DE102020002140A1 - TEST KIT FOR CONTAMINATION-FREE PERFORMANCE OF SECRET TESTS - Google Patents

Abstract

Test kit for the contamination-free collection and analysis of a secretion sample, the test kit comprising a sampler, a test cassette and a safety bag.

Description

The invention relates to a test kit for the contamination-free performance of secretion tests, in particular for the contamination-free removal and analysis of a secretion sample, and a method for performing secretion tests with the aid of such a test kit.

A secretion test is the examination of a body fluid (secretion) for the presence of certain components, such as prohibited substances, antibodies or pathogens. The secretion to be examined can be saliva, for example. In this context, a contamination-free implementation is understood to mean that the secretion test can be carried out by a person (operator) on the person to be examined (test subject) without the operator and / or his environment with saliva or reagents necessary for carrying out the test are required, is contaminated.

Such secretion tests are typically used to obtain information about whether a person is infected with certain pathogens. For this purpose, a swab is typically taken from the mucous membrane to be examined. This is then analyzed with the help of a special laboratory. The laboratory test is typically carried out under certain safety requirements, as it must be ensured that the person performing the analysis does not come into contact with potentially infectious material on the one hand and with harmful reagents that may be necessary to carry out the analysis on the other hand. Carrying out this laboratory analysis is therefore usually not possible for the person who took the sample, but requires special safety training for the person carrying out the analysis. In Germany this is mostly a security training course for security level 2 or even higher.

The analysis of the taken sample is therefore often time-consuming, as it is usually necessary that the sampler with which the smear was carried out is packed in a contamination-proof manner and first sent to the special laboratory, where it is then examined and finally the test result after the Evaluation is sent back.

Another use case for secretion tests is the detection of the consumption of prohibited substances. For this purpose, rapid tests have already been developed in the past, which allow a test to be carried out directly on site without the saliva sample having to be sent to a laboratory. In these cases, however, fewer harmful reagents are usually required for the analysis of the sample and it is usually not assumed that the person examined is highly infectious. However, since the latter can never be ruled out, it would also be desirable in this context to have a device that allows secretion samples to be analyzed while adhering to increased safety requirements for the operator.

For example, suggests EP 2 902 099 B1 present a sample preparation and test system in which a saliva sample can be tested for the presence of various substances, such as D-amphetamine, morphine, tetrahydrocannabinol, cocaine or amphetamines, directly at the point of collection.

However, the test described therein can pose various risks. So the one out requires EP 2 902 099 B1 known test for example shaking the test device, whereby in the worst case there may be the risk that small amounts of these reagents escape or that the operator comes into contact with drops of secretion from the person to be examined by shaking the device. It can therefore not be completely guaranteed that a person who carries out such a test on a test person is completely protected from harmful material that originates either from the test person or from the test materials themselves. Therefore, when performing the EP 2 902 099 B1 the necessary safety requirements according to security level 2, as they are necessary for the handling and handling of infectious material, are usually not complied with.

It would therefore be desirable in any case to have a quick test that can be carried out directly on site, which nevertheless meets the necessary safety measures.

The present invention is therefore based on the object of providing an improved test system for the contamination-free examination of secretion samples. In particular, a test system is to be provided with which detection of human pathogens can be carried out quickly and easily without the need to transfer the sample to a special laboratory, while at the same time ensuring the necessary safety measures to protect the person performing the test.

To solve this problem, the invention proposes a test kit according to claim 1 and a method for carrying out a secretion test with the aid of such a test kit according to claim 10. Refinements are in each case the subject of the dependent claims.

A test kit according to the invention has a sampler, a test cassette and a security bag.

The sampler is rod-shaped with a first and a second section. The first section is a handle. The second section is equipped with a porous material. The porous material is preferably absorbent. With the help of the sampler, a swab of the mucous membrane to be examined can be carried out. To do this, the sampler is held by the handle and the second section is guided over the corresponding mucous membrane. The porous section absorbs the secretion to be analyzed. The sampler also has an indicator area in the area of the second swab. The indicator area shows when a sufficient amount of secretion has been absorbed. To do this, the indicator area can change its color.

The test cassette has a housing, a receptacle for the sampler and a display device for the test result. The housing contains all the reagents necessary for analyzing the secretion obtained. The test cassette also has a securing tab. The securing tab is attached to the outside of the housing. The safety tab serves as an early start safety device. It is designed as a tangible and movable projection. Before starting the test, the securing tab is firmly attached to the test cassette. To perform the test, the operator must break the safety tab. The securing tab therefore forms a physical lock.

The inside of the test cassette is designed in such a way that the test can be carried out after inserting the sampler and removing the securing tab by manipulating the test cassette exclusively from the outside, for example by shaking the test cassette and / or knocking it on a solid surface and / or let it rest for a certain period of time. This can be done, for example, as in EP 2902099 B1 which are expressly referred to at this point and the disclosure of which is hereby incorporated in its entirety. The one in the EP 2902099 B1 The sampler described here corresponds to the sampler at hand, the test cassette described here corresponds to the starter of the EP 2902099 B1 and the safety tab here corresponds to the tab for the early start safety device.

1. 1. mit Hilfe des Probenehmers die Sekretprobe gewonnen wird,
2. 2. der Probenehmer anschließend in die Testkassette eingesetzt wird, so dass Probenehmer und Testkassette eine miteinander verbundene Einheit, im Weiteren als Testvorrichtung bezeichnet, bilden, und
3. 3. die Analysereaktion innerhalb der Testkassette stattfindet, wobei die Testkassette verschlossen bleibt und lediglich von außen durch den Operator manipuliert und das Ergebnis visuell begutachtet wird.

It goes without saying that other design variants for the sampler and test cassette are also conceivable and that the subject matter of the invention is in no way based on the EP 2 902 099 B1 disclosed variant is limited. The only requirement is that the basic principle is retained, namely that

1. 1. the secretion sample is obtained with the help of the sampler,
2. 2. the sampler is then inserted into the test cassette so that the sampler and test cassette form an interconnected unit, hereinafter referred to as a test device, and
3. 3. the analysis reaction takes place inside the test cassette, the test cassette remaining closed and only manipulated from the outside by the operator and the result being assessed visually.

The composite assembly of sampler and test cassette is referred to as a test device. If the sampler and test cassette are assembled to form the test device, they are firmly connected to one another in such a way that they cannot accidentally fall apart again. For this purpose, it is conceivable, for example, that the sampler can snap into the test cassette. The test cassette and / or the sampler can thus have a latching device.

The safety bag offers the advantage that the secretion test can be carried out with the aid of the test kit provided, while maintaining the safety that is normally prescribed for safety laboratories. The security bag has the shape of a pocket with an inside, an outside and an opening. The opening can be closed in a liquid-tight manner. The security bag is therefore designed in such a way that it can completely accommodate the test device composed of the sampler and test cassette and can then be closed in a liquid-tight manner. The security bag is also designed in such a way that the operator can carry out all the necessary steps that are necessary after the assembly of the sampler and the test cassette for analyzing the sample taken without the security bag having to be opened again. In contrast to a conventional analysis in the security laboratory, in which the sample has to be reopened and further processed after being sent, the test kit according to the invention can therefore be used to carry out an analysis directly on site and also by operators who have no special security training.

After assembling the sampler and the test cassette, the analysis of the sample typically requires the following mechanical steps, regardless of the sequence: The safety tab of the test cassette is broken off, the test device is shaken, the test device is left to stand on a flat surface for a certain period of time, the test device is hit on a flat surface.

It can therefore be seen that it is advantageous if the security bag is made of transparent material. The material is also preferably particularly tear-resistant. Furthermore, the material can preferably be burned without leaving any residue. The material can be labeled. Alternatively, the security bag can have a field for an inscription on the outside. The material of the security bag is preferably a film.

It can also be seen that it is advantageous if the security bag is liquid-tight. The security bag can be a sterilization bag. The security bag can have a double wall. The security bag can consist of two layers of a film-shaped material which are connected to one another circumferentially, an opening being formed for inserting the test device. The connection of the layers of the film-shaped material can be formed by a double seam. The double seam is preferably a double weld seam.

It can also be seen that it is advantageous if the security bag has at least one locking mechanism. It is conceivable that the locking mechanism is a pressure lock. It is also conceivable that the locking mechanism is a slide lock. It is also conceivable that the closure mechanism is an adhesive closure. It is particularly advantageous if the locking mechanism is a double locking mechanism. The locking mechanism can have a first lock and a second lock. The first and the second closure can each be a closure of the same type, they can also be different types of closure. For example, it is conceivable that the first fastener is a slide fastener and the second is an adhesive fastener. For example, after the test device has been inserted, the security bag can only be closed by the slide fastener, for example a Ziploc® fastener, and then additionally secured with an adhesive fastener. The adhesive fastener can be designed, for example, in the form of a self-adhesive flap. It is therefore conceivable that the security bag is a zip lock bag, slide lock bag, or a bag with a double locking mechanism.

In any case, it is advantageous if the security bag is designed in such a way that handling is easy. For this purpose, it is favorable if the radius and the height of the outer cylinder of the security bag is 1.25 to 10 times the radius and the height of the outer cylinder of the test device assembled from the sampler and test cassette. It is particularly advantageous if the radius and the height of the outer cylinder of the security bag is twice to five times the radius and 1.25 to twice the height of the outer cylinder of the assembled test device comprising sampler and test cassette. The outer cylinder is understood to mean the smallest cylindrical shape into which the test device can be placed completely. The height of the outer cylinder therefore corresponds to the height of the test device, the radius of the outer cylinder corresponds to the radius of the circumference of the vertical projection of the test device when it is on a flat surface. The perpendicular projection of the test device is the two-dimensional shape that the test device has when it stands upright on a flat surface and is viewed from above.

The security bag is correspondingly 1.25 times to 10 times larger, so that the operator has sufficient degrees of freedom when operating the test device contained in the security bag without the security bag being destroyed by the operator. It is particularly advantageous if the horizontal extent of the security bag is 1.25 to 10 times larger than the radius of the outer cylinder plus the maximum length of the security flap. In this way, the safety tab can be conveniently broken off. It is particularly advantageous if the security bag is two to five times larger than the test device in the horizontal orientation.

In other words: the size of the security bag and the test device are matched to one another. The security bag is dimensioned in such a way that the test device can be operated when the test device is completely inserted into the security bag and the security bag is closed.

In particular, the security bag is dimensioned such that the operator can break off the security tab of the test cassette when the test device is inserted into the bag without the operator having to reach into the bag. For this purpose, the operator grips the wall of the security bag together with the security tab located in the security bag and pulls the security tab together with the wall of the security bag until it breaks off from the test cassette within the security bag.

It is advantageous if the security bag is larger than the test device by a certain factor. At the same time, the security bag should not be too big. It has been found to be favorable if the security bag is 1.25 times to ten times the dimension in the relevant direction, particularly preferably twice to five times in the horizontal orientation. The relevant direction is that direction in which the safety tab from the test device canceled. It can be seen that the relevant direction is that direction in which the operator has to carry out an action when operating the test device. In other words: if the test device has an extension in a certain direction that corresponds to a first length, for example the radius of the outer cylinder, the security bag, when the test device is inserted, has 1.25 to ten times the extension in the same direction, preferably twice to five times expansion in the horizontal orientation.

It can also be seen that it can be advantageous if the security bag has position markings. The position markings can have different colors and / or patterns. A first color or a first pattern can indicate that this point is operated with the first hand and a second color or a second pattern can indicate that this point is operated with the second hand. The position markings can be numbered consecutively.

It can also be seen that it can be advantageous if the security bag has a wall thickness of at least 25 μm and at most 1000 μm, preferably at least 50 μm and at most 200 μm. In other words, the film material from which the security bag is made has a thickness of at least 25 μm and at most 1000 μm, preferably at least 50 μm and at most 200 μm. With a corresponding wall thickness, handling through the bag is easy on the one hand, and the security bag has sufficient tear resistance on the other.

It can also be advantageous if the security bag has a hold-open device. It can be a tension spring, a cardboard strip or the like. In any case, the hold-open device is designed to prevent the security bag from falling shut before the test device is inserted. At the same time, the hold-open device is designed so that the security bag can be kept open without. that the operator has to reach into the security bag at the edge of the security bag, for example. The hold-open device can therefore have a folding mechanism, a snap mechanism and / or a tensioning device.

In this context it is also conceivable that the test kit has a filling aid. The filling aid can be inserted into the opening of the safety bag. The filling aid can be a funnel, in particular a foldable funnel. The funnel can be round or flat. It can be conical or shaped like a shovel or shovel. The filling aid can be attached to the safety bag and serve as a slide for the test device. It is conceivable that the filling aid can be folded so that it can then be folded up and also inserted into the safety bag. This offers the advantage that the filling aid can be disposed of together with the test device in the closed safety bag.

It is also advantageous if the security bag has a bottom. In the simplest case, the security bag is rectangular and consists of two layers of a transparent film material described above, which are firmly connected to one another on three sides. Two of these sides form the side seams of the security bag, the third side forms the bottom seam. In the area of the bottom seam, the security bag can be designed in such a way that the security bag together with the test cassette located therein can be placed on a flat surface without the test cassette falling over. It is conceivable that there is a plate in the security bag that forms the bottom. This plate can be called a floor reinforcement. For example, it can be a piece of cardboard that is inserted into the security bag and forms a bottom surface.

• a. Entnehmen einer Probe mit Hilfe des Probennehmers
• b. Zusammensetzen des Probennehmers und der Testkassette zu einer Testvorrichtung
• c. Überführen der Testvorrichtung in den Sicherheitsbeutel
• d. Verschließen des Sicherheitsbeutels
• e. Schütteln des Sicherheitsbeutels samt Testvorrichtung
• f. Ruhenlassen der Testvorrichtung
• g. Abbrechen der Sicherungslasche der Testkassette im Sicherheitsbeutel
• h. Eindrücken des Probennehmers in die Testkassette im Sicherheitsbeutel
• i. Aufschlagen des Sicherungsbeutels samt Testkassette auf eine feste Oberfläche
• k. Auswertung des Testergebnisses durch visuelle Begutachtung

In a further aspect, the invention relates to a method for carrying out a secretion test with the aid of a test kit for carrying out secretion tests without contamination, the method comprising the following steps:

• a. Taking a sample with the help of the sampler
• b. Assembling the sampler and the test cassette to form a test device
• c. Transferring the test device into the safety bag
• d. Closing the security bag
• e. Shake the safety bag including the test device
• f. Allowing the test device to rest
• G. Break off the securing tab of the test cassette in the security bag
• H. Push the sampler into the test cassette in the security bag
• i. Open the security bag together with the test cassette on a solid surface
• k. Evaluation of the test result through visual assessment

Thereby the steps a and b carried out by the subject to be examined. For the step c the operator provides the opened security bag. The test person can then use the Place the assembled test device in the open safety bag without contact.

• 1 einen schematischen Aufbau eines Testkits mit Probennehmer, Testkassette und Sicherheitsbeutel
• 2a einen schematischen Aufbau einer zusammengesetzten Testvorrichtung, bestehend aus Probenehmer und Testkassette, bei der die Sicherungslasche im gesicherten Zustand ist
• 2b einen schematischen Aufbau einer zusammengesetzten Testvorrichtung, bestehend aus Probenehmer und Testkassette, bei der die Sicherungslasche im abgebrochenen Zustand ist
• 2c einen schematischen Aufbau einer zusammengesetzten Testvorrichtung, die in einen Sicherheitsbeutel eingesetzt ist
• 3 einen schematischen Ablauf der Durchführung eines Speicheltests mit Hilfe des Testkits

Further features, details and advantages of the invention emerge from the wording of the claims and from the following description of exemplary embodiments and on the basis of the drawings. Show it:

• 1 a schematic structure of a test kit with sampler, test cassette and security bag
• 2a a schematic structure of an assembled test device, consisting of sampler and test cassette, in which the securing tab is in the secured state
• 2 B a schematic structure of an assembled test device, consisting of sampler and test cassette, in which the securing tab is in the broken state
• 2c a schematic structure of an assembled test device, which is inserted in a security bag
• 3 a schematic sequence of the implementation of a saliva test with the help of the test kit

1 shows a test kit 10 having a sampler 1 , a test cassette 2 and a security bag 3 having. The sampler 1 has a handle 11 and a mouthpiece 12th . The mouthpiece 12th has an indicator section 13th on.

The mouthpiece 12th is equipped with an absorbent and / or porous material. The indicator section 13th is colored with an indicator color when not in use. Once the porous material of the mouthpiece 12th has absorbed a sufficient amount of saliva, the indicator section will discolor 13th . In a variant is the indicator section 13th Colorless when not in use and discolored as soon as a sufficient amount of saliva has been absorbed. Other design variants for samplers 1 and test cassette 2 are also conceivable. In any case, the test cassette points 2 an opening 21 on into which the sampler 1 can be used. The opening 21 can be funnel-shaped. In one variant there is the opening 21 equipped with a locking device. The sampler 1 then engages in the opening when inserted 21 one and subsequently are samplers 1 and test cassette 2 inextricably linked. After inserting the sampler 1 into the opening 21 are samplers 1 and test cassette 2 firmly (permanently) connected to each other. The connected unit of sampler 1 and test cassette 2 is also referred to as test device 20 in the following.

You can still see in 1 that the test cassette 2 a securing tab 22nd having.

Also shows 1 that the backup bag 3 an opening 31 having. The opening 31 is dimensioned such that the test device 20 can be passed through comfortably and without contact. The security bag 3 is dimensioned such that the entire test device 20 can be accommodated therein in the assembled state. You can see that the security bag 3 is so large that it can be completely closed when the test device 20 is in the security bag 3 is located. The security bag 3 has a locking device 32 .

In 2a you can tell that the sampler 1 and the test cassette 2 are assembled to the test device 20. The test device 20 has a length L1 and a lateral expansion R1 . The security tab 22nd is in the unused state and is firmly attached to the test cassette 2 locked. The length L1 corresponds to the height of a conceivable outer cylinder around the test device 20. The lateral expansion R1 corresponds to the diameter of this outer cylinder.

In 2 B one also recognizes the from sampler 1 and test cassette 2 composite test fixture 20. Here is the safety tab 22nd canceled. Here, too, the test device 20 has a length L2 and a lateral expansion R2 . You can see that the length L2 the length L1 and by breaking off the safety tab 22nd has remained unchanged. The lateral expansion R2 with broken safety tab 22nd however, it is greater than the lateral extent R1 that the test device 20 has when the safety tab 22nd has not yet been broken. You can see that the lateral expansion R2 by the length S1 of the safety lash 22nd is greater than the lateral extent R1 . The lateral expansion R2 of the test device 20 with the safety tab broken off 22nd corresponds to the outer cylinder of the test device 20 with the safety tab broken off.

In 2c you can see how the test device 20 from the 2a and 2 B in the security bag 3 of the test kit 10 is used. The security bag 3 has a length L3 and a lateral expansion R3 . You can see that the length L3 of the security bag 3 is greater than the length L2 of the test device 20. It can also be seen that the lateral expansion R3 of the security bag 3 is greater than the lateral extent R2 of the test device 20 with the safety tab broken off 22nd . The lengths shown R3 and R2 are only shown here as an example and do not correspond to the actual proportions. According to the present invention and as already stated above is the lateral expansion R3 1.25 to ten times larger than the lateral extent R2 . In particularly favorable design variants, the lateral expansion R3 of the security bag 3 twice to five times larger than the lateral extent R2 of the test device 20 with the safety tab broken off. Also the length L3 of the security bag 3 is correspondingly greater than the length L1 or the length L2 of the test device 20. Here, too, it is preferred if the length L3 of the security bag 3 1.25 to ten times greater than the length L1 of the test device 20. It is particularly favorable here if the length L3 of the security bag 3 1.25 times to two times larger than the length L1 of the test device 20.

3 shows a schematic sequence of the implementation of a method for the contamination-free analysis of a secretion sample with the aid of the in the 1 , 2a , 2 B and 2c test kits shown 10 .

In a first step, the sampling step a , takes the subject to be examined with the help of the sampler 1 a secretion sample. To do this, he strokes the mouthpiece 2 over the mucous membrane to be examined. This can be the lining of the throat. It can also be the nasal mucosa or any other with the mouthpiece 2 accessible mucous membrane of the subject.

In the second step, the step composition of the test device b , the subject sets the sampler 1 into the opening 21 the test cassette 2 a. Sampler 1 and test cassette 2 are assembled in this way to form the test device 20.

In the third step, the step of transferring the test device c , the subject then places the assembled test device 20 in the security bag 3 . The operator can do this with the security bag 3 Keep it open and the test subject places the test device 20 in a contactless manner in the security bag that is kept ready 3 . The operator and the test subject have no contact. In other words: the step of transferring the test device c is contactless.

In the fourth step, the step of closing the security bag d , the operator closes the security bag 3 . The operator only touches the outside of the security bag 3 . Since this had no contact with the test device 20 or the test subject thanks to the steps carried out previously, the security bag is handled without contamination (contamination-free handling) 3 possible by the operator.

• f Ruhenlassen der Testvorrichtung 20,
• g Abbrechen der Sicherungslasche 22 der Testkassette 2 im Sicherheitsbeutel 3,
• h Eindrücken des Probennehmers 1 in die Testkassette 2 im Sicherheitsbeutel 3,
• i Aufschlagen des Sicherungsbeutels 3 samt Testkassette 2 auf eine feste Oberfläche,
• k Auswertung des Testergebnisses durch visuelle Begutachtung.

In the fifth step, the performing the analysis step A. , the operator carries out the analysis of the secretion sample. In a preferred embodiment variant, this includes performing the analysis A. the following steps e , f , G , H , i and k : e Shake the safety bag 3 including test device 20,

• f allowing the test device 20 to rest,
• g Breaking off the securing tab 22nd the test cassette 2 in a security bag 3 ,
• h Push in the sampler 1 into the test cassette 2 in a security bag 3 ,
• i Open the security bag 3 including test cassette 2 on a solid surface,
• k Evaluation of the test result through visual assessment.

You can see that the operator is performing the steps e to j the security bag 3 between itself and the test device 20. In this way, the operator is protected from contamination by secretion or reagents.

List of reference symbols

1

Sampler

2

Test cassette

3

Security bag

10

Test kit

11

handle

12th

Mouthpiece

13th

Indicator section

21

opening

22nd

Safety tab

31

opening

32

Locking mechanism

R1

lateral expansion

R2

lateral expansion

R3

lateral expansion

L1

length

L2

length

L3

length

A.

analysis

a

sampling

b

Assemble the test device

c

Transferring the test device

d

Closing the security bag

e

Shake the safety bag including the test device

f

Let rest

G

Break off the securing tab

H

Push in the sampler

i

Opening the security bag including the test cassette,

k

Evaluation of the test result through visual assessment.

QUOTES INCLUDED IN THE DESCRIPTION

This list of the documents listed by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent literature cited

• EP 2902099 B1 [0006, 0007, 0014, 0015]

Claims (10)

Test kit for the contamination-free removal and analysis of a secretion sample, the test kit having a sampler (1), a test cassette (2) and a safety bag (3). Test kit according to Claim 1 , characterized in that the security bag (3) consists of transparent material. Test kit according to one of the preceding claims, characterized in that the security bag (3) is liquid-tight. Test kit according to one of the preceding claims, characterized in that the security bag (3) has at least one locking mechanism. Test kit according to one of the preceding claims, characterized in that the radius and the height of the outer cylinder of the security bag (3) is 1.25 times to 10 times, preferably twice to five times the radius and 1.25 times to twice the height of the Umzylinders the assembled test device (20) from sampler (1) and test cassette (2) is. Test kit according to one of the preceding claims, characterized in that the security bag (3) has position markings. Test kit according to one of the preceding claims, characterized in that the security bag (3) has a wall thickness of at least 25 µm and at most 1000 µm, preferably at least 50 µm and at most 200 µm. Test kit according to one of the preceding claims, characterized in that the security bag (3) has a hold-open device. Test kit according to one of the preceding claims, characterized in that the security bag (3) has a bottom. Method for performing a saliva test using a test kit according to one of the Claims 1 until 9 , the method comprising the steps of: a. Taking a sample with the aid of the sampler b. Assembling the sampler and the test cassette to form a test device c. Transferring the test device into the security bag d. Closing the security bag e. Shaking the safety bag together with the test device f. Allowing the test device to rest g. Breaking off the securing tab of the test cassette in the security bag h. Pushing the sampler into the test cassette in the security bag i. Opening the security bag together with the test cassette onto a solid surface k. Evaluation of the test result through visual assessment

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