CA2395306A1 - Test element analysis system - Google Patents

Test element analysis system Download PDF

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Publication number
CA2395306A1
CA2395306A1 CA002395306A CA2395306A CA2395306A1 CA 2395306 A1 CA2395306 A1 CA 2395306A1 CA 002395306 A CA002395306 A CA 002395306A CA 2395306 A CA2395306 A CA 2395306A CA 2395306 A1 CA2395306 A1 CA 2395306A1
Authority
CA
Canada
Prior art keywords
light guide
light
detection zone
guide layer
carrier film
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.)
Granted
Application number
CA002395306A
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French (fr)
Other versions
CA2395306C (en
Inventor
Wolfgang Petrich
Wilfried Schmid
Gerrit Kocherscheidt
Jean-Michel Asfour
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
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Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2395306A1 publication Critical patent/CA2395306A1/en
Application granted granted Critical
Publication of CA2395306C publication Critical patent/CA2395306C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/8483—Investigating reagent band
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/7703—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator using reagent-clad optical fibres or optical waveguides

Abstract

Test element analysis system for the analytical investigation of a sample, in particular of a body liquid of human beings or animals, comprising test elements (2) with a carrier film (s) and a test field (7) fixed to the flat side (6) of the carrier film (5), the test field (7) containing a reagent system the reaction of which with the sample (21) leads to an optically measurable change in the detection zone (24) which is characteristic for the analysis, and an evaluation instrument with a measuring device for measuring the optically measurable change. In order to obtain a very high measuring accuracy and an easy handling at the same time, the carrier film (5) of the test element (2) comprises a light guide layer (26), the detection zone (24) of the test field (7) is in optical contact to the light guide layer (26) in a coupling out zone (33), enabling the coupling out of light from the light guide layer (26) to the detection zone (24), the primary light (29) of the light emitter (16) is coupled into the entry surface (31) in the light guide layer (26) in such a manner that a light guide section (32) of the light path of the primary light (29) runs between the entry surface and the detection zone (24) inside the carrier film (5), and the secondary light is reflected from the detection zone (24) into the light guide layer (26) in such a manner that a light guide section (34) of the light path of the secondary light runs between the detection zone (24) and the detector (17) inside the light guide layer (26).

Claims (14)

1. Test element analysis system for the analytical investigation of a liquid sample, in particular of a body liquid of human beings or of animals, comprising test elements (2) with a carrier film (5) of plastic material and a test field (7) secured to a flat side (6) of the carrier film (5) which test field is contacted, in order to perform an analysis, with the sample (21) in such a manner that liquid sample components penetrate into the test field (7), wherein the test field (7) contains a reagent system the reaction of which with components of the sample (21) causes an optically measureable change in a detection zone (24) located on the side of the test field (7) directed towards the carrier film (5), said change being characteristic for the analysis and an evaluation instrument (3) with a test element holder (12) for positioning a test element (2) in a measuring position, and with a measuring device (18) for measuring the optically measurable change in the detection zone (24), wherein the measuring device (18) comprises a light emitter (16) for irradiating primary light (29) onto the detection zone (24) and a detector (17) for detecting secondary light (35) diffusely reflected from the detection zone (24), characterized in that the carrier film (5) of the test element (2) comprises a light guide layer (26), the carrier film (5) comprises a coupling out zone (33) which is a part of the flat side of the carrier film (5) to which the test field (7) is fixed and within which the detection zone (24) of the test field (7) is in optical contact to the carrier film (5) in such a manner that light is coupled out from the light guide layer (26) into the detection zone (24), the primary light (29) of the light emitter (16) is coupled into the light guide layer (26) via an entry surface (31), in such a manner that a light guide section (32) of the light path of the primary light (29) between the entry surface (31) and the detection zone (24) runs inside the interior of the light guide layer (26) and the secondary light which is diffusely reflected from the detection zone (24) is reflected into the light guide layer (26) and a light guide section (34) of the light path of the secondary light between the detection zone (24) and the detector (17) runs inside the carrier film (5).
2. Test element analysis system according to claim 1, characterized in that the test element (2) is positioned in the measuring position in such a manner that a first partial section (22) of the test element is located inside the housing (11) of the evaluation instrument (3) and a second partial section (23) protrudes from the housing (11) of the evaluation instrument (3) to be easily accessible, wherein the entry surface (31) is located in the first partial section (22) and the test field (7) is located in the second partial section (23).
3. Test element for the analytical investigation of a liquid sample, in particular of a body liquid of human beings or animals, with a carrier film (5) of plastic material and a test field (7) secured to a flat side (6) of the carrier film (5) which test field is contacted, in order to perform an analysis, with the sample (21) in such a manner that liquid sample components penetrate into the test field (7), wherein the test field (7) contains a reagent system the reaction of which with components of the sample (21) causes an optically measurable change in a detection zone (24) which is a part of the test field (7), the change being characteristic for the analysis, and wherein primary light irradiated onto the detection zone is diffusely reflected therefrom characterized in that the carrier film (5) of the test element (2) comprises a light guide layer (26), the carrier film (5) comprises a coupling out zone (33) which is a part of the flat side of the carrier film (5) to which the test field (7) is fixed and within which the detection zone (24) of the test field (7) is in optical contact to the carrier film (5) in such a manner that light is coupled out from the light guide layer (26) into the detection zone (24), the light guide layer (26) comprises an entry surface (31) for coupling in primary light in such a manner that a light guide section (32) of the light path of the primary light coupled into the light guide layer (26) runs inside the light guide layer (26) between the entry surface (31) and the detection zone (24), the secondary light which is diffusely reflected from the detection zone (24) is reflected into the light guide layer (26), and a light guide section (34) of the light path of the secondary light runs between the detection zone (24) and the detector (17) inside the carrier film (5).
4. Test element according to claim 3, characterized in that the side of the light guide layer (26) opposed to the coupling out zone (33) is adapted, at least in sections thereof, to cause a change of the light propagation direction of the primary light (29) towards the detection zone (24).
5. Test element according to any one of claims 3 or 4, characterized is that the side of the light guide layer (26) which is opposed to the detection zone (24) is adapted, at least in sections thereof, to cause a change of the propagation direction of the secondary light (35) diffusely reflected from the detection zone, to coincide with the direction of the light guide layer (26) leading towards the detector (17).
6. Test element according to any one of claims 3 to 5, characterized in that the test field (7) is sufficiently absorbent to transport liquid sample components in the coupling out zone to the flat side (6) of the carrier film (5) to which the test field (7) is secured in such a manner that the liquid sample components wet the light guide layer (26) in the coupling out zone (33).
7. Test element according to any one of claims 3 to 6, characterized in that the light guide layer (26) in the coupling out zone (33) is roughened in order to improve the coupling out of the primary light.
8. Test element according to any one of claims 3 to 7, characterized in that the test field (7) contains components causing strong optical diffusion.
9. Test element according to any one of claims 3 to 8, characterized in that the carrier film (5) comprises two light guide layers, the primary light is coupled into a first light guide layer serving as primary light guide (27), and the secondary light from the detection zone (24) is coupled into a second light guide layer serving as secondary light guide (28).
10. Test element according to claim 9, characterized in that the test field (7) is fixed to the flat side (6) of the primary light guide (27) which is opposed to the secondary light guide (28).
11. Test element according to any one of claims 9 or 10, characterized in that the light guide layers (27, 28) are separated, at least on a part of their length, by an optical barrier (39).
12. Test element according to claim 11, characterized in that the optical barrier comprises three partial layers, a first partial layer (43) being adjacent to the primary light guide (27) and having a refraction index which is lower than the refraction index of the primary light guide (27), a second partial layer (44) being adjacent to the secondary light guide (27) and having a refraction index which is lower than the refraction index of the secondary light guide, and a third partial layer (45) running between the first partial layer (43) and the second partial layer (44) and being metallically reflecting.
13. Method for the analytical investigation of a sample, in particular of a body liquid of human beings or animals, using a test element analysis system according to claim 1, characterized in that the primary light (29) emitted from the light emitter (16) is coupled into the light guide layer (36) through the entry surface (31), the coupled in primary light (29) is guided inside the light guide layer (26) to the coupling out zone (33) where it is coupled out in such a manner that it illuminates at least a part of the detection zone (24), secondary light generated by diffuse reflection in the detection zone (24) is transported inside the light guide layer (26) towards the detector (17) and the secondary light is coupled out from the light guide layer (26) towards the detector (17).
14. Method according to claim 13, using a test element according to any one of claims 3 to 11, characterized in that the primary light is transported in the primary light guide (27) from the coupling in surface (31) to the coupling out surface (33), and inside the secondary light guide (28) towards the detector (17).
CA2395306A 1999-12-24 2000-12-08 Test element analysis system Expired - Fee Related CA2395306C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP99125874.0 1999-12-24
EP99125874 1999-12-24
PCT/DE2000/004394 WO2001048461A1 (en) 1999-12-24 2000-12-08 Test element analysis system

Publications (2)

Publication Number Publication Date
CA2395306A1 true CA2395306A1 (en) 2001-07-05
CA2395306C CA2395306C (en) 2011-08-02

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2395306A Expired - Fee Related CA2395306C (en) 1999-12-24 2000-12-08 Test element analysis system

Country Status (14)

Country Link
US (4) US7262061B2 (en)
EP (1) EP1240503B1 (en)
JP (1) JP3655588B2 (en)
KR (1) KR100816799B1 (en)
CN (1) CN1243968C (en)
AU (1) AU771677B2 (en)
BR (1) BR0016711A (en)
CA (1) CA2395306C (en)
CZ (1) CZ20022206A3 (en)
DE (1) DE10084176D2 (en)
HK (1) HK1053510A1 (en)
MX (1) MXPA02006170A (en)
PL (1) PL201164B1 (en)
WO (1) WO2001048461A1 (en)

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KR20020063581A (en) 2002-08-03
PL201164B1 (en) 2009-03-31
EP1240503B1 (en) 2018-01-17
PL355578A1 (en) 2004-05-04
AU771677B2 (en) 2004-04-01
JP2003518618A (en) 2003-06-10
BR0016711A (en) 2002-09-03
MXPA02006170A (en) 2003-01-28
WO2001048461A1 (en) 2001-07-05
EP1240503A1 (en) 2002-09-18
HK1053510A1 (en) 2003-10-24
US8119069B2 (en) 2012-02-21
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US8535609B2 (en) 2013-09-17
AU2829901A (en) 2001-07-09
US20110033341A1 (en) 2011-02-10
CA2395306C (en) 2011-08-02
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KR100816799B1 (en) 2008-03-26
US20030157724A1 (en) 2003-08-21
CN1243968C (en) 2006-03-01
USRE44788E1 (en) 2014-03-04
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US7262061B2 (en) 2007-08-28
DE10084176D2 (en) 2003-01-16

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