WO2019226971A1

WO2019226971A1 - Push- or twist- initiated blood metering, filtering and storage

Info

Publication number: WO2019226971A1
Application number: PCT/US2019/033879
Authority: WO
Inventors: Brandon T. Johnson; Brian Weinberg; Daniel GUSSIN; Catherine FINK; Keith Kopitzke
Original assignee: Boston Microfluidics, Inc.
Priority date: 2018-05-24
Filing date: 2019-05-24
Publication date: 2019-11-28
Also published as: EP3801904A1; EP3801904A4; SG11202011617QA

Abstract

A device uses twist- or push-initiated force to collect, meter, filter and store a blood sample. In one implementation, the push-initiated force may be provided in a cassette-type housing that also collects, meters, filters and/or stores the blood sample.

Description

PUSH- OR TWIST- INITIATED BLOOD METERING, FILTERING AND STORAGE

CROSS REFERENCE TO RELATED APPLICATIONS This application claims priority to a co-pending U.S. Provisional Patent

Application Ser. No. 62/675,870 filed May 24, 2018 entitled“Push- Or Twist- Initiated Fluid Metering, Filtering and/or Storage”, a co-pending U.S. Provisional Application Ser. No. 62/715,476 filed August 7, 2018 entitled“Push- Or Twist- Initiated Blood Metering, Filtering and/or Storage”, a co-pending U.S. Provisional Application Ser. No. 16/173,101 filed October 29, 2018 entitled“Push- Or Twist- Initiated Blood Metering, Filtering and/or Storage”, and a co-pending U.S. Provisional Application Ser. No.

62/820,411 filed March 19, 2019 entitled“Cassette for Blood Sample Measurement Collection and Storage”.

The entire contents of each of the above- referenced applications are hereby incorporated by reference.

BACKGROUND

Technical Field This application relates to devices and methods for blood sample collection, metering, filtering and storage.

Background Information

Blood used for diagnostic testing is usually extracted from a patient with a hypodermic needle and collected in a test tube. The collected blood is then packaged for shipment to a remote lab where various diagnostic tests are performed. However, many diagnostic tests require significantly less volume than the collected sample. Separation of cellular components from the sample is also needed for some tests. Many tests only require small blood samples, where a finger stick rather than a hyperdermic needle can produce enough blood. But this small amount of blood cannot be easily transported to a lab. If the testing method cannot be immediately used at the same time the blood is extracted, a convenient reliable method of capturing, prepping, and preserving small amounts of blood is needed.

SUMMARY

A device uses twist- or push-initiated force to collect, meter, filter and store a blood sample. The device includes a housing, a metering assembly, a filter, and blood storage media.

The metering assembly is disposed on top of the device and contains a well into which a blood sample is introduced. The well defines two regions - a lower region that provides a metered or defined volume of blood, and an upper region that accepts blood in excess of the metered portion. The bottom of the well is sealed with a pierceable membrane. A cap engages the well to provide a pushing or twisting (screwing) force to the metering assembly to force collected blood from the lower region into the upper region.

An absorbent element is located adjacent to and in fluid communication with the upper region.

In operation, the cap engages the well at a ledge located between the upper and lower regions of the well, to thereby force blood through one or more ports in the housing onto the absorbent element.

The pushing or twisting force provided by the cap also serves to rupture the pierceable membrane. In some embodiments, that rupturing can be provided by a post or other protrudion located on an inner surface of bottom of the housing.

The filter is positioned beneath the well, that is, below the pierceable membrane, and also provides fluid communication between the well and the storage media for the metered blood sample. In some configurations, the metering assembly may contain a dry anticoagulant composition that is reconstituted when blood is introduced into the device.

The collection media may, in some implementations, be a separation media that separates plasma from whole blood in the metered blood sample.

The blood separation media preferably contains at least one region that can be easily removed from the device for analysis.

In other configurations, the housing is provided as a cassette-type arrangement, where hinged door provides a push-initiated force. In this arrangement, a cover may be provided to protect the device and prevent undesired activation or access during shipment. In this arrangement, a blood collection sub assembly includes one or more microfluidic channels to collect a blood sample and meter it. The channel(s) may collect blood from a sample port via a passive type wicking action or in other ways. The sample port may be an oval-shaped cup with an upper ridge that provides a surface on which the user may scrape their finger to encourage blood collection. A fill window coupled to the channel(s) at the far end enables the user to monitor the progress of sample collection.

A frame (or support) assembly includes a collection element such as LF1 paper or some other suitable membrane or media for storing the sample. The collection element may be treated with various agents or composed of different parts that dry, separate, filter, stabilze, treat, or analyze the sample in different ways. Notches on the frame may be provided to further align with ribs on a bottom housing.

A top housing piece may be provided with a hinged door that is activated after taking a sample. Two small, breakable bridges may hold the hinged door 1150 in place during assembly and before the sample is collected. A certain amount of force, such as a few pounds, breaks the bridges, permitting the hinged piece to snap down into a final horizontal position to close the device after use.

To collect a blood sample, the patient’s pricked finger is scraped along an upper edge of the blood collection well permitting blood to drip down into the port below. As the port is filled, the blood flows into the microfluidic channels and eventually reaches the final fill window. After a sufficient blood sample is taken, the hinged door is snap- closed by the user. This closing action then also actually activates contact between the exit end of the microfluidic channels and the collection paper. In other words, the end of the channel where the blood has reached is initially lifted off of disposed and away from the collection paper. However, pressing down on the top housing breaks the bridge pieces so that the sample port now comes in contact with the edge of the collection paper, which then will initiate a wicking process of the blood into the paper.

BRIEF DESCRIPTION OF THE DRAWINGS The description below refers to the accompanying drawings, of which:

Fig. 1 is perspective view of the example device;

Fig. 2 is a longitudinal cross-section;

Fig. 3 is a transverse cross-section;

Fig. 4 is a perspective view of a bottom cover;

Fig. 5 is a perspective view of a cassette device that includes a hinged or sliding door that supplies a push-initiated force.

Fig. 6 is an exploded view the device shown in Fig. 5.

Fig. 7 shows a blood collection assembly in more detail.

Fig. 8 shows a support assembly.

Fig. 9 illustrates the device in an initial stage of being assembled.

Fig. 10 shows the top housing being assembled.

Fig. 11 A shows the top housing facing downwards to engage pins into holes in the bottom piece.

Fig. 11B is a closer view of one implementation where a microfluidic

subassembly may have thinned portions or perforations designed to break when a door is closed.

Fig. 12 shows the device being used to collect a blood sample.

Figs. 13A and 13B show the door being closed.

Figs. 14A and 14 B show a hinged port cover being closed over the device after the sample is taken.

Figs. 15A and 15 B are alternate design for the port cover.

Figs. 16A and 16 B are another design for the closure.

Figs. 17 and 18 show how the device is disassembled to obtain access to the sample. DETAILED DESCRIPTION OF AN ILLUSTRATIVE

EMBODIMENT

Fig. 1 is a perspective view of a device 100 for collecting and storing a metered amount of a blood sample. In one implementation, the device 100 is used to collect, store, and dry a blood sample for transport, such as to a remote laboratory for further analysis.

The device 100 generally consists of a housing or frame 102, a volume metering assembly 104, and a blood sample storage area 120.

The volume metering assembly 104 consists of cap or hat 106 that engages a collection well 108 disposed above or on the frame 102. A Polyvinyl Alcohol (PVA) foam or other blood absorptive material (shown in Figs. 2 and 3) is preferably fixed adjacent the well 108, such as at or near the bottom rim of the cap 106. The collection well 108 consists of two regions, a lower region 109 that in this embodiment is generally cylindrical in shape, and an upper region 111 defined by a tapered flange 150. A circumferential ledge 110 is located within the well 108 at a determined distance down from the flange 150. The lower region 109 has a defined volume for holding a metered amount of blood. The upper region 111 is used to collect a volume of blood in excess of the defined volume.

The storage area 120 contains a storage media 122 and an optional window 124 for viewing the collected blood sample. Suitable storage media 122 are described in more detail below.

Fig. 2 and Fig. 3 are longitudinal and transverse cutaway views showing the device 100 im more detail. The lower region 109 of the well 108 is wider at the top than at its bottom. A foam ring 130 or other absorbtive material is placed beneath the ledge 110 and surrounds the well. A foil or other pierceable material layer 132 either defines the bottom of the well, or is disposed around or near an opening 133 in the bottom of the well 108.

Also visible in Figs. 2 and 3 is a filter media 134 disposed beneath or surrounding the pierceable material layer 132 at the bottom of the well 108. The filter 134 may be a media such as cotton, or a a synthetic sponge essentially composed of Polyvinyl Alcohol (PVA) or other open-celled, highly absorbent porous foam that wicks aqueous solutions. The filter 134 serves to control the flow of blood exiting the well 108 and flowing towards the storage area 120.

A storage media 122 such as a sucrose treated paper 136 is disposed within and supported by the frame 102 within the storage area 120. The storage media 122 may be a microfluidic separation membrane capable of separating blood plasma from whole blood. Other types of storage media 122 or treated papers 136 suitable for drying and storing blood may be used. One end of the paper 136 is placed adjacent the bottom of the well 108, typically at the exit point of the filter media 134; the other end of the paper 136 extends to the far end 145 of the frame 102. A bottom cover section 138 supports the paper 136 and may have a series of pegs 139 spaced apart from one another and/or ledges 143 to further support and hold the paper 136 in position.

Channels 142 formed in the frame 102 near the filter 134 may also support the paper 136 and/or direct a collected blood sample onto the paper 136.

The device 100 may be shipped with a peelable label or other protective cover (not shown) fixed over or within the well 108.

In operation, a caregiver or patient peels off the protective label or cover (if present) to expose the open well 108. They then stick their finger and drop blood into the well 108. Enough blood should be dispensed from the finger stick to fill the well 108 beyond the ledge 110 but not so much blood as to reach beyond the flange 150. By adding enough blood to fill up beyond that ledge 110, there is at least a minimum, metered, defined volume collected within the lower portion 109 of the well 108, in the area between the ledge 110 and the bottom foil 132. Defined small volumes from about 50 microliters (uL) to 300 microliters (uL) are typical.

The cap 106 is then dropped down to engage the device 100, such as via the inner (lower) rim of the flange 150. The cap is then pushed down or twisted to provide a positive force to close the well 108 and close off the defined volume in the lower tapered portion 109. If the cap 106 is a twist cap, internal threaded portions further encourage the cap 106 to close off the well 108 and provide positive mechanical force.

The twist or pushing action also pushes blood in excess of the defined volume, that is the blood located in the upper portion 111 into the surrounding foam 130 located underneath the ledge. In some embodiments, the excess blood may flow through one or more channels or ports 148 located around the outer periphery of the well 108 into the foam 130. In some embodiments, a ring shaped foam 130 may also be located around the periphery of the cap to further help to collect the excess blood.

The force of pressing down or twisting on the cap 106 also breaks the foil 132 on the bottom of the well 108. Such rupturing of the foil may be encouraged by one or more posts or protrusions 154 located in the bottom 138 of the frame 102. Blood then starts to flow towards the paper strip 136, through the filter material 134. The filter material may control how fast the blood flows to the paper 136.

The filter material 134 may also act as a compliant member, so that when the cap 106 is pushed or twisted down, it further assists with maintaining closure at the bottom of the well 108. Once the blood reaches the paper 136, it continues to flow laterally away from the well 108 towards end 145. If the paper is a separation media, plasma may be separated from whole blood as the paper 136 wicks the blood away from the filter. With the cap 106 firmly in place, the device is thus sealed for transport to a remote laboratory.

The device 100, including the bottom 138 or other parts of the frame 102 or other components should be easily disassembled so that the lab can access the stored blood and/or plasma sample on the paper 136. The paper 136 may be removable from the frame 102 so that a lab may cut it up, punch holes in it, or otherwise process it.

Additional design details are possible. For example, ribs 158 may be provided on outer rim of the the cap 106, to provide a greater area to enble the user to grip and/or twist the cap 106.

An anti -coagulant, such as a dry composition anti-coagulant, may be stored within the metering assembly 104 and activated when blood is placed in the well. Ledge 110 aroung the periphery of the well 108 may also be particularly sized to define the overall outer diameter of the cap 106 independent of the volume defined by the lower portion 109.

In another embodiment, the device is implemented as a cassette-type device that collects, meters and stores body fluids such as a blood sample. The cassette form factor includes a hinged or sliding door that provides the push-initiated force.

Fig. 5 is a perspective view of the assembled cassette device 500 which inclides a cover 601 and housing 603. Fig. 6 is an exploded view of the cassette device 500 showing its five primary components more particularly, including a sample port cover 601, a top housing 602, a blood collection (or“chip”) assembly 603, bottom housing 604 and frame assembly 605.

Fig. 7 shows the blood collection assembly 603 in more detail. It includes a blood collection chip 701 and some sort of a sealer or adhesive on the bottom such as a Pressure Sensitive Adhesive (PSA) 702. The blood collection chip includes one or more microfluidic channels 704 to collect a blood sample and meter it. In one implementation, the channel is a serpentine-shaped channel roughly a one millimeter in diameter and with a length to hold a sample of about 180 - 200 microliters. However other dimensions are possible. The channel 704 collects blood from a sample port 705 via a passive type wicking action from any fluid deposited in the sample port. In this particular design, the sample port 705 is an oval-shaped cup with an upper ridge 706. The ridge provides a surface on which the user may scrape their finger to encourage blood collection. However other designs for the sample port are possible.

The microfluidic channel(s) 704 can be self-hydrophilic or in other

implementations the channel(s) may be coated with anticoagulant.

A fill window 707 coupled to the channel(s) at the far end enables the user to monitor the progress of sample collection. To ensure a metered amount of blood has been collected, a method of separating the microfluidic channel from the sample collection well may be implemented to avoid overfilling. This may include a channel that breaks away upon activation (such as by snapping the device closed, described in more detail below) or otherwise seperates the fluid contact. Fig. 8 shows the frame (or support) assembly 605 in more detail, including a collection element 801 such as LF1 paper, a top frame 802 and a bottom frame 803. Notches are formed on the outside edges and used for alignment and for assembly purposes. One end 805 of the top frame may be open.

The frame pieces 802, 803 may be formed from different color mylars to differentiate the frame pieces from the LF1 paper 801. The frame assembly 605 may be assembled on a high throughput machine where there will be adhesive to bonded the parts together. In that approach, the parts may be delivered as a roll of series connected pieces to ease mass production.

The collection element 801 may be LF1 paper or some other suitable membrane or media for storing the sample. The collection element may be treated with various agents or composed of different parts that dry, separate, filter, stabilze, treat, or analyze the sample in different ways.

Fig. 9 shows the device 500 in an initial stage of being assembled. First the frame assembly 605 is located and retained in the bottom housing 604 via guide pins 901 or tabs that align with notches 902 in the frame 605. The notches on the frame are further aligned with ribs on the bottom housing, and pressed down in place. Depending on the exact type of polystyrene, plastic, or other resilient material used for the bottom housing, it is likely that the frame assembly 605 does not have to be firmly pressed into place as it just needs to be located and held in place with at least some friction. The port cover 601 is also snapped into one end of the bottom housing 604.

Fig. 10 shows the top housing 602 being assembled. The microfluidic chip 603 may be turned upside down. Four posts or pins 1010 on the microfluidic chip 603 may then be aligned with four hexagonal holes in the top housing. A press fit then holds these two parts together. In Fig. 11 A, the assembled top housing is rotated so that it is facing downward, and can now be pressed into place by engaging round pins of the top piece into hexagonal holes in the bottom piece. The pins and holes are designed to allow for tolerances within the molding process - a so-called Mattel™ fit.

It should be noted that the top housing 603 includes a thinned down area 1110, to provide a living hinged“door” 1150 that is activated after taking a sample.

Referring briefly to the cross-sectional view of the top housing in Fig. 13 A, two small bridges 1310 of plastic hold the hinged piece (or door) 1150 in place during assembly and before the sample is collected. Preferably formed of a styrene, the bridges 1310 can flex the door 1150 once or twice before they break, for example, after about a five-degree flex. A certain amount of force, such as a few pounds are needed to break the bridges 1310, permitting the hinged piece 1150 to snap down into a final horizontal position to close the device after use.

Fig. 12 shows how the device is used to collect a blood sample. The patient’s (or other user’s) pricked finger is scraped along an upper edge of the blood collection well 705 permitting blood to drip down into the port below. As the port is filled, the blood flows into the microfluidic chip (not shown in Fig. 8). When the blood passes through the channel(s) it eventually reaches the final window 707 that the user will see that they have collected enough blood for a complete sample.

In some implementations, additional windows may be placed between the sample port and the final window, so that the user can monitor the progress of collecting enough blood. Any or all such window(s) in the housing would preferably be flush with the outside surface of the device.

Returning attention to Figs. 13 A and 13B, after a blood sample is taken, the hinged piece 1150 is snap closed by the user. This snap closing action then also actually activates contact between the exit end of the microfluidic channels and the collection element 801. In other words, the end of the channel where the blood has reached is initially lifted off of and away from the collection media 801. However, pressing down on the door 1150 breaks the bridge pieces so that the sample port now comes in contact with the edge of the collection element 801, which then will start a wicking process of the blood into the collection element 801.

A slight interference fit may be provided by a slight bow in the frame pieces 802 and/or 803 supporting the collection element 801, to ensure good contact between the end of the microfluidic channel and the collection element 801. That’s another reason why the frame is preferably open 805 at one end, so that the channels may come into direct contact with the collection element 801 to start the wicking process when the hinged door 1150 is closed. With the sample port 705 being open on the other end, a vent on the back side

(not shown) may be provided that encourages the blood to be completely wicked out of the microfluidic channels onto the collection paper.

Fig. 11B shows how the microfluidic subassembly (chip) 701 may have a thinned out portion 1152 or perforations 1156 in its substrate or channels. Protrusions 1154 also engage the inner surface of door 1150. Thus, when door 1150 is pushed down to activate the device, not only does the downward force on the door 1150 cause the chip 701 to come in contact with the collection element 801, but also the chip 701 now breaks. By closing the door and triggering the break, only a predetermined amount of the collected sample will now actually exit from the chip 701 onto the collection media 801. The amount of the sample taken is determined by the area of the microfluidic channels in section 1160 of the chip 701. Any excess collected by the microfluidics channels in section 1162 on the other side of the break (e.g, the section nearest the hinge) will not flow onto the collection element 801. Fig. 14A and 14B show how the hinged port cover 601 is snapped over (clasped or locked) after the sample is collected. This closes off any biohazard presented by the sample port before shipping. Pins in the cover and holes 1420 in the housing should be sized and shaped provide a one- time snap closure so that the sample port 705 is permanently captured and so that the cover 601 cannot easily be pulled off such as with a fingernail. This provides protection against accidental tampering, but not necessarily intentional tampering and so forth.

With the port cover 601 now closed, the cassette device 500 is fully contained and ready to be shipped to a remote laboratory such as within a pouch (not shown).

Figs. 15A and 15B are an alternate design for the port cover 601. Here the port cover 1501 is a molded, living hinge on the bottom housing. The advantage of this arrangement is that it eliminates one extra part to mold and inventory and so forth. The disadvantage is that if the hinge between the port cover and the top housing is a little bit flexible or not perfectly flat when formed it might affect assembly.

Figs. 16A and 16B are another alternate design for the closure. This approach provides a sliding cover piece (or cap) 1610 is shaped to engage a line or ridgel630 formed on or between the top and/or bottom housings. A detent or other feature inside the housing may hold sliding cover 1610 in place before the device is used. After the blood sample collection operation is completed, the user just simply slide the cap 1610 to the far edge, which in turn presses down on the door 1150 to cover and lock the port in one motion. That is, the user can grip the cassette 500 with say the left hand on the one end, and slide the cover towards the right-side end to close the cassette. In other arrangements, the sliding cover 1610 can be designed to slide in the opposite direction, which may require extending the cassette a little bit to provide a surface area behind the collection port. In other arrangements (not shown in the drawings) a twisting motion of the cap on a threaded housing can serve to activate the device and to sever the metered blood sample from the sample well. Twisting of the cap can also move the exit end of the microfluidic channel into contact with the absorbtive media by moving them closer in the vertical and/or horizontal axis. Some iterations may include the use of ramps in the housing to reliably reposition components.

In some implementations a cassette composed of the sample collection well and microfluidic chip can be a separate unit. The cassette is used to collect the blood sample and is then inserted into device. This may simplifythe housing that holds the frame assembly as the insertion of the cassette would provide the activating motion to create fluid contact with the absorbtive media.

Figs. 17 and 18 show how the device is disassembled at the laboratory. On one end of the cassette there was only a single pin engaging into a hexagonal hole 1320 (see Figs. 13 A and 13B), so the press fit is easily overcome to access the inside of the device.

As shown in Fig. 17, one approach is for a lab technician to hold the device in their right hand, and pull down with the thumb of their left hand on the other end, to easily“peel” open the frame assembly 605 (similar to how a banana is peeled open) to now expose the collection paper. As per Fig. 18, they can now with the right hand dispose of the cassette while continuing to hold the frame in the left hand. The technician can then use a tool with the open right hand and punch one or more holes in the paper to collect a plasma- only portion of the sample, for example.

As shown, finger recesses in the frame and or cover piece assist with the disassembly process. In addition, a bar code may be placed on the back side of the frame during manufacture and thus becomes visible at this final disassembly stage.

What is claimed is:

Claims

1. A blood sample collection device comprising:

a housing;

a collection well;

a metering component coupled to the collection well for collecting a metered portion of the blood sample;

absorptive media, disposed in a frame, adjacent to and in fluid communication with the metering component; and

a movable member engaging an upper region of the collection well, and providing push- driven mechanical force to intiate collection of a blood sample onto the absorptive media.

2. The device of claim 1 wherein a breakable tab is disposed between the movable member and the frame supporting the absorptive media.

3. The device of claim 2 wherein a hinged cover is disposed over the collection well.

4. The device of claim 1 wherein the the metering component is diposed on on a substrate composed of two components that separate upon application of the mechanical force.

5. The device of claim 1 wherein the well and metering component form a subassembly that is disposed adjacent the frame containing the absorbtive media.

6. The device of claim 1 wherein the collection well has a top portion and a bottom portion, with opening location at a top, the collection well further defined by a lower region having a defined volume for collecting a metered portion of the blood sample, and an upper region for accepting an excess portion of the blood sample in excess of the defined volume and the device further comprises:

a pierceable membrane located adjacent the bottom of the collection well;

a cap engaging the upper region of the well, and providing twist- or push- initiated mechanical force on the well, and also piercing the membrane in response to the mechanical force;

and wherein the absorptive media is disposed adjacent and in fluid

communication with the upper region of the well, and for storing the excess portion of the blood sample in excess of the defined volume;

7. The device of claim 6 additionally comprising:

a filter, disposed adjacent the pierceable membrane, for filtering the metered portion of the blood sample to provided a filtered blood sample; and

a storage media, for storing the filtered blood sample.

8. The device of claim 7 additionally wherein the storage media is disposed below the pierceable membrane.

9. The device of claim 6 additionally wherein the defined volume is further defined by a ledge formed on the periphery of the well.

10. The device of claim 9 additionally wherein fluid communication between the upper region of the well and the absorptive media is provided by one or more ports formed in the housing adjacent the ledge.

11. The device of claim 10 additionally wherein the cap engages the ledge for providing the twist- or push- initiated mechanical force.

12. The device of claim 1 additionally wherein the absorbtive media is a microfluidic separation media for separating plasma from whole blood in the blood sample.

13. The device of claim 12 additionally comprising one or more supports for supporting the microfluidic separation media within the housing.

14. The device of claim 1 additionally comprising:

an anticoagulant disposed within the metering component.

15. The device of claim 6 additionally comprising:

a post located on the housing below the well adjacent the pierceable membrane, and positioned to rupture the pierceable membrane upon application of the mechanical force.

16. The device of claim 1 wherein the absorptive media is removable from the housing after application of the mechanical force.

17. The device of claim 1 additionally comprising:

a removable protective layer disposed on the collection well.

18. A blood sample collection device comprising:

a housing;

a metering component comprising a collection well and a cap,

the collection well having an opening at a top and a pierceable membrane located adjacent a bottom, the collection well further defined by a lower region having a defined volume for collecting a metered portion of the blood sample, and an upper region for accepting an excess portion of the blood sample in excess of the defined volume, and the cap engaging the upper region of the well, and providing twist- or push- initiated mechanical force on the well, and also piercing the membrane in response to the mechanical force;

absorptive media, disposed adjacent and in fluid communication with the upper region of the well, for storing the excess portion of the blood sample in excess of the defined volume;

a storage media, disposed within the housing adjacent the filter, for storing the the filtered blood sample.

19. A device for collecting a small volume blood sample, comprising:

(a) a multipart housing comprised of a first part connected to a second part to define an interior space;

(b) a metering assembly disposed on the first part of the housing, wherein the metering assembly is configured to receive a small volume of a blood sample from a patient and deliver a smaller defined volume of blood elsewhere inside the housing, wherein the metering assembly is moveably retained in the first part of the housing such that it can be moved into the housing by application of force by a user, wherein the metering assembly comprises:

(i) a well accessible to the user through an open top and comprising an upper region and a lower region, wherein the upper region is bounded by a first well wall and a lower flange and the lower region is bounded by a second well wall extending from the lower flange and a bottom opening sealed with a pierceable membrane,

wherein the volume defined by the lower region defines the smaller defined volume to be delivered by the metering assembly and wherein the pierceable membrane that seals the bottom of the well is positioned proximate to a post protruding from the interior surface of the second part into the interior space of the housing such that when the metering assembly is moved into the interior space of the housing a sufficient distance the post can rupture the pierceable membrane,

(ii) at least one port with an opening in or adjacent to the lower flange and which provides a flow path from the upper region of the well to an overflow region that comprises absorptive media, and

(iii) a dry anticoagulant composition configured for reconstitution upon addition of a blood sample to the well;

(c) a cap configured for insertion into the upper region of the well and to sealingly engage the lower flange of the upper region, wherein by moving the cap to engage the lower flange, blood in the upper region of the well is forced through the port(s) in the lower flange into the absorptive media in the overflow region of the metering assembly;

(d) a filter disposed around the post and, when the pierceable membrane is ruptured by the post, in fluid communication with the lower region of the well; and

(e) a blood separation media disposed in the interior space of the housing in fluid communication with the filter, wherein the blood separation media comprises at least one removable sample region.

20. A device for collecting a fluid sample comprising:

a sample port cover,

a top housing,

a fluid collection assembly,

a bottom housing, and

a frame assembly, wherein

the fluid collection assembly includes a sample port, an exit end, and one or more microfluidic channels disposed on a substrate, the microfluidic channels coupled to collect a fluid sample from the sample port via passive wicking action, and the substrate having at least one area of reduced dimention;

the frame assembly includes a storage element disposed between a top frame a bottom frame, with a least one end of either top frame or bottom frame being open and disposed adjacent but spaced away from the exit end of the fluid collection assembly, and the storage element comprising a storage media for storing the fluid sample;

the top housing including a door and an area of reduced thickness providing a living hinge for the door, such that pushing on the door causes the fluid communication between the exit end of the collection assembly and the storage element.