• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    The invention relates to a device for the targeted testing of a liquid sample originating from the human organism, in particular a blood sample, for infection of the organism with the SARSCoV-2 coronavirus, comprising a carrier plate (1) with at least two test strip holders in each of which one with a sample holder section (32 ) and a test section (34) provided with test strips (3, 3'), the first test strip 3 and the second test strip 3' each having different color-marked antigens specific to the coronavirus in the region of the sample receiving section for binding to the corresponding human Anti-SARS-CoV2 immunoglobulins IgG and IgM and wherein the test sections (34) of each of the two test strips (3, 3') have a first test line (341) with capture antibody for human immunoglobulin M and a second test line (342) with capture antibody for human immunoglobulin G, each one test line for IgM and for IgG.
    公开号:AT17386U1
    申请号:TGM50081/2020U
    申请日:2020-04-16
    公开日:2022-02-15
    发明作者:
    申请人:Protzek Ges Fuer Biomedizinische Technik Gmbh；
    IPC主号:
    专利说明:

    description
    DEVICE FOR TARGETED TESTING FOR CORONAVIRUS-SARS-COV-2 INFECTION
    The invention relates to a device for the targeted testing of a liquid sample originating from the human organism for infection of the organism with the coronavirus SARS-CoV-2 according to protection claim 1.
    The corona virus disease COVID-19 is an infectious disease caused by a novel virus SARS-CoV-2 and was first diagnosed in humans in 2019. This virus led to a pandemic within a short period of time. In an effort to contain the rapid spread of the coronavirus, it is necessary to identify infected people. For this purpose, if there is a suspicion of infection with the novel coronavirus, swabs are taken from the relevant persons, after which the samples are sent to a laboratory for laboratory diagnostic clarification as quickly as possible. Here, the genetic material in the sample is amplified using the so-called polymerase chain reaction (PCR) and then examined for infected genomes. Due to the time required and the increasing number of samples sent to the laboratories, there are considerable bottlenecks in testing and, in addition, there is an increasing period of time from sample collection to the announcement of the test result.
    [0003] Due to the length of time required for the formation of antibodies in the human organism (7-10 days after infection), a test that checks the immune response instead of the pathogen is hardly suitable for early detection. On the other hand, it is becoming increasingly important epidemiologically and for the public reaction to the pandemic to recognize the past infections with the resulting immunity and to know their number. It can be assumed from these people that once the course of the disease has been secured and they have fully recovered, there will be no further risk of infection, nor will they continue to need protective devices.
    This is where the present invention comes in. The invention is based on the object of providing a device for the targeted testing of analytes in a liquid sample from the human or animal organism for infection of the organism with the coronavirus SARS-CoV-2, which allows a liquid sample to be tested with minimal effort immediately after it has been taken possible and provides a test result in the shortest possible time. According to the invention, this object is achieved by a device having the features of claim 1.
    The invention provides a device for testing analytes in a liquid sample originating from the human or animal organism for infection of the organism with the coronavirus SARS-CoV-2, which enables testing immediately after sample collection and the test result available on site in the shortest possible time. Because there are at least two test strip holders on a carrier plate, in each of which a test strip provided with a sample holder section is arranged, with the first test strip 3 and the second test strip 3' each having different colors in the area of the sample holder section, for the coronavirus specific antigens for binding to the corresponding human anti-SARS-CoV2 immunoglobulins IgG and IgM, and the test sections (34) of each of the two test strips 3, 3' have a first test line 341 with capture antibodies for human immunoglobulin M and a second test line 342 with capture antibody for human immunoglobulin G, which forms a test line for IgM and for IgG, an immediate analysis of a given blood sample with regard to the presence of immune reactions to a SARS-CoV-2 infection is possible. By simultaneously analyzing the blood sample for glycoprotein immunoglobulin M and glycoprotein immunoglobulin G, the test can also provide information about how long
    an existing initial infection is already in the past. Because the two test strips have different gold-labeled protein antigens specific for this coronavirus for binding to immunoglobulin M and G (IgM and IgG), so that they each have different epitopes where the antibody can attack, an extended detection window is realized . With the help of this device, those test persons who have already survived the respiratory diseases COVID-19 caused by the coronavirus are also recorded.
    The device according to the invention is based on the basic idea of analyzing a blood sample from the subject for the presence of immune reactions, which allows a more differentiated statement about the respective immune status. For this purpose, a liquid sample in the form of a drop of blood is applied to the two different test strips with different protein antigens for binding to the human immunoglobulins M and G (IgM and IgG), whereby an extended detection window is realized. The test result can be read directly on site after a short time.
    In a further development of the invention, a sample carrier holder is arranged, which accommodates a "Dried Blood Spot" sample carrier (DBS sample carrier). This enables the tamper-proof deposition of a drop of blood for a later PCR analysis. The DBS sample carrier preferably has at least a sample application area marked in a circle, the sample carrier being particularly preferably made of cellulose, in particular in the form of a filter paper.
    In an embodiment of the invention, the carrier plate is made of cardboard, with existing test strip receptacles and/or sample carrier receptacles preferably being formed by embossing. In this way, the support plate can be produced inexpensively and the device can be disposed of in an environmentally friendly manner.
    In a further embodiment of the invention, the carrier plate is not detachably provided with a particularly biodegradable cover film, which cover film has at least one recess in the region of the sample receiving sections of the test strips and/or the sample carrier, which is closed by a detachable cover. The detachable cover is preferably delimited by a perforation line made in the cover film. This protects the test strips and the sample carrier against external influences.
    In a further development of the invention, the carrier plate has two sections which are pivotably connected to one another, a first section accommodating the at least two test strips and the second section accommodating the DBS sample carrier. This enables the device to be deposited in a space-saving manner.
    In an embodiment of the invention, a test strip evaluation graphic, in particular in the form of a matrix, is arranged on one section, preferably on the second section. This supports an immediate evaluation of the test strip results displayed by the test personnel.
    Other developments and refinements of the invention are specified in the remaining dependent claims. An embodiment of the invention is shown in the drawings and will be described in detail below. Show it:
    [0013] FIG. 1 shows the schematic representation of a SARS-CoV-2 test device and [0014] FIG. 2 shows the representation of a test strip of the device from FIG. 1 in a step section.
    The device selected as an exemplary embodiment for the targeted testing of a liquid sample originating from the human or animal organism for infection of the organism with the coronavirus SARS-CoV-2 consists essentially of a carrier plate 1, which is provided with two test strip receptacles, each take up a test strip 3, 3' for carrying out a "lateral flow" immunoassay. Furthermore, a “dried blood spot” sample carrier (DBS sample carrier) 2 is arranged on the carrier plate 1 .
    The carrier plate 1 is formed in the embodiment of a single, centrally provided with a crease 13 cardboard blank. By the crease 13, the support plate 1 is in one
    first section 11 and a second section 12 which are pivotally connected to each other. The two test strips 3 , 3 ′ are arranged on the first section 11 . A DBS sample carrier 2 is positioned in the second section 12 . The carrier plate 1 is provided with a cover film 4 over its entire surface, over which the test strips 3, 3' and the DBS sample carrier 2 are fixed.
    The structure of the test strips 3, 3 'is shown in Figure 2 in step section. This has a carrier film 31 on which a sample receiving section 32 is arranged at one end. Immediately adjacent and partially below the sample receiving portion 32 is an antigen coating 33 on the carrier film 31 containing virus-specific antigen conjugated to gold particles. The antigen coating section 33 is followed by a test section 34, which is designed in the form of a membrane on which a first test line 341 and a second test line 342 as well as a control line 343 are located at a distance from one another and IgM immunoglobulins or the control line immunoglobulin have been formed and are invisible before a sample is applied. An absorber section 35 is arranged on the test strip 3 at its end opposite the sample receiving section 32 .
    In the exemplary embodiment, two different test strips 3, 3' are arranged. In the antigen coating 33 of the first test strip 3 there is a gold-marked virus-specific protein antigen for binding to anti-SARS-Cov-2 immunoglobulins G and M (IgG, IgM) that have been formed, so that they can enter into an immunological reaction with this protein . The second test strip 3' has an antigen coating 33 analogous to the first test strip 3, but in which there is another virus-specific protein antigen, different from the first test strip 3, for binding to the anti-SARS-Cov-2 immunoglobulins G and M ( IgG, IgM) so that they can also enter into an immunological reaction accordingly.
    The cover film 4 is formed in the embodiment of a decomposable, colored film, which is provided with transparent trained, clear, low-reflection control windows 41. A sample application window 42 is arranged at a distance from the control windows 41 and is formed by a recess made in the cover film 4 . The sample application windows 42 are arranged in such a way that one sample application window 42 is positioned over a sample receiving section 32 of a test strip 3, 3'. Furthermore, a recess 43 is arranged in the cover film 4, which allows access to the sample application area 21 of the DBS sample carrier 2. The recess 43 is a - closed detachable cover - not shown.
    To carry out a test, a drop of blood from a subject is applied as sample liquid through a sample application window 42 of the cover layer 4 onto the sample application section 32 of each test strip 3, 3'. The sample liquid flows in the direction of the test section 34 by capillary action. It first comes into contact with the antigen coating section 33 in which the protein antigens conjugated with gold particles are located. Alternatively, the protein antigens can also be conjugated with another suitable color label.
    Before a test is carried out, no lines 341, 342 can be seen in the test sections 34. When carrying out a test, a sample liquid in the form of a drop of blood is applied through a sample application window 42 of the cover layer 4 onto the sample application section 32 of each test strip 3, 3'. The sample liquid flows in the direction of the test section 34 by capillary action. It first comes into contact with the antigen coating section 33, which contains the specific antigen of the test strip 3 or test strip 3' conjugated with gold particles in a standardized (dosed) amount. The antigen molecules are carried along by the sample liquids, which flow through the respective test section 34 of the test strips 3, 3°. If the sample liquid does not contain the analyte to be determined (Anti-Cov-2 IgM or IgG), or if the dose is lower than the display limit set in the test strip 3, 3', then no antigen-antibody complex is formed. When flowing through the respective test section 34, the water present in the area of the test lines 341 and 342 can
    Antibodies directed against human IgM and I9G do not bind gold-labeled antigen-antibody complex. Therefore, none of the IgG or IgM test lines 341, 342 can form, which would otherwise acquire a red or brown color due to the binding of the gold-antigen-antibody complex. The test result is therefore negative.
    If the blood sample contains the analytes to be determined, these are already connected to form an antigen-antibody complex in the area of the antigen coating section 33 of the test strip 3 or 3'. Accumulation therefore occurs in the test section 34, depending on the presence of anti-SARS-Cov-2 IgM or anti-SARS-Cov-2 IgM, so that a visible test line 341 or 342 can form. The test result is positive if either test line is formed. The control line 343 indicates whether a sufficient amount of blood or buffer has been applied, i.e. whether the test has been carried out correctly. In FIG. 2, the test lines 341 and 342 are colored, which is why the test is positive with regard to the corresponding analyte.
    The DBS sample carrier 2 is made of cellulose, presently in the form of a filter paper, and is provided with a sample application area 21 marked in a circle. Another drop of blood is applied to the sample application area 21 of the DBS sample carrier 2 and is preserved there. Subsequent to the test, a confirmation analysis can be carried out with the blood sample deposited in the sample application area 21, for example with the aid of a PCR analysis. The advantage here is that the biological material is fixed when the sample is taken and can no longer be manipulated, and that any reactions that impair the original sample state, such as those caused by proteases, etc., no longer take place.
    To evaluate the test, a test strip evaluation graphic 5 is arranged on the second section 12 of the support plate 1 in the form of a matrix in the exemplary embodiment. By arranging a first test strip 3 for the glycoproteins IgM and IgG and a second test strip 3', also for the glycoproteins IgM and IgG, eight different test results are possible. A proiri it is expected that the display of IgM or IgG directed against the SARS-CoV2 virus on each of the two test strips will be shown separately by the test lines in each of the test strips being in the same arrangement. However, since two different antigenic determinants of the virus are used, a possibly different immunogenicity or sensitivity can lead to different constellations of results or possibly be compensated.
    The glycoprotein IgM is an antibody which, according to current knowledge, is formed upon initial contact with the corona virus of the SARS-CoV-2 subspecies and for this reason indicates the acute infection phase of the disease Covid 19. The glycoprotein IgG is formed in a delayed defense phase and remains in the body for a long time. The detection of IgG thus indicates a recovered Covid 19 disease. If the test result is negative for both IgG and IgM, it can be assumed that either there is no disease or the disease was so recent that the body has not yet started the immune system. If the result is positive for IgM and negative for IgG, it is likely that the subject is in an early stage of infection. If the result is positive for both IgM and IgG, an acute infection phase can be assumed in which the subject has already built up an endogenous immunity. If the result is negative for IgM and positive for IgG, the patient is in a late phase of the disease or has already recovered.
    The above conclusions are based on the current state of knowledge about the virus. Only an advanced testing practice will show whether - as assumed - the time-dependent formation of first anti-SARS-CoV2 IgM and more lasting anti-SARS-CoV2 1gG actually correlates with the disease stage or recovery stage.
    The device according to the invention is characterized by a compact design, which in mobile use enables both a reliable test for the respiratory disease Covid 19 and at the same time the deposit of a blood sample for further analysis. By manufacturing the device essentially from cardboard materials is also a
    environmentally friendly disposal of this single-use device. The method according to the invention thus enables a rapid, mobile test of the immune status of a subject, which provides information about an infection with the coronavirus SARSCoV-2. If the result is negative, a subsequent analysis of a blood sample, for example using a PCR method, is indicated in order to be able to rule out a possible fresh infection. Against the background of the lower viral load of the blood compared to a smear, a smear should also be analyzed afterwards.
    权利要求:
    Claims (7)
    [1]
    1. Device for the targeted testing of a liquid sample originating from the human organism, in particular a blood sample, for infection of the organism with the SARS-CoV-2 coronavirus, comprising a carrier plate (1) with at least two test strip receptacles in each of which one with a sample receptacle section (32 ) and a test section (34) provided with test strips (3, 3'), the first test strip 3 and the second test strip 3' each having different color-marked antigens specific to the coronavirus in the region of the sample receiving section for binding to the corresponding human have anti-SARS-CoV2 immunoglobulins IgG and IgM and the test sections (34) of each of the two test strips 3, 3' have a first test line 341 with capture antibody for human immunoglobulin M and a second test line 342 with capture antibody for human immunoglobulin G, whereby a test line is formed for IgM and for IgG is.
    [2]
    2, device according to claim 1, characterized in that a sample carrier receptacle is arranged, which receives a "dried blood spot" - sample carrier (DBS sample carrier) (2).
    [3]
    3. Device according to claim 2, characterized in that the DBS sample carrier (2) has at least one circularly marked sample application area (21), the sample carrier (2) preferably being made of cellulose, in particular in the form of a filter paper.
    [4]
    4. Device according to one of the preceding claims, characterized in that the carrier plate (1) is made of cardboard, existing test strip receptacles and/or sample carrier receptacles being preferably formed by embossing.
    [5]
    5. Device according to one of the preceding claims, characterized in that the carrier plate (1) is non-detachably provided with a cover film (4), which cover film (4) in the region of the sample receiving sections (32) of the test strips (3, 3') and /or the sample carrier (2) has at least one recess (42) which is closed by a detachable cover which is preferably delimited by a perforation line introduced in the cover film (4).
    [6]
    6. Device according to one of claims 2 to 5, characterized in that the carrier plate (1) has two pivotally connected sections (11, 12), wherein a first section (11) the at least two test strips (3, 3 °) and the second section (12) receives the DBS sample carrier (2).
    [7]
    7. Device according to claim 6, characterized in that a test strip evaluation graphic (5), in particular in the form of a matrix, is arranged on one section, preferably on the second section (12).
    1 sheet of drawings
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    同族专利:
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    引用文献:
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    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
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