KR20120086985A - Diagnostic kit and manufacturing method of the same - Google Patents

Abstract

PURPOSE: A diagnosis kit and a method for manufacturing the same are provided to improve sensitivity and to prevent physical damage or contamination without a separate protection sheet. CONSTITUTION: A diagnosis kit comprises: a diagnostic strip(20) having a sample pad(110) and a signal detection pad(150) on the upper side of a support(191); and a kit case(300) containing the diagnostic strip. The upper side of the support is placed to correspond to the lower side of the kit case. The kit also comprises a sample injection hole formed at the kit case and a sample pad exposing area on the upper side of the support. The diagnostic strip further comprises a fixation pad attached on the upper side of the sample pad. A method for manufacturing the kit comprises: a step of preparing the diagnostic strip and a step of placing the sample injection hole at the lower side of the kit case.

Description

Diagnostic kit and its manufacturing method {DIAGNOSTIC KIT AND MANUFACTURING METHOD OF THE SAME}

The present invention relates to a diagnostic kit for use in an immunoassay method and a method of manufacturing the same.

A diagnostic kit is a device that tests or examines the presence of a single or multiple substances in a liquid sample, such as a urine or blood sample. Specifically, the modern diagnostic business is being integrated into one point-of-care testing (POCT). Point-Of-Care Testing (POCT) refers to equipment that can be used by the general public without specialized knowledge. Currently, the diagnosis area is expanding from the hospital to the field and the individual.

In particular, rapid diagnostic kits, represented by immunochromatographic analysis, are used to identify diseases or identify changes in the health care field, and qualitatively and quantitatively examine trace analytes in various fields such as food, biological process, and environment. Is developed in an easy way. The field of health care is also expanding its application to pregnancy, ovulation, infectious diseases, drug abuse, acute myocardial infarction and cancer.

In a conventional immunochromatographic assay system, the labeled antibody and polymerized detection antibody are accumulated in a dry state on the conjugation pad. When the sample is added, the conjugate is dissolved and reacts with the analyte in the liquid phase. This reaction occurs when the sample solution moves along the fluid flow that occurs in capillary phenomena, and sandwich bonds form an immune conjugate between the conjugate and the analyte (antigen). The immunoconjugate is captured by immobilized antibodies that move up the membrane and react specifically with the analyte, generating a signal proportional to the analyte concentration. And the generated signal is measured by the diagnostic device. However, the sensitivity of the sensor can be greatly affected by the distance between the detector (eg sensor) and the diagnostic kit of the diagnostic device during measurement. Therefore, the necessity of a diagnostic kit having a structure that can minimize the distance between the diagnostic kit and the detector is required. This is emerging.

The present invention has been made to solve the above-described problems, and unlike the existing, by placing the diagnostic strip so that the upper surface of the support to correspond to the lower surface of the diagnostic kit case, the sensitivity of the diagnostic device by minimizing the distance between the diagnostic strip and the diagnostic device The purpose is to provide a structure of diagnostic kits that can increase the accuracy and make more accurate measurements.

As a means for solving the above problems, the diagnostic kit of the present invention comprises a diagnostic strip provided with a sample pad and a signal detection pad on the upper surface of the support; A diagnostic kit case accommodating the diagnostic strip; It includes, the upper surface of the support is disposed to correspond to the lower surface of the diagnostic kit case.

In the diagnostic kit of the present invention, a sample inlet formed in the diagnostic kit case and a sample pad exposure area of the upper surface of the support may be provided at a position corresponding to the sample inlet.

The sample pad exposing area may be implemented in a structure in which the support is opened to expose a portion of the sample pad.

In addition, the sample pad exposure area may be implemented as a sample pad exposure hole structure formed through the support.

In the above-described diagnostic kit of the present invention, the diagnostic strip includes: a fixing pad attached to an upper surface of the sample pad; It may be configured to include more.

In addition, the support may be formed of a transparent material.

As a means for solving the above problems, the diagnostic kit manufacturing method of the present invention comprises a diagnostic strip manufacturing step of manufacturing a diagnostic strip having a detection area on the upper surface of the support; Arranging the prepared diagnostic strip so that an upper surface of the support corresponds to a lower surface of a diagnostic kit case provided with a sample inlet; . ≪ / RTI >

In the method of manufacturing a diagnostic kit of the present invention, the diagnostic strip manufacturing step includes: a pad manufacturing step of manufacturing a sample pad and a signal detection pad having the detection area; A support processing step of processing the support to form a sample pad exposure area at a position corresponding to the sample inlet; A pad fixing step of fixing the pad to the upper surface of the processed support; . ≪ / RTI >

The support processing step may include: generating the sample pad exposure region by forming an open structure in the support such that a portion of the sample pad is exposed; Or generating a sample pad exposure area by forming a sample pad exposure hole formed through the support; . ≪ / RTI >

According to the present invention, by arranging the diagnostic strip in the diagnostic kit so that the upper surface of the support body corresponds to the lower surface of the diagnostic kit case, the sensitivity can be improved by minimizing the distance between the sensor area of the diagnostic device and the detection area of the signal detection pad. have. In particular, if the sensor of the diagnostic device is a magnetoresistive sensor that responds sensitively to the distance, it is possible to obtain a useful effect of improving the sensitivity.

In addition, when the support of the diagnostic strip is formed of a transparent material, there is an advantage that can be used not only for quantitative analysis but also for qualitative analysis.

In addition, according to the present invention, it is possible to protect the detection area from external physical damage or contamination without a separate protective sheet and can be implemented by minimizing the change in the manufacturing process has an economical advantage in terms of manufacturing cost.

1 is a cross-sectional conceptual view showing the configuration of a conventional immunochromatography diagnostic kit.
2 illustrates a configuration of a diagnostic kit including a diagnostic strip according to an embodiment of the present invention.
3 illustrates another embodiment of a diagnostic strip in the configuration of the diagnostic kit of FIG. 2.
4 and 5 are flowcharts illustrating a method of manufacturing a diagnostic kit according to an embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. However, it is to be understood that the embodiments shown in the specification and the drawings shown in the drawings are only exemplary embodiments of the present invention, and that various equivalents and modifications may be substituted for them at the time of the present application. In addition, in describing the preferred embodiment of the present invention, if it is determined that the detailed description of related known functions or configurations may obscure the gist of the present invention, the detailed description thereof will be omitted. In addition, the meaning of each term will be interpreted based on the contents throughout the present specification. The same reference numerals are used for parts having similar functions and functions throughout the drawings.

1 illustrates a structure of a diagnostic kit of a conventional immunochromatography method. As shown in (a) and (b) of FIG. 1, a general immunochromatography diagnostic strip 10 used for immunochromatographic analysis includes an elongated rectangular support body 180 made of an adhesive plastic material. And a sample pad 110, a conjugate pad 130, a signal detection pad 150, and an absorption pad 170, which are disposed on the support in a substantially sequentially order from one side to the other side. In addition, the diagnostic kit cases 200 and 300 are provided with sample inlets 210 and 310, and are generally formed in a structure that can be separated into upper cases 200a and 300a and lower cases 200b and 300b.

The sample pad 110 absorbs a liquid sample (or analyte) to be analyzed and ensures a uniform flow of the liquid sample. The conjugate pad 130, which is disposed to partially overlap with the other end of the sample pad 110, includes a flowable conjugate that specifically binds to the analyte contained in the liquid sample, and thus the sample pad 110 As the liquid sample introduced through) passes through the conjugate pad 130 in the X direction, specific binding between the analyte and the flowable conjugate occurs.

The signal detection pad 150 disposed at a position next to the sample pad 110 and the conjugate pad 130 is usually a detection zone 151 and a control zone which are spaced apart from each other by a certain distance. zone) 153. In this case, the detection area 151 is an area for checking whether an analyte is present in the liquid sample, and the control area 153 is an area for checking whether the liquid sample has normally passed through the detection area 151. .

The absorption pad 170 is disposed at a position next to the signal detection pad 150, that is, at a position adjacent to the other end of the support 180. The absorbent pad 170 absorbs the liquid sample that has passed through the signal detection pad 150 and assists in capillary flow of the liquid sample on the immunochromatography diagnostic strip 10.

The diagnostic strip 10 as described above is generally disposed such that the lower surface of the support 180 corresponds to the lower surface of the diagnostic kit case 200 as shown in FIG. Since the diagnostic strip 10 uses the sample pad 110 and the conjugation pad 130, the overall thickness thereof is generally 2 to 3 mm thick. When the signal is detected by the diagnostic device, the detection area 153 and the diagnostic device are used. There is a problem in that the distance of the period cannot be further shortened by the above-described thickness, so the sensitivity is lowered.

In addition, when the above-described diagnostic strip 10 is disposed in the diagnostic kit case 300 having the detection hole 320 as shown in FIG. There is a risk that the signal detection pad 150 is damaged in the process or measurement process.

 Figure 2 illustrates the configuration of a diagnostic kit including a diagnostic strip according to an embodiment of the present invention.

1 and 2, in the present embodiment, the diagnostic strip 20 includes a sample pad 110 and a signal detection pad 150 on an upper surface of the support 191 as shown in FIG. It consists of a structure provided. In addition, the control strip 130 and the absorbent pad 170 may be further included in the same manner as the diagnostic strip 10 of FIG. 1, and the signal detection pad 150 is provided with a detection area 151. Region 153 may be provided.

The diagnostic strip 20 is disposed in an inverted form such that the upper surface of the support 193 corresponds to the lower surface of the diagnostic kit case 300 as shown in FIGS. 2B and 2C. .

Therefore, the support 191 needs to be formed in a structure in which the liquid sample can be absorbed into the sample pad 110 when the liquid sample is administered to the diagnostic kit. For this purpose, the support 191 may include a sample pad exposure area. .

In addition, the diagnostic strip 20 further includes a fixing pad 197 formed on the upper surface of the sample pad 110 to fix the sample pad 110 when the diagnostic strip 20 is mounted on the diagnostic kit case 300. Can be. In this case, the fixing pad 193 is preferably formed of the same material as the support 191, and is formed in a structure connected to the support 191 or the support 191 extends to form the sample pad 110. It may be formed in a structure surrounding the shape.

The diagnostic kit case 300 is provided with a sample inlet 310. The apparatus may further include a detection hole 320 for detecting a signal of the detection region 151 through a diagnostic device or visually confirming the detection result.

The sample pad exposure area of the support 191 is formed at a position corresponding to the sample inlet 310 to have a structure in which the sample pad 110 can be exposed. In the present exemplary embodiment, the sample pad exposure area is implemented as a structure of the sample pad exposure hole 195 formed through the support 191. However, the sample pad exposure area is not limited thereto, and the structure is opened so that a part of the sample pad 110 is exposed. It may be formed as. A more detailed description thereof will be given in the description of FIG. 3.

As the sample pad exposure area is formed on the support 191, when the liquid sample is administered to the sample inlet 310, the liquid sample may be absorbed into the sample pad 110 without the influence of the support 191.

The diagnostic strip 20 of the diagnostic kit is disposed in an inverted form so that the upper surface of the support 191 corresponds to the lower surface of the diagnostic kit case 300, so that the sample pad 110 or the conjugate is relatively thicker than the support 191. Due to the gating pad 130, it is possible to minimize the distance from the sensor of the diagnostic device, thereby improving the sensitivity.

In addition, without a separate protective sheet for protecting the signal detection pad 150, it is possible to protect the signal detection pad 150 from external physical damage or contamination, thereby reducing the manufacturing cost of the diagnostic kit. .

In addition, it is possible to obtain the effect of improving the sensitivity by minimizing changes in the structure or manufacturing process of the existing diagnostic kit.

Meanwhile, the support 191 may be formed of a transparent material, for example, a polyvinyl chloride (PVC) resin or polyethylene terephthalate (PET), which is a known plastic material, and in this case, quantitative analysis using a diagnostic device. In addition, it is possible to implement a diagnostic kit that can be used for qualitative analysis, and also to minimize the distance of visible visual observation, making it easy to check the detection result. However, the material of the support 191 described above is one example, and may be said to form the support 191 of the present invention with all transparent plastic materials that are currently developed and commercialized, or that may be implemented according to future technological developments.

3 illustrates another embodiment of a diagnostic strip in the configuration of the diagnostic kit of FIG. 2.

2 and 3, the diagnostic strip 30 of the present embodiment does not implement the sample pad exposure area of the support 197 in the form of the sample pad exposure hole 195 of FIG. 2, but the sample pad 110. It may be formed in a structure that is open so that a portion of the region is exposed.

That is, the length when the sample pad 110, the conjugation pad 130, the signal detection pad 150, and the absorption pad 170 are all attached is referred to as L1, and the sample inlet 320 of the diagnostic kit case 300 is referred to as L1. When the length of the region of the sample pad 110 corresponding to L2 is L2, the open structure may be formed by forming the length of the support 191 to have the length of L1-L2. The other descriptions are the same as those described above with reference to FIG. 2 and will be omitted.

4 and 5 are flowcharts illustrating a method of manufacturing a diagnostic kit according to an embodiment of the present invention.

Referring to FIG. 4, the diagnostic kit according to the present embodiment may be manufactured by the following method. First, a diagnostic strip having a sample pad and a signal detection pad is prepared on an upper surface of the support (S100). It is preferable that the diagnostic strip further includes a conjugation pad and an absorption pad. And the diagnostic strip prepared in step S100 is arranged so that the upper surface of the support corresponds to the lower surface of the diagnostic kit case provided with the sample inlet (S200) and assembled the diagnostic kit (S300).

4 and 5, in step S100, a sample pad and a signal detection pad including a detection area are manufactured (S110), and the support is processed to expose the sample pad exposure area at a position corresponding to the sample inlet of the diagnostic kit case. Forming (S130), the pad made in step S110 to the upper surface of the processed support is made by fixing (S150).

Of course, the sample pad and the signal detection pad manufactured in step S110 may form a diagnostic strip together with the conjugation pad and the absorption pad as described above.

Meanwhile, in step S130, the sample pad exposure area may be implemented by forming an opening structure in the support so that a portion of the sample pad is exposed when the sample pad is fixed to the support. The open structure of the support may be implemented by shortening the length of the support to support only a partial region of the sample pad.

In addition, in step S130, the sample pad exposure area may be implemented by forming a sample pad exposure hole formed through the support. That is, a hole is formed in the support, but the sample pad exposure area can be realized by forming a hole at a position corresponding to the sample inlet of the diagnostic kit case.

The sample pad exposure area of the support formed in step S130 described above allows the liquid sample administered to the sample inlet of the diagnostic kit case to be absorbed into the sample pad when the diagnostic strip is mounted on the diagnostic kit case.

Thereafter, the pads prepared in step S110 are applied by applying an adhesive to the support processed in step S130, and then sequentially fixed to prepare a diagnostic strip (S150).

Diagnostic kit manufactured by the above-described method can minimize the distance between the sensor and the signal detection pad of the diagnostic device, thereby improving the sensitivity. In addition, it is possible to protect the signal detection pad from external physical damage or contamination without a separate protective sheet, thereby reducing the manufacturing cost of the diagnostic kit.

As described above and described with reference to a preferred embodiment for illustrating the technical idea of the present invention, the present invention is not limited to the configuration and operation as shown and described as such, without departing from the scope of the technical idea It will be understood by those skilled in the art that many variations and modifications to the present invention are possible. Accordingly, all such suitable modifications and variations and equivalents should be considered to be within the scope of the present invention.

10: conventional immunochromatography diagnostic strip
20: diagnostic strip including the support of the opening structure
30: diagnostic strip including a support having a sample pad exposure hole
110: sample pad 130: conjugation pad
150: signal detection pad 151: detection area
152: control area 170: absorbent pad
191: support having a sample pad exposure hole
193: fixing pad 195: sample pad exposure hole
197: support of the open structure
200: diagnostic kit case without a detection hole
300: diagnostic kit case equipped with a detection hole
210, 310: Sample inlet 320: Detection hole

Claims (9)

A diagnostic strip provided with a sample pad and a signal detection pad on an upper surface of the support;
A diagnostic kit case accommodating the diagnostic strip; Including,
A diagnostic kit disposed so that an upper surface of the support corresponds to a lower surface of the diagnostic kit case.
The method according to claim 1,
A sample inlet formed in the diagnostic kit case;
And a sample pad exposing area of the upper surface of the support at a position corresponding to the sample inlet.
The method according to claim 2,
The sample pad exposure area,
And a diagnostic kit having a structure in which the support is opened to expose a portion of the sample pad.
The method according to claim 3,
The sample pad exposure area,
A diagnostic kit implemented with a sample pad exposure hole structure formed through the support.
The method according to claim 4,
The diagnostic strip may include a fixing pad attached to an upper surface of the sample pad;
Diagnostic kit further comprising.
6. The method according to any one of claims 1 to 5,
The support is a diagnostic kit formed of a transparent material.
A diagnostic strip manufacturing step of manufacturing a diagnostic strip having a sample pad and a signal detection pad on an upper surface of the support;
Arranging the prepared diagnostic strip so that an upper surface of the support corresponds to a lower surface of a diagnostic kit case provided with a sample inlet;
Diagnostic kit manufacturing method comprising a.
The method of claim 7,
The diagnostic strip manufacturing step,
A pad manufacturing step of manufacturing the signal detection pad having a sample pad and a detection area;
A support processing step of processing the support to form a sample pad exposure area at a position corresponding to the sample inlet;
A pad fixing step of fixing the pad to the upper surface of the processed support;
Diagnostic kit manufacturing method comprising a.
The method according to claim 8,
The support processing step,
Generating a sample pad exposure region by forming an open structure in the support to expose a portion of the sample pad; or
Generating a sample pad exposure area by forming a sample pad exposure hole formed through the support;
Diagnostic kit manufacturing method comprising a.

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