SAMPLE TEST CARD AND SAMPLE LOADING METHOD THEREOF

20210170393 · 2021-06-10

    Inventors

    Cpc classification

    International classification

    Abstract

    The present disclosure provides a sample test card and a sample loading method thereof, relates to the technical field of microbiological testing. The present disclosure includes sample wells arranged in an array; the sample wells are connected together through a flow channel network, and the sample wells are filled with a sample through a unified intake port. Sample filling is completed by vacuuming; during filling, a liquid sample is firstly filled, and air or other inert gas or insoluble liquid is filled; liquid sample volume and air volume are formed in proportion in the sample wells. In the present disclosure, the filled liquid sample is controlled not to fill the sample wells completely, and there are sufficient air space in sample wells, so that the sample wells are independent from each other to avoid contamination, and more sample wells can be arranged on the test card with the same size.

    Claims

    1. A sample loading method of a sample test card, wherein the sample test card has a slab structure; a plurality of sample wells, a fluid intake port and a fluid flow channel network are sealed and arranged inside the sample test card, and the fluid flow channel network communicates with the fluid intake port and the sample wells; transparent blocks are arranged inside the sample wells of the sample test card; the transparent blocks divide the sample wells into storage chambers and observation chambers; both the sample test card and the transparent blocks are made of transparent materials the sample well comprises a storage chamber and an observation chamber; the observation chamber is a thin layer structure, and the thin layer of the observation chamber is transparent in the vertical direction and is used for microscopic observation; and a liquid test sample is incompletely filled in the sample well, gas is present in an upper part of the sample well and the flow channel network, to achieve a proportional relationship between an amount of liquid test sample in the sample well and a gas volume; and the method comprises the following steps: SS01, providing a liquid test sample and a sample test card; SS02, inserting one end of a fine pipette into a fluid intake port on the sample test card, and connecting the other end of the fine pipette to the liquid test sample in a test tube; sealing the sample test card, liquid test sample, test tube, and a bracket for placement in a sample loading chamber for vacuuming, so that air in each sample well, flow channel network and fine pipette in the sample test card is discharged through the liquid test sample, and a vacuum chamber reaches a certain vacuum degree; SS03, after vacuuming to a certain vacuum degree, slowly introducing air into the vacuum chamber so that the liquid test sample in the test tube is sucked into the flow channel through the fine pipette to reach the sample well, and filling the sample well with the liquid test sample; in the process of introducing air, achieving the desired requirement of the vacuum degree to complete partial filling of the sample well with the liquid test sample, and separating the liquid test sample in the fine pipette from that in the test tube; and SS04, continuing to introduce air into the vacuum chamber until the pressure in the vacuum chamber is consistent with the atmospheric pressure; wherein at this time, the liquid test sample remaining in the flow channel network flows into the sample well, and air flows into the flow channel network and the sample well.

    2. (canceled)

    3. (canceled)

    4. (canceled)

    5. The sample loading method of a sample test card according to claim 1, wherein the vacuum chamber in SS03 undergoes deflation, and the vacuum degree in the deflation of the vacuum chamber is controlled so that the liquid test sample slowly flows into the sample well, and the volume of the sample filled in the sample well reaches a proportion required in the entire sample well.

    6. The sample loading method of a sample test card according to claim 1, wherein the fine pipette is further inserted into a water-insoluble solvent with smaller specific gravity than water in another test tube after separating the liquid test sample in the fine pipette from that in the test tube in SS03; in SS04, the solvent is finally left in the flow channel network and the upper part of the sample well.

    7. The sample loading method of a sample test card according to claim 1, wherein, an inert gas or a gas mixture without oxygen is introduced into the vacuum chamber in both SS03 and SS04 when used in an anaerobic microbial test.

    8. The sample loading method of a sample test card according to claim 1, wherein a total volume of the liquid test sample provided is less than that of all sample wells; first the liquid test sample is filled into the test card, and next, when the liquid test sample is used up, the test card is filled with air until the end of the sample loading; the flow channel network and the upper part of the sample well are filled with air, so that the volume of the sample filled in the sample well reaches a proportion required in the entire sample well.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0032] In order to more clearly explain the technical solutions of the embodiments of the present disclosure, the drawings needed to describe the embodiments will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present disclosure, and other drawings can be obtained by those of ordinary skill in the art based on these drawings without creative work.

    [0033] FIG. 1 is a top view of the structure of a sample test card in Embodiment 1 of the present disclosure;

    [0034] FIG. 2 is an exploded schematic cross-sectional view of a sample test card in Embodiment 1 of the present disclosure;

    [0035] FIG. 3 is a schematic cross-sectional view of a sample test card in Embodiment 1 of the present disclosure;

    [0036] FIG. 4 is a schematic cross-sectional view of a sample well in Embodiment 1 of the present disclosure;

    [0037] FIG. 5 is an exploded structural diagram of a sample test card in Embodiment 2 of the present disclosure;

    [0038] FIG. 6 is a top view of the structure of a sample test card in Embodiment 2 of the present disclosure;

    [0039] FIG. 7 is a schematic cross-sectional view of a sample test card in Embodiment 2 of the present disclosure;

    [0040] FIG. 8 is a schematic cross-sectional view of a sample well in Example 2 of the present disclosure;

    [0041] In the drawings, a list of parts represented by each reference number is as follows:

    [0042] 1—Sample test card, 2—sample well, 3—fluid intake port, 4—fluid flow channel network, 5—transparent block, 6—storage chamber, and 7—observation chamber.

    DETAILED DESCRIPTION

    [0043] The technical solutions in the embodiments of the present disclosure will be described clearly and completely in conjunction with the drawings in the embodiments of the present disclosure. Obviously, the described embodiments are only a part of, not all of, the embodiments. Based on the embodiments of the present disclosure, all other embodiments obtained by a person of ordinary skill in the art without creative work shall fall within the protection scope of the present disclosure

    Embodiment 1

    [0044] Please refer to FIGS. 1 to 4. The present disclosure provides a sample test card. The sample test card 1 has a slab structure, a plurality of sample wells 2, a fluid intake port 3 and a fluid flow channel network 4 are sealed and arranged inside the sample test card 1, and the fluid flow channel network 4 communicates with the fluid intake port 3 and the sample wells 2; transparent blocks 5 are arranged inside the sample wells 2 of the sample test card 1; the transparent blocks 5 divide the sample wells 2 into storage chambers 6 and observation chambers 7.

    [0045] The storage chambers 6 are communicated with the observation chambers 7, the observation chambers 7 are in the center of the sample wells, the observation chambers 7 are 0.1-0.5 mm thin layers, so as to ensure a better microscopic imaging effect; The transparent blocks 5 of the upper cover plate in the sample test card 1 have a light-guide effect; when using microscopic observation, the structure in the vertical direction of the observation layer should be ensured to have better transparency.

    [0046] Preferably, both the sample test card 1 and the transparent blocks 5 may be made of transparent materials or transparent film materials.

    [0047] Preferably, the sample well 2 may be composed of a storage chamber 6 and an observation chamber 7; the observation chamber 7 may be a thin layer structure, and the thin layer of the observation chamber may be transparent in the vertical direction and may be used for microscopic observation.

    [0048] A sample loading method of a sample test card is provided, where a liquid test sample is incompletely filled in the sample well, gas is present in the upper part of the sample well and the flow channel network, to achieve the proportional relationship between the amount of liquid test sample in the sample well and the gas volume; including the following steps:

    [0049] SS01, providing a liquid test sample and a sample test card;

    [0050] SS02, inserting one end of a fine pipette into a fluid intake port on the sample test card, and connecting the other end of the fine pipette to the liquid test sample in a test tube; sealing the sample test card, liquid test sample, test tube, and a bracket for placement in a sample loading chamber for vacuuming, so that air in each sample well, flow channel network and fine pipette in the sample test card is discharged through the liquid test sample, and a vacuum chamber reaches a certain vacuum degree;

    [0051] SS03, after vacuuming to a certain vacuum degree, slowly introducing air into the vacuum chamber so that the liquid test sample in the test tube is sucked into the flow channel through the fine pipette to reach the sample well, and filling the sample well with the liquid test sample; in the process of introducing air, achieving the desired requirement of the vacuum degree to complete partial filling of the sample well with the liquid test sample, and separating the liquid test sample in the fine pipette from that in the test tube; and

    [0052] SS04, continuing to introduce air into the vacuum chamber until the pressure in the vacuum chamber is consistent with the atmospheric pressure; where at this time, the liquid test sample remaining in the flow channel network flows into the sample well, and air flows into the network and the sample well.

    [0053] Preferably, the vacuum chamber in SS03 may undergo deflation, and the vacuum degree in the deflation of the vacuum chamber may be controlled so that the liquid test sample slowly flows into the sample well, and the volume of the sample filled in the sample well may reach a proportion required in the entire sample well.

    [0054] Preferably, the fine pipette may be inserted into a water-insoluble solvent with smaller specific gravity than water in another test tube after separating the liquid test sample in the fine pipette from that in the test tube in SS03. In SS04, the solvent may be finally left in the flow channel network and the upper part of the sample well.

    [0055] Preferably, an inert gas or a gas mixture without oxygen may be introduced into the vacuum chamber in both SS03 and SS04 when used in an anaerobic microbial test.

    [0056] Preferably, a total volume of the liquid test sample provided may be less than that of all sample wells; according to the above sample loading method by vacuuming, first the liquid test sample may be filled into the test card, and next, when the liquid test sample is used up, the test card may be filled with air until the end of the sample loading. The flow channel network and the upper part of the sample well may be filled with air, so that the volume of the sample filled in the sample well reaches a proportion required in the entire sample well.

    [0057] Sample loading of the test card of the present disclosure: The sample of the test card is liquid, the intake port of the test card is inserted into a fine pipette, the other end of the pipette is placed in a test tube or container containing a liquid sample, and the test card is placed flat; the three are in a vacuum chamber, which is vacuumed to a pressure of 0.7-0.9 PSIA; the vacuum chamber and the sample wells and flow channels inside the test card are under vacuum negative pressure, and air is introduced into the vacuum chamber; at this time, the liquid sample is sucked into pipette from the port inserted into the test tube, introduces through the intake port, main flow path of the card, and branch flow paths, and finally reaches the sample wells. When the loading volume of the sample well reaches the desired amount, the intake port of the pipette is removed from the liquid sample in the test tube or the pipette is pulled up from the intake port of the test card, and air is introduced into the vacuum chamber continuously; at this time, air enters the intake port of the test card, the main flow path, and branch flow paths and finally reaches the sample wells. As air is introduced slowly and continuously, air is continuously filled into the sample wells until the vacuum chamber is released to atmospheric pressure, and the entire sample loading process ends. The control of the amount of sample loaded into the sample well is achieved by detecting the pressure in the vacuum chamber; in addition, and control of the speed of introducing air ensures the consistency of the amount of sample loaded in each sample well.

    [0058] Herein, air filled in the latter part of the sample loading process makes the main flow path, branch flow paths, and the upper half of the sample wells be filled with air, so as to completely isolate each sample well. This method of not fill the sample wells with liquid sample completely has a better isolation effect, which is more reliable and more convenient to avoid inter-well contamination. In addition, the flow channel may be short enough, and the sample wells are arranged more compactly. Compared with the test card of the same size in the prior art, more sample wells may be arranged to meet the testing requirements.

    [0059] Herein, in case of an anaerobic biological sample, the gas released after vacuuming after sample loading may be an inert gas or a gas mixture without oxygen to ensure the growth of microorganisms in an oxygen-free state. When the test card is preferably used for antibiotic drug susceptibility test, a powder containing antibiotics is attached to the sample well, and is controllably located at the bottom of the sample well, which improves the hydrophilicity of the bottom; the liquid sample first reliably reaches and fills the bottom when the test card is loaded, so that there is no air bubble in the observation chamber.

    [0060] Herein, when another method for controlling the sample volume of sample well of the test card is used: according to the proportional relationship between the liquid sample volume and the air volume in the sample well required by the test card, the total amount of samples required by all sample wells is calculated, and the same amount of total liquid sample is accurately provided when loading the sample; the sample is loaded in the same way. When ensuring that one end of the fine pipette is inserted into the bottom of the liquid sample test tube, the liquid sample is first sucked when loading the sample; when all the liquid samples are sucked, the vacuum chamber still has a certain negative pressure, and air continues to be filled slowly until the vacuum chamber is released to atmospheric pressure. The entire sample loading process ends, so that the liquid sample volume and the gas volume in the sample well reach a predetermined proportional relationship to achieve an isolation effect between the sample wells.

    [0061] Herein, when the test card of the present disclosure is used, after the sample is loaded, the intake port of the test card is closed to prevent biological contamination caused by the outflow of the sample.

    [0062] Herein, the test card maintains a horizontal state during the sample loading process and the detection process in the instrument.

    [0063] The test card of the present disclosure is especially used in the rapid drug susceptibility test of microscopic observation.

    [0064] The production process of the test card of the present disclosure: The test card of the present disclosure is a carrier used to complete the detection of biological samples. Different powered reagents are attached to the sample wells. The attachment process of the powered reagents is the main production process of the test card. Firstly, the desired liquid reagent is added into the grooves of the card body, and the liquid reagent in the grooves of the card body is evaporated, lyophilized or dried by other means, so that the desired different reagents are attached to the sample wells. After drying, the card body and the cover plates are pressed together to complete the main production of the test card. When the test card is used, the liquid sample dissolves the powered reagents in the sample wells.

    Embodiment 2

    [0065] Please refer to FIGS. 5 to 8. The present disclosure provides a sample test card. The sample test card 1 has a slab structure, a plurality of sample wells 2, a fluid intake port 3 and a fluid flow channel network 4 are sealed and arranged inside the sample test card 1, and the fluid flow channel network 4 communicates with the fluid intake port 3 and the sample wells 2; transparent blocks 5 are arranged inside the sample wells 2 of the sample test card 1; the transparent blocks 5 divide the sample wells 2 into storage chambers 6 and observation chambers 7.

    [0066] The storage chambers 6 are communicated with the observation chambers 7, the observation chambers 7 are on the sides of the sample wells, the observation chambers 7 are 0.1-0.5 mm thin layers, so as to ensure a better microscopic imaging effect; The transparent blocks 5 of the upper cover plate in the sample test card 1 have a light-guide effect; when using microscopic observation, the structure in the vertical direction of the observation layer should be ensured to have better transparency.

    [0067] Preferably, both the sample test card 1 and the transparent blocks 5 may be made of transparent materials or transparent film materials.

    [0068] Preferably, the sample well 2 may be composed of a storage chamber 6 and an observation chamber 7; the observation chamber 7 may be a thin layer structure, and the thin layer of the observation chamber may be transparent in the vertical direction and may be used for microscopic observation.

    [0069] Herein, for the upper and lower surfaces defined by the card body 1, a plurality of sample wells 2 are distributed between the upper and lower surfaces, a main flow path and branch flow paths constitute a flow channel network arranged on the upper surface and connected to each sample well 2 and the fluid intake port 3.

    [0070] Herein, a lower cover plate 2 is a slab; grooves are distributed on the upper surface, and the grooves correspond to the sample wells in the card body; the lower surface of the card body 1 is bonded to the upper surface of the lower cover plate, and the sample wells and the grooves on the lower surface form bottom-closed sample wells and thin layer observation chambers; the thickness of the observation chambers is formed by the gap of the corresponding parts, and preferably the thickness may be 0.1-0.5 mm, used for microscopic observation of microorganisms; to introduce an image processing method, especially to realize quick identification of the testing effect of antibiotics, all the components of the test card in the vertical direction of the thin layer of the observation chamber are transparent, which are used for microscopic observation of the light passing through the light path.

    [0071] The assembly of the test card: The lower surface of the card body 1 is bonded to the upper surface of the lower cover plate, and the upper surface of the card body 1 is pasted with a transparent sealing film to form a sealed flow channel network and sealed sample wells.

    [0072] The production process of the test card of the present disclosure: First, the card body 1 and the lower cover plate are pasted together to form sample wells opened above; desired reagents are added to the sample wells, evaporated, lyophilized or dried by other means to make powdered reagents be attached to the surface of the sample wells, and a sealing film is attached to the upper surface of the test card to complete the main production of the test card. When in use, the liquid sample dissolves the powdered reagents in the sample wells.

    [0073] In the description of this specification, the descriptions referring to the terms “one embodiment”, “example”, “specific example”, etc. mean that the specific features, structures, materials, or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present disclosure. In this specification, the schematic representation of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described may be combined in any one or more embodiments or examples in any suitable manner.

    [0074] The preferred embodiments of the present disclosure disclosed above are only used to help illustrate the present disclosure. The preferred embodiments neither describe all the details in detail, nor limit the present disclosure to the specific embodiments described. Obviously, a plurality of modifications and changes can be made according to the content of this specification. This specification selects and specifically describes these embodiments, in order to better explain the principle and practical application of the present disclosure, so that those skilled in the art can well understand and use the present disclosure. The present disclosure is only limited by the claims, full scope thereof and equivalents.