KR102425258B1 - Sample collection and analysis all-in-one device, and method for providing information for disease diagnosis using the same - Google Patents

Abstract

The present invention relates to an integrated sample collection and analysis device, and a method for providing information for disease diagnosis using the same, wherein the device can accurately collect a sample volume by selecting a nozzle corresponding to a target volume, and stably mount a strip to provide a sample Since the detection efficiency and sensitivity are extremely excellent by having a push stick that accurately reacts with

Description

Sample collection and analysis all-in-one device, and method for providing information for disease diagnosis using the same

The present invention relates to a specimen collection and analysis integrated device, and a method for providing information for disease diagnosis using the same.

Many analytical procedures and analyzers are usually used to test bodily fluids for substances of diagnostic value. Serum/plasma, blood and urine are the most tested body fluids. When blood is used as the test body fluid, there is an advantage in that it is possible to obtain information on the patient's health status by collecting the analyte at a relatively high concentration.

If a specific substance can be detected and quantitatively measured, it is possible to monitor various drug administration, to determine various hormonal imbalances, to quantify physiologically active proteins, and to diagnose diseases through detection of pathogens.

In order to simplify the investigation process, a kit that can perform both sample collection and analysis was devised (Korean Patent No. 10-1136654), but there were cases where the strip was not stably fixed, resulting in a defect that did not proceed. This can also affect sensitivity. It was confirmed that there are difficulties in the process of coating the inside so that there is no problem in the inner riding of the capillary in the member for collecting the sample using the capillary phenomenon.

Accordingly, in the device for disease diagnosis, the present inventors can select a nozzle corresponding to a target capacity to accurately collect a sample volume, and in a device having a pushstick that accurately reacts with the sample by stably mounting the strip, It was confirmed that the detection efficiency and sensitivity were remarkably excellent.

Accordingly, the object of the present invention is

Hollow case with both ends open;

Removable at the lower end of the case, a nozzle provided with a collecting pipe; and

It is inserted from the upper end of the case and includes a push stick for mounting the strip that slides along the longitudinal axis of the case,

a first locking groove formed in the case for fixing after inserting the pushstick; a second locking groove spaced apart from the first locking groove in the lower end direction along the longitudinal axis of the case for fixing after sliding the pushstick and formed in the same standard as the first locking groove; And it is to provide an integrated device for collecting and analyzing specimens, including a locking protrusion formed on the pushstick to correspond to both the first locking groove and the second locking groove.

Another object of the present invention is

a sampling step of collecting a sample by selecting a nozzle having a collection tube corresponding to a target capacity;

In a hollow case in which a nozzle is coupled to the lower end, a push stick having a fixed strip is inserted into the upper end of the case and sliding along the longitudinal axis of the case, thereby bringing the strip into contact with the sample in the collection tube; and

An object of the present invention is to provide a method for providing information for diagnosing a disease using an integrated sample collection and analysis device, which includes a detection step of confirming whether a sample reacts on the strip after it is developed into a strip.

The present invention relates to an integrated sample collection and analysis device, and a method for providing information for disease diagnosis using the same. A push stick that accurately reacts with the sample by mounting is provided.

The present inventors selected a nozzle corresponding to the target capacity, coupled the nozzle to the case, and inserted a push stick mounted with the strip into the case after sample collection, thereby inducing a reaction by contacting the strip with the sample.

In general, in an immunochromatographic analysis (Lateral flow immunoassay) kit, a quantitative sample and buffer should be directly quantified and injected by a user. There is no problem if it is a professional medical institution or laboratory equipped with equipment capable of quantitative collection and dispensing, but it is difficult for the general public at home to have equipment for quantitative collection and dispensing. The device of the present invention is designed to collect samples and buffers in a quantitative manner, and since the amount of the buffer corresponding to the kit component corresponds to the quantitative, and also the amount of the buffer developed after the reaction corresponds to the quantitative, especially a pipette for quantitative collection Ordinary people can easily use it without having to have a measuring instrument or other measuring tools.

Hereinafter, the present invention will be described in more detail.

One aspect of the present invention is

Hollow case with both ends open;

Removable at the lower end of the case, a nozzle provided with a collecting pipe; and

It is inserted from the upper end of the case and includes a push stick for mounting the strip that slides along the longitudinal axis of the case,

a first locking groove formed in the case for fixing after inserting the pushstick; a second locking groove spaced apart from the first locking groove in the lower end direction along the longitudinal axis of the case for fixing after sliding the pushstick and formed in the same standard as the first locking groove; and a locking protrusion formed on the pushstick to correspond to both the first locking groove and the second locking groove, and an integrated sample collection and analysis device.

In the case, a result window may be formed to confirm color development at a point where a reaction is expected to appear on the strip. The color development of the strip may appear in the form of an inspection line, but is not limited thereto. The result window may be formed in a size so that the point where the control line of the strip appears to give reliability of the reaction along with the test line can also be confirmed.

The test line may be formed by immobilizing a biomolecule capable of binding a sample to one or more points on the strip to be displayed. The biomolecule may be, for example, one or more selected from the group consisting of antigens, antibodies, genes, peptides, phages, sugars and cells, but is not limited thereto.

As used herein, the term “sample” is a target for reaction by being applied to the device of the present invention, and refers to a material separated from a sample or a subject that may contain the sample.

Samples are from the group consisting of whole blood, plasma, blood products, urine, sweat, tears, pericardial fluid, peritoneal fluid, pleural fluid, cerebrospinal fluid, gastric fluid, respiratory secretion fluid, semen, synovial fluid, vomit fluid, ulcer drainage, ascites, saliva and amniotic fluid. It may be one or more types selected, but is not limited thereto.

The reaction on the strip may appear as a result of a color reaction induced by the reaction of the sample with a developing solution or a material previously impregnated in the strip.

Instead of forming a result window to check the inspection line or control line of the strip, the material of the case may be selected as a transparent one. In this case, since the strip is manufactured in a completely closed, closed type without being opened, there is an advantage in protecting the examiner from the high-risk group of infection.

The specimen collection and analysis integrated device may include a coupling groove and a coupling protrusion corresponding to each other formed on the coupling surface of the case and the nozzle.

For example, one or more pairs of embossed coupling protrusions and corresponding intaglio coupling grooves for coupling may be formed at one point on the coupling surface of the case and the nozzle, or a line circumferentially along the coupling surface of the case and the nozzle. An embossed coupling protrusion formed in the shape and an intaglio coupling groove corresponding thereto may be formed. Alternatively, the coupling surface of the case and the nozzle may be engaged and coupled without a coupling groove and coupling protrusion by forming a step difference.

The nozzle is press-fitted and coupled to the lower end of the case, so that it can operate as an external substrate, which is one component together with the case.

The collection tube may perform a function of collecting a sample using a capillary phenomenon, and the amount of sample that can be held in one collection can be set in various ways by selecting the volume of the collection tube according to the purpose and purpose. The volume of the collecting pipe may be variously determined according to the inner diameter and length, for example, may be selected from 5 to 30 ul, but is not limited thereto.

The coating treatment inside the collection tube may be performed using Tween 20, a cellulose-based polymer solution, or a surfactant.

The material of the nozzle may be a plastic material having a strong hydrophilic property, and mainly corresponds to a cellulose series, for example, cellulose acetate. In the case of using cellulose acetate, the capillary phenomenon may be well performed during sample collection without a processing process of separately performing coating treatment inside the collection tube, and thus the sample may be fully used.

The push stick is inserted into the outer substrate to which the nozzle is coupled to the lower end of the case to operate as an inner substrate, and supports for stably mounting the strip may be formed on both sides of the pushstick. Since the strip is mounted on the push stick and fixed by the support, it moves according to the movement of the push stick after being mounted. The number of strips mounted on the pushstick may be one, but the present invention is not limited thereto.

The strip may include a sample pad and a membrane pad.

The sample pad may be in contact with the collection tube inside the nozzle to absorb the sample.

The membrane pad includes a position of one or more test lines on which a reaction result of a sample using a standard diagnostic reagent is displayed to perform an enzymatic reaction or an immunological diagnostic method.

In one embodiment of the present invention, the strip is composed of a sample pad, a conjugation pad, a whole blood separation pad, a membrane pad and an absorption pad in the order of reacting with the sample first.

The conjugation pad may be prepared by pre-impregnating an enzyme or antibody capable of binding or reacting with a sample.

The whole blood separation pad may be used to make the test line more visible by preventing the development of blood cell components when whole blood is used as a sample.

The absorption pad may serve to absorb the reaction solution and the sample after the reaction has been completed.

The inclined jaw is formed on the supports on both sides of the push stick, and since the width of the space for mounting the strip becomes narrower as it goes down to the floor by the inclined jaw, when the user presses the push stick to mount the strip, Since both sides of the strip and the contact portion of the inclined jaw receive pressure, they can be stably fixed by the frictional force formed accordingly.

The inclined jaw may be formed in a region where the moisture absorption pad is positioned when the strip is mounted, but is not limited thereto.

The first locking groove is formed in the case and engages with the locking protrusion of the inserted pushstick to fix the pushstick at a position where the insertion is completed.

The second locking groove is formed in the case, and the pushstick slides and engages with the locking protrusion coming out of the first locking groove, and serves to fix the pushstick at the position where the sliding is completed.

The locking protrusion is formed on the pushstick and engages the first locking groove so that the pushstick inserted into the upper end of the case can be fixed at the position where the insertion is completed, and then comes out of the first locking groove and moves as much as the sliding distance of the pushstick. Thus, by engaging the second locking groove, the strip mounted on the pushstick is fixed at a position in contact with the sample.

Another aspect of the present invention is

a sampling step of collecting a sample by selecting a nozzle having a collection tube corresponding to a target capacity;

In a hollow case in which a nozzle is coupled to the lower end, a push stick having a fixed strip is inserted into the upper end of the case and sliding along the longitudinal axis of the case, thereby bringing the strip into contact with the sample in the collection tube; and

A detection step of checking whether the sample reacts on the strip after it is developed into a strip

It is a method for providing information for disease diagnosis using a sample collection and analysis integrated device comprising a.

The sampling step refers to a process in which the capillary phenomenon is induced by contacting the end of the collection tube provided in the nozzle with the sample, and the sample is stored inside the collection tube. The sampling may be performed regardless of whether the nozzle is coupled to the lower end of the case.

The developing step may be performed by bringing the end of the collecting tube provided in the nozzle into contact with the developing solution, so that the sample already stored in the collecting tube is developed together with the developing solution from the collecting tube to the strip in contact with it. The developing solution may be absorbed in the same principle as the sample collection by contacting the end of the collection tube provided in the nozzle, and may be mixed with the sample already stored in the collection tube.

A commonly used buffer solution may be used as the developing solution, and deionized water, PBS (phosphate buffer saline), phosphate, borate, Tris, hydroxyethylpiperazineethanesulfonic acid ( At least one buffer selected from the group consisting of hydroxyethyl piperazine ethane sulfonic acid; HEPES) and 2-[N-morpholino]ethanesulfonic acid ((2-(N-morpholino)ethanesulfonic acid; MES) may be used.

The unfolding step may be performed in the form of an external substrate in which a nozzle is coupled to the lower end of the case, and at this time, a push stick having a strip mounted on the upper end of the hollow case may be inserted as an inner substrate. When inserting, the locking projection of the pushstick corresponds to the first locking groove formed in the case to fix the pushstick.

In one embodiment of the present invention, in the process in which the mixture of the sample and the developing solution is developed from the collection tube to the strip, the pushstick slides and moves in the lower end direction along the longitudinal axis of the case, the first locking groove formed in the case The locking projection of the pushstick corresponding to the first locking groove is spaced apart from the first locking groove and corresponds to the position of the second locking groove formed in the case with the same standard, and the strip mounted on the pushstick slid along the longitudinal axis of the case is inside the case. As it moves, it reaches the inside of the nozzle coupled thereto, and is carried out by contacting the mixture of the sample and the developing solution stored in the collection tube.

The detection step may be performed by confirming whether the mixture of the sample and the developing solution in contact with the strip is developed along the strip, thereby showing color development by immunochromatography or enzymatic reaction. The color development of the strip may appear in the form of an inspection line, but is not limited thereto. In order to give the reliability of the results, it can be additionally checked whether a control line appears or not.

The present invention relates to an integrated sample collection and analysis device, and a method for providing information for disease diagnosis using the same, wherein the device can accurately collect a sample volume by selecting a nozzle corresponding to a target volume, and stably mount a strip to provide a sample Since the detection efficiency and sensitivity are extremely excellent by having a push stick that accurately reacts with

1A is a component diagram of a device according to an embodiment of the present invention.
1B is a perspective view illustrating an assembled state when a device according to an embodiment of the present invention is manufactured using a transparent material.
1C is a perspective view illustrating an assembled state when a result window for checking an inspection line is formed in a device according to an embodiment of the present invention.
1D is a perspective view illustrating an inclined jaw formed on a support target of a device according to an embodiment of the present invention.
2A is a perspective view illustrating a coupled state when a push stick is inserted in a device according to an embodiment of the present invention.
2B is a perspective view illustrating a coupled state when the push stick is slid in the device according to an embodiment of the present invention.
3A is a perspective view showing that the nozzle and the case are coupled by a step formed on the coupling surface in the device according to the embodiment of the present invention.
3B is a perspective view showing that the nozzle and the case are coupled by the coupling groove and coupling protrusion formed at one point of the coupling surface in the device according to the embodiment of the present invention.
Figure 3c is a perspective view showing that in the device according to an embodiment of the present invention, the nozzle and the case are coupled by the coupling groove and the coupling protrusion formed in the form of a line circumferentially along the coupling surface.
4A is an evaluation result comparing the performance of the device coated with the inside of the collection tube according to the embodiment of the present invention compared to the existing card-type kit using positive standard plasma as a sample.
4B is an evaluation result comparing the performance of the device coated with the inside of the collection tube according to the embodiment of the present invention compared to the existing card-type kit using whole blood as a sample.
5A is a photograph showing a state in which a sample is collected in a collection tube using a nozzle which is a component of a device according to an embodiment of the present invention.
5B is an evaluation result comparing the performance of a device manufactured by injection with cellulose acetate according to an embodiment of the present invention compared to a conventional card-type kit using whole blood as a sample.

Hereinafter, preferred embodiments of the present invention in which the objects of the present invention can be specifically realized are described with reference to the accompanying drawings. In describing the present embodiment, the same names and the same reference numerals are used for the same components, and an additional description thereof will be omitted below.

An embodiment of the sample collection and analysis integrated device of the present invention and a method for providing information for diagnosing a disease using the same will be described with reference to FIGS. 1 to 3 of the present specification.

1A is a component diagram of a device 1 according to an embodiment of the present invention. When the device 1 is assembled according to such a component diagram, FIG. 1b is a perspective view showing an assembled state when the case 11a is made of a transparent material, and FIG. 1c is an inspection line on the case 11a It is a perspective view showing the assembled state when the result window 114 for 1D is a perspective view showing the inclined jaw 124 formed on the support 122 of the push stick 12a.

According to an embodiment of the present invention, the sample collection and analysis integrated device 1 includes an external substrate 11 including a case 11a and a nozzle 11b detachable thereto; and an internal substrate 12 including a push stick 12a.

A first locking groove 113a and a second locking groove 113b are formed in the case 11a, and a result window 114 for confirming the results when using the sample collection and analysis integrated device may be formed, but the case ( It is not essential if the material of 11a) is transparent.

The nozzle 11b has a collection pipe 111 for sampling a sample, and is press-fitted to the lower end of the case 11a to be coupled, so a collection tube 111 having a standard corresponding to the target capacity of the sample that the user wants to collect. ) can be selected and used with a nozzle 11b.

Since the capacity of the collecting pipe 111 can be designed in various ways, when the device 1 is used, the nozzle 11b having the collecting pipe 111 corresponding to the target capacity is freely selected and coupled to the case 11a. can be used by

Numerical values of length, inner diameter, and outer diameter that determine the capacity of the collecting pipe 111 may be variously changed depending on the situation and applied to the production of the nozzle 11b.

The push stick 12a is provided with a locking protrusion 121 corresponding to the first locking groove 113a and the second locking groove 113b of the case 11a when sliding, and a support 122 for mounting the strip. is formed An inclined jaw 124 is formed on the inside of the support 122, and when the strip is mounted, it can be stably fixed.

Insertion of the push stick 12a may be performed by holding the handle 123 located at the opposite end of the insertion direction by the user, and sliding is performed by the user protruding out of the upper end of the case 11a in the inserted state of the push stick 12a. This can be done by pressing the handle 123 and further inserting the push stick 12a in the direction in which it has already been inserted.

2A is a perspective view showing a coupled state when the push stick 12a is inserted in the sample collection and analysis integrated device 1 according to an embodiment of the present invention, and FIG. 2B is a coupling when the push stick 12a is sliding. It is a perspective view showing the state in which it was made.

When the inner substrate 12 composed of the push stick 12a is inserted into the outer substrate 11 , the locking protrusion 121 of the inner substrate 12 is in the first locking groove 113a of the outer substrate 11 . corresponded At this time, the handle 123 is maintained in a protruding form at the upper end of the outer substrate 11, and can slide the inner substrate 12 by pressing it. As a result of sliding, the protrusion of the handle 123 outside the outer substrate 11 is reduced, and the locking protrusion 121 corresponds to the second locking groove 113b.

Figure 3a shows that when the nozzle 11b is coupled to the case 11a in the external substrate 11 according to the embodiment of the present invention, the nozzle 11b and the case 11a are coupled by a step formed on the coupling surface. 3b is a perspective view showing that the nozzle 11b and the case 11a are coupled by the coupling groove 112a and the coupling protrusion 112b formed at one point of the coupling surface, FIG. 3c is the nozzle 11b ) and the case (11a) is a perspective view showing that the coupling by the coupling groove (112a) and the coupling projection (112b) formed in the form of a circumferential line along the coupling surface.

As the nozzle 11b is press-fitted to the lower end of the case 11a and coupled, the coupling groove 112a and the coupling protrusion 112b are engaged with each other to constitute the coupling device 112 .

Example 1: Performance evaluation of coated sample collection and analysis all-in-one device

After 20 ul of the sample was dispensed into the conventionally used card-type kit for HIV diagnosis, 100 ul of buffer was added, and the sample using a device coated with Tween 20 (0.01%) inside the collection tube according to the present invention. 20 ul was collected and then reacted in a 300 ul buffer tank.

HIV standard plasma (Type 1: KFDA Anti-HIV-1 Mixed Titer Performance Panel 12/038, Type 2: Seracare Accuset HIV 1/2 Performance Panel 088-0331) was treated with a high-positive (high concentration) of 10.0 or more, and a medium-positive (medium-positive) In Fig.), a concentration of 4.0 to 6.0 and a low positive (low concentration) concentration (Index, S/Co) of 1.0 to 2.5 were applied and used as positive samples, and positive and negative whole blood samples were used as whole blood samples.

As can be seen in FIG. 4A , when positive standard plasma was used as a sample, the sensitivity of the test line and the control line was similar to both the existing card-type kit and the device (self) of the present invention, regardless of the HIV type.

On the other hand, as shown in FIG. 4B , when whole blood was used as a sample, both the existing card-type kit and the self kit of the present invention did not show false positives in the negative whole blood, regardless of the HIV type, and the sensitivity of the control line was similar. Even in the high-positive sample, similar results were obtained without difference in sensitivity, but in the case of the low-positive and medium-positive samples, it was observed that the overall device of the present invention had weaker sensitivity compared to the existing card-type kit.

Example 2: Performance evaluation of a cellulose acetate material sample collection and analysis integrated device

The device of the present invention was manufactured in the same manner as in Example 1, but the raw material was selected as cellulose acetate and injected, so that a separate coating treatment was not performed on the inside of the collection tube, as shown in FIG. 5A. After that, performance evaluation was performed using whole blood as a sample in the same way as compared to the existing card-type kit.

As can be seen in Figure 5b, when whole blood was used as a sample, it was confirmed that there was no difference in sensitivity between the existing card-type kit and the device (self kit) of the present invention regardless of low, medium, and high positive, and accordingly, the present invention demonstrated that the performance of the device of the existing card type is similar to that of the kit.

1: device
11: External board
11a: case
11b: nozzle
111: collection tube
112: coupling device
112a: coupling groove
112b: bonding protrusion
113a: first locking groove
113b: second locking groove
114: result window
12: internal board
12a: push stick
121: stumbling block
122: support
123: handle
124: inclined jaw

Claims (7)

Hollow case with both ends open;
Detachable to the lower end of the case, a nozzle provided with a collecting pipe; and
It is inserted from the upper end of the case and includes a push stick for mounting the strip that slides along the longitudinal axis of the case,
a first locking groove formed in the case for fixing after inserting the pushstick; a second locking groove spaced apart from the first locking groove in the lower end direction along the longitudinal axis of the case for fixing after sliding the pushstick and formed in the same standard as the first locking groove; and a locking protrusion formed on the pushstick to correspond to both the first locking groove and the second locking groove,
The push stick is an integrated device for collecting and analyzing specimens, in which supports and inclined jaws for mounting the strip are formed on both sides. According to claim 1, wherein the device will include a coupling groove and coupling protrusion corresponding to each other formed on the coupling surface of the case and the nozzle, the sample collection and analysis integrated device. The device of claim 1, wherein the material of the nozzle is cellulose acetate. delete A method for providing information for disease diagnosis, comprising the following steps performed by a user with an integrated device for collecting and analyzing a sample:
a sampling step of collecting a sample by selecting a nozzle having a collection tube corresponding to a target capacity;
In a hollow case in which a nozzle is coupled to the lower end, a push stick having a strip fixed to a support and an inclined jaw is inserted into the upper end of the case and slides along the longitudinal axis of the case, thereby bringing the strip into contact with the sample in the collecting tube. deployment stage; and
A detection step of checking whether the sample reacts on the strip after it is developed into a strip;
In the unfolding step, as the locking protrusion of the pushstick corresponding to the first locking groove formed in the case moves toward the lower end along the longitudinal axis of the case as the pushstick slides, it is spaced apart from the first locking groove to the case in the same standard. This is performed by corresponding to the position of the formed second locking groove. The method of claim 5 , wherein the developing step is performed by bringing the end of the collecting tube into contact with the developing solution so that the sample is developed from the collecting tube together with the developing solution into a strip. delete

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