CN115629203A - Sampling, preprocessing and detection integrated rapid detection device - Google Patents

Sampling, preprocessing and detection integrated rapid detection device Download PDF

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Publication number
CN115629203A
CN115629203A CN202211572824.7A CN202211572824A CN115629203A CN 115629203 A CN115629203 A CN 115629203A CN 202211572824 A CN202211572824 A CN 202211572824A CN 115629203 A CN115629203 A CN 115629203A
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sampling
sampling rod
rod
detection
liquid
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CN115629203B (en
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卢润丰
栗享
何文龙
殷剑峰
王春香
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Jiangsu Kangwei Century Biotechnology Co ltd
Shanghai Weifan Medical Laboratory Co ltd
Beijing Jianwei Medical Laboratory Co ltd
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Jiangsu Kangwei Century Biotechnology Co ltd
Shanghai Weifan Medical Laboratory Co ltd
Beijing Jianwei Medical Laboratory Co ltd
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/28Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/38Diluting, dispersing or mixing samples
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983Viruses

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  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • General Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Urology & Nephrology (AREA)
  • Virology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biotechnology (AREA)
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  • Investigating Or Analysing Biological Materials (AREA)
  • Sampling And Sample Adjustment (AREA)

Abstract

The invention provides a rapid detection device integrating sampling, preprocessing and detection. The detection device provided by the invention avoids the risks of sample exposure and sample pollution when detecting pathogens such as novel coronavirus.

Description

Sampling, preprocessing and detection integrated rapid detection device
Technical Field
The invention relates to the technical field of biology, in particular to an integrated nasopharyngeal swab antigen rapid detection device.
Background
At present, in the detection process of pathogen antigens (such as novel coronavirus antigens), sampling, pretreatment and detection are mostly separated, namely, sampling is carried out through a nasopharyngeal swab, then the nasopharyngeal swab head carrying the sample is added into a pretreatment reagent for treatment, and then detection is carried out through a detection test strip. This testing process causes the secondary pollution of sample easily, need drop into the antigen detection test paper strip with the treatment fluid after pretreatment reagent and sample mixture when detecting, complex operation and the pollution exposure risk appears many times, are unfavorable for daily family to use. The existing integrated detection device is basically designed for integration of sampling and pretreatment or pretreatment and detection, and a sample treatment solution cannot be pretreated in the device and detected simultaneously.
Disclosure of Invention
In one aspect, the present invention provides a detection apparatus comprising:
1) A sampling part 100 including a sampling head 1, a hollow sampling rod 2 and a vent branch pipe 5, wherein the sampling head 1 is arranged at a first end of the sampling rod 2, a sample treatment liquid layer 7 and a high-viscosity liquid retaining layer 8 are sequentially filled in the sampling rod 2 from top to bottom, the sampling rod 2 is provided with one or more through holes 9 below the liquid retaining layer 8, the vent branch pipe 5 is arranged at a second end close to the sampling rod 2, the vent branch pipe 5 is communicated with the inside of the sampling rod 2 at one end thereof, and a sealable screw cap 6 is arranged at the other end thereof;
2) A detection part 200 connected to the second end of the sampling rod 2 through a rotary valve 4, the detection part 200 including a detection chamber 10, the detection chamber 10 communicating with the rotary valve 4 through a capillary 12; and
3) The sampling cover 300 with one closed end can cover the sampling head 1 and the through hole 9 arranged on the sampling rod 2 when the sampling cover is fixed on the sampling rod 2.
In some embodiments, the liquid retaining layer having high viscosity comprises silicone oil.
In some embodiments, the silicone oil is a dimethicone having a number average molecular weight of 10,000 to 30,000.
In some embodiments, the silicone oil is a dimethicone having a number average molecular weight of about 20,000.
In some embodiments, the inner diameter of the sampling rod 2 at the portion accommodating the sample treatment liquid layer 7 and the retention liquid layer 8 is 0.5-0.8cm.
In some embodiments, the sampling cap 300 and the sampling rod 2 are fixed by a screw thread therebetween.
In some embodiments, the sampling cap 300 and the sampling rod 2 are fixed by a clamping groove.
In some embodiments, the sampling rod 2 is provided with a first annular protrusion and a second annular protrusion at intervals, the first annular protrusion is positioned below the second annular protrusion and is provided with a protrusion notch; an annular groove is formed in the sampling cover 300, the first annular protrusion is matched with the annular groove to fix the sampling cover 300 on the sampling rod 2, and meanwhile, the inside and the outside of the sampling cover 300 are communicated with air through the protrusion gap; the first annular protrusion and the annular groove cooperate to secure the sampling cap 300 to the sampling rod 2 while preventing liquid from passing through the interface between the second annular protrusion and the annular groove.
In some embodiments, the switch of the rotary valve comprises two layers of rubber gaskets with triangular notches.
In one aspect, the invention provides the use of the above described detection device in the detection of a novel coronavirus antigen.
The detection device provided by the invention realizes the integration of the sampling, pretreatment and detection processes, and avoids the risks of sample exposure and sample pollution when pathogens such as novel coronavirus are detected.
Drawings
Fig. 1 is a schematic structural diagram of an integrated detection device provided by the present invention.
FIG. 2 is a schematic view of a rotary valve configuration. (A) a cross-sectional view of a rotary valve; (B) a top view of the lower pad; (C) top view of upper pad.
Detailed Description
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
The terms "upper", "lower", "above" and "below" used herein to indicate the positional relationship of the components are the positional relationship when the detecting device is placed vertically as shown in fig. 1.
The term "retaining fluid" as used herein refers to a highly viscous liquid that is capable of retaining a sample processing fluid within a thief rod such that the sample processing fluid does not flow out of the thief rod until sampling is not taking place (e.g., during shipping). When the holding liquid is filled in the sampling rod filled with other liquid (complementary and compatible with the holding liquid) with one end closed to form a liquid holding layer, it can actually function to separate the air inside and outside the sampling rod, thereby maintaining the position of itself and the sample processing liquid in the sampling rod. A suitably viscous holding liquid can be determined experimentally as follows: the liquid that will keep is added to the equal open sampling rod that is in the horizontality in both ends, forms and keeps the liquid layer (need not to form the liquid layer that two surfaces are accurate parallel, as long as can the shutoff sampling rod internal diameter can), lets the sampling rod be in vertical state afterwards, and the liquid layer can be kept in a period of time (like in 5-20 seconds) not too fast flow and still shutoff sampling rod not formed yet, and the shutoff time overlength also should not be simultaneously, for example no longer than 1 minute. Suitable retaining liquids are, for example, silicone oils, such as dimethylsilicone oils. The dimethylsilicone fluids with different molecular weights have different viscosities, and the dimethylsilicone fluids with suitable molecular weights can be determined by the above method. When the inner diameter of the sampling rod is 0.6cm and the height of the liquid layer of the sample treatment is 5cm or more, this can be achieved by using dimethylsilicone oil having an average molecular weight of 10,000 to 30,000, and preferably, dimethylsilicone oil having an average molecular weight of about 20,000.
As used herein, a "sample processing fluid" refers to a fluid, typically a buffer, that is capable of dissolving or mixing a sample in a sample head for subsequent testing (e.g., immunoassay). For example, the sample processing fluid may include the following components: pH buffers, detergents and preservatives. The pH buffer may be selected from Tris-HCl, PBS and TAPS. The pH of the sample treatment fluid may be 7.0-10.0. The detergent may be selected from Tween-20, brij 58 and Triton X-100. The preservative may be selected from ProClin 300 and sodium azide.
The integrated nasopharyngeal swab detection device provided by the invention can replace a common kit comprising a sampling swab, a container filled with sample treatment liquid and a detection test strip, and has the advantages of simple structure, convenience in use and the like.
The present invention will be described in detail below with reference to the accompanying drawings.
Referring to fig. 1, the present invention provides an integrated nasopharyngeal swab testing device in the shape of a rod, which mainly comprises a sampling portion 100 and a testing portion 200, both of which are generally hollow tubular structures, and a sampling cap 300.
The sampling portion 100 includes a sampling head 1, a sampling rod 2, and a sampling handle 3 connecting the two. The sampling head 1 is located at one end of the sampling part 100, is used for extending into the oral cavity, nasal cavity or other parts for sampling, and can be round or oval, and the surface of the sampling head is coated with a sampling cotton ball or other sampling materials. The sampling handle 3 can be arranged to be slightly thinner relative to the sampling head 1 and the sampling rod 2 so as to reduce the discomfort brought to the person to be sampled when sampling. The other end of the sampling part 100 is connected to the detecting part 200 through the rotary valve 4. In addition, a sampling rod vent branch pipe 5 is arranged at the part of the sampling rod 2 close to the rotary valve 4, one end of the vent branch pipe 5 is communicated with the inside of the sampling rod 2, and the other end is provided with a closable screw cap 6. The sampling rod 2 is pre-loaded with a sample treatment liquid layer 7 in its inner lumen, and a liquid retention layer 8 is provided below the sample treatment liquid layer 7. The retaining liquid in the retaining liquid layer 8 is selected from a highly viscous liquid that is insoluble in the sample processing liquid, so that when both the screw cap 6 and the rotary valve 4 are closed (sealed), their positions in the sampling rod 2 remain substantially unchanged, thereby also retaining the sample processing liquid above them in the sampling rod 2, and not being able to flow downward when the sampling rod 2 is in a vertical state. When the screw cap 6 is opened and the sampling rod 2 is in a substantially vertical state, both the holding liquid and the sample processing liquid move downward by the self-weight of the holding liquid layer 8 and the weight of the sample processing liquid layer 7. One or more through holes 9 for communicating the inside and the outside of the sampling rod 2 are provided between the liquid retention layer 8 and the sampling handle 3 at the lower part of the sampling rod 2.
In one embodiment, the rotary valve 4 is configured as shown in FIGS. 2A-2C. The rotary valve 4 comprises a lower gasket 4-1 and an upper gasket 4-2 (figure 2A), the lower gasket 4-1 is composed of a rubber sheet 4-1-1 with a triangular notch and an outer edge connecting rotary ring 4-1-2 (figure 2B), and the upper gasket 4-2 is composed of a rubber sheet 4-2-1 with a triangular notch and an outer edge connecting rotary ring 4-2-2 (figure 2C). The triangular notches on the upper gasket 4-2 and the lower gasket 4-1 are staggered or overlapped by rotating, so that a sealing or opening state is realized.
The sampling cap 300 is a tubular structure with one end closed, and can cover at least the through hole 9 provided at the lower part of the sampling head 1 and the sampling rod 2 when being sleeved at the lower part of the sampling part 100. In some embodiments, the sampling cap 300 can be secured to the sampling rod 2 by simply sizing the inner diameter of the sampling cap 300 appropriately and maintaining an interface therebetween that prevents the passage of liquid. In other embodiments, the sampling cap 300 and the sampling rod 2 can be fixed by a clamping groove or a thread. For example, an annular protrusion is provided on the surface of the sampling rod 2, an annular groove is provided in the sampling cap 300, and the sampling cap 300 is fixed to the sampling rod 2 by the engagement of the annular protrusion and the annular groove. Preferably, two annular protrusions are provided at intervals on the sampling rod 2: an upper annular protrusion and a lower annular protrusion. When the annular groove in the sampling cap 300 is engaged with the lower annular protrusion, a first fixing position is formed, which can fix the sampling cap 300 to the sampling rod 2, but keeps the inside and the outside of the sampling cap 300 in air communication. For this purpose, one or several projection notches may be provided on the lower annular projection. When the annular groove of the sampling cap 300 is engaged with the upper annular protrusion, a second fixing position is formed, which can fix the sampling cap 300 on the sampling rod 2 while preventing liquid (e.g., sample processing liquid) from passing through the catching groove. For this purpose, the surface of the upper annular protrusion may be provided with a rubber layer to prevent liquid (e.g., sample processing liquid that has contacted the sampling head 1) from passing through the card slot when the annular groove of the sampling cap 300 is engaged with the upper annular protrusion. These two fixing positions can also be formed similarly when fixing by means of a screw: this can be achieved by manually controlling the tightness of the bite between the threads. Relatively speaking, the dual annular protrusion is suitable for users who are not familiar with the operation method of the detection device, and the situations that the sample processing liquid can not soak the sampling head 1 or the liquid leaks due to operation errors are not easy to occur.
The detection part 200 is connected with one end of the sampling rod 2 through the rotary valve 4, a detection cavity 10 is arranged in the detection part, and a detection test strip 11 is placed in the detection cavity 10 in advance. The detection cavity 10 is communicated with the inner cavity of the sampling rod 2 through a capillary tube 12. The capillary 12 may be connected to the rotary valve 4 via a funnel-shaped suction opening 13. The capillary 12 allows a limited amount of sample processing fluid to enter the detection chamber 10 when used for detection. The detecting part 200 is made of a transparent material (e.g., polyethylene or polycarbonate) to facilitate observation of the result of the detection reaction.
The sampling part 100, the detecting part 200 and the sampling cap 300 of the integrated detecting device provided by the invention can be mainly made of transparent plastic materials (such as polyethylene or polycarbonate) so as to facilitate the observation of the liquid flow and the detection result. The preparation method can adopt injection molding or blow molding. The test portion 200 may be obtained by joining two injection-molded parts (e.g., bonding) and placing the test strip 11 in the test cavity 10 to be formed before joining. In order to fit the test strip 11, the diameter of the test portion 200 may be larger than the diameter of the sampling rod 2. The holding liquid may be filled into the sampling rod 2 while it is in a horizontal state, followed by closing the lower portion of the sampling rod 2, leaving the sampling rod 2 in a vertical state, filling the sample processing liquid therein through the screw cap 6, followed by closing the screw cap 6 (and the rotary valve 4).
The following description will take nasal sampling as an example to illustrate the use of the integrated detection device provided by the present invention. When in use, the sampling cover 300 is taken down, and the sampling head 1 is extended into the nasal cavity for sampling according to the conventional method. After sampling, the sampling cap 300 is lightly fitted back to the sampling rod 2, and the inside of the sampling cap 300 is kept in communication with the outside air (in the first position when fixed by a clamping groove or a thread). With the vertical placement of thief rod 2, unscrew spiral cover 6 for the interior sample treatment liquid of thief rod 2 communicates with each other with the air, makes under the action of gravity keep liquid (layer) and sample treatment liquid (layer) all move down, and when sample treatment liquid reachd through-hole 9, accessible through-hole 9 flowed out and soaks sampling head 1 in sample lid 300. After soaking for several minutes (such as 3 minutes), upwards promote sample cap 300 relative thief rod 2 to tightly overlap on thief rod 2 (when fixed through draw-in groove or screw thread mode, be the second position), screw up spiral cover 6 simultaneously, invert thief rod 2, open rotary valve 4, make the sample treatment fluid that soaks sampling head 1 loop through-hole 9, rotary valve 4, suction inlet 13 and capillary 12 and get into detection chamber 10 and contact detection test paper strip 11, carry out the detection reaction, observe the testing result afterwards.
The detection device integrating sampling, pretreatment and detection can be used for antigen detection of novel coronaviruses (and other viruses, such as hepatitis B virus, mycoplasma pneumoniae, rubella virus, herpes simplex virus and the like), is simple to operate, convenient and quick to use, and is particularly suitable for replacing antigen detection kits of household novel coronaviruses. The detection device provided by the invention integrates the three steps of acquisition, sample release (pretreatment) and sample detection, so that the sample is prevented from being exposed, the cross contamination is prevented, the use is convenient and quick, the product volume is reduced, and the transportation cost is saved.

Claims (10)

1. A detection device, comprising:
1) The sampling part (100) comprises a sampling head (1), a hollow sampling rod (2) and a vent branch pipe (5), wherein the sampling head (1) is arranged at the first end of the sampling rod (2), a sample treatment liquid layer (7) and a high-viscosity liquid retaining layer (8) are sequentially filled in the sampling rod (2) from top to bottom, one or more through holes (9) are formed in the sampling rod (2) below the liquid retaining layer (8), the vent branch pipe (5) is arranged at the second end close to the sampling rod (2), the vent branch pipe (5) is communicated with the inside of the sampling rod (2) at one end of the vent branch pipe, and a rotary cover (6) is arranged at the other end of the vent branch pipe in a sealing manner;
2) A detection portion (200) connected to said second end of said sampling rod (2) through a rotary valve (4), said detection portion (200) comprising a detection chamber (10), said detection chamber (10) being in communication with said rotary valve (4) through a capillary tube (12); and
3) The sampling cover (300) is fixed on the sampling rod (2) and can cover the sampling head (1) and the through hole (9) arranged on the sampling rod (2).
2. The detection device according to claim 1, wherein the liquid retaining layer having high viscosity comprises silicone oil.
3. The detecting unit according to claim 2, wherein the silicone oil is a dimethylsilicone oil having a number average molecular weight of 10,000 to 30,000.
4. The detecting unit according to claim 2, wherein the silicone oil is a dimethylsilicone oil having a number average molecular weight of 20,000.
5. The detection device according to claim 1, wherein the inner diameter of the sampling rod (2) at the portion accommodating the sample treatment liquid layer (7) and the retention liquid layer (8) is 0.5-0.8cm.
6. The testing device according to claim 1, wherein the sampling cap (300) and the sampling rod (2) are fixed by a screw thread.
7. The testing device according to claim 1, wherein the sampling cap (300) and the sampling rod (2) are fixed by a clamping groove.
8. The detection device according to claim 7, wherein the sampling rod (2) is provided with a first annular protrusion and a second annular protrusion at intervals, the first annular protrusion is positioned below the second annular protrusion and is provided with a protrusion notch; an annular groove is formed in the sampling cover (300), the first annular protrusion is matched with the annular groove to fix the sampling cover (300) on the sampling rod (2), and meanwhile, the inside and the outside of the sampling cover (300) are communicated through the protrusion gap; the first annular projection cooperating with the annular groove to secure the sampling cap (300) to the sampling rod (2) while preventing liquid from passing through the interface between the second annular projection and the annular groove.
9. The test device of claim 1, wherein the switch of the rotary valve comprises two layers of rubber gaskets with triangular notches.
10. Use of the test device of any one of claims 1 to 9 in the testing of novel coronavirus antigens.
CN202211572824.7A 2022-12-08 2022-12-08 Sampling, preprocessing and detection integrated rapid detection device Active CN115629203B (en)

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040014237A1 (en) * 2002-03-18 2004-01-22 Nobuyuki Sugiyama Swab testing device and method
US20080199851A1 (en) * 2006-02-21 2008-08-21 Richard Laswell Egan Methods and compositions for analyte detection
CN206033755U (en) * 2016-01-13 2017-03-22 宝洁公司 Oral cavity sampling swab
JP2019111272A (en) * 2017-12-26 2019-07-11 有限会社サプライズ Manufacturing method of cotton swab
CN216116887U (en) * 2021-09-02 2022-03-22 益思美诠生物科技(上海)有限公司 Sampling detection integrated device
CN114848027A (en) * 2022-04-06 2022-08-05 同济大学 Cotton swab capable of instantly detecting new coronavirus
US20220249070A1 (en) * 2019-03-27 2022-08-11 Jiangsu Gemkeeper Biotech Company, Ltd. Integrated device for medical sampling and testing
CN114994316A (en) * 2022-07-12 2022-09-02 嘉兴学院 New hat nucleic acid detection device of integral type
CN115327138A (en) * 2022-08-04 2022-11-11 江苏康为世纪生物科技股份有限公司 Portable fecal occult blood detection device

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040014237A1 (en) * 2002-03-18 2004-01-22 Nobuyuki Sugiyama Swab testing device and method
US20080199851A1 (en) * 2006-02-21 2008-08-21 Richard Laswell Egan Methods and compositions for analyte detection
CN206033755U (en) * 2016-01-13 2017-03-22 宝洁公司 Oral cavity sampling swab
JP2019111272A (en) * 2017-12-26 2019-07-11 有限会社サプライズ Manufacturing method of cotton swab
US20220249070A1 (en) * 2019-03-27 2022-08-11 Jiangsu Gemkeeper Biotech Company, Ltd. Integrated device for medical sampling and testing
CN216116887U (en) * 2021-09-02 2022-03-22 益思美诠生物科技(上海)有限公司 Sampling detection integrated device
CN114848027A (en) * 2022-04-06 2022-08-05 同济大学 Cotton swab capable of instantly detecting new coronavirus
CN114994316A (en) * 2022-07-12 2022-09-02 嘉兴学院 New hat nucleic acid detection device of integral type
CN115327138A (en) * 2022-08-04 2022-11-11 江苏康为世纪生物科技股份有限公司 Portable fecal occult blood detection device

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