EP3870028A1 - Probenanalyseeinrichtung sowie entnahmeelement für eine probenanalyseeinrichtung - Google Patents
Probenanalyseeinrichtung sowie entnahmeelement für eine probenanalyseeinrichtungInfo
- Publication number
- EP3870028A1 EP3870028A1 EP19795163.5A EP19795163A EP3870028A1 EP 3870028 A1 EP3870028 A1 EP 3870028A1 EP 19795163 A EP19795163 A EP 19795163A EP 3870028 A1 EP3870028 A1 EP 3870028A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- analysis device
- sample analysis
- removal
- sample
- air duct
- 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.)
- Pending
Links
- 238000004458 analytical method Methods 0.000 title claims abstract description 79
- 238000005070 sampling Methods 0.000 title abstract description 18
- 210000001124 body fluid Anatomy 0.000 claims abstract description 25
- 239000010839 body fluid Substances 0.000 claims abstract description 25
- 210000003296 saliva Anatomy 0.000 claims abstract description 19
- 238000007664 blowing Methods 0.000 claims abstract description 5
- 238000012360 testing method Methods 0.000 claims description 27
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 15
- 230000029058 respiratory gaseous exchange Effects 0.000 claims description 8
- 238000001746 injection moulding Methods 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 claims description 4
- 239000000654 additive Substances 0.000 claims description 3
- 230000000996 additive effect Effects 0.000 claims description 3
- 230000000241 respiratory effect Effects 0.000 abstract 1
- 238000003255 drug test Methods 0.000 description 9
- 239000003814 drug Substances 0.000 description 6
- 229940079593 drug Drugs 0.000 description 6
- 239000007788 liquid Substances 0.000 description 5
- 238000003466 welding Methods 0.000 description 4
- 239000000463 material Substances 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 230000002745 absorbent Effects 0.000 description 2
- 239000002250 absorbent Substances 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 238000007493 shaping process Methods 0.000 description 2
- 238000010146 3D printing Methods 0.000 description 1
- 206010006326 Breath odour Diseases 0.000 description 1
- 230000035508 accumulation Effects 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 206010013781 dry mouth Diseases 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 240000004308 marijuana Species 0.000 description 1
- 238000005476 soldering Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4845—Toxicology, e.g. by detection of alcohol, drug or toxic products
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0045—Devices for taking samples of body liquids
- A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/497—Physical analysis of biological material of gaseous biological material, e.g. breath
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/94—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B2010/0083—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements for taking gas samples
- A61B2010/0087—Breath samples
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B2010/0225—Instruments for taking cell samples or for biopsy for taking multiple samples
Definitions
- the present invention relates to a sample analysis device for analyzing at least one human body fluid sample and a sampling element for such a sample analysis device.
- Test systems for prohibited substances, such as drug tests, are already known from the prior art.
- Drug test systems of this type are known for example from EP 2 564 196 B1, EP 2 637 021 A1, EP 2 823 309 B1 or EP 2 722 669 A1 or EP 2 909 633 A1.
- saliva samples in particular are brought into contact with corresponding test strips so that the presence of appropriate drugs or drug consumption can be inferred by means of appropriate markings.
- EP 2 823 309 B1 in particular describes such a rapid drug test.
- a sample analysis device for analyzing at least one human body fluid sample with the features of claim 1.
- a sample analysis device for analyzing at least one human Body fluid sample in particular saliva sample is provided, with at least one base body, with at least one analysis element for the body fluid sample, with at least one removal element for the body fluid sample and with at least one air duct for passing human breathing air, wherein the base body has the analysis element, in the assembled state that Removal element is releasably attached to the base body and forms with the analysis element at least one analysis contact area for transferring the body fluid sample to the analysis element, the air guide channel being attached to the removal element, the removal element further comprising at least one removal area for the body fluid sample, the air guide channel at least has an open end for blowing air and the open end is arranged adjacent to the removal area.
- the invention is based on the basic idea that a sample analysis device can be used both as a drug test or for analyzing a body fluid sample and at the same time for analyzing the breathing air.
- the sampling element for the samples namely here a sample of a body fluid, such as a saliva sample, as well as a sample of breathing air is made easily available.
- a problem with drug users is that they may be able to provide little saliva because they have a so-called "dry mouth”. This is particularly a problem for cannabis users.
- Due to the fact that the air duct and the corresponding injection opening are arranged in the area of the removal area for the removal of the body fluid sample, it is possible to take both breathing air and a saliva sample with a single removal step. This is due to the fact that the blowing in of air already requires that the sampler leads the sampling element to his mouth and can then also comparatively easily moisten the corresponding removal area for the body fluid sample with saliva.
- the removal element has at least one mouth contact area in which the removal area is arranged.
- the mouth contact area can be a mouthpiece or a molded mouthpiece on which the sampler can blow through the removal element and the corresponding air duct.
- the removal area with which the saliva sample can be taken is then also provided as part of the mouth contact area.
- the removal area then preferably collects saliva, which can then be fed to a drug (quick) test.
- the saliva collected in this way is subjected to a corresponding test, e.g. is fed to one or more test strips.
- This can be, for example, a lateral flow drug test.
- a lateral flow drug test Such a system is known for example from EP 2 823 309 B1.
- the analysis of the air we breathe is in particular a test to determine the so-called “breath alcohol”, ie the alcohol content of the air we breathe.
- the removal element can be designed as a purely mechanical element.
- the removal element has no electronics whatsoever. It can be designed in such a way that it is used exclusively for directing the breathed-in air for sampling and for collecting saliva for the drug (quick) test.
- the removal area can have at least one hollow projection that is open on one side. This facilitates, for example, the production by means of plastic injection molding of the removal element. This also simplifies the shaping of the removal area itself. In particular, it is then conceivable that no accumulations of material are required here, but rather corresponding hollow projections can be provided here, which accordingly also facilitate the sampling or can serve as a supporting structure for corresponding absorbents or as a saliva sampling device itself.
- the removal hollow projection can have at least one open projection end and at least one closed projection end opposite this end. Such a configuration makes a particularly stable and at the same time enables material-saving shaping. Such a shape can also be implemented inexpensively.
- the removal area itself can be provided with at least one fleece pad for receiving the body fluid sample.
- the fleece pad can be an absorbent fleece that can simply soak up saliva, for example, but at the same time can also release it again when pressed onto corresponding test strips of the sample analysis device.
- the fleece pad can be attached to the removal hollow projection by means of at least one material connection, in particular a welded connection. Fastening by means of a welded connection ensures that the fleece is not contaminated by, for example, adhesive or the like, and the absorbability of the fleece pad is thereby impaired.
- a welded connection enables a secure material connection that is also durable, even over a longer storage period. It is also conceivable to create such a connection by soldering or by an appropriate heat point (or any other contour, such as a heat line) during assembly.
- the fleece pad is attached to the closed projection end. This enables a secure attachment to the removal hollow projection.
- the closed end of the projection also allows the fleece pad to be securely supported, so that the end of the projection can also be supported accordingly during the sampling.
- the air duct is formed in one part or in several parts.
- the air duct is made in several parts.
- the air guide duct is divided into several ducts, so that the air flow is divided accordingly.
- the appropriate division of the air flow also makes it conceivable and possible to surround a viewing window on the removal device accordingly, so that in the case of a forked air duct!
- a corresponding viewing window can be provided between the two air guide channels. The viewing window is used to view the corresponding display areas of the sample analysis device, in which it can be shown whether drugs have been consumed or not.
- the air duct branches in sections into at least one first partial air duct and at least one second partial air duct.
- the air duct can have at least one further open end, to which at least one adapter piece can be attached for connection to at least one alcohol test device.
- the adapter piece is integrally formed directly on the air duct. The adapter piece enables connection to a corresponding blower tube or connector of an alcohol test device.
- the adapter piece can have a geometry that can be adapted to different alcohol testing devices. It is particularly conceivable that the adapter piece has an at least partially frustoconical section or a conical section. This makes it possible to be able to place different connection tubes for the alcohol test device with different diameters on the adapter piece or on the adapter piece and to be able to establish a corresponding air-conducting connection.
- the adapter piece can have at least one predetermined breaking point.
- the predetermined breaking point makes it possible to be able to break off the adapter piece here, for example in order to be able to directly connect the air duct to a tube or an alcohol test device.
- the air duct can also extend or be designed asymmetrically between its two ends in the direction of its longitudinal axis. As a result of an asymmetrical shape, the air duct can be guided around a corresponding viewing window of the removal element, for example when the air duct is not divided.
- the sample analysis device can be manufactured by means of injection molding and / or additive manufacturing.
- the removal element is conceivable to be formed in two parts, the air guiding channels being placed as a separate piece on a base element of the removal element and then being able to be glued and / or welded there accordingly. Welding is preferred.
- the sample analysis device can be designed as a passive sample analysis device.
- the sample analysis device has no energy source, such as a battery or an electrical energy source.
- the saliva sample and corresponding capillary forces in the test strip as well as additional markers that are used there can already indicate this.
- the present invention relates to a removal element for a sample analysis device as described above.
- the removal element has the features of the removal element as above, i.e. in particular in addition to the air duct for passing human breathing air, which is attached to the sampling element, further at least one sampling area for the body fluid sample, wherein the air duct has at least one open end for blowing in air and the open end is arranged adjacent to the sampling area.
- Fig. 1 is a perspective view of a first embodiment of a
- Fig. 2 is a perspective view of the removal element according to the
- Embodiment of FIG. 1; 3 shows a view of the removal area of the removal element according to FIG. 2;
- FIG. 4 shows a further exemplary embodiment of a sample analysis device according to the present invention.
- Fig. 5 is a perspective view of the removal element for the
- FIG. 6 is a view of the removal area of the embodiment of FIG. 5.
- FIG. 1 shows a perspective view of a first exemplary embodiment of the sample analysis device 10 for analyzing saliva.
- the sample analysis device 10 is a multiple drug test, as is known, for example, from Securetec as, for example, DrugWipe 5S or DrugWipe 6S. Further information is also explained, for example, in EP 2 823 309 B1.
- the sample analysis device 10 has a base body 12.
- a removal element 18 is provided, by means of which the saliva sample can be taken and correspondingly pressed onto the test strip 16 when it is reinserted on the base body 12.
- a slide 20 is provided, which is displaced relative to the base body 12 and can release an analysis liquid reservoir 22.
- An analysis liquid is stored in the analysis liquid reservoir 22, which is released accordingly by pressure on the reservoir and can then make the drug test results correspondingly visible in the viewing window by means of appropriate reactions.
- an air duct 24 is arranged on the removal element 18.
- the air duct 24 has a mouthpiece 26 and an adapter piece 28.
- the air guide duct 24 is divided into two partial air ducts 30 and is symmetrical overall.
- the partial air ducts 30 are then brought together again in the direction of the adapter piece 28.
- the adapter piece 28 has a geometry that can be adapted to different alcohol testing devices.
- the adapter piece 28 is further provided with a predetermined breaking point 34, so that the adapter piece 28 can also be broken off accordingly and a piece of pipe can be connected directly to the end of the air duct 24.
- the removal element 18 has a removal area 36 in the area of the mouthpiece 26.
- the removal area 36 has three removal hollow projections 38.
- a fleece pad 40 with welding spots 42 is fastened to the removal hollow projections 38 by means of ultrasonic welding.
- the removal hollow projections 38 have an open projection end 38a and a closed projection end 38b opposite this end.
- the fleece pad 40 is fastened accordingly and is also supported flatly.
- FIG. 2 shows a perspective view of the removal element 18 shown in FIG. 1, which is correspondingly mounted on the sample analysis device 10 in FIG. 1.
- 3 shows the removal element 18 with a view of the mouthpiece 26 and the removal area 36.
- the removal element 18 is manufactured by means of injection molding.
- the air duct 24 is manufactured as an injection molded part, which is correspondingly placed on the base body 12 of the removal element 18 and welded there.
- a laser welding process is mentioned as a conceivable process.
- the functioning of the sample analysis device 10 is as follows:
- the removal device 18 is removed from the base body 12 of the sample analysis device 10 and the sampler takes the mouthpiece 26 into the mouth, as a result of which the removal area 36 can also come close to the tongue of the sampler. This enables the sampler to wet the fleece pads 40 by means of the tongue and to give a saliva sample.
- Breathing air can then be delivered through the mouthpiece 26 to a connected alcohol test device.
- the alcohol test device is connected via the adapter piece 28, on which a corresponding connection tube is pushed onto the conical connection surface 32.
- the drug test function is described for example in EP 2 823 309 B1.
- FIG. 4 shows a further exemplary embodiment of a sample analysis device 110.
- the sample analysis device 110 has the same structural and functional features as above in connection with the sample analysis device 10 shown and described in FIGS. 1 to 3.
- the adapter piece 28 is replaced by a pipe connection piece 128, it being possible for a corresponding pipe to be inserted into the ring slot 128a on the pipe connection piece 128.
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE202018106075.9U DE202018106075U1 (de) | 2018-10-24 | 2018-10-24 | Probenanalyseeinrichtung sowie Entnahmeelement für eine Probenanalyseeinrichtung |
PCT/EP2019/078968 WO2020084030A1 (de) | 2018-10-24 | 2019-10-24 | Probenanalyseeinrichtung sowie entnahmeelement für eine probenanalyseeinrichtung |
Publications (1)
Publication Number | Publication Date |
---|---|
EP3870028A1 true EP3870028A1 (de) | 2021-09-01 |
Family
ID=68387313
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP19795163.5A Pending EP3870028A1 (de) | 2018-10-24 | 2019-10-24 | Probenanalyseeinrichtung sowie entnahmeelement für eine probenanalyseeinrichtung |
Country Status (4)
Country | Link |
---|---|
EP (1) | EP3870028A1 (de) |
AU (1) | AU2019364688A1 (de) |
DE (1) | DE202018106075U1 (de) |
WO (1) | WO2020084030A1 (de) |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE4113199A1 (de) | 1991-04-23 | 1992-10-29 | Retronic Gmbh | Verfahren und vorrichtung zur ermittlung des blut-alkohol-wertes durch analyse der atemluft |
NO2765420T3 (de) * | 2009-09-09 | 2018-04-14 | ||
EP2381258A1 (de) | 2010-04-26 | 2011-10-26 | Securetec Detektions-Systeme AG | Mikrofluidiksystem mit Probenvorbehandlung |
CN103607960A (zh) * | 2011-07-01 | 2014-02-26 | 3M创新有限公司 | 用于筛选吸毒者的方法和装置 |
EP2637021A1 (de) | 2012-03-06 | 2013-09-11 | Securetec Detektions-Systeme AG | Verfahren und Vorrichtung zum Nachweis von Analyten |
EP2722669A1 (de) | 2012-10-22 | 2014-04-23 | Securetec Detektions-Systeme AG | Verfahren und Vorrichtung zum Nachweis von illegalen Drogen |
DE102013000901B4 (de) * | 2013-01-18 | 2014-09-25 | Dräger Safety AG & Co. KGaA | Vorrichtung zur Aufnahme und Abgabe von Speichel |
WO2016166623A1 (en) * | 2015-04-17 | 2016-10-20 | Cannabix Technologies Inc. | Cannabis drug detection device |
US20170030882A1 (en) * | 2015-05-01 | 2017-02-02 | Ahkeo Ventures LLC | Systems and methods for dipstick diagnostic tools and related methods |
CN207352027U (zh) * | 2017-10-23 | 2018-05-11 | 深圳安维森实业有限公司 | 吹嘴装置 |
-
2018
- 2018-10-24 DE DE202018106075.9U patent/DE202018106075U1/de active Active
-
2019
- 2019-10-24 WO PCT/EP2019/078968 patent/WO2020084030A1/de unknown
- 2019-10-24 AU AU2019364688A patent/AU2019364688A1/en active Pending
- 2019-10-24 EP EP19795163.5A patent/EP3870028A1/de active Pending
Also Published As
Publication number | Publication date |
---|---|
AU2019364688A1 (en) | 2021-05-27 |
DE202018106075U1 (de) | 2020-01-27 |
WO2020084030A1 (de) | 2020-04-30 |
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