CA1228246A - Apparatus for the evaluation of a test carrier for the analytical determination of components of a body fluid - Google Patents

Apparatus for the evaluation of a test carrier for the analytical determination of components of a body fluid

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Publication number
CA1228246A
CA1228246A CA000456657A CA456657A CA1228246A CA 1228246 A CA1228246 A CA 1228246A CA 000456657 A CA000456657 A CA 000456657A CA 456657 A CA456657 A CA 456657A CA 1228246 A CA1228246 A CA 1228246A
Authority
CA
Canada
Prior art keywords
test carrier
test
tilting
positioning means
carrier
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000456657A
Other languages
French (fr)
Inventor
Dieter Meinecke
Rainer Van Rijckevorsel
Manfred Pauli
Rudolf Schussler
Thomas Jack
Dieter Knoll
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Roche Diagnostics GmbH
Original Assignee
Boehringer Mannheim GmbH
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 Boehringer Mannheim GmbH filed Critical Boehringer Mannheim GmbH
Priority to CA000530520A priority Critical patent/CA1234707A/en
Application granted granted Critical
Publication of CA1228246A publication Critical patent/CA1228246A/en
Expired legal-status Critical Current

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84Systems specially adapted for particular applications
    • G01N21/8483Investigating reagent band
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47Scattering, i.e. diffuse reflection
    • G01N21/4738Diffuse reflection, e.g. also for testing fluids, fibrous materials
    • G01N2021/4776Miscellaneous in diffuse reflection devices
    • G01N2021/478Application in testing analytical test strips

Abstract

ABSTRACT
An apparatus for the evaluation of a flat test carrier for the analytical determination of com-ponents of a body fluid, has a measurement unit and a positioning means which positions and firmly holds a test carrier in a measurement position so that its test field is present in a definite position with regard to the measurement unit; for the evaluation of test carriers with a covering layer fixed in the manner of a flap on one edge of the test carrier, the apparatus includes, an aperture element with a contact surface adapted to press on the covering layer, at least one of the aperture element and the positioning means being mounted and operable in such a manner that the contact surface in the last phase of approaching the covering layer is adapted to make, relative to the test carrier, a tilting movement about a tilting axis which lies in close proximity to the fixing edge of the covering layer; in a different embodiment the positioning means includes at least first and second holding means, the first holding means firmly holding the test carrier close to an insertion end and the second holding means firmly holding the test carrier close to its handling end, a supporting surface on which the test carrier lies at least partly in its measurement position, and the positioning means includes a tensioning element which tensions the test carrier in the measurement position along its longitudinal axis between the first and second holding means; the apparatus of the invention permits simple handling and exactitude of evaluation.

Description

~122~ 6 The pre~ent invention is concerned with an apparatus for the evaluation of a tes~ carrier for the analytical determination of components of a body fluid with a measurement unit and a positioning device by means of which the test carrier i~ positioned and finmly held in a measurement position in such a manner that it~ test field is pre~ent in a definite position with regard to the mea3urement unit.
For the determination of components of body fluids, for example blood or urine, solid test carriers are increasingly used in clinical chemi~try.
In comparison with the well-known method~ in which sam~les were mixed with liquid reagents, these pro-cesses are especially characterised by a considerably simplified carrying out. In principle, the test carrier has only to be brought into contact with the sample and then placed in a comparatively si~ply constructed e~aluation apparatus. In this way, there can be achieved a high degree of dependabili~y, even in the case of handling by per~onnel with little training. Furthermore, such apparatu~ can be ~ituated decentrally where the analy~is i~ required and the re~ult is available without any problem~ in a short timeO
Test carrier~ of a comparatively simple nature have been known for many year~ in the form of te~t strip~ in which a te~t field containing the reaction layer is applied to a longitudinal synthetic resin strip, the thickne~s and material of which are such that it is, in toto, flexible. Ever since it has been possible to combine the colour reaction on the test field of such test strips with a high degree of exactitude with the concentration Oc the component to be determined, the test strips have also been evaluated quantitatively with the help of appropriate apparatus. As a rule, this take~ place by measuring the diffu3e reflectivity of the test field surface after the reaction with the use of a reflection photometer.
~ he quality and the properties of use of the apparatus employed for the evaluation are determined lS essentially by the means pre~ent therein for position-ing the test field relative to the measurement unit of the apparatug~ On the one hand, this must be such that the test carrier can be inserted as simply and problem-free as possible and can again be removed after the measurement has been carried out. However, the positioning device must, at the same time, also be able to place the test field in a precisely re-producible manner in the same place relative to the measurement unit. For a flat test carrier, such as is used in the apparatus according to the present invention, this requir~ment must be observed in two regards. On the one hand, an evaluable surface of ~4--the test field must be precisely positioned under the measurement unit. In this regard, high requirements are often demanded becau~e the evaluable test field surface is very small in order, on the one hand, only to utilise the most homogeneous middle region of the test field and, on the other hand, to be able to manage with as little reagents as possible and also the smallest possible amounts of sample. In the second place, the distance between the test field surface and the measurement unit must be extremely exactly reproducible since any uncontrolled variation of this distance would falsify the measurement result.
Known apparatus of the initially mentioned kind are described, for example, in European Patent Specific-ation ~o. 003748~ and in British Patent Specifications Nos. 1303758 and 1598086. In the case of all of these apparatus, the positioning of the test carrier formed as a test strip in the direction of its test field surface is achieved by inserting the test strip into an appropriate canal or slot, the side walls of whichguide the test strip until it comes to lie against a stop. The canal can also be used to achieve an adjustment in the direction vertical to the test field surface when it is conically shaped, as can be seen, for example, from British Patent Specification ~o.
1303758. In this case, however, the insertion of the test strip is difficult.

~Z~ 6 Especially advantageous test carriers, such as are de cribed in Federal Republic of Germany Patent Specification No. 3130749, make it pos ible to carry out the desired analytical detenminations directly on S a blood sample without it being necessary previously to obtain plasma or serum by centrifuging. For this purpose, the te~t carrier described therein has a flat separation layer arranged on the base strip, on one end of which i~ applied the blood sample. The separ-ation layer consists of glass fibre material whichretains the red blood corpuscles in the region of the point of application of the blood sample. The blood plasma, on the other hand, spreads out in the layer so that, in the region of the separation layer remotè
from the point of application of the blood sample, a pool of plasma is available. Over this there i9 present at least one reaction layer which consists of a paper impregnated with reagents and is fixed on only one edge of the test carrier in the manner of a flap.
Between this layer and the separation layer there can be pre~ent a hydrophobed me3h. The reaction can be simply commenced in such a test carrier, af~er the plasma has been obtain~d in the above-de~cribed manner, by applying a full-face pressure on the flap which is only fixed on one side. For the evaluation of such a test carrier, the appropriate evaluation device must have a poqitioning mean~ which precisely ~282~6 positions the test trip regardless of whether it is or is not pressed against the measurement unit.
It is an object of the present invention to provide an improved apparatus for the evaluation of test carriers and especially its means for the reception and positioning of the test carrier in order to achieve the simplest possible handling and the highest exactitude of the evaluation.
Thus, according to a first main aspect of the present invention, there is provided an apparatus for the evaluation of a longitudinally extending, flexible test carrier for the analytical determination of components of a body fluid, the test carrier having an insertion end to be inserted into the apparatus and a handling end serving for handling thereof, said apparatu~ having a measurement unit and a positioning means, by means o~ which the test carrier is positioned and securely held in a measurement position in such a manner that its test field is present in a definite position with regard to the measurement unit, wherein the positioning means includes at least two holding means, one of which firmly holds the test carrier close to its insertion end and the other of which firmly holds the test carrier close to its handling 2S end by means, in each case, of a fixing element, a supporting surface being provided on which the test carrier lies at least partly in its measurement , . . ~ ,. .i ~1.2Z~

position and the positioning means includes a tension-ing element by mean~ of which the test carrier i~
tensioned in its measurement position along its longitudinal axis between the holding means.
~he measure of holding the preferably strip-shaped test carrier under tension along its longitudinal axis on both sides provides considerable advantage3 in spite of apparent diqadvantages with regard to the simplicity of the construction. In particular, the test strip i~ very precisely held în it~ longitudinal direction. In this way, it is, for example, possible precisely to read a magnet code applied to its rear side (i.e. on the side facing the supporting surface), after fixing. By means of this measure, it i5 also possible to press on the magnetic reading head for reading the magnetic code from behind with the necessarily applied pressure without having, of necessity, to exert a counterpressure on the front side of the test carrier (i.e. the side remote from the supporting surface~.
The holding means can be constructed in various ways in such a manner that they have an opening po~ition, in which they free the test carrier, and a closed position, in which they hold it. There can be used, for example, appropriate clamps which are operated magnetically or by spring pressure. According to a preferred embodiment of the present invention, the fixing element does not hold the test carrier by force locking but rather holds it in an appropriate rec2~s of the test carrier by engaging therein in a fonm-locking manner. In the case of an especially simple construction, the recess i9 a hole provided in the test carrier close to its ends in which, in the closed position of the holding element, a pin-shaped holding element engages. In contradistinction to simple clamps, this construction has the advantage that the holding means are easy to operate and yet firmly hold the test carrier so well that, under a comparatively high tension, it can be placed in its longitudinal direction.
Instead of having a circular cross-section, the fixing pin can also have some other cross-section, the receqses in the test carrier thereby being adapted to the particular cross-sectional shape in such a manner that this is held and tensioned in a precise and reproducible manner.
The tensioning in the longitudinal direction of the test carrier can be achieved in various ways, for example by electrical means. Especially simple is a preferred embodiment in which, for example, a pneumatic or simple mechanical spring element impinge 9 against at least one of the holding elements in the longitudinal direction of the test strip away from the middle thereof with a pre-tensioning. The longitudinally ~L~2~ 6 extending test carrier is, in tha case of such a construction, preferably first fixed on the holding element associated with its insert end and then, against the prestressing, on its handling end, the holding element is brought into engagement with the corresponding reces~ of the test carrier. Thiq can take place manually. However, an appropriate slider can also be provided which is preferably simultane-ously able to initiate such apparatus functions which, after the fixing of the test carrier, ~ust be initiated.
The ~lider can also be constructed as a flap which closes the reception opening of the apparatus.
In order to simplify the insertion of the test strip and the holding of its insertion end, the appropriate holding means is, according to a further preferred embodiment, constructed in such a manner that it has a guide element for the insertion end of the test strip. The guide element preferably includes a groove narrowing conically in the direction of insertion or a corresponding slot which brings the insartion end of the test carrier into a position in which the holding element of the holding device can penetrate into the corresponding recess of the test carrier. At the same time, the guide element also provides for a guiding in a direction vertical to the surface of the test strip.

In order to bring the holding device a3sociated with the insertion end of the test carrier from the open po~ition into the closed position, in which its holding element engages in the recess of the test carrier, it is preferably operable from the insertion end of the test carrier. For this purpose, there ~an be provided, for example, a photoelement which, in the case of insertion of the test carrier, initiates an electromagnetic operation of the holding element.
Especially preferred is an operating element which includes a tiltable lever device which is in operating association with a spring element. The more detailed construction can preferably correspond to the con-struction described in European Patent Specification ~o. 0037484. In this way, with simple means and without the necessity of an additional source of energy, there is achieved a dependable operation of the holding means associated with the insertion end of the test carrier. For the ejection of the test carrier, the lever device can advantageously be connected with an ejection rod, which is operated manually or with the help of adjuvant means, when the test carrier i5 to be ejected.
According to an especially preferred embodiment, the positioning device is so constructed that a spring-mounted pressure plate presses against the clamped test carrier approximately in the region of it~ te~t field from its re~r facing the supporting surface. The pressure plate is preferably mounted in such a manner that, in the region in which, in operation, it springinyly yield , it i~ tiltable on all side~.
On the other hand, in the measurement position, the measurement unit pres~es preferably with apeTtu~e plate or the like from the front of the test carrier on to its test field.
By mean~ of this construction, two important advantages are combined with one an~ther. On the one hand, the pressure plate presses against the rear of the test field as soon as this is held in the holding position, independently of whether a counterpressure is exerted on the test field from the other side.
The pressure plate can preferably be tempered. In this way, the test field is already brought to the desired temperature immediately after cla~ping of the test carrierO Independently thereof, it is possible first to exert pressure on ~he test field from its -~
upper side at a later point of time, which is of especial importance when the above-mentioned test carrier with a flap is to be evaluated according to Eederal Republic of Germany Patent Specification No.
3130749~ In the second place, by means of th~e elastic pre~sure plate, different test field thick-nesse3 and practically scarcely avoidable tolerances in the guiding of the measurement unit or of its ,~ , , .

9L2~ L6 measurement aperture can be compensated in an advantageous manner.
Preferably, the supporting surface iq constructed, at least in partial region~, in a form curving convex-edly away from the test carrier. From this result~,independently of the more detailed construction of the curvature J a handling advantage because the handling end of the test carrier, so long as this is only held by the holding means associated with its insertion end, has a predetermined distance from the supporting surface so that the test carrier can be easily inserted and taken out. The curved supporting surface also simplifies the pressing of the handling end of the test carrier, in the manner described here-inbefore, with the help of a slider via the spring-loaded holding element in the longitudinal direction of the test carrier, bringing its recess into engage-ment with the fixing element of the holding means.
A curved supporting surface is also especially 2Q aavantageous when the test carrier carries on its rear side a magnetic code which is to be read off by an appropriate reading head. In order to achieve the necessary close contact between the slot of the read-ing heaa and the magnetic coating of the test carrier, the supporting surface fQr the test carrier and the path of movement of the reading head relative to this i 9 SO constructed that the apex of the reading head at that point of its path of movement is higher than the supporting surface of the test strip. It is thereby achieved that, on every part of the path of movement, the tensional forces acting upon the te~t strip produce a component in the direction of the reading head. In principle, this can also he achieved with a completely straight-running supporting surface, from which the reading head pro-jects slightly. However, a better pressing on between the magnetically coated surface and the reading head is achieved when the supporting surface is comparatively curved in the region of the path of movement of the reading head and the reading head projects slightly.
Constructively, a solution is especially simple in which the positioning device is, in its totality, tiltable about a tilting axis and in which the magnetic reading head is mounted fixedly on the apparatuq. The supporting surface thereby runs in the region of the relative path of movement of magnetic layer and reading head circularly around the tilting axis and has a slot through which the reading head projects slightly with regard to the supporting surface.
Since, in the case of this construction, the magnetic reading head is fixedly positioned on the apparatus, 2S it can be provided especially simply with an adjus~ment device. The po~itioning device, which ln toto is tilt-able, can be advantageously 90 arranged in the apparatus ~2~

as a whole that the test strip can easily be gripped in the holding means in an end position of the tilting path, wherea~ in the other tilting position, the test field is brought into contact with t~e measurement unit and is evaluated. During the movement from the first into the second end position, the reading of the magnetic code takes place. Thi8 coding contains, in particular, data regarding the charge-specific evalu-ation curve, i.e. in the case of a reflection-photometric evaluation, the functional relationshipbetween the measured diffuse reflectivity and the concentration of the substance to be detenmined in the sample. In addition, further information can also be given, especially regarding the process con-ditions to be maintained by the apparatus, for examplethe temperature and measurement time.
According to a second main aspect of the present invention, it concerns an apparatus of the initially described kind which is especially constructed for the evaluation of the types of test carriers already mentioned, which have a covering layer in the manner of a flap fixed on one edge of the test carrier. As already mentioned, special embodiments of such test carriers are described in Federal Republic of Germany 25 Patent Specification ~o. 3130749. It is here an important feature that the pressing of the covering layer on to the test carrier takes place in such a 4~

manner that the inclusion of bubbles between the covering layer (flap) and the plasma pool pra~ent thereunder iq avoided as far as possible.
In order to achieve this object, the apparatuq according to the present invention has a aperture element with a contact surface for pressing on the covering layer, the aperture element and/or the positioning device thereby being mounted and operable in such a manner that the contact surface, in the last phase of the approach to the covering layer, makes a tilting movement about a tilting axis relative to the test carrier, which tilting axis is in close proximity to the fixing edge of the covering layer.
The aperture element is, in the simplest case, a metal part with a flat lower contact surface which is brought into contact with the flap of the test carrier and with a circular hole, which serves as a window, through which the coloration of the test layer connected to the flap can be eva~uated optically. By means of the descriked mc,vement, it is achieved that the pressure in the case of pressing the contact sur-face of the aperture element agains~ the flap is uniformly propagated in the region of the test field, with the avoidance of air inclusion~.
Especially preferably, the aperture element is mounted and operable in such a ~anner that the contact surface in the last phase of the approach to the ~est ~2~ 6 carrier flap makes a sliding relative movem nt away from the fixing edge of the flap. In this way, the danger of air inclusions is still better avoided and the flap is pres~ed against in an especially uniform manner.
It is to be stressed that the solution according to the second main aspect of the present invention iq advantageously used in combination with that according to the first main aspect but, independ-ently thereof, i~ also of importance.
The complicated movement of the aperture elementrelative to the test carrier can, in principle, be realised with the help of appropriate servo drives and electronic controls in various ways. However, in practice, the necessary dependability and the cost-favourable construction is to be taken into account.
It is thereby especially advantageous when, for the case in which the whole positioning means is tiltable in the above-described manner, the same drive is also used for pressing on the test carrier flap. In this sense, it is advantageous when the aperture element is connected via a coupling mechanism with the drive for the positioning means. Especially advantageously, the aperture element is, in operation, a part secur01y connected with the measurement unit, the mentioned drive thereby driving the positioning means and the measurement unit via the coupling mechanism in such ~2~

a manner that the desired relative movement between the positioning means and the measurement unit is achieved.
Practically suitable are here all coupling mechanisms which work sufficiently free of play, are simply constructed and do not require too much force.
In particular, there can be used an appropriate link guiding. Especially preferred, because it is partic-ularly ~imply constructed and is dependable in function, 0 i9 a coupling mechanism which has two interengaging toothed rims which, via corresponding, for example, sector-shaped connecting parts, are connected, on the one hand, with the measurement unit and, on the other hand, with the positioning means. The two toothed lS rims run circularly about two tilting axes about which are tilted, on the one hand, the constructional unit of the positioning means and, on the other hand, the constructional unit of the measurement unit.
A part of the constructional unit carrying the positioning means forms the pressure plate, the sur-face of which facing the test carrier preferably runs substantially tangentially to the curvature of the supporting surface and passes over smoothly into this.
The contact surface of the aperture element, which is provided for pressing on the flap of an appropriate test carrier, preferably doe~ not run vertically to the radius crossing its middle about the tilting axis ~2~2~3Z~6 of the conqtructional unit carrying the measurement device. On the contrary, it is preferably so orientated that a vertical on the contact surface runs on the side of the tilting axis of the measure-ment device remote from the positioning means. Thetoothed rim associated with the measurement unit preferably haq a smaller diameter than the toothed rim associated with the positioning means.
By means of this method of construction, there is achieved a simple and dependable coupling of the two constructional units. By means of experiments, such an arrangement of the constructional parts can readily be detenmined that the mentioned geometric conditions in the case of the coming close of the measurement aperture with its contact surface to the flap of the test carrier are fulfilled.
As mentioned above, the apparatus according to the present invention is especially suitable for the evaluation of test carriers of the kind described in Federal Republic of Germany Patent Specification No.
3130749. The mentioned advantages of the individual constructional features are hereby combined with one another in an ideal manner. Due to the clamping of the strip-shaped test carrier between the holding means, this is precisely positioned. At the same time, the pressure plate presses from bahind against the teqt carrier in the region of the test field and begins to heat this. This is po~sible while, at the same time, 3till no pres~ure i~ exerted from the opposite side on the te~t field. In this time, the plasma-obtaining phase takes place in the manner described hereinbefore. At a point of time related to the test in question and with an appropriate speed, the constructional unit carrying the positioning means is then tilted from its first position into the second position, whereby a preferably magnetic coding present on the rear side of the test carrier can be read off.
The course of movement can be readily controlled in such a manner that, at a predetenmined point of time, the measurement unit wnth the measurement aperture presses over it~ contact surface on the flap of the test carrier and thus the reaction is initiated.
Insofar as it is desire~, a ventilation phase can also be provided in which the measurement unit i9 again tilted back in order to take the pressure from the test field and to expose this to a ventilation.
Finally, at a further predetermined point of time, the contact surface of the measurement shutter i9 pressed with the measurement unit against the test field and the measurement i~ carried out.
Further advantages and feature~ important for t~e present invention are to ke gathered from the embodiments de~cribed hereinafter in more detail, with reference to the accompanying drawings, in which~

Fig. 1 is a schematic illu~tration of a part of an apparatus according to the preAent invention, especially of the constructional units carrying the measurement unit and the positioning means, a test strip-shaped test carrier having just been inserted, Fig. 2 is the device according to Fig. 1 in which the holding means associated with the insertion end of the test carrier is present in its closed position, Fig. 3 is the device according to Fig. 1 with a com-pletely inserted test carrier gripped between two holding means, Fig. 4 is the device according to Fig. 1 in which the positioning means and the measurement unit are present in the measurement position, Figs. 5a to 5c are schematic illustrations of the courses of movement in the case of pressing a test carrier flap on to the test carrier, and 0 Fig. 6 is a cross-section view along the line VI-VI
in Fig. 4.
Fig. 1 shows schematically a side view of the device with a reception slider 2 carrying the position-ing means and a carrier slider 4 for a measurement 5 unit 6. The measurement unit is here constructed as an Ulbricht's sphere by means of which the diffuse reflection is measured reflection photometrically from 12~i an illuminated test field. Within the scope of the present invention, there can, of course, be used other meaqurement units. The reception slider 2 and the carrier slider 4 have sector-shaped parts which, S on their end surfaces, have interengaging toothed rims 8, 10. The two sliders 2, 4 are tiltable about axes of rotation 12, 14, a direct coupling of the movement taking place because of the toothed rimsO
The two sliders, each with the parts fixed thereto, form tiltable constructional units. For the tilting of the reception slider and thus also of the carrier slider, there is provided an electric motor (not illustrated). On a housing 16, which is here only indicated, there is provided a displaceable flap 18, by means of which a reception opening 20 can be closed~ Through the reception opening 20, there can be inserted a test carrier, constructed as a test strip 22, with its insertion end 23. The device with the reception slider 2 and the carrier slider 4 is arranged on a frame within the housing 16. In the region of the reception opening, the reception slider
2 has a curved supporting surface 24 for the test strip 22; an unimpeded insertion of the test strip 22, firmly held on its handling end 25, is possible without difficulty.
Furthermore, the reception slider 2 contains an operational element in the form of a lever device ~L~Z8Z~6 constructed a3 a cam plate 26, with which a ~top pin 28 i~ coupled~ With the front end 50, the test ~trip 22 lie~ again~t the upper end of the cam plate 26.
By means of a ~pring element 30, the cam plate is impinged against by a force not only in the first end position illustrated in FigO 1 but also in the second end position illustrated in Fig~. 2 to 4, in each case in the direction away from an apex of the tilting path lying between the two end position3. In the region of the stop pin 28, there is also present on the reception slider 2 a guide element 32 with a guide ~lot 34 for the test strip 22. The guide slot runs slightly conicall~ not only in t~e plane of the drawnng but also in a plane vertically thereto. The guide element 32 thereby guides the insertion end 23 of the test strip 22 into the position in which the stop pin 28 can penetrate into the corresponding recess 52 of the test strip 22. Furthermore, with the cam plate 26 there is also connected an ejection rod 36. On the other end of the reception slider 2, there is present a second holding mean~ for the te~t strip 22 This includes, as holding element, a tension pin 38 which is baised outwardly by a spriny 40 which is supported on a countermounting 41.
2~ In the region of the supporting ~urface 24, there is secured on the frame a reading head 42 for a magnetic code applied to the rear 54 of the te3t ~.
sj ~LZ~ 6 strip 22. rhe supporting ~urface 24 of the reception ~lider 2 has, for the reader head 42l a ~lot 44 extending in it3 longitudinal direction. The ~lot 44 i~ essentially closed by means of a 91ide 43 in the illustrated position of the reception ~lider 2. The ~lide 43 i~ movable in the reception sli~er 2 on bolt~
45 arranged vertically to the plane of the drawing.
By means of a mechanism (not illustrated), the slider 43 can be moved to the side ~or opening the slot 44 for the reading head 42 in the case of tilting the reception slider 2. The reading head 4~ projects at a predetermined distance over the supporting Qurface 24 for the test strip. Finally, a pres~ure plate 46 is provided in order to give, in the measurement position, a definite pressing-on pressure and, further-more, also a plane-parallel positioning of the test field. The associated spring element 48 has a progressive spring characteristic for the tolerance equilibrationO
Fig. 2 show~ the device with a fully inserted test strip 22. By means of the front end 5C of the test strip 22, the cam plate 26 i~ tilted into the illustrated po~ition. Details thereof are given in European Patent Specification No. 0037484. The stop pin 28 was hereby moved upwardly and it now engages in a reces~ 52 of t~e test strip. The insertion end 23 of the test strip 22 is con~equently positioned in .i ~ææ~4~

a definite manner on the reception slider 2.
In Fig. 3, there i~ illustrated the flap 18 in the position closing the reception opening 20. In the case of pushing down the flap 18, with the help of a corresponding projection 19, the test strip 22 is also pressed on the curved supporting surface 24.
The tension pin 38 was also inserted simultaneously into a further recess 53 of the test strip 22. As can be seen, the spring 40 impinges against the tension pin 38 with a force in the longitudinal direction of the test strip away from its middle so that a corres-ponding pulling force acts on the test strip 22 and this is thus firmly tenqioned on the reception slider 2. The reading head 42 projects somewhat over the supporting surface 24, a good embracing by the test strip 22 thereby being obtained. On the rear S4 of the test strip 22, there is present a magnetic layer which contains binary coded data. These data are, in the case of tilting the slider in the direction of the arrow 56, automatically read and correspond-ingly evaluated in an appropriate electronic device.
Fig. 4 illustrates the end position of the tilting movement. It can be seen that, by means of tilting the reception slider 2 with regard to the positionally-fixed reading head 42, this is present, after the tilting procedure, on the handling end of the test strip 22, i.e. the magnetic reading head ~.~28Z~Ç~

has, during the tilting movement, passed over the whole of the part of the test strip 22 covered with a magnetic layer.
Fig. 4 shows the reception slider 2 and the measuxement unit 6 in the measurement position. The measurement shutter 58 lies in a defined manner on the measurement field 60 of the test strip, a pre-determined pressing-on pressure thereby being maintained via the pressure plate 46 and the spring element 48.
Fig. 5 shows schematically, in a greatly enlarged illustration, various phases of the movement of the contact surface 59 of the shutter 58 in the case of coming close to the test strip 22, this thereby forming a positionally fixed illustrated reference point. There can be seen a plasma-obtaining layer 51 on the base strip 29 o~ the test strip 22, lying full-facedly. Above this, there is present a covering layer, which is rectangular in plane view, constructed as a flap 62, only one edge 63 of which is attached to the base strip 29 (in the illustrated embodiment via the plasma-obtaining layer 61). In the movement phase illustrated in Fig. 5a, one edge o the contact surface 59 has just contacted the flap ;62 and begins to press this downwardly. In Fig. Sb, the flap 62 is present in a position shortly before it comes into contact with the plasma-obtaining layer ~L228Z46 61. In Fig. 5c, the contact surface 59 lies com-pletely on the flap 62 and this on the plasma-obtaining layer 61. It can be seen that the contact surface 59 perfonms a movement which is essentially composed of two component~, namely, a tilting move-ment and a movement in a direction parallel to the surface of the test strip 22 away from the fixing edge 63 of the flap 62. The tilting movement, has in the illustrations in Fig. 5, in which, as mentioned, the reference system moves with the te~t strip 22 so that this appears positionally fixed in the Figure, no fixed tilting axis. As i5 to be seen from the Figures, however, the tilting axis moves in the illustrated approaching phase in any case in the proximity of the fixing edge 63 of the flap 62 and runs substantially parallel to this. It thereby results that, in the last phase of the approach of the contact surface 59 to the flap 62, the pressure exerted by the contact surface 59 on the flap away from its fixing edge thus 9 in the illustration in Fig. 5, increases from left to right. In this way, air inclusions are avoided. It is thereby not harmful that, as is to be seen in Fig. 5a, at the commencement of the approach-ing phase, the contact surface 59 first contacts the flap 62 on the end remote from the fixing edge 63. The only thing which is decisive is that the described tilt-ing movement is realised in the last phase of the approaching (Fig. 5b, Fig. 5c).

~.~

~8~6 An even more uniform pressing of the flap 62again~t the plasma-obtaining layer 61 is achieved by the de~cribed movement components parallel to the surface of the test carrier in Fig. 5 from left to right.
The course of movement described with reference to Fig. 5 can be realised, in the case of a con-struction such as is illustrated in Fig~. 1 to 4, in that the pressure plate 46 and the measurement aperture elemenl 5~ are arranged relative to the radii ~Rl, R2) in each case crossing their middle, from the associated tilting axes 12 or 14, in appropriate manner, the momentary movement in the approaching phase thereby being determined not only by the tilt of the pressure plate 46 or of the measurement apertu~e element 58 to the ~adii in question but also by their distance from the tilting axis. Which arrangement is to be chosen in a partic-ular case can be detenmined with the help of the principles of gears by drawing or by optimisation experiments. A construction of the illustrated type w~ich has proved to be especially advantageous is one in which the pressure plate 46 continues substantially tangentially the curvature of the supporting surface 24 and in which the contact ~urface 59 of the measure-ment aperture 58 i~ ~o tilted ayainst the radiu~ (R2)crossing its middle from the associated tilting axis 14 is inclined that a vertical (L) runs on the , -2~-contact ~urface 59 on the side of the tilting axis 14 remote fr~m the reception slider 2.
Fig. 6 shows, on an enlarged scale, the lower part of the measuresnent unit 6 wqth the apelture element 58.
There i~ also to be seen a carrier 76 with a heating plate 78, which are parts of the pressure plate 46.
Between the heating plate 78 and the measurement 58 is to be seen the test strip 2~ with the te~t ~ield (consisting of the plasma-obtaining layer 61 and the flap 62), the test strip 22 thereby extend-ing vertically to the plane of the drawing. The heat-ing plate 78 i~ a part of a heating device which has a heating element 80. On the measurement aperture element 58 there is also arranged a heating plate 82 with heat-ing elements 84. It is especially advantageous that the pressure plate, even in the case of the phase illustrated in Fig. 3, i.e. as soon as the test strip 22 is gripped between the two holding means, is pressed from behind in the region of the test field 60 against the test strip 22. In this way, a pre-heat-ing is possible even in this phase and thus pos~ibly a comparatively long time before the measurement unit 6 with the measurement aperture 58 is pressed from the front side against the test field 60 (Fig. 4). In this way, a pretempering is po~sible, which may lead to a considerable saving of time.

,~.

Claims (17)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
1. An apparatus for the evaluation of a longitudi-nally extending, flexible test carrier for the analytical determination of components of a body fluid, the test carrier having an insertion end adapted to be inserted into the apparatus and a handling end serving for handling thereof, said apparatus having a measurement unit and a positioning means adapted to position and securely hold a test carrier in a measurement position in such a manner that its test field is present in a definite position with regard to the measurement unit, the positioning means including at least first and second holding means, said first holding means being adapted to firmly hold the test carrier close to its insertion end and said second holding means being adapted to firmly hold the test carrier close to its handling end, a supporting surface on which the test carrier is adapted to lie at least partly in its measure-ment position, and said positioning means including a tensioning element adapted to tension the test carrier in said measurement position along its longitudinal axis between the first and second holding means.
2. An apparatus according to claim 1, wherein each of said at least first and second holding means com-prises a fixing element.
3. An apparatus according to claim 2, wherein the fixing element is adapted to engage form-lockingly in a recess of the test carrier.
4. An apparatus according to claim 3, wherein the tensioning element is a spring element associated with one of the fixing elements by means of which the test carrier is tensioned in the direction of the longitudinal axis of the test carrier.
5. An apparatus according to claim 2, wherein said first holding means has a guiding element by means of which the insertion end of the test carrier, in the case of insertion, is guided into a definite position and the fixing element of said first holding means is coupled with an operating element which, in the case of insertion of the test carrier, is operable by the insertion end of the test carrier.
6. An apparatus according to claim 5, wherein the operating element includes a tiltable lever device which is tiltable between two end positions and engages with a spring element in such a manner that it is spring-loaded in a direction away from an apex between the two end positions.
7. An apparatus according to claim 1, wherein the supporting surface includes a pressure plate which is spring mounted in such a manner that it is adapted to be full-facedly pressed against the surface of the test carrier facing the supporting surface in the region of the test field against the test carrier.
8. An apparatus according to claim 7, wherein said pressure plate is a temperable plate.
9. An apparatus according to claim 1, wherein the supporting surface includes a region which is associated with the handling end of the test carrier, and wherein the supporting surface is, at least in said region, curved in such a manner that the handling end of the test carrier is a predetermined distance from the supporting surface in said region when the test carrier is only held by the holding means associated with its insertion end.
10. An apparatus according to claim 1, 2 or 3, wherein the positioning means is, in its totality, tiltable by means of a tilting drive about a tilt-ing axis, the supporting surface thereby being curved at least partly circularly about the tilting axis and having a slot extending in its longi-tudinal direction, which slot has dimensions such that a magnetic reading head securely mounted on the apparatus can contact the surface of the test carrier facing the supporting surface through the slot during the tilting movement.
11. An apparatus according to claim 1, for the evaluation of test carriers with a covering layer fixed in the manner of a flap on one edge of the test carrier, said apparatus comprising:
an aperture element with a contact surface adapted to press on the covering layer, at least one of the aperture element and the position-ing means being mounted and operable in such a manner that the contact surface in the last phase of approaching the covering layer is adapted to make relative to the test carrier, a tilting movement about a tilting axis which lies in close proximity to the fixing edge of the covering layer.
12. An apparatus according to claim 11, wherein the at least one of the aperture element and the positioning means is mounted and operable in such a manner that the contact surface performs, in the approaching phase, a movement which, apart from the tilting components, also has a component parallel to the surface of the test carrier away from the fixing edge.
13. An apparatus according to claim 11, wherein the aper-ture element is, in operation, a part connected with the measure-ment unit and the measurement unit is guided via a coupling mechanism and is drivable by the same drive as the positioning means.
14. An apparatus according to claim 13, wherein the coupling mechanism includes:
first and second interengaging toothed rims, the first rim being securely attached with the positioning means and the second rim being securely attached with the measurement unit, the first rim running circularly about the tilting axis and coaxially to the circularly running part of the reception surface, the measurement device being tiltably mounted about a tilting axis, the second rim running circularly about its tilting axis, and the pressure plate and the contact surface of the aperture element being oriented relative to the radius of the circle, described by the related toothed rims, crossing their middle, such that contact surface in the last phase of approaching the covering layer is adapted to make relative to the test carrier, a tilting movement about a tilting axis which lies in close proximity to the fixing edge of the covering layer.
15. An apparatus according to claim 13, wherein the coupling mechanism includes:
first and second interengaging toothed rims, the first rim being securely attached with the positioning means and the second rim being securely attached with the measurement unit, the first rim running circularly about the tilting axis and coaxially to the circularly running part of the reception surface, the measurement device being tiltably mounted about a tilting axis, the second rim running circularly about its tilting axis, and the pressure plate and the contact surface of the aperture element being oriented relative to the radius of the circle, described by the related toothed rims, crossing their middle, such that the contact surface performs, in the approaching phase, a movement which, apart from the tilting components, also has a component parallel to the surface of the test carrier away from the fixing edge.
16. An apparatus according to claim 14 or 15, wherein the contact surface is oriented to the radius, crossing its middle, of the circle described by the second toothed rim in such a manner that a vertical on the contact surface runs on the side remote from the positioning means of the tilting axis of the measurement device and the surface of the pressure plate facing the test carrier runs substantially tangentially to the curvature of the supporting sur-face.
17. An apparatus according to claim 14 or 15, wherein the second toothed rim has a smaller diameter than the first toothed rim.
CA000456657A 1983-06-16 1984-06-15 Apparatus for the evaluation of a test carrier for the analytical determination of components of a body fluid Expired CA1228246A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA000530520A CA1234707A (en) 1983-06-16 1987-02-24 Apparatus for the evaluation of a test carrier for the analytical determination of components of a body fluid

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DEP3321785.8 1983-06-16
DE3321785A DE3321785A1 (en) 1983-06-16 1983-06-16 DEVICE FOR POSITIONING AND HOLDING A TEST STRIP FOR OPTICAL-MEDICAL MEASUREMENTS

Related Child Applications (1)

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CA000530520A Division CA1234707A (en) 1983-06-16 1987-02-24 Apparatus for the evaluation of a test carrier for the analytical determination of components of a body fluid

Publications (1)

Publication Number Publication Date
CA1228246A true CA1228246A (en) 1987-10-20

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US (2) US4780283A (en)
EP (2) EP0129220B1 (en)
JP (1) JPS6014170A (en)
AT (2) ATE56274T1 (en)
AU (1) AU549333B2 (en)
CA (1) CA1228246A (en)
DD (1) DD222124A5 (en)
DE (3) DE3321785A1 (en)
DK (1) DK290384A (en)
ES (1) ES533482A0 (en)
HU (1) HU189912B (en)
ZA (1) ZA844491B (en)

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AU549333B2 (en) 1986-01-23
DD222124A5 (en) 1985-05-08
EP0129220B1 (en) 1990-09-05
JPH0423754B2 (en) 1992-04-23
HUT35851A (en) 1985-07-29
JPS6014170A (en) 1985-01-24
EP0371003A2 (en) 1990-05-30
US4780283A (en) 1988-10-25
DK290384A (en) 1984-12-17
EP0129220A3 (en) 1987-04-08
ES8503439A1 (en) 1985-03-01
DE3321785A1 (en) 1984-12-20
ATE83862T1 (en) 1993-01-15
ES533482A0 (en) 1985-03-01
EP0371003A3 (en) 1990-08-01
EP0129220A2 (en) 1984-12-27
ZA844491B (en) 1985-02-27
US4937050A (en) 1990-06-26
ATE56274T1 (en) 1990-09-15
HU189912B (en) 1986-08-28
EP0371003B1 (en) 1992-12-23
DE3486018D1 (en) 1993-02-04
DK290384D0 (en) 1984-06-13
AU2927684A (en) 1984-12-20
DE3483118D1 (en) 1990-10-11

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