CN221686381U - A detection kit - Google Patents

Abstract

The utility model provides a test kit, which includes a test card and a sample collection device, the sample collection device includes a collection bottle, a sampler and a separator, the two opposite ends of the sample collection device are respectively provided with a sample inlet and a sample outlet, the through hole of the separator is located at the lower part of the sample inlet, the sampling rod is inserted into the collection bottle from the sample inlet through the through hole of the separator, and the liquid pipetting head is set as a quantitative capillary. The sample collection device of the utility model is used to collect and collect samples during the detection process, which is convenient for sample collection and storage, and can quantitatively absorb test samples, thereby ensuring the accuracy of quantitative detection.

Description

A detection kit

Technical Field

The utility model relates to the technical field of medical detection instruments, in particular to a device for sample collection and quantitative sampling, and a detection kit using the sample collection device.

Background Art

Feces, as human waste, has become a test sample for intestinal disease-related indicators. It has the advantages of little damage to the human body and easy sampling. For example, feces are the first choice as a test sample for intestinal pathogens such as intestinal adenosis, rotavirus, Clostridium difficile, and intestinal physical and chemical function tests such as fecal occult blood and calprotectin. Because the composition of fecal samples is complex and there are large individual differences, and the content of the substance to be tested is low, it is generally necessary to collect a small amount of sample from the original feces with a sampling stick before testing, then dilute and mix the sample, and finally take a certain amount of the mixed solution to test physiological indicators such as calprotectin.

For example, U.S. Patent US6780160 is a patent for sample collection that can quantitatively collect samples. A diaphragm is installed in the collection bottle filled with buffer solution, and a through hole is provided in the middle of the diaphragm. The sampling part of the sampling rod is designed with a spiral groove. When the sampling rod is inserted from the through hole into the collection bottle, the diaphragm scrapes off the excess sample attached to the area outside the groove of the sampling rod, thereby achieving quantitative collection of fecal samples. The sample attached to the sampling rod and passing through the through hole is mixed with the buffer solution in the collection bottle to form a mixed liquid. When the mixed liquid is used as a sample for testing, the tip of the closed dripper at the bottom of the collection bottle needs to be broken off, and the mixed liquid is squeezed out of the dripper. This process can easily cause the operator to be stained with the sample, and the volume of the droplets squeezed out of the dripper cannot be controlled, and quantitative dripping of the sample mixed liquid cannot be achieved.

Utility Model Content

The utility model provides a detection kit, which includes a new sample collection device, which can realize quantitative sampling and quantitative dripping of sample mixed solution, thereby realizing accurate quantitative detection of the detection kit, and can avoid contamination to the operator during operation.

Specifically, the utility model provides a detection kit, including a detection card and a sample collection device, wherein a detection test paper is arranged in the detection card, and is characterized in that the sample collection device includes a collection bottle, a sampler and a separator, wherein an inlet and an outlet are arranged at opposite ends of the sample collection device, respectively, the separator is connected to the inlet in the collection bottle, and a sampling rod of the sampler is inserted into the collection bottle from the inlet through the through hole of the separator, the sample collection device also includes an adder, the adder includes a pipette head and a grasping part, the pipette head is arranged as a quantitative capillary, and the pipette head is inserted into the collection bottle from the outlet end.

Furthermore, a sample adder bracket is provided at the sample outlet end of the sample collection device, and the sample adder bracket includes a sample outlet and a storage cavity, one end of the storage cavity is open, and the other end of the storage cavity facing the inside of the collection bottle is closed.

Furthermore, the sampler also includes a stopper, the liquid pipetting head of the sampler is located in the storage cavity, and the stopper liquid of the sampler seals the sample outlet of the sampler bracket.

Furthermore, corresponding to the sampler bracket, the plug of the sampler and the sample outlet of the sampler bracket are interference fit.

Furthermore, the sample outlet of the sample pipette support and the opening size of the liquid pipette head storage chamber are different.

Furthermore, the sampler comprises a sampling rod, a sampling head located at the end of the sampling rod and a gripping portion, and recessed portions are arranged at intervals on the outer wall of the sampling head.

Furthermore, the separation element is a funnel-shaped structure, the upper part of the funnel is connected to the injection port, and the through hole at the lower part of the funnel is located below the injection port.

Furthermore, the detection card includes a sample addition hole and an observation window.

Furthermore, a diluent hole is provided upstream of the sample addition hole of the detection card, and an observation window is provided downstream of the sample addition hole.

Furthermore, the test strip is a lateral flow test strip.

Beneficial Effects

By utilizing the cooperation between the sampling head and the through hole of the separator of the sample collection device of the utility model, quantitative sample collection is achieved, and the collected sample is mixed with the reagent in the collection bottle according to a predetermined ratio; the capillary pipette head of the sampler can accurately absorb the mixed sample, thereby achieving quantitative and accurate detection of the detection kit. The interference fit between the sampling rod of the sampler and the through hole of the separator, as well as the interference fit between the sampler stopper and the sampler bracket sample outlet, can prevent the liquid in the collection bottle from leaking out and will not dirty the operator's hands. Before taking the mixed sample, the sampler pipette head is temporarily stored in the pipette head storage chamber, so that the sampler pipette head does not come into contact with the liquid in advance, which can avoid the situation where the mixed sample is not easy to enter the pipette head due to the solution being absorbed in advance.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a schematic diagram of a sample collection device of the present invention, wherein the collecting bottle is made of transparent material.

FIG. 2 is an exploded view of the sample collection device shown in FIG. 1 .

FIG. 3 is a schematic diagram of a collection bottle of another sample collection device of the present invention.

Fig. 4 is a cross-sectional view taken along the line A-A of Fig. 3 .

Figure 5 is a cross-sectional view of the sampler and the sample injector both inserted into the collecting bottle and loaded with reagents.

FIG. 6 is an exploded view of the sample collection device shown in FIG. 5 at a first angle.

FIG. 7 is an exploded view of the sample collection device shown in FIG. 5 from another angle.

FIG. 8 is a schematic diagram showing the sample injector and the collection bottle being separated.

FIG. 9 is a schematic diagram showing the sampler being removed from the collection bottle.

FIG. 10 is a schematic diagram of the sampler being inserted into a sample.

FIG. 11 is a schematic diagram of the sampler being reinserted into the collection bottle.

FIG. 12 is a schematic diagram of flipping the sample collection bottle after collecting the sample.

FIG. 13 is a schematic diagram showing the sample injector being removed from the collection bottle.

FIG. 14 is a schematic diagram of the pipette tip of the pipette being inserted into a collection bottle to absorb the solution.

FIG. 15 is a schematic diagram of a pipette head containing a sample solution adding sample to a test card.

FIG. 16 is a schematic diagram of a pipette tip containing a sample solution being inserted into a sample loading hole of a test card.

DETAILED DESCRIPTION

The sample collection device 1 shown in Figures 1 and 2 comprises a collection bottle 10, a sampler 20 and a sample injector 30. The collection bottle 10 is provided with a sample inlet 11 and a sample outlet end, the sample outlet end having a sample outlet 12 and a separator 13. The separator is located in the collection bottle and connected to the sample inlet. The sampler 20 is inserted into the bottle through the sample inlet 11 via the separator 13, and the pipette head 31 of the sample injector 30 is inserted into the bottle through the sample outlet 12.

The sampler 20 is inserted into the collecting bottle 10 through the sample inlet 11 , the sample is transferred into the collecting bottle 10 through the sampler 30 , and the sampler 30 is inserted into the collecting bottle through the sample outlet 12 to obtain the liquid sample in the collecting bottle.

The sampler 20 includes a sampling head 21, a sampling rod 22 and a gripping portion 23. The sampling head 21 is the lower end of the sampling rod 22, and the sampling head 21 includes recessed portions 211 provided at intervals on the outer wall. Of course, the shape of the sampling head 21 can also be other shapes, such as a spiral groove or a long strip groove provided on the outer wall of the end of the sampling rod 22. When sampling, the sampling head 21 is inserted into a sample such as feces, so that the sample is stored in the recessed portion 211 such as the concave surface or groove of the sampling head.

In the embodiment where the sample inlet and the separator are integrally formed, the sample inlet 11 is located above the separator 13, and the separator 13 extends toward the inside of the collection bottle to form a funnel-shaped structure, and the opening size of the lower through hole 131 of the funnel-shaped structure is roughly equivalent to or slightly smaller than the cross-sectional size of the sampling head 21. When the sampler with the fecal sample attached is inserted into the collection bottle 10 through the sample inlet 11 and the through hole 131 of the separator 13, the inner edge of the lower through hole 131 of the separator contacts the sample on the sampling head 11, thereby scraping off the excess sample outside the recessed part 211 of the sampling head, ensuring that a fixed amount of the sample to be tested can be collected, and the fixed amount of sample is the sample stored in the recessed part 211 of the sampling head. The excess sample scraped off from the sampling head can be accumulated in the upper part 132 of the funnel. The assembly of the sample inlet 11 and the separator 13 integrally formed can be assembled to one end of the collection bottle body by ultrasonic welding. The separator can also be integrally formed with the collection bottle body with the sample inlet.

In the embodiment where the separator 13 is an independent component, the collecting bottle 10 includes a sample inlet 11, and the separator 13 is a funnel-shaped structure. The separator is connected to the sample inlet 11. Specifically, the upper part 132 of the funnel is tightly matched with the inner wall of the sample inlet, for example, an O-ring is installed on the outer wall of the separator. In the embodiment where the separator 13 is a T-shaped structure, the through hole 131 of the separator is arranged at the "│" of the T-shape, and the "─" of the separator is clamped on the upper end of the bottle body. A certain space can also be left between the "─" of the separator and the upper end wall of the bottle body for collecting the scraped excess sample.

In the embodiment where the cross-sectional dimension of the sampling head 21 of the sampler is slightly smaller than the cross-sectional dimension of the sampling rod 22, there is an interference fit between the sampling rod 22 and the through hole 131 of the separator. When the sampling head is fully inserted into the collection bottle and contacts the reagent, the outer wall of the sampling rod is in close contact with the inner wall of the through hole of the separator, which ensures that the reagent liquid in the collection bottle is in a reliable sealed state and will not flow out from the through hole of the separator.

The injection port 11 can be provided with a separate cover, or the gripping portion 23 of the sampler can be designed as a cover of the injection port. When the sampler is inserted into the bottle body, the gripping portion 23 with a cover function is used to cover the injection port 11 to prevent the liquid in the collection bottle from flowing out of the injection port.

The pipette 30 includes a pipette head 31 and a gripping portion 33. The pipette may also include a connecting arm 32, and the pipette head 31 is connected to the gripping portion 33 via the connecting arm 32. In the embodiment where the pipette head 31 is a capillary structure, the front end of the capillary structure is provided with a pipette port 311, and the rear end is provided with a liquid outlet 312, and a certain space 313 is left above the liquid outlet so that the gas in the pipette head can be discharged from the liquid outlet. When the sampling head with the sample is fully inserted into the collection bottle and contacts with the reagent in the collection bottle to form a mixed liquid, the sample collection device is turned over, and the pipette port of the pipette head contacts the mixed liquid, and the sample in the pipette head can be subsequently transferred to a detection device (such as a detection card).

The sample outlet 12 can be provided with a separate cover, or the gripping portion 33 of the sample injector can be designed as a cover of the sample outlet. After the pipette head 31 of the sample injector 30 is inserted into the bottle through the sample outlet 12, the gripping portion 33 with a cover function is used to cover the sample outlet 12 to prevent the liquid in the bottle from flowing out of the sample outlet 12.

The sample collecting device 1 shown in Figures 3 to 8 includes a collecting bottle 10, a sampler 20 and a sampler 30. The sample collecting device also includes a sample inlet 11, a separator 13, and a sampler bracket 14. The sampler bracket 14 is provided with a sample outlet 141. The separator 13 with the sample inlet 11 is located at one end of the collecting bottle, and the sampler bracket 14 with the sample outlet 141 is located at the other end of the collecting bottle.

The structures of the separator 13 and the sampler 20 and the matching relationship therebetween are the same as those shown in Figures 1 and 2. The sampling rod 22 of the sampler 20 is inserted into the collection bottle through the through hole 131 of the separator 13 through the sampling port 11, and the gripping portion 23 of the sampler 20 covers the sampling port 11.

The sampler support 14 used in conjunction with the sampler 30 includes a sample outlet 141 and a storage cavity 142. The sampler support 14 is installed at one end of the collection bottle 10, the sample outlet 141 connects the inside of the collection bottle with the outside, and the storage cavity 142 has one end open and the other end facing the inside of the collection bottle is closed.

As shown in FIG. 8 , the sampler bracket 14 can be mounted on the collecting bottle 10 by ultrasonic welding, and the separator 13 and the collecting bottle 10 can also be integrally formed.

The sampler 30 includes a pipette head 31, a gripping portion 33 and a plug 34, wherein the pipette head 31 and the plug 34 are located on the gripping portion 33. The sampler 30 may also include a connecting arm 32, through which the pipette head 31 is connected to the gripping portion 33. The sampler 30 is plug-in connected to the sampler bracket 14, and the plug 34 of the sampler is interference fit with the sample outlet 141 of the sampler bracket. Before sampling, the pipette head 31 of the sampler 30 is stored in the storage cavity 142, and the plug 34 of the sampler is plugged in the sample outlet 141 of the sampler bracket.

The liquid pipetting head 31 may be a capillary structure, with a liquid pipetting port 311 at the front end and a liquid outlet 312 at the rear end. A certain space may be left above the liquid outlet so that the gas in the liquid pipetting head can be discharged from the liquid outlet 312. After the capillary liquid pipetting port 311 contacts the liquid, the liquid will be automatically sucked into the capillary of the liquid pipetting head under the action of the capillary siphon. The capillary may be a quantitative capillary of different specifications, such as 1 μL, 5 μL, etc. for liquid pipetting.

The sample collection device shown in FIG1 is not provided with an injector bracket 14, and the pipette head 31 of the injector is directly inserted into the collection bottle body filled with liquid. Before the sampler 20 transfers the sample to the collection bottle, the pipette head 31 of the injector inserted into the collection bottle will contact the liquid reagent in the collection bottle. When the pipette head is a capillary structure, the reagent in the bottle will be automatically sucked into the capillary, that is, before sampling, there is already liquid in the pipette head 31. This may result in that after the sample and the liquid are mixed, the pipette head 31 of the injector can no longer suck in the mixed liquid for detection, or the sample collection device needs to be turned over several times before the mixed liquid to be detected can enter the capillary pipette head 31.

The sample collection device shown in FIG. 3 to FIG. 5 is provided with a pipette holder 14. Before the sample is mixed with the reagent, the pipette head 31 of the pipette is stored in the storage chamber 142. Since one end of the storage chamber is sealed, the pipette head 31 is isolated from the reagent in the collection bottle. Therefore, before the sampler 20 transfers the sample to the collection bottle 10, the pipette head 31 of the pipette 30 will not contact the liquid reagent in the collection bottle 10. After the sample is mixed with the reagent, the pipette head 31 of the pipette is taken out of the storage chamber 142. At this time, there is no liquid in the capillary of the pipette head 31 of the pipette. Therefore, the pipette head 31 of the pipette is inserted into the sample outlet 141 to absorb the mixed liquid in the collection bottle. After the pipette head is inserted from the sample outlet and contacts the liquid, the capillary of the pipette head can quickly absorb the mixed sample.

The sample outlet 141 of the sampler holder 14 and the opening size of the pipette head storage chamber 142 can be different, so that the pipette head and the plug can be prevented from being misplaced during assembly. For example, if the opening of the sample outlet 141 is larger than the opening of the storage chamber 142, if the sampler 30 is inserted in a manner that the plug 34 and the sample outlet 141 are paired during assembly, the sampler can be smoothly installed on the sampler holder; if the sampler is inserted in a manner that the plug and the storage chamber are paired during assembly, it is difficult to insert the plug into the storage chamber, so it can be reminded that the installation position may be wrong.

In order to allow the sample collection device to be placed upright, the gripping portion of the sampler and the gripping portion of the sampler may each have a horizontal surface, so that the sample collection device 1 can be placed upright on the operating table regardless of which end is facing downward.

The sample collection device may be made of materials such as plastic.

The method of using the sample collection device is described by taking the sample collection device 1 shown in FIG. 5 , FIG. 6 , and FIG. 7 and the calprotectin detection card shown in FIG. 15 and FIG. 16 as examples.

The sample collection device 1 is pre-installed with reagent 50, and the sampling rod 22 of the sampler is inserted into the through hole 131 to prevent the reagent in the collection bottle 10 from flowing out of the through hole 131. The stopper 34 of the sampler is inserted into the sample outlet 141 to prevent the reagent from flowing out of the sample outlet 12. The sampler pipette head 31 is temporarily stored in the pipette head storage chamber 142. The sampler pipette head 31 is a 5μL capillary.

The test card 70 includes a sample addition hole 71, a diluent hole 72 is arranged upstream of the sample addition hole, and an observation window 73 is arranged downstream of the sample addition hole. A test strip is installed in the test card, for example, a test strip based on the lateral flow principle.

As shown in Figures 9 and 10, the sampler 20 is pulled out and inserted into the stool sample 60 to take different parts of the stool sample; as shown in Figure 11, the sampler 20 containing the sample is reinserted into the collection bottle 10 to mix the sample and the reagent; as shown in Figures 12, 13 and 14, the sample collection device 1 is turned over so that the injector 30 is on top; the injector 30 is pulled out from the sampler bracket 14, and the injector pipette head 31 is inserted into the sampling port 141 of the sampler bracket 14, and 5 μL of the mixed sample is siphoned into the collection bottle 10; as shown in Figures 15 and 16, the pipette head 31 that has completed the liquid aspiration is contacted with the sampling hole 71 of the detection card 70, and the sampling operation is completed after the sample solution is adsorbed to the sampling hole.

After the sample addition is completed, 80 μL of diluent is added to the diluent well 72 , and the result is viewed in the observation window 73 , or the test result is read by an instrument such as a fluorescent immunoassay analyzer.

Example 1 Sealing Test of Sample Collection Device

Randomly take 20 sample collection devices shown in Figures 5, 6 and 7. Experimental steps: Take out the sampler 20, pour the diluent from the sampling port 11 until the collection bottle is full, reinsert the sampler 20 and wipe the outside of the sample collection device dry. Place these 20 sample collection devices filled with 6 ml of diluent horizontally into a transparent vacuum dryer (ASONE), and place a dry paper towel under each sample collection device. Turn on the transparent vacuum dryer, vent to a negative pressure of 0.05 MPa, turn off the transparent vacuum dryer, and observe whether the dry paper towel is wet, so as to determine whether the sample collection device has leakage. The experimental results show that the sample collection device of the utility model does not leak and has good sealing.

Example 2: Liquid aspiration accuracy test of sample collection device

Randomly take 10 sample collection devices shown in Figures 5, 6 and 7. Experimental steps: Take out the sampler 20, inject 6 ml of diluent from the injection port 11, and reinsert the sampler 20 to its original position. Insert the sampler 20 into the fecal sample, and then insert it into the collection bottle through the injection port and the separator again, and shake and mix. Invert the sample collection device, pull out the sampler 30 of the sample collection device, insert the sampler's liquid suction head 31 into the sample outlet 141 of the sampler bracket and suck the liquid (fecal mixture). And the sampler is weighed once before and after the liquid suction to obtain the liquid suction amount of the sampler each time (liquid suction amount = weight of the sampler after the sample suction - weight of the sampler before the sample suction), and the experimental results are shown in Table 1. From the experimental results, the liquid suction accuracy of the sampler is high.

Table 1

Claims (10)

1. The utility model provides a detection kit, includes detection card and sample collection device, is equipped with detection test paper in the detection card, its characterized in that, sample collection device includes collecting bottle, sampler and separator, and sample collection device's relative both ends are equipped with sample inlet and play appearance mouth end respectively, and the separator is connected on the sample inlet in the collecting bottle, and the sampling pole of sampler inserts in the collecting bottle from the through-hole of sample inlet through the separator, sample collection device still includes the application of sample ware, and the application of sample ware includes imbibition head and pinch portion, and the imbibition head sets up to quantitative capillary, and the imbibition head inserts in the collecting bottle from the appearance mouth end.

2. The test kit of claim 1, wherein the sample collection device has a sample applicator support at the sample outlet end, the sample applicator support comprising a sample outlet and a storage chamber, the storage chamber having an opening at one end and the storage chamber being closed toward the other end of the interior of the collection bottle.

3. The test kit of claim 2, wherein the applicator further comprises a stopper, the pipette head of the applicator being positioned in the storage chamber, the stopper of the applicator hydraulically sealing the sample outlet of the applicator holder.

4. The test kit of claim 3, wherein the stopper of the applicator is in an interference fit with the outlet of the applicator holder.

5. The test kit of claim 2, wherein the sample outlet of the sample applicator support and the pipette head storage chamber have different opening sizes.

6. The test kit of claim 1, wherein the sampler comprises a sampling rod, a sampling head at the end of the sampling rod, and a handle, and the outer wall of the sampling head is provided with concave parts at intervals.

7. The test kit of claim 1, wherein the separating member is of a funnel-shaped structure, the upper portion of the funnel is connected to the sample inlet, and the through hole in the lower portion of the funnel is located in the lower portion of the sample inlet.

8. The test kit of claim 1, wherein the test card comprises a loading well and a viewing window.

9. The test kit of claim 8, wherein the test card has a dilution well upstream of the well and a viewing window downstream of the well.

10. The test kit of any one of claims 1-9, wherein the test strip is a lateral flow strip.