DE10258016A1 - Diagnostic blood-sampling instrument with micro-needle, is self-contained, applies suction resiliently when sampling, and is transparent, to observe color change reaction - Google Patents

Abstract

The casing retains all components within it, apart from the injection needle (17). It deforms resiliently, to reduce the internal pressure in the collection chamber (7) for sampled fluid. The evaluation location (2) at least, is transparent. This enables observation of the optically-active reagent. The casing (1) has a support plate (12) for the needle, which is drawn inside when out of use, and only emerges for sample-taking. The plate is sterile and carries a film covering (5) which is pulled off for use. The plate is penetrable by the micro-needle. It comprises a soft, closed-pore material. Following penetration by the needle, and needle withdrawal back inside, it virtually re-seals against fluid. Further variants of the design, based on the foregoing principles, are also described.

Description

The invention relates to a diagnostic device

• - one Casing, which is a collection room for sample liquid contains
• - one Injection needle that opens into the sample liquid collection space,
• - one Line for Sample liquid, which is the gathering room for sample liquid connects to a reaction station at which there is at least one reagent, which is suitable, if necessary, with the sample liquid react, and
• - one Evaluation body that enables the user, if necessary, that Determine the presence of a reaction (preamble of the claim 1).

Such a diagnostic device is from the DE 4427725 C2 known. Here, blood sample is taken with an injection syringe and then forwarded via a line to a test device, where it is subjected to contact with reagents, in order to then indicate by a color reaction whether the sample taken is positive in the sense of the test or not. Chemical or biochemical reagents for this purpose are known in large quantities and do not form the subject of the invention. Rather, all known reagents, insofar as they are suitable for the test sequence, can be used in the diagnostic device according to the invention. Reagents for examining the presence of prostate cancer or malaria are particularly noteworthy, but especially a Borrelia infection, for example as a result of tick bites.

As is well known, Borrelia infections attack as a result of tick bites and bites. there typical reddening of the skin forms at the puncture site so-called erythema migrans. In many cases, however, this feature occurs just blurred and atypical, causing a borrelia infection at least initially not distinguish it from a mild infection can, which is common with tick bites occurs, but usually completely is harmless.

The body reacts through education of antibodies in the blood for a borrelia infection, so that this is detected in the blood can be. Unfortunately it takes a long time for these antibodies to be detected in the blood can, up to about 30 days. The result is that in the event of a borrelia attack treatment late uses that an excruciating Patients have to wait until there is certainty that an infestation has occurred or not, and that even unnecessary treatments respectively.

The infestation is proven through a blood test and is done by doctors or healthcare professionals carried out, because the necessary reagents are toxic, and also the handling with the possibly contaminated tip of the injection needle trained handling. Now there are many people who only then see a doctor if under no circumstances can it be avoided. That Lyme disease has already reached a difficult stage is accordingly difficult to treat and often leaves permanent damage, can be seen.

But if it were possible to design an "idiot-proof" test device, in addition, very early on could be used after detection of the tick bite, then would many people who have received a tick bite, not one Visit a medical facility. Such a test device would be e.g. for kindergartens, youth camps, Hunting households, hikers etc. suitable.

More or less automated devices are already known ( DE 3887491 T2 . DE 69117731 T2 . DE 69416828 T2 . DE 69421582 T2 . DE 69405866 T2 . DE 69131933 T2 . DE 19830405 A1 . DE 69117731 T2 . DE 694168208 T2 , the generic DE 4427725 C2 etc.), of which for example the generic DE 4427725 C2 shows a syringe immune system in which a blood sample is taken intravenously and then checked in an external hand-held analyzer.

The known facilities require however, all a medical professional for sampling and / or Sample evaluation, but are in part in individual practice e.g. operated by a country doctor.

The invention has two findings based on:

• - on the bite site is much earlier than anywhere in the bloodstream, no later than if there is a slight reddening there is already a formation of antibodies occurs in the body fluid present there, but probably only there, are already detectable.
• - Further should the use of a diagnostic device be so easy and safe, that no one has access unless they use brute force to have toxic reagents.

But this requires the body fluid in the field of bite and Stitch point can be removed.

In addition, the test reagents, the yes are toxic and the body fluid, which are infectious with the person carrying out the examination under no circumstances in contact come even if this makes gross mistakes.

This object is achieved according to the invention solved, that the generic diagnostic device mentioned above is further developed that the housing

• - the other parts of the device, the injection needle also takes up in its interior,
• - elastic is deformable to a negative pressure acting on the space for sample liquid manufacture, and
• - at least is transparent at the evaluation point in order to look at the to enable optically active reagent.

The device thus forms a hermetic closed unit, which, apart from the injection needle, from the elastic housing is surrounded. This unit is connected to the environment only once, if namely the housing at the start of the diagnosis pressed together and the air contained therein escapes. The reforming casing then sucks the sample liquid through the injection needle.

While it would be possible, the case at least to be carried out in two parts, about as a syringe housing and pistons, but this would be then when all equipment of the device is housed within the housing would, because of the too big Dimensions simply too bulky and too expensive. It would be too possible, the elastic housing already deformed to deliver, it is only after triggering a Reshape the locking device would, but it is questionable whether this deformed elastically over perhaps years casing its elasticity would be maintained by Not to mention the problems of locking.

The housing according to the invention therefore preferably has a check valve on that it allows that the in the housing contained air or that in the housing contained protective gas can escape when the housing is compressed.

Basically, the case could be like an enlarged hypodermic syringe be formed with a freely protruding needle which has the usual length. According to one Embodiment of the invention, however, it is preferred that the housing bearing surface has, which surrounds the injection needle and substantially extends perpendicular to this, and that the injection needle as Microneedle is formed.

"Microneedle" is understood here to mean a hollow needle, which is only a few millimeters long, essentially perpendicular to skin surface penetrates the skin and there in the subcutaneous area or close to it ends. The microneedle is therefore able to work in the immediate area the outside opening of the Stabbing the skin with a fluid sample refer to. The contact surface against the skin ensures that the puncture is essentially perpendicular to the surface of the skin and done exactly localized. The contact surface preferably has one round outer surface, in whose center the microneedle emerges from the contact surface, so that a simple but quite precise Positioning of the microneedle possible is.

The microneedle can be with a cap be covered before attaching and piercing the microneedle withdrawn from this and after pulling out the microneedle the skin is put back on. Here, however, it can be inexperienced and clumsy user may be injured with the needle tip. According to a further embodiment of the invention, it is therefore proposed that that the microneedle is in a position when the device is not in use Rest position is in which it is drawn into the housing, and only for Sampling from the contact area exit. The micro needle therefore occurs again after the sampling back to their rest position and becomes airtight again due to the elastic thickening Hole completed. An accidental flow of liquid is thus avoided.

So it doesn't have to be near the microneedle manipulated with a cap or the like, and after sampling the user does not have to pay any attention to the microneedle because them back into the device has moved in and can therefore no longer cause injuries.

There is another improvement in that the sterile contact surface with the outlet channel of the microneedle in the rest position when not in use by one Peel-off film is covered. The peel-off film ensures that the bearing surface remains sterile until the diagnostic device is used.

The microneedle that is only used when sampling from the contact surface emerges, can be guided in an outlet channel, the support plate constantly enforced. It is possible to make the support plate practically rigid.

According to an embodiment of the invention but it is advantageous that the platen is not completely rigid Material exists and are first pierced by the microneedle must if it is moved out of its rest position. So it will sterility inside the device ensured.

The platen is preferred made of a material that closes behind the microneedle when this has moved back to its rest position. Closing this piercing opening is largely liquid-tight, so no sample liquid, that could still emerge from the microneedle on the outside of the device can occur. Even if you use the device sterile cover of the contact surface the used device remains on the outside largely sterile and is in any case not with the sample liquid contaminated.

The microneedle could be connected at its distal end to a plunger, which it passes through and which is attached in the sample liquid collection chamber in a sealed but slidable manner. This would be the function reversal of an injection syringe. A simpler embodiment, however, consists in the fact that the microneedle is firmly connected to the walls of the collecting space for sample liquid, and that this collecting space is on the inside of the housing is sealed by an air-permeable but liquid-tight membrane, and that the collecting space can be moved so much by compressing the elastically deformable housing that the microneedle comes out of the rest position into a position in which it has fully emerged from the contact surface.

It is thus possible to have the contact area in the area to put on the tick bite site, precisely by light lateral Move to position and then press on the housing whose Wall due to the deformation that occurs on the walls of the collecting space suppressed, so that the microneedle firmly connected to it emerges from the contact surface and bores into the skin. The pressure exerted on the housing against the bearing surface presses the patient’s skin, ensures that the microneedle entirely penetrates the skin, and thus exactly in the intended Area. the vent of the housing takes place through the check valve already mentioned in its wall, the but sucking in outside air prevented when the housing seeks again because of its elasticity Starting position.

The compensation of the negative pressure can through the hollow needle, as far as a channel in the platen is provided or remains through which air enters the interior of the equipment can get if the housing pressed together and seeks to return to its original form. This channel in the platen is preferred by the microneedle stabbed when it extends for sampling and closes preferred again when the microneedle comes to rest.

Since the hollow needle after the withdrawal of the bearing surface can suck in free air, with the reshaping of the housing too the collecting space and thus the microneedle retracted again until this takes its rest position.

It is particularly advantageous that the walls of space for sample liquid are connected to the wall of the housing by traction means, so that when reshaping of the deformed housing the room can be pulled back to the rest position together with the microneedle are, even if the negative pressure in the housing, that on the outer bottom of the collecting area and is lower than that surrounding the device Atmospheric pressure, causes the collection area to be drawn in in the same direction. That is because the microneedle can be pulled back into the housing particularly quickly.

A locking device is preferred for this purpose provided the space for sample liquid and keeps the microneedle in its rest position. This locking device reliably holds the Collection room with the microneedle in the rest position, so not about the microneedle can accidentally come out.

When the housing is compressed exerted pressure on the collecting room, so that it reaches a second position with the microneedle in which the microneedle from the contact surface protrudes. The collecting space is also preferred in this “working position” by the latching device held so that this preferred two positions of the collection chamber keeps bistable.

The line can be designed as a channel be, but is preferably designed as a capillary membrane.

If the sample material mixture only promoted in the capillary then it remains essentially unchanged. However, since a separation of the Mixture of sample material, for example, according to the viscosity, makes sense according to the invention suggested that the capillary membrane be a strip of absorbent material, for example blotting paper, essentially inertly bonded to the housing securely through the casing extends. Spread in such a strip of absorbent material the individual components of the sample material mixture differ from, the length of the strip is essential. This is where processes take place like they do with diffusion. So the length of the Strip form an essential criterion, if for example components the sample material mixture required for diagnosis, so much earlier arrived at the evaluation site that the evaluation takes place before the portion of the sample material mixture to be examined by infiltration other portions diluted becomes. Essentially, there are carrier-bound ones along the fleece membrane Immunoadsorption techniques application. That way, one is special early Diagnosis possible, because it gets by with minimum quantities that are caused by the effect of the seepage strip, which the capillary membrane forms, regardless of the gravity of other liquid parts separately become. These processes in the capillary membrane are unhindered by the fact that they are in the casing securely fixed and possibly multiple or spiral over one certain distance becomes. The housing needed therefore appropriate dimensions if necessary.

The trained as a capillary membrane Line is preceded by a non-woven pad, preferably with a crystalline anticoagulant is wetted and for the lysis of solid components such as erythrocytes is suitable, is always independent of by adding reagent (buffer) the spatial Location of the device the promotion of the sample material mixture additionally for sure.

First, however, soak the sample material mixture preferably a non-woven sheet that feeds the capillary membrane mentioned, leakage from the microneedle is at least difficult and ensures that even if the collection chamber is not completely filled should, enough Sample material mixture for the diagnosis is provided and placed in the capillary membrane becomes.

The fleece plate, however, takes on the sealing of the collection chamber when in this contains a container for a reaction medium for carrying out the diagnosis, which is preferably only released from the sample material mixture, which for this purpose dissolves a cover or sealing layer.

As a container for the chemical and / or biological Reagent can also be a container for a buffer / dilution reagent at the end of the line be attached with a methacrylic copolymer seal that can be destroyed by the sample material mixture, the container which has a check valve preferably consisting of thin hard plastic, surrounded by a sealing, integrated silicone layer for Prevent premature fluid leakage owns, depending of the sealing thickness opens after a few minutes. The sample-induced opening of the check cap causes the liquids to leak and mix. The mechanical Check cap tension is to the interior of the container directed. The pH-dependent transition from solid to liquid the methacrylic copolymer is well known. Just before this container the line crosses the evaluation point at which a reagent is present when in contact with the sample material mixture and brought the activation reagent, optionally shows a color reaction. The fleece stretch between the start of the immunological reaction and the evaluation site is chosen to be a response between the sample material mixture consisting of sample liquid and preferably buffer reagent, and activation reagent on the Capillary membrane considered and optionally shows a color reaction. It is also possible to have two To provide reagents and two containers one at each end of the capillary strip.

The type of discoloration at the evaluation site can indicate whether a positive result is present or not. However, if, for example, there is no discoloration if the result is negative, it is proposed according to a further development of the invention that a further evaluation point in the vicinity of the first one is crossed by the line and contains a reagent which indicates by color reaction whether the sample material mixture or the sample liquid and the activation reagent is present, regardless of whether the first evaluation site shows a color reaction or not. This further evaluation point should be as close as possible to the first in order to avoid false reports as far as possible. At the end of the fleece membrane there is possibly a further container which, if the ummunchromatographic examination requires it, should enable two-way chromatography. ( DE 694 16 828 T2 )

The housing can have any shape have as far as a contact surface is available. However, it has proven to be particularly expedient that the housing is essentially hemispherical, the platen with the platen being circular and the microneedle is arranged centrally to this. The hemisphere may be easy to enclose by hand and closes hence the touch the microneedle.

If the inside of the housing Stretches are not sufficient, a side, hollow protuberance can Recording of the line and the evaluation point (s) on the hemispherical casing be scheduled. This protuberance can also be used as a handle for any contaminated bearing surface is far away.

At the evaluation point (s) as well as on the collection chamber can or can be in an opaque housing wall Windows are used to observe the color reaction (s) enable. To In one embodiment of the invention, however, it is preferred that the housing wall, unless they're for the view of the evaluation point (s) is transparent as a carrier for inscriptions and images is formed. For example, Comparison swatches to make it easier diagnosis or an expiry date.

The subject of a favorite embodiment the invention is illustrated in the accompanying schematic Drawing closer explained. In these show:

1 the embodiment of the diagnostic device according to the invention in perspective, cut open and obliquely from below,

2 a detail of another diagnostic device similar to that of the 1 schematically and in cross section, and

3 a detail similar 2 , but in one embodiment of the diagnostic device that the 1 similar.

1 shows a hemispherical, closed housing made of a transparent, durable, elastic, largely inert to the materials used and occurring in the environment. For example, there is a hemisphere shell with a bottom 13 welded, on the outside a flat contact surface 12 forms ( 2 and 3 ). The contact surface 12 is from a sterile, removable cover sheet 5 covered.

The floor 13 is relatively stiff compared to the hemisphere shell. It has a cylindrical thickening projecting into the center of the hemisphere 15 by a blind hole 14 is penetrated, which is essentially perpendicular to the support surface 12 extends, but not completely penetrated the platen.

There is a non-return valve in the wall of the hemisphere 9 that the air or the protective gas inside the hemispherical housing 1 can leak when the housing 1 is compressed but no more air in it Interior of the case 1 lets come. In the compressed, but pressure-free housing 1 therefore, when its walls expand again, there is a strong negative pressure.

In the housing 1 there is an essentially cylindrical collecting chamber 7 in front, one end of which is made of a gas-permeable but liquid-tight membrane 18 and the other end through a chamber floor 16 is closed, which is made in one piece with the cylinder jacket-shaped collecting chamber wall made of rigid, inert plastic.

This floor 16 is from a microneedle 17 interspersed, one end of which is sharpened and the other end of which has a flange on the inner surface of the bottom 16 is glued on while the shaft of the microneedle 17 the ground 16 interspersed and movable in the bore 14 rests. There is a fleece plate between the flange and the interior of the collecting chamber 23 , ( 2 ) On the ground 16 the collection chamber 7 there is a fleece plate 23 that the top opening of the microneedle 17 towards the interior of the collection chamber 7 covers.

On the outside of the cylindrical wall of the collection chamber 7 are ledges 19 formed.

On the ground 13 of the housing are middle and projecting inside two disc springs 8th made of plastic, the larger of which has a central opening, that of the collecting chamber 7 light and their outer projections 19 is permeated with resistance. These outside ledges 19 sit on the smaller of the disc springs 8th on.

The smaller disc spring has openings through which a capillary strip 6 can pass through on the fleece plate 23 takes its exit. This capillary strip is described in more detail below.

When assembling the diagnostic device, the unit is first removed from the collection chamber 7 that with the gas permeable membrane 18 is locked, and the microneedle 17 in the hole 14 inserted: another press on the collecting chamber 7 causes this with the outer protrusions 19 between the two disc springs 8th to get that on the floor 13 are attached at least in places. So is the microneedle 17 held in a position where the tip of the microneedle 17 still inside the hole 14 located.

Will be after welding the hemisphere on the floor 13 and putting it on with the contact surface 12 of a subject squeezed this hemisphere shell, the air or the protective gas in the housing escapes at least partially through the check valve 9 until the hemisphere shell against the collecting clip 7 rests. Another strong pressure presses the contact surface 12 firmly against the subject's skin and causes the collection chamber 7 , against the force of the smaller disc spring 8th to be pressed against the floor until the chamber floor 16 on the thickening of the soil 13 seated. The tip of the hollow needle pierces the bottom of the blind hole 14 and penetrates the subject's skin by a predetermined, shallow depth. The smaller disc spring 8th is here with the outer ledge 19 overcome and the collection chamber 7 snaps below the smaller plate spring 8th on.

Now the housing 1 released, it tries to deform back. At the same time, a thread is pulling 10 which is the collection chamber 7 with the hemispherical shell of the housing 1 connects the collection chamber 7 back into the case 1 back. During this reshaping of the housing 1 This creates a strong negative pressure, the sample liquid initially from the puncture site and then from the hollow microneedle 17 into the collection chamber 7 sucks. In the course of further reshaping by the needle 17 air is sucked in until this is prevented by the support plate, which closes again after the microneedle has been withdrawn. Thus, the used housing always remains a little deformed at this point, so that the device is easily recognizable as used.

With the collection chamber 7 stands the end of a strip-shaped channel 6 in connection, which emerges from this laterally, arched through the housing 1 swings and on the other hand on this near the ground 13 ends.

The channel 6 is made of a strip of absorbent material, such as fire-extinguishing paper, and penetrates between one of the disc springs 8th and the floor 13 the from the disc springs 8th formed locking device without part of the plate springs 8th to touch. Also the check valve 9 and the thread 10 are from the channel 6 not touched.

The channel 6 takes over the transport of the liquid from the collection chamber by capillary action 7 , and largely independent of the pressure conditions prevailing in the housing.

When executing the 2 the channel ends 6 in on a membrane, not shown here, which is a container 4 for a reactant. If the sample liquid or a portion of it has reached this membrane, which consists, for example, of a pH-dependent polymer material, then it dissolves it at least to the extent that the contents of the container 4 , for example antihumaglobulin fluid with the addition of other stabilizing substances, leak out the end of the channel 6 wet and yourself, from the container 4 spreading out, with which sample liquid can intimately mix.

Just before the container 4 there are two evaluation points in the channel 2 . 3 arranged, namely, from the container 4 outgoing, first an evaluation office 3 for the negative control, which indicates by color reaction that a sample material mixture, including consisting of free unbound colloidal gold particle-labeled specific peptides, is present and an evaluation office 2 by color reaction the output of the reaction between the sample liquid, the contents of the container 4 and shows a reagent at the evaluation site 2 is present, for example a specific antigen-antibody complex for the detection of IgG and IgM antibodies against Borrelia burgdorferi.

Located at both evaluation points 2 . 3 if there is a color reaction, the test is positive. Is only at the evaluation point 3 if there is a color reaction, the test is negative. If there is no color reaction, the test must be repeated with another device.

It is expressly mentioned that the device according to the invention can be used not only for the Borrelia test, but also for other tests for which the presence of a small amount of body fluid from the subcutaneous connective tissue is necessary and sufficient, which is simple by means of a color reaction can be investigated, for example, drug screening as part of traffic monitoring, PSA screening, pregnancy tests, malaria examination, etc. This device allows the use of existing and long-known tests, but also enables the development of future tests and thus provides a universal tool for the Diagnostics that can be used successfully even by completely inexperienced people based on the instructions on the case 1 are printed.

In the embodiment of the 3 is the container 21 for the reactant within the collection chamber 7 and at the beginning of the streak 6 , The container 21 points to the interior of the collection chamber 7 towards a non-return flap valve 22 that is tightly closed, but can be opened using the sample liquid.

You can also use both reagent chambers 4 and 21 be provided (e.g. in 1 ).

The hemispherical housing made of polyethylene compound can only have a diameter of about 2.5 cm. The collection chamber 7 consists of hard plastic. The fleece plate is white, so that it can be observed through the housing when enough sample liquid is sucked in and the fleece plate 23 has discolored accordingly. The amount of aspiration can only be about 30 to 50 microliters.

The container 21 contains 200 to 300 microliters of commercially available buffer solution, such as phosphate buffer.

The test for the presence of Borrelia antibodies is known. A purple band in the control window shows the correct one Test sequence shows, such a discoloration in the test window shows the presence of Borrelia antibodies. If no discoloration the experiment must be repeated.

All trials and tests with the diagnostic device according to the invention can be carried out known. The relevant publications are the person skilled in the art known.

1

casing

2

evaluation Unit

3

second evaluation Unit

4

container

5

cover

6

channel

7

plenum

8th

Disc springs

9

check valve

10

traction means

12

bearing surface

13

ground

14

drilling

15

thickening

16

chamber floor

17

microneedle

18

gas permeable membrane

19

facing projection

21

chamber for activation reagent

22

check valve

23

fleece floor

Claims (27)

Diagnostic device with a housing ( 1 ) which is a collection room ( 7 ) for sample liquid, an injection needle ( 17 ) in the collection room ( 7 ) for sample liquid, a line ( 6 ) for sample liquid covering the collecting space ( 7 ) for sample liquid connects to a reaction station at which there is at least one reagent which is suitable for reacting with the sample liquid if necessary, and an evaluation point ( 2 ), which enables the user to determine if there is a reaction, characterized in that the housing ( 1 ) the other parts of the device, from the injection needle ( 17 ) apart from that, constantly accommodates in its interior, is elastically deformable, in order to get onto the collecting space ( 7 ) produce negative pressure acting on the test liquid, and at least at the evaluation point ( 2 ) is transparent to allow a view of the optically active reagent. Diagnostic device according to claim 1, characterized in that the housing ( 1 ) has a support plate, which the injection needle ( 17 ) surrounds and extends essentially perpendicular to it, and that the injection needle as a microneedle ( 17 ) is trained. Diagnostic device according to claim 2, characterized in that the microneedle ( 17 ) are in a rest position when the device is not in use det in the housing ( 1 ) has moved in, and only for taking samples from the support plate with the support surface ( 12 ) exit. Diagnostic device according to claim 3, characterized in that the bearing surface ( 12 ) the support plate is sterile and has a peel-off film before use ( 5 ) is covered. Diagnostic device according to one of claims 3 or 4, characterized in that the support plate from the emerging microneedle ( 17 ) can be drilled through. Diagnostic device according to claim 5, characterized in that the support plate consists of a material, preferably a soft, closed-pore material, of which the microneedle ( 17 ) drilled outlet channel after retracting the microneedle ( 17 ) closes again at least largely liquid-tight. Diagnostic device according to one of claims 3 to 6, characterized in that the microneedle ( 17 ) with the walls of the collecting room ( 7 ) for the test liquid, that this collecting space ( 7 ) to the inside of the housing ( 1 ) is sealed by an air-permeable but liquid-tight membrane, and that the collecting space ( 7 ) by compressing the elastically deformable housing ( 1 ) is so movable that the microneedle ( 17 ) comes from the rest position into a position in which it is fully out of the contact surface ( 12 ) has emerged. Diagnostic device according to claim 7, characterized in that the floor of the collecting space ( 7 ) of an absorbent, air-permeable material ( 23 ) into which the microneedle ( 17 ) flows into. Diagnostic device according to claim 8, characterized in that the walls of the collecting space ( 7 ) for test liquid by traction means ( 10 ) with the wall of the housing ( 1 ) are connected so that when the deformed housing is deformed back ( 1 ) the collecting room ( 7 ) together with the microneedle ( 17 ) can be pulled back into the rest position. Diagnostic device according to one of claims 7 to 9, characterized in that a latching or holding device ( 8th ) is provided, which the collection room ( 7 ) for sample liquid and thus the microneedle ( 17 ) holds in its rest position. Diagnostic device according to one of claims 7 to 10, characterized in that a latching or holding device ( 8th respectively. 15 ) is provided, which the collection room ( 7 ) for sample liquid and thus the microneedle ( 17 ) holds in their extended position. Diagnostic device according to one of claims 1 to 11, characterized in that the line as a capillary membrane ( 6 ) which is attached to a fleece cushion (fleece bottom) ( 23 ) is connected, which can preferably be used for the lysis of erythrocytes and is wetted with a crystalline anticoagulant. Diagnostic device according to claim 12, characterized in that the capillary membrane as a strip ( 6 ) made of absorbent material, preferably blotting paper or a similar material, essentially fixed on one side by the housing ( 1 ) extends. Diagnostic device according to claims 10 or 11 and 13, characterized in that the holding device ( 8th ) Has recesses that extend from the strip ( 6 ) is passed through unhindered, at least in the rest position of the microneedle ( 17 ). Diagnostic device according to one of claims 1 to 14, characterized in that the line ( 6 ) a container ( 4 ; 21 ) is assigned for an activation reagent. Diagnostic device according to claim 15, characterized in that the container ( 4 ) at the end of the line ( 6 ) is arranged. Diagnostic device according to claim 15, characterized in that the container ( 21 ) at the beginning of the line within the collecting room ( 7 ) is arranged. Diagnostic device according to one of claims 16 or 17, characterized in that the container ( 4 ) is provided with a cover that can be destroyed by the sample liquid. Diagnostic device according to one of claims 16 or 17, characterized in that the container ( 21 ) with a valve, preferably a check valve ( 22 ) is provided. Diagnostic device according to claim 19, characterized in that the check valve ( 22 ) has a valve body which is held in its closed position by a holder which can be destroyed by the sample liquid. Diagnostic device according to one of claims 1 to 20, characterized in that the line ( 6 ) the evaluation office ( 2 ) at which a reagent is present which, if brought into contact with the sample liquid and the activating agent, may show a color reaction. Diagnostic device according to claim 21, characterized in that at the beginning of the fleece bottom (fleece cushion) ( 23 ) and at the end of the line ( 6 ) a container ( 4 respectively. 21 ) is attached for a reagent, with a seal which can be destroyed by the sample liquid or sample material liquid and which in turn opens an opening of a non-return valve ( 22 ) and that the line ( 6 ) just before the distal container ( 4 ) the evaluation office ( 2 ) at which an activation reagent, antigen or antibody-specific peptide binding site and sample material mixture is present, which preferably indicates specific antibodies or antigens if necessary by a color reaction when an antigen-antibody complex is present. Diagnostic device according to claim 21 or 22, characterized in that a further evaluation point ( 3 ) near the first ( 2 ), preferably between these ( 2 ) and the container ( 4 ; 21 ), from the management ( 6 ) is crossed or touched and contains a reagent that indicates by color reaction whether the sample liquid or the sample liquid and the activation reagent is present, regardless of whether the first evaluation point ( 2 ) shows a color reaction or not. Diagnostic device according to one of claims 21 to 23, characterized in that a further evaluation point ( 3 ) near the first ( 2 ), preferably between these ( 2 ) and the distal container ( 4 ), from the management ( 6 ) is crossed or touched at which there is a sample material mixture, antihuman globulin or antihuman antigen-specific peptide binding site and activation reagent that indicates a color reaction in the absence of specific antibodies or specific antigen in the sample liquid, regardless of whether the first evaluation site ( 2 ) shows a color reaction or not. Diagnostic device according to one of claims 2 to 24, characterized in that the housing ( 1 ) is essentially hemispherical, the support plate with the support surface ( 12 ) is circular and the microneedle ( 17 ) is arranged centrally to this. Diagnostic device according to claim 25, characterized in that a lateral, hollow protuberance for receiving the line ( 6 ) and the evaluation office (s) ( 2 . 3 ) on the hemispherical housing ( 1 ) is scheduled. Diagnostic device according to one of claims 1 to 26, characterized in that the housing wall, insofar as it is not for the view of the evaluation point (s) ( 2 . 3 ) or the transparent collection chamber ( 7 ) must remain transparent, is designed as a carrier for inscriptions and illustrations.