CN104142392B - A kind of trace sample Test paper - Google Patents

A kind of trace sample Test paper Download PDF

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Publication number
CN104142392B
CN104142392B CN201410410075.7A CN201410410075A CN104142392B CN 104142392 B CN104142392 B CN 104142392B CN 201410410075 A CN201410410075 A CN 201410410075A CN 104142392 B CN104142392 B CN 104142392B
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CN
China
Prior art keywords
sample
test paper
blood
negative pressure
stabilizing solution
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
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CN201410410075.7A
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Chinese (zh)
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CN104142392A (en
Inventor
岳朋
周锦源
盛威玮
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Shenzhen Ling Zhi Medical Science And Technology Co Ltd
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Shenzhen Ling Zhi Medical Science And Technology Co Ltd
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Priority to CN201410410075.7A priority Critical patent/CN104142392B/en
Priority to PCT/CN2014/085711 priority patent/WO2016026165A1/en
Publication of CN104142392A publication Critical patent/CN104142392A/en
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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
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements

Abstract

The present invention relates to vitro detection technical field, be specially a kind of trace sample Test paper, comprise test paper body and sample collecting device.Sample pad is provided with haemocyte filter membrane, and haemocyte filter membrane is provided with stabilizing solution reservoir, and sample collecting device comprises a negative pressure part and an anti-freezing sample tube.The present invention, by arranging anti-freezing sample tube in sample collecting device, significantly can reduce the blood coagulation phenomenon of blood sample, reduces the loss of blood plasma, thus can reduce the collection capacity of blood sample.Sample pad arranges stabilizing solution reservoir, blood sample is added drop-wise to Absorbable organic halogens and dilute blood sample in stabilizing solution reservoir, further minimizing blood coagulation phenomenon, thus the blood plasma in blood sample is utilized more fully, make finger tip blood can be used as the detection sample of quick detection test paper, and sample collection amount can be less than 1 μ L.By arranging negative pressure cabin, the liquid in reservoir can be made to flow in sample pad more completely, rapidly, improving the utilization factor of sample.

Description

A kind of trace sample Test paper
Technical field
The present invention relates to vitro detection technical field, particularly relate to a kind of trace sample Test paper.
Background technology
Along with progress and the growth in the living standard of society, people more and more pay close attention to self health, more and more pay attention to the early diagnosis of disease and screening.Therefore, more detection meanss of more accurately diagnosing easily are needed to meet this requirement.Diagnose test paper, as the detection means that a kind of extensively detected personnel, medical worker and users accept extensively, it possesses quick and easy, lower-price characteristic, is more and more subject to everybody attention.
Fast diagnose test paper is a kind of solid reagent that recent two decades grows up.It has the advantages such as simple and easy, quick, accurate and inexpensive.Be the most simply with a test paper, soak sample, compare with Standard colour board, just can obtain result of laboratory test.Because it has broken away from valuable instrument and equipment, greatly reduce laboratory fee use, the dark welcome by vast health service unit, is significant to the medical test of the vast rural area of China and industrial and mineral grass-roots unit.
The development of China in fast diagnose test paper is very fast, and kind aspect is not second to US and European.As medicaments insensitive test paper, urea nitrogen quantitative test paper etc., existing many decades of application; Multinomial associating test paper (as eight, seven, six etc.) is also succeeded in developing.In the sensitivity, storage life of test paper, had new progress, end item reaches international most advanced level.But, the current the most scabrous problem of fast diagnose test paper is that the sample collection amount needed for test paper is large, especially blood, due to the very easily blood coagulation of finger tip blood, finger tip blood cannot be applied detect as sample, need to gather venous blood, but also need the sample size of at least 20ul, thus the collection of blood sample needs professional to operate, and is difficult to spread in users' hand.
Summary of the invention
The present invention is directed to existing quick detection test paper cannot apply finger tip blood and make sample, and the sample size required is large, cause the problem of sample collection inconvenience, provide one finger tip blood to be detection sample, and only need trace sample can carry out the trace sample Test paper detected.
For achieving the above object, the present invention by the following technical solutions,
A kind of trace sample Test paper, comprise a test paper body and sample collection dress device, described test paper body comprises a base plate, and is located on base plate and closely connected successively sample pad, pad, reaction film and absorption pad, and described reaction film is provided with detection zone and quality control region.
Described sample pad is provided with haemocyte filter membrane, and described haemocyte filter membrane is provided with a stabilizing solution reservoir, and the groove face of described stabilizing solution reservoir is provided with a groove lid, and the bottom land of described stabilizing solution reservoir is provided with a fluid port, and described fluid port is provided with a sealed piece.
Furtherly, described groove lid is a groove face film, and described groove face film is provided with a groove face film and takes off ear; Described sealed piece is a sealed membrane, and the surrounding sealing of described sealed membrane is pasted on the surrounding of fluid port, and sealed membrane is provided with a sealed membrane extended to outside stabilizing solution reservoir and takes off ear.
Preferably, described stabilizing solution reservoir built with blood stabilizing solution, the edta buffer liquid of described blood stabilizing solution to be pH be 6.8-7.6.
Described sample collecting device comprises a negative pressure part and an anti-freezing sample tube, and one end of described anti-freezing sample tube is communicated with negative pressure part.
Furtherly, described anti-freezing sample tube is a U trap that anticoagulant is housed, and described siphonal one end is communicated with negative pressure part, and the siphonal other end is provided with a tube sealing film.
Preferably, described anticoagulant is the heparin solution of 0.1-1.5wt%.
Described test paper body also comprises a negative pressure cabin, and described base plate, sample pad, pad, reaction film, absorption pad and haemocyte filter membrane are located in negative pressure cabin, and stabilizing solution reservoir is located on negative pressure cabin, and stabilizing solution reservoir is communicated with by fluid port with negative pressure cabin.
Furtherly, space is provided with between described sample pad and haemocyte filter membrane.
Furtherly, the pressure of described negative pressure cabin is 10-300Pa.
Compared with prior art, the invention has the beneficial effects as follows: the present invention, by arranging anti-freezing sample tube in sample collecting device, significantly can reduce the blood coagulation phenomenon of blood sample, reducing the loss of blood plasma, thus the collection capacity of blood sample can be reduced.Sample pad arranges stabilizing solution reservoir, blood sample is added drop-wise to Absorbable organic halogens and dilute blood sample in stabilizing solution reservoir, further minimizing blood coagulation phenomenon, thus the blood plasma in blood sample is utilized more fully, make finger tip blood can be used as the detection sample of quick detection test paper.By arranging negative pressure cabin, the liquid in reservoir can be made to flow in sample pad more completely, rapidly, improving the utilization factor of sample.The pressure of negative pressure cabin is 10-300Pa, has both made liquid from reservoir, can arrive sample pad fast, can avoid again causing haemocyte broken because pressure is excessive, disturbs final testing result.The U trap that anticoagulant is housed is set in sample collecting device, before sample of blood, drawn, the anticoagulant in U trap is extruded, one deck anticoagulant film can be formed at siphonal inwall, by anticoagulant film to anticoagulation blood, make the structure of sample collecting device simple, easy and simple to handle by this setting.The present invention is by arranging sample collecting device and reservoir and negative pressure cabin, and can realize only gathering micro-fingertip blood sample and accurately can detect disease, sample collection amount can be less than 1 μ L.
Accompanying drawing explanation
Fig. 1 is the sample collecting device of embodiment 1 structural representation when not loading anticoagulant;
Fig. 2 is the sample collecting device of embodiment 1 structural representation when anticoagulant is housed;
Fig. 3 is the structural representation after the anticoagulant in the sample collecting device of Fig. 2 is extruded;
Fig. 4 is the sample pad of embodiment 1, pad, reaction film and absorption pad are located at the structural representation after base plate;
Fig. 5 is the perspective view of the test paper body of embodiment 1;
Fig. 6 is the structural representation of A-A section in Fig. 5;
Fig. 7 is the vertical view of the test paper body of embodiment 1;
Fig. 8 is the vertical view after the test paper body of embodiment 1 removes groove face film;
Fig. 9 is the structural representation after the test paper body loading plastic support frame of embodiment 1.
Embodiment
In order to more fully understand technology contents of the present invention, below in conjunction with specific embodiment, technical scheme of the present invention being described further and being illustrated.
Embodiment 1
With reference to Fig. 1-9, a kind of quick detection test paper for Diagnosing Cardiac disease that the present embodiment provides, comprises test paper body 20, sample collecting device 10 and plastic support frame 30.Wherein, test paper body 10 is made up of base plate 25, sample pad 21, pad 22, reaction film 23, absorption pad 24, haemocyte filter membrane 26, stabilizing solution reservoir 28 and negative pressure cabin 27; Sample collecting device 10 is made up of negative pressure part 11 and anti-freezing sample tube 12.
As shown in Figure 1-2, negative pressure part 11 in sample collecting device 10 is an elastic ball, anti-freezing sample tube 12 is a U trap that anticoagulant 14 is housed, this siphonal one end sealing is inserted in elastic ball, U trap is communicated with elastic ball, the siphonal other end is then sealed with tube sealing film 13, and anticoagulant 14 is kept in U trap.In the present embodiment, the anticoagulant 14 in U trap is the heparin solution of 0.3wt%.Before using, remove tube sealing film 13, by extruding elastic ball, the anticoagulant 14 in U trap is discharged, make siphonal inwall form one deck anticoagulant film 15, as shown in Figure 3.Then U trap being moved to sample place draw blood sample, because there being one deck anticoagulation oxidant layer 15 in U trap, significantly can reduce the blood coagulation phenomenon of blood sample.
As shown in Figure 4, sample pad 21, pad 22, reaction film 23 and absorption pad 24 are located at respectively on base plate 25 and are also closely connected successively; Meanwhile, reaction film 23 be arranged in parallel detection zone 231 and a quality control region 232, and detection zone 231 is between quality control region 232 and pad 22, forms test paper matrix.Described detection zone 231 i.e. reaction film 23 is coated with can with the region of the antibody of determined antigen specific binding, what in the present embodiment, quilt is wrapped in detection zone 231 is troponin I antibody; Described quality control region 232 i.e. reaction film 23 is coated with can with the region of the antigen of tracer specific binding, what in the present embodiment, quilt is wrapped in Quality Control 232 district is troponin I antigen.Described pad 22 is made up of mass of glass fibers and the collaurum tracer be coated in mass of glass fibers.(in other embodiments, can also find according to disease detection principle and existing research, wrap by other material in pad 22, detection zone 231 and quality control region 232.)
As shown in Figure 5 and Figure 6, test paper matrix is placed in negative pressure cabin 27, and negative pressure cabin 27 inwall above sample pad 21 arranges a haemocyte filter membrane 26, make to leave a space between haemocyte filter membrane 26 and sample pad 21, by vacuumizing, the pressure in negative pressure cabin 27 is set to 30Pa.Above negative pressure cabin 27 and haemocyte filter membrane 26, arrange a stabilizing solution reservoir 28, the bottom land of stabilizing solution reservoir 28 is provided with a fluid port, negative pressure cabin 27 can be communicated with stabilizing solution reservoir 28 by this fluid port.Fluid port arranges a sealed piece, and the sealed piece in the present embodiment is a sealed membrane 284, and the sealing of the surrounding of sealed membrane 284 is pasted on the surrounding of fluid port, and sealed membrane 284 is provided with a sealed membrane extended to outside stabilizing solution reservoir 28 takes off ear 283.Temporarily fluid port can be sealed by sealed membrane 284, make negative pressure cabin 27 become an airtight space.When needing negative pressure cabin 27 to be communicated with stabilizing solution reservoir 28, take off ear 283 by lift sealed membrane and sealed membrane 284 is torn off.Arrange a groove lid at the groove face of stabilizing solution reservoir 28, the groove lid in the present embodiment is a groove face film 281, and the surrounding of groove face film 281 and the surrounding cell wall of stabilizing solution reservoir 28 seal to be pasted, and makes stabilizing solution reservoir 28 become an airtight space.Meanwhile, groove face film 281 is also provided with a groove face film and takes off ear 282, as shown in Fig. 5, Fig. 7-8, when needing the groove face film 281 opening stabilizing solution reservoir 28, take off ear 282 by lift groove face film.In stabilizing solution reservoir 28, load blood stabilizing solution, form test paper body 20.Blood stabilizing solution in the present embodiment to be pH be 7.0 edta buffer liquid.
As shown in Figure 9, test paper body 20 is loaded in plastic support frame 30, this plastic support frame 30 is provided with sample introduction window 32 and a view window 31, sample drop can be added in stabilizing solution reservoir 28 by the sample introduction window 32 of plastic support frame 30, by the situation of change of view window 31 observable detection zone 231 and quality control region 232.Prepared quick detection test paper is designated as TP1.
In other embodiments, other material with blood coagulation resisting function can also be used to load in U trap as anticoagulant 14, and when using heparin solution as anticoagulant 14, also can select the heparin solution of 0.1-1.5wt%.The edta buffer liquid of can also to be pH the be 6.8-7.6 of the blood stabilizing solution in stabilizing solution reservoir 28.
The using method of this trace sample Test paper: the tube sealing film 13 first tearing U trap one end on sample collecting device 10, extruding negative pressure part 11 makes the anticoagulant 14 in U trap get rid of, and then U trap is moved to finger tip to bleed place unclamp negative pressure part 11, finger tip blood is entered in U trap under the suction function of sample collecting device 10, becomes blood sample to be detected.Then the capping film 281 on stabilizing solution reservoir 28 is punctured by sample introduction window 32 with sample collecting device 10, and the blood sample in U trap is clamp-oned in stabilizing solution reservoir 28, then left and right weak vibrations stabilizing solution reservoir 28, makes blood sample evenly be diluted in blood stabilizing solution.Then, first lifting cover facial mask is taken off ear 282 and is taken off by capping film 281, then lifts sealed membrane and take off ear 283 and taken out by sealed membrane 284, and negative pressure cabin 27 is communicated with stabilizing solution reservoir 28.Blood sample dilution in stabilizing solution reservoir 28 flows through rapidly haemocyte filter membrane 26 and enters in sample pad 21 under the double action of gravity and negative pressure, and haemocyte is wherein trapped within haemocyte filter membrane 26.Under capillary siphoning effect, liquid flows through sample pad 21, pad 22, detection zone 231, quality control region 232 and absorption pad 24 successively and carries out corresponding specific reaction.Check result is observed finally by view window 31.
Embodiment 2
A kind of quick detection test paper for detecting heart disease that the present embodiment provides, its structure is substantially identical with the quick detection test paper described in embodiment 1, and difference is: the pressure in negative pressure cabin is set to 10Pa.Prepared quick detection test paper is designated as TP2.
Embodiment 3
A kind of quick detection test paper for detecting heart disease that the present embodiment provides, its structure is substantially identical with the quick detection test paper described in embodiment 1, and difference is: the pressure in negative pressure cabin is set to 20Pa.Prepared quick detection test paper is designated as TP3.
Embodiment 4
A kind of quick detection test paper for detecting heart disease that the present embodiment provides, its structure is substantially identical with the quick detection test paper described in embodiment 1, and difference is: the pressure in negative pressure cabin is set to 100Pa.Prepared quick detection test paper is designated as TP4.
Embodiment 5
A kind of quick detection test paper for detecting heart disease that the present embodiment provides, its structure is substantially identical with the quick detection test paper described in embodiment 1, and difference is: the pressure in negative pressure cabin is set to 200Pa.Prepared quick detection test paper is designated as TP5.
Embodiment 6
A kind of quick detection test paper for detecting heart disease that the present embodiment provides, its structure is substantially identical with the quick detection test paper described in embodiment 1, and difference is: the pressure in negative pressure cabin is set to 300Pa.Prepared quick detection test paper is designated as TP6.
Embodiment 7
A kind of quick detection test paper for detecting heart disease that the present embodiment provides, its structure is substantially identical with the quick detection test paper described in embodiment 1, and difference is: the pressure in negative pressure cabin is set to 400Pa.Prepared quick detection test paper is designated as TP7.
Comparative example 1
Preparing one for detecting the quick detection test paper of heart disease according to prior art, being specially: this quick detection test paper comprises a base plate, sample pad, pad, reaction film and absorption pad are then located at respectively on base plate and are also closely connected successively.Meanwhile, reaction film be arranged in parallel a detection zone and a quality control region, and detection zone is between quality control region and pad.Detection zone is coated with troponin I antibody, quality control region is coated with troponin I antigen, pad is made up of mass of glass fibers and the collaurum tracer be coated in mass of glass fibers.(in pad, detection zone and quality control region, wrap the material of quilt and the identical of embodiment 1.) then pack with plastic support frame, can sample drop be added in sample pad by the sample introduction window of plastic support frame, by the situation of change of view window observable detection zone and quality control region.Prepared quick detection test paper is designated as TP8.
Respectively by collection capacity be 0.8 μ L, 1 μ L, 2 μ L, 10 μ L, 20 μ L collect the finger tip blood of 100 heart disease patients respectively, and detect respectively with quick detection test paper TP1-TP8 prepared by above-described embodiment and comparative example.The recall rate of each quick detection test paper is as shown in the table.
0.8μL 1μL 2μL 10μL 20μL
TP1 100% 100% 100% 100% 100%
TP2 100% 100% 100% 100% 100%
TP3 100% 100% 100% 100% 100%
TP4 50% 60% 65% 70% 75%
TP5 30% 40% 45% 55% 60%
TP6 10% 20% 20% 25% 30%
TP7 5% 7% 10% 15% 20%
TP8 0 0 0 0 20%
From the data of upper table, the present invention is by arranging harvester and arrange negative pressure cabin and stabilizing solution reservoir in sample pad, and can realize only gathering trace sample and accurately can detect disease, sample collection amount can be less than 1 μ L.
The above only further illustrates technology contents of the present invention with embodiment, so that reader is easier to understand, but does not represent embodiments of the present invention and is only limitted to this, and any technology done according to the present invention extends or recreation, all by protection of the present invention.

Claims (10)

1. a trace sample Test paper, comprise a test paper body and a sample collecting device, described test paper body comprises a base plate, and is located on base plate and closely connected successively sample pad, pad, reaction film and absorption pad, described reaction film is provided with detection zone and quality control region, it is characterized in that:
Described sample pad is provided with haemocyte filter membrane, and described haemocyte filter membrane is provided with a stabilizing solution reservoir, and the groove face of described stabilizing solution reservoir is provided with a groove lid, and the bottom land of described stabilizing solution reservoir is provided with a fluid port, and described fluid port is provided with a sealed piece;
Described sample collecting device comprises a negative pressure part and an anti-freezing sample tube, and one end of described anti-freezing sample tube is communicated with negative pressure part.
2. a kind of trace sample Test paper according to claim 1, it is characterized in that, described test paper body also comprises a negative pressure cabin, described base plate, sample pad, pad, reaction film, absorption pad and haemocyte filter membrane are located in negative pressure cabin, stabilizing solution reservoir is located on negative pressure cabin, and stabilizing solution reservoir is communicated with by fluid port with negative pressure cabin.
3. a kind of trace sample Test paper according to claim 2, is characterized in that, be provided with space between described sample pad and haemocyte filter membrane.
4. a kind of trace sample Test paper according to claim 3, it is characterized in that, the pressure of described negative pressure cabin is 10-300Pa.
5. a kind of trace sample Test paper according to claim 1, it is characterized in that, described sealed piece is a sealed membrane, and the surrounding sealing of described sealed membrane is pasted on the surrounding of fluid port.
6. a kind of trace sample Test paper according to claim 5, it is characterized in that, described groove lid is a groove face film.
7. a kind of trace sample Test paper according to claim 6, it is characterized in that, described stabilizing solution reservoir is built with blood stabilizing solution.
8. a kind of trace sample Test paper according to claim 7, is characterized in that, the edta buffer liquid of described blood stabilizing solution to be pH be 6.8-7.6.
9. a kind of trace sample Test paper according to claim 1, it is characterized in that, described anti-freezing sample tube is a U trap that anticoagulant is housed, and described siphonal one end is communicated with negative pressure part, and the siphonal other end is provided with a tube sealing film.
10. a kind of trace sample Test paper according to claim 9, it is characterized in that, described anticoagulant is the heparin solution of 0.1-1.5wt%.
CN201410410075.7A 2014-08-18 2014-08-18 A kind of trace sample Test paper Expired - Fee Related CN104142392B (en)

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CN106338599B (en) * 2016-09-29 2018-01-30 厦门科牧智能技术有限公司 A kind of urine test paper structure and urine examination method
CN108982875A (en) * 2018-08-13 2018-12-11 张明程 The preparation and application of Selenoprotein P colloidal-gold detecting-card
CN110441510A (en) * 2019-08-02 2019-11-12 黄河科技学院 Immunochromatographytest test kit
CN110736830A (en) * 2019-11-18 2020-01-31 威尚生物技术(合肥)有限公司 detection cards for autoimmune colloidal gold
CN113122426B (en) * 2021-03-08 2022-12-13 河南优得生物技术有限公司 Biological cell sap test box capable of being detected at any time and conveniently
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