CN104142392A - Trace sample test paper - Google Patents

Trace sample test paper Download PDF

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Publication number
CN104142392A
CN104142392A CN201410410075.7A CN201410410075A CN104142392A CN 104142392 A CN104142392 A CN 104142392A CN 201410410075 A CN201410410075 A CN 201410410075A CN 104142392 A CN104142392 A CN 104142392A
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CN
China
Prior art keywords
sample
test paper
negative pressure
stabilizing solution
pad
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Granted
Application number
CN201410410075.7A
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Chinese (zh)
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CN104142392B (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
Application granted granted Critical
Publication of CN104142392B publication Critical patent/CN104142392B/en
Expired - Fee Related legal-status Critical Current
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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 invention relates to the technical field of in vitro detection, and particularly relate to trace sample test paper which comprises a test paper body and a sample collector. A hemocyte filter membrane is arranged on a sample pad, a stabilizing solution storage tank is arranged on the hemocyte filter membrane, and the sample collector comprises a negative pressure piece and an anti-coagulation sample pipe. According to the trace sample test paper, the anti-coagulation sample pipe is arranged in the sample collector, and thus the blood coagulation of a blood sample can be remarkably reduced, the loss of blood plasma is reduced, and thus the collecting quantity of a blood sample can be reduced. the stabilizing solution storage tank is arranged on the sample pad, the blood sample is dropwise added in the stabilizing solution storage tank so that the blood sample can be stabilized and diluted, thus the coagulation is reduced, and thus blood plasma in the blood sample is fully utilized, blood in fingertip can be used as a detection sample of rapid detection test paper, and the sample collecting quantity can be less than 1 mu L. By arranging a negative pressure bin, a liquid in the storage tank can completely and rapidly flow in the sample pad, and thus the utilization rate of the sample is increased.

Description

A kind of trace sample Test paper
Technical field
The present invention relates to vitro detection technical field, relate in particular to a kind of trace sample Test paper.
Background technology
Along with social progress and growth in the living standard, people more and more pay close attention to the health of self, and the early diagnosis of disease and screening are more and more paid attention to.Therefore, need more detection meanss of more accurately diagnosing easily to meet this requirement.Diagnose test paper, the detection means of accepting extensively as a kind of extensively detected personnel, medical worker and users, 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, with Standard colour board comparison, just can obtain result of laboratory test.Because it has broken away from valuable instrument and equipment, greatly reduce laboratory fee use, be deeply subject to the welcome of vast health service unit, the medical test of the vast rural area of China and industrial and mineral grass-roots unit is significant.
The development of China aspect 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.Aspect the sensitivity of test paper, storage life, having new progress, end item has reached international most advanced level.But, the current the most scabrous problem of fast diagnose test paper is that the required sample collection amount of test paper is large, especially blood, due to the very easily blood coagulation of finger tip blood, cannot apply finger tip blood and detect as sample, need to gather venous blood, but also need at least sample size of 20ul, thereby the collection of blood sample needs professional to operate, be 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 requiring is large, cause the problem of sample collection inconvenience, it can finger tip blood be detection sample that one is provided, and the trace sample Test paper that only needs trace sample to detect.
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 tight connected sample pad, pad, reaction film and absorption pad successively, and described reaction film is provided with detection zone and Quality Control district.
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 extending to outside stabilizing solution reservoir and takes off ear.
Preferably, in described stabilizing solution reservoir, blood stabilizing solution is housed, described blood stabilizing solution is that pH is the edta buffer liquid of 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 one the U trap of anticoagulant to be 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, the heparin solution that described anticoagulant is 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 can be communicated with by fluid port with negative pressure cabin.
Furtherly, between described sample pad and haemocyte filter membrane, be provided with space.
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 anti-freezing sample tube is set in sample collecting device, can significantly reduce the blood coagulation phenomenon of blood sample, reduce the loss of blood plasma, thereby can reduce the collection capacity of blood sample.Stabilizing solution reservoir is set in sample pad, blood sample is added drop-wise in stabilizing solution reservoir and can be stablized and dilute blood sample, further reduce blood coagulation phenomenon, thereby 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 negative pressure cabin is set, can make the liquid in reservoir flow in sample pad more completely, rapidly, improve the utilization factor of sample.The pressure of negative pressure cabin is 10-300Pa, has both made liquid can from reservoir, arrive fast sample pad, can avoid again causing haemocyte fragmentation 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, can form one deck anticoagulant film at siphonal inwall, by anticoagulant film, blood is played to anticoagulation, make the simple in structure, easy and simple to handle of sample collecting device by this setting.The present invention, by sample collecting device and reservoir and negative pressure cabin are set, can realize and only need the micro-fingertip blood sample of collection can accurately detect disease, and sample collection amount can be less than 1 μ L.
Brief description of the drawings
Fig. 1 is the structural representation of the sample collecting device of embodiment 1 while not packing anticoagulant into;
Fig. 2 is the structural representation of the sample collecting device of embodiment 1 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 that sample pad, pad, reaction film and the absorption pad of embodiment 1 is 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 that the test paper body of embodiment 1 removes the vertical view after groove face film;
Fig. 9 is that the test paper body of embodiment 1 packs the structural representation after plastic support frame into.
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 is described further and is 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 one the U trap of anticoagulant 14 to be housed, this siphonal one end sealing is inserted in elastic ball, U trap is communicated with elastic ball, the siphonal other end is sealed with tube sealing film 13, and anticoagulant 14 is kept in U trap.In the present embodiment, the heparin solution that the anticoagulant 14 in U trap is 0.3wt%.Before use, remove tube sealing film 13, by extruding elastic ball, the anticoagulant in U trap 14 is discharged, make siphonal inwall form one deck anticoagulant film 15, as shown in Figure 3.Then U trap is moved to sample place draw blood sample, because there being one deck anticoagulant layer 15 in U trap, can significantly 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 closely connected successively; Meanwhile, on reaction film 23, be arranged in parallel a detection zone 231 and a Quality Control district 232, and detection zone 231 is between Quality Control district 232 and pad 22, forms test paper matrix.Described detection zone 231 be on reaction film 23, be coated with can with the region of the antibody of determined antigen specific binding, coated on detection zone 231 in the present embodiment is troponin I antibody; Described Quality Control district 232 be on reaction film 23, be coated with can with the region of the antigen of tracer specific binding, coated in Quality Control 232nd district in the present embodiment is troponin I antigen.Described pad 22 is made up of mass of glass fibers and the collaurum tracer being coated in mass of glass fibers.(in other embodiments, can also find according to disease detection principle and existing research coated other material in pad 22, detection zone 231 and Quality Control district 232.)
As shown in Figure 5 and Figure 6, test paper matrix is placed in negative pressure cabin 27, and on negative pressure cabin 27 inwalls above sample pad 21, a haemocyte filter membrane 26 is set, make to leave a space between haemocyte filter membrane 26 and sample pad 21, by vacuumizing, the pressure in negative pressure cabin 27 is made as to 30Pa.One stabilizing solution reservoir 28 is set above negative pressure cabin 27 and haemocyte filter membrane 26, and 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.One sealed piece is set on fluid port, 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 extending to outside stabilizing solution reservoir 28 and takes off ear 283.Can temporarily fluid port be sealed by sealed membrane 284, make negative pressure cabin 27 become an airtight space.When negative pressure cabin 27 need to be communicated with stabilizing solution reservoir 28, can take off ear 283 sealed membrane 284 is torn off by lifting sealed membrane.At the groove face of stabilizing solution reservoir 28, a groove lid is set, the groove lid in the present embodiment is a groove face film 281, and the surrounding cell wall sealing of the surrounding of groove face film 281 and stabilizing solution reservoir 28 is pasted, and makes stabilizing solution reservoir 28 become an airtight space.Meanwhile, on groove face film 281, be also provided with a groove face film and take off ear 282, as shown in Fig. 5, Fig. 7-8, need to open the groove face film 281 of stabilizing solution reservoir 28 time, take off ear 282 by lifting groove face film.In stabilizing solution reservoir 28, pack blood stabilizing solution into, form test paper body 20.Blood stabilizing solution in the present embodiment is that pH is 7.0 edta buffer liquid.
As shown in Figure 9, test paper body 20 is packed in plastic support frame 30, this plastic support frame 30 is provided with a sample introduction window 32 and a view window 31, sample introduction window 32 by plastic support frame 30 can be added to sample drop in stabilizing solution reservoir 28, by the situation of change in view window 31 observable detection zones 231 and Quality Control district 232.Prepared quick detection test paper is designated as TP1.
In other embodiments, can also use other material with blood coagulation resisting function to pack 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%.Blood stabilizing solution in stabilizing solution reservoir 28 can also be that pH is the edta buffer liquid of 6.8-7.6.
The using method of this trace sample Test paper: the tube sealing film 13 that first tears U trap one end on sample collecting device 10, extruding negative pressure part 11 is got rid of the anticoagulant 14 in U trap, and then U trap being moved to finger tip bleeds and locates and unclamp negative pressure part 11, finger tip blood is entered in U trap under the suction function of sample collecting device 10, become 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 stabilizing solution reservoir 28 is slightly rocked in left and right, and blood sample is evenly diluted in blood stabilizing solution.Then, first lifting cover facial mask is taken off ear 282 capping film 281 is taken off, then lifts sealed membrane and take off ear 283 sealed membrane 284 is taken out, and negative pressure cabin 27 is communicated with stabilizing solution reservoir 28.Flow through rapidly under the double action of gravity and negative pressure haemocyte filter membrane 26 entering in sample pad 21 of blood sample dilution in stabilizing solution reservoir 28, haemocyte is wherein trapped within on haemocyte filter membrane 26.Under capillary siphoning effect, liquid flow through successively sample pad 21, pad 22, detection zone 231, Quality Control district 232 and absorption pad 24 carry out corresponding specific reaction.Finally observe check result by view window 31.
Embodiment 2
A kind of quick detection test paper for detection of heart disease that the present embodiment provides, the quick detection test paper described in its structure and embodiment 1 is basic identical, and difference is: the pressure in negative pressure cabin is made as to 10Pa.Prepared quick detection test paper is designated as TP2.
Embodiment 3
A kind of quick detection test paper for detection of heart disease that the present embodiment provides, the quick detection test paper described in its structure and embodiment 1 is basic identical, and difference is: the pressure in negative pressure cabin is made as to 20Pa.Prepared quick detection test paper is designated as TP3.
Embodiment 4
A kind of quick detection test paper for detection of heart disease that the present embodiment provides, the quick detection test paper described in its structure and embodiment 1 is basic identical, and difference is: the pressure in negative pressure cabin is made as to 100Pa.Prepared quick detection test paper is designated as TP4.
Embodiment 5
A kind of quick detection test paper for detection of heart disease that the present embodiment provides, the quick detection test paper described in its structure and embodiment 1 is basic identical, and difference is: the pressure in negative pressure cabin is made as to 200Pa.Prepared quick detection test paper is designated as TP5.
Embodiment 6
A kind of quick detection test paper for detection of heart disease that the present embodiment provides, the quick detection test paper described in its structure and embodiment 1 is basic identical, and difference is: the pressure in negative pressure cabin is made as to 300Pa.Prepared quick detection test paper is designated as TP6.
Embodiment 7
A kind of quick detection test paper for detection of heart disease that the present embodiment provides, the quick detection test paper described in its structure and embodiment 1 is basic identical, and difference is: the pressure in negative pressure cabin is made as to 400Pa.Prepared quick detection test paper is designated as TP7.
Comparative example 1
Prepare a quick detection test paper for detection of heart disease according to prior art, be specially: this quick detection test paper comprises a base plate, sample pad, pad, reaction film and absorption pad are located at respectively on base plate and are closely connected successively.Meanwhile, on reaction film, be arranged in parallel a detection zone and a Quality Control district, and detection zone is between Quality Control district and pad.On detection zone, be coated with troponin I antibody, be coated with troponin I antigen in Quality Control district, pad is made up of mass of glass fibers and the collaurum tracer being coated in mass of glass fibers.(in pad, detection zone and Quality Control district, coated material and embodiment's 1 is identical.) then pack with plastic support frame, sample drop can be added in sample pad by the sample introduction window of plastic support frame, by the situation of change in view window observable detection zone and Quality Control district.Prepared quick detection test paper is designated as TP8.
Be that 0.8 μ L, 1 μ L, 2 μ L, 10 μ L, 20 μ L collect respectively 100 heart disease patients' finger tip blood by collection capacity 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, by harvester being set and negative pressure cabin being set in sample pad and stabilizing solution reservoir, can realize and only need collection trace sample can accurately detect disease, and 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 that embodiments of the present invention only limit to this, and any technology of doing according to the present invention is extended or recreation, is all subject to protection of the present invention.

Claims (10)

1. a 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 tight connected sample pad, pad, reaction film and absorption pad successively, described reaction film is provided with detection zone and Quality Control district, 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 can be 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, between described sample pad and haemocyte filter membrane, is provided with space.
4. a kind of trace sample Test paper according to claim 3, 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, 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, is characterized in that, described groove lid is a groove face film.
7. a kind of trace sample Test paper according to claim 6, is characterized in that, in described stabilizing solution reservoir, blood stabilizing solution is housed.
8. a kind of trace sample Test paper according to claim 7, is characterized in that, described blood stabilizing solution is that pH is the edta buffer liquid of 6.8-7.6.
9. a kind of trace sample Test paper according to claim 1, is characterized in that, described anti-freezing sample tube is one the U trap of anticoagulant to be 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, is characterized in that the heparin solution that described anticoagulant is 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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CN105891494A (en) * 2016-06-14 2016-08-24 焦作百奥泰科生物科技有限公司 Fluorescence immunochromatography test paper for detecting citrinin
CN106338599A (en) * 2016-09-29 2017-01-18 厦门科牧智能技术有限公司 Urine test paper structure and urine test 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
CN113122426A (en) * 2021-03-08 2021-07-16 顾余 Biological cell sap test box capable of being detected at any time and conveniently

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CN106338599A (en) * 2016-09-29 2017-01-18 厦门科牧智能技术有限公司 Urine test paper structure and urine test 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
CN113122426A (en) * 2021-03-08 2021-07-16 顾余 Biological cell sap test box capable of being detected at any time and conveniently

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