WO2001036099A1

WO2001036099A1 - Disposable test device

Info

Publication number: WO2001036099A1
Application number: PCT/AT2000/000301
Authority: WO
Inventors: Christa Poiger; Krista Fiala; Josef Kachelmeier; Josef Pucher
Original assignee: Dipro Diagnostics Handels Gmbh
Priority date: 1999-11-15
Filing date: 2000-11-14
Publication date: 2001-05-25
Also published as: AU1371401A; AT4305U1

Abstract

The invention relates to a disposable test device, in particular for detecting the presence of solid substances or substances containing solid matter, for example drugs. Said device is characterised by a detection device (1) comprising a receiving end (14) for the substance to be analysed. The detection device (1) contains or has at least one corresponding indicator substance and a cover or closure device (2) which can be connected to the detection device (1) after the substance to be analysed has been deposited in the receiving end. A solvent or mobile solvent for the substance to be analysed can be released in the cover or closure device during the connection of the latter to the detection device (1), thus enabling a simple and reliable detection, even of solid or poorly soluble substances.

Description

TEST DEVICE FOR A ONE-WAY TEST

The present invention relates to a test device for a disposable test, in particular for the detection of substances or substances containing solids, such as drugs.

For rapid tests or disposable tests of liquid substances, differently designed, strip-like test elements are known, which are impregnated with corresponding re-coating substances and with which a first test evaluation regarding the ingredients of the sample or first test results regarding the possibly suspected presence of a by immersion in a liquid sample Ingredient can be performed. Such training is known for example from DE-A 198 06 291. A corresponding preliminary analysis is generally to be carried out for analyzes of liquid samples, it being immediately apparent that, in some cases, complex laboratory facilities are sometimes only available at a few locations or at a few institutions.

While a large number of test devices for the detection of ingredients in liquid samples are known and on the market, in particular a check or detection of solid substances or substances containing solids is mostly significantly more complex and difficult to carry out at almost any location, since known detection elements or Test devices are not directly available for such solids or substances containing solids. It can therefore be attempted to dissolve the solids or substances containing solids in suitable solvents in a liquid sample to obtain, which can be examined or checked with known test devices for liquid samples if necessary. It is immediately clear that such a preparation of a liquid sample is usually not easy or can only be carried out under difficult conditions or local conditions.

The aim of the present invention is to provide a test device for a disposable test, in particular for the detection of substances that contain solids or substances, such as drugs, for example check existing ingredients.

To achieve this object, a test device of the type mentioned at the outset is essentially characterized by a detection device with a receiving end for the substance to be examined, the detection device containing or having at least one corresponding detection substance, and one with the detection device after receiving the substance to be examined on Receiving end connectable cover or closure device in which a solvent or eluent for the substance to be investigated can be released when connected to the detection device. Because the detection device according to the invention is provided with a receiving end for the substance to be investigated, corresponding detection substances or at least one detection substance for special purposes can be safely and reliably accommodated in the detection device, it being proposed according to the invention that the substance to be examined which for example formed by a powdery solid is to take up or apply at the end of the detection device. Furthermore, according to the invention, a cover or closure device that can be connected to the detection device is provided, in which a solvent or eluent for the substance to be investigated is directly contained, and when the detection device is connected to the cover or closure device, that directly inside the solvent or eluent taken up in the covering or sealing device is released, so that the powdered solid, for example powdery solid, taken up at the receiving end of the detection device of the test device according to the invention is dissolved in the solvent free of environmental influences and accordingly protected, whereupon the solution with the dissolved Solid penetrates into the interior of the detection device and reacts with at least one detection substance contained therein, or a determination of solids or constituents thereof is possible. Naturally, viscous or liquid substances to be examined can also be absorbed at the receiving end, whereupon after closing the covering or closing device and simultaneously releasing the solvent or eluent, any further loosening of the substance to be examined or a reliable introduction thereof into the detection device succeeds, in cooperation with the detection substances contained therein, to carry out a check or examination and to assign the substance to be examined.

Such a test device according to the invention can be made correspondingly small and thus easy to handle and available, so that without much effort Checking substances, such as drugs, for example, which are present in solid form, is possible.

For a proper introduction of the substance to be examined into the interior of the detection device, in which at least one detection substance is contained, it is provided according to a preferred embodiment of the test device that the detection device has at least one strip-like element in its interior, which has at least one detection substance, wherein the strip-like element protrudes from the detection device at the receiving end or is in contact with a receiving element arranged at the receiving end. Such strip-like elements can be known per se from use in connection with the checking of liquid samples and, by taking up the substance to be examined at the projecting end or by contacting a corresponding receiving element, ensure that the substance to be examined is safely introduced into the interior of the Test device safe. Such a recording element can be detachably provided at the recording end of the detection device, for example, or different, appropriately designed recording elements can be provided when used in connection with different substances to be detected. In this context, it is provided according to a preferred embodiment that the receiving element from a sponge or the like. is formed, with such a receiving element, for example, pulverulent substances being appropriately absorbed in the pores, in order to then, in cooperation with the action of the running agent or solvent contained in the covering or closing device and to be released, a proper transport of the substance to be examined in the Interior of the test device or the detection device thereof is possible.

If strip-like elements are provided for the detection device, the strip-like elements for the subsequent, reliable identification of the substance to be detected must be formed by immersing or taking up a solvent or eluent from a material that is suitable for a liquid absorption and thus possibly relatively soft his. To damage such a strip-like element or a plurality of essentially side-by-side, strip-like elements of the detection device when receiving the substance to be examined and / or during subsequent introduction into the cover or closure device for receiving the liquid Laufbzw. To avoid solvents, it is proposed according to a further preferred embodiment that the end of the strip-like element (s) protruding from the detection device is on a side surface on a support or. Support pad is in particular made of a reinforced or more rigid material compared to the strip-like elements. Such a support or support underlay ensures a corresponding resistance of the strip-like elements, the support or support underlays also a subsequent, reliable introduction into the cover or closure device without damaging the strip-like element or elements (e) is achievable. It is preferably provided that the support or support base is made of a material that is reinforced or, in particular, more rigid than the strip-shaped elements. For simple handling and proper connection of the individual elements of the test device according to the invention, in particular for releasing the liquid solvent or solvent, it is proposed according to a further preferred embodiment that the covering or closing device is formed by a cap-like element which is sealingly connectable to the detection device at the receiving end and which has, in the interior, a storage space, for example closed off by an open membrane, for receiving the barrel or Has solvent. In a cap-like element of this type, a correspondingly large amount of the liquid eluent or solvent can also be reliably taken up, so that any larger amounts of a solid to be examined, if present, can also be reliably dissolved and subsequently analyzed.

Since the barrel or solvent contained in the cover or closure device may only be released when it is completely connected or latched to the detection device, it can be assumed that only a corresponding partial volume of the cover or closure device with the barrel or Solvent is filled. In order to enable a simple check of the integrity of the cover or closure elements before putting on or assembling with the detection device, provision can furthermore be made for the cover or closure device to have an additional sealing film at its free end, as is further the case corresponds to the preferred embodiment of the test device according to the invention. Such a sealing film is easy to insert or fix the cover or closure device on the detection device and in particular at the end of the recording the same can be removed, so that if the sealing foil is intact, it can be assumed that the solvent or solvent taken up inside the covering or sealing device is ready for use and, for example, not contaminated.

For a simple and reliable sealing after fixing the cover or closure device on the detection device, it is provided according to a further preferred embodiment that the detection device and the cover or closure device with mutually complementary profiles or contours for a positive connection and locking of the Have cover or closure device on the detection device, such complementary profiles can be formed in a simple manner by corresponding hook-like projections and corresponding recesses or bayonet-like closure elements. In this context, it is proposed according to a further preferred embodiment that the detection device can be locked with a separate closure cap. Through such permanent or permanent removal of a separate end cap on the detection device, the results obtained in the test device can be kept under lock and key, for example for later proof procedures, without, for example, a subsequent change of the test result being possible if a particularly dry or after the test has been carried out, a separate closure cap containing no supplementary substance is fixed to the detection device instead of the cover or closure device and thus enables the test result to be stored in a sealed manner without subsequent falsification. When using disposable tests or rapid tests, an essential criterion is that a first statement as quickly as possible, for example about the presence of an ingredient in a sample, is possible or that information about approximate concentrations of a sample examined is obtained quickly, for example by Use of color indicators becomes possible. In this context, it is proposed for the test device according to the invention in accordance with a further preferred embodiment that the detection device is designed with at least one display element and / or viewing window, in particular sealed to the inside of the detection device, for displaying the result of the examined substance, so that by providing a display element and / or viewing window in which, for example, color changes or color indicators, after introduction of the, in particular solid, substances dissolved in the solvent or solvent, which react with the detection substances contained in the detection device, make it possible to make a statement about the sample to be examined.

In a correspondingly simple embodiment, the test device according to the invention can be designed in such a way that the detection device is designed with a receiving element, so that, if necessary, different test devices which respond to different substances can be used or, in the case of combination tests, rapid statements about the presence of at least one ingredient from a group of ingredients is possible. According to a preferred embodiment, however, it is proposed that a plurality of strip-like elements be juxtaposed in the detection Device is recorded and that the streak-like elements contain different detection substances or different concentrations thereof, so that with such a plurality of strip-like elements which contain different detection substances or different concentrations thereof, in a single test procedure and after recording a single sample on a common one End of the test device after placing a common cover or closure element, an examination of the sample for different ingredients can be carried out.

In order to be able to reliably demonstrate or check the functionality of the test device according to the invention during use, even after a possibly longer storage period, the invention preferably further provides that at least one indicator for indicating the functionality of the test device is provided in the detection device, such an indicator according to Penetration of the substance to be examined dissolved in the solvent or solvent enables a reliable statement that the detection substances contained in the test device have retained their effectiveness.

The invention is explained in more detail below with reference to exemplary embodiments schematically illustrated in the accompanying drawing. In this show:

1 shows a schematic illustration of a first embodiment of the test device according to the invention, FIG. 1a showing a detection device with a strip-like element protruding from the receiving end, and FIG. 1b showing a covering or closing device that can be connected to the receiving end of the detection device; FIG. 2 shows the test device shown in FIG. 1 while the cover or closure device is being placed or fixed on the detection device;

3 shows a modified embodiment of a test device according to the invention, FIG. 3a again showing a detection device and FIG. 3b a cap-like covering or closing device; and

4 shows a further modified embodiment of a test device according to the invention with a plurality of strip-like elements, FIG. 4a a schematic top view, partly in section, of the detection device and FIG. 4b a sectional view of a cover or connection device that can be connected to the detection device of FIG Shows closure device; and FIG. 5 shows a further modified embodiment of a test device according to the invention with a plurality of strip-like elements which are supported at their projecting end by a support pad, similar to the illustration according to FIG. 4, FIG. 5a, a schematic plan view, partly in section, of the Detection device and FIG. 5b shows a sectional illustration of a cover or closure device that can be connected to the detection device of FIG. 5a.

1 and 2 it can be seen that a test device consists of a detection device 1 and a cap-like cover or closure device 2, in this embodiment a strip-like element 3 is accommodated in the detection device 1, which at the end of the Detection device 1 from the

Detection device 1 protrudes. Due to the projecting end of the strip-like element, the tip 4 of a surface 5 shown schematically in FIG. for example powder-like substance 6, whereupon after putting on the cap or the cap-like covering or Closure device 2 the tip 4 of the strip-shaped element penetrates into a storage space 7 for a running or solvent, the cap-like cover or. Closure device 2 is held on the detection device 1 by means of profiles 8 schematically indicated in FIGS. 1 and 2. When the cap 2 is completely pushed onto the detection device 1, the running solvent or solvent contained in the storage space 7 is released and causes a corresponding release of the substance absorbed by the protruding end of the strip-shaped element 3, which along the strip-like element 3 into the Penetrates inside the detection device 1.

At least one viewing window or display element 9 is provided in the detection device 1, sealingly against the interior of the detection device 1, a test line and a test line being visible, for example, in the area of the viewing field or display window 9 with the aid of an indicator for indicating the functionality of the test device, while A display image for special ingredients to be determined is recorded in a pattern field 10.

For a more extensive and reliable protection of the interior of the cap-like cover or closure device and in particular of the storage space 7 filled with the barrel or solvent, a sealing film 11 is additionally indicated in FIG. 1b, which can be removed immediately before the cap 2 is put on and accordingly enables a check of the intact content of the cap 2. FIG. 3 shows an embodiment modified from the embodiment according to FIGS. 1 and 2, a strip-like element 3 being provided in an elongated detection device, on the free end of which a substance to be examined can be taken up. After the cap-like covering or closing device 2 shown in FIG. 3b has been put on, a running agent or solvent contained in the inside of the closing device 2 is again released from the storage space 7, after which, in the visible or pattern fields 9 and 10, a proof is again provided of corresponding substances can be achieved easily and quickly. The display or sample fields 9 and 10 are in turn sealed accordingly with respect to the interior of the detection device 1, so that after the cap 2 has been fixed, the test results can also be reliably detected over longer periods of time. The profiling, again indicated by 8, for the fixing of the cap-like covering or closing device can be designed in such a way that a non-destructive detachment of the cap from the detection device 1 is not possible, so that a corresponding detection regarding the in ingredients contained in the sample succeed.

In Fig. 3a, a cap-like protective element for the detection device 1 is also indicated schematically at 16.

In the embodiment according to FIG. 4, a plate-like or flat detection device 12 is provided, in which a plurality of strip-like elements, again designated by 3, are contained. While in the embodiments according to FIGS. 1 to 3 a strip protruding from the detection device 1 at the receiving end of the detection device 1, a sponge-like receiving element 13 is provided in the embodiment according to FIG. 4 at the receiving end, with which, for example, again by painting over a surface having the substance to be examined, the powdery substance of the sponge-like receiving element 13 is received, the sponge-like element being contacted with the strip-like elements provided in the interior of the detection device 12, which are impregnated with or contain different detection substances. After the substance to be investigated has been taken up by the receiving element 13, a correspondingly adapted, cap-like cover or closure device 14 is placed, which is shown schematically in FIG. 4b, with a storage space in the interior of the cap-like cover or closure device 14 15 is provided for a running or solvent.

With the design shown in FIG. 4, a plurality of different ingredients can thus be achieved at the same time by providing different detection substances on the strip-like elements, with corresponding display or viewing windows being provided for this purpose, which are not shown in FIG. 4 for the sake of clarity are.

FIG. 5 shows a further modified embodiment, the detection device 12 again having a plurality of strip-like elements 3 which protrude from the detection device 12. In the area of the projecting ends 4, a support or support base 17 is provided on one side of the strip-like elements 3. see, this support pad 17 is made of a reinforced or more rigid material than the strip-like elements 3. The support pad 17 reliably damages, for example kinking, the projecting ends 4 of the strip-like elements 3 during the absorption of the substance to be detected and / or when it is introduced into the cap-like cover or closure device, again designated by 14, in particular if it penetrates into the Storage space 15 for a solvent or solvent is prevented.

5a, corresponding display or viewing windows 18 are also indicated in the area of the individual, strip-like elements 3.

After the test has been carried out, a correspondingly shaped, separate protective cap can be permanently attached to the detection device 1 or 12 for storage or safekeeping instead of the respective cover or closure devices 2 or 14.

Claims

Patent claims

1. Test device for a disposable test, in particular for the detection of substances or substances containing solids, such as drugs, characterized by a detection device (1, 12) with a receiving end (4, 13) for the substance (6) to be examined, whereby the detection device contains or has at least one corresponding detection substance (1, 12), and a cover or cover which can be connected to the detection device (1, 12) after the substance to be examined is picked up at the receiving end (4, 13) Closure device (2, 14) in which a solvent or eluent for the substance to be examined can be released when connected to the detection device (1, 12).

2. Test device according to claim 1, characterized in that the detection device (1, 12) has in its interior at least one strip-like element (3) which contains at least one detection substance, the strip-like element (3) from the detection device at the receiving end (4 ) protrudes or is in contact with a recording element (13) arranged at the end of the recording.

3. Test device according to claim 2, characterized in that the receiving element (13) of a sponge or the like. is formed.

4. Test device according to claim 1, 2 or 3, characterized in that the end (4) of the strip-like element (3) protruding from the detection device (12) protrudes on a side surface on a support or support underlay (16) in particular from a striped like elements (3) reinforced or more rigid material is stored.

5. Test device according to one of claims 1 to 4, characterized in that the covering or closing device (2, 14) is formed by a cap-like element which can be sealingly connected to the detection device (1, 12) at the receiving end and which has a storage space (7, 15), for example closed off by an openable membrane, for receiving the solvent or solvent.

6. Test device according to one of claims 1 to 5, characterized in that the covering or closing device (2) has an additional sealing film (11) at its free end.

7. Test device according to one of claims 1 to 6, characterized in that the detection device (1, 12) and the cover or closure device (2, 14) with mutually complementary profiles or contours for a positive connection and locking of the cover or closure device (2, 14) on the detection device (1, 12).

8. Test device according to one of claims 1 to 7, characterized in that the detection device (1, 12) can be locked with a separate closure cap.

9. Test device according to one of claims 1 to 8, characterized in that the detection device (1, 12) with at least one to the inside of the detection device

(1, 12) in particular sealed display element and / or Viewing window (9) is designed to display the result of the substance under investigation.

10. Test device according to one of claims 1 to 9, characterized in that a plurality of strip-like elements (3) are accommodated side by side in the detection device (12) and that the strip-like elements (3) contain different detection substances or different concentrations thereof.

11. Test device according to one of claims 1 to 10, characterized in that in the detection device (1, 12) at least one indicator is provided for displaying the functionality of the test device.