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WO1996008723A1 - Quick test for the differentiation of the features of erythrocytes - Google Patents

Quick test for the differentiation of the features of erythrocytes Download PDF

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Publication number
WO1996008723A1
WO1996008723A1 PCT/EP1995/003493 EP9503493W WO9608723A1 WO 1996008723 A1 WO1996008723 A1 WO 1996008723A1 EP 9503493 W EP9503493 W EP 9503493W WO 9608723 A1 WO9608723 A1 WO 9608723A1
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WO
WIPO (PCT)
Prior art keywords
paper
rapid test
test according
zones
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.)
Ceased
Application number
PCT/EP1995/003493
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German (de)
French (fr)
Inventor
Hans Seifert
Wolf Von Thun
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NOBIS LABORDIAGNOSTICA GmbH
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NOBIS LABORDIAGNOSTICA GmbH
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Priority to EP95931995A priority Critical patent/EP0781415A1/en
Priority to AU35222/95A priority patent/AU3522295A/en
Publication of WO1996008723A1 publication Critical patent/WO1996008723A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • 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
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/554—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being a biological cell or cell fragment, e.g. bacteria, yeast cells
    • G01N33/555—Red blood cell
    • 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
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • 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

Definitions

  • the invention relates to a rapid test for differentiating erythrocyte characteristics, particularly suitable for use as a bedside test for the simple and quick determination of blood groups or their confirmation from capillary blood, but which can also be carried out with erythrocyte suspensions if the cell density corresponds to that of whole blood.
  • the test card can also be used to document the test.
  • Bedside tests are prescribed as confirmation tests immediately before the transfusion, since the donor is generally not present during the transfusion in order to avoid confusion of preserved blood. Such tests have been described since about 1908 and were first carried out in the presence of the donor. Since 1955, an ABO / Rh bedside test has been used on cardboard boxes with dried-in antisera, followed by tests with ready-to-use, liquid antisera, then dipsticks based on Elisa.
  • the test according to the invention is based on the method of capillary analysis or paper chromatography based on Runge and Schönbein.
  • the paper-chromatographic separation of proteins is a common but time-consuming method.
  • the determination of ABO group antigens in decayed blood using ascending paper chromatography in hydrochloric acid / methanol Systems described the antigens are determined after subsequent elution (Kuchkinov, A textbook. Vopr. Sud. Med. Ekspert. Veshchestv. Dokazatel'stv, 1982, 38-44 (Chemical Abstracts 101, 1984, 67173)).
  • This cumbersome procedure is of course completely unsuitable for a bedside test, in which speed, accuracy and documentability are important.
  • the object of the invention is therefore to provide a quick, easy-to-use, safe and documentable test for blood group confirmation.
  • capillary analytical blood group confirmation can be carried out using paper and a running medium, erythrocytes being transported through the running medium and permanent migration being available due to their different migration. If suitable antisera are added, this transport of the erythrocytes is blocked by their agglutination, since the agglutinates are immobile. Chromatography papers do not allow a differentiation between agglutinated and non-agglutinated bleeding, although the paper production for these papers has been optimized for consistency and reproducibility.
  • the invention therefore relates to a rapid test for differentiating erythrocyte features on paper, on which the corresponding antisera are applied, and the differentiation is possible optically and permanently through the different migration of the erythrocytes by means of an eluent.
  • Another object of the invention is therefore the use of the test according to the invention for the rapid determination of blood groups, their differentiation and / or the determination of blood group incompatibilities.
  • Another object of the invention is a so-called
  • Bedside test card for the quick and safe check of donor and recipient blood directly before the transfer and its documentation, as well as the production of these cards.
  • Suitable types of paper for the test according to the invention are unsized papers, preferably filter paper (such as laboratory filter paper or coffee filters), flow paper (such as kitchen paper, blotting paper, dry wipes made of paper or absorbent paper, for example for laboratory tables) or hygienic paper (such as toilet paper or household towels, towels, handkerchiefs) and paper napkins). Papers of the quality of toilet paper, wipes, coffee filters, absorbent paper are particularly preferred, paper qualities for coffee filters and absorbent paper for laboratory tables being very particularly preferred.
  • the papers can preferably also have a one-sided coating of solvent-impermeable material, preferably polyethylene, by means of which the attachment to the documentation test card is made considerably easier and which prevents solvents and test substances from penetrating into the test card.
  • FIG. 1 A practical embodiment of the rapid test according to the invention is shown as an example in FIG. 1.
  • the analysis field (3) has a comb-like appearance with several running zones (5), preferably four.
  • the width of the running zones (5) being able to be reduced to up to 0.5 mm and the distances between the running zones (5) being reduced to 0.1 mm.
  • the antisera applied in the antisera application zone (5) are mono- or polyclonal commercial preparations with the specificities anti-A, anti-B and anti-D, and monoclonal antisera are particularly preferred. They were found to be optimal for this procedure. At these positions, 2-5 ⁇ l antiserum in commercial concentration is applied manually as required and the blood group systems to be tested. For standard examinations, the antisera are preferably already applied industrially by customary printing processes.
  • the capillary blood (from the fingertip or the earlobe) or the donor blood is first placed on the storage field (8), which preferably consists of an impermeable and indifferent Foil exists from which the individual test fields are fed.
  • the remainder can preferably also be covered with a film after drying and serves as a reference sample for tests that may be required later, especially forensic tests.
  • 2-5 ⁇ l are then added to the test blood application zone (5).
  • a flow agent suitable for the transport of the erythrocytes such as, for example, LISS (lower ionic strength solution) or PBS (phosphate buffered saline) solutions, preferably physiological saline, is used as the flow agent for the analysis.
  • LISS lower ionic strength solution
  • PBS phosphate buffered saline
  • the superplasticizer front will reach the end of the running zone (7) after a few seconds, with the blood stain on agglutination at the application zone of the antisera (6 ) remains or moves with the superplasticizer if the agglutination is weak or missing.
  • the analysis field (3) shown in FIG. 1 is only to be regarded as an example within the scope of the invention and the restriction to 4 running zones (7) is only one possible embodiment. Embodiments with only one running zone and with any number are of course possible, so that a single test can be used to test for further antisera. Miniaturization is also possible, the width of the running zones (5) being able to be reduced to up to 0.5 mm and the distances between the running zones (5) being reduced to 0.1 mm. As a result, many can do so in a small space Different tests are done side by side with a very small amount of test blood.
  • a particular advantage of the test according to the invention is also the considerably reduced amount of test blood. Compared to 70 to 100 ⁇ l in previous tests, only 2 to 5 ⁇ l blood are required.
  • Monoclonal antisera of the specificities Anti-M and Anti-N, as well as Anti-Le-a and Anti-Le-b have also been tested in this way as rapid tests and offer the above-mentioned tests from capillary blood as well as from erythrocyte suspension. decisive time advantage in the Sehnell selection of blood supplies.
  • the test is therefore generally suitable for the rapid differentiation of erythrocyte characteristics with monoclonal antibodies of the IgM class, for example the Duffy, Kell-Cellano, Kidd, Lewis, Lutheran, MNSs, P , Rhesus, HLA system or the plasma protein polymorphism.
  • the rapid test according to the invention is particularly suitable for the industrial production of bedside test cards, in that a card made of paper, cardboard or a suitable plastic material is pre-printed with the necessary information and fields for receiving information. Then the analysis field (3) made of coated paper and the reference field (8) for taking the blood sample are glued on.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Chemical & Material Sciences (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Mycology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

The invention is concerned with a quick test for the differentiation of the features of erythrocytes in which antisera contained on paper inhibit the migration of erythrocytes by a solvent in different ways as well as the use of this test for the determination of blood groups and their compatibilities. In addition a bed-side test card is claimed on which this test is used as well as the manufacturing of such cards.

Description

Schnelltest zur Differenzierung von Erythrozvtenmertanalen Rapid test to differentiate erythrocyte metal channels

Beschreibungdescription

Gegenstand der Erfindung ist ein Schnelltest zur Differenzierung von Erythrozytenmerk alen, vor allem geeignet zur Verwendung als Bedside-Test zur einfachen und schnellen Bestimmung von Blutgruppen oder deren Bestätigung aus Kapillarblut, der aber auch mit Erythrocytensuspensionen durchführbar ist, wenn die Zelldichte derjenigen von Vollblut entspricht, wobei die Testkarte gleichzeitig zur Dokumentation des Tests verwendbar ist.The invention relates to a rapid test for differentiating erythrocyte characteristics, particularly suitable for use as a bedside test for the simple and quick determination of blood groups or their confirmation from capillary blood, but which can also be carried out with erythrocyte suspensions if the cell density corresponds to that of whole blood. the test card can also be used to document the test.

Bedsidetests sind als Bestätigungstests unmittelbar vor der Transfusion vorgeschrieben, da im allgemeinen der Spender bei der Transfusion nicht selbst zugegen ist, um Verwechslungen von Blutkonserven auszuschließen. Derartige Tests sind seit etwa 1908 beschrieben und wurden zuerst in Anwesenheit des Spenders durchgeführt. Seit 1955 wurde auf Kartons mit eingetrockneten Antiseren ein ABO/Rh Bedsidetest verwendet, es folgten Teste mit gebrauchsfertigen, flüssigen Antiseren, dann Dipsticks auf Elisa-Basis.Bedside tests are prescribed as confirmation tests immediately before the transfusion, since the donor is generally not present during the transfusion in order to avoid confusion of preserved blood. Such tests have been described since about 1908 and were first carried out in the presence of the donor. Since 1955, an ABO / Rh bedside test has been used on cardboard boxes with dried-in antisera, followed by tests with ready-to-use, liquid antisera, then dipsticks based on Elisa.

Alle diese Tests benötigen mindestens 1-2 Minuten zur Austestung, ggf. noch 10 Minuten zur Vorbereitung und sind bis auf die Dipsticks nur durch schriftliches Protokoll dokumentierbar.All of these tests require at least 1-2 minutes for testing, possibly another 10 minutes for preparation and can only be documented with a written record except for the dipsticks.

Der erfindungsgemäße Test basiert auf der auf Runge und Schönbein zurückgehenden Methode der Kapillaranalyse bzw. Papierchromatograpnie. Die papierchro atographische Auftrennung von Proteinen ist eine gängige, jedoch aufwendige Methode. So ist zum Beispiel die Bestimmung von ABO-Gruppen-Antigenen in verwestem Blut mittels aufsteigender Papierchromatographie in Salzsäure/Methanol- Systemen beschrieben, wobei die Antigene nach anschließender Elution bestimmt werden (Kuchkinov, Aktual. Vopr. Sud.-Med. Ekspert. Veshchestv. Dokazatel'stv, 1982, 38-44 (Chemical Abstracts 101, 1984, 67173)). Dieses umständliche Verfahren ist natürlich völlig ungeeignet für einen Bedside-Test, bei dem es auf Schnelligkeit, Genauigkeit und Dokumentierbarkeit ankommt.The test according to the invention is based on the method of capillary analysis or paper chromatography based on Runge and Schönbein. The paper-chromatographic separation of proteins is a common but time-consuming method. For example, the determination of ABO group antigens in decayed blood using ascending paper chromatography in hydrochloric acid / methanol Systems described, the antigens are determined after subsequent elution (Kuchkinov, Aktuell. Vopr. Sud. Med. Ekspert. Veshchestv. Dokazatel'stv, 1982, 38-44 (Chemical Abstracts 101, 1984, 67173)). This cumbersome procedure is of course completely unsuitable for a bedside test, in which speed, accuracy and documentability are important.

Bekannterweise ist zudem die papierchromatographische Bestimmung von Blutgruppen nicht möglich, da Chromatographiepapiere keine Differenzierung zwischen agglutinierten und nicht agglutinierten Blutproben erlauben.As is known, it is also not possible to determine blood groups by means of paper chromatography, since chromatography papers do not allow a differentiation between agglutinated and non-agglutinated blood samples.

Aufgabe der Erfindung ist daher die Bereitstellung eines schnellen, einfach zu handhabenden, sicheren und dokumentierbaren Tests zur Blutgruppenbestätigung.The object of the invention is therefore to provide a quick, easy-to-use, safe and documentable test for blood group confirmation.

Überraschenderweise wurde nun gefunden, daß eine kapillaranalytische Blutgruppenbestätigung mittels Papier und einem Lauf ittel durchführbar ist, wobei Erythrozyten durch das Laufmittel transportiert werden und durch deren unterschiedliche Migration eine dauerhafte Dokumentation zur Verfügung steht. Bei Zusatz von passenden Antiseren wird dieser Transport der Erythrozyten durch deren Agglutination blockiert, da die Agglutinate immobil sind. Chromatographiepapiere erlauben keine Differenzierung zwischen agglutinierten und nicht agglutinierten Bluten, obwohl für diese Papiere die Papierherstellung auf Konstanz und Reproduzierbarkeit optimiert wurde.Surprisingly, it has now been found that capillary analytical blood group confirmation can be carried out using paper and a running medium, erythrocytes being transported through the running medium and permanent migration being available due to their different migration. If suitable antisera are added, this transport of the erythrocytes is blocked by their agglutination, since the agglutinates are immobile. Chromatography papers do not allow a differentiation between agglutinated and non-agglutinated bleeding, although the paper production for these papers has been optimized for consistency and reproducibility.

Gegenstand der Erfindung ist daher ein Schnelltest zur Differenzierung von Erythrozytenmerkmalen auf Papier, auf welchem die entsprechenden Antiseren aufgetragen werden, und die Differenzierung durch die unterschiedliche Migration der Erythrozyten durch ein Laufmittel optisch und dauerhaft möglich ist. Ein weiterer Gegenstand der Erfindung ist daher die Verwendung des erfindungsgemäßen Tests zur raschen Bestimmung von Blutgruppen, deren Unterscheidung und/oder der Bestimmung von Blutgruppenunverträglichkeiten.The invention therefore relates to a rapid test for differentiating erythrocyte features on paper, on which the corresponding antisera are applied, and the differentiation is possible optically and permanently through the different migration of the erythrocytes by means of an eluent. Another object of the invention is therefore the use of the test according to the invention for the rapid determination of blood groups, their differentiation and / or the determination of blood group incompatibilities.

Ein weiterer Erfindungsgegenstand ist eine sogenannteAnother object of the invention is a so-called

Bedside-Testkarte zur raschen und sicheren Überprüfung von Spender- und Empfängerblut direkt vor der Übertragung und deren Dokumentation, sowie die Herstellung dieser Karten.Bedside test card for the quick and safe check of donor and recipient blood directly before the transfer and its documentation, as well as the production of these cards.

Geeignete Papiersorten für den erfindungsgemäßen Test sind ungeleimte Papiere, bevorzugt Filtrierpapier (wie z.B. Laborfiltrierpapier oder Kaffeefilter) , Fließpapier (wie z.B. Küchenkrepp, Löschpapier, Trockentücher aus Papier oder Aufsaugpapier, beispielsweise für Labortische) oder Hygienepapier (wie z.B. Toilettenpapier oder Haushaltstücher, Handtücher, Taschentücher und Servietten aus Papier) . Besonders bevorzugt sind Papiere der Qualität Toilettenpapier, Abtrockentücher, Kaffeefilter, Aufsaugpapier, wobei ganz besonders bevorzugt Papiergualitäten für Kaffeefilter und Aufsaugpapier für Labortische sind. Die Papiere können bevorzugt auch eine einseitige Beschichtung aus lösungsmittelundurchlässigem Material, bevorzugt Polyethylen, aufweisen, durch welches die Befestigung auf der Dokumentations-Testkarte erheblich erleichtert wird und die ein Eindringen von Lösungsmitteln und Testsubstanzen in die Testkarte verhindert.Suitable types of paper for the test according to the invention are unsized papers, preferably filter paper (such as laboratory filter paper or coffee filters), flow paper (such as kitchen paper, blotting paper, dry wipes made of paper or absorbent paper, for example for laboratory tables) or hygienic paper (such as toilet paper or household towels, towels, handkerchiefs) and paper napkins). Papers of the quality of toilet paper, wipes, coffee filters, absorbent paper are particularly preferred, paper qualities for coffee filters and absorbent paper for laboratory tables being very particularly preferred. The papers can preferably also have a one-sided coating of solvent-impermeable material, preferably polyethylene, by means of which the attachment to the documentation test card is made considerably easier and which prevents solvents and test substances from penetrating into the test card.

Eine praktikable Ausführungsform des erfindungsgemäßen Schnelltests ist als Beispiel in Fig. 1 dargestellt. Auf dieser nur als beispielhaft zu betrachtenden Testkarte bedeutetA practical embodiment of the rapid test according to the invention is shown as an example in FIG. 1. On this test card, which can only be regarded as an example, means

l - Beschriftungsfelder zur Aufnahme derl - Labeling fields to accommodate the

Identifikationsangaben für Spender und/oderIdentification information for donors and / or

Empfänger,Receiver,

2 - ggf. ein zusätzliches Informationsfeld für technisch und dokumentarische Angaben, Signaturen etc. ,2 - if necessary, an additional information field for technical and documentary information, signatures Etc. ,

3 - aufgeklebt je Probe ein Analysenfeld aus den o.g. Trennmaterialien mit3 - one analytical field from the above Separation materials with

4 - der Auftragsfläche für das Lauf- oder Fließmittel,4 - the application area for the eluent or superplasticizer,

5 - mindestens einer linearen Auftragszone für das Testblut,5 - at least one linear application zone for the test blood,

6 - mindestens einer linearen Auftragszone der Antiseren und 7 - mindestens einer Laufzone für die nicht agglutinierten Erythrozyten,6 - at least one linear application zone of the antisera and 7 - at least one running zone for the non-agglutinated erythrocytes,

8 - einem Vorratsfeld je Probe, auf welchem das entnommene Kapillarblut bzw. Blut zunächst aufgetragen wird.8 - a storage field per sample, on which the capillary blood or blood is initially applied.

In bevorzugter Form hat das Analysenfeld (3) ein kammartiges Aussehen mit mehreren Laufzonen (5) , bevorzugt vier. Es ist jedoch auch eine Miniaturisierung möglich, wobei die Breite der Laufzonen (5) auf bis zu 0,5 mm und die Abstände zwischen den LaufZonen (5) auf 0,1 mm verringert werden kann.In a preferred form, the analysis field (3) has a comb-like appearance with several running zones (5), preferably four. However, miniaturization is also possible, the width of the running zones (5) being able to be reduced to up to 0.5 mm and the distances between the running zones (5) being reduced to 0.1 mm.

Die in der Antiseren-Auftragszone (5) aufgetragenen Antiseren sind mono- oder polyklonale kommerzielle Präparate der Spezifitäten Anti-A, Anti-B und Anti-D, besonders bevorzugt sind monoklonale Antiseren. Sie wurden als optimal für dieses Verfahren gefunden. An diesen Positionen werden 2-5μl Antiserum in handelsüblicher Konzentration manuell je nach Bedarf und auszutestenden Blutgruppensystemen aufgetragen. Bevorzugt sind für Standard-Untersuchungen die Antiseren bereits industriell durch übliche Druckverfahren aufgetragen.The antisera applied in the antisera application zone (5) are mono- or polyclonal commercial preparations with the specificities anti-A, anti-B and anti-D, and monoclonal antisera are particularly preferred. They were found to be optimal for this procedure. At these positions, 2-5μl antiserum in commercial concentration is applied manually as required and the blood group systems to be tested. For standard examinations, the antisera are preferably already applied industrially by customary printing processes.

Zur Durchführung des Tests wird das Kapillarblut (aus der Fingerbeere oder dam Ohrläppchen) oder das Spenderblut zunächst auf das Vorratsfeld (8) gegeben, welches bevorzugt aus einer undurchlässigen und indifferenten Folie besteht, von welcher die einzelnen Testfeider beschickt werden. Der verbleibende Rest kann vorzugsweise nach Eintrocknung ebenfalls mit einer Folie abgedeckt werden und dient als Referenzprobe für gegebenfalls später zusätzlich erforderliche Tests, vor allem forensischer Art. Von diesem Kapillarblut bzw. Spenderblut werden dann 2-5μl auf die Testblut-Auftragszone (5) gegeben.To carry out the test, the capillary blood (from the fingertip or the earlobe) or the donor blood is first placed on the storage field (8), which preferably consists of an impermeable and indifferent Foil exists from which the individual test fields are fed. The remainder can preferably also be covered with a film after drying and serves as a reference sample for tests that may be required later, especially forensic tests. From this capillary blood or donor blood, 2-5μl are then added to the test blood application zone (5).

Als Fließmittel für die Analyse dient ein für den Transport der Erythrozyten geeignetes Fließmittel, wie beispielsweise LISS- (lower ionic strenghts solution) oder PBS-Lösungen (phosphate buffered saline) , bevorzugt physiologische Kochsalzlösung. Werden ca. 100-500 μl Fließmittel auf die Fließmittel-Auftragszone (4) der waagerecht liegenden Testkarte gegeben, so erreicht die Fließmittelfront schon nach wenigen Sekunden das Ende der Laufzone (7) , wobei der Blutfleck bei Agglutination an der Auftragszone der Antiseren (6) verbleibt oder bei schwacher oder fehlender Agglutination sich mit dem Fließmittel bewegt.A flow agent suitable for the transport of the erythrocytes, such as, for example, LISS (lower ionic strength solution) or PBS (phosphate buffered saline) solutions, preferably physiological saline, is used as the flow agent for the analysis. If approx. 100-500 μl of superplasticizer is added to the superplasticizer application zone (4) of the horizontal test card, the superplasticizer front will reach the end of the running zone (7) after a few seconds, with the blood stain on agglutination at the application zone of the antisera (6 ) remains or moves with the superplasticizer if the agglutination is weak or missing.

überraschend sind Schnelligkeit und Sensitivität derSpeed and sensitivity are surprising

Methode, die nur Sekunden braucht, während herkömmliche Tests aus dem Stand der Technik im Bereich von eventuell 10-15 Minuten liegen.A method that takes only seconds, whereas conventional tests from the prior art are in the range of possibly 10-15 minutes.

Das in Fig. 1 dargestellte Analysenfeld (3) ist im Rahmen der Erfindung nur als Beispiel anzusehen und die Beschränkung auf 4 Laufzonen (7) nur eine mögliche Ausführungsform. Es sind selbstverständlich Ausführungsformen mit nur einer Laufzone sowie mit einer beliebigen Zahl möglich, sodaß mit einem einzigen Test gegen weitere Antiseren geprüft werden kann. Auch eine Miniaturisierung ist möglich, wobei die Breite der Laufzonen (5) auf bis zu 0,5 mm und die Abstände zwischen den Laufzonen (5) auf 0,1 mm verringert werden kann. Dadurch können auf kleinem Raum sehr viele unterschiedliche Test nebeneinander gemacht werden mit sehr geringer Menge an Testblut.The analysis field (3) shown in FIG. 1 is only to be regarded as an example within the scope of the invention and the restriction to 4 running zones (7) is only one possible embodiment. Embodiments with only one running zone and with any number are of course possible, so that a single test can be used to test for further antisera. Miniaturization is also possible, the width of the running zones (5) being able to be reduced to up to 0.5 mm and the distances between the running zones (5) being reduced to 0.1 mm. As a result, many can do so in a small space Different tests are done side by side with a very small amount of test blood.

Ein besonderer Vorteil des erindungsgemaßen Tests ist auch die erhebliche reduzierte Menge an Testblut. Gegenüber 70 bis 100 μl bei bisherigen Tests werden nur noch 2 bis 5 μl Blut benötigt.A particular advantage of the test according to the invention is also the considerably reduced amount of test blood. Compared to 70 to 100 μl in previous tests, only 2 to 5 μl blood are required.

Monoklonale Antiseren der Spezifitäten Anti-M und Anti-N, sowie Anti-Le-a und Anti-Le-b sind ebenfalls auf diese Weise als Schnelltests erprobt worden und bieten sowohl aus Kapillarblut wie aus Erythrocytensuspension herkömmlichen Testen den o.g. genannten entscheidenden Zeitvorteil bei der Sehnellauswahl von Blutkonserven. Der Test bietet sich daher neben dem ABO-Blutgruppensyste allgemein für die schnelle Differenzierung von Erythrozytenmerkmalen mit monoklonalen Antikörpern der IgM-Klasse an, zum Beispiel der Duffy-, Kell-Cellano-, Kidd-, Lewis-, Lutheran-, MNSs-, P-, Rhesus-, HLA-System oder des Plasmaproteinpolymorphismus.Monoclonal antisera of the specificities Anti-M and Anti-N, as well as Anti-Le-a and Anti-Le-b have also been tested in this way as rapid tests and offer the above-mentioned tests from capillary blood as well as from erythrocyte suspension. decisive time advantage in the Sehnell selection of blood supplies. In addition to the ABO blood group system, the test is therefore generally suitable for the rapid differentiation of erythrocyte characteristics with monoclonal antibodies of the IgM class, for example the Duffy, Kell-Cellano, Kidd, Lewis, Lutheran, MNSs, P , Rhesus, HLA system or the plasma protein polymorphism.

Da Blutgruppenverträglichkeiten vor einer Übertragung ausgetestet werden müssen, bietet sich der erfindungsgemäße Schnelltest auf Papier besonders zur industriellen Herstellung von Bedside-Testkarten an, indem eine Karte aus Papier, Karton oder einem geeigneten Kunststoffmaterial mit den notwendigen Angaben und Feldern zur Aufnahme von Informationen vorbedruckt wird. Anschließend werden dann das Analysenfeld (3) aus beschichtem Papier aufgeklebt sowie das Referenzfeld (8) für die Aufnahme der Blutprobe. Since blood group compatibility must be tested before transmission, the rapid test according to the invention is particularly suitable for the industrial production of bedside test cards, in that a card made of paper, cardboard or a suitable plastic material is pre-printed with the necessary information and fields for receiving information. Then the analysis field (3) made of coated paper and the reference field (8) for taking the blood sample are glued on.

Claims

Patentansprüche claims 1. Schnelltest zur Differenzierung von Erythrozytenmerkmalen, dadurch gekennzeichnet, daß auf Papier aufgetragene Antiseren die durch ein Laufmittel bewirkte Migration der Erythrozyten in unterschiedlicher Weise hemmen.1. Rapid test for the differentiation of erythrocyte characteristics, characterized in that antisera applied to paper inhibit the erythrocyte migration caused by an eluent in different ways. 2. Schnelltest gemäß Anspruch 1, dadurch gekennzeichnet, daß das Papier ein ungelei tes Papier ist, bevorzugt von der Qualität Filtrierpapier, Fließpapier, Hygienepapier.2. Rapid test according to claim 1, characterized in that the paper is an ungelei tes paper, preferably of the quality filter paper, blotting paper, tissue paper. 3. Schnelltest gemäß Anspruch 1 oder 2, dadurch gekennzeichnet, daß das Papier von der Qualität eines mit Polyethylen beschichteten Aufsaugpapiers für Labortische ist.3. Rapid test according to claim 1 or 2, characterized in that the paper is of the quality of a polyethylene coated absorbent paper for laboratory tables. 4. Schnelltest gemäß Anspruch 1, dadurch gekennzeichnet, daß auf dem Papier mindestens ein Antiserum der verschiedenen Blutgruppensysteme aufgetragenen ist.4. Rapid test according to claim 1, characterized in that at least one antiserum of the different blood group systems is applied to the paper. 5. Schnelltest gemäß Anspruch 4, dadurch gekennzeichnet, daß das Antiserum ein monoklonales Antiserum des AB0- Systems und/oder des Rhesus-Systems ist.5. Rapid test according to claim 4, characterized in that the antiserum is a monoclonal antiserum of the AB0 system and / or the rhesus system. 6. Schnelltest gemäß Anspruch 1, dadurch gekennzeichnet, daß das Laufmittel zur Differenzierung eine LISS-, PBS- oder physiologische Kochsalzlösung ist.6. Rapid test according to claim 1, characterized in that the eluent for differentiation is a LISS, PBS or physiological saline. 7. Schnelltest gemäß Anspruch 1, dadurch gekennzeichnet, daß das Papier (3) ein kammförmiges Aussehen hat mit einer Auftragzone (4) für das Laufmittel und zwei oder mehr Laufzonen (7) zur Differenzierung.7. Rapid test according to claim 1, characterized in that the paper (3) has a comb-like appearance with an application zone (4) for the solvent and two or more running zones (7) for differentiation. 8. Schnelltest gemäß Anspruch 7, dadurch gekennzeichnet, daß das Papier vier Laufzonen (7) hat.8. rapid test according to claim 7, characterized in that the paper has four running zones (7). 9. Verwendung des Schnelltests gemäß Anspruch 1 zur Bestimmung von Erythrozythenmerkmalen.9. Use of the rapid test according to claim 1 for Determination of erythrocyte features. 10. Verwendung des Schnelltests gemäß Anspruch 1 zur10. Use of the rapid test according to claim 1 for Bestimmung von Blutgruppen und/oder Unverträglichkeit von Blutgruppen.Determination of blood groups and / or intolerance to blood groups. 11. Verwendung des Schnelltests gemäß Anspruch 1 als Bedside-Test.11. Use of the rapid test according to claim 1 as a bedside test. 12. Bedside-Testkarte enthaltend a) ein oder mehrere12. Bedside test card containing a) one or more Identifikations- bzw. Informationsfelder (1, 2) , b) ein oder mehrere Analysenfelder aus Papier (3) mit einem Auftragsfeld für das Laufmittel (4) , ein oder mehreren Auftragszonen für die Blutprobe (5) und die Antiseren (6) sowie Laufzonen (7) für die nicht agglutinieren Erythrozyten und c) ein oder mehrere Voratsfelder (8) .Identification or information fields (1, 2), b) one or more analysis fields made of paper (3) with an order field for the eluent (4), one or more order zones for the blood sample (5) and the antisera (6) and running zones (7) for the non-agglutinated erythrocytes and c) one or more reserve fields (8). 13. Bedside-Testkarte gemäß Anspruch 12, dadurch gekennzeichnet, daß sie zwei Analysenfelder (3) mit je vier Laufzonen (7) und zwei Voratsfelder (8) enthält.13. Bedside test card according to claim 12, characterized in that it contains two analysis fields (3), each with four running zones (7) and two reserve fields (8). 14. Bedside-Testkarte gemäß Anspruch 12, dadurch gekennzeichnet, daß die Antiseren in den Auftragszonen (6) industriell aufgedruckt sind.14. Bedside test card according to claim 12, characterized in that the antisera in the application zones (6) are industrially printed. 15. Verfahren zur Herstellung von Bedside-Testkarten, dadurch gekennzeichnet, daß eine entsprechende Karte vorbedruckt wird mit Hinweisen zur Eintragung von Informationen, auf die derartige Karte zwei kammförmige Analysenfelder (3) aus beschichtetem15. A method for producing bedside test cards, characterized in that a corresponding card is pre-printed with instructions for the entry of information on the card of this type two comb-shaped analysis fields (3) made of coated Papier und zwei Referenzfeider (8) zur Aufnahme der Blutprobe aufgeklebt werden und die entsprechenden Antiseren auf die dafür vorgesehenen Auftragszonen (6) aufgedruckt werden. Paper and two reference fields (8) for taking up the blood sample are stuck on and the corresponding antisera are printed on the designated application zones (6).
PCT/EP1995/003493 1994-09-13 1995-09-06 Quick test for the differentiation of the features of erythrocytes Ceased WO1996008723A1 (en)

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EP0781415A1 (en) 1997-07-02
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