KR20200086905A - In-vitro diagnostic kit having chamber for counting leukocyte - Google Patents

Abstract

The present invention relates to an in vitro diagnostic kit having a leukocyte counting chamber, a diagnostic strip comprising at least one test line; A sample inlet for providing a predetermined open space into which a blood sample including a target substance and leukocytes is injected and a diagnostic reading window for confirming a diagnosis result on the at least one detection line are provided on the upper surface, and for absorbing the blood sample, A diagnostic kit in which the diagnostic strip is installed inside such that the sample pad of the diagnostic strip is exposed to a part of the open space of the sample inlet and the detection film of the diagnostic strip including the at least one detection line is positioned correspondingly below the diagnostic reading window. Body; And a monolayer space that is integrally connected to the opposite side of the diagnostic progression direction of the diagnostic strip from the body of the diagnostic kit, and a portion of the blood sample injected into the sample inlet and the layer of the blood sample injected into the sample inlet into capillary phenomenon. A capillary tube connecting the sample inlet and the monolayer space so as to be introduced therein is provided therein, and a leukocyte count reading window is provided to correspond to the monolayer space to enable white blood cell count through identification of the monolayer space. Includes; chamber for counting white blood cells provided on the upper surface.

Description

In vitro diagnostic kit with white blood cell counting chamber {IN-VITRO DIAGNOSTIC KIT HAVING CHAMBER FOR COUNTING LEUKOCYTE}

The present invention relates to an in vitro diagnostic kit capable of simultaneously performing a monolayer function of leukocytes in a blood sample for leukocyte counting together with a diagnosis and quantification function of a target substance in a blood sample using a side immunochromatography assay.

In vitro diagnostic kit using Lateral flow immunochromatographic assay (LFIA) uses antigen-immune reaction to test target substances present in trace amounts in various specimens once in a short time (One-step) It is a method that can be qualitatively and quantitatively analyzed and applied to various diagnostic items.

In vitro diagnostic kits using this lateral immunochromatography method, when a sample such as blood is dropped on a thin membrane sample pad, the specimen moves laterally through the conjugation pad to the detection membrane and specifically binds to the labeled particles and specific antibodies Thus, it can be seen that a target substance exists for the diagnosis of a specific condition in the sample.

Furthermore, it is also possible to quantify the level of the target substance in the sample by analyzing the result of the diagnostic in vitro diagnostic kit.

In recent years, in vitro diagnostic kits using lateral immunochromatography analysis have been continuously developed and developed in various functional additions and improved diagnostic performance, and prior art documents related to this have been published in the Republic of Korea Registered Patent Publication. There is a "hybrid immune response diagnostic kit" of 10-1806167 (hereinafter referred to as "prior art").

However, existing in vitro diagnostic kits, including the prior art, have focused on improving characteristics such as diagnostic speed and accuracy specific to a specific diagnostic object, or concentrating on improving structural characteristics to efficiently diagnose multiple diagnostic objects simultaneously.

Particularly, when a sample prepared with blood is applied to a diagnostic kit, it is only a diagnosis or quantification of a specific target substance in the blood, and when a separate diagnostic process using blood is to be performed, additional samples are obtained and the test must be progressed. There was.

The present invention was created to solve the above problems, and an object of the present invention is to provide a technique capable of performing a diagnosis and quantification of a target substance in a blood sample and simultaneously performing counting of wall blood cells in a blood sample. .

Furthermore, the present invention was created to solve the above problems, and another object of the present invention is to apply a sample of any concentration among a wide range of samples ranging from low to high concentrations to an in vitro diagnostic kit to perform diagnosis. It is to provide a technique for accurately performing the quantification of a target substance in a sample.

In order to achieve the above object, an in vitro diagnostic kit having a leukocyte counting chamber of the present invention includes: a diagnostic strip including at least one test line; A sample inlet for providing a predetermined open space into which a blood sample including a target substance and leukocytes is injected and a diagnostic reading window for confirming a diagnosis result on the at least one detection line are provided on the upper surface, and for absorbing the blood sample, A diagnostic kit in which the diagnostic strip is installed inside such that the sample pad of the diagnostic strip is exposed to a part of the open space of the sample inlet and the detection film of the diagnostic strip including the at least one detection line is positioned correspondingly below the diagnostic reading window. Body; And is formed extending from the body of the diagnostic kit is integrally connected to the opposite side of the diagnostic progression direction of the diagnostic strip, a tomography space in which blood samples are introduced and collected, and a portion of the blood sample injected into the sample inlet to the tomography space A capillary tube connecting the sample inlet and the monolayer space so as to be introduced by the capillary phenomenon is provided therein, and is positioned correspondingly over the monolayer space to allow white blood cell count through the identification of the monolayer space. It includes; a counting reading window is provided on the upper surface of the white blood cell counting chamber.

Here, the diagnostic strip, the support; The sample pad is attached to the upper portion of the support, a portion of the blood sample containing the target material and white blood cells injected into the sample inlet is absorbed; A conjugation pad that is attached to the upper portion of the support in a form that is sequentially connected to the sample pad, and which specifically binds to the target substance and includes a first antibody conjugated with a label; The at least one detection line is attached to the upper portion of the support in a form that is sequentially connected to the conjugation pad, and the antibody to which the target substance specifically bound to the first antibody specifically binds is immobilized. Detection film; And it is attached to the upper portion of the support in a form that is sequentially connected to the detection film, the absorption pad is absorbed by the remaining sample that has passed through the detection film; may include.

In addition, the diagnostic kit body may be divided into a first space in which the open space of the sample input port is exposed to the sample pad and a second space corresponding to the rest other than the first space, and a target material injected into the sample input port And a part of the blood sample including leukocytes, which has been moved to the first space, is absorbed by the sample pad and sequentially passes through the conjugation pad, the detection membrane and the absorption pad, and includes the target material and leukocytes injected into the sample inlet. The rest of the blood samples moved to the second space are introduced into the tomographic space of the white blood cell counting chamber through the capillary tube.

In addition, the blood sample including the target material and leukocytes injected into the sample inlet of the diagnostic kit body is preferably provided in a state in which red blood cells in the sample are removed through a pre-treatment process of erythrocyte hemolysis.

In addition, the detection membrane may include: a first detection line to which a second antibody that specifically binds the target substance specifically bound to the first antibody is immobilized; A second detection line fixed at a position where a third antibody, to which the target substance specifically bound to the first antibody specifically binds, is spaced apart from the first detection line; And a control line in which the fourth antibody to which the first antibody specifically binds is fixed at a position spaced apart from the second detection line, and the detection film is based on the conjugation pad side. The first detection line, the second detection line and the control line may be sequentially formed.

According to an embodiment, the second antibody fixed to the first detection line and the third antibody fixed to the second detection line may be provided with the same antibody, and according to another embodiment, the first detection line The second antibody immobilized on and the third antibody immobilized on the second detection line may be provided with different antibodies, and specific for the target substance specifically bound to the first antibody of the second antibody The binding site may be different from the specific binding site for the target substance specifically bound to the first antibody of the third antibody.

According to the present invention has the following effects.

First, it is possible to simultaneously perform a diagnosis and quantification function of a target substance in a blood sample using a side immunochromatography analysis, and simultaneously a monolayer function of a white blood cell in a blood sample for white blood cell counting.

Second, the diagnosis and quantification function of the target substance in the blood sample is simultaneously performed, and the blood sample is introduced into the tomographic space in the white blood cell counting chamber to spread evenly in a single layer, so that only white blood cells are observed without overlapping various components in the blood sample and accurate counting is performed. Can.

Third, by providing two or more detection lines that specifically bind to the same target substance in the sample on the diagnostic strip in the extensive in-vitro diagnostic kit, performing high-concentration samples to carry out in-vitro diagnostics, the quantification of the target substance in the sample is carried out with high reliability. Can be.

1 is a perspective view showing the structure of an in vitro diagnostic kit having a white blood cell counting chamber of the present invention.
Figure 2 is an exploded perspective view showing the structure of an in vitro diagnostic kit having a leukocyte counting chamber of the present invention.
3 is a plan view showing the structure of an in vitro diagnostic kit having a leukocyte counting chamber of the present invention.
4 is a cross-sectional view showing the structure of an in vitro diagnostic kit having a leukocyte counting chamber of the present invention.
5 is a perspective view showing the structure of a diagnostic strip in an in vitro diagnostic kit having a leukocyte counting chamber of the present invention.

With reference to the accompanying drawings, a preferred embodiment of the present invention will be described in more detail, but for the brevity of description, the already well-known technical parts will be omitted or compressed.

<Explanation of the structure of an in vitro diagnostic kit having a leukocyte counting chamber>

Referring to Figures 1 and 5, the in vitro diagnostic kit 100 having a chamber for leukocyte counting of the present invention includes a diagnostic kit body 110; Diagnostic strip 120; And a white blood cell counting chamber 130.

The diagnostic kit body 110 is a housing configuration that allows the diagnostic strip 120 to be installed in a separate receiving space provided therein as illustrated in FIGS. 1 to 4.

Here, the diagnostic kit body 110 includes at least one detection line 125 of the sample input port 110H and the diagnostic strip 120 providing a predetermined open space into which a blood sample B containing a target substance and white blood cells is injected. , 126, 127) A diagnostic reading window 110W for confirming the diagnosis result on the top surface is provided.

The sample inlet 110H is an open space for injecting a sample obtained by an experimenter performing a diagnosis, and the sample inlet provided on one side of the diagnostic kit body 110 of the in vitro diagnostic kit 100 with the white blood cell counting chamber of the present invention The sample injected into (110H) is preferably provided as a blood sample (B) containing a specific target material and white blood cells.

Specifically, the reason for specifying and applying a blood sample (B) containing a specific target substance and leukocytes to a sample injected into an in vitro diagnostic kit 100 having a leukocyte counting chamber of the present invention is the use of a diagnostic strip 120 This is to collectively provide a diagnosis and quantification function of a specific target substance in a blood sample (B) and a tomography function for counting leukocytes in a blood sample (B) using the white blood cell counting chamber 130 at the same time.

Here, the blood sample (B) injected into the in vitro diagnostic kit 100 provided with the white blood cell counting chamber of the present invention includes the target material and the white blood cells through separate buffer pretreatment, but the diagnosis of the target material and the white blood cells Ensure that the counting is done accurately and effectively.

Specifically, the buffer solution to be pre-treated in the blood sample (B) injected into the in vitro diagnostic kit 100 having the white blood cell counting chamber of the present invention is a buffer solution (specifically, 1X PBS) , pH 7.2) may include sodium azide (NaN ₃ ) to prevent contamination or fluorescence-conjugated antibody for use in an immune response for immunochromatographic analysis. Most importantly, it is desirable to include a red blood cell hemolytic component such as 0.1% TritonX-100 for removing red blood cells from the blood sample (B) through hemolysis.

Through this, the blood sample (B) injected into the in vitro diagnostic kit (100) with the white blood cell counting chamber of the present invention undergoes a pre-treatment process for hemolysis of red blood cells, and consequently, the red blood cells in the blood sample (B) Eliminates the problem that red blood cells in the monolayered blood sample (B) inhibit the counting accuracy of the white blood cells in the course of counting the white blood cells without affecting the diagnosis and quantification of the target substances, including the target material and white blood cells without can do.

And the sample inlet 110H is diagnosed such that a portion of the sample pad 122 for absorption of the blood sample of the diagnostic strip 120 installed inside the diagnostic kit body 110 is exposed to a part of the open space as shown in FIG. 3. Kit body 110 is provided on one side of the upper surface.

In other words, a part of the open space of the sample inlet 110H is exposed at one end of the sample pad 122 of the diagnostic strip 120 installed inside the diagnostic kit body 110 (an end opposite to the direction of movement of the blood sample and the direction of diagnosis). , Part of the blood sample (B) injected into the sample input port (110H) is absorbed by the sample pad 122 of the diagnostic strip 120, as shown in FIG.

As shown in FIG. 4, the open space of the sample inlet 110H is a first space T1 where one end of the sample pad 122 of the diagnostic strip 120 installed inside the diagnostic kit body 110 is exposed, and It is divided into a second space (T2) corresponding to the rest.

Here, a portion (B1) of the blood sample (B) containing the target material and white blood cells injected into the sample input port (110H) is moved to the first space (T1) is once the sample pad (122) of the diagnostic strip (120) To be absorbed by the conjugation pad 123, the detection film 124 and the absorption pad 128, which will be described later, are sequentially moved to allow diagnosis and quantification of the target material.

In addition, the remaining (B2) moved to the second space (T2) of the blood sample (B) containing the target material and leukocytes injected into the sample input port (110H) capillary of the white blood cell counting chamber 130 to be described later Through the tube (130C), the leukocyte counting chamber (130) is moved into the tomographic space (130T) by capillary action.

Next, the diagnostic reading window 110W is a transparent glass cover window configuration, as shown in FIG. 3, at least one detection line 125 of the diagnostic strip 120 installed inside the diagnostic kit body 110, It is provided on the upper surface of the diagnostic kit body 110 so that the detection film 124 including 126 and 127 can be identified.

Specifically, the diagnostic reading window 110W is provided in a place where the detection film 124 of the diagnostic strip 120 installed inside the diagnostic kit body 110 among the upper surfaces of the diagnostic kit body 110 can be positioned to correspond to the bottom. It should be, and is provided in a place spaced apart a predetermined interval toward the direction of movement and diagnosis of the blood sample based on the sample input port 110H.

The diagnostic strip 120 is configured to be diagnosed by using a lateral immunochromatographic assay (LFIA) of a sample injected into the body of the diagnostic kit body 110 and injected, and at least one detection line ( Test Line), but most preferably, it includes at least two or more detection lines (Test Line) unlike the conventional one so as to enable the quantification of target substances in a high concentration sample.

First, the diagnostic strip 120 includes a support 121, a sample pad 122, a conjugation pad 123, a detection membrane 124 and an absorption pad 128, and a lateral induction type (Lateral flow assay, LFA) ) It is preferably provided as a diagnostic strip.

Here, the support 121, as shown in Figure 5, the sample pad 122, the conjugation pad 123, the detection film 124 and the absorption pad 128 is attached to the upper body for sequentially connecting the body to provide.

Specifically, as shown in FIG. 5, a conjugation pad 123, a detection film 124, and an absorption pad 128 are sequentially attached to the upper portion of the support 121, as shown in FIG. The sample pad 122 and the conjugation pad 123, the conjugation pad 123 and the detection film 124, the detection film 124 and the absorption pad 128 are in close contact with each other in order, so that the sample pad 122 ), a path through which the sample injected is passed through the conjugation pad 123 and the detection film 124 to finally reach the absorption pad 128 is provided according to the capillary phenomenon.

First, the sample pad 122 is an area in which a sample (Serum, plasma, urine, swear, other bio fluid, etc.) containing a target material is injected by being attached to an upper portion of the support 121, and is used for capillary action of the sample including the target material. It is located at the top of the path along the route.

Here, the sample absorbed by the sample pad 122 is preferably a blood sample including a target material and leukocytes as described above, which is a function of the white blood cell counting function through the white blood cell counting chamber 130 to be described later. This is to proceed simultaneously with diagnosis and quantification functions.

Next, the conjugation pad 123 is attached to the upper portion of the support 121 next to the sample pad 122, as shown in FIG. 5, and is attached to the first antibody in a conjugated manner. It includes.

Here, the labeling substance to be conjugated to the first antibody can cause fluorescence expression of a specific light intensity depending on the binding saturation, so that qualitative labeling of the diagnostic result and quantitative labeling of the diagnostic level are possible gold-nanoparticles (Gold- nano particle). Fluorescence molecules such as fluorescent beads (Fluorescence bead), FITC (poly L-lysine-fluorescein isothiocyanate), or chromogenic enzymes such as horseradish peroxidase (HRP) are not limited to a specific labeling material and can be variously implemented.

In addition, in one embodiment, the labeling substance to be conjugated to the first antibody may be prepared from a substance such as FSD 647 NHS ester (BioActs).

Specifically, the target material in the sample injected into the sample pad 122 moves to the conjugation pad 123 and causes an antigen-antibody reaction with the first antibody to which the labeling substance inside the conjugation pad 123 is conjugated, thereby making each specific Will be combined.

Through this, the target material is labeled in the conjugation pad 123, and the first antibody to which the label material is conjugated is formed.

Next, the detection film 124 is attached in a form sequentially connected to the top of the support 121, the conjugation pad 123, as shown in Figure 5, the first detection line 125, the second detection line It is a porous membrane comprising (126) and the control line (127).

Here, the detection film 124 is a porous film that can be made of a polymer material such as nitrocellulose (NC), polyvinylidene fluoride (PVDF), (charge modified) Nylon or PES (Polyethersulfone), and the polymer material of the detection film 124 provided Depending on the binding form of the antibody, it can be applied in correspondence with an electrostatic bond or a hydrophobic bond.

Specifically, some of the first antibody to which the labeling material is conjugated in the conjugation pad 123 moves to the detection film 124 in a form in which the targeting material is bound, and the first antibody to which the remaining labeling material is conjugated is the targeting material. The unbounded state is moved to the detection film 124 as it is.

Accordingly, the target material that has moved into the detection film 124 is labeled, and the first antibody to which the labeling material is bonded is applied to the first detection line 125 or the second detection line 126 applied in the detection film 124. It will react with the second antibody or the third antibody.

In addition, the first antibody that is moved into the detection film 124 is not labeled and only the labeling material is bonded, the first detection line 125 and the second detection line 126 applied in the detection film 124 After passing through, the control line 127 reacts with the fourth antibody.

Here, the first detection line 125 is fixedly installed with a second antibody capable of specifically binding to each other by causing an antigen-antibody reaction of a sample derived from a sample specifically bound to the first antibody to which the labeling material is conjugated. .

In addition, the second detection line 126 is fixedly installed with a third antibody capable of specifically binding to each other by causing an antigen-antibody reaction of a sample derived from a sample specifically bound to the first antibody to which the labeling material is conjugated. , It is provided at a position spaced apart from the first detection line 125 in the detection film 124.

In addition, in the control line 127, a target antibody derived from the sample is not bound, and a fourth antibody capable of specifically binding to each other by fixing the first antibody in the original state to which the labeling material is conjugated causes an antigen-antibody reaction. It is installed, and is provided at a position spaced from the second detection line 126 in the detection film 124.

As a result, as shown in FIG. 5, the first detection line 125, the second detection line 126 and the control line 127 in the detection film 124 are first, starting from the conjugation pad 123 side. The detection line 125, the second detection line 126, and the control line 127 are sequentially formed in this order.

Therefore, the first antibody to which the target substance is bound among the first antibodies to which the labeling substance that moves into the detection film 124 from the conjugation pad 123 side is bonded is the first detection line 125 rather than the second detection line 126. And a binding reaction first, and thus saturation of the antigen-antibody binding in the detection line proceeds first in the first detection line 125.

According to an embodiment, the second antibody fixed to the first detection line 125 and the third antibody fixed to the second detection line 126 are provided with the same antibody under the premise that the target substance causing the binding reaction is the same or different antibodies It can be provided as.

Therefore, when the second antibody fixed to the first detection line 125 and the third antibody fixed to the second detection line 126 are provided with different antibodies, the target specifically bound to the first antibody of the second antibody The specific binding site for a substance is different from the specific binding site for a target substance specifically bound to the first antibody of the third antibody.

In other words, when the second antibody fixed to the first detection line 125 and the third antibody fixed to the second detection line 126 are provided with different antibodies, the specific binding to the target substance is the same, Different binding sites.

Furthermore, the specific binding affinity for the target substance specifically bound to the first antibody of the second antibody is the specific binding to the target substance specifically bound to the first antibody of the third antibody. It is provided higher than the binding affinity.

That is, the first detection line 125 in the detection film 124 is located at the tip of the second detection line 126 compared to the second detection line 126 based on the movement path from the sample pad 122 of the sample to the absorption pad 128. The characteristics of preferential binding reaction with a target substance specifically bound to 1 antibody and the specific binding affinity for the target substance specifically bound to the first antibody of the second and third antibodies Based on the characteristics, the saturation of the specific binding between the second antibody fixed to the first detection line 125 and the target substance is determined by the specific binding between the third antibody fixed to the second detection line 126 and the target substance. It occurs earlier than saturation.

Finally, the absorption pad 128 is attached in a form that is sequentially connected after the detection film 124 to the upper portion of the support 121, as shown in Figure 5, the detection film 124 coarse residual sample or residual labeling material The conjugated first antibody is absorbed.

In addition, the absorbent pad 128 serves to provide power for various moving materials due to capillary phenomena, including specimens.

The extensive in vitro diagnostic kit 100 of the present invention having such a constitutional characteristic can be performed with high reliability of quantification of a target substance in a sample even when an in vitro diagnosis is performed using a high concentration sample, so that the concentration of the sample capable of accurate quantification The range can be widened from low to high.

The leukocyte counting chamber 130 is integrally connected from the diagnostic kit body 110 to the opposite side of the diagnostic progression of the diagnostic strip 120 (diagnostic reading window 110W side), and the chamber configuration in which the blood sample for leukocyte counting is monolayered to be.

To this end, the white blood cell counting chamber 130 is capillary tube into the tomographic space 130T where a part of the blood sample injected into the tomography space 130T and the sample inlet 110H through which the blood sample B introduced therein can be collected is spread. A capillary tube 130C connecting the sample inlet 110H and the tomographic space 130T is provided inside so as to be introduced by the phenomenon.

In addition, the white blood cell counting chamber 130 is positioned correspondingly over the tomographic space 130T, and the white blood cell count reading window 130W corresponding to a cover made of a transparent material such as glass to enable the white blood cell count through confirmation of the tomographic space 130T ) Is provided on the upper surface.

Here, the capillary tube (130C) is a configuration that provides the mobility of the blood sample (B) by inducing a capillary phenomenon through structural characteristics, forming a narrow interior space compared to the sample inlet (110H) and the monolayer space (130T) do.

Specifically, the capillary tube 130C should be provided within a range of 0.5 mm to 1.5 mm in height and width (most preferably 1.0 mm), and a diameter level when the inner space is provided in a cylindrical shape It should be provided within the range of 0.5 mm to 1.5 mm (most preferably 1.0 mm).

This is a structural feature for effectively generating inflow and movement into the capillary tube (130C) due to the capillary force of the blood sample (B) moved after injection into the second space (T2) of the sample inlet (110H). .

In addition, the open space (in particular, the second space (T2)) and the tomography space (130T) of the sample inlet (110H) is provided in a wider and larger form than the capillary tube (130C).

Specifically, the tomography space 130T should be provided within a range of 0.5mm to 1.5mm (most preferably 1.0mm) in the level of height. The level of width should be provided in excess of 1.5mm.

In particular, the height level of the tomographic space 130T should be provided within the range of 0.5mm to 1.5mm (most preferably, to be provided at 1.0mm) to effectively monolayer the white blood cells, and when it exceeds this, the tomographic space 130T When observing and counting leukocytes, other components in the blood are easily overlapped with white blood cells, and there is a problem of impairing the accuracy and reliability of the white blood cell count, and if it is less than this, the white blood cells do not spread evenly, so that the fault does not occur properly This is because there is a problem that hinders the accuracy and reliability of the white blood cell count.

As described above, the blood sample B moved from the second space T2 of the sample input port 110H to the tomographic space 130T in the white blood cell counting chamber 130 through the capillary tube 130C is uniformly distributed while being monolayered. After the predetermined start has elapsed, the white blood cells of the blood sample (B) tomographically layered in the tomographic space 130T, which can be confirmed by the leukocyte count reading window 130W, are counted using a separate imaging device such as a CCD camera. (Count) is enabled.

In other words, using a separate imaging imaging device such as a fluorescence microscope or a CCD camera, the blood sample B, which has been tomographically processed after inflow into the tomographic space 130T of the white blood cell counting chamber 130, is imaged through the leukocyte count reading window 130W. Alternatively, after direct observation, the number of white blood cells in a specific region may be calculated through detection of a specific wavelength or signal region, or the number of white blood cells in a specific region may be directly calculated to calculate the level of total white blood cells using the corresponding ratio. Can.

That is, the in vitro diagnostic kit 100 provided with the white blood cell counting chamber of the present invention provides a diagnostic and quantification function of a target substance in a blood sample using a side immunochromatography analysis through the diagnostic kit body 110 and the diagnostic strip 120. At the same time, it is possible to simultaneously provide a monolayer function of leukocytes in a blood sample for leukocyte counting through the leukocyte counting chamber 130.

The embodiments disclosed in the present invention are not intended to limit the technical spirit of the present invention, but to explain, and the scope of the technical spirit of the present invention is not limited by these embodiments. The scope of protection should be interpreted by the claims below, and all technical spirits within the scope equivalent thereto should be interpreted as being included in the scope of the present invention.

100: in vitro diagnostic kit with white blood cell counting chamber
110: diagnostic kit body
110H: Sample input port 110W: Diagnostic reading window
120: diagnostic strip
121: support 122: sample pad
123: conjugation pad 124: detection film
125: first detection line 126: second detection line
127: Control line 128: Absorption pad
130: white blood cell counting chamber
130T: Single layer space 130C: Capillary tube
130W: Leukocyte count reading window
B: blood sample

Claims (7)

A diagnostic strip including at least one test line;
A sample inlet providing a predetermined open space into which a blood sample including a target substance and leukocytes is injected and a diagnostic reading window for confirming a diagnosis result on the at least one detection line are provided on the upper surface, and for absorbing the blood sample, A diagnostic kit in which the diagnostic strip is installed inside such that the sample pad of the diagnostic strip is exposed to a part of the open space of the sample inlet and the detection film of the diagnostic strip including the at least one detection line is positioned correspondingly below the diagnostic reading window. Body; And
It is formed extending from the body of the diagnostic kit and is integrally connected to the opposite side of the diagnostic progression direction of the diagnostic strip, and a portion of a blood sample injected into the sample inlet and a layer of a single layer into which the inflowed blood sample can be collected and capillaries are introduced into the layer. A capillary tube connecting the sample inlet and the monolayer space so as to be introduced by the phenomenon is provided therein, and is positioned correspondingly over the monolayer space so that the white blood cell count is possible through the identification of the monolayer space. Characterized in that it comprises a; leukocyte counting chamber provided on the upper surface of the reading window;
In vitro diagnostic kit with chamber for leukocyte counting.
According to claim 1,
The diagnostic strip,
Support;
The sample pad is attached to the upper portion of the support, a portion of the blood sample containing the target material and white blood cells injected into the sample inlet is absorbed;
A conjugation pad comprising a first antibody attached to the support in a form that is sequentially connected to the sample pad, specifically bound to the target substance, and a labeling substance conjugated thereto;
The at least one detection line that is attached to the upper portion of the support in a form that is sequentially connected to the conjugation pad, and the antibody to which the target substance specifically bound to the first antibody specifically binds, is immobilized. Detection film; And
It is attached to the upper portion of the support in a form that is sequentially connected to the detection film, the absorption pad is absorbed by the remaining sample that has passed through the detection film; characterized in that it comprises a
In vitro diagnostic kit with chamber for leukocyte counting.
According to claim 2,
The body of the diagnostic kit is divided into a first space in which the open space of the sample inlet is exposed to the sample pad and a second space corresponding to the rest other than the first space,
A portion of the blood sample containing the target substance and white blood cells injected into the sample inlet is moved to the first space is absorbed by the sample pad and sequentially passes through the conjugation pad, detection membrane and absorption pad,
The rest of the blood sample including the target material and white blood cells injected into the sample inlet is moved to the second space and is introduced into the tomographic space of the white blood cell counting chamber through the capillary tube.
In vitro diagnostic kit with chamber for leukocyte counting.
According to claim 3,
A blood sample including a target substance and leukocytes injected into the sample inlet of the body of the diagnostic kit is characterized by being provided in a state where red blood cells in the sample are removed through a pre-treatment process of erythrocyte hemolysis.
In vitro diagnostic kit with chamber for leukocyte counting.
According to claim 2,
The detection film may include: a first detection line to which a second antibody to which the target substance specifically bound to the first antibody specifically binds is fixed; A second detection line fixed at a position where a third antibody, to which the target substance specifically bound to the first antibody specifically binds, is spaced apart from the first detection line; And a control line in which a fourth antibody to which the first antibody specifically binds is fixed at a position spaced apart from the second detection line.
The detection film is characterized in that the first detection line, the second detection line and the control line are sequentially formed on the basis of the conjugation pad side.
In vitro diagnostic kit with chamber for leukocyte counting.
The method of claim 5,
The second antibody fixed to the first detection line and the third antibody fixed to the second detection line are provided with the same antibody.
In vitro diagnostic kit with chamber for leukocyte counting.

The method of claim 5,
The second antibody immobilized on the first detection line and the third antibody immobilized on the second detection line are made of different antibodies and target the target material specifically bound to the first antibody of the second antibody. The specific binding site is characterized in that it is different from the specific binding site for the target substance specifically bound to the first antibody of the third antibody.
In vitro diagnostic kit with chamber for leukocyte counting.

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