in certain patients.
A specific test f'or human hemoglobin has been devised. This test - the Haemselect test - theoretically registers only human 20 hemoglobin and not ~nim~l blood from meat or other agents and therefore theoretically does not require the patient to be on a special diet. Another possible advantage is that human blood from the upper gastrointestinal tract may be digested by the time it reaches the stool and the only human blood detected would be that from the distal 25 bowel. A serious drawback of the Haemselect test is that it is expensive for a screening test and requires specially trained individuals to perfoIm and read the test.
W O 97/46864 PCTrUS97/08612 A need therefore exists for an inexpensive and easy-to-use test which has a minimal incidence of false positives and can be readily used in a doctor's office. The invention of the present application meets that need.
SUMMARY OF THE INVENTION
In accordance with one aspect of the present invention, there is provided a testing device includin~ a first panel, a first aperture in 10 the first panel, a second panel and a second aperture in the second panel opposite the first aperture. A sheet is deposed between the first and second panels for recei~ing a specimen through the first aperture. The sheet has first and second portions disposed on opposite sides of a longitudinal a~xis of the first panel onto which the 1~ specimen is placed. A first aperture cover is mounted on the first panel and overlies the first aperture. A second aperture cover is mounted on the second panel and overlies the first portion of the sheet. A third aperture co~er is also mounted on the second panel and overlies the second portion of the sheet. The second and third 20 covers are movable independentl~v of each other to selectively expose the first and second portions of the sheet.
According to a preferred aspect, the first and second apertures are rectan~lar a~d extend transversely across the first and second 25 panels. The first co~ er is preferably hingedly mounted along a hinge line extending transversely of the first panel, and the second cover is preferably hingedly mounted along a hinge line extending longitudinally of the second panel. The thi~d cover is preferal: ly CA 022~7164 1998-12-04 W 097146864 PCTrUS97/08612 hingedly mounted along a hinge line extending longitudinally of the second panel~
The sheet may be a single piece of paper, typically filter paper, 5 with a hydrophobic dividing strip separating the first and second portions to prevent or minimi~e possible leakage of developing solution from the first portion to the second portion. Alternatively, the first and second portions may be comprised of two separate pieces of filter paper separated by a hydrophobic barrier. The paper sheet 10 may be impregnated with reagent (e.~,. guaiac) over the entire area thereof, or may be impregated with reagent (guaic) only on the first portion and plain unimpregnated filter paper for the second portion.
The hydrophobic material may be wax or other suitable solid organic material.
In another preferred aspect, the first and second portions are provided with indicating means for locating where specimen is to be placed on the sheet through the first aperture and where developing solution is to be placed on the first portion through the second 20 aperture. At least one of the indicating means, usually that in the second portion, is preferably comprised of a perforated zone which is removable from the sheet. Preferably, the third cover overlies the removable zone.
In accordance with a particularly preferred aspect of the invention, the first panel has three apertures extending transversely of the first panel and the second panel has two apertures opposite the three apertures which extend longitudinally of the second panel. A
. . .
CA 022F,7164 1998-12-04 support panel for the sheet is provided between the first and second panels with apertures corresponding to the apertures in the first panel. Each of the three apertures in the first panel has a respective cover hingedly mounted along a hinge line extending transversely of 5 the longitudinal axis of the panel and overlying a respective aperture and respective first and second portions of the sheet. A single second cover is hingedly mounted on the second panel along a hinge line extending longitudinally of the second panel and overlies the three first portions. A single third cover is hingedly mounted on the second 10 panel along a hinge line extending longitudinally of the second panel and overlies the three second portions. The second and third covers are selectively movable ~ith respect to each other to expose the first and second portions as desired According to another preferred feature, the device may carry printed matter on the first panel such as patient details and instructions for opening of the respective covers to revea~ the apertures on which the ;,pecimen is smeared. Printed matter may also be provided on the second panel, such as instructions to the 20 doctor for conducting tecting of specimens.
A further preferred feature of the device is that sticking of the cover to the specimen is prevented by providing the inside surfaces of the respective aperture co~ ers ~ith a non-stick coating~ such a ~,vax 25 layer.
According to yet another aspect of the invention, there is provided a method of analvzing a specimen using a specimen testing CA 022~7164 1998-12-04 W O 97/46864 PCTrUS97/08612 device according to the invention. The method includes the steps of obt~inin~ a specimen, for example a fecal specimen, opening an aperture cover on the first panel, smearing a portion of the specimen on the first and second portions of the sheet through the first 5 aperture, and closing the first aperture cover to overlie the aperture and the specimen on the sheet. A first analysis of the specimen is carried out by opening the aperture cover on the second panel to expose the first portion of the sheet carrying the specimen and applying a reagent to the exposed first portion through the second 10 panel. Depending on the outcome of the first analysis, the other aperture cover on the second panel is selectively opened to expose the second portion of the sheet carrying the specimen and filrther analysis is carried out, for example in a laboratory.
The presentinvention enjoys numerous advantages. In particular, the device is embodied in one card which readily facilitates transference between the doctor and the patient and between the doctor and another testing location, such as a laboratory.
The device is easy to use by the patient and is inexpensive to produce.
20 A particularly important advantage is that the device allows a first test to be carried out by the doctor and, in the event that a specimen is positive, subsequent testing can be carried out on the same specimen.
BRIEF DES(~RIPTION OF THE DRAWINGS
The invention will now be desclibed with reference to the accompanying drawings, in which:
_ CA 022=,7164 1998-12-04 W O 97/46864 PCTrUS97/08612 Figure 1 is a perspective view of the device of the invention showing one cover in the open position;
Figure 2 is a perspective view of the device of Fi,,~ure 1 as 5 viewed from the other side and showing one cover in the open position;
Figures 3a, 3b and 3c are an exploded view of the device of Figure 1 showing the outer panels and the support panel carrying the 10 sheet therebetween; and Fit~ures 4a, 4b and 4c ~how perspective views of alternative embodiments of the de~ice of the invention DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Referring to Figures 1-3. where like numbers refer to the same elements, a device of the in~-ention, ~enerally referenced 2, is shown 20 which includes first and second panels 4, 6 with a support panel 8 disposed between the first and second panels 4, 6 carrying a absorbent sheet 9 on which a specimen is placed. The first panel 4 has three rectangular apertures 10, 12, 14 extending transversely of a longitudinal axis L of the f~rst panel. Each aperture has a 25 respective cover 16, 18 and 20 hingedly mounted to the first panel along a hinge line 22, 24, 2t~i extending transversely of the lont,itudinal axis L. Each co~ er 16, 18. 20 is hinged~y movable independently of the other bet~veen a closed position as sho~,vn for CA 022~7l64 Isss-l2-04 W 097/46864 PCTrUS97/08612 covers 18 and 20 where the cover overlies the aperture, and an open position as shown for cover 16 where the aperture 10 and underlying sheet 9 are exposed.
5 The second panel 6 includes two rectangular apertures 28,30 extending longitudinally of the longitudinal axis L and positioned opposite the transversely extending apertures 10, 12,14 in the first panel 4. Aperture 28is provided with a cover 32 and aperture 30 is provided with a cover 34. Covers 32 and ~34 are each hingedly 10 mounted along a respective hinge line 36, 38, each of which extends parallel to longitudinally axis L of second panel. Each cover 32,34 is movable independently of each other between a closed position as shown for cover 34 where the cover overlies the aperture 30, and an open position as shown for cover 32 where the aperture 28 and 15 underlying sheet 9 are exposed.
The support panel 8 is positioned between the first and second panels 4, 6 and supports sheet 9. Sheet 9 is made of an absorbent material, and is typically filter paper impregnated with a reagent 20 which will react with hemoglobin components from blood and a peroxide solution to form a colored compound. Examples of suitable reagents are guaiac, tetramethyl benzidene, orthotoluidine and other similar chromogens. In the embodiment illustrated herein, the reagent impregnated in sheet is guaiac. The support panel 8 has 25 apertures 11 corresponding to the apertures in the first panel.
Referring to Figure 3, Fi~,ures 3a and 3c show- the first and second panels 4,~ with the respective first and second covers CA 022~7164 1998-12-04 overlying the apertures. In Fi~ure 3c, the second panel is oriented upwards for ease of viewing. Figure 3b shows sheet 8 disposed between panels 4 and 6. In the embodiment illustrated, the sheet 9 is a single piece of filter paper having first and second portions 40, 42 5 separated from each other by a dividing region 44, which may comprise a hydrophobic material, for example wax. The first portion 40 is impregnated with the reagent and the second portion 42 is not impregnated with reagent. It is possible however for both portion to be impregnated with reagent provided impregnation of the second 10 portion does not adversely affect any subsequent testing which might be conducted using the second portion. The first and second portions are visible through the apertures when the respective covers are in the open position. Each of the portions 40, 42 is provided with indicating means 46, 48, tvpic211y circular zones in dashed outline, in 16 order to assist the user in knowing where to smear sample on the sheet. Moreover, the zones 48 have perforations 50 to enable the zones 48 to be removed from the sheet 9 for further analysis (described in more detail below:).
The outer panels 4. 6 and the support panel 8 are preferably formed of paper or cardboard in which the apertures are die-cut along with perforations in the outer panels to form the covers. The panels could equally be made from other suitable materials such as a plastic material. A tab 52 is formed on each cover and is engageable with a 25 slit 54 to maintain the co~ er in the closed position. The slit 54 may be formed during the die-cutting operation mentioned above.
The sheet 9 is tvpicallv cut f~om a length of filter paper with a CA 022~7164 1998-12-04 ~ 10 repeating pattern of perforations 50 corresponding to the zones 48.
The sheet 9 may be formed from one piece of filter paper with the hydrophobic dividing region 44 separating the first and second portions. Alternatively, the first and second portions may be two 5 separate pieces of filter paper each constituting the first and second portions of the sheet, and separated by a hydrophobic region.
The device is assembled by overlying the panels 4 and t~ with the support panel 8 carrying the sheet 9 therebetween. The assembly 10 is held together with a suitable glue or adhesive. In order to minimi7:e sticking of the covers to the specimen, the panels 4 and 6 are provided on their inner surfaces 56, 58 with a layer of non-stick material, typically a wax layer. In this way, the perforated zones 48 carrying the specimen can be removed without them sticking to the 15 inner surfaces of the covers on the first and second panels.
The panels 4, 6 and support panel 8 are assembled such that the apertures in the first panel and the support panel are opposite the apertures in the second panel, and the first and second portions 20 on the sheet are aligned with the apertures in each panel. In this way, specimens placed on the sheet through the apertures in the first panel can be accessed and tested through the apertures in the second panel.
The first panel 4 may be provided with appropriate printed matter at the top and bottom to assist the user. For example, the patient'~ name, address and instructions on how to use the device may be printed at the top of the first panel in the region 60. Printed CA 022~7164 1998-12-04 matter may also be provided at the top and bottom of the second panel. For example instructions to the doctor as to how to carry out testing by opening respective covers on the second panel 6 may be provided at 62.
In use, where a fecal sample is to be analyzed, a cover on the first panel 4 of the device is opened and a fecal specimen is smeared through the aperture on the ~rst and second portions of the exposed sheet. The cover is then closed. A second fecal sample tak~n at a 10 different time as a result of a different bowel movement is then smeared onto the first and second portions of the sheet through the second aperture on the first panel and the cover is closed. The third specimen from yet a different bowel movement at a different time is smeared onto the first and second portions through the third aperture 16 on the first panel and the cover is closed. To conduct a first analysis, the cover on the seeond panel covering the first portions on which specimen has been applied is opened and developer solution is applied to the circular zone ~6 of each first portion. If a specimen tests positive, as evidenced, for example, by the development of a blue 20 color, the cover on the second panel covering the second portions is opened, and the respective perforated circular zone 48 of the second portion of the sheet carrving the positive specimen is removed from the sheet and subjected to further analysis (e.g. an immunochemical test).
Figures 4a and 4b show an alternative embodiment of the device of the invention includin~ a first panel 4' with one aperture 10' extending transversely of longitudinal axis L and ~ cover 1~' CA 022~7l64 l998-l2-04 W O 97t46864 PCTrUS97/08612 overlying the aperture 10', a second panel fi~vith two apertures 2 8', 3 O' each with an independently moveable cover 3 2', 3 4' hin gedly mounted along hinge lines 3 6', 3 8' extending parallel to axis L, and a support panel 8' positioned between the first and second panels with 5 a sheet 9' having first and second portions 40', 4 2' divided by a dividing region 44'. The covers on the first and second panels overlie the first and second portions 40', 42' of sheet 9'.
Figure 4c shows a structural variation of the device of Figures 10 4a and 4b where the second panel 6' has a single transversely extending aperture 2 8' opposite the single aperture in the first panel with two independently moveable covers 30', 32' hingedly mounted along hinge lines 3 6', 3 8' extending transversely of axis L. The device of Eigure 4a-4c is constructed and used in the same manner as for the 15 embodiment described with reference to Figures 1-~, and is adapted for situations where it is not necessary to collect and analyze a plurality of specimens.
Further modifications of the invention will be readily apparent 20 to those skilled in the art. For example, the invention has been described above with reference to the preferred embodiment where three transversely extending rectangular apertures are present in the first panel 4 and two longitudinally extending rectangular apertures are in the second panel fi. The invention, however, is not limited to 25 devices comprising three apertures in the first panel. Embodiments comprising fewer apertures in the first and second panels are described above. Other embodiments with more or less than three apertures in the first panel may be constructed and used as the W O 97/46864 PCT~US97/08612 analytical situation demands.
In the above description, the apertures are illustrated as rectangular. However, any desired shape may be used, for example 5 oval or circular.
The device has been described as including a support panel 8.
However, it is possible, depending on the dimensions of the device and the thickness of the filter paper, to dispense with the support 10 panel and place the sheet 9 directly between the first and second panels 4, t~
The invention has been described with reference to analysis of fecal samples for stool occult blood. However, the device may be used 1~ for screening and testin~ of other biological specimens, for example blood and AIDS tests, urine tests and pregnancy tests.
While the present invention has been described in considerable detail, the invention disclosed herein is not limited to the detailed 20 description, and is to be afforded the full scope of the appended claims and all equivalents thereto.
Claims (20)
1. A specimen testing device, comprising.
a first panel;
a first aperture in said first panel;
a second panel;
a second aperture in said second panel opposite said first aperture;
a sheet disposed between said first and second panels for receiving a specimen through said first aperture, said sheet, in said first aperture having first and second portions disposed on opposite sides of a longitudinal axis of said first panel;
a first aperture cover mounted on said first panel and overlying said first aperture;
a second aperture cover mounted on said second panel and overlying said first portion of said sheet;
a third cover aperture cover mounted on said second panel and overlying said second portion of said sheet; said second and third aperture covers being movable independently of each other to expose said first and second portions respectively.
a first panel;
a first aperture in said first panel;
a second panel;
a second aperture in said second panel opposite said first aperture;
a sheet disposed between said first and second panels for receiving a specimen through said first aperture, said sheet, in said first aperture having first and second portions disposed on opposite sides of a longitudinal axis of said first panel;
a first aperture cover mounted on said first panel and overlying said first aperture;
a second aperture cover mounted on said second panel and overlying said first portion of said sheet;
a third cover aperture cover mounted on said second panel and overlying said second portion of said sheet; said second and third aperture covers being movable independently of each other to expose said first and second portions respectively.
2. A device according to claim 1, wherein said first and second apertures extend transversely across said first and second panels.
3. A device according to claim 2, wherein said apertures are rectangular.
4. A device according to claim 1, wherein said first cover is hingedly mounted along a hinge line extending transversely of said first panel.
5. A device according to claim 1, wherein said second cover is hingedly mounted along a hinge line extending transversely of said second panel.
6. A device according to claim 1, wherein said third cover is hingedly mounted along a hinge line extending transversely of said second panel.
7. A device according to claim 1, wherein said first and second portions are divided by a dividing region.
8. A device according to claim 7, wherein said dividing region comprises a hydrophobic strip.
9. A device according to claim 1, wherein said first and second portions are provided with indicating means for locating where specimen is to be placed on the sheet.
10. A device according to claim 9, wherein at least one of said indicating means is comprised of zone which is removable from said sheet.
11. A device according to claim 10, wherein said zone is defined by perforations.
12. A device according to claim 10, wherein said third cover overlies said removable zone.
13. A device according to claim 1, wherein said first panel has three apertures extending transversely of said first panel and said second panel has two apertures extending longitudinally of said second panel, said apertures in said second panel being opposite said apertures in said first panel.
14. A device according to claim 13, wherein each of said three apertures in said first panel has a respective cover and wherein a single cover is hingedly mounted on said second panel along a hinge line extending longitudinally of said second panel and overlies said first portion in each of said three apertures, and wherein a single third cover is hingedly mounted on said second panel along a hinge line extending longitudinally of said second panel and overlies said second portions in each of said three apertures, said second and third covers being selectively movable with respect to each other to expose said first and second portions.
15. A device according to claim 1, wherein said first and second panels have printed matter thereon.
16. A device according to claim 1, wherein an inner surface of said first and second covers is provided with a non-stick wax layer.
17. A device according to claim 1 wherein said sheet is supported on a support panel disposed between said first and second panels.
18. A method of analyzing a specimen using a specimen testing device including a first panel having a first aperture, a second panel having a second aperture opposite the first aperture and a sheet disposed between the first and second panels for receiving a specimen through the first aperture, said sheet in said first aperture having first and second portions disposed on opposite sides of a longitudinal axis of the first panel, a first aperture cover mounted on the first panel and overlying the first aperture, a second aperture cover mounted on the second panel and overlying the first portion of the sheet and a third aperture cover mounted on the second panel and overlying the second portion of the sheet, said second and third covers being movable independently of each other to expose the first and second portions respectively, said method comprising the steps of:
(a) obtaining a specimen;
(b) opening a first cover on said first panel to expose said first and second portions through said first aperture;
(b) smearing a portion of said specimen on said first and second portions through said first aperture;
(c) closing said first cover to overlie said first aperture;
(d) opening a second cover on said second panel to expose said first portion of said sheet carrying said specimen;
(e) applying a reagent to said first portion of said sheet; and (f) selectively opening said third cover on said second panel and testing said specimen on said second portion.
(a) obtaining a specimen;
(b) opening a first cover on said first panel to expose said first and second portions through said first aperture;
(b) smearing a portion of said specimen on said first and second portions through said first aperture;
(c) closing said first cover to overlie said first aperture;
(d) opening a second cover on said second panel to expose said first portion of said sheet carrying said specimen;
(e) applying a reagent to said first portion of said sheet; and (f) selectively opening said third cover on said second panel and testing said specimen on said second portion.
19. A method according to claim 18, wherein a zone of said second portion is removed from said sheet for further analysis.
20. A method according to claim 18, wherein the specimen is a fecal specimen.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/658,543 US5747344A (en) | 1996-06-05 | 1996-06-05 | Device and method for screening fecal occult blood specimens |
| US08/658,543 | 1996-06-05 | ||
| PCT/US1997/008612 WO1997046864A1 (en) | 1996-06-05 | 1997-05-23 | Device and method for screening fecal occult blood specimens |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2257164A1 true CA2257164A1 (en) | 1997-12-11 |
Family
ID=24641682
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002257164A Abandoned CA2257164A1 (en) | 1996-06-05 | 1997-05-23 | Device and method for screening fecal occult blood specimens |
Country Status (10)
| Country | Link |
|---|---|
| US (1) | US5747344A (en) |
| EP (1) | EP0941467A1 (en) |
| JP (1) | JP2000512382A (en) |
| CN (1) | CN1226964A (en) |
| AU (1) | AU727638B2 (en) |
| CA (1) | CA2257164A1 (en) |
| IL (1) | IL127334A0 (en) |
| NO (1) | NO985687L (en) |
| NZ (1) | NZ333029A (en) |
| WO (1) | WO1997046864A1 (en) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5948687A (en) * | 1996-06-05 | 1999-09-07 | Cleator; Iain G.M. | Device and method for screening fecal occult blood specimens |
| US6271046B1 (en) * | 1997-10-06 | 2001-08-07 | Enterix, Inc. | Apparatus and method for analyte detection |
| FR2792724B1 (en) * | 1999-04-26 | 2001-05-25 | Biomerieux Sa | DEVICE FOR COLLECTING AND PRESERVING A BIOLOGICAL SAMPLE AND ITS IMPLEMENTING METHOD |
| US6474694B1 (en) | 2001-06-05 | 2002-11-05 | Moore North America, Inc. | Medical test form |
| AU2003234561A1 (en) * | 2002-05-14 | 2003-12-02 | Ottfried Waldenburg | Device for and method of testing occult blood in feces |
| US7488450B2 (en) * | 2004-03-04 | 2009-02-10 | Beckman Coulter, Inc. | Analyte collection and detection devices |
| US8679420B2 (en) * | 2004-07-22 | 2014-03-25 | Immunostics, Inc. | Fecal sampling device and method |
| ATE437365T1 (en) * | 2004-07-22 | 2009-08-15 | Immunostics Inc | SAMPLE TEST CARRIER AND METHOD FOR TESTING OCCULT BLOOD IN Stool |
| US7427505B2 (en) * | 2004-07-22 | 2008-09-23 | Immunostics, Inc. | Fecal occult blood testing device and method |
| US20080241940A1 (en) * | 2004-07-22 | 2008-10-02 | Lastella Vincent P | Fecal sampling device and method |
| US7195878B2 (en) * | 2004-09-30 | 2007-03-27 | Cryo-Genomics | Device and method for fecal testing |
| US20090117660A1 (en) * | 2005-04-30 | 2009-05-07 | Oakville Hong Kong Co., Limited | Devices and methods for sample collection and analysis |
| WO2006116917A2 (en) * | 2005-04-30 | 2006-11-09 | Oakville Hong Kong Co., Limited | Devices and methods for sample collection and analysis |
| US8114587B2 (en) * | 2005-06-23 | 2012-02-14 | Ambergen, Inc. | Methods for the detection of colorectal cancer |
| US7288413B2 (en) * | 2005-08-12 | 2007-10-30 | Beckman Coulter, Inc. | Combined chemical and immunochemical fecal occult blood test |
| US20070092401A1 (en) * | 2005-10-26 | 2007-04-26 | Feier Liao | Devices and methods for sample collection and analysis |
| EP1932480B1 (en) * | 2006-12-15 | 2015-03-11 | Bio-Optica Milano S.p.A. | Support element for biopsy and kit for collecting and treating biopsies comprising this support |
| AU2008209598B2 (en) * | 2007-01-22 | 2013-11-28 | Orasure Technologies, Inc. | Container and method for supporting home testing and diagnosis of infectious diseases |
| US8304596B2 (en) | 2008-04-11 | 2012-11-06 | Immunostics, Inc. | Fecal sampling device and method |
Family Cites Families (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3933594A (en) * | 1974-08-16 | 1976-01-20 | Polaroid Corporation | Method and device for determining the concentration of a substance in a fluid |
| AT360176B (en) * | 1977-07-01 | 1980-12-29 | Roehm Gmbh | TEST CARD FOR DETECTING THE Occult BLOOD IN THE CHAIR |
| US4367750A (en) * | 1980-11-03 | 1983-01-11 | Levine Robert A | Device for obtaining stool samples |
| US4259964A (en) * | 1979-07-09 | 1981-04-07 | Levine Robert A | Device for obtaining stool samples |
| US4365970A (en) * | 1981-05-01 | 1982-12-28 | Smithkline Instruments, Inc. | Specimen test slide and method for testing occult blood |
| US4578358A (en) * | 1983-05-03 | 1986-03-25 | Warner-Lambert Company | Collection of specimens and detection of occult blood therein |
| US4742002A (en) * | 1984-01-16 | 1988-05-03 | Helena Laboratories Corporation | Test kit and method for determining the presence of blood in a specimen and for testing the effectiveness of peroxidase inactivating solution |
| US4808379A (en) * | 1985-02-08 | 1989-02-28 | Wardlaw Stephen C | Device for obtaining stool samples and detecting occult blood |
| US4645743A (en) * | 1986-03-11 | 1987-02-24 | Smithkline Diagnostics, Inc. | Method and device for collecting and testing for fecal occult blood |
| US4789629A (en) * | 1986-11-24 | 1988-12-06 | Smithkline Beckman Corporation | Method and device for collecting and testing for fecal occult blood |
| US5238847A (en) * | 1987-05-20 | 1993-08-24 | Boehringer Mannheim Gmbh | Test kit and process for the determination of an analyte in a pasty sample |
| US5310680A (en) * | 1987-09-16 | 1994-05-10 | Smithkline Diagnostics, Inc. | Test for fecal occult blood |
| JP2645429B2 (en) * | 1987-09-16 | 1997-08-25 | スミスクライン・ダイアグノスティクス・インコーポレイテッド | Improved fecal occult blood test |
| US5182191A (en) * | 1988-10-14 | 1993-01-26 | Pacific Biotech, Inc. | Occult blood sampling device and assay |
| US5196167A (en) * | 1989-04-04 | 1993-03-23 | Helena Laboratories Corporation | Fecal occult blood test product with positive and negative controls |
| US5100619A (en) * | 1989-05-09 | 1992-03-31 | Beckman Instruments, Inc. | Device and method for collecting fecal occult blood specimens |
| US5106582A (en) * | 1990-12-18 | 1992-04-21 | Smithkline Diagnostics, Inc. | Specimen test slide and method of testing for fecal occult blood |
| US5264181A (en) * | 1992-01-24 | 1993-11-23 | Robert Schreiber | Occult blood testing device |
| US5171529A (en) * | 1992-01-24 | 1992-12-15 | Robert Schreiber | Occult blood testing device |
-
1996
- 1996-06-05 US US08/658,543 patent/US5747344A/en not_active Expired - Lifetime
-
1997
- 1997-05-23 IL IL12733497A patent/IL127334A0/en unknown
- 1997-05-23 NZ NZ333029A patent/NZ333029A/en unknown
- 1997-05-23 WO PCT/US1997/008612 patent/WO1997046864A1/en not_active Application Discontinuation
- 1997-05-23 CN CN97196922.1A patent/CN1226964A/en active Pending
- 1997-05-23 EP EP97926650A patent/EP0941467A1/en not_active Withdrawn
- 1997-05-23 AU AU31363/97A patent/AU727638B2/en not_active Ceased
- 1997-05-23 CA CA002257164A patent/CA2257164A1/en not_active Abandoned
- 1997-05-23 JP JP10500608A patent/JP2000512382A/en active Pending
-
1998
- 1998-12-04 NO NO985687A patent/NO985687L/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP0941467A1 (en) | 1999-09-15 |
| NO985687D0 (en) | 1998-12-04 |
| JP2000512382A (en) | 2000-09-19 |
| NO985687L (en) | 1998-12-04 |
| WO1997046864A1 (en) | 1997-12-11 |
| US5747344A (en) | 1998-05-05 |
| AU3136397A (en) | 1998-01-05 |
| AU727638B2 (en) | 2000-12-21 |
| CN1226964A (en) | 1999-08-25 |
| EP0941467A4 (en) | 1999-09-15 |
| NZ333029A (en) | 2000-08-25 |
| IL127334A0 (en) | 1999-09-22 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FZDE | Discontinued |