throbber
4-08-1998 S:~i AIV1
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`FROM!~~
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`~ @) 8UNqES·RE:PUBLllC
`DEUT&CHLAND
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`DEUTSCHE$
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`.PATENTAMT
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`@ Aktenzeichel\:.
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`Belcaftntmachung
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`I Anmaldetag:
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`1111m11m111lin1m11111l1u11111~
`® Gebrauchsmuster
`® ;-:,··1..s}o0
`II G01 N 3Q/'liD -
`®DE 29702825 U 1
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`29702825.l
`19. 2. 97
`10. ~ 97
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`@lnl\aber:
`•The Utrimatec.Pharma IL Health Products Gmt>H.
`22926 Ahren&burg. Df
`•
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`@ Vel"tl'elsr.
`H21rmsen & Utesf:het. Rechtsa11walte,
`f'atentan..,ilte. 20097 ,..amburg
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`@ Tecutreifanhalter
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`1 of 20
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`4-08-1998 8:31AM
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`FROM
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`. T~tstn~ifeoho.lter
`
`Die Erfindung becrifft einen Teststreifenhalter
`
`fur Chromatographie(cid:173)
`
`,
`
`teststrei fen.
`
`s
`
`10
`
`Seit langem ist der Nachweis besrimmter Stoffe in FH.issigkeiten, wie z; 8. in
`
`Slut oder Urin, duri;:h das Eimauchen von praµarienen Teststreifen bekannt.
`
`Solche T e:ttstreifen be.stehen ublic:herweise aus einem Kunststofftrager, auf
`dem ein saugendes Tragermacerial aufgebracht ist, das die F.lussigkeit
`<Jufsaugt und einem Nachweisfeld zufuhrt. Bei positivem Ausgang des Tests,
`d.h. bei Vorhandensein des nachzuweisenden SroffP.s in der Flussigkeit,
`
`vetfirbt sich der' Nachweisbereich.
`
`°'· . :.
`
`J.:5
`
`Solche _Testst~il'@n werden seit langem als Schwangerschaftstesr, aber auc;h
`als Diabetestest oder ~ei der Behandlung von Orogenabnangigen eingesetzt,
`
`die
`
`in
`
`regelm.;IBigen Abstanden nachweisen. mussen, daB. sie - keine
`
`Rauschmittel eingenommen haben. Seispielsweise Barbiturate und Alkaloide
`
`las?en ~ich innerhalb einer ·gewissen Zeitspanne nach der Zufuhr in den
`
`menscnlic;hen Karper im Urin nad-rweisen.
`
`20
`
`:?S
`
`In der Praxis hat diese Nachweismethode, insbesondere bei der Behandlung
`
`von Drogenabhangigen,
`
`jedocn einige Nachreile. Die vel"'INendeten
`
`Teststreifen eignen sich jeweils nur fur den Nachweis eines bestimmcen
`
`Stoffes. Bei Personen, bei denen davon 9uszugehen ist. daB sie verscniedene
`
`Rauschmittel k.onsumieren, muB der Test also mit verschiedenen
`
`•
`
`Nachweisstre~fen durchgefuhrt werden. Die Streifen sind \.iblic:herweise im
`
`oberen 8ereich auf der Tragerruckseitl! marlc.iert. Um Verwec:hslungen .Zu
`
`verhindern. muR jede Streifenserie. also jeder einzelne Streifen zusatzlich
`
`..
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`2 of 20
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`. "'·(cid:173).
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`-.
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`·-.· .
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`1
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`•.
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`-2-
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`mit dem Namen der getesreten Perscri beschriftet werden. Oiese Arbeir
`
`erfordert eine erhebliche Zeic. die im Praxisablauf nicht immer vomanden ist.
`
`AuSerdem bestehc die Gefahr, daB die Aufschrift mit der aggressiven
`
`Flussigkeit in Verbindung kommt und verwischt.
`• ~~ I
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`Oaruber hin·aus bestehel'l fur die mit der Durchfuhrung der Tests betrauten
`
`Personen
`
`neben
`
`hygienischen Problemen
`
`auch
`
`emstzunehmende
`
`gesundheitliche Gefahren beim Umgang mit in(izierten l<orperflussigkeiten.
`
`10
`
`AuBerdem lconnen die offenliegenden Nachweisfelder der Teststreifen leicht
`
`bei ein~m Manipularionsversuch beschadigt werden. Dies ist moglicherweise
`
`nichr immer sofort offensichtlich.
`
`. ,.
`
`Aufgabe der vorliegenden Erfindung
`S~~i~dgkeiten. insbesondere beim Test mit mehr als einem Teststreifen, zu
`
`ist es. die oben ge:>childerten
`
`15
`
`vermei(jen.
`
`Erfin~unrpgemaB wird ein Halter fur T eststreifen vorgeschlagen, der dadurdi
`
`geke.nnzeichnet
`
`isr, daB ein oder mehrere Teststreifen
`
`in . passende
`
`20 Aussparungen des Halters derartig einlegbar sind, da& der Teststreifen mil
`
`dem in die Probe zu cauchenden Ende aus dem Halter hervorsteht.
`
`Oadurch wird ermoglic:ht, da6 der Streifen auf hygiP.riische Art. und Weise in
`
`die Probe eingetaucht warden kann. Im F'alle, daB eine Nac;:h ...... eismoglichkeit
`
`25
`
`fur mehrere Scaffe gewunschr wird. k6nnen auch mehrere Strcifen in den
`
`Halter eingelegt und dann gleichzeitig in die Probe eingetaucht werden.
`
`Mehrere Arbeitsgange we~den so zu einem ArbeitSgang zusammengefaSr .
`
`.....
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`4-08-1998 8:32AM
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`FROM
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`·..:(cid:173)
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`
`A;.if dem Halter-besteht dann die Moglichk.eit, in uber~ichtlicher Art und
`
`Weise die ·analysierten Stoffe, das ·Testergebnis und --datum sowili den
`Nameo der uotersuchren Person zu vermerken. Die Cefahr, c:faB die
`
`A1.1fschrift verwischt. kanl\ erheblich reduziert _werden.
`
`s
`
`In einer bevorz.ugten Weiterbildung der Erfindung wird das im Halter
`befindli~tu~ Ende, das dem in die Probe einzutauchenden Ende gegenuber
`liegt, gegen einen Anschlag geschoben. Dadurch ist gevvahrteistet. ~aB alle
`
`Streifen~. deren GroBe genormt ist. um die gleiche Lange aus dem Haher
`
`10
`
`herausstehen.
`
`Vorzugsweise 'i"ird der Halter .als Kunststoffplatte mit streifenfonnigen
`
`Vertiefungen ausgefuhct. Diese Vertiefungen sind bevorzugt so tief, wie die
`
`Teststreifen dick sind. Die TestStreifen kOnnen dann
`
`in den Halrer
`
`IS
`
`eingeklemmt werden. Es kann aber auch eine einseitig ldebende Klebefolie
`
`uber Halter und Streifen gek.lebt ._.erden, die die ·Teststreifeo .in ihrer Position
`
`halt.
`
`Eire· solche Klebefolie kann im Bereich der Nachweisfelder der Streifen
`
`20
`
`transparente Aussparungen aufweisen, die den Blick auf die Nachweisfelder
`
`freigibt. Die Nac......,eisf~lder sind so gegen Manipulationen und Zerstorung
`
`gesichert.
`
`Die K.lebefolie bzw. der Halter sind vorzugsweise beschriftbar. Sie l.:;onnen
`
`25
`
`enlWeder als vorgefertigte T esrsets beispief5\Neise mit :zwei bis zehn,
`
`imbesondere mir drei bis sechs Teststreifen, fabrikmaSig gefertigt und mit
`
`den Namen der analysierten Stoffe beschriftet sein. Au8erdem k.ann auf dem
`
`;
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`Halter oder der Klebefolie a.uch die Bedeurung der Verfarbc.mg des
`.
`·.
`..
`.·
`~.'.
`· N~chweisfeldes eric:lart sein. Zusatzlic:h kOnl'\en Haher oder folie beschriftb•r
`
`sein, ·urn das Unrersudlung5ergebnis und <Jaturn sowie den Pat,ientennamen
`. ~bzw. eine laufende tden1ifilc:arionsnummer aufzubringen.
`':·
`
`Bezuglid1
`
`anderer
`
`be"or2ugter Ausfuhrungsformen wird
`
`auf die
`
`I
`
`Unteranspruche Bezug genommen.
`
`Die Erliridung .wird im folgenden anhand der beigefugten Abbildungen an
`eirem Beispiel naher erlautert:
`
`io
`
`fig .. .J.
`
`F"11:. 2
`
`IS
`
`z@igt einen
`
`erfi ndungsgem:iC!.en H<llter
`
`in perspektivischet
`
`Darscellung.
`
`.zeigt eine
`
`selbsrldebende A.bdeckfol ie zur Fixierong der
`Teststreifen im eriindungsgemaBen Halter.
`
`Fi!;. 3 .
`
`zeigt einen
`
`t:!rfindungsgemagen Halter mit
`
`funf ·eingeleg?en
`
`Teststreifen.
`
`In Fig .. 1 i$r der Halter 1 i:u sehen, der als flache Kunststoffplatte mit funf
`
`10
`
`streifenformigen Vert~eful'lgen ausgefuhrt
`
`bei$pielsweise eirie Breite von 5,8 mm. was
`
`isr. Diese Vertiefungen haben
`ir::t etwa der Breite es
`
`handelsublic.hen Teststreifens entspricht. Diese Vertiefungen sind um ger.au
`
`das MaB v~rtiefl, das der Dicke eines handelsublichen Teslstreifens
`entsprid1t. Die handelsublichen Teststreifl!n sind e.l'Na 75 mm tang. Die
`.....
`Verriefungen irn Halter si"nd so gewahlt, dars das Ende des Teststreifens, das
`in die Probe eingelauchr werden muB. aus dem Haher neraussteht. Es bietel
`
`2.s
`
`sich beispieb"Veise eine Lange \'On 65 mm fur die Vertiefungen an. Die
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`5
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`10
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`Vertiefungen sind durch die Stege 3 voneinander beabstaridet, Hier lc:ann
`
`elWa ein Absrand vo!'l 2.75 m~ gew~hlt werden. Jeder gr015ere Abstand ist
`
`.unproblematisch. hingegen sollCe der Abstan~ der Srreifen nicht ~u eng
`gewahh werden, damit die Streif en nictn· mireinander in e@ruhrung geraten.
`
`Die irt°Fig. 2 gezeigte selbstklebende Abdeckfolie 4 ist aur ihrer Rudc:seite
`selbstklebend. Sie wird auf den Halter 1 mit den eingelegten Testslreifen
`aufgeklebt und fixiert so die Srreifen in ihrer Position. Oie Abdeckfolie weist
`Kla~ich.tfenster S im 8ereich der An2eigefefder der Teststreifen auf. Die
`Anzeigefelder sind dami1 abgedeckt und gegen Manipula(ionen und
`
`Zerstorung gesichert. Weiterhin verfugr die Abdecldolie i.iber bereirs vorher
`
`besclyiftete oder im Einzelfall beschriftba1e ·Felder 6. in die sich der vom
`ICi[k Oaruber
`i'linaus hat die
`
`Streifen nacngewiesene Stoff eintragen
`
`Abdeckfolie noch Felder 7, auf denen eine Bedienungsanleitung at1fgebracht
`
`oder aufbringbar
`ist,
`sowie Felder B,
`auf deneri die moglichen
`Ergetfnisanzei~en dargestell~ sind. AuBerdem
`vorlianden, auf dem Testda.tum und Pa,ient, oder auch Werbung aufgebracht
`
`ist noch ein
`
`freies Feld
`
`werden k_ann .
`•
`
`In Fig. 3
`isc ein fertig praparierter Testreifenhalter 1 mit aufgebrachter
`Abs;f eckfol ie 4 ~ ie •ingel egren T eststrei fen 1 Oa bis .1 Oe dargestellt.
`
`• •
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`6 of 20
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`10
`
`IS
`
`1. Hahef' fUr Test$treifen, dadurch gelc@nnzeiclioet, daS ein oder rnehrere
`
`T eswreifen ( 1 OJ
`
`in passende A.usspan.iogen (2> des Halters (1) derart .
`
`(101 rnit dem in die Probe zu
`einlegbar sind, da6 der Testsrreifen-
`cauchenden Ende aus dem 1-talter ( 1) heivors~eht.
`
`·I
`
`2. Testsrreifenhalter nach A.n$pruch 1. dadurch gekennzeichner, daB das
`
`dem einzutauchenden Ende gegenuberliegende Ende des Teststreifens
`(10) gegen einen Ansd1lag (11) im Halter (1) schiebbar ist.
`
`3. Teststreifenhalter nach Anspruch 1 oder 2, dadurcn g.ekennzeichnet. daB
`der Halter (1) A.ussparungen (2) fur zwei bis zehn. insbesondere drei bis
`sechs Streif en (1 O) aufweisr.
`
`4 ~ Teststreifenhalrer nach einem der Anspruche 1 bis 3, dadurch
`
`gekecinzeichnet. daB der Halter
`
`( 1) eine
`
`Kunsts~offplatte. mit
`
`streifeofOrmigen Vertiefungen (2) ist.
`
`20
`
`5. Testsrreifenhalter nach einem der Anspruche
`
`bis 4. dadurch
`
`.gekellnzeichnet, daB die Tesrstreifen (10) in den Halter
`
`einklemmbar
`
`sind.
`
`6. Teststreifenhalter nach einem der Anspruche
`
`bis 4, dadurch
`
`2:;
`
`gekennzeic:hnef, daB die Teststreifen (10) in den HahE!r (1) einklebbar
`
`sind ..
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`4-08-1998 8:34AM
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`FROM
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`P. 10
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`-2~
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`7. Testsr.reifenhalter nach ·einem der Anspr"Uche 1 bis· 6, dadurch
`
`gelcennzeichnet.. daS der Haher (1 > mit einer einseitigen Klebefolie (4)
`abdec:kbar isl.
`
`S
`
`8. Teslstreifenhaher ·nach Anspruch. 7, d<Jdurch gek~onzeichnet, daB die
`
`Klebefolie (4) zur Fixierung der Tes•streifen (10) am Halrer (1) dient.
`
`9. Tescstreifenhalrer nac:h. Anspruch 7 oder 8. dadurch gekennzeichnet daB
`
`die Klebefolie (4) wenigstens im Bereich (5) der Nachweisfelder der
`
`10
`
`Streifen (10) transparent ist.
`
`lo. Testscreifenhaller nach einem der Anspruche 7 bis 9, dadurch
`gclc:ennzeichnet. daB die Klebefolie (4) beschrifter oder beschriftbar ist.
`
`15
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`MA438899
`8av4
`- 998 8:34.AM
`4-08 1
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`FROM
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`P. 11
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`rHIS PAGE BLANK«Ubt-1:.
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` DE 297 02 825 U1
`
`
`
`[barcode]
`(51) Int. Cl.5:
`B 01 L 9/00
`G 01 N 30/[90]
`[handwritten:] Subclass: G01N 35/00
`
`
`
`
`
`
`
`
`(19) Federal Republic of Germany
`
`
`
`[seal]
`
`German Patent Office
`
`
`
`
`(21) Application number: 297 02 825.1
`(22) Filing date:
`February 19, 1997
`(47) Registration date:
`October 4, 1997
`(43) Notice in the
` Patent Gazette:
`
`May 22, 1997
`
`
`
`(12) Utility Model
`(10) DE 297 02 825 U1
`
`(73) Proprietor:
`
`“The Ultimate” Pharma & Health Products
`GmbH, 22926 Ahrenburg, DE
`
`
`
`(74) Representative:
`
`Harmsen & Utescher, European Attorneys,
`Patent Attorneys, 20097 Hamburg
`
`
`
`(54) Test Strip Holder
`
`DE 297 02 825 U1
`
`
`
`
`
`
`
`
`
`BEST AVAILABLE COPY
`
`GERMAN FEDERAL GOVERNMENT PRINTING OFFICE 03.97 702 221/314 2/7
`
`
`
`11 of 20
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`February 22, 1997
`
`Test Strip Holder
`
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`The invention relates to a test strip holder for chromatography test strips.
`
`For a long time it has been known to determine certain substances in body fluids, such as, for
`example, in blood or urine, by immersing prepared test strips. Such test strips typically consist of a
`plastic substrate, to which is applied an absorbing substrate material that absorbs the fluid and is
`fed to a detection field. If the test result is positive, i.e., the material to be detected is present in the
`fluid, then the detection range changes color.
`
`Test strips of this type have been used for a long time as a pregnancy test, but also as a diabetes test
`or in the treatment of drug addicts, who have to demonstrate at regular intervals that they have not
`taken any narcotics. For example, barbiturates and alkaloids can be detected in the urine in a
`defined period of time after delivery into the body.
`
`However, this method of detection, in particular, in the treatment of drug addicts, has some
`drawbacks in real life. The test strip that is used lends itself only to the detection of a specific
`substance. Therefore, for persons, for whom it must be assumed that they consume a variety of
`narcotics, the test has to be administered with a number of different detection strips. The strips are
`usually marked in the upper region on the back of the substrate. In order to eliminate confusion,
`each strip series, i.e. each individual strip, must also be labelled with the name of the person tested.
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`February 22, 1997
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`This work requires a considerable amount of time that is not always available in the daily routine of
`the clinic. In addition, there is the risk that the label will make contact with the aggressive fluid and
`become blurred or will be smeared.
`
`Moreover, the handling of infected body fluids presents not only hygienic problems, but also
`increasingly health risks for those persons who are responsible for conducting the tests.
`
`In addition, the exposed fields of detection of the test strips may be easily damaged when trying to
`handle them. It is possible that such damage may not always be immediately apparent.
`
`The object of the present invention is to avoid the problems described above, in particular, when
`testing with more than one test strip.
`
`The invention proposes a holder for test strips that is characterized by the feature that one or more
`test strips can be inserted into matching recesses of the holder in such a way that the test strip
`projects out of the holder with the end that is to be immersed in the sample.
`
`This feature allows the strip to be dipped into the sample in a hygienic manner. In the event that a
`way to detect a plurality of substances is desired, a plurality of strips may also be placed into the
`holder and then immersed in the sample at the same time. This approach makes it possible to
`combine multiple working steps into one working step.
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`February 22, 1997
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`Then there is the option of indicating clearly and distinctly the substances to be analyzed, the test
`results, the test date and the name of the person tested. The risk that the label will be blurred or
`smeared can be significantly reduced.
`
`In a preferred further development of the invention the end, which is located in the holder and
`which is located opposite the end to be immersed in the sample, is pushed against a stop. This
`arrangement ensures that all of the strips having a size that is standardized will project out of the
`holder by the same length.
`
`The holder consists preferably of a plastic plate with recesses in strip form. These recesses are
`preferably as deep as the test strips are thick. Then the test strips can be clamped into the holder.
`However, an adhesive film that bonds only on one side may also be glued over the holder and the
`strips; and this adhesive film holds the test strips in their position.
`
`Such an adhesive film may have transparent recesses in the region of the detection fields of the
`strips, so that the recesses offer a view of the detection fields. This arrangement ensures that the
`detection fields are protected against physical manipulation and destruction.
`
`The adhesive film and the holder respectively can be preferably labelled. Both the adhesive film
`and the holder may be manufactured as a prefabricated test kit, for example, with two to ten, in
`particular, with three to six, test strips and can be labelled with the names of the substances to be
`analyzed. In addition, it is also possible to state the significance of the change in color of the
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`February 22, 1997
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`shows an inventive holder in a perspective view.
`
`
`detection field on the holder or the adhesive film. In addition, the holder or the film may be labelled
`in order to affix the test results, the test date as well as the patient name and/or a running
`identification number.
`
`With respect to additional preferred embodiments reference is made to the dependent claims.
`
`The invention is explained in detail below by means of an example with reference to the
`accompanying drawings.
`
`Figure 1
`
`Figure 2
`
`shows a self-bonding cover film in order to secure the test strips in the holder of the
`invention.
`
`shows an inventive holder with five inserted test strips.
`
`
`Figure 3
`
`In Figure 1 the holder 1 can be seen. Said holder is designed as a flat plastic plate with five recesses
`in strip form. These recesses have, for example, a width of 5.8 mm, which is equal more or less to
`the width of a commercially available test strip. These recesses are recessed by exactly the amount
`that corresponds to the thickness of a commercially available test strip. The commercially available
`test strips are about 75 mm long. The recesses in the holder are selected in such a way that the end
`of the test strip, which has to be immersed in the sample, projects out of the holder. A length of, for
`example, 65 mm is useful for the recesses. The recesses are spaced
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`February 22, 1997
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`apart from each other by means of webs 3. In this case a distance of about 2.75 mm can be selected.
`Any larger space interval is not a problem, but the distance between the strips should not be
`selected too narrow, so that the strips do not make contact with each other.
`
`The self-bonding cover film 4 that is shown in Figure 2 is self-bonding on only its rear side. Said
`cover film is glued on the holder 1 with the inserted test strips and, as a result, secures the strips in
`their position. The cover film has transparent windows 5 in the region of the indicator fields of the
`test strips. As a result, the indicator fields are covered and protected against physical handling and
`destruction. Moreover, the cover film has fields 6, which have already been labelled or can be
`labelled in the individual case and into which the substance, detected by the strip, can be entered.
`Moreover, the cover film has additional fields 7, on which operating instructions are or can be
`affixed, as well as fields 8, in which the potential displays of the results are shown. In addition,
`there is also a free field, to which the test date and patient or also advertising can be affixed.
`
`Figure 3 shows a finish prepared test strip holder 1 with applied cover film 4 and inserted test strips
`10a to 10e.
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`February 22, 1997
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`Patent Claims
`
`1.
`
`Holder for test strips, characterized in that one or more test strips (10) can be inserted into
`matching recesses (2) of the holder (1) in such a way that the test strip (10) projects out of
`the holder (1) with the end that is to be immersed in the sample.
`
`Test strip holder, as claimed in claim 1, characterized in that the end of the test strip (10),
`which is opposite the end to be immersed, can be pushed against a stop (11) in the holder
`(1).
`
`Test strip holder, as claimed in claim 1 or 2, characterized in that the holder (1) has recesses
`(2) for two to ten, in particular, three to six, strips (10).
`
`Test strip holder, as claimed in any one of the claims 1 to 3, characterized in that the holder
`(1) is a plastic plate with strip-shaped recesses (2).
`
`Test strip holder, as claimed in any one of the claims 1 to 4, characterized in that the test
`strips (10) can be clamped into the holder (1).
`
`Test strip holder, as claimed in any one of the claims 1 to 4, characterized in that the test
`strips (10) can be glued into the holder (1).
`
`6
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`2.
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`3.
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`4.
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`5.
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`6.
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`7.
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`8.
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`9.
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`10.
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`February 22, 1997
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`Test strip holder, as claimed in any one of the claims 1 to 6, characterized in that the holder
`(1) can be covered with a one-sided adhesive film (4).
`
`Test strip holder, as claimed in claim 7, characterized in that the adhesive film (4) is used to
`fix the test strips (10) on the holder (1).
`
`Test strip holder, as claimed in claim 7 or 8, characterized in that the adhesive film (4) is
`transparent at least in the region (5) of the detection fields of the strips (10).
`
`Test strip holder, as claimed in any one of the claims 7 to 9, characterized in that the
`adhesive film (4) is labelled or can be labelled.
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`TOTAL OF 10 PAGES
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`February 22, 1997
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`
`Affidavit of Accuracy
`
`This is to certify the attached document, DE 297 02 825, has been translated from
`
`German into English by staff members of TransPerfect Translations familiar with
`
`both the German and English languages and are to the best of our knowledge,
`
`ability and belief, true and accurate translations.
`
` ForTransP - Translations
`
`Sworn to before me this
`Friday, May 13"‘, 2016
`
`
`
`Signature, otary Public
`
`
`
`
`
`ASHLEY H. TALHAM
`Notary Public
`
`‘
`.1 commonwealth of Massachusefls
`My Commission EXWB5 AUOI-I31 25- 2°22
`
`
`
`
`20 of 20

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