CN211955502U

CN211955502U - Detection test paper

Info

Publication number: CN211955502U
Application number: CN202020606209.3U
Authority: CN
Inventors: 左园; 袁小路; 石丹垚; 宗小林; 甘建民
Original assignee: Minkang Medical Technology Tianjin Co ltd
Current assignee: Minkang Medical Technology Tianjin Co ltd
Priority date: 2020-04-21
Filing date: 2020-04-21
Publication date: 2020-11-17
Anticipated expiration: 2030-04-21

Abstract

The application discloses test paper relates to medical instrument technical field. The detection test paper comprises a reaction bottom layer, a reaction layer, a blood filtering layer, a capillary sample injection layer and a hydrophilic layer which are sequentially stacked; the blood filtering layer is provided with a plurality of blood filtering areas, and the reaction layer is provided with a plurality of reaction areas; the plurality of blood filtering areas and the plurality of reaction areas are arranged in one-to-one alignment; after the blood sample is dripped from the hydrophilic layer, the capillary sample introduction layer can suck the blood sample through the capillary action, so that the blood sample flows through the plurality of blood filtering areas and then enters the plurality of reaction areas in a one-to-one correspondence manner. The test paper can carry out biochemical detection rapidly and efficiently, and can realize the detection of multiple biochemical indexes.

Description

Detection test paper

Technical Field

The application relates to the technical field of medical equipment, in particular to detection test paper.

Background

For biochemical detection projects, the detection is usually carried out in hospitals after venous blood drawing is adopted to prepare samples, the time consumption is long, and the detection is difficult for patients with inconvenient actions. For some chronic patients, only the biochemical index level of the patient, such as creatinine level, needs to be monitored daily in daily life to know the condition of the patient in real time, and an accurate detection result is not needed.

SUMMERY OF THE UTILITY MODEL

The application provides a test paper can carry out biochemical detection fast high-efficient to can realize the detection of multiple biochemical index simultaneously.

The application provides a detection test paper, which comprises a reaction bottom layer, a reaction layer, a blood filtering layer, a capillary sample injection layer and a hydrophilic layer which are sequentially stacked; the blood filtering layer is provided with a plurality of blood filtering areas, and the reaction layer is provided with a plurality of reaction areas; the plurality of blood filtering areas and the plurality of reaction areas are arranged in one-to-one alignment; after the blood sample is dripped from the hydrophilic layer, the capillary sample introduction layer can suck the blood sample through the capillary action, so that the blood sample flows through the plurality of blood filtering areas and then enters the plurality of reaction areas in a one-to-one correspondence manner.

According to the technical scheme, the blood filtering layer is provided with the plurality of blood filtering areas, the reaction layer is provided with the plurality of reaction areas which are aligned with the blood filtering areas one by one, and each aligned blood filtering area and each aligned reaction area can be used for detecting one biochemical index, so that the detection test paper can be used for simultaneously realizing the detection of a plurality of biochemical indexes. Simultaneously, different blood filtering areas and reaction areas are aligned and matched one by one, so that the blood sample can be shunted to enter different reaction areas for detection, and the detection result cannot be influenced by mutual interference. And the capillary sample introduction layer can rapidly suck a blood sample through capillary action, so that biochemical detection can be rapidly and efficiently carried out.

In a first possible implementation manner of the present application, the capillary sample injection layer includes a diffusion base layer and a double-sided adhesive layer; the double-sided adhesive layer is positioned on the upper side of the diffusion base layer, the diffusion base layer is provided with a plurality of diffusion holes, and the diffusion holes and the plurality of blood filtering areas are arranged in one-to-one alignment; the double-sided adhesive layer is provided with a long and narrow flow guide through groove, one end of the flow guide through groove is connected with the hydrophilic layer, and the other end of the flow guide through groove is communicated with the diffusion holes.

Above-mentioned technical scheme, two-sided adhesive layer set up the water conservancy diversion of long and narrow form and leads to the groove, and the water conservancy diversion leads to groove one end and meets with hydrophilic layer, and the other end communicates with each other with a plurality of diffusion holes, when instiling into blood sample, aims at the arbitrary position that the water conservancy diversion led to the groove, can let blood sample flow in every diffusion hole respectively through capillary action, realizes instiling into blood sample's convenience from test paper's top to promote biochemical efficiency that detects.

In a second possible implementation manner of the present application, the capillary sample injection layer includes a diffusion base layer and two double-sided tapes disposed at an interval; the two double-sided adhesive tapes are arranged on the upper surface of the diffusion base layer and form a channel with the diffusion base layer; the diffusion basic unit is provided with a plurality of diffusion holes, and a plurality of diffusion holes are located the channel, and a plurality of diffusion holes and a plurality of blood filtering area one-to-one align the setting.

Above-mentioned technical scheme is through setting up two spaced double-sided tape on the diffusion basic unit for the upper surface of diffusion basic unit forms and the communicating channel in a plurality of diffusion holes, when instiling into blood sample, aims at an arbitrary position of channel, can let blood sample flow into respectively in every diffusion hole through capillary, realizes instiling into blood sample's convenience from test paper's top, thereby promotes biochemical efficiency that detects.

In combination with the second possible implementation manner of the present application, in a third possible implementation manner of the present application, the double-sided tape is in a strip shape, and the upper edge of the channel is in contact with the hydrophilic layer.

According to the technical scheme, the double-sided adhesive tape is in a long strip shape, so that the formed channel is in a long and narrow shape, and the upper edge of the channel is in contact with the hydrophilic layer, so that the external environment realized by capillary action is ensured.

With reference to the first possible implementation manner or the second possible implementation manner of the present application, in a fourth possible implementation manner of the present application, each of the plurality of hemofiltration zones is in accordance with a shape of each of the corresponding plurality of reaction zones; each of the plurality of hemofilter regions covers each of the corresponding plurality of diffusion holes, and an area of each of the plurality of hemofilter regions is greater than an area of each of the corresponding plurality of diffusion holes.

According to the technical scheme, in the group of diffusion holes, the blood filtering areas and the reaction areas which are in one-to-one correspondence, the shapes of the blood filtering areas and the reaction areas are consistent, the areas of the blood filtering areas are larger than the areas of the diffusion holes while the diffusion holes are covered, so that a blood sample can conveniently and completely flow into the blood filtering areas through capillary action without overflowing and mutual diffusion, and then directly and quickly flow into the corresponding reaction areas from the blood filtering areas, and the detection accuracy of the detection test paper is improved.

In a fifth possible implementation manner of the present application, in combination with the first possible implementation manner or the second possible implementation manner of the present application, the size of the diffusion substrate layer, the size of the blood filtration layer, and the size of the reaction layer are the same.

According to the technical scheme, the size of the diffusion base layer, the size of the blood filtering layer and the size of the reaction layer are consistent, and manufacturing, processing and assembling are facilitated.

In a sixth possible implementation manner of the present application, in combination with the first possible implementation manner or the second possible implementation manner of the present application, the reaction bottom layer is provided with a plurality of reflection detection holes; the multiple blood filtering areas, the multiple reaction areas, the multiple diffusion holes and the multiple reflection detection holes are arranged in one-to-one alignment mode; each diffusion hole of the plurality of diffusion holes is in accordance with a size of each reflective detection hole of the corresponding plurality of reflective detection holes.

Above-mentioned technical scheme, the size of reflection inspection hole is unanimous with the diffusion hole, detects usefulness as the light reflection, after a set of blood filtering area, reaction zone, diffusion hole and reflection inspection hole align one by one, can be convenient for carry out the light detection fast.

With reference to the first possible implementation manner or the second possible implementation manner of the present application, in a seventh possible implementation manner of the present application, the diffusion base layer is provided with three diffusion holes with the same size, and the three diffusion holes are arranged at equal intervals.

Above-mentioned technical scheme, diffusion basic unit equidistance sets up the diffusion hole that three sizes are unanimous for three biochemical index detections can be carried out simultaneously to the test paper, for example can carry out the three horizontally detections of conventional blood fat.

In combination with the first possible implementation manner or the second possible implementation manner of the present application, in an eighth possible implementation manner of the present application, a material of the diffusion base layer and a material of the reaction bottom layer are the same and are all any one of polyvinyl chloride, polyamide, polycarbonate, or polyester.

Above-mentioned technical scheme, the diffusion basic unit is the same with the material of reaction bottom, the purchase and processing of being convenient for.

In a ninth possible implementation of the present application, the reaction layer is coated with a detection reagent.

According to the technical scheme, the reaction layer is coated with the detection reagent, so that the blood sample flowing into the reaction layer reacts with the detection reagent to show color, then the color change is read through light reflection of a matched optical instrument, and the concentration of the detection item of the blood sample is obtained after the color change is compared with a standard value.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are required to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present application and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained from the drawings without inventive effort.

FIG. 1 is a schematic diagram of a test strip according to an alternative embodiment of the present application.

Icon: 10-detection test paper; 100-a reaction bottom layer; 110-reflection detection holes; 200-a reaction layer; 210-a reaction zone; 300-a blood filtration layer; 310-a blood filtration zone; 400-capillary sample injection layer; 410-a diffusion base layer; 412-diffusion holes; 420-double-sided tape; 500-hydrophilic layer.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but not all embodiments. The components of the embodiments of the present application, generally described and illustrated in the figures herein, can be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the present application, presented in the accompanying drawings, is not intended to limit the scope of the claimed application, but is merely representative of selected embodiments of the application. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.

In the description of the present application, it is to be noted that the terms "inside", "below", and the like refer to orientations or positional relationships based on orientations or positional relationships shown in the drawings or orientations or positional relationships that are conventionally arranged when products of the application are used, and are used only for convenience in describing the application and simplifying the description, but do not indicate or imply that the devices or elements referred to must have a specific orientation, be constructed in a specific orientation, and be operated, and thus, should not be construed as limiting the application.

In the description of the present application, it is also to be noted that, unless otherwise explicitly specified or limited, the terms "disposed" and "connected" are to be interpreted broadly, e.g., as being either fixedly connected, detachably connected, or integrally connected; they may be mechanically coupled, directly coupled, indirectly coupled through intervening media, or may be interconnected between two elements. The specific meaning of the above terms in the present application can be understood in a specific case by those of ordinary skill in the art.

In this application, unless expressly stated or limited otherwise, the first feature may be directly on or under the second feature or may include both the first and second features being in direct contact, but also the first and second features being in contact via another feature between them, not being in direct contact. Also, the first feature being above, on or above the second feature includes the first feature being directly above and obliquely above the second feature, or merely means that the first feature is at a higher level than the second feature. A first feature that underlies, and underlies a second feature includes a first feature that is directly under and obliquely under a second feature, or simply means that the first feature is at a lesser level than the second feature.

It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict.

Referring to fig. 1, fig. 1 shows a three-dimensional assembly structure of a test strip 10 according to an alternative embodiment of the present application.

The test paper 10 includes, from bottom to top, a reaction bottom layer 100, a reaction layer 200, a blood filtration layer 300, a capillary sample injection layer 400, and a hydrophilic layer 500, which are stacked in sequence.

The reaction bottom layer 100 may be made of any one of polyvinyl chloride, polyamide, polycarbonate or polyester, and the reaction bottom layer 100 is a long sheet. One end of the reaction substrate 100 is provided with three reflection detection holes 110 of the same size at intervals along the length direction thereof.

The reaction layer 200 may be a thin film, and the reaction layer 200 may also have a long sheet shape. The width of the reaction layer 200 is identical to that of the reaction bottom layer 100, and the length of the reaction layer 200 is smaller than that of the reaction bottom layer 100. One end of the reaction layer 200 is provided with three reaction regions 210 of the same size at intervals along the length direction thereof, the reaction regions 210 are annular grooves, each reaction region 210 is aligned with each reflection detection hole 110, and the diameter of the reaction region 210 is larger than the aperture of the reflection detection hole 110. The reaction layer 200 is attached to the upper surface of the reaction bottom layer 100, and the surface of the reaction layer 200 is coated with a detection reagent, and the detection reagent is located in the reaction region 210.

The detection reagent is selected based on the particular biochemical marker being detected. For example, when the test strip 10 is used to detect triglyceride, the detection reagent contains lipoprotein lipase >100U/ml, and 0.75 mmol/L4-aminoantipyrine with pH of 7.0. When the test paper 10 is used for detecting creatinine, the detection reagent contains 15KU/L creatininase, 18KU/L creatine hydrolase, 9KU/L sarcosine oxidase, 18KU/L horseradish peroxidase, 6KU/L ascorbate oxidase, 0.25 g/L4-aminoantipyrine and 0.28g/L chromogenic substance.

The blood filter 300 may be a thin film, and the blood filter 300 may also have a long strip shape and a size corresponding to the size of the reaction layer 200. One end of the hemofilter layer 300 is provided with three hemofilter zones 310 of the same size at intervals along the length direction thereof, the hemofilter zones 310 are also annular grooves, the diameter of the hemofilter zones 310 is the same as that of the reaction zones 210, and each hemofilter zone 310 is aligned with each reaction zone 210. When the test paper 10 is used for detecting three items of blood fat, the blood filter layer 300 is made of a nitrocellulose membrane material, and a red blood cell coagulant is adsorbed on the surface of the blood filter layer to remove red blood cells in a blood sample.

The capillary sample injection layer 400 comprises a diffusion base layer 410 and two spaced double-sided adhesive tapes 420.

The material of the diffusion base layer 410 is the same as that of the reaction substrate 100, and the diffusion base layer 410 is a long sheet-like thin plate. The diffusion substrate 410 has the same size as the blood filter 300. One end of the diffusion substrate 410 is provided with three diffusion holes 412 with the same size at intervals along the length direction, the aperture of the diffusion hole 412 is the same as that of the reflection detection hole 110, and the diffusion holes 412 are aligned with the blood filtration regions 310 one by one. The diffusion substrate 410 is attached to the upper surface of the blood filter 300.

The double-sided tape 420 is in a strip shape, two double-sided tapes 420 are adhered to the upper surface of the diffusion base layer 410 and enclose a long and narrow channel (not shown) with the diffusion base layer 410, the upper edge of the channel is in contact with the hydrophilic layer 500, and the diffusion hole 412 is located in the channel.

The hydrophilic layer 500 may be polyester in combination with polyvinylpyrrolidone, the hydrophilic layer 500 being a long strip of sheet-like film. The width dimension of the hydrophilic layer 500 is the same as the interval width dimension of the two double-sided tape 420, the length dimension of the hydrophilic layer 500 is the same as the length dimension of the double-sided tape 420, and the hydrophilic layer 500 is disposed on the upper surface of the double-sided tape 420 and is adhered to the double-sided tape 420 such that the hydrophilic layer 500 covers the entire channel and the double-sided tape 420.

After the blood sample is dropped from the hydrophilic layer 500, the capillary sample injection layer 400 can suck the blood sample by capillary action, so that the blood sample enters the reaction layer 200 after passing through the blood filter layer 300. In the diffusion holes 412, the blood filtering area 310 and the reaction area 210 which are in one-to-one correspondence, the size of the blood filtering area 310 is consistent with that of the reaction area 210, and is larger than the pore diameter of the diffusion holes 412, so that the blood sample can completely flow into the blood filtering area 310 in the blood filtering layer 300 through capillary action without overflowing and mutually diffusing. Then flows directly and rapidly from the hemofilter 300 into the corresponding reaction region 210 of the reaction layer 200, thereby improving the detection accuracy of the test strip 10. When instiling into blood sample, only need follow hydrophilic layer 500 top and aim at the arbitrary position of channel, can let blood sample flow into every diffusion hole 412 respectively through capillary action, realize instiling into blood sample's convenience from the top of test paper 10 to promote biochemical efficiency that detects.

It should be noted that the specific structure of the capillary sample injection layer 400 is not limited in the embodiments of the present application, and in some other alternative embodiments, the capillary sample injection layer 400 may be configured as the diffusion base layer 410 and the double-sided adhesive layer. The double-sided adhesive layer is a sheet-shaped film and is located on the upper side of the diffusion base layer 410. The double-sided adhesive layer is provided with a long and narrow flow guide through groove along the length direction, the upper end of the flow guide through groove is connected with the hydrophilic layer 500, and the lower end of the flow guide through groove is communicated with the diffusion holes 412, so that a structure capable of realizing capillary action is formed.

In the embodiment of the present invention, the number of the blood filtering regions 310, the number of the reaction regions 210, the number of the diffusion holes 412, and the number of the reflection detection holes 110 are three, so as to simultaneously detect three items of blood lipid, and at this time, different detection reagents are correspondingly coated in each reaction region 210, so as to simultaneously generate a color reaction with triglyceride, cholesterol, and high density lipoprotein cholesterol.

It should be noted that the specific number of the blood filtering area 310, the reaction area 210, the diffusion hole 412 and the reflection detection hole 110 is not limited in the embodiments of the present application, and in other alternative embodiments, the number of the blood filtering area 310, the reaction area 210, the diffusion hole 412 and the reflection detection hole 110 may also be two, four or other numbers, so that other physiological and biochemical indicators, such as glucose, uric acid, bilirubin and the like, can be detected simultaneously. In addition, the specific structures of the blood filtering region 310 and the reaction region 210 are not limited in the embodiments of the present application, and the blood filtering region 310 and the reaction region 210 may also be in the form of a square groove, a circular groove, or the like, as long as the blood filtering region 310 and the reaction region 210 can cover the corresponding diffusion holes 412, and the area of the blood filtering region 310 and the area of the reaction region 210 are larger than the area of the corresponding diffusion holes 412.

During detection, the blood sample flowing into the reaction layer 200 reacts with the detection reagent to develop color, and then spectral analysis of light reflection is performed by a matched optical instrument (such as a chemical analyzer), and then comparison is performed with a standard value to read color change, so as to obtain the concentration of the detection item of the blood sample.

The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A test paper is characterized in that:

the detection test paper comprises a reaction bottom layer, a reaction layer, a blood filtering layer, a capillary sample injection layer and a hydrophilic layer which are sequentially stacked;

the blood filtering layer is provided with a plurality of blood filtering areas, and the reaction layer is provided with a plurality of reaction areas;

the plurality of blood filtering areas and the plurality of reaction areas are arranged in one-to-one alignment;

when the blood sample is dripped from the hydrophilic layer, the capillary sample introduction layer can suck the blood sample through the capillary action, so that the blood sample flows through the plurality of blood filtering areas and then enters the plurality of reaction areas in a one-to-one correspondence manner.

2. The test strip of claim 1, wherein:

the capillary sample injection layer comprises a diffusion base layer and a double-sided adhesive layer;

the double-sided adhesive layer is positioned on the upper side of the diffusion base layer, the diffusion base layer is provided with a plurality of diffusion holes, and the diffusion holes and the plurality of blood filtering areas are arranged in one-to-one alignment;

the double-sided adhesive layer is provided with a long and narrow flow guide through groove, one end of the flow guide through groove is connected with the hydrophilic layer, and the other end of the flow guide through groove is communicated with the diffusion holes.

3. The test strip of claim 1, wherein:

the capillary sample injection layer comprises a diffusion base layer and two double-sided adhesive tapes arranged at intervals;

the two double-sided adhesive tapes are arranged on the upper surface of the diffusion base layer and form a channel with the diffusion base layer;

the diffusion basic unit is provided with a plurality of diffusion holes, a plurality of diffusion holes are located in the channel, a plurality of diffusion holes with a plurality of blood filtering areas align one by one and set up.

4. The test strip of claim 3, wherein:

the double-sided adhesive tape is in a strip shape, and the upper edge of the channel is in contact with the hydrophilic layer.

5. A test strip according to claim 2 or 3, wherein:

each filtered blood zone of the plurality of filtered blood zones conforms to a shape of a corresponding reaction zone of the plurality of reaction zones;

each of the plurality of hemofilter regions covers each of the corresponding plurality of diffusion holes, and an area of each of the plurality of hemofilter regions is greater than an area of each of the corresponding plurality of diffusion holes.

6. A test strip according to claim 2 or 3, wherein:

the size of the diffusion basal layer, the size of the blood filtering layer and the size of the reaction layer are consistent.

7. A test strip according to claim 2 or 3, wherein:

the reaction bottom layer is provided with a plurality of reflection detection holes;

the plurality of blood filtering areas, the plurality of reaction areas, the plurality of diffusion holes and the plurality of reflection detection holes are arranged in one-to-one alignment;

each diffusion hole of the plurality of diffusion holes is in accordance with a size of a corresponding reflection detection hole of the plurality of reflection detection holes.

8. A test strip according to claim 2 or 3, wherein:

the diffusion basic unit is provided with the unanimous diffusion hole of three size, three diffusion hole equidistance sets up.

9. A test strip according to claim 2 or 3, wherein:

the diffusion base layer and the reaction bottom layer are made of the same material and are made of any one of polyvinyl chloride, polyamide, polycarbonate or polyester.

10. The test strip of claim 1, wherein:

the reaction layer is coated with a detection reagent.