KR101981862B1 - Diagnosis strip using lateral flow - Google Patents

Abstract

The present invention relates to a diagnostic strip using a side flow, and more particularly, to a diagnostic strip using a side flow, more specifically, a multi-layered film to form a microfiltration channel, a sample solution containing blood through the channel is transferred to an asymmetric membrane by capillary action, In the asymmetric membrane, the sample solution is induced by side flow to separate the blood cells. The sample solution in which the blood cells are separated enters the reaction region located in the pore layer, which is a pore size layer of the asymmetric membrane, To a diagnostic script using an asymmetric membrane having both a separation and a reaction zone.

Description

{DIAGNOSIS STRIP USING LATERAL FLOW}

More particularly, the present invention relates to a diagnostic strip using a lateral flow, and more particularly, to a method of forming a microfluidic channel by layering a plurality of films, transporting a sample solution containing blood through the channel by capillary phenomenon and supplying the membrane to an asymmetric membrane In the asymmetric membrane, the sample solution is induced by side flow to separate the blood cells. The sample solution from which the blood cells have been separated flows into the reaction region located in the pore layer, which is a layer having a small mesopore size of the asymmetric membrane, The present invention relates to a diagnostic strip using asymmetric membranes having both hemocyte separation and reaction regions.

Recently, due to the development of medicine and medical engineering, various causes and treatment methods of various diseases have been introduced, more accurate diagnosis of various diseases has been made, more effective and safe treatment methods have been developed, Trend.

Nevertheless, diagnosis and treatment of such diseases are mainly performed in hospitals. In the case of the subject to be diagnosed, there is a problem that the diagnosis and diagnosis of the disease itself are impossible without visiting the hospital directly. Therefore, it has been difficult for patients and patients to pay a high cost of examination and treatment.

Recently, telemedicine system has been introduced as an effort to solve the above problems and difficulties due to development of electronic industry and wired / wireless communication network. Such a remote medical system is a method in which a diagnosis subject or a patient can be diagnosed at a relatively low cost at a remote place without visiting a hospital directly. However, most of them have only been diagnosed with an external abnormality, It was very limited and there were many difficulties to make an accurate diagnosis.

Recently, various diagnostic sensors have been provided as an alternative. Lateral flow immunoassay (LFA) sensors have been widely used for on-site testing such as pregnancy diagnosis, and it is easy to use and quickly analyze results It has been widely used as a rapid diagnostic technique for medical use. In addition, the lateral flow immunoassay based simple diagnostic sensor is being developed as a method for quickly inspecting the stability of the food and the health of the livestock, since the analysis cost is low and the expensive measuring instrument or professional manpower is not required.

However, it is difficult to apply the diagnostic sensor to the same field as the enzyme-based diagnostic sensor in addition to the immuno-diagnostic sensor using the antigen-antibody, and accurate diagnosis can be performed by inputting a large amount of sample.

Korean Registered Patent No. 10-0354581 (registered on September 16, 2002, hereinafter referred to as "Prior Art 1") provided an optical reading strip. The prior art document 1 is a test strip for measuring the presence or amount of analytes in a liquid by inserting the test strip into an optical reader, comprising: a leading edge and a following edge; A portion having a surface that defines a reaction region that has a coated liquid and changes reflectance by the action of the amount of analytes present in the applied liquid; Said test strip having a relatively high reflectance for said reaction zone and a distance of at least about 0.3 inches (about 0.76 cm) from said reaction zone; Further comprising a standard area extending toward said leading edge for said first edge; The apparatus comprises optical means for sequentially measuring the reflectance of the standard region when the strip is inserted into the apparatus and the reflectance of the reaction region after the strip is inserted and measuring the presence or amount of analytes in the liquid by the action of the reflectance To a test strip on which a microprocessing means is provided.

Japanese Unexamined Patent Publication No. 6-86696 (published on March 29, 1994; hereinafter referred to as 'Prior Art 2') discloses a visible test piece for blood glucose concentration. The prior art document 2 is provided with a porous body (the mother body is uniformly impregnated with a separating coating and a test reagent) having a sample side and a test side; Said matrix being adapted to receive an entire sample of blood adhered on said sample side and passing said sample towards said test side; Wherein the separating coating is capable of separating an essentially transparent component fluid containing the analyte from the total blood, the test reagent reacting with the analyte in the clear component fluid to determine the concentration of the analyte in the fluid Wherein the separating coating is capable of changing the color of the test side of the matrix depending on the level of the substrate; and wherein the separating coating is selected from the group consisting of polyvinylsulfonic acid, polyethylene glycol, polystyrenesulfonic acid, hydroxypropylcellulose, polypropylene glycol, polyvinylpyrrolidone And polyacrylic acid.

In the prior arts 1 and 2, all of the samples to be analyzed are put on the surface of the absorbent pad, and the sample to be analyzed put in the absorbent pad is separated while passing through the absorbent pad to remove foreign matter. Is supplied to the reaction pad containing the reactant attached to the reaction pad, and the reaction is carried out and confirmed by the measuring device.

In this method, since the sample is supplied to one side of the absorbent pad and then to the reaction pad attached to the opposite side of the absorbent pad, it is very difficult to control the amount of the sample to be injected by direct injection using capillary blood, can do. In addition, since the length of the sample passing through the absorbent pad is short, the foreign matter is not sufficiently separated and the detection sensitivity is low. In order to increase the detection sensitivity, the thickness of the absorbent pad must be increased. However, There is a need for research on structures that can improve detection sensitivity by separating foreign matter from samples in a new way.

Korean Registered Patent No. 10-0354581 (registered on September 16, 2002): optical read strip Japanese Unexamined Patent Publication No. 6-86696 (published on Mar. 29, 1994): Visible test piece for blood glucose concentration

Therefore, in the diagnostic strip using the side flow of the present invention,

A small amount of sample solution is introduced by capillary phenomenon and is transferred to the asymmetric membrane through the flow path to the inflow end, and the sample solution separates the blood cells and foreign substances in the sample solution while moving the asymmetric membrane composed of one or two sheets by the side flow. The sample solution in which the blood cells are separated during the movement is moved from the inlet end portion to the opposite end portion of the asymmetric membrane to a reaction region formed on the bottom surface of the pore layer having a small pore size to minimize the influx of the blood, And to provide a thin film type diagnostic strip which allows the detection of the detection by the measuring device.

According to an aspect of the present invention, there is provided a diagnostic strip,

A support on which the reaction solution is dispensed; A pore layer having a small pore size and a large pore layer having a large pore size are each formed asymmetrically on both sides and the pore layer side is disposed on the lower side and laminated on the support, And an asymmetric membrane forming a region.

The support may be composed of an upper film and a lower film through which the reaction solution is dispensed, and an asymmetric membrane may be interposed between the upper film and the lower film.

In addition, the lower film may treat a surface on which the reaction solution is dispensed to a hydrophilic surface or a minority surface. The support may further include a thickness-forming film interposed between the upper film and the lower film to guide the sample solution to the asymmetric membrane disposed at the center, or to prevent compression of the asymmetric membrane. The material may be a PET material As shown in FIG.

In addition, the lower film is a rectangular plate elongated in one axis, and on the upper surface is formed a moving region subjected to hydrophilic treatment so as to move the sample solution to an inner portion of a region having a predetermined length from the front end to the rear end, A dispensing area in which the reaction solution is dispensed at a predetermined distance in the longitudinal direction is formed and the adhesive area is formed in an area other than the hydrophilic treated area and the dispensing area of the moving area, Wherein the asymmetric membrane is attached to an upper region of the lower film, the region being a region including a dispensing region at a rear end side of a moving region of the lower film; The thickness forming film is attached between both sides of the moving region of the lower film and between the asymmetric membrane end and the lower film back end to form a sample solution flow passage and a membrane seating region; The upper film may be a rectangular plate formed to have the same size as the lower film, and may be configured to be attached to the upper part of the thick film and the asymmetric membrane.

At this time, the upper film may be subjected to hydrophilic treatment on the lower surface thereof in a region facing the moving region of the lower film.

The lower film is printed on the lower surface with black ink at a predetermined width between the end of the moving region and the reaction region and at the rear end side of the reaction region and the upper film is made of black ink The sample solution moving region and the dispensing region can be clearly distinguished from other regions by printing.

In addition, the lower film and the upper film may be formed of a transparent material, which is a moving region through which the sample solution moves, to confirm the movement of the sample solution from the outside, and a part of the asymmetric membrane is partially exposed as a transparent material portion A membrane marking portion may be formed to visually confirm that the sample solution is supplied to the asymmetric membrane.

The upper film may be provided with an arrow mark on the rear end side so as to distinguish the direction of insertion into the measuring instrument.

The thickness of the asymmetric membrane is 300 mu m, and the thickness of the asymmetric membrane is 250 mu m. When the thickness of the asymmetric membrane is 250 mu m, the thickness of the asymmetric membrane is 250 mu m.

The diagnostic strip using the side flow of the present invention by the above-

The microfluidic channel is formed by lamination of the films to induce capillary phenomenon so that a small amount of the sample solution can be easily introduced and the introduced sample solution passes through the asymmetric membrane in a side flow manner to perform sufficient foreign matter filtering, Can be improved.

Particularly, the reaction solution is first dispensed to the lower film without directly dividing into the large pore layer constituting the asymmetric membrane, and then absorbed through the small pore layer surface having the small pore size of the asymmetric membrane, (Such as proteins and chemicals) contained in the reaction solution can be increased, so that the influence of the asperity of the asymmetric structure for blood cell separation on the large upper surface can be minimized. This is because when the blood is used, since the reaction area is in the pore layer, the inflow of blood cells into the reaction area can be minimized and the detection sensitivity by the reaction can be further improved.

The asymmetric membrane can be visually inspected to see whether the sample solution has been transferred to the asymmetric membrane by displaying a part of the asymmetric membrane on the inlet side transparent window so that it can be confirmed from the outside, Optics), it is now possible to provide useful diagnostic strips, which can prevent user errors and errors in the measurement process.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1A and 1B are cross-sectional views showing an embodiment of a diagnostic strip according to the invention.
FIG. 2 (a) is an operational view of a diagnostic strip in which a reaction zone is formed by absorbing a reaction solution according to the present invention from the bottom; FIG.
FIG. 2b is a diagram showing the state of action of a diagnostic strip in which a reaction region is formed by dividing a reaction solution at an upper portion. FIG.
3 is a sectional view showing an embodiment in which the support according to the present invention is composed of an upper film and a lower film.
FIGS. 4 and 5 are a perspective view and an exploded perspective view showing a diagnostic strip according to a preferred embodiment of the present invention;
Figure 6 is a top view of the lower film of the diagnostic strip of the present invention.
FIGS. 7A and 7B are plan views showing a state in which a membrane is attached to a lower film among the diagnostic strips of the present invention. FIG.
Figure 8 is a plan view of a thickness-forming film of a diagnostic strip of the present invention.
Figure 9 is a top view of an upper film of a diagnostic strip of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described in detail with reference to the accompanying drawings. It should be understood, however, that the appended drawings illustrate only the contents and scope of technology of the present invention, and the technical scope of the present invention is not limited thereto. It will be apparent to those skilled in the art that various changes and modifications can be made within the scope of the technical idea of the present invention based on these examples.

1A and 1B are cross-sectional views showing an example of a diagnostic strip according to the present invention.

The diagnostic strip 10 according to the present invention comprises a support 20 on which the reaction solution 21 is dispensed and an asymmetric membrane 30 which is seated on the support and absorbs the reaction solution.

The support 20 may be formed of a plastic material that does not absorb the sample solution, preferably a plastic material such as PET, polyester nylon, or the like. It is possible to cause the reaction solution to be adsorbed to the membrane as much as possible without being coated on the support.

The asymmetric membrane 30 can be easily filtered by using various kinds of materials. Preferably, the asymmetric membrane 30 can be filtered by developing a sample solution by side flow using nim GX or GR manufactured by PALL. have.

The asymmetric membrane 30 has the small pore size layer 31 and the major pore layer 32 having a large pore size as shown in FIG. The reaction zone 33 formed by absorbing the reaction solution 21 is formed in the pore layer 31 so that the pore layer 31 is formed at the bottom or near the pore layer.

2A, the sample solution flowing into the inlet side, which is one end of the asymmetric membrane 30, is horizontally moved in the pore layer 31 of the asymmetric membrane, 33 or a large number of blood cells are filtered by contact with the pore layer in the process of horizontally moving to the pore layer 32 and the remaining blood cells are filtered while passing through the pore layer near the reaction region to be transferred to the reaction region, By minimizing or suppressing the inflow of the reaction region of the blood cells to participate in the reaction, the optical detection sensitivity can be improved by minimizing the hemocyte impact.

FIG. 2B shows the reaction site formation position due to the solidification of the reaction solution when the reaction solution is dispensed through the upper layer of the asymmetric membrane. When the reaction solution is dispensed from the upper part, the protein component in the reaction solution reaches the interface of the pore layer while coating the inner surface of the pore layer, and is absorbed to the lower part from the interface of the pore layer, Is coated to form a reaction region (33). When the sample solution is introduced into the asymmetric membrane under such a condition, blood cells may flow into the reaction region in the case of whole blood having a large volume ratio due to a change in pores having the function of hemocyte separation. That is, the sample solution is transferred to the reaction zone while the blood cells are separated in the horizontal movement process in the pore layer 31. In the pore layer 32, the sample solution moves horizontally in a state containing a small amount of blood cells due to the changed pore state, (33).

That is, when the reaction solution is dispensed and dried as shown in FIG. 2B, since the reaction region 33 is located on the upper surface of the small pore layer 31 contacting the large pore layer, the sample is moved to the small pore layer 31, The solution is horizontally moved to the air layer 32 and the sample solution in which the blood cells remain is also directly transferred to the reaction zone 33. Therefore, .

Of course, the length of the asymmetric membrane 30 can be increased to increase the length of the hemocytes to be filtered, but the sample solution must be further supplied by a longer length to deliver the sample solution filtered through the hemocytes to the reaction zone. Therefore, since the hemoglobin amount is also increased in proportion to the amount of the sample solution to be supplied, the hemoglobin inflow amount to the reaction region can not be reduced only by increasing the length of the asymmetric membrane.

As a method of forming the reaction zone 33 on the bottom surface of the pore layer 31 of the asymmetric membrane 30, a method of dividing the reaction solution into a support surface contacting the bottom surface of the pore layer of the asymmetric membrane, Or by inverting the asymmetric membrane so that the pore layer faces upward, and then dispensing the reaction solution. When the reaction solution is dispensed toward the upper side of the pore layer 31, the degree of penetration is largely affected by the gravity of the reaction solution itself, so that coating can be performed for the entire thickness of the pore layer, The thickness of the formed reaction region is non-uniform due to the absorption to a part of the porous layer through the small pore layer and thus the probability of contact with blood cells is increased and the detection sensitivity is lowered.

Therefore, it is preferable that the reaction solution is firstly dispensed to the support, and then the pore layer of the asymmetric membrane is placed on the pore layer so that the uptake is uniformly formed from the bottom of the pore layer to form a reaction region of uniform thickness. Particularly, the thickness of the reaction zone can be easily adjusted by controlling the amount of the reaction solution. Therefore, the reaction zone can be formed so as to be positioned within the pore layer, which is a small pore size of the asymmetric membrane, but spaced apart from the bottom surface of the pore layer. This can provide the effect of improving the detection sensitivity by providing both the function of separating the blood cells by horizontal movement and the separation of blood cells by vertical movement while nipping the reaction region 33 in the asymmetric membrane 30.

Fig. 3 shows an example in which the support is composed of an upper film 50 and a lower film 40 in the present invention. The support 20 of the present invention comprises an upper film 50 and a lower film 40. The reaction solution is dispensed to the lower film and an asymmetric membrane 30 ), And the upper film (50) is laminated on the asymmetric membrane, so that contamination of the asymmetric membrane can be prevented.

4 and 5 are a perspective view and an exploded perspective view showing a diagnostic strip according to a preferred embodiment of the present invention.

The support 20 of the present invention includes a thickness-forming film 60 (not shown) for guiding the sample solution to the asymmetric membrane 30 interposed between the upper film 50 and the lower film 40 and preventing the asymmetric membrane from being squeezed ). ≪ / RTI >

That is, the diagnostic strip 10 of the present invention comprises a support 20 and an asymmetric membrane 30. The support 30 includes a lower film 40, an upper film 50, And the asymmetric membrane 30 is attached to the lower film to move the sample solution to the side so that the reaction is performed.

The lower film 40 is formed as a rectangular plate which is long in one axis.

The upper surface of the plate body is provided with a moving region (41) for moving a sample solution, which is formed at a predetermined end portion at a front end side and is in contact with the other end portion, to a side of the other end, and a reaction liquid which reacts with the sample solution moved through the moving region A dispensing area 42 and an adhesive area 43 to which an adhesive is applied to other areas except for the moving area and the dispensing area. The adhesive region 43 may be divided into a dispensing region and a moving region and a rear region by a dispensing region and an adhesive region 43 between the dispensing region 42 and the moving region 41 may be formed by placing the membrane 30 And the adhesive region on the rear end side in the dispensing region can be used as a region for allowing the user to hold the sample by contact with the sample solution or for indicating the direction of insertion into the measuring instrument. 6, the lower film 40 is preferably made of a PET material to prevent measurement errors from external moisture. The lower film 40 has a total width of 4 to 9 mm, a length of 30 to 40 mm, a thickness of 200 to 300 mm And can be varied in length and width according to various sample solutions and diagnostic types, and is preferably formed to have a width of 5.6 mm, a length of 33 mm, and a thickness of 250 탆.

The moving region 41 formed on the front end side of the lower film is a portion forming a flow path for moving the sample solution and is formed to have a length of 5 to 15 mm from the front end side to the rear end side, . The moving region may be treated by hydrophilic or hydrophobic treatment on the inner side spaced from the both sides of the lower film by 1 to 2 mm, preferably 1.5 mm, in the inward direction so that absorption and migration of the sample solution can be facilitated.

The dispensing area 42 is formed at a position spaced apart from the moving area 41 by a predetermined distance. The dispensing area 42 reacts with the sample solution in the form of color, luminescence, fluorescence, or the like so that the dispensing area 42 can be visually or diagnosed through a measuring instrument. The dispensing area is such that the reaction solution is dispensed, the asymmetric membrane is laminated before drying, the dispensed reaction solution is absorbed into the asymmetric membrane and dried in the asymmetric membrane to form the reaction area. Such a dispensing region can be formed to have a length of 1 mm or more to allow the reaction region to be formed by absorption of the reaction solution on the asymmetric membrane bottom surface. When the distance is more than 3 mm, the improvement in discrimination performance due to the expansion of the reaction region formed on the asymmetric membrane bottom is insufficient Preferably, a length in the range of 1 to 3 mm so as to form a reaction region on the asymmetric membrane bottom by dividing.

The asymmetric membrane 30 is placed between the dispensing region 42 and the moving region 41 to expose only the components from which the blood solution and the impurities have been removed and the reaction solution formed in the asymmetric membrane located above the dispensing region 42 (33). Therefore, although the interval between the dispensing area and the moving area varies depending on the type and length of the asymmetric membrane, it can be set within a range of 5 to 12 mm. Preferably, blood is used as the sample solution and 7.5 mm is used when GX or GR (product name of PALL) is used as the asymmetric membrane.

In addition, in the dispensing area 42, the length of the rear end of the lower film is extended so that the absorbent pad is placed so that the sample solution can be easily deployed, or a region where the user can catch the diagnostic strip is provided, So that an indication indicating the insertion direction at the time of insertion can be made.

The adhesive region 43 is applied to a portion other than the hydrophilic portion of the moving region 41 and the dispensing region 42 so as to be adhered to another portion to be described later, The application of the adhesive is also performed on both side portions.

As described above, the lower film 40 has the moving area 41, the dispensing area 42 and the adhesive area 43 formed on the upper surface thereof, .

The bottom film 40 is printed with black ink on its bottom surface. Printing is performed on a portion of the moving region that is hydrophilic treated to form a lower wall of the flow path and the remaining portion except for the dispensing region. In the adhesive region, a mark may be formed in an arrow shape to indicate the direction of insertion into the measuring instrument.

As shown in the drawing, black ink may be printed on the bottom surface of the lower film 40 at a predetermined width between the end of the moving region 41 and the dispensing region 42 and at the end of the dispensing region to the rear end side. When inserting into a measuring instrument, black ink printing on both sides of the dispensing area prevents interference due to light scattering, thereby improving the measurement sensitivity, and the remaining unprinted portion can be provided in a transparent form. Particularly, in the central portion forming the flow path in the moving region, the movement of the colored sample solution can be visually confirmed.

Next, the asymmetric membrane 30 absorbs the sample solution moved into the flow path formed by the moving region 41 to induce the side flow, and removes the blood cells in the case of foreign substances, such as blood, contained in the sample solution.

Various kinds of asymmetric membranes 30 may be used. However, it is preferable that the sample solution is developed by side flow using GX or GR of PALL, so that filtering can be performed. 7A, the asymmetric membrane 30 is formed to have a size including the dispensing region 42 at the end of the moving region 41, and the reaction solution dispensed in the dispensing region 42 of the lower film 40 And the reaction zone 33 is formed in the bottom part of the inside of the pore layer 31 located in the lower part of the asymmetric membrane 30 so that the sample solution moved to the moving area is removed from the reaction area of the asymmetric membrane 30 33 to allow the reaction to proceed.

Further, as shown in FIG. 7B, the membrane marking portion 34 in which a part of the asymmetric membrane 30 is exposed as the transparent channel forming portion of the moving region is further formed, It is possible to minimize the error of the blood injection amount by confirming whether the transfer to the asymmetric membrane is visually or by the detection sensor of the apparatus. That is, when a colored fluid such as blood or a colorless fluid is used as the sample solution, it is easily confirmed by the change of the membrane marking portion 34 that the asymmetric membrane is supplied, so that the sample solution necessary for detection is sufficiently provided, . It is possible to use only the minimum amount of sample solution necessary for detection, so that the amount of sample solution used can be minimized and a uniform injection amount can be expected.

The asymmetric membrane 30 may be formed to have a thickness similar to that of a thickness-forming film to be described later. In order to obtain a compression effect, the thickness of the asymmetric membrane 30 may be 1.1 to 1.3 times as thick as the thickness- Quot; state " This can minimize the inflow of blood cells by densifying or narrowing the pores of the asymmetric membrane by the pressing, so that the hemocyte filtering effect can be improved more than using the uncompressed membrane. If the ratio is less than 1.1 times, the effect of improving the performance due to compression is insufficient. If the ratio is 1.3 times or more, the lateral flow of the sample solution is lowered due to the excessive compression and the amount of the sample solution transferred to the reaction region is lowered. It is preferable to form a thickness.

The thickness-forming film 60 is a film for setting the thickness of the flow path. As shown in Fig. 8, the thickness-forming film 60 is formed on both sides of the moving region 41 of the lower film where the hydrophilic treatment is not performed, So as to form a channel-forming space while forming a channel thickness.

The thickness-forming film 60 is formed to have a width of 1.5 mm on both sides in the lengthwise direction in the moving region 41 of the lower film so that the hydrophilic-treated portion of the lower film forms the lower wall of the channel, The thickness-forming films located on both sides of the channel-forming film may form a channel-side wall.

The thickness of the thickness-forming film 60 may vary depending on the sample solution, but may be 200-300 μm, which is the same as or similar to that of the lower film. When the sample solution is blood, the thickness of the thickness- Can be formed to have a thickness of 250 mu m.

The thickness-forming film is preferably made of a PET material in the same manner as the lower film, and the lower film is adhered to the lower film by an adhesive.

Here, when the thickness-forming film is formed to a thickness of 250 袖 m, the membrane may have a thickness of 300 袖 m so that the membrane may be partially compressed during layer bonding of the diagnostic strip to improve the filtering performance of the membrane.

9, the upper film 50 is formed into a rectangular plate having the same size as the lower film 40. In the lower surface of the upper film 50, hydrophilic treatment is applied to the moving area 51 and the remaining area is coated with an adhesive Forming film 60 and the upper surface of the membrane 30. The thickness- Preferably, the surface of the lower surface of the upper film, which is in contact with the membrane, is not coated with adhesive or partially applied, thereby preventing the adhesive from deteriorating the performance of the membrane.

In addition, the upper surface of the upper film 50 may be printed with black ink other than the portion forming the flow path in the moving region to confirm movement of the sample solution from the outside. In addition, an arrow mark 52, which is not printed in the form of an arrow, is formed on the printed portion between the upper film portion on the vertical line and the rear portion side, which is the same as the dispensing region of the lower film, and the respective films are laminated, have.

The upper film 50 is preferably made of PET, and the size of the moving region is the same as that of the lower film. However, since the upper film does not serve as a support for the asymmetric membrane like the lower film, it can be formed to a thickness of 80 to 150 nm.

Further, when the width of the flow path formed by laminating the lower film 40, the thickness forming film 60, and the upper film 50 is wide, the middle portion of the flow path width is bent, . Therefore, either or both of the lower film 40 and the upper film 50 may be provided with protrusions on the surface forming the flow path to support the intermediate portion of the flow path width, thereby preventing the upper film from bending. At this time, the projections may be formed to have the same thickness as the channel thickness, or may be formed to be somewhat smaller than the channel thickness to limit the degree of bending

As described above, the diagnostic strip 10 of the present invention formed by sequentially laminating the membrane 30, the thick film forming film 60, and the upper film 50 on the lower film 40 has a small flow path width and thickness When the sample solution is brought into contact with the front end side, it can be confirmed that it flows into the flow path by capillary phenomenon. The sample solution introduced into the flow path is transferred to the asymmetric membrane and developed. The separated foreign matter and blood cells are separated and transferred to the reaction region, and the noise due to the blood cells can be removed in the reaction region, thereby improving the detection sensitivity.

In this process, a part of the end of the asymmetric membrane is exposed to the moving region, which is the transparent portion of the diagnostic strip, so that the sample solution moved to the moving region reaches the asymmetric membrane and changes color. It is possible to provide a useful diagnostic strip that can prevent excessive supply of the sample solution.

10: Diagnostic Strip
20: Support
21: Reaction solution
30: Asymmetric membrane
31: Small pore layer 32: Large pore layer
33: Reaction zone 34: Membrane markers
40: Lower film
41, 51: Moving area 42: Dividing area
43:
50: Upper film
52: Arrow mark
60: Thickness forming film

Claims (11)

In diagnostic strips using lateral flow,
A support on which the reaction solution is dispensed;
A pore layer having a small pore size and a large pore layer having a large pore size are each formed asymmetrically on both sides and the pore layer side is disposed on the lower side and laminated on the support, An asymmetric membrane forming a region,
Wherein the support comprises a top film and a bottom film from which the reaction solution is dispensed,
Wherein the asymmetric membrane is laminated on the upper film and the asymmetric membrane is interposed between the upper film and the lower film by stacking the upper film on the asymmetric membrane,
Wherein the support further comprises a thickness-forming film interposed between the upper film and the lower film,
Wherein the thickness-forming film forms both sidewalls of a flow path for guiding the sample solution to the asymmetric membrane, and the lower film forms a lower wall of the flow path. delete The method according to claim 1,
Wherein the lower film treats the surface on which the reaction solution is dispensed with a hydrophilic or hydrophobic surface. The diagnostic strip of claim 1, wherein the thickness-forming film prevents squeezing of the asymmetric membrane. The method according to claim 1,
Wherein said support is formed of a plastic material. The method according to claim 1,
The lower film 40 is a rectangular plate formed long in one axis. On the upper surface, a moving region 41 is formed in which hydrophilic treatment is performed so that the sample solution is moved to the inner portion of the region having a predetermined length from the front end to the rear end A dispensing area 22 in which the reaction solution is dispensed at a predetermined distance in the longitudinal direction from the moving area, and an adhesive area 43 in which an adhesive is applied to other areas except for the hydrophilic treatment area and the dispensing area of the moving area, Respectively,
The asymmetric membrane 30 is attached to the upper region of the lower film and is attached to the seating region which is the region including the dispensing region 22 at the rear end side of the moving region 41 of the lower film;
The thickness forming film 60 is attached between both sides of the moving region 41 of the lower film and between the asymmetric membrane end and the lower film rear end to form a sample solution flow path and a membrane seating area;
Wherein the upper film (50) is a rectangular plate formed to have the same size as the lower film, and is configured to be attached to the upper part of the thick film and the asymmetric membrane. The method according to claim 6,
Wherein the upper film (50) is subjected to a hydrophilic treatment on a lower surface thereof in a region opposed to a moving region of the lower film. The method according to claim 6,
The lower film 40 is printed with black ink at a predetermined width at the end of the moving region and between the reaction region and at the rear end of the reaction region on the lower surface and the portion of the other region except for the moving region is printed with black ink And the sample solution moving region and the dispensing region are clearly distinguished from other regions. 9. The method of claim 8,
The lower film (40) and the upper film (50) are formed of a transparent material, which is a moving region in which the sample solution moves, to confirm movement of the sample solution from the outside,
Characterized in that a membrane marking portion (34) is formed in which a part of the asymmetric membrane (30) is partially exposed as a flow path portion of a transparent material so that the sample solution can be visually confirmed to be supplied to the asymmetric membrane. 10. The method of claim 9,
Wherein the upper film (50) is formed with an arrow mark (52) at the rear end side to distinguish the direction of insertion into the measuring instrument. 5. The method of claim 4,
The thickness of the asymmetric membrane 30 is 300 mu m and the thickness of the thickness forming film 60 is 250 mu m so that the thickness of the asymmetric membrane in the process of attaching to the lower film 40 and the upper film 50 To 250 m < 2 >.

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