CN100539953C - Sample collecting device - Google Patents
Sample collecting device Download PDFInfo
- Publication number
- CN100539953C CN100539953C CNB2007101697357A CN200710169735A CN100539953C CN 100539953 C CN100539953 C CN 100539953C CN B2007101697357 A CNB2007101697357 A CN B2007101697357A CN 200710169735 A CN200710169735 A CN 200710169735A CN 100539953 C CN100539953 C CN 100539953C
- Authority
- CN
- China
- Prior art keywords
- collecting device
- sample collecting
- sample
- cavity liquid
- mouth cavity
- Prior art date
- 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
Links
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Abstract
A kind of sample collecting device comprises: the joint portion of shank, board and connection shank and board, and described sample collecting device is made by hydrophilic fibre and hydrophobic material, and this hydrophilic fibre and hydrophobic material form capillary micropore matrix structure; Hydrophilic fibre is used to guarantee the water absorbing properties of sample collecting device, and hydrophobic material is used to keep external shape capillary micropore inner with it matrix structure of sample collecting device, and capillary micropore substrate is used for liquid sample is carried.Sample collecting device of the present invention is by the characteristic of its powerful hydrophilicity and inner capillary micropore substrate thereof, need not extraneous mechanical compress just can effectively gather and carry the oral cavity liquid sample, and can make the mouth cavity liquid of collection, conveying satisfy the needs that the detectable bar detects, thereby realize mouth cavity liquid is carried out the fast detecting of all types of target material, and its gatherer process is efficient, noinvasive, safety, can not cause any harm to detected object.
Description
Technical field
The present invention relates to a kind of sample collecting device, relate in particular to a kind of sample collecting device that can effectively gather the oral cavity liquid sample.
Background technology
Mouth cavity liquid (comprising saliva, oral mucosa exudate etc.) all is parts of human body fluid with the blood (comprising whole blood, serum and blood plasma etc.) that is widely used in Clinical detection, all belong to extracellular fluid, its most of constituent classes seemingly, especially the target substance that is significant in the Clinical detection occurs having concordance opportunity, and just there is some difference for content.The result of study of Challacombe confirms the IgG existence of the interior IgG of antimer in time in the mouth cavity liquid; Parry studies show that the specific antibody level of mouth cavity liquid by RIA and ELISA: though in the mouth cavity liquid antibody content far below serum, IgA, IgG and IgM are approximately 1/10,1/800,1/400 of serum content respectively, but enough are used for some immunology detection; Subsequently, people such as Acosta detects research with the mouth cavity liquid sample application in the parasitic disease serology; Researchers such as Archibald, Behets, Chamnanput are studied in HIV detects mouth cavity liquid.These results of study show that the detection that the mouth cavity liquid sample is used for some disease is fully feasible.
At present, various countries' medical circle pay attention to day by day carries out the research of the fast detecting aspect of some thing to be detected to using mouth cavity liquid (comprising saliva, oral mucosa exudate etc.) sample, the develop rapidly always of detectable bar technology, the sensitivity and specificity of all ingredients bar also reaches certain height.Sampling technique as the mouth cavity liquid sample then also has very long road to walk, thereby the sample collecting device that can effectively obtain the mouth cavity liquid sample becomes one of current research and development focus of industry.
Summary of the invention
The object of the present invention is to provide a kind of sample collecting device, can effectively gather the oral cavity liquid sample, and to the oral cavity liquid sample effectively filter, enrichment concentrates, be delivered to checkout gear again, for example whether reagent strip for immunochromatographydetection detection etc. contains target substance (as antibody, antigen etc.) to be used for fast detecting mouth cavity liquid sample.
For achieving the above object, the invention provides a kind of sample collecting device, comprise: the joint portion of shank, board and connection shank and board, described sample collecting device is made by hydrophilic fibre and hydrophobic material, and this hydrophilic fibre and hydrophobic material form capillary micropore matrix structure; Hydrophilic fibre is used to guarantee the water absorbing properties of sample collecting device, and hydrophobic material is used to keep external shape capillary micropore inner with it matrix structure of sample collecting device, and capillary micropore substrate is used for liquid sample is carried.
Beneficial effect of the present invention: at first, noinvasive safety: because of detecting sample is the mouth cavity liquid sample, and sample collecting device has adopted the making material that possesses certain flexibility, very little to the oral cavity mucosa irritation, seldom may cause the oral mucosa damage, be different from the gatherer process that other detect sample fully, for example: the gatherer process of blood, can not cause tissue injury to detected object, can avoid injury and psychological burden that the detected person is caused, more can reduce the probability and the risk of testing staff's occupational exposure.
Secondly, fast convenient: after gathering the oral cavity liquid sample, need not sample collecting device is carried out mechanical compress or centrifugal treating, the component to be measured in the mouth cavity liquid that sample collecting device absorbed is delivered to the detectable bar by its inner capillary micropore substrate automatically.
Once more, efficiently and accurately: the physicochemical characteristics that sample collecting device possessed has guaranteed that the amount of the mouth cavity liquid that institute gathers and carries satisfies the needs that reagent strip detects, the effective combination of immunochromatography quick detection reagent bar technology in maturation period can be in development, and the qualitative or half-quantitative detection of target substances such as antigen, antibody, medicine, drugs can be directly used in.
In sum, sample collecting device of the present invention by the characteristic of its powerful hydrophilicity and inner capillary micropore substrate thereof, need not extraneous mechanical compress just can effectively gather and carry the oral cavity liquid sample, and can make the mouth cavity liquid of collection, conveying satisfy the needs that the detectable bar detects, thereby realize mouth cavity liquid is carried out the fast detecting of all types of target material (as antibody, antigen etc.), and its gatherer process is efficient, noinvasive, safety, can not cause any harm to detected object.
Description of drawings
Below in conjunction with accompanying drawing,, will make technical scheme of the present invention and other beneficial effects apparent by the specific embodiment of the present invention is described in detail.
In the accompanying drawing,
Fig. 1 is the sketch map of sample collecting device of the present invention.
The specific embodiment
Describe the present invention below in conjunction with accompanying drawing.
As shown in Figure 1, sample collecting device comprises the joint portion 6 of shank 2, board 4 and connection shank 2, board 4; Sample collecting device is made by hydrophilic fibre and hydrophobic material, hydrophilic fibre is used to guarantee the water absorbing properties of sample collecting device, hydrophobic material is used to keep external shape capillary micropore inner with it matrix structure of sample collecting device, hydrophilic fibre and hydrophobic material form a kind of netted microcellular structure, i.e. capillary micropore matrix structure in inside; Capillary micropore substrate is used for mouth cavity liquid (comprising saliva, oral mucosa exudate etc.) sample is carried.Capillary micropore matrix structure can be kept sample collecting device and have certain rigid and flexibility, and powerful water absorbing properties can also be provided, and the transport channel of mouth cavity liquid sample is provided; In addition, the adsorption aid processing can be carried out in the sample collecting device surface, to possess the function of enrichment absorption oral cavity liquid sample.
No direct correlation between the profile of sample collecting device and the collection effect, its profile can be but be not limited to rattle plate or oar shape, should be able to guarantee that the board 4 of sample collecting device can contact with oral mucosa fully, so that the collection of mouth cavity liquid; Simultaneously, the total surface area of sample collecting device and volume affect the collection quantity and the acquisition time of mouth cavity liquid, in order to reach the needs that the detectable bar detects the oral fluid scale of construction, the sample collecting device total surface area is not less than 700 square millimeters, cumulative volume is not less than 650 cubic millimeters, wherein, the surface area of the board 4 of the sample collecting device that directly contacts with oral mucosa is not less than sample collecting device total surface area 50%.
The parameter of capillary micropore substrate is extremely crucial for the performance of sample collecting device, capillary micropore substrate itself must be kept the less size that compares, specifically, the average micropore size of capillary micropore substrate should be controlled at certain scope, purpose is to prevent that the stickum in the mouth cavity liquid sample is blocking microporous, also can filter some macromolecular substances in the mouth cavity liquid sample simultaneously, in addition also for guaranteeing that the mouth cavity liquid sample can obviously not change capillary micropore substrate.Capillary micropore substrate average pore size all can satisfy above-mentioned needs in 20um～500um scope, preferred 20um～200um.
The total void rate of capillary micropore substrate (being the total measurement (volume) of all micropores of capillary micropore substrate and the ratio of sample collecting device cumulative volume) need be controlled in certain scope, ratio height to 65%, 55%, 45%, 35% and be low to moderate 25%, 15%, 5% sample collecting device all satisfies the requirement of sampling, but preferred proportion is the total void rate below 45%, purpose is the mouth cavity liquid sample that had both guaranteed to collect q.s, guarantee that again the mouth cavity liquid sample of being gathered can be transported on the reagent strip fully, make that the residual quantity in the capillary micropore substrate reaches lower level.
The total measurement (volume) of capillary micropore substrate is no more than 500 cubic millimeters, the profile of sample collecting device and inner capillary micropore substrate is not because of the obvious change that reached capacity of the absorption to the oral cavity liquid sample, promptly absorb of profile and the volume not significantly influence of mouth cavity liquid sample to sample collecting device, can not destroy a mao minute aperture substrate significantly yet, also can influence the total measurement (volume) of mao minute aperture substrate pore size and capillary micropore substrate not obviously, especially after passing through dried, its once more absorption rate tangible change does not take place.For satisfying above-mentioned requirements, sample collecting device and capillary micropore substrate should have certain rigid or hardness, but its hardness can not produce great bodily injury to oral mucosa when gathering the oral cavity liquid sample; The total measurement (volume) of the hair minute aperture substrate that meets the demands is behind saturated absorption mouth cavity liquid sample, and the change scope is controlled at below 30%, preferably is no more than 1%.
In sum, capillary micropore substrate total measurement (volume) is no more than 500 cubic millimeters, average pore size is 20～500 microns, total void rate (being the ratio of emptying aperture footpath volume and sample collecting device cumulative volume) is no more than 80%, the density range of corresponding sample collecting device is 0.21～0.86 gram/cubic centimetre simultaneously, after tested, wherein with 20～200 microns of capillary micropore substrate average pore sizes, the total void rate is 40%～45%, the density of sample collecting device is that the performance parameter of sample collecting device of 0.48～0.52 gram/cubic centimetre is the most excellent, for example: the oral fluid scale of construction of acquisition rate and collection.
Except that the parameter of above-mentioned capillary micropore substrate, the material of sample collecting device is formed same crucial, the stock of forming sample collecting device and keeping capillary micropore matrix structure is hydrophilic fibre and hydrophobic material, hydrophilic fibre is mainly used in the water absorbing properties that guarantees sample collecting device, and hydrophobic material is mainly kept the external shape and the internal structure of sample collecting device.Hydrophilic fibre can be cotton fiber, filter paper, sponge, cloth and other hydrophilic materials; Hydrophobic material can be polyester, polyethylene, polypropylene, multi-styrene, high density polyethylene (HDPE), ultra high molecular polyethylene, Polyvinylidene fluoride, politef, nylon and polyether sulfone and other plastics, in addition, does not get rid of and uses glass, resin; Equally, do not get rid of directly with being used for the possibility that sample collecting device is made after the hydrophobic material process hydrophilic treated.In the present embodiment, hydrophilic fibre is a cotton fiber; The hydrophobic material preferred polyester; The cotton fiber that satisfies the sample collecting device making is 1: 9 to 4: 1 with weight polyester than scope, wherein wt is that 1: 9 to 3: 2 sample collecting device effect is best than scope, the performance parameter of the sample collecting device in this scope is the most excellent, for example: the oral fluid scale of construction of acquisition rate and collection.
The content of hydrophilic fibers is high more, and its hydrophilicity is strong more.And stable for the profile of keeping sample collecting device and inner capillary micropore substrate, the content of hydrophilic fibre (weight ratio) can not be higher than 80%, has certain flexibility in order to keep sample collecting device again, avoid oral mucosa is caused damage, the content of hydrophilic fibre (weight ratio) can not be lower than 8%, after tested, hydrophilic fibre accounts for the sample collecting device of sample collecting device gross weight ratio range between 8%～80% and all satisfies the demand, and preferable range is at 10%～58% sample collecting device.
The material of above sample collecting device form with and the parameter setting (as: difference of the total void rate of the pore size of capillary micropore substrate and capillary micropore substrate) of internal structure capillary micropore substrate has determined the amount of following mouth cavity liquid sample and the mouth cavity liquid sample gathered arrives the average time of filtering sealing strip through sample collecting device.
The board 4 of sample collecting device was controlled in 5 minutes from the time of oral cavity saturated absorption mouth cavity liquid sample, preferably in 1 minute, finish, simultaneously, do not having under extraneous mechanical compress or the filtering prerequisite, be adsorbed in the intramatrical mouth cavity liquid sample of capillary micropore from board 4, the time that is delivered to reagent strip through shank 2 was controlled in 10 minutes, was preferably in 2 minutes and finished.Amount by sample collecting device absorption and the mouth cavity liquid sample carried is controlled at below 1000 cubic millimeters, preferably is no more than 500 cubic millimeters.
In addition in order to guarantee that sample collecting device fully absorbs mouth cavity liquid, sample collecting device comprises further that also being located at the surface can stimulate the excretory material of mouth cavity liquid, and these materials mainly contain citric acid, tartaric acid, fumaric acid, ascorbic acid, malic acid, Sal, fructose, glucose, sucrose, artificial sweetener and aromatic etc.
The sample collecting device of the present invention use that can combine with various detectable bars, during use, board 4 is used to go deep into the oral cavity and gathers the oral cavity liquid sample, shank 2 is used to be connected at the filtration sealing strip on the detectable bar, filter filtration and the sealing process of sealing strip to the oral cavity liquid sample, make the door chamber liquid sample that enters the detectable bar have its effectiveness more, the detectable bar uses immunological technique and chromatographic theory, the material to be detected in the liquid sample of oral cavity is detected draw testing result.Specifically, sample collecting device comes disposable collection and the conveying of finishing sample by the skeleton and the composite hydrophilic fibre composition of its hydrophobic material granulometric composition, the powerful hydrophilicity of hydrophilic fibre and the enrichment function of material surface adsorbent, impel the absorption of mouth cavity liquid sample and concentrate in sample collecting device, and the mouth cavity liquid sample is carried under capillarity by the inner capillary micropore of hydrophobic material skeleton substrate, the oral cavity liquid sample is gathered and carried to the characteristic of promptly utilizing powerful hydrophilicity of hydrophilic fibre and inner capillary micropore substrate that the oral cavity liquid sample need not extraneous mechanical compress be promptly freely carried.Pass through in conjunction with having the macromolecular substances that stops Interference Detection of filtration, make the mouth cavity liquid specimen that enters the detectable bar have its effectiveness more with the filtration sealing strip of sealing process.Again in conjunction with the detectable bar that uses immunological technique and chromatographic theory, be transported to the sample application zone of detectable bar when effective mouth cavity liquid sample, by reagent strip immunochromatography principle, make the target substance in the mouth cavity liquid sample be transported to the reagent strip reaction zone, material to be detected in the liquid sample of oral cavity is carried out fast detecting, a series of biology, chemical reaction take place in this reaction zone, and demonstrate chromatic band in the detection zone and the check plot of reaction zone respectively, can read testing result in view of the above.
Sample collecting device of the present invention is suitable at the cause pathogeny imcrobe infection disease, as: the collection of mouth cavity liquid samples such as HIV antibody, HTLV antibody, helicobacter pylori antibody, hepatitis virus antibody, treponema antibody, mumps antibody, rubella antibody; Also be suitable for being directed to the mark of pathology and medicine, as: cardiolipin, lecithin, cholesterol, lipopolysaccharide and sialic acid, cotinine, cocaine, benzoylecgonine, benzodiazepine, tetrahydrocannabinol, nicotine, the ethanol theophylline, benzene appropriate because of, acetyl aminophenol, diazepam (Diazepam), nortriptyline, quinalbarbitone, phenobarbital, theophylline, testosterone, estradiol, 17-alkyl Progesterone, progesterone, thyroxine, thyrotropin, follicule-stimulating hormone (FSH), metakentrin, transforming growth factor-a, epidermal growth factor, insulin-like growth factor I and II, somatostatin, the collection of mouth cavity liquid such as globulin and sex hormone binding globulin sample; Also be suitable for other and detect thing, as: the collection of material mouth cavity liquid samples such as glucose, cholesterol, caffeine, CBG, PSA, many salivas, dehydroepiandrosterone haptoglobin.This method especially is fit to gather the mouth cavity liquid sample of human immunodeficiency virus (HIV) and hepatitis virus antibody such as (HAV, HBV, HCV).
The above for the person of ordinary skill of the art, can make other various corresponding changes and distortion according to technical scheme of the present invention and technical conceive, and all these changes and distortion all should belong to the scope that the present invention protects.
Claims (10)
1, a kind of sample collecting device is characterized in that, comprising: the joint portion of shank, board and connection shank and board, and described sample collecting device is made by hydrophilic fibre and hydrophobic material, and this hydrophilic fibre and hydrophobic material form capillary micropore matrix structure; Hydrophilic fibre is used to guarantee the water absorbing properties of sample collecting device, hydrophobic material is used to keep external shape capillary micropore inner with it matrix structure of sample collecting device, capillary micropore substrate is used for liquid sample is carried, this sample collecting device total surface area is not less than 700 square millimeters, cumulative volume is not less than 650 cubic millimeters, the surface area of board is not less than 50% of sample collecting device total surface area, the total measurement (volume) of described capillary micropore substrate is no more than 500 cubic millimeters, and, the total measurement (volume) of hair minute aperture substrate is behind saturated absorption mouth cavity liquid sample, and the change scope is below 30%; The average pore size of capillary micropore substrate is that 20～500 microns, total void rate are no more than 80%, and the density of sample collecting device correspondence is 0.21～0.86 gram/cubic centimetre.
2, sample collecting device as claimed in claim 1 is characterized in that, described sample collecting device profile is table tennis plate or oar shape.
3, sample collecting device as claimed in claim 1, it is characterized in that, the change scope of the total measurement (volume) of described capillary micropore substrate is no more than 1%, the average pore size of capillary micropore substrate is that 20～200 microns, total void rate are 40%～45%, and the density of sample collecting device is 0.48～0.52 gram/cubic centimetre.
4, sample collecting device as claimed in claim 1 is characterized in that, it is 8%～80% that described hydrophilic fibre accounts for sample collecting device gross weight ratio range, and hydrophilic fibre is cotton fiber, filter paper, sponge, cloth; Hydrophobic material is polyethylene, polypropylene, multi-styrene, high density polyethylene (HDPE), ultra high molecular polyethylene, Polyvinylidene fluoride, politef, nylon and polyether sulfone, other plastics, glass or resin; The weight ratio scope of hydrophilic fibre and hydrophobic material is 1: 9 to 4: 1.
5, sample collecting device as claimed in claim 4 is characterized in that, it is 10%～58% that described hydrophilic fibre accounts for sample collecting device gross weight ratio range, and hydrophilic fibre is a cotton fiber; Hydrophobic material is a polyester; The weight ratio scope is 1: 9 to 3: 2.
6, sample collecting device as claimed in claim 1, it is characterized in that, board was controlled in 5 minutes from the time of oral cavity saturated absorption mouth cavity liquid sample, was adsorbed in the intramatrical mouth cavity liquid sample of capillary micropore and was controlled in 10 minutes through the time that shank is delivered to the test agent bar from board; Amount by sample collecting device absorption and the mouth cavity liquid sample carried is controlled at below 1000 cubic millimeters.
7, sample collecting device as claimed in claim 1, it is characterized in that, board is no more than 1 minute from the time of oral cavity saturated absorption mouth cavity liquid sample, is adsorbed in the intramatrical mouth cavity liquid sample of capillary micropore and is no more than 2 minutes from board through the time that shank is delivered to the test agent bar; Amount by sample collecting device absorption and the mouth cavity liquid sample carried is no more than 500 cubic millimeters.
8, sample collecting device as claimed in claim 1 is characterized in that, also comprises the adsorption aid of being located at the surface, to possess the function of enrichment adsorptive liquid sample.
9, sample collecting device as claimed in claim 8, it is characterized in that, comprise further that also being located at the surface can stimulate the excretory material of mouth cavity liquid, described material is citric acid, tartaric acid, fumaric acid, ascorbic acid, malic acid, Sal, fructose, glucose, sucrose, artificial sweetener or aromatic.
10, sample collecting device as claimed in claim 1 is characterized in that, liquid sample is the mouth cavity liquid sample, and mouth cavity liquid comprises saliva, oral mucosa exudate.
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| CNB2007101697357A CN100539953C (en) | 2007-02-05 | 2007-11-15 | Sample collecting device |
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| CNB2007101697357A CN100539953C (en) | 2007-02-05 | 2007-11-15 | Sample collecting device |
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| CN102539752B (en) * | 2010-12-17 | 2014-09-24 | 苏州万木春生物技术有限公司 | Oral fluid diagnosing instrument |
| CN102565385A (en) * | 2011-12-27 | 2012-07-11 | 深圳市爱速尔生物技术有限公司 | Rapid detection instrument for epidemic antigen and antibody of living animal |
| CN102525570B (en) * | 2011-12-27 | 2013-09-11 | 深圳市爱速尔生物技术有限公司 | Sample collector |
| CN102854310A (en) * | 2011-12-27 | 2013-01-02 | 深圳市爱速尔生物技术有限公司 | Living-animal food safety rapid detector |
| CN103823059B (en) * | 2012-11-19 | 2017-02-08 | 南京路始生物科技有限公司 | Saliva direct detection device |
| JP6622050B2 (en) * | 2015-10-07 | 2019-12-18 | キヤノンメディカルシステムズ株式会社 | Capillary tube, sample collector, and sampler |
| CN114414306A (en) * | 2022-01-13 | 2022-04-29 | 杭州安旭生物科技股份有限公司 | Sample collection device and sample collection method |
| CN114403944B (en) * | 2022-03-28 | 2022-05-31 | 南通市海锐实验器材有限公司 | Closed tongue scraping type saliva DNA sampler |
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Effective date of registration: 20160119 Address after: 518000, Guangzhou International Biological Island, Guangdong, No. four, No. 5, fourth, 402, 405 Patentee after: Guangdong dream Biotechnology Co.,Ltd. Address before: Panyu District Qinghe Road Guangzhou city Guangdong province 518000 Luojia No. 88 East Graceland seat seventeen ladder 304 room Patentee before: He Nanhang |
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