WO2009119993A2 - Immunochromatography kit and manufacturing method thereof - Google Patents

Abstract

The present invention discloses an immunochromatography kit containing an immunochromatographic strip therein for immunoassay and a manufacturing method of the kit. The disclosed kit contains an immunochromatographic strip, a cover, and a bottom plate which is attached to the bottom side of the cover to enclose an immunochromatographic strip housing. The cover comprises: the immunochromatographic strip housing; a funnel-shaped inlet port which is located on the upper side of a sample pad that is connected to a sample pad housing unit and which channels a liquid sample to the detection pad for analysis; and one or more holes which are located on the upper side of an absorption pad to be connected to an absorption pad housing unit. The transparent plastic immunochromatographic strip housing comprises: the sample pad housing unit on one end of the immunochromatographic strip to contain the sample pad and a conjugate pad; the absorption pad housing unit on the other end of the immunochromatographic strip; and a signal detection pad housing unit between the sample pad housing unit and absorption pad housing unit.

Description

Immunochromatography Kits and Methods for Making the Same

The present invention relates to an immunochromatography kit having a built-in immunochromatography strip for use in immunoassay and a method for producing the same, and more particularly, to an immunochromatography kit and a method for producing the same, which are advantageous for production automation and cost reduction.

In general, immunochromatography is a method that allows the qualitative and quantitative testing of analytes in a short time by utilizing the properties of biological or chemical substances specifically attaching to each other. Or an immunochromatography kit in the form of mounting such an immunochromatography strip inside a plastic housing is generally used. When using an immunochromatography strip, a container containing a sample is required separately, but the immunochromatography kit embedded in the housing is easy to use because it does not need a separate experimental container by directly injecting the sample into the inlet prepared in the housing.

Through analysis using such an immunochromatography strip or an immunochromatography kit comprising the same, hepatitis C, using samples such as whole blood, plasma, serum, tears, saliva, urine, runny nose, and body fluids of humans or animals, Hepatitis B, influenza virus, avian influenza virus, rotavirus, AIDS, syphilis, chlamydia, malaria, typhoid, gastric ulcer, tuberculosis, SARS, dengue, leprosy and other pathogens and antibodies can be examined. In addition, they can be used to confirm the presence of pregnancy, ovulation, cancer markers, heart disease indicators, etc., and can be used to confirm the administration of drugs such as cannabis methamphetamine, hiropon, opium, amphetamines, morphine, cocaine, etc. And furthermore can be used to identify bioterrorism by detection of lysine, anthrax, burcellella, botulinum, bexonia, salmonella, cholera, Staphylococcal enterotoxin B, tullaemia, etc. It can be used for rapid testing and diagnosis in various fields, such as those that can be used to identify food poisoning bacteria such as E. coli and Yexinia.

1 is a cross-sectional view showing a representative example of an immunochromatography strip according to the prior art, Figure 2 is an exploded perspective view showing a representative example of an immunochromatography kit according to the prior art, Figure 3 is an immunochromatography of Figure 2 A perspective view illustrating the packaging method of the kit.

As shown in FIG. 1, a typical immunochromatography strip 10 used for immunochromatographic analysis is an elongated rectangular support 11 made of an adhesive plastic material, and from one side to the other on the support. It comprises a sample pad 21, a conjugate pad 22, a signal detection pad 23 and an absorption pad 24, which are disposed substantially sequentially.

Located near one end, the sample pad 21 absorbs the liquid sample (or analyte) to be analyzed and ensures a uniform flow of the liquid sample. The conjugate pad 22, which is disposed to partially overlap with the other end of the sample pad, includes a flowable conjugate that specifically binds to the analyte contained in the liquid sample, and thus through the sample pad 21. As the introduced liquid sample passes through the conjugate pad 22, specific binding between the analyte and the flowable conjugate occurs.

The signal detection pad 23 disposed at a position next to the specimen pad 21 and the conjugate pad 22 is usually a detection zone 23a and a control zone which are spaced apart from each other by a certain distance. zone) 23b. In this case, the detection area 23a is an area for checking whether an analyte is present in the liquid sample, and the control area 23b is an area for checking whether the liquid sample has normally passed through the detection area 23a. . The absorption pad 24 is disposed at a position next to the signal detection pad 23, that is, at a position adjacent to the other end of the support 11. The absorbent pad 24 absorbs the liquid sample passing through the signal detection pad 23 and assists in capillary flow of the liquid sample on the immunochromatography strip 1. In summary, the immunochromatography strip 10 is attached on the support 11 in the order of the sample pad 21, the conjugate pad 22, the signal detection pad 23, and the absorption pad 24. The sample pad 22 is moved to the absorption pad 24 via the signal detection pad 23, and an immunoassay is performed through signal detection at the signal detection pad 23.

Other modified immunochromatographic strips, although not shown, incorporate a conjugate and a signal detector in one porous pad. In addition, the sample pad, the conjugate pad, the signal detection pad, and the absorption pad may be arranged to overlap each other or to be arranged on a plastic support at regular intervals. In the latter case, the liquid sample is transferred to the sample pad, the conjugate pad, and the signal detection pad by capillary action using another medium.

The immunochromatography strip 10 as described above can be used independently for immunochromatography analysis, but for a more convenient and accurate analysis, the immunochromatography kit 10 is mounted in a plastic housing. It may be used for immunochromatographic analysis in the state of (1).

The immunochromatography kit 1 according to the prior art, as shown in FIG. 2, has an immunochromatography strip 10, a lower housing 40 containing the immunochromatography strip 10, and a lower housing. And an upper housing 50 that complementarily engages with 40. In addition, the upper housing 50 is an inlet 51 for liquid sample input for penetrating and formed at a position corresponding to the sample pad 21 of the embedded immunochromatography strip 10, and the embedded immunochromatography strip 10. And a confirmation window 53 for confirming the signal detection result, which is formed to penetrate elongated at a position corresponding to the signal detection pad 23 of the reference numeral).

In more detail with respect to the analysis process using the immunochromatography strip 10 and the immunochromatography kit 1, when the signal detection in the signal detection pad 23 is finished, the filtrate is absorbed by the absorption pad 24. Are absorbed in. At this time, if the absorbent pad 24 does not have sufficient absorbent capacity, the liquid sample or conjugate absorbed by the absorbent pad 24 flows back to the signal detecting pad 23. This tendency is further strengthened by drying of the signal detection pad 23 over time. As the liquid sample or conjugate absorbed by the absorbent pad 24 flows back to the signal detecting pad 23, the liquid sample or conjugate is reattached to the control area 23b or the detection area 23a of the signal detecting pad 23, and thus the test result. It may be difficult to keep clean, and sometimes it may react unspecifically with the signal detecting material in the detection area 23a, causing false test results.

Thus, the absorbent force of the absorbent pad 24 has a deep correlation with the background clearance.

On the other hand, the immunochromatography strip 10 is sensitive to moisture. In particular, water inactivation of the signal detection material present in the conjugate pad 22 and the detection area 23a immediately leads to an incorrect test result. This is a fatal weakness of the immunochromatography strip 10.

Therefore, the assembly of the immunochromatography strip 10 takes place in a space of 20% or less relative humidity, but in order to minimize the influence of moisture, the immunochromatography strip 10 is usually packaged together with an absorbent bag. This is the same also when assembling the immunochromatography kit 10. That is, as shown in Fig. 3, the conventional immunochromatography kit 1 is usually stored in the pouch 3 together with the absorbent bag 2 and sold. However, the process of packaging together with the absorbent bag 2 becomes a factor of reducing the packaging efficiency.

The absorbent bag 2 is usually filled with silica gel. However, silica gel has a slow absorption rate and relatively low absorption rate, so that an absorbent with improved absorbency is required to effectively remove humidity included in the work. Specifically, the absorbent composed of silica gel absorbs 8-15% of moisture in a relative humidity of 20%, has a very slow rate of absorbing moisture, and furthermore is harmful to the environment in the silica gel manufacturing process. It is a situation that there is a problem such as a large cost to waste water treatment by discharging.

4 is a cross-sectional view showing an improved example of an immunochromatography strip according to the prior art, FIG. 5 is an exploded perspective view showing an improved example of an immunochromatography kit according to the prior art, and FIG. Is a perspective view illustrating a method for packaging an immunochromatography kit.

As an improved example according to the prior art, an immunochromatography strip, as disclosed in "Immunochromatography Strips and Kits Comprising" of Korean Patent Registration No. 10-0735080, filed and patented by the applicant of the present invention And immunochromatography kits have been provided.

As shown in FIG. 4, the immunochromatography strip 10 ′, like the normal immunochromatography strip 10 as shown in FIG. 1, is an elongated rectangular support 11 made of an adhesive plastic material. ') And a sample pad 21', a conjugate pad 22 ', a signal detection pad 23', and an absorption pad 30, which are arranged substantially sequentially from one side to the other side on the support. .

However, the absorbent pad 30 has a structure including a porous support 31 and an absorbent 32 which is dispersed in the pores of the porous support 31 or adsorbed or coated on the fiber yarn of the porous support 31. It has distinctive features. Furthermore, the absorbent pad 30 is characterized by further comprising a porous film layer 33 made of a porous membrane attached to the upper surface of the porous support 31.

In addition, as shown in FIG. 5, the improved immunochromatography kit 1 ′, like the conventional immunochromatography kit 1 as shown in FIG. 2, is provided with an immunochromatography strip 10 ′, And a lower housing 40 for receiving the immunochromatography strip 10 'and an upper housing 50' that complementarily engages with the lower housing 40.

In addition, the upper housing 50 'is an inlet 51' for liquid sample introduction, which is formed to penetrate at a position corresponding to the sample pad 21 'of the embedded immunochromatography strip 10', and the embedded immunochromatography. It is similar to the one provided with a confirmation window 53 'for signal detection result confirming purposes, which is formed to penetrate in an elongated position corresponding to the signal detection pad 23' of the graphics strip 10 ', but with immunity embedded therein. It has a distinguishing feature as further comprising a vent 55 at a position corresponding to the absorbent pad 30 of the chromatography strip 10 '.

At this time, the vent 55, so that the moisture contained in the packaging material is more easily absorbed through the absorbent 32 included in the absorbent pad 30 before applying to the immunochromatography analysis, immunochromatography After application to the analysis, the liquid sample absorbed in the absorbent pad 30 is more smoothly evaporated.

In the improved immunochromatography strip 10 'and the improved immunochromatography kit 1', the absorbent 32 of the absorbent pad 30 strongly absorbs the liquid sample so that the liquid sample is the signal detection pad. By preventing the flow back to (23 ') to prevent the inspection error caused by the back flow of the conjugate, to keep the results clean even if the signal detection pad (23') is dried, it is easy to preserve the results, and also to keep the moisture in the air At the same time, there is no need to put a separate absorbent bag into the pouch (3) together with the immunochromatography strip (10 ') or the immunochromatography kit (1'). You can improve the speed.

Specifically, the absorbent pad 30 including the absorber 32 efficiently absorbs the liquid sample after the signal detection reaction is completed, promotes chromatographic flow, and prevents the occurrence of an inspection error due to the reverse flow of the liquid sample. In addition to promoting clearance, the preservation of signal detection results is also promoted. In addition, the immunochromatography strip 10 ′ and the kit 1 including the same by the enhanced absorption ability by the absorbent 32 dispersed or adsorbed or coated on the porous support 31 constituting the absorbent pad 30 are included. As shown in FIG. 6, since the moisture in the air can be sufficiently absorbed, it is not necessary to pack the pouch 3 together with a separate absorbent bag. This not only simplifies packaging and doubles the speed of automatic packaging, but also provides powerful water absorption capabilities to more effectively protect the performance of an immunochromatography strip or immunochromatography strip kit from moisture inevitably contained in the manufacturing process. To make it possible.

Although many improvements have been made as described above, the immunochromatography kit incorporating an immunochromatography strip still needs a lot of improvement in relation to its manufacturing process. Specifically, the lower housing 40 and the upper housing 50 'constituting the immunochromatography kit 1' are manufactured in an appropriate shape through a molding process using a mold, and after completion of the molding process, the immunochromatography is completed. The grading strip 10 'is placed one by one at a suitable position of the lower housing 40, and then the assembly process is performed such that the lower housing 40 is individually covered with the upper housing 50'.

In order to automate this manufacturing process, the upper and lower housings must be aligned in a certain direction, the immunochromatography strips must be correctly mounted on the lower housing, and the complementary upper and lower housings are covered by applying a pressure to the realigned upper housing. It is fixed by the uneven structure. Such complex automation processes may include frequent malfunctions of the machine due to a machine error and a size deviation of the housing, and include a process that cannot be automated in detail. In addition, the kit made of the upper and lower housings can not prevent the invasion of moisture, so the individual packaging process in the aluminum bag with a desiccant is essential.

Therefore, the manufacturing method of the manufacturing process is highly dependent on labor due to the high proportion of the process to be dependent on manual labor. In other words, a problem that is not suitable for mass production is still not suitable for mass production, given that hundreds of millions of immunochromatography strips or immunochromatography kits are consumed annually worldwide and are distributed at relatively low prices. Improvement is not an urgent problem and will not be possible.

In addition, the aluminum pouch used for moisture protection during use, the need to remove the kit to use, there is a need for a new moisture protection device without the use of aluminum bags.

The present invention has been created to solve the problems of the prior art as described above, the object of the present invention is to provide a new type of technology for moisture protection, suitable for the automation of the production process is suitable for mass production through automation The present invention provides an immunochromatography kit that is advantageous in cost reduction.

It is another object of the present invention to provide a new type of technology for moisture protection and to provide a method for producing an immunochromatography kit suitable for mass production.

An immunochromatography kit according to an embodiment of the present invention for achieving the above object, an elongated rectangular support made of an adhesive plastic material, a sample pad and a conjugate pad, a support disposed on one side of the support An immunochromatography kit containing an immunochromatography strip including an absorption pad disposed on the other side of the upper portion and a signal detection pad disposed on the center portion of the support.

Immunochromatography strips;

Made of plastic film material,

One side of the sample pad receiving portion formed to accommodate the sample pad and the conjugate pad portion to receive the immunochromatography strip, and the other side of the absorption pad receiving portion formed to receive the absorbent pad portion And an immunochromatography strip accommodating space comprising a signal detecting pad accommodating portion between the sample pad accommodating portion and the absorbent pad accommodating portion formed to receive the signal detecting pad portion.

An inlet is formed through the sample pad receiving portion to be positioned above the sample pad, the inlet is formed in a funnel shape to guide the liquid sample to be injected for analysis to the sample pad, and the liquid sample is smoothly through the inlet. One or more vents are formed to penetrate so as to flow around the sample pads,

A moisture protection plate sealed to the formed inlet and the vent with a moisture protection deposition film; And

And a bottom plate attached to the bottom side of the cover to close the immunochromatography strip receiving space.

As a preferable feature of the present invention, the width of the signal detection pad accommodating portion is formed to be wider than the width of the immunochromatography strip so that a clearance is formed at both sides of the signal detection pad portion.

In another preferred aspect of the present invention, the immunochromatography strip is attached to the bottom of the portion overlapping the signal detection pad of the support, at least two comprising at two positions corresponding to both ends of the signal detection pad The above bypass flow blocking partition member is further provided.

As another preferred feature of the invention, the plastic film isCellophane                     ,Acetyle cellolose, Polyethylene (PE), Polypropylene (pp), Ethylene vinyl acetate, Polyvinyl chloride (PVC), Polyvinyliolene chloride (PVDC), Polystyrene (PS), Polycarbonate (PC), Polyamide (PA), Nylon, Polyestor (PET) , polyvinyl                                          alcohol                     (                     PVAC                     ), Or from a material such asAmong them, two or more films are laminated to be selected as a material having enhanced moisture resistance and heat sealability.

Another desirable feature of the present invention is that the plastic film is not transparent or the color is not easy to see the result of the deep detection pad in the window window through hole is added and sealed.

In another preferred feature of the invention, the selected moisture barrier and base are selected from PET, PP, PE and aluminum films or two or more of them deposited.

As another preferred feature of the invention, the attachment of the selected moisture protection plate and the bottom plate is selected from adhesives, hot melt and heat fusion methods or two or more of them are mixed.

In the method for manufacturing an immunochromatography kit according to the present invention, a cover plate made of plastic material is prepared by using a mold having a plurality of strip receiving space moldings having a shape corresponding to the shape of the immunochromatography strip receiving space. A cover molding process of forming a cover disc which can be separated into a plurality of covers by molding by pneumatic adsorption in a state of applying heat; A punching process of forming inlets, vents, and window through-holes by punching in the plurality of immunochromatographic strip accommodating spaces formed in the cover disc through a molding process; A containment process of sealing a through hole such as an inlet formed in the cover disc through a punching process with a moisture protection film; A strip feeding step of inserting a plurality of immunochromatography strips into one of the immunochromatographic strip receiving spaces of the cover disc through the blocking process; A bottom plate attaching step of attaching a bottom plate member to the cover disc so as to close the plurality of immunochromatography strip receiving spaces into which the immunochromatography strips are respectively inserted; And a cutting step of cutting the completed immunochromatography kit assembly through the base plate attachment step to separate the plurality of immunochromatography kits.

The features and advantages of the present invention will become more apparent from the following detailed description based on the accompanying drawings. Prior to this, the terms or words used in the present specification and claims should not be interpreted in the ordinary and dictionary sense, and the inventors may appropriately define the concept of terms in order to best explain the invention of their own. It should be interpreted as meaning and concept corresponding to the technical idea of the present invention based on the principle that the present invention.

The immunochromatography kit and the method for producing the immunochromatography kit according to the present invention provide a new type of moisture preservation method and automate all processes with a simplified individual process, thus making an automated production process that is significantly less dependent on manual labor. Can be produced in large quantities in less time, thereby enabling a significant productivity improvement.

In addition, the amount of raw materials used can be reduced, thereby reducing the dependence on labor force, enabling significant cost reduction, and responding to large orders in a short time.

In addition, the product can be used without the inconvenience of opening the pouch packaging at the user's entrance, and the kit is disposable, so that it uses various materials to save production energy and minimize environmental pollution.

1 is a cross-sectional view showing a representative example of an immunochromatography strip according to the prior art,

Figure 2 is an exploded perspective view showing a representative example of an immunochromatography kit according to the prior art,

3 is a perspective view illustrating a packaging method of the immunochromatography kit of FIG.

4 is a cross-sectional view showing an improved example of an immunochromatography strip according to the prior art;

5 is an exploded perspective view showing an improved example of an immunochromatography kit according to the prior art;

6 is a perspective view illustrating a packaging method of the immunochromatography kit of FIG.

7 is a perspective view showing one embodiment of an immunochromatography kit according to the present invention;

8 is an exploded perspective view illustrating the immunochromatography kit of FIG. 7;

9 is a cross-sectional view showing the immunochromatography kit of FIG.

10 is a plan view of the immunochromatography kit of FIG. 7,

11 is a perspective view illustrating one embodiment of a method for preparing an immunochromatography kit according to the present invention;

12 and 13 are a perspective view showing a modified embodiment of the immunochromatography kit according to the present invention,

14 is a cross-sectional view of the immunochromatography kit of FIG. 12.

<Description of the symbols for the main parts of the drawings>

100: immunochromatography strip 111: support

121: specimen pad 122: conjugate pad

124: absorption pad 123: signal detection pad

125: bypass flow blocking partition member 200: cover

200 ': cover disc 210: sample pad receiver

215: inlet 220: absorbent pad accommodating part

225: vent window 230: signal detection pad receiving portion

300: bottom plate 300 ': bottom plate member

c: shield w: window

Hereinafter, an immunochromatography kit and a method of manufacturing the same according to the present invention will be described with reference to the accompanying drawings.

First, it should be noted that like elements or parts in the drawings are denoted by the same reference numerals as much as possible. In the following description of the present invention, detailed descriptions of well-known functions or configurations will be omitted in order not to obscure the subject matter of the present invention.

Figure 7 is a perspective view showing an embodiment of an immunochromatography kit according to the invention, Figure 8 is an exploded perspective view showing the immunochromatography kit of Figure 7, Figure 9 is an immunochromatography kit of Figure 7 10 is a cross-sectional view illustrating the immunochromatography kit of FIG. 7.

The immunochromatography kit according to the present invention is adapted to be suitable for mass production using an automated production system and to reduce cost through material cost reduction, as shown in FIGS. And a cover 200 having an immunochromatography strip accommodating space for accommodating the immunochromatography strip 100, and a base plate 300 attached to the bottom side of the cover 200. Is done.

The immunochromatography strip 100 is formed of an elongated rectangular support 111 made of an adhesive plastic material and a support 111 similar to the immunochromatography strips of the prior art as shown in FIGS. 1 and 4. The sample pad 121 and the conjugate pad 122 disposed on one side of the upper portion, the absorption pad 124 disposed on the other side of the upper portion of the support 111, and the signal detection disposed on the center portion of the upper portion of the support 111. Pad 123.

The cover 200 is formed to have an immunochromatography strip receiving space for receiving the immunochromatography strip 100,Cellophane                 ,                 Acetyle                 cellolose,                 Polyethylene                 (                 PE                 ),                 Polypropylene                 (                 pp                 ),                 Ethylene                                  vinyl                                  acetate                 , Polyvinyl chloride (PVC), Polyvinyliolene chloride (PVDC), Polystyrene (PS), Polycarbonate (PC), Polyamide (PA), Nylon,Polyestor (PET), psuch as olyvinyl alcohol (PVAC)It may be made of a plastic film and may be used as a material in which two or more of these films are laminated to increase moisture resistance and heat sealability. Made of a transparent thermoplastic resin-based plastic material such as PET, as described in detail below, it becomes possible to form the cover 200 through a pneumatic adsorption-type molding process using a mold in the state of applying heat, the cover Even if the 200 does not have a separate confirmation window (see reference numeral 53 ′ in FIG. 5), the signal detection pad 123 may be visually observed to confirm the analysis result. In addition, as it is made of a soft plastic material, holes such as the inlet 215 and the vent 225 described in detail below can be easily formed by a process such as punching. If the transparency is poor or raw material is added to the material, the result cannot be directly checked. Therefore, the window window can be molded into the signal detection pad accommodating part such as an injection hole or a vent by a punching process.

On the other hand, the immunochromatography kit according to the present invention, as shown in Figure 12 to 14, may be configured to increase the visibility by forming a window (w) in the signal detection pad receiving portion 230, moisture It may be configured to be sealed by the protective film (c). At this time, the protective film (c) may be peeled off as shown in FIG. 13 during use. Reference numeral 211 denotes a through hole formed at one side of the inlet 215 provided in the sample pad receiving unit 210.

That is, the window window (w) in the present invention is required depending on the material of the receiving space of the strip, but is inevitably sealed during storage of the immunoassay kit to prevent the moisture barrier (c) to protect the analyte formed in the strip (c) ); It is a film laminated with PE film, aluminum film, PP film, etc. by applying heat to the cover and removing the film when using it. Packaging can be advantageous for automation and less process than moisture protection.

In addition, by applying a hot melt to the laminated film may be bonded by a thermal fusion method. Hot melt is basically composed of polymer, adhesive resin, wax, antioxidant, etc., and it can be composed of various components depending on the material and strength of adhesive. In another method, an adhesive may be applied to a single layer film or a laminated film to enable sealing without applying heat.

In more detail, the immunochromatography strip accommodating space provided in the cover 200 may be formed to accommodate the sample pad 121 and the conjugate pad 122 of the immunochromatography strip 100. A sample pad accommodating portion formed to accommodate the sample pad accommodating portion 210 of the sample, an absorbent pad accommodating portion 220 on the other side formed to accommodate the portion of the absorbent pad 124, and a portion of the signal detection pad 123. And a signal detection pad receiver 230 between the unit 210 and the absorbent pad receiver 220.

In addition, the immunochromatography strip receiving space includes a length, a width, and a sample pad 121 constituting the immunochromatography strip 100, a suction pad 124, and a signal detection pad of the immunochromatography strip 100 to be accommodated. It is formed in a size and shape in consideration of the thickness of each portion where the 123 is disposed. That is, the sample pad receiver 210 and the absorbent pad receiver 220 have a width w in consideration of the width of the immunochromatography strip 100, and the sample pad 121 and the absorbent pad 124. Considering that the thickness of the part is thick, it is formed with a relatively deeper depth. In addition, the signal detection pad accommodating part 230 is formed with a relatively smaller depth in consideration of the thinness of the portion of the signal detection pad 123.

Meanwhile, the signal detection pad receiver 230 may be formed to have a width w corresponding to the width of the immunochromatography strip 100 similarly to the sample pad receiver 210 and the absorbent pad receiver 220. 7, 8 and 10, the cover having a width (W) wider than the width of the immunochromatography strip 100, so that the free space is formed on both sides of the portion of the signal detection pad 123. It is preferable to form If the immunochromatography strip and the cover are closely attached to each other, the liquid sample does not only move through the signal detection pad of the immunochromatography strip by capillary action, but rather the signal along the wall surface of the cover, in part by surface tension. The phenomenon that the detection pad is bypassed and moved may occur. As a result of the bypass flow, some liquid samples may not pass through the inspection line provided in the signal detection pad, thereby reducing the accuracy and reliability of the inspection result. In other words, by providing a clearance between the immunochromatography strip and the cover as described above to block the bypass flow of the liquid sample via the cover wall to obtain a reliable test results.

In addition, the cover 200 is formed to penetrate through the sample pad accommodating portion 210 and is positioned on the sample pad 121 when the immunochromatography kit is completed. The liquid sample to be injected for analysis is a sample pad ( It is provided with an inlet 215 formed in the shape of the funnel so as to guide 121. And at least one vent 225 formed through the absorbent pad receiver 220 to be positioned above the absorbent pad 124.

In the embodiment as shown in Figs. 7 to 10, four vents 225 are provided, but the number is not limited. On the other hand, it is preferable that the sample pad receiving portion 210 is formed deeper than the absorbent pad receiving portion 220 as the peripheral portion of the inlet 215 is formed in a funnel shape.

12 to 14, the present invention may not necessarily form the vent 225 selectively.

The base plate 300 is attached to the bottom side of the cover 200 to close the immunochromatography strip receiving space. The base plate 300, as the cover, Cellophane , Acetyle cellolose, Polyethylene (PE), Polypropylene (pp), Ethylene vinyl acetate, Polyvinyl chloride (PVC), Polyvinyliolene chloride (PVDC), Polystyrene (PS), Polycarbonate (PC) , Polyamide (PA), Nylon, Polyestor (PET), p- Olyvinyl alcohol (PVAC), etc. can be composed of two or more of these films are laminated to make the material with increased moisture resistance and heat sealability It can be attached by applying heat. It can be made of a material that does not need to be applied separately in the attaching process, such as a deposited aluminum sheet, an adhesive vinyl sheet, a vinyl deposited paper sheet, etc., which is provided in the form of an adhesive coated on the attaching surface and is adhesive in a tape-like manner. In addition, the hot melt may be applied to the plate applied.

Preferably, the immunochromatography strip 100 according to the present invention is attached to the bottom of the portion overlapping the signal detection pad 123 of the support 111, the two positions corresponding to both ends of the signal detection pad 123 It further comprises at least two or more bypass flow blocking partition member 125, including being attached.

8 to 10, three bypass flows including two bypass flow blocking partition members 125 are basically attached to two positions corresponding to both ends of the signal detection pad 123. Although it is provided with a blocking partition member, it would be possible to have two basic bypass flow blocking partition members or a larger number of bypass flow blocking partition members. Of course, such a bypass flow blocking partition member 125 may not be essential, but all liquid samples introduced through the inlet 215 above the sample pad 121 are analyzed by the capillary phenomenon. ) And the liquid sample is prevented from moving to the bypass flow path through the lower space of the support, at least in part, not only in the flow path such as sequentially moving to the suction pad 124 through the signal detection pad 123). Plays a desirable role. That is, the bypass flow blocking partition member 125 blocks the bypass flow of the liquid sample through the lower space of the support 111 to improve the reliability of the analysis results.

11 is a perspective view illustrating an embodiment of a method for preparing an immunochromatography kit according to the present invention.

Hereinafter, with reference to FIG. 11, the method for producing an immunochromatography kit according to the present invention as described above will be described in detail.

In brief, the method of manufacturing an immunochromatography kit according to the present invention includes a molding process for forming a cover disc 200 'to include a plurality of immunochromatography strip receiving spaces, and an inlet 215 in the cover disc 200'. ) Punching process to form a vent hole 225 and a punching method, a strip input process for introducing an immunochromatography strip 100 into each of the immunochromatographic strip receiving spaces of the cover disc 200 ', and a cover disc 200'. A bottom plate attachment step of attaching the bottom plate member 300 'to close the immunochromatography strip receiving space, and a cutting step of cutting the aggregate in a form including a plurality of immunochromatography kits and separating them into a plurality of immunochromatography kits. It includes.

In the cover molding step, using a mold (not shown) having a plurality of strip receiving space moldings having a shape corresponding to the shape of the immunochromatographic strip receiving space, the cover plate member made of soft transparent plastic material is heated. The cover disc 200 ', which can be separated into a plurality of covers, is molded by pneumatic adsorption. Although not shown, the mold set is connected to a means for applying heat and a means for forming a negative pressure for pneumatic adsorption, such as a vacuum pump, to form the cover disc 200 'by pneumatic adsorption while applying heat. Make it happen. In the embodiment shown in Figure 11 illustrates the case of forming the ten covers 200 at the same time, of course, the number is not limited. In addition, the flexible transparent plastic sheeting material may be cut to a predetermined size and supplied to the mold set, but preferably, the flexible transparent plastic sheeting material is supplied in a roll form having a predetermined width so that the cover molding is continuously performed. The process may also be performed continuously in an interlocked manner.

In the punching process, the inlet 215 and the vent 225 are formed in each of the plurality of immunochromatographic strip accommodating spaces formed in the cover original plate 200 ′ through the cover molding process as described above by punching.

Each of the immunochromatographic strips 100 of the cover original plate 200 ′, which has been punched out, is prepared with one immunochromatography strip 100 prepared before assembly. Such a strip feeding process is not one by one in each of the immunochromatography strip receiving space sequentially, but the immunochromatography strip (100) in all the immunochromatography strip receiving space provided in the cover disc 200 'through an automated production system. ) May be introduced at the same time.

Subsequently, a bottom plate attaching process is performed to attach the bottom plate member 300 'to the cover original plate 200' so as to close all of the plurality of immunochromatographic strip receiving spaces into which the immunochromatography strip 100 is introduced. The bottom plate attaching process also includes a single bottom plate member 300 cut to a size corresponding to the size of the cover original plate 200 'so as to simultaneously close all of the plurality of immunochromatographic strip receiving space sets formed on the cover original plate 200'. ') Is attached to the cover disc 200' in a simplified manner. Preferably, the cover disc member provided in the form of one roll is continuously formed to form a set of cover discs having a plurality of immunochromatography strip receiving spaces at a time, wherein the base plate member is also interlocked in roll form. The base plate attachment process may be performed to sequentially close all of the immunochromatographic strip receiving spaces formed on the cover disc by supply.

After the base plate attachment process, an immunochromatography kit assembly including a plurality of immunochromatography kits is completed, and the immunochromatography kit assembly is separated into a plurality of immunochromatography kits through a cutting process.

The immunochromatography kit manufacturing method according to the present invention as described above, considering the manufacturing process through an automated production system, all processes can be automated. In addition, instead of manufacturing one immunochromatography kit at a time through a series of manual processes, it is possible to produce multiple immunochromatography kits simultaneously through an automated series of processes, resulting in significant productivity improvements. You can do it. In addition, it is possible to reduce the use and consumption of low-cost raw materials, and to reduce the dependency on the labor force and to significantly reduce costs. Furthermore, there is no process of arranging the upper and lower housings separately from the conventional automation method, and instead of moving and covering the upper housings, the manufacturing process is simplified by replacing the upper housings with a continuous plate, thereby significantly increasing the production per hour. .

Example  One

Canine parvovirus testing using immunochromatography strips and kits

(A) Antibody Immobilized Nitrocellulose Pads

Monoclonal and goat anti-mouse immunoglobulin antibodies against canpabovirus were diluted with phosphate buffer, then sprayed onto the test and control lines of the nitrocellulose pad, respectively, using an injector and dried in a 37 ° C thermostat to immobilize them. I was.

(B) Antibody-Gold Conjugate Pad Preparation

After surface adsorption by addition of monoclonal antibody against canpabovirus to 1 ml of an aqueous colloidal gold solution, it was resuspended in phosphate buffer containing 0.7 wt% bovine serum albumin and 0.5 wt% sucrose to have an absorbance of 1. The glass fiber pads were dispensed at a ratio of 80 μl / 25 mm ² . The pad containing the gold colloid antibody conjugate was dried for 5 hours in a dehumidification chamber, and the dried pad was cut into a size of 0.5 x 300 mm.

(C) Preparation of Absorbent Pads Containing Absorbents

1 mm thick pulp was impregnated in 10% by weight aqueous calcium chloride solution to allow the aqueous absorbent solution to soak evenly on paper, then dried at 100 ° C. for 1 hour and cut into 20 × 300 mm.

(D) Immunochromatography Strip Preparation

The pads and the sample pads prepared in the steps A, B and C were sequentially adhered to the adhesive-coated polypropylene plate, so that the sample pad, the antibody-gold conjugate pad, the antibody immobilized nitrocellulose pad, and the absorption pad obtained above were obtained. The strips were cut to a size of 0.5 × 70 mm after being superimposed in a stack.

(E) Preparation of a kit comprising an immunochromatography strip

Heat the transparent PET 0.4 mm thick plate, place it on the housing mold, pneumatically open the cover model, punch out the sample inlet and vent through the punching process, and then seal the holes with PE / Al / PP It was sealed by attaching a moisture protective film by applying heat around the hole to be placed on the film deposited and sealed. Strips were placed in a protective cover and the base plate deposited with a PE / PET / Al layer was completed for the kit and stored for 1 month, 6 months, 12 months and 18 months to test each parvovirus positive and negative sample. . The test result confirmed that the analysis was performed with good sensitivity despite the passage of 18 months. This indicates that sufficient drying was done without using a separate packaging pouch.

Example  2

Hepatitis Virus Antigen Testing Using Immunochromatography Strips and Kits

Instead of using monoclonal antibodies against canpabovirus, nitrocellulose pads and antibody-gold conjugate pads were prepared in the same manner as in Example 1 except that monoclonal antibodies against human infective virus type B surface antigen (HBsAg) were used. Prepared. The absorbent pad was soaked in 10 wt% magnesium chloride aqueous solution with 1 mm thick pulp and allowed to soak in the pulp. Then, the absorbent pad was dried at 100 ° C. for 1 hour, and one side was cut into 20 x 300 mm with a porous film (polyethylene). To complete the immunochromatography strip kit as in Example 1,

Heat the PP 0.5 mm thick black plate, place it on the housing mold, apply pneumatic to open the cover model, punch the sample inlet, vent, and window through the punching process, and then seal the The film deposited with the / Al / PP layer was placed and sealed by attaching a moisture protection film by applying heat around the hole to be sealed. Strips were placed in a cover with a protective film, and the base plate deposited with a PE / Al / PP layer was completed. The kit was stored for 1 month, 6 months, 12 months, and 18 months, and each hepatitis virus positive and negative sample was tested. . The test result confirmed that the analysis was performed with good sensitivity despite the passage of 24 months.

Example  3

Pregnancy Diagnostic Tests Using Immunochromatography Strips and Kits

Instead of using monoclonal antibodies against canpabovirus, nitrocellulose pads and antigen-gold conjugates in the same manner as in Example 1 except for using monoclonal antibodies against human chorionic gonadotropin (hCG) antigens. The pad was prepared. The absorbent pad was soaked in 1 mm thick pulp in an aqueous solution of 10% by weight calcium chloride and 10% by weight magnesium chloride. The absorbent was allowed to soak in the pulp and dried at 100 ° C for 1 hour. ) And cut into 20 x 300 mm, and each of the immunochromatographic strip kits as in Example 1 was inserted into the housing through an automated equipment and sealed cut.

In detail, a sheet of dried PET 0.4 mm thick roll is passed through a hot plate continuously, moved to a housing mold, and pneumatic pressure is applied to open a cover model, and punching several inlets for easy urine sample input in a subsequent process. After opening the rolled film deposited with PET / Al / PP layer on the inlet and inserting the ultrasonically applied inlet sealing process, inserting the strip into the cover sealed with the inlet and placing the roll bottom plate deposited with PET / Al / PP layer. Ultrasonic sealing process by inserting the cutting process to fit the size of the kit was made continuously in an automated equipment to complete the kit. The prepared kits were stored for 1 month, 6 months, 12 months and 18 months to remove the protective film attached to the sample inlet, and each of the hCG positive urine and one negative sample was tested. The test result confirmed that the analysis was performed with good sensitivity despite the passage of 18 months.

On the other hand, the present invention is not limited to the described embodiments, it is obvious to those skilled in the art that various modifications and variations can be made without departing from the spirit and scope of the present invention. Therefore, such modifications or variations will have to belong to the claims of the present invention.

Claims (8)

1. An elongated rectangular support made of an adhesive plastic material, a sample pad and a conjugate pad disposed on one side of the support, an absorbent pad disposed on the other side of the support, and a signal detection disposed at the center of the support An immunochromatography kit containing an immunochromatography strip including a pad,

   Immunochromatography strips;

   Made of plastic film material,

   One side of the sample pad receiving portion formed to accommodate the sample pad and the conjugate pad portion to receive the immunochromatography strip, and the other side of the absorption pad receiving portion formed to receive the absorbent pad portion And an immunochromatography strip accommodating space comprising a signal detecting pad accommodating portion between the sample pad accommodating portion and the absorbent pad accommodating portion formed to receive the signal detecting pad portion.

   It is formed to penetrate through the sample pad accommodating part and is positioned above the sample pad, and is formed to guide the liquid sample to be introduced for analysis to the sample pad, a window for confirming the test result, and a liquid sample is inserted into the sample pad. It is formed to penetrate smoothly through the through and provided with one or more vents located around the sample pad,

   The formed inlet, the window and the vent provided with a moisture protection plate sealed with a moisture protection deposition film; And

   A bottom plate attached to the bottom side of the cover to close the immunochromatography strip receiving space;

   Immunochromatography kit comprising a.
2. The method of claim 1,

   The width of the signal detection pad receiving portion, the immunochromatography kit, characterized in that the width is formed wider than the width of the immunochromatography strip so that the clearance space on both sides of the signal detection pad portion.
3. The method according to claim 1 or 2,

   The immunochromatography strip is attached to the bottom surface of the portion overlapping the signal detection pad of the support, at least two or more bypass flow blocking partition member comprising a second position corresponding to the opposite ends of the signal detection pad attached to; Immunochromatography kits further comprising.
4. The plastic film of claim 1, wherein the plastic film is Cellophane, Acetyle cellolose, Polyethylene (PE), Polypropylene (pp), Ethylene vinyl acetate, Polyvinyl chloride (PVC), Polyvinyliolene chloride (PVDC), Polystyrene (PS), Polycarbonate (PC), Polyamide (PA), Nylon, Polyestor (PET), polyvinyl alcohol (PVAC), or other materials selected from, or two or more of these films by laminating an immunochromatography characterized in that the selected material is enhanced moisture resistance and heat sealability Kit.
5. The immunochromatography kit according to claim 1, wherein a window through hole is added and sealed when the selected plastic film is not transparent or the color depth detection result is not easy to see.
6. The immunochromatography kit according to claim 1, wherein the selected moisture barrier plate and the base plate are selected from PET, PP, PE and aluminum films, or two or more films thereof are deposited.
7. The immunochromatography kit according to claim 1, wherein the attachment of the selected moisture protection plate and the bottom plate is selected from ultrasonic, adhesive, hot melt and heat fusion methods or two or more of them are mixed.
8. In the method of producing an immunochromatography kit according to any one of claims 1 to 3,

   Using a mold having a plurality of strip receiving space moldings shaped in a shape corresponding to the shape of the immunochromatography strip receiving space, the cover plate material made of plastic material is molded by pneumatic adsorption into a plurality of covers. A cover molding process for forming a cover disc that can be separated;

   A punching process of forming inlets and vents by punching in the plurality of immunochromatographic strip receiving spaces formed in the cover disc through a molding process;

   A containment process of sealing an inlet and a vent formed in the cover disc through a punching process with a moisture protection film;

   A strip feeding step of inserting a plurality of immunochromatography strips into one of the immunochromatographic strip receiving spaces of the cover disc through the blocking process;

   A bottom plate attaching step of attaching a bottom plate member to the cover disc so as to close the plurality of immunochromatography strip receiving spaces into which the immunochromatography strips are respectively inserted; And

   A cutting step of separating the completed immunochromatography kit assembly through the base plate attachment step into a plurality of immunochromatography kits;

   Immunochromatography kit manufacturing method comprising a.

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