CN1614383A - A kind of sample collection, detection device and detection method - Google Patents

Abstract

The invention relates to a sample collecting device and a detection device, which comprises a detection card and a collection card, wherein the detection card comprises an upper plate and a lower plate which are connected together, a test strip is arranged between the upper plate and the lower plate, a reading window is arranged on the upper plate, and a through hole is arranged at the position corresponding to the test strip; the collecting card comprises an upper card and a lower card, a carrier film for bearing a sample is arranged between the upper card and the lower card, and the detecting card and the collecting card are respectively provided with a plug-in device and an inserting device which are matched with each other. The sample collecting and detecting method comprises the steps of collecting a sample on a carrier film in a collecting card; inserting the collector card onto the test card; dripping test liquid, wherein the liquid flows onto the test strip through the carrier membrane in the collection card; and reading the result. The invention has the advantages that: 1. the collection card and the test card are separated, so that various tests are facilitated. 2. The collected sample is convenient to carry and transport. 3. Quantitative sampling meeting the determination is achieved. 4. The collected sample is not easy to degrade, and the detection accuracy is improved.

Description

A kind of sample collection, detection device and detection method

technical field

The invention relates to a medical article, in particular to a sample collection, detection device and detection method for detecting fecal occult blood.

Background technique

Fecal occult blood detection is one of the important means to prevent intestinal diseases. Currently, the immunological method used to detect fecal occult blood adopts the double-antibody sandwich method. This method includes the following steps: the patient collects stool samples by himself and gives them to the doctor. samples for rapid immunoassay. Specifically, there are mainly the following methods. The first is that the patient collects the stool sample in a plastic container containing an aqueous solution at home, and then gives it to the doctor. The doctor adds the aqueous solution containing the sample to be tested dropwise on the test device equipped with a reagent strip, and then observes whether the reaction window is There is a color change to determine whether there is occult blood in the patient's stool, as disclosed in US Patent Nos. 5,514,341, 5,543,115, 5,880,942. The second method is a collection device made of paper card, such as the product of Beckman Coulter Inc. The detection method is that the patient evenly smears the stool sample on the collection card, allows the card containing the sample to dry, and then gives it to the doctor. A small test strip containing the sample is torn off from the collection card, then placed on the sample preparation area of the test card, and buffer liquid is added dropwise to detect whether the sample contains hemoglobin, as disclosed in US Patent Nos. 6,168,956, 6,548,309, and 5,846,838. The third method is that the patient collects stool on the test card, and then gives it to a doctor or a testing laboratory, and the doctor inserts the test strip into the test card and drips buffer liquid, as disclosed in US Patent 6271046, 6221678.

Among them, the disadvantage of the first method is that it is troublesome for the patient to carry and transport the sample, and the storage time of the sample is limited. If the storage time is too long, the hemoglobin will be degraded, resulting in missed detection. The disadvantage of the second method is that the samples are exposed during the doctor's operation, which is easy to cause environmental pollution, and at the same time may cause infection to the operator, and there are also cumbersome operations. The third method, although there is no obvious cumbersome operation, requires a special laboratory for detection operation, which makes the detection time too long and inconvenient.

The present invention aims to solve the defects of the above-mentioned prior art, and provides a sample collection and detection device and detection method that are convenient to operate.

The present invention solves the technical scheme that its technical problem adopts. This sample collection and detection device includes a detection card and a collection card. The detection card includes an upper plate and a lower plate connected together. A test strip is arranged between the upper and lower plates. The reading window of the test strip is provided with a through hole for dropping the test solution; the collection card includes an upper card with an upper cartoon hole and a lower card with a lower cartoon hole, between the upper card and the lower card There is a carrier film for carrying samples, and the detection card and the collection card are respectively provided with a mating plug-in device and an insertion device.

The plug-in device of the detection card is composed of a slideway, and a positioning lock is provided on the surface of the upper plate. One end of the positioning lock is connected to the upper plate, and the other end is suspended above the through hole. There is a gap for socket collection card; the connecting end between the upper plate and the positioning lock forms a retaining wall for limiting the insertion depth of the collection card.

The upper surface of the upper plate may be a horizontal plane, the upper surface of the upper plate protrudes upwards and extends horizontally to form a positioning lock, and the raised connection end between the upper plate and the positioning lock forms a retaining wall for limiting the insertion depth of the collection card . The upper plate can also be formed by the plane where the reading window is located and the plane of the liquid through hole in a stepped shape. One end of the plane of the reading window extends outward on the plane of the liquid filling hole to form a positioning lock, and the positioning lock is connected to the liquid hole. There is a gap for socket collection cards between the surfaces where the through holes of the upper plate are located. Preferably, there are two protruding rails on the lower surface of the positioning lock, which cooperate with the concave rails of the collection card to define the left and right positions of the collection card, or a liquid filling hole is opened at the position corresponding to the positioning lock and the through hole.

The connector device of the detection card can also be that the upper surface of the upper plate is composed of two stepped upper and lower planes, and the connection between the two planes forms a retaining wall for limiting the insertion depth of the collection card. Preferably, the two sides of the upper surface of the upper plate are also provided with side retaining walls that cooperate with the collection card to limit the left and right positions of the collection card, or the plane on the upper plate extends horizontally to form a positioning lock, and the positioning lock is connected to the upper plate. There is a gap for socketing the collection card between the surfaces where the holes are located, and the two sides of the upper surface of the upper plate are also provided with side retaining walls that cooperate with the collection card to limit the left and right positions of the collection card. A filling hole is arranged on the positioning lock corresponding to the through hole on the lower plane.

There may also be a protruding positioning bridge between the upper plate and the lower plate of the detection card. The protruding positioning bridge can be positioned under one end of the test strip, elevating one end of the test strip, and this end is preferably in the sample receiving area of the test strip. One end is close to the carrier membrane, so that the liquid from the carrier membrane can flow to the test strip more easily. The protruding positioning bridge can also be located above one end of the test strip. This end is preferably in the sample receiving area of the test strip. When the collection card and the test card cooperate with each other, one end of the protruding collection card is close to the carrier film, and the other end is connected to the test strip. The protruding positioning bridge acts as a liquid drainage function, so that the liquid from the carrier film can flow to the test strip more easily through the protruding positioning bridge. The protruding structure can be made of non-water-absorbing and water-permeable materials in the prior art, and can also be made of non-water-absorbing materials, such as filter paper, glass fiber, polyester film, plastic and so on.

The test strip is a test strip in the prior art, and the test strip at least includes a binding area and a reaction area. There is a labeled antigen or antibody on the binding area, and the reaction area is immobilized with a substance or substance that can be marked on the binding area. The labeled substance reacts with the composition formed by the detection substance in the sample. The test strip is preferably a prior art strip comprising a sample receiving area, a sample binding area, a sample reactive area and a water absorbing area. Using the test strip to test the detection substance in the sample may be the prior art double-antibody sandwich method or competition method, or other methods.

The insertion device of the collection card can be that the upper card and the lower card are respectively provided with an upper cartoon hole and a lower cartoon hole matched with the detection card at corresponding places with the carrier film, and the upper cartoon hole and the lower cartoon hole are connected as one; When the upper card and the lower card are hinged together, the upper cartoon hole and the lower cartoon hole are respectively on both sides of the carrier film, forming an insertion device matched with the detection card. It is preferably also provided with a protective film between the upper card and the carrier film, or a sample coating plate is also provided on the upper surface of the carrier film, and the sample coating plate has a through hole of the sample coating plate communicated with the carrier film, or a sample coating plate is provided on the upper card. There is also an inner card between the planting film, which has a through hole communicating with the upper card, and is smaller than the inner diameter of the upper card hole, and the through hole and the upper card hole together form a concave rail that cooperates with the detection card. Or the upper cartoon hole and the lower cartoon hole are connected as a whole and sealed by an easy-to-tear sheet. Most preferably, a protective film is arranged between the upper card and the carrier film, and a sample-coating plate is arranged between the protective film and the carrier film. The sample-coating plate has a through-hole for the sample-coating plate communicating with the carrier film.

The insertion device of the collection card can also be that the upper card and the lower card are respectively provided with an upper card hole and a lower card hole corresponding to the carrier film, and the connection between the upper card and the lower card is respectively provided with an upper card gap and a lower card gap , when the upper card and the lower card are hinged together, the upper cartoon hole and the lower cartoon hole are respectively on both sides of the carrier film, and the upper card gap and the lower card gap form an insertion device matched with the detection card. It is preferred that a protective film can also be provided between the upper card and the carrier film, or a sample-coating plate is provided on the upper surface of the carrier film, and the sample-coating plate has a through-hole of the sample-coating plate communicated with the carrier film, or a sample-coating plate is provided on the upper surface. There is also an inner card between the card and the planted film, which has a through hole communicating with the upper card, and is smaller than the inner diameter of the upper cartoon hole, and the through hole and the upper cartoon hole form a concave track that is matched with the detection card . Most preferably, a protective film is arranged between the upper card and the carrier film, and a sample-coating plate is arranged between the protective film and the carrier film. The sample-coating plate has a through-hole for the sample-coating plate communicating with the carrier film.

The upper card and the lower card of the collection card are made of white cardboard material in the prior art or other non-absorbent materials. The carrier film can be made of some water-absorbing materials, such as filter paper, glass fiber, polyester film and so on.

The detection sample can be the biological fluid or secretion of human or mammal, or other samples, which can be collected to detect whether there is the analyte to be detected. Biological fluids or secretions of humans or mammals include saliva, blood, serum, plasma, stool, urine, etc. Other samples can be microorganisms, plants, food, etc.

The method for collecting and detecting substances in a sample according to the present invention includes: collecting the sample on the carrier film carrying the sample in the collection card; inserting the collection card into the detection card ; Add the test liquid dropwise, and the liquid flows through the carrier film carrying the sample in the collection card to the test strip in the collection card; read the result.

The collection and detection method is further improved as follows: apply the sample to the sample coating hole on the lower card of the collection card with a sampling stick, then peel off the sample coating plate on the sample collection card, cover the upper card of the collection card; put the collection card The easy-to-tear sheet is torn off along the easy-to-tear line, exposing the protective film and carrier film of the collection card, and inserted into the test card along the upper and lower rails, and the test solution is added to the liquid filling hole; The samples on the membrane flow into the sample receiving area after mixing, and then are sucked into the reaction area; the results of the reaction area can be observed from the reading window.

The beneficial effects of the present invention are:

Methods for collecting and detecting fecal occult blood are described in detail in many US patents, such as US patents 3996006, 4225557, 4789629, 5064766, 5100619, 5106582, 5171528, 5171529, 5591645, 5622871 and 5182191. The present invention compares with the method described in the prior art, and its beneficial effect is:

1. The collection card and test card are separated, which is convenient for various inspections.

When collecting samples, especially when collecting stool samples to detect occult blood, due to the discontinuity of gastrointestinal bleeding, it is often necessary to collect stool samples several times in a row to prevent missed detection. In this way, a plurality of collection devices are connected together, which is convenient for patient collection. Multiple samples are collected at the same time, and can also be tested for different testing purposes, for example, it can simultaneously detect whether there is occult blood in the stool and whether there are harmful microorganisms, such as E.Coli.

2. The collected samples are easy to carry and transfer.

Since the sample is applied to the inside of the collection card and the collected sample is in an appropriate amount, the collected sample is easy to dry and does not deform or leak. Under the action of external pressure and vibration, accidents will not occur in the process of carrying and transmitting, such as mailing, like the above-mentioned plastic containers and sampling bottles.

3. Quantitative sampling that meets the determination requirements can be achieved.

Since the samples to be measured have quantitative requirements in different degrees, the present invention solves this quantitative problem by removing the coated sample plate and discarding redundant samples. For the second method of collecting samples, the quantitative method is used to take quantitative parts from the collected samples. The disadvantage of this method is that there are both samples to be tested and redundant samples in the samples collected before the measurement, which will limit the use of collection cards. If too many samples are taken, it may cause pollution; if a census experiment is done, a large number of samples will be gathered together to destroy the working environment of the test. However, the sampling bottle with the extract cannot complete the quantitative collection of the sample. At the same time, the coating sample plate with the through hole of the coating sample plate used for quantification can be quantified on the one hand, and the size of the aperture area of the coating sample plate should be adjusted to quantify the sample according to the measurement requirements. On the other hand, it is connected with the lower card of the collection card with stickers. After peeling off the coating template, the sticker under it can also serve as the upper and lower cards of the combined collection card.

4. The collected samples are not easy to degrade, which improves the accuracy of detection.

The invention can make the sample dry easily, inhibit the growth of microorganisms, and thus protect the target protein in the sample. However, when the plastic container is used for sampling in the first method mentioned above, when the ambient temperature is high, such as 30°C, microorganisms will breed and destroy the substance to be tested in the test sample, especially when detecting fecal occult blood. The hemoglobin in the sample is easily degraded by the microorganisms that grow in the sample, resulting in missed detection. On the other hand, the protein to be tested in the liquid state is not as stable as the solid protein. Our experiments show that: for example, 50ng/ml of hemoglobin in normal saline solution cannot be detected in a plastic bottle at room temperature for 1 hour. However, 50 μg/ml hemoglobin is placed on the surface of a solid support, such as glass fiber, after drying; and then dissolved in physiological saline, the 50 ng/ml hemoglobin aqueous solution can still be detected.

5. The doctor's operation is simple, which improves the safety of the operation and the reliability of the experimental results

For the third method mentioned above, the doctor needs to touch test strips, such as immune test strips. Although this is convenient, it requires doctors to operate with a considerable professional level. On the one hand, the test strip cannot be polluted, and on the other hand, it must be ensured that the test strip is not damaged by artificial mechanical force when inserted into the sample collection card, otherwise the experimental results will be destroyed.

For the second method mentioned above, the doctor should take the sample from the collection card and record the patient's information. In this way, on the one hand, the samples are exposed to doctors, which increases the risk of operation, and on the other hand, it is easy to mismatch patient information and experimental results. However, this invention overcomes these two difficulties. The doctor will not directly operate the sample when testing, but directly insert the collecting device into the socket of the testing device, add liquid dropwise, and read the testing result, which is easy to operate. , high efficiency; at the same time, there is no need to fill in the patient's information again, which reduces the errors in the experiment.

For the first mode, there are obviously the above two problems. The leakage of excess liquid can cause some degree of harm to the doctor, and it is easy to cause mismatch between the experimental results and the patient.

Description of drawings

Fig. 1 is a schematic diagram of the external structure of Embodiment 1 of the detection card of the present invention;

Fig. 2 is a schematic diagram of the assembly structure of Embodiment 1 of the detection card of the present invention;

Fig. 3 is a schematic diagram of the structure of the bottom surface of the upper board of Embodiment 1 of the detection card of the present invention;

Fig. 4 is a top view structural schematic diagram of Embodiment 1 of the detection card of the present invention;

Fig. 5 is a schematic diagram of a cross-sectional structure along A-A in Fig. 4;

Fig. 6 is a schematic structural diagram of the collection card of the present invention;

Fig. 7 is a schematic structural view of the upper card and the lower card of the collection card of the present invention;

Fig. 8 is a schematic diagram of the cross-sectional structure along A-A in Fig. 7;

Fig. 9 is a schematic diagram of the cooperative structure of the collection card and the detection card;

Fig. 10 is a schematic diagram of the cross-sectional structure along A-A in Fig. 9;

Fig. 11 is a schematic diagram of the structure when the collection card is inserted into the detection card;

Fig. 12 is a schematic diagram of the cross-sectional structure along A-A in Fig. 11;

Fig. 13 is a schematic diagram of a partially enlarged structure of part A in Fig. 12;

Fig. 14 is a schematic diagram of a cross-sectional structure along B-B in Fig. 11;

FIG. 15 is a schematic diagram of a partially enlarged structure of part A in FIG. 14 .

16 is a schematic diagram of the surface structure of the upper plate of the detection device according to Embodiment 2 of the present invention;

Fig. 17 is a schematic diagram of the structure of the bottom surface of the upper plate of the detection device according to Embodiment 2 of the present invention;

Fig. 18 is a schematic diagram of the surface structure of the upper plate of the detection device in Example 3 of the present invention;

Fig. 19 is a schematic diagram of the structure of the collection card according to Embodiment 3 of the present invention when it is inserted into the detection card;

Fig. 20 is a schematic structural diagram of a collection card according to Embodiment 4 of the present invention;

Fig. 21 is a schematic diagram of the unfolded structure of the collection card according to Embodiment 4 of the present invention;

Fig. 22 is a schematic diagram of the surface structure of the upper plate of the detection device in Example 4 of the present invention;

Fig. 23 is a schematic diagram of the structure of the collection card according to Embodiment 4 of the present invention when it is inserted into the detection card;

Fig. 24 is a schematic diagram of the cooperative structure of the collection card and the detection card according to Embodiment 4 of the present invention;

Fig. 25 is a schematic structural diagram of a collection card according to Embodiment 5 of the present invention;

Fig. 26 is a schematic diagram of the layered structure of the collection card according to Embodiment 5 of the present invention;

Fig. 27 is a schematic diagram of the unfolded structure of the collection card according to Embodiment 5 of the present invention;

Fig. 28 is a schematic structural view when the collection card coating sample plate of Example 5 of the present invention is taken off;

Fig. 29 is a schematic diagram of the structure of the collection card according to Embodiment 5 of the present invention when the upper card and the lower card are firmly engaged;

Fig. 30 is a schematic diagram of the three-dimensional structure when the easy-to-tear sheet of the collection card according to Embodiment 5 of the present invention is torn off;

Fig. 31 is a top view structural diagram when the easy-to-tear sheet of the collection card according to Embodiment 5 of the present invention is torn off;

Fig. 32 is a schematic diagram of the cross-sectional structure along A-A in Fig. 31;

Fig. 33 is a schematic structural diagram of a test card according to Embodiment 5 of the present invention;

Fig. 34 is a schematic diagram of the unfolded structure of the lower card in the detection card according to Embodiment 5 of the present invention;

Fig. 35 is a schematic diagram of the semi-expanded structure of the test card according to Embodiment 5 of the present invention;

Fig. 36 is a schematic diagram of the fully expanded structure of the test card according to Embodiment 5 of the present invention;

Fig. 37 is a schematic diagram of the structure of the detection card according to Embodiment 5 of the present invention when the upper plate and the lower plate are fastened together;

Fig. 38 is a schematic diagram of the cross-sectional structure of Fig. 37C-C;

Fig. 39 is a schematic diagram of the cross-sectional structure of Fig. 37A-A;

Fig. 40 is a schematic view of the right view of Fig. 37;

Fig. 41 is a three-dimensional structural schematic view of the test card according to Embodiment 5 of the present invention when the upper plate and the lower plate are tightly closed;

Fig. 42 is a schematic diagram of a partially enlarged structure of part B in Fig. 41;

Fig. 43 is a schematic diagram of the structure of the collection card inserted into the detection card according to Embodiment 5 of the present invention;

Fig. 44 is a schematic diagram of a cross-sectional structure along the D-D direction in Fig. 43;

Fig. 45 is a schematic diagram of the cross-sectional structure along the line B-B in Fig. 43 .

Description of reference signs: detection card 1, lower plate 2, test strip 3, water absorption area 3-1, reaction area 3-2, binding area 3-3, sample receiving area 3-4, upper plate 4, through hole 4- 1. Reading window 5, positioning lock 6, liquid filling hole 7, positioning bar 8, rail 9, retaining wall 10, bridge deck 11, positioning column 12, positioning hole 13, upper plate beam 14, positioning bar 15, positioning slot 16, lower plate beam 17, positioning bridge 18, bridge railing 19, side retaining wall 20, drainage strip 21; collecting card 100, inner card 101, upper card 102, lower card 103, coating sample plate 104, coating sample hole 105, coating Template through hole 106, carrier film 107, lower card opening 108, easy tear line 109, upper card opening 110, first hinge 111, second hinge 112, notch 113, protective film 114, anti-tear line 115, adhesive area 116 , card seam 117, upper slide rail 118, opening and tearing strip 119, easy-tearing piece 120, easy-tearing piece upper piece 120-1, easy-tearing piece lower piece 120-2, lower rail 121; inner upper plate 201, upper cartoon hole 202, the lower cartoon hole 203, the inner lower plate 204, the outer lower plate 205, the first half hole 206 for liquid addition, the second half hole 207 for liquid addition, the window hole 208 of the inner upper plate, the window hole 209 of the upper plate, and the third hinge 210 , the fifth hinge 211, the sixth hinge 212, the test strip groove 213, the window hole 214 of the outer lower plate, the upper card notch 215, the fourth hinge 216, the lower card notch 217, the collection card limiter 218, and the slide rail 219.

Detailed ways

The present invention will be further described below in conjunction with accompanying drawing and embodiment:

Embodiment 1: As shown in the figure, this sample collection and detection device includes a collection card 100 and a detection card 1. The detection card 1 is made of plastic and includes an upper plate 4 and a lower plate 2 connected together; the upper plate 4 The bottom is provided with a positioning column 12, and the lower plate 2 is provided with a positioning hole 13 matching the positioning column 12, and the upper plate 4 and the lower plate 2 are connected together through the cooperation of the positioning column 12 and the positioning hole 13. Such a connection is stable and easy to assemble. Described lower plate 2 and through hole 4-1 corresponding position are provided with raised positioning bridge 18, and this positioning bridge 18 has arched bridge deck 11, and bridge deck 11 both sides are provided with bridge railing 19; The width of bridge deck 11 Matches the width of test strip 3. The lower plate 2 is provided with a test strip 3, and the test strip 3 includes a sample receiving area 3-4, a binding area 3-3, a reaction area 3-2 and a water absorption area 3-1, and the liquid addition hole 7 and the through hole 4-1. The position corresponds to the sample receiving area 3-4, and the position of the reading window 5 corresponds to the reaction area 3-2. The sample receiving area 3-4 of the test strip 3 is stuck on the positioning bridge 18, so that the sample receiving area 3-4 is closer to the through hole 4-1, which is convenient for receiving the mixed solution; after the sample receiving area 3-4 is raised, it is convenient for mixing The liquid flows to the reaction zone 3-2. One end of the lower plate 2 is provided with a positioning column 15, and the positioning column 15 is provided with a slot 15-1 matching the width of the test strip 3, so as to facilitate the positioning of the test strip 3. The upper plate 4 is provided with a positioning bar 8 that is engaged with the positioning bar 15; the other end of the lower plate 2 is provided with a positioning groove 16 that matches the width of the test strip 3; the positioning bar 15, the bridge deck 11 and the positioning groove 16 are in the on the same axis. The upper plate 4 is provided with a through hole 4-1 for dripping the test solution corresponding to the sample receiving area 3-4 of the test strip 3, and the upper plate 4 is provided with a reading hole 4-1 corresponding to the reaction area 3-2 of the test strip 3. The reading window 5 of the result; the surface of the upper plate 4 is provided with a positioning lock 6, one end of the positioning lock 6 is connected with the upper plate 4, and the other end is suspended above the through hole 4-1, and the positioning lock 6 corresponds to the through hole 4-1 A liquid filling hole 7 is opened, and there is a gap between the positioning lock 6 and the surface of the upper plate 4 where the collection card 100 is inserted. The upper surface of the upper plate 4 is a horizontal plane, which protrudes upwards from the upper surface of the upper plate 4 and extends horizontally to form a positioning lock 6, and the raised connection end between the upper plate 4 and the positioning lock 6 forms a hole for limiting the insertion depth of the collection card 100. retaining wall10. The upper plate 4 and the lower plate 2 are respectively provided with an upper plate beam 14 and a lower plate beam 17, and the upper plate beam 14 and the lower plate beam 17 cooperate to clamp the test strip 3 tightly. The upper plate 4 is provided with a positioning bar 8 corresponding to the positioning column 15, and the positioning bar 8 can fasten the test strip 3 located in the clamping slot 15-1. This test card is strong, stable and easy to handle.

The collection card 100 includes an upper card 102 and a lower card 103 hinged together by a first hinge 111, the upper card 102 and the lower card 103 are made of paper and connected as one, the crease between the two is the first Hinge 111. The lower card 103 is provided with a carrier film 107, and the carrier film 107 is a water-permeable material for carrying samples. The upper card 102 and the lower card 103 are respectively provided with an upper card hole 202 and a lower card hole 203 corresponding to the carrier film 107. The upper card hole 202 and the lower card hole 203 communicate with each other to form an upper card opening 110 and a lower card opening 108. After being folded by the first hinge 111, it is located on the upper and lower sides of the carrier film 107. The two openings 108, 110 are connected as one and covered by the easy-to-tear sheet 120. The sheet 120-2 is connected with the upper card 102 and the lower card 103 through the easy-tear line 109, and the easy-tear sheet 120 can be easily torn off. After being torn off, the carrier film 107 is exposed to the outside, which is convenient for detection. The outer side of easy-tear line 109 is provided with anti-tear line 115, prevents from being torn too far when opening upper card 102. The upper surface of the carrier film 107 is glued with a detachable sample-coating plate 104 , and the sample-coating plate 104 is provided with a sample-coating plate through hole 106 communicating with the carrier film 107 . The sample plate 104 is glued on the carrier film 107 with self-adhesive, and can be easily taken off. The sample coating plate 104 is two layers of cardboard folded together, the upper cardboard has a rectangular sample coating hole 105, and the sample coating plate through hole 106 is opened on the lower cardboard. When applying a sample, the sample is evenly applied in the sample application hole 105 , and the sample infiltrates into the carrier film 107 from the through hole 106 of the application plate. After the sample is painted, the sampler 104 is removed so that the excess sample can be thrown away. The edge of the upper cardboard is connected with a tear strip 119, which is convenient for taking off the sample plate 104. A protective film 114 is pasted on the inner side of the upper card 102 corresponding to the carrier film 107 . The inner card 101 is hinged on the inner side of the upper card 102 through the second hinge 112, and the inner card 101 is also made of paper. The crease between the upper card 102 and the inner card 101 is the second hinge 112 . The protective film 114 is pasted on the inner card 101; the inner card 101 has a gap 113, and the width of the gap 113 is smaller than the width of the upper card opening 110. After the inner card 101 and the upper card 102 are folded by the hinge 112, a Ladder track. The lower card 103 is provided with an adhesive area 116 for firmly adhering the upper card 102 , and is also provided with a slot 117 for securing the upper card 102 . After the sample is applied, the upper card 102 and the lower card 103 are firmly closed, so that the sample is not exposed to the outside, is easy to carry, and will not pollute the environment. During detection, the easy-to-tear sheet 120 is torn off, the sample passes through the upper card opening 110, and the lower card opening 108 is exposed to the outside for detection. The upper slide rail 118 is formed on both sides of the opening 110 of the upper card, and the lower slide rail 121 is formed on both sides of the lower card opening 108; the bottom of the positioning lock 6 and the both sides of the liquid filling hole 7 are respectively provided with a rail 9, two rails The width between 9 is suitable for the upper slide rail 118;

During detection, the easy-to-tear sheet 120 is torn off, and the upper card opening 110 and the lower card opening 108 of the collection card 100 are respectively aligned with the surface of the rail 9 and the upper plate 4, and then the collection card 100 is pushed into the positioning lock 6 and the upper surface. The gap on the surface of the board, at this time, the rail 9 is pressed on the inner card 101 surface, and the lower rail 121 formed by the upper slide rail 118 and the lower card opening 108 together defines the left and right positions where the collection card is inserted. The stopper on the test device 1 The wall 10 limits the insertion depth of the collection device 100, so that the carrier film 107 on the collection card 100 is just located between the liquid filling hole 7 and the through hole 4-1. Add the test liquid to the liquid filling hole 7 on the positioning lock 6. After mixing with the sample on the carrier film 107, the test liquid flows into the sample receiving area 3-4 of the test strip 3 through the through hole 4-1, and then is sucked into the reaction area. 3-2. The results of reaction zone 3-2 can be observed from reading window 5.

Explanation of experimental results: detection of hemoglobin in stool with collection card and plastic detection card

Hemoglobin aqueous solution 3mg/ml was injected into the negative stool, and mixed evenly until the final concentration was 50μg/g stool. Apply the sample to the sample application hole 105 on the lower card 103 of the collection card 100 with a sampling stick, then peel off the sample application card 104 on the sample collection card 100 to have a sample margin of 0.7 cm ² , cover the upper card of the collection card 102; Collect several samples in this way. Tested at the time of collection and 24 hours later. Tear off the easy-to-tear sheet 120 of the collection card along the easy-tear line 109 to expose the protective film 114 and the carrier film 107 of the collection card, and insert it into the detection card 1 along the upper slide rail 118 and the lower slide rail 121, and add liquid About 120 μl of test solution was added dropwise to well 7. Observe the results within 5 to 10 minutes, and at the same time follow the SmithKline company's product manual trademark: Hemoccult to test the stool samples with the same hemoglobin concentration. The results of the two test systems are as follows:

Table 1 Test results of 50μg hemoglobin/g stool Test system of the present invention SmithKline Test System Detect immediately after collection + - 24 hours after collection + -

+ means masculine, - means negative

As can be seen from the above table, the collection card and detection card of the present invention are more sensitive than the product trademark of SmithKline: Hemoccult, which also shows that the test system can better detect hemoglobin in stool, thereby detecting occult blood.

Embodiment 2: As shown in Figure 16 and Figure 17, the difference from Embodiment 1 is that the upper surface of the upper plate 4 is composed of two stepped upper and lower planes, and the connection between the two planes is opened. A retaining wall 10 for limiting the insertion depth of the collection card 100 is formed, and the upper plane extends horizontally to form a positioning lock 6 , and a liquid filling hole 7 is opened on the positioning lock 6 corresponding to the through hole 4 - 1 on the lower plane 6 . In this way, the positioning lock 6 is suspended above the through hole 4 - 1 , and there is a gap between the positioning lock 6 and the surface of the upper plate 4 where the collection card 100 is inserted.

Embodiment 3: As shown in Figure 18 and Figure 19, the difference from Embodiment 2 is that: the two sides of the upper surface of the upper plate 4 are provided with side retaining walls 20 that cooperate with the collection card 100, and the lower plate 2 is connected to the communication channel. Drainage strips 21 are provided at the corresponding positions of the holes 4-1, and the drainage strips 21 correspond to the through holes 4-1 and the sample receiving area 3-4 respectively.

Embodiment 4: As shown in Fig. 20-Fig. 24, the difference from Embodiment 2 is that: the detection card 1 is not provided with a positioning lock 6, but on both sides of the upper surface of the upper plate 4, it is provided with a collection card 100. The side retaining wall 20 of the lower plate 2 is provided with a drainage strip 21 corresponding to the through hole 4-1, and the drainage strip 21 corresponds to the through hole 4-1 and the sample receiving area 3-4 respectively. The upper card 102 and the lower card 103 of the collection card are respectively provided with an upper cartoon hole 202 and a lower cartoon hole 203 corresponding to the carrier film 107, and an upper card gap 215 and a lower card gap 217 are respectively opened at the junction of the upper card 102 and the lower card 103 After the upper card 102 and the lower card 103 are folded, the upper card notch 215 and the lower card notch 217 form a slide rail 219 to cooperate with the retaining wall 10 and the side retaining wall 20 on the detection card 1 . The lower cartoon hole 203 is provided with a carrier film 107 for carrying samples, the upper cartoon hole 202 is provided with a protective film 114, and the upper surface of the carrier film 107 is provided with a sample coating plate 104, and the sample coating plate 104 is provided with a carrier film 107. Connected sample hole 105. When in use, the sample to be tested is drawn through the sample coating hole 105 on the sample coating plate 104 , the sample is evenly coated on the carrier film 107 , and the upper card 102 is closed.

During detection, collection card 100 is inserted in the detection card 1, due to the cooperation of the slide rail 121 formed by the upper card and the lower card with gaps 215, 217 and the retaining wall 10 on the detection device and the side retaining wall 20, the limit is limited. Front and back of collection card 100, left and right position, make the upper cartoon hole 202 of collection card correspond with the through hole 4-1 of upper plate 4 of test device 1, drop test liquid to the upper cartoon hole 202 of collection device, test liquid and After the sample on the carrier film 107 is mixed, it flows into the sample receiving area 3-4 on the test strip through the lower cartoon hole 203 on the collecting device and the upper plate through hole 4-1 of the testing device, and then is sucked into the reaction area 3-2 . The results of the reaction zone 3-2 can be observed from the viewing window 209 on the upper plate.

Embodiment 5: The sample collection and detection device described in the present invention includes a collection card 100 and a detection card 1. The collection card 100 includes an upper card 102 and a lower card 103 hinged together by a first hinge 111. The upper card 102 Both the lower card and the lower card 103 are made of paper and connected as one, and the crease between the two is the first hinge 111 . The lower card 103 is provided with a carrier film 107, and the carrier film 107 is a water-permeable material for carrying samples. The upper card 102 and the lower card 103 are respectively provided with an upper cartoon hole 202 and a lower cartoon hole 203 at corresponding places with the carrier film 107, and the upper cartoon hole 202 communicates with the lower cartoon hole 203 to form an upper card opening 110 and a lower card opening 108. Through the easy-tear piece 120 sealing, the easy-tear piece 120 of the easy-tear piece 120-1 and the easy-tear piece bottom piece 120-2 are connected with the upper card 102 and the lower card 103 through the easy-tear line 109, and the easy-tear piece 120 can be easily After being torn off, the carrier film 107 is exposed to the outside, which is convenient for detection. The outer side of the easy-tear line 109 is provided with a tear-proof line 115 to prevent the card from being torn too far when the card 102 is opened. The upper surface of the carrier film 107 is glued with a detachable sample-coating plate 104 , and the sample-coating plate 104 is provided with a sample-coating plate through hole 106 communicating with the carrier film 107 . The sample plate 104 is glued on the carrier film 107 with self-adhesive, and can be easily taken off. The sample coating plate 104 is two layers of cardboard folded together, the upper cardboard has a rectangular sample coating hole 105, and the sample coating plate through hole 106 is opened on the lower cardboard. When applying a sample, the sample is evenly applied in the sample application hole 105 , and the sample infiltrates into the carrier film 107 from the through hole 106 of the application plate. After the sample is painted, the sampler 104 is removed so that the excess sample can be thrown away. The edge of the upper cardboard is connected with a tear strip 119, which is convenient for taking off the sample plate 104. A protective film 114 is pasted on the inner side of the upper card 102 corresponding to the carrier film 107 . The inner card 101 is hinged on the inner side of the upper card 102 through the second hinge 112, and the inner card 101 is also made of paper. The crease between the upper card 102 and the inner card 101 is the second hinge 112 . The protective film 114 is pasted on the inner card 101; the inner card 101 and the easy-tearable sheet 120-1 of the easy-tearable sheet 120 have a gap 113 corresponding to the shape of the gap 113 and the hole 110 of the upper card. The lower card 103 is provided with an adhesive area 116 for firmly adhering the upper card 102 , and is also provided with a slot 117 for securing the upper card 102 . After the sample is applied, the upper card 102 and the lower card 103 are firmly closed, so that the sample is not exposed to the outside, is easy to carry, and will not pollute the environment. During testing, the easy-to-tear sheet 120 is torn off, the sample passes through the upper cartoon hole 110, and the lower cartoon hole 108 is exposed to the outside for testing.

The test card 1 includes an upper board 4 and a lower board 2 hinged together by a third hinge 210 , both of which are made of paper, and the crease between them is the third hinge 210 . The lower plate 2 is provided with a test strip 3 , and the upper plate 4 is provided with an upper plate window hole 209 corresponding to the test strip 3 . The test strip 3 is respectively a sample receiving area 3-4, a binding area 3-3, a reaction area 3-2, and a water absorption area 3-1 from the outer end to the inner end, and the window hole 209 on the upper plate corresponds to the reaction area 3-2. The mixed solution penetrates into the sample receiving area 3-4, and the water absorption area 3-1 sucks the mixed solution into the reaction area, and after the reaction in the reaction area 3-2, the result can be observed from the window hole 209 on the upper plate.

The inner side of the upper plate 4 is provided with an upper slide rail 118 corresponding to the upper card opening 110, upper rails are formed on both sides of the upper cartoon hole 110, and upper slide rail bars are formed on both sides of the upper slide rail. The lower plate 2 is provided with sliding rails 121 corresponding to the lower card opening 108, lower rails are formed on both sides of the lower card opening 108, and sliding rails are formed on both sides of the lower card opening 108. The detection card 1 is also provided with a collection card limiting portion 218 . The inside of the upper board 4 is connected with the inner upper board 201 through the fourth hinge 216 , the inner upper board 201 is also made of paper, and the crease between the inner upper board 201 and the upper board 4 is the fourth hinge 216 . The width of the outer end of the inner upper plate 201 matches the upper card opening 110 to form an upper slide rail 118; the inner end width of the inner upper plate 201 is greater than that of the outer end, which plays a position-limiting role. The inner upper plate 201 is provided with an inner upper plate window hole 208 matching with the upper plate window hole 209 . The inner lower plate 204 is connected to the inner side of the lower plate 2 through the fifth hinge 211, and the inner lower plate 204 is also made of paper, and the crease between the inner lower plate 204 and the lower plate 2 is the fifth hinge 211. The width of the inner lower plate 204 is matched with the lower cartoon hole 108 to form the sliding rail 121; the width of the inner end of the inner lower plate 204 is greater than that of the outer end, which acts as a limiter. The lower inner plate 204 is provided with a test strip groove 213 matching the test strip 3 . The outside of the inner lower plate 204 is connected to the outer lower plate 205 through the sixth hinge 212 , the outer lower plate 205 is also made of paper, and the crease between the inner lower plate 204 and the outer lower plate 205 is the sixth hinge 212 . The outer edge of the outer lower plate 205 forms a collection card limiting portion 218 . When the collection card 100 is pushed into the detection card 1, the inner end of the collection card 100 pushes against the collection card limiting portion 218, and the collection card limiting portion 218 acts as a limiting function. The outer lower plate 205 has a window hole 214 on the outer lower plate, which is aligned with the window hole 209 on the upper plate, the window hole 208 on the inner upper plate, and the test strip groove 213.

The outer end of the upper plate 4 is provided with a first liquid-filling hole 206 , and the upper card 102 is provided with a second liquid-filling hole 207 matching the first liquid-filling hole 206 . When the upper plate 2 and the lower plate 4 are tightly closed, the first half-hole 206 for filling liquid and the second half-hole 207 for filling liquid form the filling hole 7 . The notch 113 on the upper card 102 is smaller than the hole 110 on the upper card, and the second liquid filling half hole 207 is formed by the semicircular edge of the notch 113 .

During use, the upper plate 4 and the lower plate 2 are combined. The easy-to-tear sheet 120 is torn off again, and the upper card opening 110 and the lower card opening 108 of the collection card 100 are respectively aligned with the upper slide rail 118 and the lower slide rail 121, and then the collection card 100 is pushed in, and the collection card stopper 218 limit. At this time, the first liquid addition half hole 206 on the upper plate 4 and the second liquid addition half hole 207 on the upper card 102 just form the liquid addition hole 7, and the liquid addition hole 7 is aligned with the sample receiving area 3-4, and the liquid addition A protective film 114 and a carrier film 107 are successively separated between the hole 7 and the sample receiving area 3-4. The test solution is added dropwise to the filling hole 7. After the test solution mixes with the sample on the carrier film, it flows into the sample receiving area 3-4 of the test strip 3 through the lower card opening 108, and then is sucked into the reaction area 3-2. The results of the reaction zone 3-2 can be observed from the viewing window 209 on the upper plate.

Claims (21)

1, a kind of sample collection device, include the following card (103) that going up of upper blocking hole (202) blocked (102) and lower blocking hole (203) is arranged, between last card (102) and following card (103), be provided with the film carrier (107) of carrying sample, it is characterized in that: the insertion device that cooperates with test card (1) is arranged on the described collector cards (100), insert device by this and cooperate with docking apparatus on the test card (1).

2, sample collection device according to claim 1 is characterized in that: the insertion device on the described collector cards (100) is to be made of slide rail, cooperates with docking apparatus on the test card (1) by this slide rail.

3, sample collection device according to claim 2 is characterized in that: described slide rail (219) be by upper blocking hole and lower blocking hole communicate form upper blocking opening (110), lower blocking opening (108) and by be positioned at film carrier (107) up and down side walls form.

4, sample collection device according to claim 3, it is characterized in that: described upper blocking opening (110), lower blocking opening (108) easily tear sheet (120) and link to each other with last card (102), following card (103) by easy-torn line (109) by easily tearing sheet (120) capping.

5, sample collection device according to claim 2 is characterized in that: described slide rail (219) is to be formed by upward card breach (215) and following breach (217) side walls of blocking that last card (102) and following card (103) junction have.

6, according to claim 1,2,3 or 4 or 5 described sample collection devices is characterized in that: the described diaphragm (114) that is provided with the protection sample between card (102) and the film carrier (107) of going up.

7, according to claim 3 or 4 described sample collection devices, it is characterized in that: described going up between card (102) and the film carrier (107) is provided with interior card (114), and the diaphragm (114) of protection sample is located at and is blocked on (101) in this; Interior card (101) has breach (113) with upper blocking opening (110) corresponding position.

8, sample collection device according to claim 7 is characterized in that: the breach (113) in described on the card (101) is less than upper blocking opening (110).

9, according to claim 1 or 3 or 4 described sample collection devices, it is characterized in that: be provided with between described film carrier (107) and the last card (102) and be coated with model (104), this be coated with model (104) have communicate with film carrier (107) be coated with sample hole (105).

10, a kind of sample testing apparatus comprises upper plate (4) and lower plate (2), is provided with test-strips (3) between upper plate and the lower plate (2); Have the reading window (5) that is used to read the result on the described upper plate (4), and be provided with the through hole (4-1) of test fluid with test-strips (3) corresponding section; It is characterized in that: on test card (1), be provided with and be used for the docking apparatus that matches with collector cards (100), cooperate with insertion device on the collector cards (100) by this docking apparatus.

11, sample testing apparatus according to claim 10 is characterized in that: described docking apparatus is to be made of slideway, cooperates by the slide rail on the collector cards (100) of this slideway and collection sample.

12, sample testing apparatus according to claim 11, it is characterized in that: described slideway is the surface formation of being locked (6) by the location that upper plate (4) surface is provided with, these location lock (6) one ends are connected with upper plate (4), the other end is suspended from through hole (4-1) top, and leaves the gap of socket joint collector cards (100) between this location lock (6) and upper plate (4) surface.

13, sample testing apparatus according to claim 12, it is characterized in that: described location lock (6) is that upper plate (4) upper surface of a surface level raises up and horizontal-extending forms location lock (6) by the surface, and upper plate (4) is locked the barricade (10) that link protruding between (6) is formed for limiting collector cards (100) insertion depth with the location.

14, sample testing apparatus according to claim 12, it is characterized in that: described location lock is that the last plane by upper plate (4) extends to form in the lower plane upper horizontal, described upper plate (4) upper surface is made of two stair-stepping upper and lower two planes, and the junction between two planes is formed for limiting the barricade (10) of collector cards (100) insertion depth.

15, sample testing apparatus according to claim 11, it is characterized in that: described slideway is that the lateral retaining wall (20) that two sides by the lower plane of the upper surface of upper plate (4) are provided with slide rail (100) on gathering-device cooperates cooperates constitutes, described upper plate (4) upper surface is made of two stair-stepping upper and lower two planes, and the junction open form between two planes becomes to be used to limit the barricade (10) of collector cards (100) insertion depth.

16, sample testing apparatus according to claim 15 is characterized in that: the last planar horizontal of described upper plate (4) upper surface extends to form location lock (6), and this location lock (6) is suspended from the lower surface top that has through hole (4-1).

17, according to claim 12 or 13 or 14 or 16 described sample testing apparatus, it is characterized in that: described location locks that through hole (4-1) on (6) and the upper plate 4 is corresponding to go out to have liquid filling hole (7).

18, sample testing apparatus according to claim 11 is characterized in that: described lower plate (2) is provided with protruding location bridge (18) with through hole (4-1) corresponding position, and this location bridge (18) has the bridge floor (11) of arch; The width of the width of bridge floor (11) and test-strips (3) is complementary.

19, sample testing apparatus according to claim 11 is characterized in that: described lower plate (2) is provided with drainage strip (21) with liquid through-hole (4-1) corresponding position, and (3-4) is corresponding with through hole (4-1), sample region of acceptance respectively for drainage strip (21).

20, a kind of collection detection method of sample comprises: the collection sample arrives on the film carrier (107) of the carrying sample in the described collector cards (100); Described collector cards (100) is inserted on the described test card (1); Drip test fluid, the film carrier (107) of liquid by the carrying sample in the collector cards (100) flows on the test-strips in the collector cards (100); Read the result.

21, the collection detection method of sample according to claim 20, it is characterized in that: the sample that sample is applied to sampling rod on the following card (103) of collector cards (100) is coated with sample hole (105), then the model (104) that is coated with on the sample collection card (100) is taken off, covered going up of collector cards and block (102); The sheet (120) that easily tears of collector cards (100) is torn along easy-torn line (109), expose the diaphragm (114) and the film carrier (107) of collector cards, and be inserted in the test card (1) along last slide rail (118), glidepath (121), drip test fluid to liquid filling hole (7); Test fluid is mixed the back and is flowed into sample region of acceptance (3-4) with sample on the film carrier (107), be drawn to reaction zone (3-2) again; Can be observed the result of reaction zone (3-2) from reading window (5).

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