CA2119816C - Test strip analysis system - Google Patents

Test strip analysis system Download PDF

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Publication number
CA2119816C
CA2119816C CA002119816A CA2119816A CA2119816C CA 2119816 C CA2119816 C CA 2119816C CA 002119816 A CA002119816 A CA 002119816A CA 2119816 A CA2119816 A CA 2119816A CA 2119816 C CA2119816 C CA 2119816C
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CA
Canada
Prior art keywords
test strip
test
field area
analysis system
pressure element
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.)
Expired - Lifetime
Application number
CA002119816A
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French (fr)
Other versions
CA2119816A1 (en
Inventor
Joachim Hones
Volker Unkrig
Klaus-Dieter Steeg
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Roche Diagnostics GmbH
Original Assignee
Roche Diagnostics GmbH
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Filing date
Publication date
Application filed by Roche Diagnostics GmbH filed Critical Roche Diagnostics GmbH
Publication of CA2119816A1 publication Critical patent/CA2119816A1/en
Application granted granted Critical
Publication of CA2119816C publication Critical patent/CA2119816C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84Systems specially adapted for particular applications
    • G01N21/8483Investigating reagent band
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84Systems specially adapted for particular applications
    • G01N21/86Investigating moving sheets
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/521Single-layer analytical elements
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/525Multi-layer analytical elements

Abstract

A test strip analysis system consists of an analysis apparatus with a test strip holding means and matching test strips. The test strip holding means serves to position the test strip in a defined position relative to a measuring unit. It comprises a test strip seating means and a guide for the test strip. Exact positioning with simple handling and without sophisticated mechanical elements is achieved by the fact that at least one part of the test strip seating means, in the area in which, in the measuring position, the front section of the test strip is located, is formed as a support which is offset in height relative to the middle plane of the test field area, the test strip,,holding means comprising at the same time a pressure element which in the measuring position presses between the support and the test field area of the test strip against the side opposite the seating means of the latter. The test strip is consequently subjected to bending stress, whereby the particular distance of the at least one test field from the measuring unit is ensured.

Description

The test strips are usually composed of an elongate base layer and at least one test field arranged thereon. The test field contains one or more reagents. When it is contacted with the sample, a reaction takes place which leads ultimately to a detectable signal, in particular to a colour change in a detection layer. A reflection-photometric measurement in the analysis apparatus, by which the diffuse reflectivity of the test field surface is measured, allows the determination of the concentration of a particular fluid component (analyte), In order to impose a particular direction on the test strip during the insertion process and to ensure lateral positioning in the measuring position, the test strip holder comprises a guide. Positioning means are provided for the exact positioning of the test strips relative to the reflection photometer. The accuracy of the measurement and the ease of handling are to a substantial extent determined by 'the positioning device. The positioning of the test strip in the test strip holder refers to three dimensions in space, namely to the longitudinal and lateral directions of the test field surface and to the direction vertical to the. test field surface.
The vertical distance of the surface of the test field from the optical measuring system is a critical parameter fox an exact measurement. Since (for cost reasons) there is a growing tendency to reduce the area of the test layers, the longitudinal and lateral positioning of the test strips must also be achieved with good precision, so that as large a part as possible of the surface o~ the detection layer can be used as a measurement area. Incorrect spatial alignment o~ the test strips causes a reduction in the measurement area and hence measurement errors.
A test strip analysis system of the kind described .--.
used for positioning the test strips. In addition it is necessary for the proper functioning of the known devices to position the recesses in the test strips in an exact manner.
The problem addressed by the present invention is therefore to permit precise positioning of the test strips relative to a measuring unit in the analysis apparatus with simple and reliable handling, and to achieve this with an inexpensive design.
This pxoblem is solved according to the invention by means of a test strip analysis system, comprising an analysis apparatus with a test strip holder for~positionir~g a test strip in a defined measuring position relative to a measuring unit, and test strips with a front end~with which they axe inserted into the test strip holder, a handling end, a test field area with at least one test field between 'the handling end and the front end, a front section between. the test field area and the front end and a handling section between the test field area and the handling end, the test strip holder comprising a guide by means of which a test strip, on insertion into the 'test strip holder, is guided in its lateral direction, comprises a fixing element which engages .'in the measuring position with a recess in the test strip, and comprises a test strip seat on which a first side of the test strip rests in such away that its test field area is.at a particular distance from the', measuring unit, wherein the test strip holder, in the range in' which, in the measuring positsori,.: the front section of the test strip is located, comprises a support which is raised against the first side~of the test strip so that it is offset in height (in the direction away from the test strip seat) relative to the 2~1~8~~
middle plane o~ the test field area together with a pressure element which in the measuring position presses between the support and the test field area against the second side of the holder is in many cases located beneath a flap with retaining springs which press downwards on to the test strips. The opening and closing of this flap is an additional handling step and a possible source of errors if the flap is .
inadvertently not closed completely. In order to avoid the need for a pressure element in the vicinity of the test field in a further known apparatus grooves are provided, in which the sides of the test strip are guided. In order to ensure in such a design good accessibility of the test field for the application of blood, extremely wide test strips are required, with a :relatively small test field in the centre of the test strip width. This results in higher manufacturing costs and a greater packaging volume.
The invention allows very good accessibility of the test field and yrecise positioning at extremely low cost, as regards both the test strip. holder. and the test strips themselves.
Tn a preferred embodiment the fixing element is a stationary protruding element (hereafter designated '°retaining lug" ) with a lateral surface on which at least a part of the edge of the recess in the test strip rests. The lateral surface forms an acute. angle with the test strip surface (in the area of the recess). Thus the inclined lateral surface 'of the retaining lug forms the support.
In a first variant of this embodiment the shape and size of the recess in the test strip and the shape and size of the retaining lug are coordinated with one another so that the edge of the recess rests in the measuring position on at least two points on the lateral surface of the .retaining lug, so' --,.

In a further preferred embodiment the pressure element is stationary. Thus the test strip holder has no moving parts at all.
The invention will be described in detail below by means of exemplifying embodiments shown diagrammatically in the figures, where Fig. 1 shows a perspective view of a test strip analysis system according to the invention, Fig. 2_ shows a perspective view of a test strip holder, Fig. 3 shows a cross-sectional view along; the line III-III in Fig. 2 of a test strip holder with a test strip in the measuring position, and Fig. 4 shows a section of a second variant of the test strip holder in a cross-sectional view according to Fig. 3.
Figure 1 and Figure 3 show a 'test strip analysis ~~1~~~.0 The geometric plane passing in the test field area 13 through the middle of the base layer 5 of the test strip 4 is designated as the middle plane 22 of the test field area 13, and shown in Fig. 3.
A part of the test strip seat 20 is, in the area in which the front section 12 is located when in the measuring position, designed as a support 24, which is offset in height relative to the middle plane 22 of the test field area 6. In other wards there is a defined vertical di~~-annA n~ tro location at which the test strip 4 rests on the support 24 and the middle plane 22. In the embodiment shown a stationary cone-shaped retaining lug 26 serves both as a support 24 and as a fixing element 25 for fixing the position of the test strip 4 in its, longitudinal direction, the insertion movement of the test strip 4 being limited by a stop 32.
For this function of the retaining lug 26 it is important that it has a lateral surface 27 inclined towards the stop 32 (running at an acute angle to the test strip surface in the area of the recess 17) and that the test strip , seat 20 is so shaped in the area surrounding the retaining lug z6 that the test strip 4 has in its foremost section facing the front end 10 only two defined points of contact, namely that it butts with, its front .end 10 against the stop 32 and rests with a section 28 of the edge of the recess;~l7 which faces the front end 10 on the inclined lateral surface 27 of the retaining lug 26. The distance between the centre of the retaining lug. 26 and the stop 32 is slightly less than the distance between the centre of the recess 17 and the front end 10 of the test strip 4.
,a r~n,.~

2 ~. .~. ~ 8 :~ 6 simultaneous longitudinal positioning of the test strip 4, because the recess 17 slides on the inclined lateral surface 27 in the direction of the stop 32 and hence produces (due to the intrinsic elasticity of the base layer 5) a force component in the longitudinal direction of the test strip 4 on to the stop 32.
The distance a of the stationary pressure element ~33 from the boundary of the test field area 13 which faces the front end to of the test strip 4 preferably,amounts to between 0.35 times and_0.65 times the distance b between the boundary of the test field area 13 which faces the front end 10 and the support 24.
As can be seen from Figure 3 , the length of the test strip seat 20 is shorter than the length of the test strip 4, so that only a part of the handling section 15, namely that faping,the test ffield area 13, nests on the test strip seat 20. The other part of the handling section 15 projects freely out of the analysis apparatus 2, which simplifies the handling of the test strip 4.
As .shown in Figure 2, the test strip holder 3 comprises a guide 40 for the insertion of the test strips 4 and for their exact lateral positioning. In the area of the handling section 15 this guide can be variously configured in consideration of the stiffness of the base layer of the test strips. If the base layer is relatively stiff, it, is sufficient if the guide prevents transverse movements' of'the test strips in this area. This can be achieved for.example by means of two guide elements with guide surfaces parallel to the insertion direction and rising vertically from the test strip seat, whose distance from one another is slightly more than the width of the test strips.
In the case of relatively thin and hence flexible test from above into the gap 36 of the test strip holder 3. During the further insertion movement the front end 10 is lifted by means of the retaining lug 26 raised relative to the test strip seat 20. As soon as the retaining lug 26 engages with the recess 17, the force component described is exerted towards the stop 32, due to the downward-acting elastic stress of the test strip 4 and the oblique inclination of the lateral surface 27 of the retaining lug 26. The test strip 4 slides in the direction of the stop 32 until it has reached the defined measuring position shown in Figure 3.
The handling end 16 is pressed manually against the resistance of the springs 41 downwards against the test strip seat 20 and is fixed there by the springs 41.
Fig. 4 shows in a cut-out view an alternative second embodiment of the invention. The main difference compared with the. embodiment described above is that this test strip analysis system is designed without a stop in the area of the front erid. The other features of the embodiment described befoxe are also provided here. The retaining lug 50 and the recess l7 in the test strip 4 are of circular cross-section, so that the test strip 4, when in its measuring position, rests centrally with the edge of the recess 17 virtually .entirely on the~.lateral surface 53 of the retaining lug 50 and.
.hence is fixed on the latter.
~~ , In the embodiments shown in Figure 3 and Figure 4 the '~conically-shaped retaining lug 26, 50 simultaneously provide the functions o~ a support and of a fixing element. Both functions may however also be fulfilled by separate, elements.
For example, it would be possible to design. the test strip

Claims (27)

1. A test strip analysis system, comprising:
an analysis apparatus having a test strip holding means and a measuring unit, said test strip holding means being adapted to position a test strip in a defined measuring position relative to the measuring unit, a test strip having a front end, a handling end, a test field area with at least one test field between the handling end and the front end, a front section between the test field area and the front end, a handling section between the test field area and the handling end, and a recess in said test strip, in which said test strip holding means comprises:
a guide means for laterally guiding a test strip when it is inserted into the test strip holding means, a fixing means which in the measuring position of the test strip in the test strip holding means is in engagement with said recess in the test strip, and a test strip seating means on which a first side of the test strip rests in such a way that its test field area is at a defined distance from a predetermined location of the measuring unit, the test strip holding means further comprising:
a supporting means for supporting the front section of a test strip which is in the measurement position and adapted to support the test strip, such that it is vertically offset relative to a middle plane of the test field area, and a pressure element which in the measuring position presses against a second side of the test strip at a position which is located between the supporting means and the test field area, so that the test strip is in the measuring position subjected to bending stress, whereby the defined distance of the at least one test field from the measuring unit is ensured.
2. A test strip analysis system according to claim 1, wherein the fixing means and the supporting means are simultaneously formed by a stationary retaining element having a lateral surface which is inclined towards the test strip surface and on which at least a section of an edge of the recess in the test strip rests.
3. A test strip analysis system according to claim 2, wherein the recess in the test strip rests on the lateral surface of the retaining element in such a way that the test strip is fixed against longitudinal movements both in the direction towards its handling end and in the direction towards its front end.
4. A test strip analysis system according to claim 2, wherein a stop is provided at an insertion end of the test strip seating means and the distance between the stop and the retaining element and the distance between the front end of the test strip and the section of the edge of the recess in the test strip which faces the insertion end are coordinated with one another so that the test strip in the measuring position butts with its front end against the stop and rests with the section of the edge of the recess which faces the front end on the inclined lateral surface of the retaining element.
5. A test strip analysis system according to claim l, 2, 3 or 4, wherein the test strip seating means is so constructed that in the measuring position it does not contact the first side of the test strip between the supporting means and the pressure element, so that the test strip is tensioned freely between the support and the pressure element.
6. A test strip analysis system according to claim 1, 2, 3 or 4, wherein the pressure element is stationary and bridges the test strip guide means forming a gap between the test strip seating means and the pressure element through which gap a test strip is passed on insertion into the test strip holding means.
7. A test strip analysis system according to claim 5, wherein the pressure element is stationary and bridges the test strip guide means forming a gap between the test strip seating means and the pressure element through which gap a test strip is passed on insertion into the test strip holding means.
8. A test strip analysis system according to claim 1, 2, 3, 4 or 7, wherein the distance (a) of the pressure element from the boundary of the test field area which faces the front end of the test strip amounts to between 0.35 times and 0.65 times the distance (b) between the boundary of the test field which faces the front end and the supporting means.
9. A test strip analysis system according to claim 5, wherein the distance (a) of the pressure element from the boundary of the test field area which faces the front end of the test strip amounts to between 0.35 times and 0.65 times the distance (b) between the boundary of the test field which faces the front end and the supporting means.
10. A test strip analysis system according to claim 6, wherein the distance (a) of the pressure element from the boundary of the test field area which faces the front end of the test strip amounts to between 0.35 times and 0.65 times the distance (b) between the boundary of the test field which faces the front end and the supporting means.
11. A test strip analysis system according to claim 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10, wherein the test strip seating means is shorter than the length of the test strip, so that its handling end projects beyond the test strip seating means.
12. A test strip analysis system according to claim 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 11, wherein the test strip holding means comprises elastic spring elements located on both sides of the guide means, said elastic spring elements being adapted to press against the edges of the test strip in the handling section such that the test strip is pressed against the test strip seating means.
13. A test strip holding device for use in conjunction with an analysis apparatus, the device comprising:
a) a guide means for laterally guiding a test strip during insertion into the device, b) a fixing means adapted to engage a recess of a test strip in a measuring position of the test strip, c) a test strip seating means adapted to support a first side of a test strip such that a test field area of the test strip is at a defined distance from a predetermined location of a measuring unit, d) supporting means for supporting a front section of a test strip in the measurement position, said supporting means being adapted to support a test strip such that the test strip is vertically offset relative to a middle plane of the test field area of the strip, and e) a pressure element which in the measuring position presses against a second side of the test strip, opposed to the first side, at a position located between the supporting means and the test field area, so that, in use, a test strip in the measuring position is subjected to bending stresses such that the defined distance of the test field from the predetermined location of the measuring unit is ensured.
14. A device according to claim 13, wherein the fixing means and the supporting means are simultaneously formed by a stationary retaining element having an inclined lateral surface.
15. A device according to claim 13 or 14, wherein said pressure element is stationary and bridges the test strip guide means forming a gap between the test strip seating means and the pressure element.
16. A device according to claim 13 or 14, further including elastic spring elements located on the opposed sides of the guide means, and adapted to press against edges of a test strip such that the test strip is pressed against the test strip seating means.
17. A test strip analysis system, comprising:
at least one test strip, said at least one test strip including a front end, a handling end, and a test field area disposed between the handling end and the front end, said test field area including at least one test field thereupon, said test strip also having a front section located between the test field area and the front end, and a handling section located between the at least one test field and the handling end, said at least one test strip including a recess therein; said test strip analysis system further comprising:
an analysis apparatus having a measuring unit and test strip positioning means for positioning said at least one test strip in a defined measuring position relative to the measuring unit, said measuring unit being adjacent said test field area when said at least one test strip is positioned in the measuring position, said test strip positioning means including guide means for laterally guiding said at least one test strip when said at least one test strip is inserted into the test strip position means, fixing means for engaging with said recess in said at least one test strip, when said test strip is in the measuring position in the test strip positioning means, test strip seating means having a first side for seating a first side of the test strip wherein said seating means is so positioned that said test f field area has a predetermined distance from the measuring unit, when said test strip contacting said seating means is positioned in the measuring position, supporting means for supporting the front section of the test strip, said supporting means being vertically offset relative to a middle plane of the test field area, a pressure element disposed opposite said first side of said test strip seating means, said pressure element positioned to press against a second side of the test strip when said test strip is in said measuring position, said pressure element being located between the test field area of said test strip and the supporting means when the test strip is in the measuring position, wherein said test strip is subjected to bending stress by contacting at least the supporting means, the pressure element, and the test strip seating means, thereby ensuring the predetermined distance between the test field area and the measuring unit.
18. A test strip analysis system according to claim 17, wherein said test strip seating means is configured such that the first side of the test strip is not contacted by any portion of the test strip seating means in an area of the test strip which is disposed between the supporting means and the pressure element.
19. A test strip analysis system according to claim 17 or 18, wherein the guide means comprises two guide elements, with one of said guide elements disposed adjacent each lateral side of the test strip, and wherein the pressure element is stationary and connects the two guide elements of the guide means, thereby forming a gap between the test strip seating means and the pressure element, and wherein the test strip is inserted through the gap when being inserted into the test strip holding means.
20. A test strip analysis system according to claim 17, 18 or 19, wherein a distance between the pressure element and a boundary of the test field area facing the front end of the test strip, when the test strip is inserted into the test strip holding means, is between 0.35 and 0.65 times a distance between the front end boundary of the test field area and the supporting means.
21. A test strip analysis system according to claim 17, 18, 19 or 20, wherein a length of the test strip seating means is less than a length of the test strip, wherein a handling end of the test strip projects beyond an end of the test strip seating means.
22. A test strip analysis system according to claim 17, wherein the guide means includes two guide elements, with each of the guide elements disposed to engage a lateral side of the test strip, and wherein each of said guide elements includes elastic spring elements, said elastic spring elements being configured to press against the lateral edges of the test strip in the handling section thereof, to thereby press the test strip against the test strip seating means.
23. A test strip analysis system according to claim 17, 18, 19, 20, 21 or 22, wherein said fixing means comprises a stationary retaining element, said stationary retaining element having a lateral surface inclined away from said supporting means, wherein, when said test strip is inserted in said test strip holding means, an edge of the recess engages said inclined lateral surface.
24. A test strip analysis system according to claim 23, wherein the edge of the recess engages the stationary retaining element such that the test strip is secured against longitudinal movements in a direction toward the handling end and a direction toward the front end.
25. A test strip analysis system according to claim 23, wherein said test strip positioning means includes a stop at an insertion end of the test strip seating means, and wherein a distance between the stop and the retaining element and a distance between the front end of the test strip and an edge of the recess closest to the front end are configured such that when said test strip is in the measuring position, the front end of the test strip contacts the stop, and the edge of the recess closest to the front end engages the inclined lateral surface of the retaining element.
26. A test strip analysis system according to any one of claims 17 to 25, wherein said predetermined distance between said test field area and said measuring unit is ensured by a force provided by the bending stress which presses the test strip against the test strip seating means.
27. A method for supporting a test strip in a test strip analysis system, comprising the steps of:
providing an analysis apparatus having test strip positioning means for positioning at least one test strip in a defined measuring position relative to a measuring unit, with the test strip positioning means including guide means for laterally guiding the test strip when the test strip is inserted into the test strip positioning means, and fixing means for engaging with a recess in the test strip when the test strip is in a measuring position in the test strip positioning means, test strip seating means having a first side for seating a first side of the test strip at a predetermined position from a measuring unit, wherein said seating means is so positioned that said test field area has a predetermined distance from the measuring unit when said test strip contacting said seating means is positioned in the measuring position and supporting means for supporting the front section of the test strip, with the supporting means being vertically offset relative to a middle plane of the test field area, and a pressure element disposed opposite said first side of the test strip seating means, with the pressure element positioned to press against a second side of the test strip when said test strip is in said measuring position, with the pressure element being located between the test field area of said test strip and the supporting means when the test strip is in the measuring position;
inserting a test strip into the test strip positioning means, such that the test strip is subjected to bending stress by contacting at least the supporting means, the pressure element, and the test strip seating means, thereby ensuring a predetermined distance between the test field area and the measuring unit, by exerting a force on the test strip in a direction of the test strip seating means.
CA002119816A 1993-03-31 1994-03-24 Test strip analysis system Expired - Lifetime CA2119816C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DEP4310583.1 1993-03-31
DE4310583A DE4310583A1 (en) 1993-03-31 1993-03-31 Test strip analysis system

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CA2119816A1 CA2119816A1 (en) 1994-10-01
CA2119816C true CA2119816C (en) 2001-01-02

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