WO2022213407A1 - 采血结构和全血及指尖血检测装置和检测方法 - Google Patents

采血结构和全血及指尖血检测装置和检测方法 Download PDF

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Publication number
WO2022213407A1
WO2022213407A1 PCT/CN2021/087100 CN2021087100W WO2022213407A1 WO 2022213407 A1 WO2022213407 A1 WO 2022213407A1 CN 2021087100 W CN2021087100 W CN 2021087100W WO 2022213407 A1 WO2022213407 A1 WO 2022213407A1
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Prior art keywords
blood
detection
chamber
collection
cavity
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PCT/CN2021/087100
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English (en)
French (fr)
Inventor
凌世生
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杭州安旭生物科技股份有限公司
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Priority to EP21766095.0A priority Critical patent/EP4092412A4/en
Priority to CA3131957A priority patent/CA3131957A1/en
Priority to US17/448,723 priority patent/US20220323950A1/en
Publication of WO2022213407A1 publication Critical patent/WO2022213407A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150343—Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983—Viruses

Definitions

  • the invention relates to a blood collection structure, a whole blood and fingertip blood detection device and a detection method, in particular to a blood collection structure, whole blood and a whole blood and a fingertip blood sample used for collecting whole blood samples or fingertip blood samples, and then mixing the samples with buffer before testing. Fingertip blood detection device and method.
  • This technique of detecting the presence or absence of analyte in a sample using the principle of immunobinding reaction is widely used in various fields. It can be used to detect analytes in various biological samples (saliva, blood, urine, serum, sweat, etc.) to monitor diseases and human health conditions (early pregnancy, tumors, infectious diseases, drugs, etc.).
  • the fundamental principle of this detection technology is to establish specific binding properties between immune molecules, such as antibodies and antigens, haptens/antibodies, biotin and avidin, and so on.
  • blood as a sample for disease detection, applying immunochromatography technology, a variety of different diagnostic reagents have been developed and applied in different disease detection fields, such as: tumor marker detection, early prediction of cardiovascular disease, infection Disease screening, etc.
  • Blood is the most commonly used sample source, especially fingertip blood, which has been widely adopted by various platforms because of its minimally invasive and rapid blood collection.
  • detection devices or detection cups In the field of medical diagnosis, it is a relatively common method to use a detection device or a detection cup to collect a detection liquid sample and determine whether the liquid sample contains an analyte.
  • detection devices or detection cups generally require the sample to be collected in a sample container, the relevant technicians include a detection reagent strip and immerse a part of the reagent strip in the sample, and then remove the reagent strip and read the detection result after a period of time.
  • Most detection devices are of split structure and operated separately. The operation requirements are relatively high, and there are cases where the blood sample is contaminated or the blood sample contaminates the operator.
  • the structure of the detection device is not small enough and inconvenient to carry.
  • the present invention also provides a blood collection structure, which is integrated into the detection device, and the detection device can be integrated into a structure, which not only reduces the volume of the detection device, but also realizes integrated detection and is easy to operate.
  • the present invention provides a blood collection structure, including a collection rod, a capillary channel is arranged inside the collection rod, the bottom end of the capillary channel is located at the end of the collection rod, and the top of the capillary channel is located in the middle and upper part of the collection rod; The top end of the capillary channel is connected and communicated with the through hole.
  • a groove is provided on the outer surface of the collecting rod, the groove is located between the through hole and the top end of the collecting rod, and one end of the groove communicates with the through hole.
  • the top of the collecting rod is provided with a barb
  • the bottom of the hook groove of the barb is provided with a large through hole; the other end of the groove is connected with the barb and communicated with the through hole.
  • the capillary channels, the through holes, the grooves, and the hook grooves and through holes of the barbs on the collecting rod form the liquid circulation channels.
  • the end of the collection rod is tapered.
  • annular disc and an annular washer sleeved on the collection rod are provided in the middle of the collection rod.
  • a plurality of ribs protruding from the collecting rod are provided between the end of the collecting rod and the annular disk.
  • the rib has a right-angled triangular structure.
  • the present invention also provides a whole blood and fingertip blood detection device with an integrated structure, so that the collection and detection of blood samples can be integrated, the product structure is reduced, and the operation difficulty of the subject is reduced, and, Minimize the exposure of the operator to the sample to reduce the chance of infection and improve the safety of the operator.
  • the sample can be fully utilized for detection, so that the demand for the sample is greatly reduced, which is more conducive to the success of the detection.
  • the whole blood and fingertip blood detection device includes a blood collection structure
  • the blood collection structure includes a collection rod
  • a capillary channel is arranged inside the collection rod, the bottom end of the capillary channel is located at the end of the collection rod, and the top of the capillary channel is located at the end of the collection rod.
  • the middle part of the collection rod; the collection rod is provided with a through hole which is connected and communicated with the top end of the capillary channel.
  • a groove is provided on the outer surface of the collecting rod, the groove is located between the through hole and the top end of the collecting rod, and one end of the groove communicates with the through hole.
  • the top of the collection rod is provided with a barb
  • the bottom of the hook groove of the barb is provided with a through hole; the other end of the groove is connected with the barb and communicated with the through hole; the capillary channel and the through hole on the collection rod.
  • grooves and hook grooves and through holes of barbs form liquid flow channels.
  • the end of the collection rod is tapered.
  • the collecting rod is provided with an annular disc and an annular washer sleeved on the collecting rod.
  • a detection cavity is also included, the detection cavity is connected with the blood collection structure and communicated with the blood collection structure; the inner wall of the detection cavity is provided with a first step, and the detection cavity is connected with the blood collection structure by engaging the first step with barbs.
  • the open end of the barb engages with the first step to connect the detection cavity with the blood collection structure.
  • the top of the collection rod is inserted into the detection cavity from the bottom of the detection cavity, the end of the barb enters the detection cavity, and then the open end of the barb is compressed, and the top of the collection rod and the barb enter the detection cavity; After the open end reaches the first step, because the inner diameter of the detection chamber becomes larger, the open end of the barb bounces back to its original state, and the barb is engaged at the first step; at this time, the bottom of the detection chamber is formed by the annular gasket and the annular disc. seal.
  • the inner wall of the detection chamber is further provided with a second step above the first step; the whole blood and fingertip blood detection device further includes a buffer pad; the buffer pad is located on the second step.
  • the whole blood and fingertip blood testing device further includes a testing element located in the testing cavity and a cover sealing the testing cavity.
  • test element is located between the cushion and the cover.
  • the liquid entering the detection chamber through the collection rod first flows into the buffer pad, and then flows from the buffer pad to the test element located in the detection chamber.
  • the function of the buffer pad is to prevent the flushing liquid from the absorbing element from being too violent, a large amount of sudden rushing into the detection chamber, and the buffering effect on the test element located in the detection chamber.
  • a bracket is also included, and the bracket has a recessed hole.
  • the test element is a test strip, and the test strip is inserted into the concave hole of the bracket for fixing.
  • one end of the bracket is fixed to the cover.
  • a buffer chamber, a sealing sheet for sealing the buffer chamber, and a pipetting chamber are further included; the bottom of the pipetting chamber is sealedly connected with the buffer chamber; and the buffer is sealed in the buffer chamber.
  • the pipetting chamber has a large upper chamber and a lower small chamber; the bottom of the small chamber is sealed with the buffer chamber.
  • the sealing sheet is an aluminum foil sheet.
  • a sealing gasket is provided on the outer wall of the bottom of the detection chamber, the blood sampling structure and the detection chamber enter the pipetting chamber, and a seal is formed between the detection chamber and the pipetting chamber.
  • the blood collection structure connected to the detection cavity is inserted into the pipetting cavity, and the end of the collection rod of the blood collection structure is located just above the mouth of the pipetting cavity;
  • the end of the collection rod contacts the sealing sheet, that is, the end of the collection rod reaches the top of the buffer chamber;
  • the blood collection structure continues to move in the direction of being inserted into the pipetting chamber, the end of the collection rod pierces the sealing sheet, and the collection rod enters the In the buffer chamber, part of the buffer is mixed with part of the sample in the capillary channel of the collection rod;
  • the blood collection structure continues to move in the direction of being inserted into the pipetting chamber, and the sealing gasket on the outer wall of the detection chamber forms with the small cavity in the lower part of the pipetting chamber Sealing;
  • the blood collection structure continues to move in the direction of being inserted into the pipetting cavity, the sealed cavity space formed by the small cavity and the buffer cavity is compressed, the pressure in the cavity increases, and the buffer rushes into the
  • the detection chamber is transparent or provided with a transparent window.
  • test elements there may be one or more test elements. Multiple test elements can each detect different analytes in the sample.
  • the buffer chamber and the pipetting chamber are screwed together.
  • the cushion is in contact with the test element.
  • the lid screw caps and seals the detection chamber.
  • the present invention also provides a method for collecting and detecting blood samples, including a whole blood and fingertip blood detection device, the detection device includes a detection cavity and a blood collection structure, the inner wall of the detection cavity is provided with a first step, and the blood is collected.
  • the structure includes a collection rod, the top of the collection rod is provided with a barb, and the first step is engaged with the barb to connect the detection cavity with the blood collection structure;
  • the collection rod is provided with a capillary channel, and the bottom end of the capillary channel is located at the end of the collection rod, and the capillary channel
  • the top is located in the middle of the collection rod;
  • the top of the collection rod and the capillary channel is provided with a through hole;
  • the outer surface of the collection rod is provided with a groove, the groove is located between the through hole and the top of the collection rod, and one end of the groove is connected to the through hole
  • the other end of the groove is connected and communicated with the barb;
  • the whole blood and fingertip blood detection device also includes a buffer chamber, a sealing sheet for sealing the buffer chamber and a pipetting chamber; the bottom of the pipetting chamber is sealed with the buffer chamber;
  • the buffer is Sealed in a buffer chamber;
  • the blood collection structure collects the sample so that the capillary channel is filled with blood sample
  • the blood collection structure is moved in the pipetting chamber along the direction of being inserted into the pipetting chamber, so that the blood collection structure reaches the sealing sheet;
  • a through hole is provided at the bottom of the hook groove of the barb; the other end of the groove is connected with the barb and communicated with the through hole; the mixed liquid flows along the capillary channel, through hole, groove and through hole on the collection rod.
  • the liquid circulation channel formed by the hook groove of the barb and the through hole flows into the detection cavity.
  • the end of the collection rod is tapered; the sealing sheet is pierced through the end of the collection rod with the tapered shape.
  • a cover for covering the detection cavity is further included, and after the cover covers the detection cavity, the test element is located in the detection cavity.
  • the inner wall of the detection chamber is further provided with a second step above the first step; the detection chamber is provided with a buffer pad; the buffer pad is located on the second step; after the mixed liquid flows into the detection chamber, it first flows into the detection chamber The buffer pad flows from the buffer pad to the test element located in the detection chamber.
  • a sealing gasket is provided on the outer wall of the bottom of the detection chamber, the blood sampling structure and the detection chamber enter the pipetting chamber, and a seal is formed between the detection chamber and the pipetting chamber.
  • the collection rod is provided with an annular disk and an annular gasket sleeved on the collection rod, and the bottom of the detection chamber is sealed with the annular disk through the annular gasket.
  • the whole blood and fingertip blood detection device of the present invention realizes the collection, slow release and detection functions of blood samples through the integrated structure of the blood collection structure, the detection cavity and the buffer cavity.
  • the operation of the detection device is easy, which reduces the difficulty for the operator to use.
  • it effectively reduces the number and time that the operator contacts the sample, reduces the probability of the operator being infected, and ensures the safety of the operator, especially suitable for HIV detection, new coronavirus detection, etc.
  • the integrated detection device is provided with a buffer, so that the sample collection volume is less required, and the collection volume is optimized from milliliter level to microliter level.
  • the collection, sustained release and detection are realized in one step, which improves the success rate of detection.
  • FIG. 1 is a schematic structural diagram of the whole blood and fingertip blood detection device of the present invention.
  • FIG. 2 is an exploded schematic diagram of the whole blood and fingertip blood detection device of the present invention.
  • FIG. 3 is a schematic diagram of the blood collection structure of the present invention.
  • FIG. 4 is a schematic cross-sectional view of the blood collection structure and the detection cavity in the present invention.
  • FIG. 5 is a schematic cross-sectional view of the blood collection structure and the detection cavity in the present invention.
  • FIG. 6 is a cross-sectional view of the whole blood and fingertip blood detection device of the present invention before use.
  • FIG. 7 is a cross-sectional view of the blood collection structure of the whole blood and fingertip blood detection device of the present invention reaching the buffer cavity.
  • FIG. 8 is a cross-sectional view of the blood collection structure of the whole blood and fingertip blood detection device of the present invention reaching the sample in the buffer chamber for buffering and detection.
  • Whole blood and fingertip blood detection device 100 blood collection structure 10, collection rod 11, capillary channel 111, through hole 112, groove 113, barb 114, hook groove 115, through hole 116, open end 119 of the barb, collection Rod top 117, collection rod end 118, annular disc 120, annular washer 121, ribs 122, detection chamber 20, first step 21, second step 22, buffer pad 23, transfer chamber 30, large chamber 31, small Cavity 32, buffer cavity 40, gasket 41, test element 50, sample receiving area 501, detection area 502, buffer 60, sealing sheet 70, sealing gasket 80, cover 90, bracket 51, recess 52
  • Detection means assaying or testing for the presence of a substance or material such as, but not limited to, chemicals, organic compounds, inorganic compounds, metabolites, drugs or drug metabolites, organic tissue or metabolites of organic tissue, nucleic acids, protein or polymer. In addition, detection refers to the quantity of a test substance or material. Further, the assay also means immunoassay, chemical assay, enzymatic assay, and the like.
  • the samples referred to in the present invention refer to those substances that can be used to detect, assay or diagnose the presence or absence of the analyte of interest.
  • the sample can be, for example, a liquid sample, and the liquid sample can include blood, plasma, serum, and can also include a liquid solution formed by pre-processing solid samples and semi-solid samples.
  • the collected samples can be used for immunoassays, chemical assays, enzymatic assays, etc. to detect the presence of the analyte.
  • the sample of the present invention is a blood sample.
  • Any analyte can be analyzed with the apparatus and method of the present invention.
  • the analyte can be detected in any liquid or liquefied sample, such as blood, plasma, or serum.
  • the analyte can also be some haptenic substances, these haptens include drugs (such as drugs of abuse).
  • drugs such as drugs of abuse.
  • Substance of Abuse refers to the use of drugs (usually to paralyze nerves) for non-medical purposes.
  • DOA Drug of Abuse
  • the use of the device can also be used for the detection of drugs that are medically useful but prone to overdose, such as tricyclic antidepressants (imipramine or similar) and acetaminophen. These drugs will be decomposed into different small molecular substances after being absorbed by the human body. These small molecular substances exist in blood, urine, saliva, sweat and other body fluids or in some body fluids.
  • the device can also be used for antibody detection of the new crown virus and neutralizing antibody detection after the new crown vaccine is administered.
  • the test element 50 can be selected as a lateral flow test strip, which can detect a variety of analytes. Of course, other suitable test elements can also be used in the present invention. Various test elements can be used in combination with the present invention.
  • One form is test strips. Test strips for analysis of analytes (eg, drugs or metabolites indicative of medical conditions) in a sample can be in various formats, such as in the form of immunoassays or chemical assays. The test strips can be analyzed in a non-competitive or competitive mode.
  • the test strip includes a water-absorbing material with a sample receiving area, a reagent area and a test area. Add the sample to the sample receiving area and flow to the reagent area by capillary action.
  • the sample binds to the reagent if the analyte is present.
  • the sample then continues to flow to the detection zone.
  • Other reagents such as molecules that specifically bind to the analyte, are immobilized in the detection zone. These reagents react with the analyte (if present) in the sample and bind the analyte in this zone, or bind to one of the reagents in the reagent zone.
  • the label used to display the detection signal is present in the reagent zone or separate label zone.
  • a typical non-competitive assay model is that if the analyte is present in the sample, a signal is generated, and if the analyte is not present, no signal is generated.
  • a signal is generated if the analyte is not present in the sample, and no signal is generated if the analyte is present.
  • the test element 50 can be a test paper, and a material that absorbs or does not absorb water can be selected.
  • Test strips can include a variety of materials for liquid sample transfer.
  • One of the test paper materials can be overlaid on another material, such as filter paper overlaid on a nitrocellulose membrane.
  • One area of the test strip can be selected from one or more materials, while the other area can be selected from other different materials or materials.
  • Test strips can be adhered to a support or hard surface to improve the strength of the test strips.
  • the analyte is detected by a signal generating system, such as using one or more enzymes that specifically react with the analyte, using the method of immobilizing the specific binding substance on the detection test paper as described above, and combining one or more enzymes.
  • the composition of the signal generating system is immobilized on the analyte detection area of the test strip.
  • the signal-generating substance may be on the sample receiving area 501, the reagent area, or the detection area, or the entire test strip, and may be impregnated with one or more materials of the test strip.
  • the signal-containing solution is added to the surface of the test paper or one or more materials of the test paper are immersed in the signal-containing solution.
  • the test paper to which the signal containing solution was added was allowed to dry.
  • test strip can be arranged in the following ways: sample receiving area, reagent area, detection area, control area, determination of whether the sample is adulterated or not, liquid sample absorption area.
  • the control area is located after the detection area. All zones can be arranged on a strip of test strips using only one material. It is also possible to use different materials for different zones. Each zone can be in direct contact with the liquid sample, or different zones can be arranged according to the direction of the liquid sample flow, and the end of each zone can be connected and overlapped with the front end of another zone.
  • the material used can be a material with better water absorption such as filter paper, glass fiber or nitrocellulose membrane. Test strips can also take other forms.
  • the detection cavity 20 is generally a cavity for accommodating the test element 50 and allowing the liquid sample to enter the cavity 20 to contact the test element 50 for detection. It has various shapes and can be designed according to the shape and quantity of the test elements 50 to be accommodated.
  • the test element is the test strip 50. Therefore, in one embodiment, the detection cavity 20 is a cylinder structure, and the test strip 20 is located in the cylinder. In other embodiments, the detection cavity 20 is provided with a cover 90 sealing the upper cavity opening, and the test strip 50 is fixed on the cover 90 so as to be relatively fixed in the detection cavity 20 .
  • the cylinder body 20 has a window, and the position of the window corresponds to the detection area of the test strip, so that the test results of the test strip can be easily observed.
  • the cylinder itself is transparent, which is convenient for viewing the test results of the test strips.
  • the test strip is fixed in the hollow cylinder of the detection chamber 20 through a bracket 51. Specifically, the bracket is provided with a concave hole 92, and the test strip is inserted into the concave hole.
  • the blood collection structure includes a collection rod 11, the two ends of the collection rod are the collection rod top 117 and the collection rod end 118, and a capillary channel 111 is provided inside the collection rod. Not running through the entire collection rod, the bottom of the capillary channel is located at the end 118 of the collection rod, and the top of the capillary channel is located at the middle and upper part of the collection rod 11; the capillary channel 111 is used for collecting blood samples, more preferably, generally for collecting whole blood samples.
  • the collection rod 11 is also provided with a through hole 112 connected to and communicated with the top of the capillary channel 111 .
  • the diameter of the capillary channel is between 0.1-2 mm.
  • the diameter of the capillary channel is between 0.1-1.7 mm.
  • a groove 113 is provided on the outer surface of the collection rod 11, the groove 113 is longitudinally arranged on the outer surface of the collection rod 11, and is located between the through hole 112 and the top end 117 of the collection rod, and one end of the groove 113 is connected to the through hole 112 communication, so that the through-hole 112 is communicated.
  • the top 117 of the collection rod is provided with a barb 114.
  • the barb 114 is hollowed out in the middle to form a hook groove 115.
  • the open ends 119 of the barbs 11 and 4 will face the hollow hook groove 115. It moves everywhere, so that the outer peripheral surface of the entire barb 114 is reduced, and it is convenient to enter a cavity of a certain volume, and when the pressure disappears, the open end 119 of the barb 114 will return to its original position.
  • the hook bottom of the barb 114 has a through hole 116 larger than the hook groove 115 ; the other end of the groove 113 is connected with the barb 114 and communicated with the through hole 116 .
  • the hook groove 115 can elastically deform the open end 119 of the barb inward, and at the same time, it can also make the groove on the outer surface of the collecting rod communicate with the through hole at the end of the hook groove, so that the capillary on the collecting rod 11 can be
  • the channel 111 , the through hole 112 , the groove 113 , the barb hook groove 115 and the through hole 116 form a liquid circulation channel. More specifically, the end of the barb 116 is configured as a pointed cone, which facilitates the connecting end 117 of the collecting rod to enter the cavity.
  • the collection rod end 118 is tapered.
  • the tip of the tapered collection rod can pierce thin sheet-like objects, such as metal sheets, such as aluminum foil, tin foil, etc., or paper sheets, plastic sheets, and the like.
  • the top end 117 of the collecting rod is also set as a pointed cone, which facilitates the top end 117 of the collecting rod entering the cavity.
  • the collection rod 11 is provided with an annular disc 120 and an annular washer 121 sleeved on the collection rod, and the annular washer is located between the annular disc 120 and the top end 117 of the collection rod.
  • a plurality of ribs 122 protruding from the collecting rod are provided between the end 118 of the collecting rod and the annular disc 120 .
  • the rib 122 is a right-angled triangle structure, so that when the collection rod below the annular disc 120 is placed in the hollow cavity, the space of the hollow cavity can be occupied to a greater extent, so that the The space is squeezed smaller.
  • the whole blood and fingertip blood detection device 100 of the present invention firstly includes the aforementioned blood collection structure 10, and further includes a detection cavity 20, and the detection cavity 20 and the blood collection structure 10 are fixedly connected.
  • the detection chamber 20 has a cylindrical structure, and the inner diameter of the cylinder changes in steps, and is divided into three different inner diameters. From the bottom to the top of the detection chamber 20 , the inner diameter of the chamber gradually increases in steps. Therefore, the inner wall of the detection chamber 20 has a first step 21 and a second step 22. Insert the top end 117 of the collection rod from the bottom of the detection chamber 20. The outer circumference of the barb 114 on the collection rod is larger than the inner circumference of the bottom of the detection chamber 20.
  • the barb 114 is compressed, and the open end sinks into the cavity in the middle, so that the outer circumference of the barb 114 is adapted to the inner circumference of the bottom of the detection cavity.
  • the inner diameter of the first step 21 of the cavity 20 becomes larger, the barb 114 is not compressed, and the open end 119 returns to its original position. In this way, the diameter of the entire barb 114 is larger than the inner diameter of the detection cavity 20 under the first step 21.
  • the hook 114 is engaged at the first step 21 , so that the collection rod 11 is fixedly connected with the detection cavity 20 , so that the blood collection structure 10 and the detection cavity 20 are also fixedly connected.
  • the bottom of the detection chamber 20 is sealed with the annular disk 120 through the annular gasket 121 , so that the blood collection structure 10 and the detection chamber 20 are sealed.
  • the top of the detection chamber 20 is provided with a cover 90 , and the cover 90 seals the detection chamber 20 .
  • the cover 91 is screwed to cover the detection chamber 20 .
  • the cover 90 is also used for fixing the test element 50 .
  • the test element 50 is a test strip. Specifically, there may be multiple test strips for different analyte detection.
  • the cover 90 is provided with a card slot for holding the end of the test strip 50 so that the test strip 50 is fixed on the cover 90 .
  • a bracket 91 is snapped on the top of the cover, and the bracket 91 is used to fix the test strip.
  • the bracket is provided with a strip-shaped concave hole 91, and the test strip is placed in the concave hole to be fixed.
  • a plurality of strip-shaped concave holes can be arranged on the bracket to fix a plurality of test strips.
  • the detection area 502 of the test element 50 (test strip) is also submerged to ensure that To check the validity, a buffer pad 23 is placed on the second step 22 located above the first step 21 .
  • the end of the sample receiving area of the test element 50 is in zero-gap contact with the buffer pad 23, which can ensure that the test element 50 absorbs enough liquid to ensure the success rate of detection.
  • the liquid in the capillary channel flows into the detection chamber 20 after passing through the through holes and grooves, as well as the hook grooves and the through holes, and then reaches the buffer pad 23 for buffering, and finally flows into the test element 50 for detection.
  • the sample collection and detection device further includes a buffer chamber 40, and the buffer chamber 40 stores the buffer solution 60.
  • the sealing sheet 70 sealed in the buffer cavity.
  • the pipetting chamber 30 sealingly connected to the buffer chamber, the pipetting chamber 30 is used for receiving the absorbing part 12 and transferring the buffer 60 to the absorbing element 12 and the detection chamber 20 .
  • the buffer chamber 40 and the pipetting chamber 30 are threadedly connected, and a seal is formed therebetween.
  • a gasket 41 is provided on the top of the outer wall of the buffer chamber.
  • the pipetting chamber 30 is screwed to the buffer chamber 30 , the pipetting chamber and the buffer chamber are sealed by the gasket 41 .
  • the pipetting chamber 30 is provided with a clip (not shown in the figure), which is used to cooperate with the ribs of the blood collection structure, so that the blood collection structure is relatively fixed in the pipetting chamber, so as to avoid the blood collection structure 10 .
  • a large rotation occurs in the pipetting chamber 30, thereby ensuring a smoother operation.
  • the outer wall of the bottom of the detection chamber 20 is provided with a sealing gasket 80 , the blood collection structure 10 and the detection chamber 20 enter the pipetting chamber 30 , and the pipetting chamber contacts the inner wall of the pipetting chamber 30 through the sealing gasket 80 to form a seal.
  • the cavity in which the pipetting cavity 30 is arranged has a structure of large upper and lower lower. , that is, it includes a large cavity 31 in the upper part and a small cavity 32 in the lower part.
  • the sealing gasket 80 on the outer wall of the detection chamber contacts the small cavity 32 of the pipetting chamber, the small cavity 32 is sealed.
  • the volume of the sealed cavity formed by the small cavity and the buffer cavity is relatively small.
  • the volume of the sealed cavity is occupied by the collection rod and the ribs on it. More will be squeezed through the capillary channels, grooves, hook grooves and channels to flow into the detection cavity to ensure that the test element in the detection cavity has enough samples for detection.
  • the blood collection structure 10 connected to the detection chamber 20 is inserted into the pipetting chamber 30.
  • the end 118 of the collection rod of the blood collection structure is located just above the mouth of the pipetting chamber 30; secondly, the blood collection structure 10 is inserted along the pipetting chamber
  • the direction in the cavity 30 continues to move, and the end 118 of the collection rod contacts the sealing sheet 70, that is, the end 118 of the collection rod reaches the top of the buffer cavity 30;
  • the rod end 118 pierces the sealing sheet 70, and the collection rod 11 enters the buffer chamber 30.
  • the blood collection structure 10 continues to move in the direction of being inserted into the pipetting chamber 30, and the sealing gasket 80 on the outer wall of the detection chamber 20 forms a seal with the small cavity 32 in the lower part of the pipetting chamber 30; finally, blood collection The structure 10 continues to move in the direction of being inserted into the pipetting chamber 30, and the sealed chamber space formed by the small chamber 32 and the buffer chamber 40 is gradually compressed due to the gradual entry of the collection rod below the annular disc, and at the same time, the pressure in the chamber gradually increases , the buffer rushes into the capillary channel and mixes with the sample, and the mixed liquid flows into the detection chamber through the capillary channel, the through hole, the groove, the groove and the through hole of the barb on the collection rod.
  • the whole blood and fingertip blood detection device 100 seals the buffer 60 in the buffer chamber 40 during the production process, and the sealing sheet 70 is fixed at the opening of the buffer chamber 40 ; the pipetting chamber 30 is screwed on the buffer chamber 40 , and the bottom of the pipetting chamber and the top of the buffer chamber are sealed by the gasket 41; Fixed, wherein, the blood collection structure is sealed with the bottom of the detection cavity 20 by the annular disc and the annular gasket, and the collection rod 11 of the lower part of the annular disc is exposed outside the detection cavity 20; in the initial state, in order to keep clean and hygienic, the collection rod is exposed in the detection chamber 20.
  • the part outside the cavity 20 is individually packaged in a plastic bag in advance.
  • the blood collection structure 10 moves in the pipetting chamber 30 along the direction of being inserted into the pipetting chamber 30 until the tip 117 of the tapered collection rod of the blood collection structure reaches the sealing sheet 70 , that is, the end 117 of the collection rod reaches the buffer chamber 40 top, shown in Figure 7.
  • the end of the collection rod pierces the sealing sheet, and the collection rod enters the buffer chamber, when the buffer and the bottom end of the capillary channel are in contact with each other. , a portion of the sample in the capillary channel of the collection rod is mixed with the buffer.
  • the blood collection structure 10 and the detection cavity 20 continue to move the blood collection structure 10 and the detection cavity 20 in the same direction, and the sealing gasket on the outer wall of the detection cavity forms a seal with the small cavity in the lower part of the pipetting cavity.
  • the blood collection structure continues to move in the direction of being inserted into the pipetting chamber, the sealed chamber space formed by the small chamber and the buffer chamber is compressed, the pressure in the chamber increases, and the buffer solution rushes into the capillary channel to mix with the sample, and the mixed liquid It flows into the detection cavity through the capillary channel, through hole, groove and barb groove and through hole on the collection rod, as shown in Figure 8.

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Abstract

一种全血及指尖血检测装置（100），包括采血结构（10）和检测腔（20），检测腔（20）与采血结构（10）连接并液体相连通；该采血结构（10）包括采集杆（11），采集杆（11）内部设有毛细通道（111），毛细通道（111）底端位于采集杆（11）末端，毛细通道（111）顶端位于采集杆（11）中部；采集杆（11）上设有与毛细通道（111）的顶端连接并连通的贯通孔（112）。还提供利用该全血及指尖血检测装置（100）收集血液样本并检测的方法，全血及指尖血检测装置（100）和方法通过采血结构（10）与检测腔（20）以及缓冲腔（40）的一体式结构来实现血液样本的采集，缓释和检测功能，操作容易，减低了操作者的使用难度，降低了操作者接触样本的次数和时间，降低操作者被感染的几率，适用于HIV检测，新冠病毒检测等。该全血及指尖血检测装置（100）和方法对样本的采集量要求较小，采集量由毫升级优化为微升级。

Description

采血结构和全血及指尖血检测装置和检测方法 技术领域
本发明涉及一种采血结构和全血及指尖血检测装置和检测方法，特别涉及用于收集全血样本或指尖学样本后，使样本混合缓冲液后再检测的采血结构和全血及指尖血检测装置和方法。
背景技术
下面的背景技术用于帮助读者理解本发明，而不能被认为是现有技术。
利用免疫结合反应原理来检测样本中是否存在被分析物质的这一技术被广泛用在各个领域。可以用它来检测各种生物样本(唾液，血液，尿液，血清，汗液等等)的被分析物质来监测疾病和人类的健康状况(早孕，肿瘤，传染病，毒品等等)。这种检测技术的根本原理是建立在免疫分子之间具有特异结合的性能，例如抗体与抗原，半抗原/抗体，生物素与抗生物素等等。
以血液作为检测疾病的样本，应用免疫层析技术，目前己有多种不同的诊断试剂被开发应用于不同的疾病检测领域，例如：肿瘤标记物的检测，心血管疾病的早期预判，传染类疾病的筛选检测等。血液作为较常用的样本来源，特别是指尖血，因其采血微创，迅速，己广泛地被各种平台采用。
并且，在医疗诊断领域，利用检测装置或者检测杯来收集检测液体样本，并判断液体样本中是否含有被分析物，是一种比较普遍的方法。这样的检测装置或者检测杯一般要求样本被收集在样本容器内，相关技术人员括入一检测试剂条并使试剂条的一部分浸没在样本中，若干时间后取出试剂条并读取检测结果。
现有技术中申请号为CN201410150547.X的专利申请中，公开了具有一封口端和一开口端的一次性存储容器来采集样本并存储，然后将其插入到检测板的加样孔中加样，来进行检测。该专利申请中，采集血液的结构与检测样本的结构为分体式设计。
但现有的检测装置存在以下几个问题：
1.大多数检测装置为分体结构，分体操作。操作要求相对高，并且，存在血液样本被污染或者血液样本污染操作人员的情况。
2.检测装置结构不够小巧，不方便携带。
发明内容
本发明还提供一种采血结构，将该采血结构集成至检测装置中，能够将检测装置一体化结构，既减小检测装置体积，又实现一体化检测，操作方便。
具体来说，本发明提供一种采血结构，包括采集杆，采集杆内部设有毛细通道，所述毛细通道底端位于采集杆末端，毛细通道顶端位于采集杆中上部；采集杆上设有与毛细通道的顶端连接并连通的贯通孔。
一些优选的实施方式中，采集杆外表面上设有凹槽，所述凹槽位于贯通孔与采集杆顶端之间，并且凹槽的一端与贯通孔连通。
一些优选的实施方式中，采集杆顶端设有倒钩，倒钩的钩槽底部设有大通孔；凹槽的另一端与倒钩连接并与通孔连通。
一些优选的实施方式中，采集杆上的毛细通道、贯通孔、凹槽和倒钩的钩槽及通孔形成液体流通通道。
一些优选的实施方式中，采集杆末端为尖锥形。
一些优选的实施方式中，采集杆中部设有环形圆盘和套接在采集杆上的环形垫圈。
一些优选的实施方式中，集杆末端与环形圆盘之间设有多个凸出于采集杆的筋条。
一些实施例中，筋条为直角三角形结构。
另一方面，本发明还提供一种一体化结构的全血及指尖血检测装置，使血液样本的收集和检测能够实现一体化，减小产品结构并减少受检者的操作难度，并且，尽量少的让操作者接触样本，降低感染几率，提高操作者安全保障。并且，使用该采血结构和全血及指尖血检测装置检测，能够将样本被充分的利用用于检测，从而使样本需求量大幅下降，更有利于检测的成功。
具体的，本发明提供的全血及指尖血检测装置，包括采血结构，该采血结构包括采集杆，采集杆内部设有毛细通道，所述毛细通道底端位于采集杆末端，毛细通道顶端位于采集杆中部；采集杆上设有与毛细通道的顶端连接并连通的贯通孔。
一些优选的实施方式中，采集杆外表面上设有凹槽，所述凹槽位于贯通孔与采集杆顶端之间，并且凹槽的一端与贯通孔连通。
一些优选的实施方式中，采集杆顶端设有倒钩，倒钩的钩槽底部设有通孔；凹槽的另一端与倒钩连接并与通孔连通；采集杆上的毛细通道、贯通孔、凹槽和倒钩的钩槽及通孔形成液体流通通道。
一些优选的实施方式中，采集杆末端为尖锥形。
一些优选的实施方式中，采集杆上设有环形圆盘和套接在采集杆上的环形垫圈。
一些优选的实施方式中，还包括检测腔，检测腔与采血结构连接并液体相连通；所述检测腔内壁设有第一阶梯，通过倒钩卡合第一阶梯使检测腔与采血结构连接。具体的实施方式中，倒钩的开口端卡合第一阶梯使检测腔与采血结构连接。
一些优选的实施方式中，将采集杆顶端从检测腔底部插入检测腔，倒钩的末端进入检测腔，随后倒钩的开口端被压缩，采集杆顶端和倒钩进入检测腔；当倒钩的开口端到达第一阶梯处后，因检测腔内径变大，倒钩开口端回弹至恢复原状，倒钩卡合在第一阶梯处；此时，检测腔底部通过环形垫圈与环形圆盘形成密封。
一些优选的实施方式中，检测腔内壁还设有位于第一阶梯之上的第二阶梯；全血及指尖血检测装置还包括缓冲垫；缓冲垫位于第二阶梯上。
一些优选的实施方式中，全血及指尖血检测装置还包括位于检测腔内的测试元件和密封检测腔的盖子。
一些优选的实施方式中，测试元件位于缓冲垫和盖子之间。
一些优选的实施方式中，通过采集杆进入检测腔的液体先流入缓冲垫，再从缓冲垫上流入到位于检测腔内的测试元件上。缓冲垫作用是防止从吸收元件上的冲刷液体太剧烈，大量突然冲进检测腔，以及位于检测腔内的测试元件上，起缓冲作用。
一些优选的实施方式中，还包括托架，该托架具有凹孔。测试元件为试纸条，试纸条插入托架的凹孔内进行固定。一些实施方式中，托架一端与盖子固定。
一些优选的实施方式中，还包括缓冲腔、密封缓冲腔的密封片以及移液腔；移液腔底部与缓冲腔密封连接；缓冲液被密封在缓冲腔内。
一些优选的实施方式中，移液腔具有上部的大腔体和下部的小腔体；小腔体底部与缓冲腔密封连接。
一些实施方式中，密封片为铝箔片。
一些优选的实施方式中，所述检测腔底部外壁设有密封垫，采血结构和检测腔进入移液腔内，检测腔与移液腔之间通过密封垫形成密封。
一些优选的实施方式中，首先，将连接在检测腔上的采血结构插入移液腔，采血结构的采集杆末端位于移液腔腔口正上方；第二，采血结构沿插入移液腔内的方向继续运动，采集杆末端接触到密封片，也即采集杆末端到达缓冲腔顶部；第三，采血结构继续沿插入移液腔内的方向继续运动，采集杆末端刺破密封片，采集杆进入缓冲腔，部分缓冲液与采集杆的毛细通道内的部分样本混和；第四，采血结构继续沿插入移液腔内的方向运动，检测腔外壁的密封垫与移液腔下部的小腔体形成密封；最后，采血结构继续沿插入移液腔内 的方向运动，小腔体和缓冲腔形成的密封腔体空间被压缩，腔体内压力变大，缓冲液冲进毛细通道与样本混合，混合的液体经采集杆上的毛细通道、贯通孔、凹槽和倒钩的沟槽及通孔流入检测腔内。
一些优选的实施方式中，检测腔为透明的或设有透明窗口。
一些优选的实施方式中，测试元件可以为一个或多个。多个测试元件可以分别检测样本中不同的被分析物。
一些优选的实施方式中，缓冲腔与移液腔为螺纹连接。
一些优选的实施方式中，缓冲垫与测试元件接触。
一些优选的实施方式中，盖子螺旋盖合并密封检测腔。
另一方面，本发明还提供一种收集血液样本并检测的方法，包括全血及指尖血检测装置，该检测装置包括检测腔和采血结构，所述检测腔内壁设有第一阶梯，采血结构包括采集杆，采集杆顶端设有倒钩，通过倒钩卡合第一阶梯使检测腔与采血结构连接；采集杆内部设有毛细通道，所述毛细通道底端位于采集杆末端，毛细通道顶端位于采集杆中部；采集杆与毛细通道的顶端设有贯通孔；采集杆外表面上设有凹槽，所述凹槽位于贯通孔与采集杆顶端之间，并且凹槽的一端与贯通孔连通；凹槽另一端与倒钩连接并连通；全血及指尖血检测装置还包括缓冲腔、密封缓冲腔的密封片以及移液腔；移液腔底部与缓冲腔密封连接；缓冲液被密封在缓冲腔内；其中：
将采血结构收集样本，使毛细通道内充满血液样本；
将充满血液样本的采血结构和与之连接的检测腔插入移液腔内；
使采血结构在移液腔内沿插入移液腔内的方向运动，使采血结构到达密封片处；
使采血结构刺破缓冲腔上的密封片并进入缓冲腔，使毛细通道内的样本与缓冲液混和；
使混和的液体沿采集杆的上的毛细通道、贯通孔、凹槽和倒钩的通孔流入到检测腔内的测试元件上进行检测；
读取测试元件上的检测结果。
一些优选的实施方式中，倒钩的钩槽底部设有通孔；凹槽的另一端与倒钩连接并与通孔连通；混和的液体沿采集杆上的毛细通道、贯通孔、凹槽和倒钩的钩槽及通孔形成的液体流通通道流入检测腔。
一些优选的实施方式中，采集杆末端为尖锥形；通过尖锥形的采集杆末端刺破密封片。
一些优选的实施方式中，还包括盖合检测腔的盖子，盖子盖合检测腔后，测试元件位于 检测腔内。
一些优选的实施方式中，检测腔内壁还设有位于第一阶梯之上的第二阶梯；检测腔内设有缓冲垫；缓冲垫位于第二阶梯上；混和的液体流入检测腔后，先流入缓冲垫，再从缓冲垫上流入到位于检测腔内的测试元件上。
一些优选的实施方式中，所述检测腔底部外壁设有密封垫，采血结构和检测腔进入移液腔内，检测腔与移液腔之间通过密封垫形成密封。
一些优选的实施方式中，采集杆上设有环形圆盘和套接在采集杆上的环形垫圈，检测腔底部通过环形垫圈与环形圆盘形成密封。
有益效果
本发明的全血及指尖血检测装置通过采血结构与检测腔以及缓冲腔的一体式结构来实现血液样本的采集，缓释和检测功能。首先该检测装置的操作容易，减低了操作者的使用难度。其次有效的降低了操作者接触样本的次数和时间，降低操作者被感染的几率，保证了操作者的安全，特别适用于HIV检测，新冠病毒检测等。第三，一体化检测装置中设有缓冲液，从而对样本的采集量要求较小，采集量由毫升级优化为微升级。最后，因一体化结构，采集，缓释和检测一步实现，提高了检测的成功率。
附图说明
图1为本发明的全血及指尖血检测装置的结构示意图。
图2为本发明的全血及指尖血检测装置的分解示意图。
图3为本发明的采血结构的示意图。
图4为本发明中的采血结构与检测腔的剖面示意图。
图5为本发明中的采血结构与检测腔的剖面示意图。
图6为本发明的全血及指尖血检测装置使用开始前的剖视图。
图7为本发明的全血及指尖血检测装置的采血结构到达缓冲腔处的剖视图。
图8为本发明的全血及指尖血检测装置的采血结构到达缓冲腔内样本进行缓冲并检测的剖视图。
附图标记
全血及指尖血检测装置100，采血结构10，采集杆11，毛细通道111，贯通孔112，凹槽113，倒钩114，钩槽115，通孔116，倒钩的开口端119，采集杆顶端117，采集杆末端118，环形圆盘120，环形垫圈121，筋条122，检测腔20，第一阶梯21，第二阶梯22，缓冲垫23，转移腔30，大腔体31，小腔体32，缓冲腔40，垫圈41，测试元件50，样本接受区501，检测区502，缓冲液60，密封片70，密封垫80，盖子90，托架51,凹孔52
具体实施方式
下面对本发明涉及的结构或这些所使用的技术术语做进一步的说明。
检测
检测表示化验或测试一种物质或材料是否存在，比如，但并不限于此，化学物质、有机化合物、无机化合物、新陈代谢产物、药物或者药物代谢物、有机组织或有机组织的代谢物、核酸、蛋白质或聚合物。另外，检测表示测试物质或材料的数量。进一步说，化验还表示免疫检测，化学检测、酶检测等。
样本
本发明所指的样本指那些可以用来检测、化验或诊断是否存在感兴趣的被分析物质的物质。样本可以是，例如，液体样本，液体样本可以包括血液、血浆、血清，还可以包括固体样本和半固体样本经过预先处理后形成的液体溶液。收集来的样本可以用于免疫检测、化学检测、酶检测等方法来检测是否存在被分析物质。一个优选的实施例中，本发明的样本为血液样本。
被分析物质
用本发明的装置和方法可以分析任何被分析物质。被分析物能够在任何的液体或者液化样品中检测到，例如血液，血浆，或者血清。
被分析物质还可以是一些半抗原物质，这些半抗原包括毒品(如滥用药物)。“滥用药物”(DOA)是指非医学目的地使用药品(通常起麻痹神经的作用)。使用该装置也可以用于检测属于医学用途但又容易服药过量的检测，如三环类抗抑郁药(丙米嗪或类似物)和乙酰氨基酚等。这些药品被人体吸收后会分解成不同的小分子物质，这些小分子物质存在于血液、尿液、唾液、汗水等体液中或部分体液存在上述小分子物质。使用该装置也可以用于新冠病毒的抗体检测，以及打完新冠疫苗后的中和抗体检测。
测试元件50
测试元件50可以选用横向流动的检测试纸条，它可检测多种被分析物。当然，其他合适的 测试元件也可以运用在本发明。各种测试元件可以被组合在一起运用到本发明中。一种形式是检测试纸。用于分析样本中的被分析物(如毒品或表明身体状况的代谢物)的检测试纸可以是各种形式，如免疫测定或化学分析的形式。检测试纸可以采用非竞争法或竞争法的分析模式。检测试纸包含一具有样本接受区的吸水材料，试剂区和测试区。加样本至样本接受区，通过毛细管作用流到试剂区。在试剂区，如果存在被分析物，样本与试剂结合。然后样本继续流动到检测区。另一些试剂，如与被分析物特意性结合的分子被固定在检测区。这些试剂与样本中的被分析物(如果存在)反应并将被分析物结合在该区，或者与试剂区的某一个试剂结合。用于显示检测信号的标记物存在与试剂区或分离的标记区。
典型的非竞争法分析模式是：如果样本中含有被分析物，信号就会产生，如果不包含被分析物，就不产生信号。在竞争法中，如果被分析物不存在于样本中，信号产生，如果存在被分析物，则不产生信号。
测试元件50可以是检测试纸，可以选用吸水或不吸水的材料。检测试纸可包括多种材料用于液体样本传递。其中一种检测试纸的材料可覆盖在另一种材料上，如滤纸覆盖在硝酸纤维素膜上。检测试纸的一个区可以选用一种或多种材料，而另一区选用其他不同的一种或多种材料。检测试纸可以被黏附在某种支持物或者硬质表面用于提高拿捏检测试纸的强度。被分析物通过信号发生系统而被检测到，如利用与本分析物发生特异性反应的一种或多种酶，利用如前述将特异结合物质固定在检测试纸上的方法，将一种或多种信号发生系统的组合物固定在检测试纸的被分析物检测区。产生信号的物质可在样本接受区501，试剂区，或检测区，或整个检测试纸上，该物质可以充满检测试纸的一种或多种材料上。将含有信号物的溶液加到试纸的表面或将试纸的一种或多种材料浸没在含信号物的溶液中。使加入含信号物溶液的试纸干燥。
检测试纸的各个区可以按以下方式排列：样本接受区，试剂区，检测区，控制区，确定样本是否掺假区，液体样本吸收区。控制区位于检测区之后。所有的区可以被安排在只用一种材料的一条试纸上。也可是不同区采用不同的材料。各个区可以直接和液体样本接触，或不同的区依据液体样本流动的方向排列，将各区的末端与另一区的前端相连并交叠。所用的材料可以是吸水性较好的材料如滤纸，玻纤或者硝酸纤维素膜等。检测试纸也可以采用其他形式。
检测腔20
检测腔20通常为一个腔体，用于容纳测试元件50，并使液体样本能够进入该腔体20中接触测试元件50进行检测。其形状多样，可以根据需要容纳的测试元件50的形状及数量进 行设计。本发明中，测试元件为试纸条50，因此，一个实施例中，检测腔20为筒体结构，试纸条20位于该筒体内。另一些实施例中，检测腔20上设有密封上腔口的盖子90，试纸条50固定在盖子90上，从而相对固定的位于检测腔20内。另一些优选的实施方式中，在筒体20具有一个窗口，窗口位置与试纸条的检测区相对应，方便观测试纸条的测试结果。或者，另一些实施例中筒体本身为透明的，方便观测试纸条的测试结果。另一些实施例中，试纸条通过一个托架51固定在检测腔20的中空筒体内，具体的，托架上设有凹孔92，试纸条插入凹孔内。
在以下的详细描述中，图例附带的参考文字是这里的一个部分，它以举例说明本发明可能实行的特定具体方案的方式来说明。我们并不排除本发明还可以实行其它的具体方案和在不违背本发明的使用范围的情况下改变本发明的结构。
如图1-8所示，本发明中，采血结构包括采集杆11，该采集杆的两端为采集杆顶端117和采集杆末端118，在采集杆内部设有毛细通道111，该毛细通道并不贯穿整个采集杆，毛细通道底部位于采集杆末端118，毛细通道顶部位于采集杆11中上部；该毛细通道111用于收集血液样本，更为优选的，通常用于收集全血样本。采集杆11上还设有与毛细通道111的顶部连接并连通的贯通孔112，该贯通孔112横向贯通采集杆11，使毛细管道111中的液体可以通过贯通孔112流出采集杆11内部。一些实施例中，毛细通道的直径在0.1‐2mm之间。一个具体的实施例中，毛细通道的直径在0.1‐1.7mm之间。此外，采集杆11外表面上设有凹槽113，凹槽113纵向设置在采集杆11外表面上，其位于贯通孔112与采集杆顶端117之间，并且凹槽113的一端与贯通孔112连通，从而连通贯通孔112。
采集杆顶端117设有倒钩114，如图3所示，倒钩114因中部挖空，形成钩槽115，在受到压力时，倒钩11,4的开口端119会向中空的钩槽115处处运动，从而使整个倒钩114的外周面减小，方便进入一定体积的空腔，而当压力消失后，倒钩114开口端119会回复原位。倒钩114的钩底具有大于钩槽115的通孔116；凹槽113的另一端与倒钩114连接并与通孔116连通。因此，钩槽115既可以使倒钩开口端119向内弹性形变，同时，还可以使位于采集杆外表面的凹槽与钩槽末端的通孔液体相连通，从而使采集杆11上的毛细通道111、贯通孔112、凹槽113和倒钩钩槽115及通孔116形成一个液体流通通道。更为具体的，倒钩116的末端设为尖锥形，这样方便收集杆的连接端117进入空腔内。
一个实施例中，采集杆末端118为尖锥形。这样，尖锥形的采集杆末端能够刺破较薄的片状物体，比如金属薄片，如铝箔，锡箔等，或者纸片，塑料薄片等。并且，一个实施例中，采集杆顶端117也设为尖锥形，这样方便采集杆顶端117进入空腔内。
此外，采集杆11上设有环形圆盘120和套接在采集杆上的环形垫圈121，该环形垫圈位于环形圆盘120上和采集杆顶端117之间。采集杆末端118与环形圆盘120之间设有多个凸出于采集杆的筋条122。一些实施例中，筋条122为直角三角形结构，这样，当环形圆盘120以下的采集杆部分进行中空的腔体内后，能够更大限度的将中空腔体的空间占据，使中空腔体内的空间被挤压变小。
如图1‐8所示，本发明的全血及指尖血检测装置100，首先包括前述的采血结构10，还包括检测腔20，并且，检测腔20和采血结构10固定连接，具体的，检测腔20为筒体结构，并且，该筒体的内径有阶梯式变化，共分为三段不同的内径，由检测腔20底部到顶部，腔体的内径阶梯式逐渐变大。因此，检测腔20内壁具有第一阶梯21和第二阶梯22，将采集杆顶端117从检测腔20底部插入，采集杆上的倒钩114处的外周大于检测腔20底部的内周，倒钩114被压缩，开口端陷入中部的空腔，从而使倒钩114外周适应于检测腔底部的内周，采集杆顶端117进入检测腔20直至整个倒钩114位于第一阶梯21处后，因检测腔20的第一阶梯21处的内径变大，倒钩114不被压缩，开口端119回复至原位，这样，整个倒钩114直径大于第一阶梯21下方的检测腔20内径，因此，倒钩114卡合在第一阶梯21处，使采集杆11与检测腔20固定连接，从而采血结构10与检测腔20也固定连接。此时，检测腔20底部通过环形垫圈121与环形圆盘120形成密封，从而使采血结构10与检测腔20形成密封。
检测腔20的顶部设有盖子90，盖子90密封检测腔20。一个实施例中，盖子91螺旋盖合检测腔20。同时，本发明中，盖子90还用于固定测试元件50。一个实施例中，测试元件50为试纸条。具体的，试纸条可以为多个，用于做不同的被分析物检测。盖子90上设有卡槽，用于卡住试纸条50的末端，使试纸条50被固定在盖子90上。另一些实施例中，如图2所示，盖子内顶部卡扣有托架91，该托架91用于固定试纸条。更为具体的，托架上设有条状凹孔91，试纸条被放置于凹孔内固定。当然，托架上可以设置多个条状凹孔，固定多个试纸条。盖子90盖上检测腔20后，试纸条50则固定的位于检测腔20内。
为了使液体能够缓慢流入到测试元件50，即试纸条的样本接受区501，也为了避免过量的液体进入检测腔20，使测试元件50(试纸条)的检测区502也被淹没，确保检测的有效性，在位于第一阶梯21之上的第二阶梯22上放置有缓冲垫23。一些优选的实施例中，测试元件50的样本接受区的端部与缓冲垫23零间隙接触，这样可以保证测试元件50吸收到足够的液体，保证检测的成功率。
毛细通道内的液体经贯通孔和凹槽以及钩槽和通孔的流通后，流入到检测腔20内，再 到达缓冲垫23处缓冲，最后流入到测试元件50上，进行检测。
本发明中，一些样本在检测前需要与缓冲液60进行混和缓释，因此，该样本收集及检测的装置还包括缓冲腔40，该缓冲腔40内存放有缓冲液60，以及包括将缓冲液密封在缓冲腔内的密封片70。以及还包括密封连接在缓冲腔上的移液腔30，该移液腔30用于接纳吸收部件12并转移缓冲液60至吸收元件12以及检测腔20。一个具体的实施例中，缓冲腔40与移液腔30为螺纹连接，二者之间形成密封。具体的，在缓冲腔外壁顶部设有垫圈41，当移液腔30螺旋连接到缓冲腔30上后，通过垫圈41将移液腔和缓冲腔密封。一个具体的实施例中，移液腔30内设有卡条(图中未示出)，用于与采血结构的筋条相配合，使采血结构相对固定在移液腔内，避免采血结构10在插入的过程中在移液腔30内发生大幅的转动，从而保证操作更顺利进行。
一些实施例中，检测腔20底部外壁设有密封垫80，采血结构10和检测腔20进入移液腔30内，移液腔通过密封垫80与移液腔30内壁接触形成密封。本发明中，考虑到血液样本量较少(仅毛细通道中的部分)，与之匹配的缓冲液量也较少，一个实施例中，设置移液腔30的腔体呈上大下小结构，即包括上部的大腔体31和下部的小腔体32。当检测腔外壁上的密封垫80接触到移液腔的小腔体32处后，小腔体32被密封。这样小腔体与缓冲腔形成的密封腔体体积就比较小，采集杆进入后，密封腔体的体积被采集杆及其上的筋条占据，空间被大量挤压，血液样本与缓冲液就会更多的被挤压通过毛细通道、凹槽、钩槽和通道流入到检测腔，以保证检测腔的测试元件有足够多的样本进行检测。
在使用时，将连接在检测腔20上的采血结构10插入移液腔30，首先，采血结构的采集杆末端118位于移液腔30腔口正上方；第二，采血结构10沿插入移液腔30内的方向继续运动，采集杆末端118接触到密封片70，也即采集杆末端118到达缓冲腔30顶部；第三，采血结构10继续沿插入移液腔30内的方向继续运动，采集杆末端118刺破密封片70，采集杆11进入缓冲腔30，当采集杆内的缓冲液接触到采集杆末端，也即缓冲液接触到毛细通道的底端时，采集杆的毛细通道底端的部分样本与缓冲液混和；第四，采血结构10继续沿插入移液腔30内的方向运动，检测腔20外壁的密封垫80与移液腔30下部的小腔体32形成密封；最后，采血结构10继续沿插入移液腔30内的方向运动，小腔体32和缓冲腔40形成的密封腔体空间因为环形圆盘以下的采集杆逐渐进入被逐渐压缩，同时，腔体内压力逐渐变大，缓冲液冲进毛细通道与样本混和，混合的液体经采集杆上的毛细通道、贯通孔、凹槽和倒钩的沟槽及通孔流入检测腔内。
下面就本发明的样本收集及检测的装置用来收集并检测液体样本的方法进行详细描述。
首先，该全血及指尖血检测装置100在生产过程中就将缓冲液60密封在缓冲腔40内，密封片70固定在缓冲腔40开口处；移液腔30螺旋连接在缓冲腔40上，并且，通过垫圈41使移液腔底部和缓冲腔顶部密封；采血结构10通过采集杆顶端117的倒钩114连接在检测腔20的第一阶梯21上而使采血结构10与检测腔20相固定，其中，采血结构通过环形圆盘与环形垫圈与检测腔20底部密封，环形圆盘以下部分的采集杆11裸露在检测腔20外部；初始状态时，为保持干净卫生，采集杆裸露在检测腔20外部的部分是事先独立包装有一个塑封袋。
其次，撕开并取走塑封袋，通过采集杆的毛细通道来收集样本(比如将收集杆末端处的毛细通道对准受检者指尖被刺破并出血处，或者将收集杆末端处的毛细通道放入收集有液体样本的容器中吸收样本，使毛细通道111充满液体样本，通常为血液样本。
第三，将充满液体样本的采血结构10连通与之连接的检测腔20位移到移液腔30腔口正上方，如图7所示；然后将采血结构10和与之连接的检测腔20通过采集杆末端118插入移液腔30内。
第四，采血结构10在移液腔30内沿插入移液腔30内的方向运动，直至采血结构的尖锥形采集杆末端117到达密封片70处，也即采集杆末端117到达缓冲腔40顶部，图7所示。
第五，继续让采血结构10在移液腔30内沿插入移液腔30内的方向运动，采集杆末端刺破密封片，采集杆进入缓冲腔，当缓冲液与接触到毛细通道的底端时，采集杆的毛细通道内的部分样本与缓冲液混和。
第六，继续同一方向移动采血结构10和检测腔20，检测腔外壁的密封垫与移液腔下部的小腔体形成密封。第七，采血结构继续沿插入移液腔内的方向运动，小腔体和缓冲腔形成的密封腔体空间被压缩，腔体内压力变大，缓冲液冲进毛细通道与样本混合，混合的液体经采集杆上的毛细通道、贯通孔、凹槽和倒钩的沟槽及通孔流入检测腔内，图8所示。
第八，读取测试元件50上的检测结果，完成检测。

Claims (20)

  1. 一种采血结构，其特征在于，包括采集杆，采集杆内部设有毛细通道，所述毛细通道底端位于采集杆末端，毛细通道顶端位于采集杆中上部；采集杆上设有与毛细通道的顶端连接并连通的贯通孔。
  2. 根据权利要求1所述的采血结构，其特征在于，采集杆外表面上设有凹槽，所述凹槽位于贯通孔与采集杆顶端之间，并且凹槽的一端与贯通孔连通。
  3. 根据权利要求2所述的采血结构，其特征在于，采集杆顶端设有倒钩，倒钩的钩槽底部设有通孔；凹槽的另一端与倒钩连接并与通孔连通。
  4. 根据权利要求3所述的采血结构，其特征在于，采集杆上的毛细通道、贯通孔、凹槽和倒钩的钩槽及通孔形成液体流通通道。
  5. 一种全血及指尖血检测装置，其特征在于，包括采血结构，该采血结构包括采集杆，采集杆内部设有毛细通道，所述毛细通道底端位于采集杆末端，毛细通道顶端位于采集杆中部；采集杆上设有与毛细通道的顶端连接并连通的贯通孔。
  6. 根据权利要求5所述的全血及指尖血检测装置，其特征在于，采集杆外表面上设有凹槽，所述凹槽位于贯通孔与采集杆顶端之间，并且凹槽的一端与贯通孔连通。
  7. 根据权利要求6所述的全血及指尖血检测装置，其特征在于，采集杆顶端设有倒钩，倒钩的钩槽底部设有通孔；凹槽的另一端与倒钩连接并与通孔连通；采集杆上的毛细通道、贯通孔、凹槽和倒钩的钩槽及通孔形成液体流通通道。
  8. 根据权利要求7所述的全血及指尖血检测装置，其特征在于，采集杆末端为尖锥形；采集杆上设有环形圆盘和套接在采集杆上的环形垫圈。
  9. 根据权利要求8所述的全血及指尖血检测装置，其特征在于，包括检测腔，检测腔与采血结构连接并液体相连通；所述检测腔内壁设有第一阶梯，通过倒钩卡合第一阶梯使检测腔与采血结构连接；将采集杆顶端从检测腔底部插入检测腔，倒钩的末端进入检测腔，随后倒钩的开口端被压缩，采集杆顶端和倒钩进入检测腔；当倒钩的开口端到达第一阶梯处后，因检测腔内径变大，倒钩开口端回弹至恢复原状，倒钩卡合在第一阶梯处；此时，检测腔底部通过环形垫圈与环形圆盘形成密封。
  10. 根据权利要求9所述的全血及指尖血检测装置，其特征在于，检测腔内壁还设有位于第一阶梯之上的第二阶梯；全血及指尖血检测装置还包括缓冲垫；缓冲垫位于第二阶梯上；通过采集杆进入检测腔的液体先流入缓冲垫，再从缓冲垫上流入到位于检测腔内的测试元件上。
  11. 根据权利要求10所述的全血及指尖血检测装置，其特征在于，全血及指尖血检测装置还包 括位于检测腔内的测试元件和密封检测腔的盖子；测试元件位于缓冲垫和盖子之间；通过采集杆进入检测腔的液体先流入缓冲垫，再从缓冲垫上流入到位于检测腔内的测试元件上。
  12. 根据权利要求9所述的全血及指尖血检测装置，其特征在于，还包括缓冲腔、密封缓冲腔的密封片以及移液腔；移液腔底部与缓冲腔密封连接；缓冲液被密封在缓冲腔内。
  13. 根据权利要求12所述的全血及指尖血检测装置，其特征在于，所述检测腔底部外壁设有密封垫，采血结构和检测腔进入移液腔内，检测腔与移液腔之间通过密封垫形成密封。
  14. 根据权利要求13所述的全血及指尖血检测装置，其特征在于，首先，将连接在检测腔上的采血结构插入移液腔，采血结构的采集杆末端位于移液腔腔口正上方；第二，采血结构沿插入移液腔内的方向继续运动，采集杆末端接触到密封片，也即采集杆末端到达缓冲腔顶部；第三，采血结构继续沿插入移液腔内的方向继续运动，采集杆末端刺破密封片，采集杆进入缓冲腔，缓冲液与采集杆的毛细通道内的部分样本混和；第四，采血结构继续沿插入移液腔内的方向运动，检测腔外壁的密封垫与移液腔下部的小腔体形成密封；最后，采血结构继续沿插入移液腔内的方向运动，小腔体和缓冲腔形成的密封腔体空间被压缩，腔体内压力变大，缓冲液冲进毛细通道与样本混合，混合的液体经采集杆上的毛细通道、贯通孔、凹槽和倒钩的沟槽及通孔流入检测腔内。
  15. 一种收集血液样本并检测的方法，其特征在于，包括全血及指尖血检测装置，包括全血及指尖血检测装置，该检测装置包括检测腔和采血结构，所述检测腔内壁设有第一阶梯，采血结构包括采集杆，采集杆顶端设有倒钩，通过倒钩卡合第一阶梯使检测腔与采血结构连接；采集杆内部设有毛细通道，所述毛细通道底端位于采集杆末端，毛细通道顶端位于采集杆中部；采集杆与毛细通道的顶端设有贯通孔；采集杆外表面上设有凹槽，所述凹槽位于贯通孔与采集杆顶端之间，并且凹槽的一端与贯通孔连通；凹槽另一端与倒钩连接并连通；全血及指尖血检测装置还包括缓冲腔、密封缓冲腔的密封片以及移液腔；移液腔底部与缓冲腔密封连接；缓冲液被密封在缓冲腔内；其中：
    将采血结构收集血液样本，使毛细通道内充满血液样本；
    将充满血液样本的采血结构和与之连接的检测腔插入移液腔内；
    使采血结构在移液腔内沿插入移液腔内的方向运动，使采血结构到达密封片处；
    使采血结构刺破缓冲腔上的密封片并进入缓冲腔，使毛细通道内的样本与缓冲液混和；
    使混和的液体沿采集杆的上的毛细通道、贯通孔、凹槽和倒钩流入到检测腔内的测试元件上进行检测；
    读取测试元件上的检测结果。
  16. 根据权利要求15所述的方法，其特征在于，倒钩的钩槽底部设有通孔；凹槽的另一端与倒钩连接并与通孔连通；混和的液体沿采集杆上的毛细通道、贯通孔、凹槽和倒钩的钩槽及通孔形成的液体流通通道流入检测腔。
  17. 根据权利要求15所述的方法，其特征在于，检测腔内壁还设有位于第一阶梯之上的第二阶梯；检测腔内设有缓冲垫；缓冲垫位于第二阶梯上；混和的液体流入检测腔后，先流入缓冲垫，再从缓冲垫上流入到位于检测腔内的测试元件上。
  18. 根据权利要求15所述的方法，其特征在于，采集杆末端为尖锥形；通过尖锥形的采集杆末端刺破密封片。
  19. 根据权利要求15所述的方法，其特征在于，所述检测腔底部外壁设有密封垫，采血结构和检测腔进入移液腔内，检测腔与移液腔之间通过密封垫形成密封。
  20. 根据权利要求15所述的方法，其特征在于，采集杆上设有环形圆盘和套接在采集杆上的环形垫圈，检测腔底部通过环形垫圈与环形圆盘形成密封。
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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050232813A1 (en) * 2004-04-16 2005-10-20 Karmali Rashida A Specimen collecting, processing and analytical assembly
CN1917810A (zh) * 2004-02-06 2007-02-21 拜尔健康护理有限责任公司 用于对在体液内的分析物进行测量的方法和设备
WO2013025899A1 (en) * 2011-08-16 2013-02-21 Bayer Healthcare Llc Vent configuration for a blood sampler
CN105842434A (zh) * 2016-03-16 2016-08-10 杭州安旭科技有限公司 一种样本收集检测装置
CN108670272A (zh) * 2018-06-21 2018-10-19 英科新创(厦门)科技有限公司 一种末梢血采集诊断一体化装置
CN110477958A (zh) * 2019-08-09 2019-11-22 杭州安旭科技有限公司 一种收集及检测样本的方法
CN210401424U (zh) * 2019-06-03 2020-04-24 杭州安旭科技有限公司 样本收集部件
CN112034150A (zh) * 2019-06-03 2020-12-04 杭州安旭科技有限公司 样本收集及检测的装置和方法

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH08101190A (ja) * 1994-09-30 1996-04-16 Otax Kk 血液分離装置
WO2002100275A1 (en) * 2001-06-08 2002-12-19 Roche Diagnostics Gmbh Sampling devices and methods for bodily fluids
JP2009136485A (ja) * 2007-12-06 2009-06-25 Jms Co Ltd 検査器具
US9176090B2 (en) * 2009-04-07 2015-11-03 Panasonic Healthcare Holdings Co., Ltd. Sensor chip, and measurement device and blood test device in which this sensor chip is used

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1917810A (zh) * 2004-02-06 2007-02-21 拜尔健康护理有限责任公司 用于对在体液内的分析物进行测量的方法和设备
US20050232813A1 (en) * 2004-04-16 2005-10-20 Karmali Rashida A Specimen collecting, processing and analytical assembly
WO2013025899A1 (en) * 2011-08-16 2013-02-21 Bayer Healthcare Llc Vent configuration for a blood sampler
CN105842434A (zh) * 2016-03-16 2016-08-10 杭州安旭科技有限公司 一种样本收集检测装置
CN108670272A (zh) * 2018-06-21 2018-10-19 英科新创(厦门)科技有限公司 一种末梢血采集诊断一体化装置
CN210401424U (zh) * 2019-06-03 2020-04-24 杭州安旭科技有限公司 样本收集部件
CN112034150A (zh) * 2019-06-03 2020-12-04 杭州安旭科技有限公司 样本收集及检测的装置和方法
CN110477958A (zh) * 2019-08-09 2019-11-22 杭州安旭科技有限公司 一种收集及检测样本的方法

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