CN1207056A - Diagnostic test apparatus - Google Patents

Diagnostic test apparatus Download PDF

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Publication number
CN1207056A
CN1207056A CN 96199487 CN96199487A CN1207056A CN 1207056 A CN1207056 A CN 1207056A CN 96199487 CN96199487 CN 96199487 CN 96199487 A CN96199487 A CN 96199487A CN 1207056 A CN1207056 A CN 1207056A
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CN
China
Prior art keywords
sample
sample collection
equipment
collection equipment
analyte
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Pending
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CN 96199487
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Chinese (zh)
Inventor
迈克尔·约翰·查德
菲力普·罗伯特·古德温
克里斯多夫·约翰·史密斯
罗伯特·伍尔斯顿
伯纳德·萨姆斯
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Cortecs Ltd
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Cortecs Ltd
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Application filed by Cortecs Ltd filed Critical Cortecs Ltd
Priority to CN 96199487 priority Critical patent/CN1207056A/en
Publication of CN1207056A publication Critical patent/CN1207056A/en
Pending legal-status Critical Current

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Abstract

Sample collection apparatus (101, 101a) is provided which allows for fast, accurate, repeatable sample collection, particularly of blood and saliva samples. This apparatus is adapted to interconnect with a device (106) designed to carry out analyte detection. Kits comprising the sample collection apparatus (101, 101a) are also provided.

Description

Diagnostic test apparatus
The present invention relates to a kind of liquid sample that is used to gather, particularly is Biosample, as the equipment of blood or saliva.This equipment is suitable for gathering the sample of using for diagnostic test very much, and the present invention also provides the kit of the above-mentioned test usefulness of a kind of confession.
The quick diagnosis test is adopted at home by patient more and more and is used in its clinic by the doctor.By means of diagnose test apparatus and/or provide and gather sample and can carry out these tests to its kit that carries out the required various utensils of diagnostic test.This just makes many these type of tests make things convenient for without any confusion and to carry out quickly.An example of this type of test is " HELISAL " test that is used for being undertaken by blood sample the H.pylori Infect And Diagnose.
Certainly, this type of test and must can provide required precision, the order of accuarcy that this precision can reach or can reach near hospital laboratory at least for the experimental rig/kit that carries out this type of test and provide.In addition, common situation is that the required sample size of test is limited to a particular range.For the use in the family, and even for the use of doctor in the clinic, all have the problem of accurately measuring sample size.In addition, the sample that may have " biohazard " may be difficult to carry.Therefore, needed is the equipment of certain form, and this equipment is allowed sample collection within suitable volume scope, meanwhile, reduced the danger that the user contacts with sample to greatest extent.
Generally speaking, at present, at first be to gather sample, then it to be transferred on the apparatus, this apparatus may be a device, or analog, or a simple test tape, tests at this.For example, for blood sample is tested, the personnel that carry out this test puncture the finger of checked object possibly, use a simple capillary aspirates blood samples then.Then, this blood sample is transferred on experimental rig or the test tape, so that react.Obviously, if a kind of sample that can accurately gather " fixing " amount can be provided, discharge this sample then in the following manner, promptly can all accurately and apace form sample at every turn, guaranteeing the repeatably sample collection equipment of accurate result of the test thus, will be more satisfactory then.
The applicant has visualized this kind equipment.This equipment is easy to use, can be suitable for gathering dissimilar samples and different sample sizes at an easy rate, and can also reduce the danger that the user contacts sample to greatest extent, particularly on sample being transferred to the device that is used for this sample is carried out diagnostic test in.Particularly, this equipment is designed to link to each other with device that an analyte inspection body is housed or housing.The connection of two parts is guaranteed can accurately provide sample when testing at every turn, thereby this sample can be transferred to inspection body quickly and accurately.
Therefore, at first, the invention provides and be suitable for and one the device of analyte inspection body or the sample collection equipment that housing is coupled to each other be housed, wherein when being coupled to each other with said apparatus or housing, provide sample by following mode, promptly at least a portion of arbitrary sample will be transferred to above-mentioned device or housing from collecting device in this collecting device.Be that this collecting device comprises that one is suitable for the second portion that first and that the user controls includes sample collection mechanism when gathering sample adaptably.
This collecting device can be designed to only one push away simply, just can be associated in device that analyte inspection body is housed or housing.But, in one embodiment, this collecting device also comprises the aligning guide that is suitable for guaranteeing correct guidance sample collection equipment when being coupled to each other with verifying attachment or housing.An example of this aligning guide is a guide rail, or is used for and the projection of the groove alignment that forms at verifying attachment or housing.In addition, aligning guide itself also can be used as interconnect device.
Be specially adapted in the preferred embodiment of blood sample collection one, blood specimen collection mechanism comprises at least two elements, when this element is contacted with liquid, is suitable for receiving certain sample size between two elements.Particularly, this equipment will be worked by drawing sample by capillarity, and said elements is contacted with sample.What element was preferably elongated also can for example make with plate, maybe can form broach shape structure.In another structure, can provide the two-dimensional arrangement of the element that forms the space therebetween.This equipment can only be suitable for gathering the sample of specified quantitative at an easy rate by means of the volume that changes the space between the two elements.Preferred embodiment is included in four, five or six elongated members in the broach shape structure, is provided at three, four or five spaces of depositing sample that per two interelements form respectively.
The accurate characteristic of said elements and configuration are not most important.But, obviously can not make this element with hydrophilic material.In addition, the spacing between the two elements should make sample to be drawn and to remain between the two elements.If spacing is too big, then can not reach above-mentioned requirements.The essential characteristic that its configuration must have is that liquid sample can accurately be provided, and it is discharged fast and reliably.An embodiment that can realize this feature makes by the structure that makes collecting mechanism to realize that when it is interconnected its most surface area contacts with partial test device or housing.For example, a kind of structure will provide sample collection mechanism to contact with the common test tape with the porous material manufacturing, or with a usefulness porous material manufacturing and be designed to when interconnected, draw sample and sample is transferred to the intermediary element that will react part contact.
Using a kind of material, also may be very useful as the heparin coated coupons collector that reduces or eliminate blood clotting.
Be specially adapted to gather in the preferred embodiment of saliva sample at another, sample collection mechanism is made of the main body that a usefulness absorbent material is done.An example of suitable material is the absorbent material that comprises one or more sintered polymers.Useful polymer comprises plastics, as sintering polyethylene (PE).
This material has biocompatibility, can not ftracture, fragmentation, distortion etc., and also fast Absorption liquid consistently.In addition, this material has the aperture that is controlled, and like this, can form this material by following mode, and promptly it will make the material that has sucked easily be transferred to/be disposed to " downstream " element in arbitrary complete diagnosis utensil.Can adopt many modes to control the aperture.At first, can adopt polymer powder with different average particle size particle size.If can not get having just the polymer powder in required aperture, so, just the powder with bigger average pore size can be ground to required particle size.The average particle size particle size of the polymer powder of particularly suitable is 20 μ m to 500 μ m.
The another way of control particle size is to regulate the filling of polymer powder in the mould before sintering.But, adopt this method only the aperture may be changed to lesser extent.
In order to ensure absorbing hydrophilic liquid well,, can adopt more hydrophilic polymer as saliva.Yet, also can handle, to strengthen its hydrophily to more not hydrophilic polymer material.Can before or after sintering circuit, carry out above-mentioned processing.The example of this type of processing comprises with surfactant/moistening temperature agent such as lauryl sodium sulfate (SDS), or the processing of preferably carrying out with biocompatible agent such as Crodasinic LS30, chemical treatment, electricity is handled or radiation treatment, improves the surface property of material thus.
In order to produce this absorbent material, one or more polymer powder is mixed in mould.Can by means of or do not carry out the filling of mould by means of mechanical oscillation, this will depend on desired packing density.Then, this mixture is heated to sintering temperature in mould, promptly is higher than the temperature of melting point polymer, thereby make the pellet fusing of polymer and adhere to each other, make fully flowing of its porosity characteristic that loses material but be not enough to produce.
Degree of heat on polymer that can reach or the various melting point polymer will depend on the melt viscosity of polymer or each polymer.If the polymer that selection has high melt viscosity, then the comparable fusion temperature of the sintering temperature that is adopted is much higher.Yet,, sintering temperature must be controlled near the fusing point of polymer very modestly if melt viscosity is lower.
Can adopt arbitrary suitable material mfg. moulding die with good heat-conducting.Mould is remained on required temperature, till polymer or each polymer melt satisfactorily.Then, cooling die and absorbent material taken out from mould.
Be this materials processing to be become a liner or swab, this member to be convenient to gather sample adaptably as saliva.This material is easy to handle and process and is suitable for being shaped to specific configuration.
In another embodiment, the equipment that is provided allows the user to select the dissimilar acquisition elements that can be connected with first " handing " part.
For example, can provide this equipment with the form of a kit, this kit is provided with first and the many different acquisition elements as " standard " part.Different acquisition elements can only be the different broach shape device that is designed to gather the various sample amount.Perhaps, can provide a broach linear element, also have absorbent material pad as described herein.So the user can select the suitable acquisition elements that is used for the sample that will gather.
Therefore, can use this equipment to gather the sample of fixed amount.In text of the present invention, so-called " fixing " typically refers to the volume in proper range of the test that is used for adopting sample size.Do not need absolute accuracy, only need be enough to be accurate to assurance provides the degree of sample being carried out the sufficient material of any test usefulness.For example, will adopt the diagnose test apparatus part, sample should be enough to guarantee test device not " underload " or " overload ".
Therefore, under the situation of " broach " type of employing device, the space between the two elements will limit the sample volume, and the user only need guarantee that the space between the element is full of by sample.Under the situation of absorbent material of packing in equipment, can adopt " appropriately " display that comprises certain pattern, this display will make the user can confirm to gather whether the sample of for example saliva of q.s.Therefore, people can be with a kind of food coloring, as blue food coloring, and that part of absorbent material of the portion of the handle that closes on harvester most of packing into.In case liquor sample contacts this food coloring, just dissolving and diffusion of food coloring (in fact portion of the handle can to small part hollow, to hold the pigment of dissolving) shows thus and gathered enough samples.
Equipment of the present invention can be with any suitable material manufacturing, and certain, its necessary condition is the absorbing component that certain pattern is provided in suitable part.This type of material can comprise that those can be shaped to the material of required configuration.Can also will be suitable for by machined or the material that cuts into required configuration.The example of this type of material is to use in this area and be the known conventional plastics of those skilled in the art.
As discussed herein, when being coupled to each other with verifying attachment or housing, equipment of the present invention will provide sample exactly, thereby when when suitable mechanism contacts, can discharge or shift sample.Therefore, pack into the device or the housing of analyte inspection body will comprise the mechanism that is used for sample is transferred to said apparatus or kit.Like this, will discharge fixing sample size from this equipment, thereby can make the analyte checking procedure, for example diagnostic test begins.
Secondly, the present invention will provide a kind of kit that is used for the analyte of test sample, and this kit comprises:
(i) the sample collection equipment that is limited as mentioned; With
(ii) be used to check the mechanism of analyte.
Suitably, be used to check the mechanism of analyte to comprise:
I) reaction zone; With
Ii) be used for sample is transferred to the mechanism of reaction zone.
Suitably, reaction zone is positioned at the suitable material of a usefulness, is with as the examination of nitrocellulose, nylon or similar material manufacturing.Be used for the mechanism that sample is transferred to reaction zone can be a kind of porous or absorbent material, as filter paper or similar articles.When kit is used for checking the analyte of blood sample, because normal conditions are that analyte exists only in the blood plasma, so at first the red blood cell in the separated plasma is effective.Therefore, this equipment also can comprise the mechanism that is used for from the blood plasma washed corpuscles.Just prevent that with observing with regard to the interference of examining any color reaction that is used for checking analyte, this also is useful.In one embodiment, the mechanism that is used for sample is transferred to reaction zone also can be used for from the blood plasma separating red corpuscle.
Usually, reaction zone will have one or more the reagent with its combining with analyte of fixing.For example, when the analyte that will check is antibody, reaction zone can have with its fix be used for antibody one or more combine the companion body, for example, the antigen of one or more that can combine with antibody.Perhaps by another kind of scheme, when the analyte that will check was antigen, reaction zone can have one or more the antigen that fixes with it and use and combine the companion body, the antibody that if can combine with antigen.
In a concrete preferred embodiment, the existence of the analyte admissible test H.pylori that check, promptly analyte is a kind of antigen, it is a kind of antigen that stems from H.pylori; Perhaps when analyte was a kind of antibody, it was a kind of antibody that combines with at least a antigen that stems from H.pylori.
Best, make this equipment and analyte inspection body be suitable for being coupled to each other, thereby their are connected, they just can not split, and have guaranteed not take place the leakage of sample thus.Therefore, in use, gather sample size by sample collection equipment.Then, collecting device and analyte inspection body are coupled to each other.This sample will provide to analyte inspection body from collecting device, be transferred to reaction zone thus.At last, will carry out the observation of result of the test.
In addition, the present invention will provide:
A) when gathering sample, particularly blood sample or saliva sample, use equipment of the present invention;
B), particularly during the analyte in blood sample or the saliva sample, use kit of the present invention at test sample; With
C) step that adopts the best equipment of the present invention that provides as the part of kit of the present invention to gather sample size is provided for a kind of method that is used for the analyte of test sample, this method.Among the embodiment in this regard, this method is used for checking the analyte of blood sample or saliva sample, and H.pylori infects in particular for diagnosis.
Preferred embodiment of the present invention now is described in detail in detail with reference to the accompanying drawings, and accompanying drawing comprises:
Fig. 1 shows an embodiment of sample collection equipment;
Fig. 2 shows the sample collection equipment shown in Figure 1 of the analyte inspection body that comprises a kind of form;
Fig. 3 shows the sample collection equipment shown in Figure 1 that comprises an analyte inspection body cutaway view;
Fig. 4 shows another embodiment of sample collection equipment, and expression comprises " blood sample " collector and " saliva " collector of the analyte inspection body of another kind of pattern; With
Fig. 5 shows " blood sample " collector shown in Figure 4 of the cutaway view of the analyte inspection body that comprises another pattern.
Fig. 1 shows an embodiment of sample collection equipment of the present invention.This equipment 1 is made up of first 2 and second portion 3, and first 2 is designed to and can be held by the user, and second portion 3 is used for sample collection.Part second portion 3 is formed by some elongate articles 4, and this elongate articles forms a series of spaces 5 between it.In use, second portion 3 can be placed to the liquid that makes it with for example blood contacts.By means of capillarity, the sample size of liquid will flow into above-mentioned space 5.
In Fig. 2, device 1 is adjacent with the member that is device 6 forms that is suitable for the analyte in the test sample.As can be seen, the second portion 3 of sample collection equipment 1 can be inserted in an opening 7 that forms on the device 6.Therefore, in use, be connected with device 6 by its second portion 3 being inserted opening 7, can make the collecting device 1 that carries sample.Then, sample can be transferred on the nitrocellulose bar 8, this reaction zone can be observed by a window 9 that cuts out by at least a portion anabolic reaction district of this nitrocellulose bar on the upper surface 10 of device 6.Therefore, can be observed the result of test by this window 9.Shown embodiment also provides a reference region 11, can observe this reference region by one second window 12 that cuts out on the upper surface 10 of device 6.
When by means of the color reaction viewing test as a result the time, above-mentioned reference region can provide the basis of the result in the identification reaction district 8.Perhaps, this reference region can constitute one " test is finished " district.This will allow the user to confirm to have packed into to be enough to be used in obtaining the material of reliable result of the test.
In Fig. 3, show the device 6 that longitudinally dissects, therefore clearly show its internal structure more.In use, by its second portion 3 is inserted in the opening of offering on the device 67, sample collection equipment 1 and device 6 are fixed.In case finish insertion, the sample size that is kept in the space 5 between two elongate articles 4 contacts with a member that comprises a kind of porous/absorbent material 13.This member will be used for sample is transferred to nitrocellulose bar 8 from collecting device.In addition, if sample is a blood sample, it also will be used for from the blood plasma washed corpuscles.The lower surface of member 13 contacts with the upper surface of nitrocellulose bar 8, so sample also will be inhaled into along bar 8 roughly entering nitrocellulose bar 8 downwards along member 13.
Whole nitrocellulose bar 8 can constitute reaction zone, perhaps, more generally be, only a part of nitrocellulose bar will constitute reaction zone, and if analyte is arranged in sample, what fix with it will be one or more the reagent that can combine with analyte.
For example, exist in the test of H.pylori antibody in the blood sample in check, at least a portion nitrocellulose bar 8 will have one or more the antigen that stems from H.pylori that fixes with it.When sample passes through strip 8, the arbitrary H.pylori antibody that is present in the blood sample will combine with fixing antigen.Then, can read result of the test by following manner, promptly for example in nitrocellulose bar 8, add a kind of common reagent that can combine (as a kind of AIG (antiIgG) antibody) with antibody, this reagent again with a color reagent, combine as the latex particle of colour.Therefore, when the antibody that is used for sample combines with antigen, a kind of color density will appear.
The further improvement of device 6 provides a control zone.This control zone can be near reaction zone.A kind of reference reagent can be incorporated in this control zone.In use, this control zone can be designed to can be in conjunction with arbitrary colored reagent, and this reagent passes reaction zone, but does not combine with it.Like this, combine with the control zone by the reagent that makes this " excessive ", can evaluation test.
Thus, this control zone allows the user to guarantee that test moves and eliminated false negative correctly.
The collector 101a that Fig. 4 shows another embodiment of " blood sample " collector 101 and comprises a described mass of absorbent material herein.Equally, collector 101,101a have a second portion 103/103a that can be used for sample collection by the 102/102a of first and that the user holds.If " blood sample " collector 101 has an elongate articles 113 between first 102 and collector part 103.Being designed to of collecting part 103 can be gathered that part of of sample and be made up of some elongate articles 104, and this elongate articles defines a plurality of spaces 105 betwixt.The use of this type of collector is identical with collecting device shown in Figure 11.
Saliva collector 101a comprises and is designed to 102a of first that can be held by the user and the second portion 103a that is made of a mass of absorbent material.
The device 106 that is suitable for the analyte in the test sample is suitable for receiving collector 101/101a through opening 107.The result that the window 109 that warp cuts out on the upper surface 110 of device 106 can be read diagnostic test.
In Fig. 5, show device 106 and " blood sample " collector 101 of longitudinally dissecing.This figure clearly show that collector 101 is how can interact with device 106, discharges the sample that remains in the collecting part 103 that is formed by elongate articles 104.When opening 107 inserts device 106 with collector, collecting part 103 is that elongate articles 113 is by guide rail 115 guiding then.Collector 101 also is provided with engaging mechanism 117, and this engaging mechanism engages with corresponding mechanism 116 on being located at device 106.These mechanisms are bonded with each other and with collector 101 fix in position, make elongate articles 113 and collecting part 103 stretch into the inside of device 106, thereby elongate articles 104 contacts with absorbent member 114, and absorbent member 114 contact with a nitrocellulose bar 108.Therefore, sample will pass the absorbent member 114 that also can be suitable for washed corpuscles from corresponding blood plasma, enter in the nitrocellulose bar 108 that carries out diagnostic test.

Claims (49)

1. one kind is suitable for and a kind of device of analyte inspection body or sample collection equipment that housing is coupled to each other of being equipped with, comprise sample collection mechanism, it is characterized in that, when being coupled to each other with said apparatus or housing, sample collection mechanism is provided with by following mode, and promptly at least a portion sample in this equipment will be transferred to said apparatus or the housing from collecting device.
2. sample collection equipment as claimed in claim 1 is characterized in that, this equipment comprises that a first and that is suitable for being held by the user comprises the second portion of sample collection mechanism.
3. sample collection equipment as claimed in claim 2 is characterized in that, comprises that the second portion of sample collection mechanism can split with first.
4. as each the described sample collection equipment in the claim 1 to 3, it is characterized in that this equipment also comprises and is suitable for aligning guide that described equipment and said apparatus or housing correctly are coupled to each other.
5. sample collection equipment as claimed in claim 4 is characterized in that, described aligning guide also constitutes and is coupled to each other mechanism.
6. as each the described sample collection equipment in the claim 1 to 5, it is characterized in that sample collection equipment is suitable for being used for sample is transferred to mechanism on said apparatus or the housing along the contact of the major part of its surface area, described mechanism is positioned at above-mentioned housing.
7. sample collection equipment as claimed in claim 6 is characterized in that, this sample collection mechanism comprises at least two elements, and when at least two above-mentioned elements were contacted with a kind of liquid, said elements was suitable for holding betwixt certain sample size.
8. sample collection equipment as claimed in claim 7 is characterized in that, absorbs fixing sample size by means of capillarity.
9. as claim 7 or 8 described sample collection equipment, it is characterized in that at least two above-mentioned elements are elongate articles.
10. sample collection equipment as claimed in claim 9 is characterized in that above-mentioned element is made by plate.
11. sample collection equipment as claimed in claim 9 is characterized in that above-mentioned element forms a comb structure.
12. sample collection equipment as claimed in claim 11 is characterized in that, above-mentioned broach is formed by four, five or six elongate articles, is provided at three, four or five spaces that hold sample size that form between each two respectively.
13. each the described sample collection equipment as in the claim 1 to 12 is characterized in that, is provided with the row's element that is provided with by two dimension, forms the space between per two elements.
14. sample collection equipment as claimed in claim 6 is characterized in that, above-mentioned sample collection mechanism comprises absorbent material, preferably makes a liner.
15. sample collection equipment as claimed in claim 14 is characterized in that, above-mentioned absorbent material is handled, to increase its hydrophily.
16. sample collection equipment as claimed in claim 15 is characterized in that, above-mentioned processing comprises with wetting agent such as SDS or Crodasinic LS30 processing.
17. each the described sample collection equipment as in the claim 1 to 16 is characterized in that, this equipment be suitable in case with the device that is provided with analyte inspection body just link can not with its fractionation.
18. a kit that is used for the analyte of test sample comprises:
(i) the sample collection equipment as limiting in in claim 1 to 17 each; With
(ii) be used to check the mechanism of analyte;
It is characterized in that, be used for checking the mechanism of an analyte device or the housing of packing into.
19. kit as claimed in claim 18, wherein, analyte inspection body comprises:
(i) reaction zone; With
(ii) be used for sample is transferred to the mechanism of reaction zone;
It is characterized in that at least a portion reaction zone is suitable for combining with the analyte that will be verified.
20. as the kit of claim 19, it is characterized in that, on the band that part is made by nitrocellulose, nylon or similar material, form above-mentioned reaction zone as stating.
21., it is characterized in that the lower surface that at least a portion is used for sample is transferred to the mechanism of above-mentioned reaction zone contacts with the upper surface of the above-mentioned band of at least a portion as claim 20 as the kit stated.
22. each the described kit as in the claim 19 to 21 is characterized in that, be used for the mechanism that sample is transferred to above-mentioned reaction zone is comprised a kind of porous or absorbent material.
23. each the described kit as in the claim 19 to 22 is characterized in that, also comprises the mechanism that is used for from the blood plasma separating red corpuscle.
24. kit as claimed in claim 23 is characterized in that, the mechanism that is used for sample is transferred to reaction zone also is used for from the blood plasma separating red corpuscle.
25. each the described kit as in the claim 19 to 24 is characterized in that, above-mentioned reaction zone has one or more the reagent that can combine with analyte that is fixed thereon.
26. the kit described in claim 25, it is characterized in that, the analyte of checking be a kind of antibody and above-mentioned reaction zone be fixed with thereon one or more be used for this antibody in conjunction with the companion body, as one or more the antigen that can combine with above-mentioned antibody; Perhaps the analyte that will test is a kind of antigen, and above-mentioned reaction zone be fixed with thereon one or more be used for this antigen in conjunction with the companion body, the antibody of one or more that if can combine with this antigen.
27. kit as claimed in claim 26 is characterized in that, when the analyte that will check was a kind of antigen, this antigen was the antigen of a kind of H.pylori of stemming from; Perhaps, when the analyte that will check was a kind of antibody, this antibody was a kind of antibody that can combine with at least a antigen that stems from H.pylori.
28. each the described kit as in the claim 18 to 27 is characterized in that, above-mentioned device or housing are suitable for being coupled to each other with the said sample collecting device, thereby when connecting, prevent to take apart.
29. each the described kit as in the claim 18 to 28 is characterized in that this kit is used for checking the analyte of blood sample.
30. a sample collection equipment comprises at least two elements, when at least two above-mentioned elements were contacted with a kind of liquid, said elements was suitable for holding betwixt certain sample size.
31. sample collection equipment as claimed in claim 30 is characterized in that, draws the sample of fixed amount by means of capillarity.
32., it is characterized in that this equipment comprises that is suitable for the user has above-mentioned at least two elements with hand-held first and of holding a second portion as claim 30 or 31 described sample collection equipment.
33. each the described sample collection equipment as in the claim 30 to 32 is characterized in that at least two above-mentioned elements are elongate articles.
34. sample collection equipment as claimed in claim 33 is characterized in that said elements is made by plate.
35., it is characterized in that above-mentioned element forms a kind of comb structure as claim 33 or 34 described sample collection equipment.
36. sample collection equipment as claimed in claim 35 is characterized in that, forms broach by four, five or six elongate articles, is provided at three, four or five spaces that hold sample size that form between per two respectively.
37. each the described sample collection equipment as in the claim 30 to 36 is characterized in that, is provided with the element of a row by two-dimensional arrangement, forms the space therebetween.
38. each the described sample collection equipment as in the claim 30 to 37 is characterized in that, this equipment is suitable for contacting with an analyte inspection body.
39. sample collection equipment as claimed in claim 38 is characterized in that, is coupled to each other by means of this equipment of making and the device or the housing that are provided with analyte inspection body, and this equipment is contacted with analyte inspection body.
40. sample collection equipment as claimed in claim 39 is characterized in that, this equipment is suitable in case link with the device that is provided with analyte inspection body, this equipment just can not with its fractionation.
41. as the purposes of each the described sample collection equipment in claim 1 to 15 or 30 to 40 when gathering sample size.
42. purposes as claimed in claim 41 is characterized in that, sample size is a blood sample.
43. as each the described kit in the claim 18 to 29, the purposes during analyte in test sample.
44. purposes as claimed in claim 43 is characterized in that, sample is a blood sample.
45. comprising, a method that is used for the analyte of test sample, this method adopt the step of gathering a certain amount of sample as each the described sample collection equipment in claim 1 to 15 or 30 to 40.
46. method as claimed in claim 45 is characterized in that, the said equipment provides as the part as each the described kit in the claim 18 to 29.
47., it is characterized in that described sample is a blood sample as claim 45 or 46 described methods.
48. each the described method as in the claim 45 to 47 is characterized in that, this method comprises also the mechanism that employing provides determines whether there is analyte in the sample in kit.
49. as each the described method in the claim 45 to 48, this method constitutes an a kind of part that is used to diagnose the method that H.pylori infects at least.
CN 96199487 1995-11-13 1996-11-13 Diagnostic test apparatus Pending CN1207056A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN 96199487 CN1207056A (en) 1995-11-13 1996-11-13 Diagnostic test apparatus

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB9523163.5 1995-11-14
GB9523288.0 1995-11-14
CN 96199487 CN1207056A (en) 1995-11-13 1996-11-13 Diagnostic test apparatus

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CN1207056A true CN1207056A (en) 1999-02-03

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CN 96199487 Pending CN1207056A (en) 1995-11-13 1996-11-13 Diagnostic test apparatus

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CN106148160A (en) * 2015-03-27 2016-11-23 深圳华大基因科技服务有限公司 Cell separation apparatus and cell isolation method
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CN102576031A (en) * 2009-06-02 2012-07-11 因福皮亚有限公司 Sampling/sample-injecting apparatus and biodata-measuring set comprising same
CN102576031B (en) * 2009-06-02 2015-07-29 因福皮亚有限公司 Sampling/sample injections device and comprise its biological data measure external member
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CN102650601A (en) * 2011-02-25 2012-08-29 霍尼韦尔国际公司 Microfluidic separation of plasma for colormetric assay
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CN106148160B (en) * 2015-03-27 2018-04-20 深圳华大基因科技服务有限公司 Cell separation apparatus and cell isolation method
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CN111107935A (en) * 2017-08-03 2020-05-05 菲帛罗缇埃克斯有限公司 Lateral flow assay device for skin care applications

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