WO2011145895A2

WO2011145895A2 - Reflective light absorbance measuring apparatus and integrated apparatus for measuring reflective light absorbance and for lateral flow assay comprising same

Info

Publication number: WO2011145895A2
Application number: PCT/KR2011/003703
Authority: WO
Inventors: 김병철; 이재민; 정정혁
Original assignee: 바디텍메드 주식회사
Priority date: 2010-05-19
Filing date: 2011-05-19
Publication date: 2011-11-24
Also published as: KR20110127386A; WO2011145895A3; KR101190190B1

Abstract

The present invention relates to a reflective light absorbance measuring apparatus, and to an integrated apparatus capable of simultaneously performing a lateral flow assay and reflective light absorbance measurement. The integrated apparatus for measuring reflective light absorbance and for lateral flow assay according to the present invention enables both the light absorbance measurement and lateral flow assay for a sample to be performed, and comprises a reflective light absorbance measuring apparatus and a lateral flow assay apparatus arranged in the vicinity of the reflective light absorbance measuring apparatus. The reflective light absorbance measuring apparatus of the present invention measures light absorbance in a quicker, more convenient and easier manner while maintaining a predetermined level of accuracy, and the integrated apparatus simultaneously obtains information on the lateral flow assay and information on the light absorbance measurement.

Description

Reflective Absorbance Measurement Apparatus and Reflective Absorbance and Lateral Flow Analysis-Integrated Apparatus

The present application relates to a reflective absorbance measuring device and an integrated device capable of performing both reflective absorbance measurement and lateral flow analysis.

The development of new diagnostic methods and diagnostic tools by qualitatively or quantifying trace substances in biopsies, such as blood or urine, has progressed rapidly over the past three decades and is still rapidly developing. Since the first introduction of radioimmunoassay (RIA) using radioisotopes in the 1950s, enzyme immunoassay (ELISA) was developed and developed in the 70s and 80s. ELISA immunoassay is now one of the most used methods and has become an essential tool in the research of medicine and life sciences. Recently, modified ELISA assays have been developed, one of which involves analyzing a large number of samples at once by immobilizing multiple antibodies in 96-wells.

In typical immunodiagnostic methods, including RIA and ELISA, one type of analyte can usually be quantified using expensive analyzers in laboratories in a complex multi-step process. Therefore, it is not easy to use in a small hospital, emergency room, home, etc. without such facilities or equipment. Diagnostic products designed to compensate for this weak point is a simple diagnostic kit using immunochromatography method. The immunochromatography method can be used as a diagnostic kit to apply whole blood, serum, and urine biopsies to the designed device so that the test results can be quickly confirmed. One example of immunochromatography methods is the use of lateral flow analysis methods, which are widely used in various fields such as pregnancy diagnosis, cancer diagnosis, the presence of other specific proteins or genes, or microbial detection. However, lateral flow assays are based on specific reactions between two substances, such as, for example, antigen-antibody responses, which are included in the blood to correct and / or secure them with these tests, or to obtain additional information. For example, the concentration of other substances, such as hemoglobin, was inconvenient to be taken separately and measured using a separate absorbance measuring instrument / apparatus. In addition, a separate absorbance measuring device / apparatus generally transmits light to perform absorbance measurement, so that a light source, a light detector, and a measurement device containing a sample are not easily disposed.

The present invention was created to solve the problems as described above, the problem to be solved by the present application is to provide a reflective absorbance measuring device that can quickly and easily measure the absorbance while maintaining a certain accuracy.

In addition, another problem to be solved by the present application is to provide a reflection absorbance measurement and lateral flow analysis integrated device that can be performed in a single device quickly and simply while maintaining the lateral flow analysis and absorbance measurement.

The present application is a base member formed with a sample receiving portion; A cover member covering an upper end of the base member; And a light transmitting member interposed between the base member and the cover member, wherein the cover member is provided with a sample inlet for feeding the sample into the sample receiving portion and a reflected light side window so as to be perpendicular to the sample receiving portion. The member provides a reflective absorbance measuring device positioned to correspond to the reflected light measuring window.

The present application also provides a reflective absorbance measuring apparatus including a bottom portion for reflecting light incident through the light transmitting member.

The present application also provides a reflective absorbance measuring device, wherein the reflected light measuring window extends in one direction on the cover member, and the sample accommodating part extends in the one direction on the base member.

The present application also provides a reflectance absorbance measuring apparatus having two sample inlets, and the reflected light measuring window is formed between the two sample inlets.

The present invention also provides a reflective absorbance measuring device wherein the light transmitting member is formed at a position lower than the sample inlet.

The reflective absorbance measuring apparatus of the present application includes a light source disposed above the cover member, and an upper side of the cover member to measure an amount of light reflected from the light source after being irradiated to the sample receiving unit through the light transmitting member. It may further comprise a photo detector disposed in. The photo detector may be arranged to deviate on a vertical line in which the light source exists.

The present application also provides an apparatus for reflection absorbance and lateral flow analysis in which absorbance measurement and lateral flow assay of a sample can be performed all at once, the aforementioned reflection absorbance measuring device, and the reflection absorption measurement A reflective absorbance and lateral flow analysis integrated device comprising a lateral flow analysis device disposed adjacent to the device.

The present invention also provides a reflective absorbance and lateral flow analysis integrated device which is formed in a straight line or side by side the reflective absorbance measuring device.

The present invention also provides a reflective absorbance and lateral flow analysis integrated device of two or more of the reflective absorbance measuring device and the lateral flow analysis device.

The present application also includes two reflective absorbance measuring devices and two lateral flow analysis devices, and one reflective absorbance measuring device and one lateral flow analysis device are arranged on a straight line, and the other reflective absorbance measuring device is provided. And one side flow analysis device is also arranged in a date, the two-day reflective absorbance measuring device and side flow analysis device provides a reflective absorbance and side flow analysis integrated device arranged side by side.

Apparatus of the present application is not only easy loading (loading) of the sample, but also by the absorbance measurement is made by reflection, absorbance measurement can be made more simply and easily while maintaining a certain accuracy.

In addition, since the lateral flow analysis and the absorbance measurement are performed in one device, the lateral flow analysis information and the absorbance measurement information can be measured together more quickly and easily while maintaining a predetermined accuracy.

1 is an exploded perspective view of a reflective absorbance measuring apparatus according to an embodiment of the present application.

2 is an exploded perspective view of a reflective absorbance measuring apparatus according to an embodiment of the present application with a light transmitting member inserted into a reflected light measuring window.

3 is a perspective view of a reflective absorbance measuring apparatus according to an embodiment of the present application.

4 is a plan view of the cover member of the reflective absorbance measuring apparatus according to an embodiment of the present application.

5 is a plan view of the base member of the reflective absorbance measuring apparatus according to an embodiment of the present application.

6 is a cross-sectional view taken along the line VI-VI of FIG. 3.

7 is a cross-sectional view showing a schematic use example of the reflective absorbance measuring apparatus according to an embodiment of the present application.

8 is a front view of a reflective absorbance measuring apparatus according to an embodiment of the present application.

9 is an exploded perspective view of a reflective absorbance measurement and side flow analysis integrated device according to another embodiment of the present application.

10 is an exploded perspective view of a reflective absorbance measurement and side flow analysis integrated device according to another embodiment of the present application with the light transmitting member inserted into the reflected light measuring window.

11 is a perspective view of a reflective absorbance measurement and lateral flow analysis integrated device according to another embodiment of the present application.

12 is a plan view of a cover member of a reflective absorbance measurement and lateral flow analysis integrated device according to another embodiment of the present disclosure.

13 is a plan view of a base member of a reflective absorbance measurement and lateral flow analysis integrated device according to another embodiment of the present disclosure.

14 is a cross-sectional view taken along the line XIV-XIV of FIG. 11.

15 is a front view of a reflective absorbance measurement and lateral flow analysis integrated device according to another embodiment of the present application.

16 is a perspective view of a reflective absorbance measurement and side flow analysis integrated device according to another embodiment of the present application.

FIG. 17 shows the absorbance measured by the reflective absorbance measuring device of the reflective absorbance measuring device according to one embodiment of the present application or the reflective absorbance measuring and lateral flow analysis integrated device according to another embodiment of the present application, converted into Hb concentration. The result is a graph comparing the result of the conventional Hb concentration measurement.

18 is a reflection absorbance measurement and lateral flow analysis integrated device according to another embodiment of the present application to obtain the Hb concentration through the reflection absorbance measuring device and to measure the A1c through the lateral flow analysis device converted to HbA1c concentration results It is a graph compared with the conventional HbA1c concentration measurement results.

1 to 8, the reflective absorbance measuring apparatus 100 according to the exemplary embodiment of the present application includes a base member 110 including a sample accommodating portion 111 on which a sample 300 is placed, and a base member. A sample member (121, 123) and a base member including a cover member (120) covering the upper end of the (110), and the cover member (120) formed so that the sample (300) can be injected into the sample receiving portion (111). When the upper end of the cover 110, the sample receiving portion 111 includes a reflection light measuring window 125 formed in a vertically corresponding portion, and a light transmitting member 127 inserted into the reflected light measuring window 125 It is characterized by. Referring to FIGS. 6 and 7, the cover member 120 is covered with the base member 110 to be interlocked with each other at an interface 130 thereof, thereby substantially waterproof and aerosol proof. It becomes a seal.

Hereinafter will be described in detail with reference to the accompanying drawings an embodiment of the present application.

1 is an exploded perspective view of a reflective absorbance measuring apparatus according to an embodiment of the present application, Figure 2 is an exploded perspective view of the reflective absorbance measuring apparatus according to an embodiment of the present application with the light transmitting member inserted into the reflected light measuring window 3 is a perspective view of a reflective absorbance measuring apparatus according to an embodiment of the present disclosure.

4 is a plan view of the cover member of the reflective absorbance measuring apparatus according to an embodiment of the present application, Figure 5 is a plan view of the base member of the reflective absorbance measuring apparatus according to an embodiment of the present application.

6 is a cross-sectional view taken along line VI-VI of FIG. 3, and FIG. 7 is a cross-sectional view illustrating a schematic use example of a reflective absorbance measuring apparatus according to an exemplary embodiment of the present disclosure. 8 is a front view of a reflective absorbance measuring apparatus according to an embodiment of the present application.

As shown in FIG. 1 to FIG. 8, the reflective absorbance measuring apparatus 100 according to the exemplary embodiment of the present invention covers a base member 110 having a sample accommodating portion 111 and an upper end of the base member 110. The cover member 120 and a light transmitting member 127 interposed between the base member 110 and the cover member 120, the cover member 120 is a sample 300 to the sample receiving portion 111 Reflective light measuring window 125 is formed to be perpendicular to the sample inlet (121, 123) and the sample receiving portion for injecting, and the light transmitting member 127 is positioned so as to correspond to the reflected light measuring window, the reflective absorbance It is a measuring device. Referring to FIGS. 6 and 7, the cover member 120 is covered with the base member 110 to be interlocked with each other at an interface 130 thereof, thereby substantially waterproof and aerosol proof. It becomes a seal.

Here, the sample 300 refers to a material including an analyte that can be used in the device of the present application, and is a liquid or liquid-like fluid material, for example, various solid tissues / cells, blood, saliva, urine, sweat, Body hair or material extracted therefrom, or the like, or various materials such as materials collected from the environment (eg, atmosphere, soil, water, etc.). Examples include, but are not limited to, blood, urine, saliva, and the like may include whole blood, plasma, serum, or blood, plasma, serum, etc. that have undergone a predetermined treatment (eg, anticoagulant). . Extracts of tissues or cells are for example selected from carbohydrates, lipids, nucleic acids, proteins and the like. The analyte is not limited thereto, for example, but a marker associated with various diseases, such as C-Reactive Protein (CRP), Prostate Specific Antigen (PSA), alpha-Feto Protein (AFP), and CA-125 (Cancer). Antigen 125), CA19-9, microalbumin, HbA1c (Hemoglobin A1c), cTn-I / T (Cardiac Troponin I and T) and the like.

1, 2, 5, 6, and 7, the sample accommodating part 111 may reflect the light source 400 incident through the light transmitting member 127 to the bottom part 111a. It may be characterized in that it comprises a.

A material capable of reflecting the light source 400 incident through the light transmitting member 127 may be used for the bottom portion 111a of the present application. The material may be appropriately selected according to the type of the light source 400. For example, when an LED or a laser is used as the light source 400, any white polymer material may be used as the reflective material. For example, ABS (Acrylonitrile, Butadiene, Styrene), PS (Polystyrene), PE (polyethylene), PP (polypropylene) and the like can be used. Alternatively, a smooth reflective surface having specular reflection characteristics, such as metals such as aluminum, titanium, or chromium, may be used. However, the above-described reflective material is provided as an example, and the material of the bottom 111a is not limited thereto.

For example, referring to FIG. 7, light emitted from the light source 400 is incident on the sample 300 through the light transmitting member 127 at a position corresponding to the reflected light measuring window 125, and then the bottom portion ( It may be diffusely reflected at 111a and travel out again through the light transmitting member 127.

In addition, referring to FIG. 6, the sample 300 is introduced into the sample accommodating part 111 through the

sample inlets

121 and 123. After the sample 300 is input, the sample is sampled as shown in FIG. It is accommodated in the receiving portion 111. At this time, it is preferable that the height of the received sample 300 is equal to or lower than the lower surface of the light transmitting member 127 as shown in FIG. Referring to FIG. 7, when the light irradiated from the light source 400 through the light transmitting member 127 passes through the sample 300 and reaches the bottom 111a of the sample accommodating portion 111, the light is reflected. This is because the absorbance with respect to the uniform thickness can be measured only when the sample 300 is formed to be equal to or higher than the lower surface of the light transmitting member 127.

Accordingly, the light transmitting member 127 may have a lower surface formed at a position lower than the

sample inlets

121 and 123. That is, in order for the sample 300 to be unloaded higher than or lower than the lower surface of the light transmitting member 127, the lower surface of the light transmitting member 127 is preferably formed at a lower position than the

sample inlets

121 and 123.

In addition, as long as the height is adjusted as described above, it is not necessary to accurately measure the volume of the sample 300 to be unloaded using a pipette every time, as in the conventional case, to 1 μl unit, thereby reducing errors due to the absence of accurate quantification. It can be convenient for the user. That is, when the sample 300 is filled to at least the lower surface of the light investment member 127, the volume of the sample 300 to be loaded onto the sample accommodating part 111 is determined, and thus the use is much easier. For example, the user may take a certain amount of sample 300 with a pipette and then unload the sample to a line filling the sample accommodating portion 111. The volume of the sample to be loaded will depend on the specific size of the device, but if the device is made for use with i- Chroma (Bodytec Med, Korea) as a reader, the size of the device is not limited thereto. It is approximately 1.5 cm (width) x 4 cm (length) x 0.4 cm (height), wherein the volume of the sample to be loaded can range from about 50 μl to about 250 μl, in particular about 100 μl.

At this time, the size of the device refers to the size of the reflective absorbance measuring apparatus 100, the size of the reflective absorbance measurement and side flow analysis integrated device 200 to be described later is approximately 1.5cm (width) × 9.3cm (length) It may be, but not limited to, a height of 0.4 cm.

In addition, the size of the reflected light measurement window 125 may be set differently according to the specific size of the device, the conditions of the light source 400 and the light detector 500, the material of the light transmitting member 127, etc. Is manufactured for use in i- Chroma (Bodytec Med Co., Korea), the size of the reflected light measuring window 125 may be approximately 0.5cm (width) x 0.7cm (length). In another embodiment, when the cover member and the light transmitting member of the present application are made of the same material, the half-light measuring window serves as a light transmitting member, in which case the light transmitting member, the

sample inlets

121 and 123 and the reflected light measurement Areas other than windows should be surface treated to prevent light transmission.

However, the height of the received sample 300 is not necessarily equal to or higher than the lower surface of the light transmitting member 127, and may be flexibly adjusted according to the type of the sample 300 to measure absorbance. In addition, the height or thickness of the received sample 300 may be adjusted by adjusting the thickness of the light transmitting member 127. In one embodiment of the present application when the sample receiving portion 111 is filled through one of the sample inlet (121, 123) so that the height of the received sample 300 is equal to or higher than the lower surface of the light transmitting member 127 Is produced.

In addition, at least two

sample inlets

121 and 123 may be formed. If only one sample inlet is formed, air enters the sample accommodating part 111, and the sample 300 is not properly input to the sample accommodating part 111, or air that is not mixed with the injected sample 300 is mixed to measure incorrect absorbance. This can be done. Therefore, a plurality of

sample inlets

121 and 123 may be formed in order to facilitate the input of the sample 300 and, if necessary, the discharge of the sample, and to perform accurate absorbance measurement. For example, if there are two, one may be used for the input of a sample, and the other may be formed in a structure through which air can pass to cause a capillary phenomenon.

For example, the

sample inlets

121 and 123 may include two

sample inlets

121 and 123, and the reflection light measuring window 125 may be formed between the two

sample inlets

121 and 123. You can do

1, 2, and 6, the reflected light measuring window 125 may be formed at a portion vertically corresponding to the sample accommodating part 111 when the cover member 120 covers the upper end of the base member 110. Since the reflection light measuring window 125 is formed between the two

sample inlets

121 and 123, the sample accommodating part 111 is also positioned between the two

sample inlets

121 and 123. Therefore, for example, referring to FIG. 6A, after the sample 300 is injected into the sample inlet 121 on the right side, absorbance measurement is performed and the sample 300 is discharged into the sample inlet 123 on the left side. Can be. The sample inlets 121 and 123 may have the same size or different sizes. When the sizes of the

sample inlets

121 and 123 are different, the large sample inlet 121 becomes the main inlet of the sample, and the small sample inlet 123 is disposed in the sample accommodating part 111 when the sample is unloaded. It can also play a secondary role, such as allowing air to settle out.

In addition, the reflective absorbance measuring apparatus 100 according to an exemplary embodiment of the present disclosure may include a light source 400 disposed above the cover member 120, and a sample accommodating part through the light transmitting member 127 from the light source 400. The light detector 500 may further include a photo detector 500 disposed above the cover member 120 to measure an amount of light that is reflected after being irradiated to the 111. In this case, one or more light sources 400 may be provided as necessary. As the light source, for example, but not limited to, a light emitting diode (LED), ultra violet (UV), and a laser may be used. For example, a 540 nm wavelength LED can be used for hemoglobin measurements. However, it is possible to use a variety of wavelengths depending on the measurement target, for example, the measurement of nucleic acid proteins can be used UV light source of 255 ~ 380nm band. The amount of reflected light measured by the photo detector 500 may be converted into a concentration of an object to be measured according to a known method.

In addition, the light detector 500 may be disposed to be deflected on a vertical line in which the light source 400 is present.

As the influence of the surface reflected light, that is, the light reflected from the upper or lower surface of the light transmitting member 127 is minimized, the accuracy of absorbance measurement may be increased. To this end, as shown in FIG. 7, the light source 400 and the light detector 500 are preferably disposed away from the light detector 500 such that they are not on the same vertical line. Here, the arrangement so as to deviate means that the arrangement so as not to be on the same vertical line. Therefore, since they are arranged to be on the same horizontal line so as not to be on the same vertical line may be included in one embodiment of the present application.

In addition, the reflected light measuring window 125 may be formed to extend in one direction on the cover member 120, and the sample accommodating part 111 may be formed to extend in one direction on the base member 110.

That is, the reflection light measuring window 125 and the sample accommodating part 111 may be formed to extend in one direction so as to freely arrange the light source 400 and the light detector 500 for minimizing the influence of the surface reflected light. Can be. Accordingly, the light source 400 and the photo detector 500 may be disposed to minimize the influence of the surface reflected light along a direction parallel to one direction. In this case, the light source 400 and the photo detector 500 are preferably not disposed on the same vertical line as described above. As such, the reflected light measuring window 125 and the sample accommodating part 111 are formed to extend in one direction so that the position of the given light source 400 can be accommodated more widely. That is, according to the position of the light source 400 at the time of absorbance measurement, the range in which the present apparatus can be set can be wider.

The reflective absorbance measuring apparatus 100 of the present disclosure may be manufactured in various shapes and sizes according to the type of the reader. For example, it can be manufactured in strip form and can be used in various absorbance measuring instruments (readers) that can accommodate such strip-shaped devices, and the size can be variously made accordingly. Reflective absorbance measurement apparatus 100 of the present application can be widely used in the reader for measuring the absorbance in a reflective manner, for example, but not limited to i- Chroma (Bodytec Med Co., Korea), blood It may be applicable to coagulometer and the like.

1 to 8 according to an embodiment of the present application, the square shape 110a through the square hole 120a may serve as a standard reflector for generating a signal for background calibration. In addition, the square hole 120a and the square shape 110a may also serve as a physical structural aid for the base member 110 and the cover member 120 to be engaged with each other. In addition, the semi-circular protrusion (120b) may be a portion that makes it easy to hold the device when you want to discharge the sample. Such matters may also be applied to the rectangular holes 120a, the square shapes 110a, and the semi-circular protrusions 120b shown in FIGS. 9 to 15 in the reflective absorbance measurement and lateral flow analysis integrated apparatus according to another embodiment of the present disclosure. The same may apply. 1 to 15 of the present application is illustrative, the shape of each part employed therein is also illustrative and it will be apparent to those skilled in the art that various shapes may be employed.

Hereinafter, a reflective absorbance measurement and side flow analysis integrated device according to another embodiment of the present application will be described. Here, in all the drawings for demonstrating embodiment of this application, the thing which has the same function is attached | subjected with the same code | symbol, and the detailed description is abbreviate | omitted. In addition, when the above-described reflective absorbance measuring apparatus 100 is included in the reflective absorbance measurement and lateral flow analysis integrated device 200 according to another embodiment of the present application, the reference numeral 210 according to the notation of FIGS. To be given.

9 is an exploded perspective view of a reflective absorbance measurement and side flow analysis integrated device according to another embodiment of the present application, Figure 10 is a reflective absorbance according to another embodiment of the present application with the light transmitting member inserted into the reflected light measurement window An exploded perspective view of a measurement and lateral flow analysis integrated device, and FIG. 11 is a perspective view of a reflective absorbance measurement and lateral flow analysis integrated device according to another embodiment of the present disclosure.

12 is a plan view of a cover member of the reflective absorbance measurement and lateral flow analysis integrated device according to another embodiment of the present application, and FIG. 13 is a base of the reflective absorbance measurement and lateral flow analysis integrated device according to another embodiment of the present application. It is a top view of the member.

FIG. 14 is a cross-sectional view taken along the line XIV-XIV of FIG. 11, and FIG. 15 is a front view of the reflective absorbance measurement and side flow analysis integrated device according to another embodiment of the present disclosure.

9 to 15, the reflective absorbance measurement and lateral flow analysis integrated apparatus 200 according to another embodiment of the present disclosure may measure the absorbance of the sample 300 and the target analyte of the sample 300. ) Is a reflection absorbance measurement and lateral flow analysis integrated device 200, which is a lateral flow assay (quantitative or qualitatively) to measure both quantitatively or qualitatively. The integrated device means that the absorbance measuring device and the lateral flow analyzer are physically connected, and the lateral flow analysis disposed adjacent to the aforementioned reflective absorbance measuring device 210 and the reflective absorbance measuring device 210 is described. Device 220. Adjacent arrangements can be made in various ways to suit the structure / shape of the reader used. For example, in one embodiment of the present application, the reflective absorbance measuring device 210 and the lateral flow analysis device 220 are located in front and rear (or rear and front) in the longitudinal direction as shown in FIGS. 9 to 15. Although not shown, the absorbance measuring device and the lateral flow analysis device may be formed in a form arranged side by side from side to side.

Here, the arrangement means that the device is arranged along the long side direction of the device, that is, the longitudinal direction, and the side-by-side arrangement may mean that the device is arranged along the short side of the device, that is, the transverse direction.

In addition, the reflective absorbance measuring device 210 and the lateral flow analysis device 220 may each be one or more. For example, two reflective absorbance measuring apparatuses 210 may be formed, and one lateral flow analyzing apparatus 220 may be formed. By way of example, in one embodiment of the present disclosure, the unitary device may include one lateral flow analysis device 220 and two reflective absorbance measurement devices 210. When they are arranged in a date, two reflective absorbance measuring apparatuses 210 may be arranged back and forth with one lateral flow analyzer 220 at the center. Alternatively, two reflective absorbance measuring devices 210 may be disposed to the left and right, with one side flow analysis device 220 at the center, or the side flow analysis device 220 may be disposed at the front (or the rear) and two The reflective absorbance measuring device 210 may be arranged in a row behind (or in front of) the light absorbance measuring device 210. Alternatively, one side flow analysis device 220 may be disposed on the left side (or right side), and the two reflective absorbance measuring apparatuses 210 may be arranged side by side on the right side (or the left side thereof). In addition, the reflective absorbance measuring device 210 and the lateral flow analysis device 220, each provided with one or more may be variously arranged according to the structure / shape of the reader used.

The reflective absorbance measuring device 210 and the lateral flow analysis device 220 may be two or more, respectively. For example, as shown in FIG. 16, the reflective absorbance measuring device 210 and the lateral flow analysis device 220 are two, respectively, one of the two reflective absorbance measuring devices 210 and one side flow. The analysis device 220 is arranged in a date, and the other reflective absorbance measuring device 210 and one lateral flow analysis device 220 are also arranged in a date and two reflective absorbance measuring devices ( 210 and the lateral flow analysis device 220 may be arranged side by side. In other words, the reflective absorbance measuring device 210 arranged side by side and the side flow analysis device 220 also arranged side by side may have a lined up order in front and rear (or reverse order).

In this way, the reflective absorbance measuring device 210 and the lateral flow analysis device 220 are integrally formed so that the lateral flow analysis and the absorbance measurement are performed in one device 200, thereby the lateral flow analysis information and the absorbance measurement information. Can be made more quickly and easily.

9 to 15, the reflective absorbance measuring device 210 includes a base member 110 including a sample accommodating portion 111 on which a sample 300 is placed, and an upper end of the base member 110. It includes a cover member 120 to cover the cover member 120, the

sample inlet

121, 123 is formed so that the sample 300 can be injected into the sample receiving portion 111, the upper end of the base member 110 It is characterized in that it comprises a reflected light measuring window 125 formed in a portion corresponding to the sample receiving portion 111 and the vertical when the cover, and a light transmitting member 127 inserted into the reflected light measuring window 125.

On the other hand, the lateral flow analysis device 220 is a lateral flow assay (lateral flow assay) for quantitatively or qualitatively measuring the target analyte (analyte) of the sample 300 can be implemented through a known configuration and those skilled in the art You may choose the appropriate one.

In addition, referring to FIG. 14, when the cover member 120 is covered with the base member 110 formed through the reflective absorbance measuring device 210 and the lateral flow analysis device 220, they are engaged with each other at the interface 230. Interlocking, substantially waterproof and aerosol proof seals.

9 to 15, basically, the lateral flow analysis device 220 is disposed adjacent to the reflective absorbance measuring device 210 and has a separate sample inlet 221 and a measurement window formed in the cover member 120. (223) And a strip receiving portion 225 capable of receiving the strip 600 described below in the base member 110. The measurement window 223 may be a window for measuring the binding of the antigen antibody in the lateral flow analysis.

Absorbance measurement apparatus of the present application and the one-piece device capable of lateral flow analysis including the same can be made of chemically stable synthetic resin and combinations thereof. For example, but not limited to polyethylene, polypropylene, polystyrene, polyethylen terephthalate, polyamide, polyester, polyvinyl chloride, polyurethane, polycarbonate, polyvinylidene chloride, polytetrafluoromethylene, polyether Various plastics of thermosetting and thermoplastic such as mead and combinations thereof can be prepared using known molding methods. However, the present invention is not necessarily limited thereto, and any material may be used as long as the material is suitable for the purpose of the present apparatus. In addition, the apparatus of the present application may be manufactured using injection, rotation, extrusion and / or calendering methods according to various kinds of known molding methods, such as, but not limited to, the type of material. In one embodiment of the present invention the device of the present invention is a cover member and the base member is ABS resin (Acrylonitrile, Butadiene, Styrene), the transparent window is injection molded acrylic Are manufactured. Those skilled in the art will be able to select materials and molding methods suitable for the purpose of the present application from various known materials and molding methods for manufacturing the device. In addition to the synthetic resin, various additives for producing a device suitable for the purpose of the present application, for example, fillers, plasticizers, stabilizers, colorants, antistatic agents and the like can be used as needed.

The lateral flow analysis herein is for example using immunochromatography analysis. In the lateral flow analysis apparatus 220 of the present application, various known strips 600 (see FIG. 9) may be used, but are not limited thereto, for example, those disclosed in Korean Patent Publication No. 2009-0006999 or 2005-0072015 may be used. have. In the strip structure of the patent lateral flow analysis, a sample pad to which a sample is applied, a release pad coated with a detection antibody, and a membrane for development in which a sample is moved and separated and an antibody antigen reaction occurs (mainly Nitrocellulose) or strips, and an absorption pad for the sample to move continuously. The detection antibody is immobilized on, for example, colloidal gold particles to label the detection. Latex beads or carbon particles may be used instead of gold particles. Diagnostic kits for lateral flow analysis are usually designed to detect analytes in the form of sandwiches. The analyte in the liquid sample is applied to the sample pad and begins to move, first developing in the form of an antigen-antibody conjugate by first reacting with a detection antibody that is unfixedly coated on the release pad. As it moves, it reacts with the capture antibody immobilized on the developing membrane once more to form a sandwich-like complex. Since the capture antibody is immobilized on the developing membrane, if antigen-antibody reactions continue to occur, accumulation of the complex takes place on the fixed side of the capture antibody. Since proteins are transparent to the naked eye, the formation and relative amounts of complexes are determined by the amount of gold or silver particles attached.

The integrated device 200 of the present disclosure may be manufactured in strip form and may be used in various absorbance measuring equipment (readers) capable of accommodating such strip form device, and the size may be variously manufactured accordingly. Equipment in which the integrated device 200 of the present application can be used is not limited to, for example, i- Chroma (Bodytecmed Co., Korea) or Triage System (Biosite, Sweden), Triage System (Biosite), RAMP System (Response Biomedical, Canada), and may be applicable to all cases in which the measurement by the absorption method is added in all measurement methods using the lateral flow method.

The reflective absorbance measuring device 210 may be used for detecting and / or quantifying various biological materials using absorbance measurement. For example, but not limited to, absorbance measurements for detecting changes in color, generation / change of substances, etc. due to chemical reactions by addition of hemoglobin (Hb), microorganisms, proteins and DNA, and other enzymes / catalysts Water pollution (BOD, COD), GPT / GOT (Liver Function) test, enzyme activity test using NADH production (eg ADH alcohol dehydrogenase, antioxidant activity). Information that can be measured in the lateral flow analysis device 220 is not limited thereto, but high sensitivity C-reactive protein (hsCRP), MicroCRP, HbA1c (glycosylated hemoglobin), microalbumin, PSA (prostate specific antigen), and AFP (alpha- fetoprotein) and cTnI (Cardiac Troponin I). In the case of lateral flow analysis, a predetermined correction, for example, Hb correction, is performed on the measured value for the accuracy of the measured value. When the integrated device of the present application is used, this information can be obtained in one measurement. For example, previously, the HbA1c test was performed separately from the Alc test using lateral flow and the hemoglobin test using absorbance. However, when using the integrated device of the present application, such inspection can be performed at once to obtain comprehensive information. By way of example, the use of the integrated device of the present application in a reader, for example I-Chroma, allows these two measurements to be performed at once.

That is, in the past, the measurement of information such as HsCRP, A1c through the lateral flow analysis tool and the measurement of information such as Hb using a separate absorbance measurement tool was time delayed and cumbersome, but the application 200 is integrated Since both information can be measured, comprehensive information can be obtained much more quickly and easily. In addition, since the absorbance measurement is performed by the reflection type, the arrangement of the present application 200, the light source 400, and the photo detector 500 is much simpler than the transmission absorbance measurement. In addition, as can be seen through the test results (see FIG. 18) to be described later, while the rapidity, simplicity and the like is secured, the predetermined accuracy in the measurement is also secured.

9, 10, and 14, the sample accommodating part 111 includes a bottom part 111a reflecting the light source 400 incident through the light transmitting member 127. You can do

The reflected light measuring window 125 may be formed to extend in one direction on the cover member 120, and the sample accommodating part 111 may be formed to extend in one direction on the base member 110.

As shown in FIGS. 9 to 12 and 14, the

sample inlets

121 and 123 are composed of two

sample inlets

121 and 123, and the reflection light measuring window 125 has two

sample inlets

121 and 123. It may be characterized in that formed between.

In addition, the reflective absorbance measuring device 210 is irradiated from the light source 400 disposed above the cover member 120 to the sample accommodating part 111 through the light transmitting member 127 from the light source 400 and then reflected. It may further include a photo detector 500 for measuring the amount of light coming out. In addition, the light detector 500 may be disposed to be deflected on a vertical line in which the light source 400 is present.

To verify the performance of the reflective absorbance measuring apparatus 100 of the reflective absorbance measuring apparatus 100 according to an embodiment of the present application or the reflective absorbance measuring and lateral flow analysis integrated apparatus 200 according to another embodiment of the present application In order to perform the Hb concentration conversion test by measuring the absorbance. As described above, in order to remove the influence of the surface reflected light, the light source 400 is disposed away from the light detector 500 such that the light source 400 and the light detector 500 are not on the same vertical line as shown in FIG. 7. This is preferable. However, the light source 400 and the light detector 500 are not necessarily disposed in the order or position as shown in FIG. 7, and may be disposed in a direction that minimizes the influence of the surface reflected light.

FIG. 17 compares the result calculated through the arrangement of the light source 400 and the photo detector 500 having the same shape as that of FIG. 7 with existing results. As shown in FIG. 7, the blood sample 300 processed through the sample inlet 121 is placed in the sample accommodating part 111, and then the sample 300 placed in the sample accommodating part 111 by the light source 400 (LED) having a wavelength of 520 nm. ) Was irradiated through the light transmitting member 127. The reflected reflected light was measured by the photodetector 500 to obtain absorbance, and converted into Hb concentration.

In Figure 17, the Y side is the Hb concentration obtained through the present application (100, 210), the X-axis is the Hb concentration measured by the model of the existing Hemocue (Hemocue) Hb-301. As shown in FIG. 17, the plurality of Hb concentration data (Y-axis) through the

present application

100 and 210 and the plurality of Hb concentration data (X-axis) through the existing apparatus corresponding thereto are Y = 1.0187X-3.8905 (R ² = 0.9855), it can be seen that the values almost equal to each other (values close to Y = X) are measured.

As can be seen from the test results, by measuring the absorbance by the reflection, the absorbance and hemoglobin concentration measurement can be made more simply and easily while maintaining a certain accuracy.

Next, verify the comprehensive information measurement performance through the combination of the reflective absorbance measuring device 210 and the lateral flow analysis device 220 of the reflective absorbance measurement and lateral flow analysis integrated device 200 according to another embodiment of the present application In order to perform the HbA1c concentration measurement test. In order to measure the HbA1c, the Hb concentration must first be measured by the reflective absorbance measuring device 210. Therefore, a part of the sample 300 prepared for measuring the HbA1c is introduced into the sample accommodating part 111 through the sample inlet 121. Absorbance and Hb concentration are measured. In addition, A1c is measured through the lateral flow analyzer 220. The HbA1c concentration was converted using the two measured values, respectively.

That is, FIG. 18 compares the result of measuring the substance concentration of HbA1c, which is a diabetic marker, through the present application 200 with the result measured by the existing apparatus. Here, the existing apparatus used a standard measuring instrument which is controlled by the VARIANT II as a reference instrument.

In FIG. 18, the Y side is the HbA1c concentration obtained through the present application 200, and the X axis is the HbA1c concentration measured by the existing apparatus. As shown in FIG. 18, the plurality of HbA1c concentration data (Y-axis) through the present application 200 and the plurality of HbA1c concentration data (X-axis) through the existing apparatus corresponding thereto are Y = 1.0024X + 0.2327 (R ² = 0.976), it can be seen that almost the same values (values close to Y = X) are measured.

As can be seen from the test results, the lateral flow analysis and the absorbance measurement are performed in one device 200, thereby combining the lateral flow analysis information and the absorbance measurement information more quickly and easily while maintaining a certain accuracy. Measurement of the information can be made.

Although the embodiments of the present application have been described above, the scope of the present application is not limited thereto, and all of the ranges that are easily changed by the person skilled in the art to which the present application pertains from the embodiments of the present application are recognized as equivalent. Includes changes and modifications.

As used herein, the symbols are as follows.

100. Reflective absorbance measuring device 110. Base member

110a. Square shape 111. Sample compartment

111a. Bottom 120. Cover member

120a. Square hole 120b. Semicircular protrusion

121. Sample inlet 123. Sample inlet

125. Reflected light measuring window 127. Light transmitting member

130. Boundaries

200. Reflective absorbance measurement and side flow analysis integrated unit

210. Reflective absorbance measuring device 220. Lateral flow analysis device

221.Sample inlet 223. Measuring window

225. Strip receptacle 230. Interface

300. Sample 400. Light source

500. Light Detector 600. Strip

The device of the present invention can measure absorbance more quickly, simply and easily, while maintaining a certain accuracy.In the case of an integrated device, the lateral flow analysis information and the absorbance measurement information can be measured at a time, so that the accuracy and convenience Economics are promoted.

Claims

A base member having a sample receiving portion;

A cover member covering an upper end of the base member; And

A light transmitting member interposed between the base member and the cover member,

The cover member includes a sample inlet for feeding a sample into the sample accommodating part and a reflection light side window to be perpendicular to the sample accommodating part,

And the light transmitting member is positioned to correspond to the reflected light measuring window.
In claim 1,

The sample accommodating part further comprises a bottom portion for reflecting light incident through the light transmitting member.
In claim 1,

The reflected light measuring window is formed extending in one direction on the cover member,

The sample accommodating part is a reflective absorbance measuring device is formed extending in one direction on the base member.
The method according to any one of claims 1 to 3,

The sample inlet is two,

The reflected light measuring window is a reflection type absorbance measuring device formed between the two sample inlet.
In claim 4,

And a light absorbing member having a lower surface formed at a lower position than the sample inlet.
The method according to any one of claims 1 to 5,

A light source disposed above the cover member, and

And a light detector disposed above the cover member to measure an amount of light reflected from the light source through the light transmitting member and then reflected from the sample accommodating portion.
In claim 6,

And the photo detector is disposed so as to deviate on a vertical line in which the light source exists.
It is an integrated device for reflection absorbance and lateral flow analysis that can measure both absorbance of samples and lateral flow assay.

Integrated reflective absorptive and lateral flow analysis comprising at least one reflective absorbance measuring device according to any one of claims 1 to 7, and at least one discharge flow analyzing device disposed adjacent to the reflective absorbance measuring device. Device.
In claim 8,

And said reflective absorbance measuring device and said lateral flow analysis device are arranged in a line or side by side.
In claim 8,

And said reflective absorbance measuring device and said lateral flow analysis device are two or more reflection absorbance and lateral flow analysis integrated devices, respectively.
In claim 10,

The reflective absorbance measuring device and the lateral flow analysis device are each two,

The one reflective absorbance measuring device and one lateral flow analysis device is arranged in a date, the other reflective absorbance measuring device and one lateral flow analysis device is also arranged in a date,

The two-day reflective absorbance measuring device and the lateral flow analysis device is a side-by-side reflective absorbance and lateral flow analysis integrated device.