CA2531459A1 - Device and method for simultaneous carrying out of blood group determination, serum cross-check and antibody detection test - Google Patents

Device and method for simultaneous carrying out of blood group determination, serum cross-check and antibody detection test Download PDF

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Publication number
CA2531459A1
CA2531459A1 CA002531459A CA2531459A CA2531459A1 CA 2531459 A1 CA2531459 A1 CA 2531459A1 CA 002531459 A CA002531459 A CA 002531459A CA 2531459 A CA2531459 A CA 2531459A CA 2531459 A1 CA2531459 A1 CA 2531459A1
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CA
Canada
Prior art keywords
indicator zones
indicator
fragments
antibodies
blood
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
CA002531459A
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French (fr)
Other versions
CA2531459C (en
Inventor
Peter Schwind
Klemens Loester
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.)
Grifols Diagnostic Solutions Inc
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2531459A1 publication Critical patent/CA2531459A1/en
Application granted granted Critical
Publication of CA2531459C publication Critical patent/CA2531459C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/80—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood groups or blood types or red blood cells
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/97—Test strip or test slide
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/807—Apparatus included in process claim, e.g. physical support structures
    • Y10S436/808—Automated or kit
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/807—Apparatus included in process claim, e.g. physical support structures
    • Y10S436/81—Tube, bottle, or dipstick

Abstract

The invention relates to a device for the simultaneous qualitative or quantitative determination of several analytes in a liquid sample, comprising a membrane (2) with a charging zone (5), for the application of the liquid sample, at least two indicator zones which can interact with the analyte(s) and at least one absorption region (3), which accepts the fluid after passing through the indicator zones, whereby the indicator zones lie between the charging zone (5) and an absorption region (3), characterised in that the flow directions (flow tracks) are essentially parallel from the application zone (5) through each indicator zone to an absorption region (3) and at least two different flow tracks are present. The invention further relates to a method for the determination of several analytes or derivatives thereof in a liquid sample, comprising: application of the sample to the charging zone (5) of a membrane of the device as given in claims 1 to 8, whereby said sample is present in sufficient amounts to permit the sample fluid to flow in the direction of the absorption region (3) through the indicator zones and to permit the analytes or derivatives thereof in the liquid sample to form a complex in the indicator zone.

Claims (25)

1. Device for the simultaneous and qualitative or quantitative determination of a plurality of analytes in a liquid sample, comprising at least one membrane (2) with - an application zone (5) for the application of the liquid sample, -at least one group of at least two indicator zones, which are able to interact with the analyte(s) and - at least one absorption region (3) which takes up the liquid after having passed the indicator zones wherein the indicator zones are located between the application zone (5) and the absorption region (3), characterized in that the flow directions from the application zone (5) through the respective indicator zones of a group towards an absorption region (3) (flow tracks) are substantially parallel and that at least two different flow tracks are present.
2. Apparatus according to claim 1, wherein the indicator zones are so arranged that the test liquids for any one flow track flow through not more than one indicator zone.
3. Device according to claim 1, wherein the indicator zones are arranged in a diagonal V-, W-, M-, N-shaped or linear row.
4. Device according to any one of claims 1 to 3, wherein at least two rows of indicator zones are arranged in the flow direction one behind the other and/or laterally staggered and the indicator zones of the different rows are arranged in relation to one another with a gap there between so that the test liquid for any one flow track flows through not more than one indicator zone.
5. Device according to claim 1 or 3, wherein at least two rows of indicator zones are arranged in the flow direction one behind the other and/or side by side and the indicator zones of the different rows in relation to one another are arranged without a gap there between so that the test liquid for any one flow track passes through more than one indicator zone.
6. Device according to claims 1 to 3, wherein at least two groups of indicator zones are arranged which are disposed starting from the application zone in different flow directions.
7. Device according any one of claims 1 to 6, wherein the indicator zones comprise antibodies or antibody fragments or lectines, antigens or antigen epitopes and/or cells or cell fragments.
8. Device according to any one of claims 1 to 7, wherein the indicator zones comprise in particular antibodies or antibody fragments against blood group antigens or antigen epitopes and membranes or cell fragments of blood groups A1, A2, B and/or O erythrocytes.
9. Device according to any one of claims 1 to 7, wherein the indicator zones comprise in particular antibodies or antibody fragments against blood group antigens or antigen epitopes and synthetic peptides, recombinant antigens and/or antibodies or antibody fragments against infective markers.
10. Device according to any one of claims 1 to 7, wherein the indicator zones comprise in particular antibodies or antibody fragments against blood group antigens or antigen epitopes and fragments of thrombocytes and/or lymphocytes.
11. Device according to any one of claims 1 to 10, wherein all the membranes (2) preferably consist of polyethylene, nitrocellulose or nylon.
12. Device according to any one of claims 1 to 11, wherein downstream of the application zone (5) and upstream of the indicator zones at least one sealing element (4) is provided on the membrane (2).
13. Device according to any one of claims 1 to 12, wherein downstream of the sealing element (4) and upstream of the indicator zones at least one conjugate pad is applied.
14. Device according to any one of claims 1 to 13, wherein the components of the device have been applied onto a support layer (1) for mechanical reinforcement.
15. Device according to any one of claims 1 to 14, wherein the components of the device are integrated in a casing.
16. Use of the device according to any one of claims 1 to 11 for the analysis of blood, in particular for the simultaneous performance of blood group determinations and serum reverse grouping (serum cross-check) and/or antibody detection test.
17. Use of the device according to any one of claims 1 to 11 for the analysis of blood, in particular for the simultaneous performance of blood group determinations and the detection of infection serological markers or fragments thereof.
18. Use of the device according to any one of claims 1 to 11 for the analysis of blood, in particular for the simultaneous performance of blood group determinations and the detection of antibodies against blood cells, in particular anti-thrombocyte or anti-lymphocyte antibodies or the respective fragments thereof.
19. Process for the determination of a plurality of analytes or their derivatives in a liquid sample, comprising:

the application of the sample onto the application zone (5) of at least one membrane (2) of the device according to any one of the preceding claims 1 to 15, wherein this sample is present in adequate amounts in order to induce the test liquid to flow in the direction of the absorption region (3) through the indicator zones and to induce the analytes or their derivatives in the test liquid to form a complex in the indicator zones.
20. Process according to claim 19, wherein the analytes or their derivatives are blood group antigens or antigen epitopes, antibodies directed against blood group antigens or fragments thereof, antibodies or fragments thereof directed against thrombocytes or leukocytes or antibodies or fragments thereof directed against infective agents or antigens of infective agents or antigen epitopes.
21. Process according to claims 19 or 20, wherein the analytes or their derivatives include in particular antigens or antigen epitopes of the blood group systems ABO, Rh and Kell.
22. Process according to claims 19 or 20, wherein the analytes or their derivatives include in particular antibodies or fragments thereof against thrombocytes and/or lymphocytes.
23. Process according to claims 19 or 20, wherein the analytes or their derivatives include in particular antibodies or fragments thereof against bacterial and/or viral agents or viral or bacterial antigens or antigen epitopes.
24. Process against any one of claims 19 to 23, wherein the liquid samples comprise preferably complete blood, blood cell concentrate, serum, plasma and/or test liquid, for example control serum or control cells.
25. Process according to any one of claims 19 to 24, wherein at least two types of indicator particles are used of which at least one type represents erythrocytes.
CA2531459A 2003-07-09 2004-07-08 Device and method for simultaneous carrying out of blood group determination, serum cross-check and antibody detection test Expired - Fee Related CA2531459C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10330981A DE10330981B4 (en) 2003-07-09 2003-07-09 Apparatus and method for simultaneously performing blood grouping, serum cross-checking and antibody-screening
DE10330981.0 2003-07-09
PCT/EP2004/007525 WO2005005986A1 (en) 2003-07-09 2004-07-08 Device and method for simultaneous carrying out of blood group determination, serum cross-check and antibody detection test

Publications (2)

Publication Number Publication Date
CA2531459A1 true CA2531459A1 (en) 2005-01-20
CA2531459C CA2531459C (en) 2012-10-30

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2531459A Expired - Fee Related CA2531459C (en) 2003-07-09 2004-07-08 Device and method for simultaneous carrying out of blood group determination, serum cross-check and antibody detection test

Country Status (22)

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US (1) US7745228B2 (en)
EP (1) EP1644737B1 (en)
JP (1) JP5090733B2 (en)
KR (1) KR101120080B1 (en)
CN (1) CN1894584B (en)
AT (1) ATE410687T1 (en)
AU (1) AU2004256206B2 (en)
BR (1) BRPI0412412B8 (en)
CA (1) CA2531459C (en)
CY (1) CY1108704T1 (en)
DE (2) DE10330981B4 (en)
DK (1) DK1644737T3 (en)
ES (1) ES2315684T3 (en)
HK (1) HK1095879A1 (en)
IL (1) IL172997A (en)
MX (1) MXPA06000345A (en)
NZ (1) NZ544544A (en)
PL (1) PL1644737T3 (en)
PT (1) PT1644737E (en)
RU (1) RU2358267C2 (en)
WO (1) WO2005005986A1 (en)
ZA (1) ZA200601127B (en)

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Also Published As

Publication number Publication date
CN1894584B (en) 2010-10-13
JP2009513938A (en) 2009-04-02
NZ544544A (en) 2009-02-28
ES2315684T3 (en) 2009-04-01
PL1644737T3 (en) 2009-04-30
RU2006103023A (en) 2006-08-10
WO2005005986A1 (en) 2005-01-20
US7745228B2 (en) 2010-06-29
IL172997A0 (en) 2006-06-11
BRPI0412412B1 (en) 2019-04-24
PT1644737E (en) 2009-01-14
EP1644737A1 (en) 2006-04-12
DK1644737T3 (en) 2009-02-02
KR101120080B1 (en) 2012-03-23
MXPA06000345A (en) 2006-07-03
ATE410687T1 (en) 2008-10-15
DE502004008216D1 (en) 2008-11-20
RU2358267C2 (en) 2009-06-10
BRPI0412412B8 (en) 2021-07-27
EP1644737B1 (en) 2008-10-08
US20070042499A1 (en) 2007-02-22
BRPI0412412A (en) 2006-08-22
KR20060091288A (en) 2006-08-18
DE10330981A1 (en) 2005-02-10
JP5090733B2 (en) 2012-12-05
IL172997A (en) 2010-12-30
AU2004256206A1 (en) 2005-01-20
DE10330981B4 (en) 2010-04-01
CN1894584A (en) 2007-01-10
CA2531459C (en) 2012-10-30
HK1095879A1 (en) 2007-05-18
CY1108704T1 (en) 2014-04-09
AU2004256206B2 (en) 2010-03-04
ZA200601127B (en) 2007-09-26

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