CN212904930U

CN212904930U - Equipment and test strip for immunochromatography detection

Info

Publication number: CN212904930U
Application number: CN202020743169.7U
Authority: CN
Inventors: 商涛; 费凤琴; 孔健希; 赵弟萍; 郑珍珍; 陈亚茹
Original assignee: Leadway HK Ltd
Current assignee: Leadway HK Ltd
Priority date: 2020-05-08
Filing date: 2020-05-08
Publication date: 2021-04-06
Anticipated expiration: 2030-05-08

Abstract

The utility model provides an equipment and detection examination strip for immunochromatography detects belongs to the check out test set in POCT field, and this equipment includes card lid and cassette to and be located the examination strip between card lid and the cassette, the examination strip is including the buffer pad, mark pad, detection pad and the sample absorption pad that set gradually, the mark pad contains the mark zone, the examination strip still includes sample receiving module, sample receiving module sets up the buffer pad with between the mark zone, the sample adds the mouth and sets up on the sample receiving module, sample receiving module includes a filter pad. The device is miniaturized, convenient to carry and simple to operate, can rapidly give out a detection result, is very suitable for rapid diagnosis and large-scale screening of new-type coronavirus, SARS-CoV, avian influenza, dengue fever virus, malaria, Ebola virus, influenza virus and other epidemic diseases, and has extremely high clinical popularization and application values.

Description

Equipment and test strip for immunochromatography detection

Technical Field

The utility model belongs to the technical field of biological detection, in particular to an immunochromatography detection device and a test strip for detecting pathogens such as novel coronavirus SARS-CoV-2 and the like.

Background

The worldwide pandemic of COVID-19 reminds people of the ongoing and recurring challenge of infectious agents. The continuous monitoring, timely diagnosis and powerful research on SARS-CoV-2 to understand the basic biological characteristics of new pathogens help people to make effective countermeasures.

In addition, pathogens such as Severe Acute Respiratory Syndrome (SARS) coronavirus (SARS-CoV), Middle East Respiratory Syndrome (MERS) coronavirus (MERS-CoV), dengue virus, malaria, ebola virus, zika virus, influenza virus (including avian influenza virus), various hepatitis viruses, and HIV threaten human survival. There is also a need for continuous monitoring and timely diagnosis of these pathogens.

One of the major detection methods for SARS-CoV-2 and other pathogens is PCR-based viral nucleic acid detection. Nucleic acid detection methods have high specificity and sensitivity, but the methods usually take several hours to give a detection result, and in an epidemic outbreak period, due to limited medical resources and time and labor consumption of nucleic acid detection, a large number of suspected patients are overstocked because of failure to obtain timely diagnosis, an optimal treatment period is missed, the patients turn to serious illness and even die, and the risk of disease spread is increased. The nucleic acid detection method requires specialized instruments with high cost, such as a nucleic acid extractor and a nucleic acid amplification reaction instrument, and also requires specialized technicians to operate the instruments and interpret the detection results, so that the method is not suitable for early primary screening in communities, primary hospitals, airports, customs, even families and the like. In addition, such methods require nucleic acid extraction from clinical specimens, which also requires professional personnel to perform the procedures, but errors in nucleic acid extraction can affect the detection results of viral nucleic acids.

Therefore, a detection device which is small, convenient to carry, faster, low in cost and capable of detecting pathogens such as SARS-CoV-2 in real time is particularly needed, and no professional is required to operate the detection device, so that ordinary people can complete detection by operating according to instructions, and early differential diagnosis can be performed.

SUMMERY OF THE UTILITY MODEL

The utility model provides an immunochromatography device for detecting pathogens such as SARS-CoV-2 can in time give the testing result in several minutes to ten minutes, and the cost is lower, and ordinary crowd just can detect according to the description operation, and the size still needs little than bank credit card, very conveniently carries, only needs 5 ~ 20 microliter clinical sample just can realize detecting in addition, and the preliminary examination in early stage that is particularly suitable for basic units such as community.

The clinical specimen used for the detection may be blood (serum, plasma, or whole blood), a clinical specimen such as urine or spinal fluid, or a clinical specimen such as feces that needs to be pretreated in advance.

The utility model provides an equipment for immunochromatography detects, including card lid and cassette to and be located the examination strip between card lid and the cassette, the examination strip is including the buffer pad, the mark pad that set gradually, detection pad and sample absorption pad, establishes sample entry on the card lid, a serial communication port, the mark pad contains the mark area, the examination strip still includes sample receiving module, sample receiving module sets up the buffer pad with between the mark area, sample entry sets up on the sample receiving module.

Furthermore, a blank area is arranged on the marking pad and is a sample receiving module.

Further, the sample receiving module is a blank pad.

Furthermore, a buffer solution adding port is formed in the card cover and located above the buffer solution pad, and the buffer solution adding port is located at the upstream of the sample adding port.

Furthermore, the card cover is also provided with an observation window, and the observation window is positioned above the detection pad.

Further, the buffer pad and the marking pad are located in different areas of the same substrate.

The utility model also provides a detection examination strip for immunochromatography detects, detection examination strip is including buffer pad, mark pad, detection pad and the sample absorption pad that sets gradually, the mark pad contains the mark zone, the examination strip still includes sample receiving module, sample receiving module sets up the buffer pad with between the mark zone.

Further, the sample receiving module is a blank pad.

Further, the length of the blank area is 1/4-1/2 of the mark pad.

Further, any two adjacent pad parts are overlapped, and the overlapping area between any two adjacent pad parts is 0.5-5 mm long.

The utility model also provides an equipment for immunochromatography detects, including card lid and cassette to and be located the examination strip between card lid and the cassette, the examination strip is including the buffer pad, the mark pad that set gradually, detection pad and sample absorption pad, establishes the sample inlet on the card lid, the mark pad contains the mark zone, the examination strip still includes sample receiving module, sample receiving module sets up the buffer pad with between the mark zone, the sample inlet sets up on the sample receiving module, sample receiving module includes a filter pad.

Further, the filter pad at least partially covers the marker pad.

Further, the filter pad is a filter paper with a thickness of 0.1 mm.

The utility model also provides a detection examination strip for immunochromatography detects, detection examination strip is including buffer pad, mark pad, detection pad and the sample absorption pad that sets gradually, the mark pad contains the mark zone, the examination strip still includes sample receiving module, sample receiving module sets up the buffer pad with between the mark zone, sample receiving module includes a filter pad.

Further, the filter pad at least partially covers the marker pad.

Further, the filter pad is a filter paper with a thickness of 0.1 mm.

Has the advantages that: (1) the blank space used in the utility model separates the added sample from the marker on the marker pad by a certain distance, ensures that the sample uniformly flows to the marker on the marker pad and is fully mixed and reacted with the marker;

(2) the buffer solution inlet is positioned at the upstream of the sample inlet, so that the added sample is closer to the labeling area, therefore, after a small amount (5-20 microliter) of sample is added, the sample contacts the label in the labeling area, and before the buffer solution is added through the buffer solution inlet, the sample has enough time to be uniformly and sufficiently mixed and incubated with the label, so that the label is sufficiently dissolved and uniformly released from the labeling pad and reacts with the analyte in the sample, and thus, when the buffer solution arrives, the uniform diffusion of the sample and the label can be promoted, so that the detection sensitivity and consistency are improved, and in addition, the problems of large CV difference and low sensitivity among multiple measurements when a small amount of sample is added can be solved;

(3) the advantage of providing an integrated buffer pad instead of a buffer pad and a label pad that overlap each other is that after the sample is added first, the subsequent addition of buffer solution can better promote the diffusion of the sample and the label, and the amount of sample used can be reduced because when overlapping together, some buffer solution will diffuse from around the overlapping portion, which can be detrimental to better promote the diffusion of the sample and the label;

(4) the immunochromatography apparatus adds a filter pad between a buffer pad and a label pad, and the reason for adding the filter pad is that when blood samples such as serum, plasma and whole blood are added, particles such as cholesterol, chylomicron and high-density lipoprotein in the blood samples (particularly, high blood lipid blood samples) can block pores in the detection pad, so that the samples cannot rapidly pass through the detection pad, even cannot reach a detection line and a control line, and the detection fails. The added filter pad can filter particles such as chylomicron and high density lipoprotein in blood, so that the particles are prevented from blocking pores in the detection pad, and the pores in the detection pad can not be blocked even if more blood samples are added. Therefore, the method can realize good detection accuracy, high sensitivity, good detection uniformity and good repeatability.

(5) The nucleic acid of a clinical sample is not required to be extracted in advance, the clinical sample or the pretreated clinical sample is directly detected, and the detection result can be given in time within minutes to tens of minutes;

(6) the detection can be realized only by 5-20 microliter of clinical samples, and the kit is suitable for early primary screening of communities and other basic layers;

(7) the utility model can detect SARS-CoV-2IgM and IgG antibodies in serum, plasma and whole blood, has the advantages of high sensitivity, good specificity, fast and objective detection result, and provides reliable result for diagnosing novel coronavirus infection;

(8) the test strip of the utility model can be stored for 12 months at 2-30 ℃ and still maintain stability;

(9) the utility model provides an immunochromatography device for detecting pathogens such as SARS-CoV-2, which is smaller than a bank credit card in size, is very convenient to carry, and can be detected by common people operating according to the instruction.

Drawings

FIG. 1: the utility model discloses an exploded view of immunochromatography equipment in a first embodiment.

FIG. 2: the present invention is a schematic diagram of a test strip in a first embodiment.

FIG. 3: the utility model discloses immunochromatography equipment in the first embodiment operation scheme.

FIG. 4: the utility model discloses an exploded view of immunochromatography equipment in a fourth embodiment.

FIG. 5: the fourth embodiment of the present invention is an exploded view of a test strip.

Detailed Description

In the first embodiment of the present invention, as shown in fig. 1 to 3, in the immunochromatographic apparatus 100 for detecting a pathogen such as SARS-CoV-2, the immunochromatographic apparatus 100 includes a housing and a test strip 1 accommodated in the housing. The test strip 1 comprises a buffer pad 11, a label pad 12, a detection pad 13 and a sample absorption pad 14, which are sequentially overlapped together. The detection pad 13 is made of nitrocellulose, glass fiber, polyethersulfone, nylon, or the like, preferably nitrocellulose. The detection pad 13 is provided thereon with a first detection line 15, a second detection line 16 and a control line 17. The buffer pad 11 is made of a water-absorbing material, and may be made of glass fiber or nonwoven fabric. The marking pad 12 is also made of a water-absorbent material, and may be selected from polyester film, glass fiber, or non-woven fabric.

The strip 1 also includes a bottom support 10, the bottom support 10 being made of a hydrophobic material such as conventional polyvinyl chloride to ensure that the sample does not leak out of the bottom support 10. The detection pad 13 is disposed on the base support 10. A buffer pad 11 is disposed on the base support 10, one end of the buffer pad 11 partially overlapping the marking pad 12; a marking pad 12 is disposed on the base support 10, one end of the marking pad 12 partially overlaps the buffer pad 11, and the other end of the marking pad 12 partially overlaps the detection pad 13; the sample absorption pad 14 is disposed on the bottom support 10 and made of a hydrophilic material, preferably filter paper, and one end of the sample absorption pad 14 partially overlaps the detection pad 13. The marking pad 12 includes a blank area 18 and a marking area 19, the blank area 18 being located between the buffer pad 11 and the marking area 19 of the marking pad 12, the marking area 19 being located at or near an end of the marking pad 12 that partially overlaps the detection pad 13. The blank region 18 means that the region is free of the marker, and the marked region 19 means that the region is coated with the marker. Preferably, the blank region 18 is adjacent to and connected to the marked region 19. The blank region 18 has a length of 1/4-1/2 of the marking pad 12. The label coated on the labeling region 19 is usually a colored particle such as gold colloid or latex, which is combined with the antigen or antibody, or a fluorescent microsphere (e.g. polystyrene microsphere containing lanthanide) which is combined with the antigen or antibody, so that the labeling region 19 presents a certain color, or presents an optical signal after being excited by excitation light. In addition, the overlapping area between any two adjacent pads is 0.5-5 mm long.

It should be noted that the detection lines on the detection pad 13 can be adjusted according to actual needs, for example, when detecting one analyte, only one detection line needs to be set, and when detecting 3 or more analytes, a corresponding number of detection lines can be set.

The shell is formed by combining the clamping cover 2 and the clamping seat 3 through ultrasonic welding, buckling or glue bonding. The clamping cover 2 and the clamping base 3 are made of plastic materials. The middle of the clamping seat 3 is provided with a test strip groove 32 for placing the test strip 1. Preferably, be equipped with a plurality of downwardly extending buckles (not shown in the figure) on the card lid 2, be equipped with a plurality of draw-in grooves 31 that extend upwards on the cassette 3, the buckle that sets up on the card lid 2 and the draw-in groove 31 one-to-one that sets up on the cassette 3 to make when assembling the utility model discloses an immunochromatography equipment 100, card lid 2 and cassette 3 can firmly be fixed together, and fix examination strip 1 in examination paper groove 32. Preferably, the plurality of hooks 21 on the card cover 2 are symmetrically distributed on both sides of the card cover 2, and the plurality of slots 31 on the card holder 3 are symmetrically distributed on both sides of the card holder 3.

The card cover 2 is also provided with a buffer solution adding port 21, a sample adding port 22 and an observation window 23. The buffer inlet 21 is located upstream of the sample inlet 22, which allows the sample to be introduced closer to the label zone 19, so that when a small amount (5-20 microliters) of sample is introduced first, the sample contacts the label in the label zone 19 first, and there is sufficient time for the sample to uniformly and sufficiently mix and incubate with the label before the buffer is introduced through the buffer inlet 21, ensuring that the label is sufficiently solubilized and uniformly released from the label pad 12 and reacts with the analyte in the sample, thus promoting uniform diffusion of the sample and label when the buffer arrives, thereby improving detection sensitivity and consistency. This also solves the problem of large CV differences between measurements and low sensitivity when small amounts of sample are added.

The buffer solution inlet 21 is located above the buffer solution pad 11, and when a buffer solution (usually, a few drops of the buffer solution) is added through the buffer solution inlet 21, the buffer solution can reach the buffer solution pad 11, and then the buffer solution flows through the label pad 12, the detection pad 13 and the sample absorption pad 14 in sequence under the capillary action, and during the flowing process, one or more analytes in the sample and the labels in the label pad 12 are driven to move to the first detection line 15, the second detection line 16 and the control line 17 provided on the sample absorption pad 14, which can reduce the volume of the test sample required and accelerate the analysis rate. The buffer is preferably a common PBS buffer, borate buffer, or the like. Identification labels may be provided at the outer edges of the detection window 23, the sample addition port 22 and the buffer addition port 21 for indication and distinction.

The sample introduction port 22 is located above the marking pad 12 and partially or completely exposes the blank area 18 on the marking pad 12, but does not expose the marked area 19 on the marking pad 12. The detection window 23 is arranged above the first detection line 15, the second detection line 16 and the comparison line 17 of the detection pad 13, so that a tester can observe color changes on the first detection line 15, the second detection line 16 and the comparison line 17 by naked eyes to judge a detection result.

When one or more analytes exist in a sample, the color of the detection line is positively or negatively correlated with the existence or nonexistence of the analytes according to different detection principles (double-antigen sandwich method, double-antibody sandwich method, competition method, indirect method and capture method), and the color shade of the detection line is positively or negatively correlated with the concentration of the analytes. However, regardless of the detection principle employed, the control line 17 should develop a color that would otherwise indicate a problem or failure of the strip.

In the second embodiment of the present invention, the immunochromatographic apparatus 100 is different from the first embodiment in that the buffer pad 11 and the label pad 12 are integrated, not overlapped together, and thus the buffer strip 1 includes the buffer pad 11, the detection pad 13, and the sample absorption pad 14, which are overlapped together in this order. The integration means that the buffer pad and the marking pad are located in different areas of the same substrate. The buffer pad 11 includes a blank area 18 and a mark area 19, the mark area 19 is located at or near an end of the buffer pad 11 partially overlapping the detection pad 13, and the blank area 18 is located upstream of the mark area 19. The blank region 18 means that the region is free of the marker, and the marked region 19 means that the region is coated with the marker. The advantage of providing an integrated buffer pad 11 instead of a buffer pad 11 and a label pad 12 that overlap each other is that the subsequent addition of buffer after the sample has been added can better promote the diffusion of the sample and the label, and the amount of sample used can be reduced because when overlapping, some of the buffer will diffuse from around the overlapping portion, which can be detrimental to better promote the diffusion of the sample and the label.

In the third embodiment of the present invention, the immunochromatographic apparatus 100 differs from the first embodiment in that a blank pad is located between a buffer pad and a label pad, the buffer pad, the blank pad and the label pad are sequentially overlapped together, and there is a partial overlap between any two adjacent pads, and the overlap region between two adjacent pads is 0.5 to 5 mm long. When making the test strip, the blank pad does not contain the label in the label pad 12. The blank pad is made of a water absorbent material, such as fiberglass. The blank pad may include a blank area.

In the fourth embodiment of the present invention, as shown in fig. 4 and 5, a filter pad 181 is added between the buffer pad 11 and the label pad 12 in the immunochromatographic device 100, and the filter pad 181 is made of a water-absorbing material, preferably a filter paper with a thickness of 0.1 mm. The filter pad 181 at least partially covers the labeling area 19 and may not cover the labeling area 19, and preferably, the filter pad 181 at least partially covers the labeling area 19, so that the added sample can directly reach the labeling area 19 after being filtered by the filter pad 181, and can be sufficiently mixed with the label in the labeling area 19, incubated, and reacted. The sample addition port 22 is provided above the filter pad 181.

The reason for adding the filter pad 181 is that when a blood sample such as serum, plasma, and whole blood is added, particles such as cholesterol, chylomicron, and high-density lipoprotein in the blood sample (particularly, a hyperlipidemic blood sample) block pores in the detection pad, so that the sample cannot rapidly pass through the detection pad, or even cannot reach the detection line and the control line, thereby causing detection failure. The added filter pad can filter particles such as chylomicron and high density lipoprotein in blood, so that the particles are prevented from blocking pores in the detection pad, and the pores in the detection pad can not be blocked even if more blood samples are added. Therefore, the method can realize good detection accuracy, high sensitivity, good detection uniformity and good repeatability.

In the fifth embodiment of the present invention, a test strip is used to detect pathogens such as SARS-CoV-2 in a sample, the test strip includes a buffer pad 11, a label pad 12, a detection pad 13 and a sample absorption pad 14, which are overlapped in sequence, and the buffer pad 11, the label pad 12, the detection pad 13 and the sample absorption pad 14 are arranged in the same manner as the test strip of the first embodiment of the present invention. The blank area 18 and the marked area 19 on the marking pad 12 are arranged as in the first embodiment of the present invention. The cushioning pad 11, the marked area 19 of the marked pad 12 and the sample absorbing pad 14 are covered with a non-setting adhesive, and the blank area 18 is not covered with a setting adhesive for adding a sample. In use, a sample is applied directly to the blank area 18 of the strip and then a portion of the buffer pad 11 of the strip is inserted into the buffer fluid, the sample, together with the label in the label area 19, flows with the buffer fluid to the detection pad 13, completing the assay.

In the sixth embodiment of the present invention, a test strip is used to detect pathogens such as SARS-CoV-2 in a sample, the test strip includes a buffer pad 11, a blank pad, a marker pad 12, a detection pad 13 and a sample 14 absorption pad which are overlapped in sequence, and the buffer pad 11, the blank pad, the marker pad 12, the detection pad 13 and the sample 14 absorption pad are arranged as in the third embodiment of the present invention. The blank pad is located between buffer pad and the mark pad, and any two adjacent pads have partial overlap, and the overlap area length between two adjacent pads is 0.5 ~ 5 millimeters. The blank region 18 is disposed on the blank pad. The cushioning pad 11, the marked area 19 of the marked pad 12 and the sample absorbing pad 14 are covered with a non-setting adhesive, and the blank area 18 is not covered with a setting adhesive for adding a sample. In use, a sample is applied directly to the blank area 18 of the strip and then a portion of the buffer pad 11 of the strip is inserted into the buffer solution, the sample, along with the label in the label area 19, flows to the detection pad 13 with the buffer solution, completing the assay.

In any embodiment of the present invention, substances such as anti-erythrocyte antibodies or specific lectins can be coated and fixed on the blank area or the blank pad or the filter pad and the label pad to bind erythrocytes or delay the movement of erythrocytes, so that the erythrocytes in the whole blood sample do not interfere with the detection result when added to the whole blood sample.

The following description will be made by using the immunochromatographic device 100 of the first embodiment of the present invention to simultaneously detect SARS-CoV-2IgM and IgG antibodies in blood (serum, plasma or whole blood). This is not intended to limit the scope of the invention but to provide a further understanding of the invention.

After SARS-CoV-2 as one new type of coronavirus invades human body, plasma cell in the body produces and secretes specific antibody to defend under the action of virus antigen in certain latent period, and IgM antibody is produced first and IgG antibody is produced subsequently. One study on patients with COVID-19 showed that after SARS-CoV-2 virus invades the body, IgM antibodies were produced in about 5 to 7 days, and IgG antibodies were produced in about 10 to 15 days. The existence of SARS-CoV-2 virus infection in vivo or in the recent past can be indirectly judged by detecting the existence of specific antibodies IgM and IgG in the blood sample.

When SARS-CoV-2IgM and IgG antibodies in blood are detected, SARS-CoV-2 antigen (hereinafter referred to as "gold-labeled antigen") labeled with colored particles such as colloidal gold or latex (here, colloidal gold is exemplified) is coated on the label pad 12, and the SARS-CoV-2 antigen may be any one of 29 kinds of proteins (e.g., spike protein) of SARS-CoV-2 or a partial fragment thereof, or may be a mixture of at least two kinds of proteins or a partial fragment thereof of SARS-CoV-2. When the added blood reaches the label pad 12, the gold-labeled antigen specifically binds to SARS-CoV-2IgM or IgG antibodies (if present) present in the blood, forming a gold-labeled antigen-IgG or gold-labeled antigen-IgM complex. The labeling pad 12 is coated with a non-human IgG antibody (hereinafter referred to as "rabbit IgG antibody" as an example) labeled with a colored particulate such as colloidal gold or latex (here, colloidal gold is used as an example).

The first detection line 15 disposed on the detection pad 13 is used for detecting SARS-CoV-2IgM antibodies, and anti-human IgM antibodies, such as mouse anti-human IgM antibodies, goat anti-human IgM antibodies, chicken anti-human IgM antibodies, camel anti-human IgM antibodies, etc., are fixed on the first detection line 15, and can bind to human IgM existing in blood, and the description is made with mouse anti-human IgM antibodies. When the gold-labeled antigen-IgM complex reaches the first detection line 15, the gold-labeled antigen-IgM complex specifically binds to the murine anti-human IgM antibody on the first detection line 15, thereby causing color development on the first detection line 15.

The second detection line 16 provided on the detection pad 13 is used for detecting SARS-CoV-2IgG antibodies, and the second detection line 16 is fixed with anti-human IgG antibodies, such as mouse anti-human IgG antibodies, goat anti-human IgG antibodies, chicken anti-human IgG antibodies, camel anti-human IgG antibodies, etc., which can bind to human IgG present in blood, and the description is given here with respect to mouse anti-human IgG antibodies. When the gold-labeled antigen-IgG complexes reach the second detection line 16, the gold-labeled antigen-IgG complexes specifically bind to the mouse anti-human IgG antibody on the second detection line 16, thereby causing color development on the second detection line 16.

The control line 17 is fixed with an anti-rabbit IgG antibody such as a chicken anti-rabbit IgG antibody, a sheep anti-rabbit IgG antibody, a camel anti-rabbit IgG antibody, etc. (herein, a sheep anti-rabbit IgG antibody), and when the gold-labeled rabbit IgG reaches the control line 17, the sheep anti-rabbit IgG antibody fixed on the control line 17 can bind to the gold-labeled rabbit IgG, thereby causing the control line 17 to develop color. Regardless of the presence or absence of SARS-CoV-2IgM and IgG antibodies in the blood, control line 17 should develop color after the end of the assay, otherwise it would indicate failure of the strip.

In the detection, 5 to 20 microliters (10 microliters) of blood is added through the sample inlet 22, two or three drops of buffer solution (PBS buffer solution) are added, and after 15 to 20 minutes, the color development of the first detection line 15, the second detection line 16 and the control line 17 is observed and judged according to the following criteria:

(1) positive IgM: the first detection line 15 is colored, namely a red strip appears, the second detection line 16 is not colored, and the control line 17 is colored, which indicates that SARS-CoV-2IgM antibody is contained in the blood sample; (2) IgG is positive: the first detection line 15 is not colored, the second detection line 16 is colored, and the control line 17 is colored, which indicates that SARS-CoV-2IgG antibody is contained in the blood sample; (3) IgM negative and IgG negative: the first detection line 15 does not develop color, the second detection line 16 does not develop color, and the control line 17 develops color, which indicates that the blood sample does not contain SARS-CoV-2IgM antibody and IgG antibody; (4) and (3) failure: control line 17 does not develop color, indicating failure of the strip.

In addition, identification labels may be provided on the outer edges of the detection window 23, the sample addition port 22, and the buffer addition port 21 to indicate and distinguish between them, for example, "M" and "G" identification labels may be provided on the outer edges of the detection window 23 to indicate that the analytes detected by the red bands appearing in the corresponding positions of the detection window 23 are IgM and IgG, respectively, and are detection lines, and "C" identification labels may be provided on the outer edges of the detection window 23 to indicate that the red bands appearing in the corresponding positions of the detection window 23 are control lines. The label "B" is provided on the outer edge of the buffer solution inlet port 21 and the label "S" is provided on the outer edge of the sample inlet port 22 to distinguish between the buffer solution inlet port 21 and the sample inlet port 22, thereby preventing the wrong sample addition and buffer solution addition. In addition, a "SARS-CoV-2" label is provided at one end of the card cover 2, indicating that the object to be detected is SARS-CoV-2.

Although the present invention has been described with reference to the preferred embodiments, it should be understood that the scope of the present invention is not limited to the above embodiments, and various changes and modifications can be made by one skilled in the art without departing from the spirit and scope of the present invention.

Claims

1. The device for immunochromatography detection comprises a clamping cover, a clamping seat and a test strip positioned between the clamping cover and the clamping seat, wherein the test strip comprises a buffer pad, a marking pad, a detection pad and a sample absorption pad which are sequentially arranged, and a sample inlet is arranged on the clamping cover.

2. The apparatus of claim 1, wherein the filter pad at least partially covers the marker pad.

3. The apparatus of claim 1, wherein the filter pad is a filter paper having a thickness of 0.1 mm.

4. The apparatus of claim 1, wherein the card cover is provided with a buffer solution inlet port, the buffer solution inlet port is positioned above the buffer solution pad, and the buffer solution inlet port is positioned upstream of the sample inlet port.

5. The apparatus of claim 1, wherein the card cover further comprises a viewing window, the viewing window being positioned over the detection pad.

6. The apparatus of claim 1, wherein the buffer pad and the marking pad are located in different areas of the same substrate.

7. A test strip for immunochromatography detection, comprising a buffer pad, a labeling pad, a detection pad and a sample absorption pad which are arranged in sequence, wherein the labeling pad comprises a labeling region, the test strip further comprises a sample receiving module, the sample receiving module is arranged between the buffer pad and the labeling region, and the sample receiving module comprises a filter pad.

8. The test strip of claim 7, wherein the filter pad at least partially covers the label pad.

9. The test strip of claim 7, wherein the filter pad is a 0.1mm thick filter paper.

10. The test strip of claim 7, wherein the buffer pad and the label pad are located in different regions of the same substrate.