WO1999057559A1 - Dispositif permettant de recueillir un liquide organique et de le faire secher - Google Patents
Dispositif permettant de recueillir un liquide organique et de le faire secher Download PDFInfo
- Publication number
- WO1999057559A1 WO1999057559A1 PCT/US1999/009479 US9909479W WO9957559A1 WO 1999057559 A1 WO1999057559 A1 WO 1999057559A1 US 9909479 W US9909479 W US 9909479W WO 9957559 A1 WO9957559 A1 WO 9957559A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- channel
- blood
- internal compartment
- opening
- porous
- Prior art date
Links
- 238000001035 drying Methods 0.000 title claims description 17
- 210000001124 body fluid Anatomy 0.000 title claims description 13
- 239000010839 body fluid Substances 0.000 title claims description 12
- 210000004369 blood Anatomy 0.000 claims abstract description 87
- 239000008280 blood Substances 0.000 claims abstract description 87
- 239000000463 material Substances 0.000 claims abstract description 48
- 230000002745 absorbent Effects 0.000 claims abstract description 19
- 239000002250 absorbent Substances 0.000 claims abstract description 19
- 210000002966 serum Anatomy 0.000 claims description 15
- 239000011148 porous material Substances 0.000 claims description 14
- 230000002209 hydrophobic effect Effects 0.000 claims description 11
- 238000004891 communication Methods 0.000 claims description 8
- 229920003023 plastic Polymers 0.000 claims description 6
- 239000004033 plastic Substances 0.000 claims description 6
- 210000000601 blood cell Anatomy 0.000 claims description 5
- 229920001903 high density polyethylene Polymers 0.000 claims description 4
- 239000004700 high-density polyethylene Substances 0.000 claims description 4
- 239000007788 liquid Substances 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 4
- 239000004699 Ultra-high molecular weight polyethylene Substances 0.000 claims description 3
- 230000004888 barrier function Effects 0.000 claims description 3
- 229920000785 ultra high molecular weight polyethylene Polymers 0.000 claims description 3
- 239000012528 membrane Substances 0.000 description 43
- 239000012530 fluid Substances 0.000 description 15
- 238000004458 analytical method Methods 0.000 description 8
- 238000000926 separation method Methods 0.000 description 8
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- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 3
- 239000004698 Polyethylene Substances 0.000 description 3
- 102000007066 Prostate-Specific Antigen Human genes 0.000 description 3
- 108010072866 Prostate-Specific Antigen Proteins 0.000 description 3
- 239000008103 glucose Substances 0.000 description 3
- 239000011159 matrix material Substances 0.000 description 3
- 102000017011 Glycated Hemoglobin A Human genes 0.000 description 2
- 239000000470 constituent Substances 0.000 description 2
- 238000011109 contamination Methods 0.000 description 2
- 238000010828 elution Methods 0.000 description 2
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- 238000005259 measurement Methods 0.000 description 2
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- 229920006395 saturated elastomer Polymers 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 239000011800 void material Substances 0.000 description 2
- 102000004506 Blood Proteins Human genes 0.000 description 1
- 108010017384 Blood Proteins Proteins 0.000 description 1
- 229920000742 Cotton Polymers 0.000 description 1
- 108010014663 Glycated Hemoglobin A Proteins 0.000 description 1
- 229920006382 Lustran Polymers 0.000 description 1
- 229920000339 Marlex Polymers 0.000 description 1
- 229920001410 Microfiber Polymers 0.000 description 1
- 101100216185 Oryza sativa subsp. japonica AP25 gene Proteins 0.000 description 1
- 206010060862 Prostate cancer Diseases 0.000 description 1
- 208000000236 Prostatic Neoplasms Diseases 0.000 description 1
- 229920005822 acrylic binder Polymers 0.000 description 1
- 238000004026 adhesive bonding Methods 0.000 description 1
- 238000001042 affinity chromatography Methods 0.000 description 1
- 239000012491 analyte Substances 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
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- 206010012601 diabetes mellitus Diseases 0.000 description 1
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Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
- B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
- B01L2200/06—Fluid handling related problems
- B01L2200/0678—Facilitating or initiating evaporation
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/06—Auxiliary integrated devices, integrated components
- B01L2300/0681—Filter
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/08—Geometry, shape and general structure
- B01L2300/0809—Geometry, shape and general structure rectangular shaped
- B01L2300/0816—Cards, e.g. flat sample carriers usually with flow in two horizontal directions
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/08—Geometry, shape and general structure
- B01L2300/0887—Laminated structure
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2400/00—Moving or stopping fluids
- B01L2400/04—Moving fluids with specific forces or mechanical means
- B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
- B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
- B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
Definitions
- the present invention is directed generally to the field of collecting and drying samples of body fluid such as blood.
- the preferred embodiments are devices for collecting and drying capillary or venous blood samples for the subsequent analytical, quantitative determination of clinical chemistry analytes.
- BACKGROUND Methods for assaying the constituents of blood are indispensable tools in the diagnosis and treatment of human disease.
- Analysis of dried blood is advantageous as the blood sample can be self-collected, and shipment of the blood sample to the laboratory is simplified since storage at ambient temperature and shipping through regular mail is permitted.
- Analysis of dried blood is further advantageous in that the sample poses a reduced risk of biohazardous exposure and the sample remaining after initial analysis can be stored in a repository for later use.
- blood may be collected and dried on absorbent material for subsequent clinical assays.
- blood can be collected and dried on Schleicher & Schuell no. 903TM specimen collection paper and assayed for the presence of glycosylated hemoglobin (Little et al., "Collection of Blood on Filter Paper for Measurement of Glycated Hemoglobin by Affinity Chromatography", Clin. Chem. 32: 869-871 (1986); Little et al., "Measurement of Glycosylated Whole- Blood Protein for Assessing Glucose Control in Diabetes: Collection and
- PSA prostate-specific antigen
- One problem with collecting and drying blood is that the spots are not always uniform in the disbursement of whole blood/serum/whole blood cell components throughout the total volume of the matrix, leading to inconsistencies in analysis.
- One significant advantage of the present invention is that it allows for the collection and drying of blood samples that are of uniform volume and integrity. As a result, the analytical results are more accurate and reproducible.
- Another advantage of the present invention is that once the blood sample is inside the apparatus there is a diminished risk of contamination or loss of integrity of the sample.
- the present invention relates to a device for consistently collecting and drying capillary or venous blood samples of a uniform quantity and integrity.
- the devices described below include a housing that defines an external opening, an internal compartment, and a channel interconnecting the opening and the compartment.
- the compartment is bounded at least in part by porous hydrophobic sheet material and encloses absorbent material.
- the sheet material allows water vapor to pass while retaining liquids.
- the absorbent material contained in the internal compartment optionally extends into the channel.
- a body fluid such as blood is applied through the external opening in the housing and is then drawn into the absorbent material in the internal compartment via the channel.
- the absorbent material in the internal compartment is saturated with fluid, then no more fluid will be drawn in to the device as the capillary action of the material will cease.
- the water- and air-vapor permeable nature of the sheet material allows fluid to dry in the housing without disassembling the device. After the fluid sample has dried, the device is disassembled and the sample or part of the sample is analyzed for the presence of a fluid constituent.
- the facile nature of operating this device permits even a user untrained in the blood collection arts to prepare a defined sample size of dried body fluid such as blood for laboratory analysis. As a result, the assay results are reproducible and consistent.
- Figures 1 (a), (b) and (c) and (d) describe component parts of a first preferred device for collecting and drying blood samples.
- Figure 2 is a longitudinal sectional view of a second preferred embodiment of this invention.
- Figures 3 and 4 are enlarged sectional views of the indicated portions of Figure 2.
- Figures 5, 6, 7 and 8 are bottom, side, top and end views, respectively, of the upper part 14 of the device 10 of Figures 2 through 4.
- Figures 9, 10, 11 , and 12 are cross-sectional views taken along the corresponding section lines of Figures 5 and 7.
- Figures 13, 14, 15, and 16 are top, side, bottom, and end views, respectively, of the lower part 16 of the device 10 of Figures 2 through 4.
- Figures 17, 18, and 19 are cross-sectional views taken along corresponding section lines of Figures 13 and 15.
- Figures 20, 21 , and 22 are bottom, side, and top views, respectively, of the plug 18 of the device 10 of Figures 2 through 4. 4
- Figure 23 is a fragmentary cross-sectional view of an alternative version of the device of Figures 2 through 4.
- Figure 1(c) is a base plate 1.
- Figure 1 (b) shows a middle plate 2 with which defines an opening 3 and a lateral channel 4.
- Fig. 1(a) is a top plate 6 having an aperture 7.
- the lateral channel 4 is filled with a strip 5', which is made of a porous hydrophilic material which will act to create a capillary draw of fluid through the sample collection disc 1.
- the opening 3 is filled with a sample collection disc 5, made of an absorbent material.
- Stacking the plates on top of each other assembles the device 8 (Fig. 1(d)).
- the middle plate 2 (Fig. 1(b), containing a sample collection disc 5 in the opening 3 and a strip 5' in the lateral channel 4, is placed flat on top of the base plate 1 (Fig. 1 (c)).
- the top plate 6 is placed flat on top of the middle plate 2 such that the aperture 7 is directly over the lateral channel 4 containing the strip 5'.
- the plates may be assembled using fastening or chemical means. Those skilled in the mechanical arts will recognize a wide variety of fastening and chemical means that can serve to hold the stacked plates (top plate 6, middle plate 2, housing absorbent material and the base plate 1 ) together to form the assembled device 8 (Fig. 1 (d)).
- the strip 5' and the sample collection disc 5 should be composed of a hydrophilic medium that can uniformly absorb and distribute a fluid, such as wet whole blood.
- the absorbent material used for the sample collection disc 5 should allow for the covalent capture and binding of clinical chemistry analytes, and their subsequent drying and elution all the while maintaining their composition and integrity.
- Schleicher & Schuell no. 903TM specimen collection paper is suitable for the collection and drying of blood samples.
- Schleicher & Schuell no. 903TM specimen collection paper is a pure cotton linter paper that was specifically designed for the collection and transport of bodily fluids. This material is well known to be suitable as a dried blood collection matrix, however, it exhibits an inherent variability in the void volume of the blood held per area, which limits its performance in accuracy and reproducibility of quantitative clinical chemistry analyte determination.
- the identified material of choice is a porous hydrophilic plastic medium
- Porex® Plastics 70 ⁇ m Lateral-FlowTM X-4588 (Porex Technologies Corp.; Fairburne, GA). This medium is a hydrophilic high-density polyethylene (HDPE) material manufactured at varying thickness and pore size specifications. For our purposes we have identified an average pore size of 70 ⁇ m and thickness of 0.021-0.029" to adequately allow the flow of whole blood through the device with adequate capture and binding of clinical chemistry analytes.
- the Porex® Plastics 70 ⁇ m Lateral-FlowTM material is permeable to water and air vapor, thus allowing for the uptake and drying of a capillary or venous blood of the sample collection disc 5, while it is still contained within the assembled device 8 (Fig. 1 (d)). This material provides significant advantages in producing a uniform distribution and volume of blood resulting in a dried blood sample that yields a more accurate and reproducible quantitative determination of clinical chemistry analytes.
- the plates, top plate 6, middle plate 2, and base plate 1 are made of a hydrophobic plastic material that does not absorb fluid.
- the identified material of choice is a non-porous hydrophobic plastic medium - Porex® T3 (Porex Technologies Corp., Fairburne, GA).
- This medium is an ultra-high molecular weight polyethylene (UHMW) material manufactured at varying thickness and pore size.
- UHMW ultra-high molecular weight polyethylene
- the Porex® T3 7 ⁇ m material is impermeable to water and air flow, thus providing an opening 3 and a lateral channel 4 for the 6
- sample collection disc 5 uptake of a capillary or venous blood sample into sample collection disc 5 and strip 5' while preventing liquid from escaping the device during the drying of blood in sample collection disc 5.
- the user applies a blood sample (not shown) to the aperture 7.
- the blood sample is drawn into the device by the capillary action of the absorbent material in the channel, strip 5', and then into the sample collection disc 5.
- the application process is so simple that even a user untrained in the practice of blood collection and transfer may apply the sample successfully to the device.
- the untrained user can use the device by obtaining capillary blood from a self-administered finger stick using a finger lancet.
- the capillary blood that flows from the finger stick is applied at the aperture 7 of the blood collection device.
- the application may take place in a hospital, physician's office, health clinic, worksite health center, or even in the user's home.
- the strip 5' and the sample collection disc 5 have absorbed the maximum void volume of the porous material, no more blood is drawn in to the device as the capillary action of the material is exhausted.
- Using the same sized sample collection disc for each device will ensure that the samples take up the same volume of blood, within a negligible defined range. Because the sample collection disc 5 takes up a precise volume of capillary or venous blood, the dried blood contained within the sample collection disc 5 will allow for more accurate and precise analytical determinations of clinical chemistry analytes.
- the absorbent material that comprises the strip 5' and sample collection disc 5 should substantially fill the lateral channel 4 and the opening 3, respectively. This will help to prevent voids in the housing of the device and produce a more uniform sample.
- the device When blood sample in the sample collection disc 5 is dry, the device is disassembled and the sample collection disc 5 is removed.
- the dried blood sample can be kept inside the device at ambient temperatures and sent to a laboratory for testing.
- disc 5 may then be subjected to quantitative analytical determinations of numerous clinical chemistry analytes.
- Those skilled in the clinical chemistry arts will recognize a wide variety of assays that may be performed on dried blood samples. (See e.g., Hoffman et al., (1996), supra; Little et al., (1986), supra; Little et al., (1985), supra).
- Figures 2 through 23 relate to a second preferred embodiment of a device for collecting and drying a body fluid such as blood.
- the device 10 includes a housing 12 that is made up of an upper part 14 (Figures 5-12), a lower part 16 ( Figures 13-19), and a plug 18 ( Figures 20-22).
- the upper part 14 defines an external opening 20 centered within a recess 22.
- the external opening 20 is aligned with an axis A, and the opening 20 provides fluid communication between the exterior of the housing 12 and a channel 24.
- the channel 24 is oriented substantially transversely to the axis A in this embodiment. In other embodiments, the channel 24 can be oriented at other nonparallel angles with respect to the axis A.
- the channel 24 provides a fluid flow path from the external opening 20 to an internal compartment 26 that is laterally offset from the external opening 20.
- the upper part 14 defines first and second openings 28, 30 that are in fluid communication with the internal compartment 26.
- First and second ribs 32, 34 extend around the internal compartment 26, the channel 24 and the external opening 20.
- the lower part 16 defines first and second recesses 36, 38 positioned and sized to receive the first and second ribs 32, 34, respectively.
- the lower part 16 also defines three legs 40. These legs 40 extend downwardly from the lower surface of the lower part 16 and provide stable support for the device 10.
- the lower part 16 also defines a cylindrically shaped socket 42 that is in fluid communication with the internal compartment 26.
- the plug 18 is sized to fit within the socket 42 in a press fit such that the plug 18 can be inserted into and removed from the housing 12 in a convenient manner.
- the plug 18 defines a central passageway 44 that is in 8
- the plug 18 defines a slightly enlarged distal end and the socket 42 defines a slightly enlarged internal end.
- These features provide increased retention forces tending to hold the plug 18 in place when the plug 18 is fully inserted into the socket 42.
- Other retention methods may be used, including for example screw threads, bayonet locks, splines, snap fits, and the like.
- the upper part 14 defines a ledge 46 adjacent to the first opening 28, and the plug 18 defines a ledge 48 adjacent to the central passageway 44.
- the ledges 46, 48 retain the porous sheets described below in position in the internal compartment 26.
- a vapor-permeable, liquid-barrier layer such as a porous hydrophobic membrane 50 is positioned immediately adjacent to the ledge 46
- a vapor-permeable, liquid-barrier layer such as a porous hydrophobic membrane 52 is positioned immediately adjacent to the ledge 48.
- the ledges 46, 48 hold the membranes 50, 52 in place during use.
- three sheets of porous material are mounted in the internal compartment 26 between the hydrophobic membranes 50, 52. These three sheets include a blood transport membrane 54, a blood separation membrane 56, and a serum collection membrane 58.
- the blood transport membrane 54 transports the selected body fluid (blood in this example) across the entire area of the internal compartment 26, and the blood transport membrane 54 is in fluid communication with the channel 24.
- the blood separation membrane 56 operates as a filter that separates blood cells from blood serum.
- the serum collection membrane 58 is positioned on the opposite side of the blood separation membrane 56 from the channel 24.
- the device 10 is assembled by first placing the hydrophobic membrane 50, the blood transport membrane 54, and the blood separation membrane 56 in the compartment-defining recess of the upper part 14. Then the lower part 16 is assembled to the upper part 14. As shown in Figures 2 y
- the lower part 16 locks the blood separation membrane 56 in place, thereby restraining any of the membranes 50, 54, 56 from moving out of the internal compartment 26 as long as the upper and lower parts 14, 16 remain in an assembled condition.
- the upper and lower parts 14, 16 can be held together by any suitable method, including a mechanical press fit, a mechanical welding or heat sealing operation, or an adhesive bonding operation.
- the plug 18 carrying the serum collection membrane 58 and the hydrophobic membrane 52 is positioned in the socket 42, thereby closing the internal compartment 26.
- a drop of body fluid such as blood is introduced into the recess 22.
- the walls of the channel 24 are preferably formed of a material that facilitates capillary flow, and the channel 24 therefore conducts body fluid such as blood from the external opening 20 to the internal compartment 26, where the body fluid is introduced onto the blood transport membrane 54. Serum from the blood then passes through the blood separation membrane 56 (which blocks the flow of blood cells), and serum is collected on the collection membrane 58.
- the porous hydrophobic membranes 50, 52 allow vapor to escape from the internal compartment 26 while preventing the movement of blood out of the internal compartment 26. Once the membranes 54, 56 are saturated with blood, the capillary action ceases and no further blood is transported into the internal compartment 26 by the channel 24.
- the blood sample including the serum collected on the serum collection membrane 58, dries.
- the user can see a reddening of the blood separation membrane 56 through the second opening 30 to confirm proper operation of the device 10.
- the plug 18 can be removed from the socket 42, thereby removing the serum collection membrane 58 from the internal compartment 26 for analysis.
- the dried serum sample can then be analyzed in any desired manner. 10
- the device 10 can be used in a manner similar to the device 8 of Figure 1(d), and the materials and analysis techniques described in connection with the device 8 can be used with the device 10.
- the internal compartment 26 can define a volume less than 1 ml and the channel 24 can define a cross-sectional dimension of less than 3 mm.
- the porous element in the embodiment described above substantially fills the entire internal compartment 26.
- the porous element in a dry state fills at least 20% of the volume of the internal compartment 26.
- High density polyethylene filter with pore size of 80-120 microns e.g. Porex Technologies X4588
- Borosilicate microfiber glass filter with acrylic binder resin e.g. Millipore AP20 and AP25
- an additional filter membrane such as a reinforced mixed cellulose esters filter (e.g. Millipore AW19) is placed between the membranes 56 and 58. 11
- a reinforced mixed cellulose esters filter e.g. Millipore AW19
- Table 2 provides examples of dimensions that can be used for the device 10.
- Width of channel 24 1.6
- the upper and lower parts 14, 16 and the plug 18 can be injection molded if desired from many suitable material.
- the selected material should provide the capillary action described above that draws blood from the external opening 20 via the channel 24 to the internal compartment 26.
- ABS e.g. Bayer Lustran ABS 243
- polyethylene e.g. Phillips Marlex PE HHM 5502 BN
- the sheets of porous material 54, 56, 58 can be replaced with a single porous element 62, as shown in Figure 23.
- the device does not separate blood serum from blood cells, but rather dries the unseparated blood in the porous element 62.
- the device of Figure 23 is identical to the device of Figure 2, except for the porous element 62. For this reason, comparable reference numerals have been used in Figure 23 and in Figure 3. 12
- the blood transport membrane, the blood separation membrane 56 and the serum collection membrane 58 are preferably formed of hydrophilic media that can uniformly absorb and distribute a fluid such as wet blood.
- the absorbent material used for the serum collection membrane 58 and the porous element 62 can allow for the non-covalent capture and binding of clinical chemistry analytes and their subsequent drying and elution, all the while maintaining their composition and integrity.
- the materials described above in conjunction with the device 8 can be used for the porous element 62.
- the devices 8, 10 provide the advantage of collecting a well-controlled volume of blood. This precision of collection allows for more accurate and precise analytical determination of clinical chemistry analytes.
- the dried blood sample can be kept inside the devices 8, 10 at ambient temperatures and sent to a laboratory for testing. Because the devices 8, 10 allow one to easily collect a defined volume of blood in the dried blood sample, even an untrained user can precisely and consistently collect samples for testing that are of optimum quality and quantity for accurate and precise analytical analysis.
- Another advantage of the devices 8, 10 is that once the blood sample is inside the apparatus there is a lowered chance of contamination or loss of integrity of the sample.
- the housings protect the sample from being contaminated or physically compromised.
- membrane is intended broadly to encompass a wide variety of porous materials, including but not limited to membrane filters, depth filters, and various porous sheet materials.
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Hematology (AREA)
- Clinical Laboratory Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU37764/99A AU3776499A (en) | 1998-05-01 | 1999-04-29 | Device for collecting and drying a body fluid |
EP99920212A EP1082612A1 (fr) | 1998-05-01 | 1999-04-29 | Dispositif permettant de recueillir un liquide organique et de le faire secher |
US09/674,407 US6524533B1 (en) | 1998-03-06 | 1999-04-29 | Device for collecting and drying a body fluid |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US8406598P | 1998-05-01 | 1998-05-01 | |
US60/084,065 | 1998-05-01 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1999057559A1 true WO1999057559A1 (fr) | 1999-11-11 |
Family
ID=22182673
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1999/009479 WO1999057559A1 (fr) | 1998-03-06 | 1999-04-29 | Dispositif permettant de recueillir un liquide organique et de le faire secher |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP1082612A1 (fr) |
AU (1) | AU3776499A (fr) |
WO (1) | WO1999057559A1 (fr) |
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6406919B1 (en) | 1999-12-16 | 2002-06-18 | Biosafe Laboratories, Inc. | Whole blood collection device and method |
US6524533B1 (en) | 1998-03-06 | 2003-02-25 | Biosafe Medical Technologies, Inc. | Device for collecting and drying a body fluid |
US7115421B2 (en) * | 2002-04-17 | 2006-10-03 | Biosafe Medical Technologies, Inc. | Method and device for measurement of hematocrit |
CN102711978A (zh) * | 2010-01-08 | 2012-10-03 | 塔斯马尼亚大学 | 多孔聚合物整料、其制备方法及其用途 |
WO2013144743A1 (fr) * | 2012-03-31 | 2013-10-03 | Dbs System Sàrl | Dispositif et procédé pour l'analyse de gouttes de fluide séché |
US9927331B2 (en) | 2012-03-30 | 2018-03-27 | Waters Technologies Corporation | Sample carrier for dried biological samples |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4987085A (en) * | 1987-06-22 | 1991-01-22 | Chemtrak Inc. | Blood filtering metering device |
US5139685A (en) * | 1991-03-26 | 1992-08-18 | Gds Technology, Inc. | Blood separation filter assembly and method |
-
1999
- 1999-04-29 WO PCT/US1999/009479 patent/WO1999057559A1/fr not_active Application Discontinuation
- 1999-04-29 AU AU37764/99A patent/AU3776499A/en not_active Abandoned
- 1999-04-29 EP EP99920212A patent/EP1082612A1/fr not_active Withdrawn
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4987085A (en) * | 1987-06-22 | 1991-01-22 | Chemtrak Inc. | Blood filtering metering device |
US5139685A (en) * | 1991-03-26 | 1992-08-18 | Gds Technology, Inc. | Blood separation filter assembly and method |
Cited By (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6524533B1 (en) | 1998-03-06 | 2003-02-25 | Biosafe Medical Technologies, Inc. | Device for collecting and drying a body fluid |
US6406919B1 (en) | 1999-12-16 | 2002-06-18 | Biosafe Laboratories, Inc. | Whole blood collection device and method |
US6673627B2 (en) | 1999-12-16 | 2004-01-06 | Biosafe Medical Technologies, Inc. | Whole blood collection device |
US7115421B2 (en) * | 2002-04-17 | 2006-10-03 | Biosafe Medical Technologies, Inc. | Method and device for measurement of hematocrit |
CN102711978A (zh) * | 2010-01-08 | 2012-10-03 | 塔斯马尼亚大学 | 多孔聚合物整料、其制备方法及其用途 |
CN102711978B (zh) * | 2010-01-08 | 2015-11-25 | 塔斯马尼亚大学 | 多孔聚合物整料、其制备方法及其用途 |
US9927331B2 (en) | 2012-03-30 | 2018-03-27 | Waters Technologies Corporation | Sample carrier for dried biological samples |
WO2013144743A1 (fr) * | 2012-03-31 | 2013-10-03 | Dbs System Sàrl | Dispositif et procédé pour l'analyse de gouttes de fluide séché |
US9795960B2 (en) | 2012-03-31 | 2017-10-24 | Dbs System Sa | Device and method for dried fluid spot analysis |
US10335784B2 (en) | 2012-03-31 | 2019-07-02 | Dbs System Sa | Device and method for dried fluid spot analysis |
Also Published As
Publication number | Publication date |
---|---|
EP1082612A1 (fr) | 2001-03-14 |
AU3776499A (en) | 1999-11-23 |
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