WO2025038922A1

WO2025038922A1 - Sample collection kit

Info

Publication number: WO2025038922A1
Application number: PCT/US2024/042652
Authority: WO
Inventors: Jason Kelley; Craig ROUSKEY; Gabriel Paulino
Original assignee: Renegadexbio, Pbc
Priority date: 2023-08-17
Filing date: 2024-08-16
Publication date: 2025-02-20

Abstract

A kit for the collection of samples of bodily fluids into receptacles and sending the samples to a laboratory for analysis.

Description

TITLE

SAMPLE COLLECTION KIT

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This Application claims the benefit of US Provisional Application Serial No, 63/520.287, filed .August 17, 2023, incorporated by reference in its entirety herein

TECHNICAL FIELD

[0002] The disclosed technology relates generally to the collection of bodily fluids, and particularly to devices, systems, and methods providing for the collection of bodily fluids into a receptacle and sending it to a laboratory for analysis.

BACKGROUND

[0003] Blood used for diagnostic testing is most often 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 actual collected sample. Separation of cellular components from the sample is also needed for some tests.

[0004] Devices, systems and methods to facilitate collection of bodily fluids are necessary for the growing field of personalized medicine. As point-of-care devices continue to improve, an often-overlooked area relates to the collection of samples from untrained users. Currently, biological samples are commonly obtained via either simple-to-use methods or devices, as with generic lancing devices, or trained personnel, as with phlebotomy venipunctures. To transfer the bodily fluid to a container, receptacle, or an analysis device, multiple steps are required that are time consuming, error prone and/or cumbersome.

[0005] Many tests only require small blood samples, where a finger stick rather than a hypodermic needle can produce enough blood. But this small amount of blood cannot be easily transported to a remote lab. If the testing method cannot be immediately used at the same time the blood is extracted, convenient and reliable methods of collecting, prepping, and preserving small amounts of blood are still needed.

[0006] Thus, there is a need in the art for improved ways for handling and shipping microfluidic devices for fluid handling and transfer, and related systems and methods. SUMMARY

[0007] An aspect provides a kit for one or more fluid collection devices, wherein the kit is configured to provide a fluid collection device to a subject to collect a sample of a bodily fluid from the subject in the fluid collection device and ship the sample of the bodily fluid to a laboratory for testing and/or analysis.

[0008] The kit may comprise a fluid collection device for collecting a sample of blood from the user.

[0009] The fluid collection device may comprise a housing; an actuator movable relative to the housing; a skin piercing feature at least partially within the housing and operably coupled to the actuator, wherein movement of the actuator toward skin of the subject is configured to cause the skin piercing feature to move toward the skin of the subject and cause a flow of blood from the subject; a collection site positioned to receive the skin piercing feature; and a conduit disposed within the housing configured to convey a sample of the blood from the subject to a collection reservoir, the conduit comprising a first end in fluid communication with the collection site; a second end configured to releasably engage the collection reservoir.

[0010] The kit may further comprise a fluid collection device for collecting a sample of urine from the subject.

[0011] The kit may comprise a fluid collection device for collecting a sample of blood from the subject and a fluid collection device for collecting a sample of urine from the subject.

[0012] The kit may comprise a package configured to contain a fluid collection device configured to collect a blood sample from the subject; a blood reservoir configured to releasably engage the fluid collection device and receive the blood sample; a closure for the reservoir to contain the blood sample; and a label for the blood reservoir. The package may further comprise a biohazard bag. The package may further comprise one or more additional components selected from the group consisting of a heat pack, alcohol swab, bandage, absorbent pad, instructions for using the fluid collection device and instructions for handling the blood sample.

[0013] The fluid collection device for drawing blood from a subject may comprise a collector comprising a housing; an actuator movable relative to the housing; a skin piercing feature at least partially within the housing and operably coupled to the actuator, wherein movement of the actuator toward skin of the subject is configured to cause the skin piercing feature to move toward the skin of the subject; a collection site positioned to receive the skin piercing feature and receive blood from the subject after the skin of the subject is pierced; a conduit having a first end and a second end disposed within the housing wherein the first end is in fluid communication with the collection site and the second end configured to be releasably engaged and in fluid communication to a blood sample reservoir; wherein the conduit is configured to convey blood from the collection site to the blood reservoir.

[0014] The kit may comprise a package configured to contain a fluid collection device configured to collect a urine sample from the subject; a urine reservoir configured to releasably engage the fluid collection device and receive the blood sample; and a closure for the reservoir to contain the blood sample; and a label for the urine reservoir. The fluid collection device may comprise a urine cup. The package may further comprise a biohazard bag. The package may further comprise one or more additional components selected from the group consisting of a disposable dropper, absorbent pad, and instructions for collecting and handling the urine sample. [0015] The kit may further comprise swabs for obtaining oral, rectal and/or vaginal samples, labels for oral, rectal and/or vaginal samples, containers for the oral, rectal and/or vaginal samples, instructions for obtaining oral, rectal and/or vaginal samples.

[0016] The kit may further comprise a container for shipping the collected sample or samples to a laboratory for testing and/or analysis. The kit may further comprise a package configured to contain shipping materials for sending the samples to the laboratory, wherein the shipping material may include items selected from the group consisting of a biohazard bag, a return package, a shipping label and packager and return instructions. The return package may comprise a prelabeled shipping bag.

[0017] Additional items in the kit may include one or more of the following selected from the group consisting of a blood spot card, blood spot card instructions, additional biohazard bag, silica gel desiccant packet, lancets, bandages, sterile gauze, alcohol swab, and instructions for use.

BRIEF DESCRIPTION OF DRAWINGS

[0018] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings.

[0019] Figures 1 through 3 depict aspects of the kit according to a preferred embodiment. [0020] FIG. 1 A is a perspective view of a fluid collection device, according to an exemplary embodiment.

[0021] FIG. IB is a perspective view of the embodiment of FIG. 1A, applied to the skin of a subject, according to an exemplary embodiment.

[0022] FIG. 1C is a further perspective view of the embodiment of FIG. 1A, wherein the reservoir is being removed, according to an exemplary embodiment.

[0023] FIGS. 2A-C show views of the another fluid collection device, according to an exemplary embodiment.

[0024] FIGS. 3A-B show views of a sample shipping kit, according to an exemplary embodiment.

DETAILED DESCRIPTION

[0025] The various embodiments disclosed or contemplated herein relate to a single device that can be used by untrained or minimally trained persons to both collect bodily fluid, seamlessly contain the bodily fluid, and send the bodily fluid sample to a laboratory for testing and/or analysis. [0026] A fluid collection device can be used to collect, meter, and store a body fluid sample for a subsequent assay. Fluid collected from a patient is first introduced into the device via a sample port, such as by directing blood samples from a subject’s upper arm to a sample collection reservoir using the fluid collection device.

[0027] A kit comprising the fluid collection device and additional components for collecting a bodily fluid sample from a subject may be provided to the subject, together with materials for shipping the collected sample to a laboratory. The kit may comprise a package configured to contain a fluid collection device configured to collect a blood sample from the subject; a blood reservoir configured to releasably engage the fluid collection device and receive the blood sample; and a closure for the reservoir to contain the blood sample; and a label for the blood reservoir.

[0028] The package may further comprise one or more additional components selected from the group consisting of a heat pack, alcohol swab, bandage, absorbent pad, instructions for using the fluid collection device and instructions for handling the blood sample.

[0029] The fluid collection device for drawing blood from a subject may comprise a collector comprising a housing; an actuator movable relative to the housing; a skin piercing feature at least partially within the housing and operably coupled to the actuator, wherein movement of the actuator toward skin of the subject is configured to cause the skin piercing feature to move toward the skin of the subject; a collection site positioned to receive the skin piercing feature and receive blood from the subject after the skin of the subject is pierced; a conduit having a first end and a second end disposed within the housing wherein the first end is in fluid communication with the collection site and the second end configured to be releasably engaged and in fluid communication to a blood sample reservoir; wherein the conduit is configured to convey blood from the collection site to the blood reservoir. Suitable fluid collection devices include those described in US Patents 10,426,390; 10,492,716; 10,779,757; and 11,510,659, incorporated by reference herein in their entirety.

[0030] As is shown in FIGS. 1A-B, in exemplary embodiments, the collector 100 generally comprises a housing 10 having first 12 and second 14 ends, and which is configured to be in fluidic communication with at least one reservoir 104, such as a tube or cartridge by way of a fitting or coupling portion 103, which is also called a “collar” in certain embodiments, and an outflow channel 112. In exemplary embodiments, the reservoir 104 can be removably attached to the housing 10, by way of the coupling portion 103, such that it may be detached, as is shown in FIG. 1C. In certain embodiments, the reservoir 104 can be a standard Eppendorf tube press- fitted on the fitting 103. In further embodiments, the reservoir 104 can also be custom made and utilize capillary forces or solely gravitational forces to fill. The tube 104 can thus act as a removable and standardized reservoir 104 for containing or gathering the fluid that can be simply and easily detached and inserted into existing and established testing or lab equipment. By way of example, where the fluid is blood, the tube 104 can be easily inserted into clinical and laboratory equipment or workflows for diagnostics and/or biomarker detections. The reservoir 104 may be a standardized Eppendorf tube press-fitted onto the device 100 by a fitting 103. After collection of the sample, the reservoir 104 can be removed from the collector 100 and capped for shipment to a laboratory. The package also contains a blood sample label to be affixed to the reservoir 104 after collection of the sample. The label may be positioned across the junction between the cap and reservoir 104 so that it can serve as a tamper evidence feature.

[0031] In use, as best shown in FIG. IB, the collector 100 is placed on the skin of a subject such that the distal portion 104B of the fluid reservoir 104 is oriented in a substantially vertically down position. As a result of this orientation, bodily fluids collected at the collection sites 101 are drawn in by the fluidic network 102 for transport to the fluid reservoir 104, facilitated by gravity [0032] The device may have at least one actuator 110 and is configured to be placed against the skin of a subject 1, as shown in FIG. IB. Upon depressing or otherwise operating the actuator 110, at least one lancet, needle or other skin puncture device is deployed to pierce the subject's skin and cause blood or other bodily fluid to pool near the collection areas for uptake into the conduit.

[0033] In other embodiments, the fluid collection devices include those described in US Patents 8,021,873; 8,846,310; 9,861,978; 10,180,421; 10,562,022; 11,358,138; 11,358,139; 11,360, 076; and 11,484,877, incorporated by reference herein in their entirety.

[0034] Figures 2A-C depict views of an exemplary device according to these embodiments. The blood sample collection device comprises a housing configurable from an open position (See Fig. 2A) to a closed position (See Fig. 2B). The device also comprises a sample collection well for collecting the fluid sample; two or more capillaries configured to draw in fluid from the sample collection well through capillary action; a membrane disposed within the housing; and a plunger rack comprising two or more plungers, wherein the plunger rack is disposed within the housing, and wherein the two or more plungers comprise two or more ends disposed in line with the two or more capillaries and arranged to dispense the fluid in the two or more capillaries onto the membrane when the housing is moved from the open position to the closed position.

[0035] FIG. 2A is an isometric view of an example fluid collection device 1100. The device 1100 includes a two-piece housing 1101 that supports and encloses a fluid sample port 1102. The housing 1101 includes a first housing piece 1101-A and second housing piece 1101-B. In this view, the housing is in the open position with the two housing pieces 1101- A, 1101-B spaced apart from one another, to provide access to the sample port 1102. A sample collection well 1104 and one or more capillaries 1105 located adjacent the sample port 1102 are partially visible in this figure. A window 1150 in the housing permits a user to confirm the status of one or more portions of a fluid sample in the process of being collected and/or stored within the device 1100.

[0036] FIG. 2B is a similar isometric view of the device 1100. In this view, a blood sample has been taken via the sample port 1102, and the two housing pieces 1101-A and 1101-B have been pushed together to place the device 1100 in a closed position. In this closed position, the window 1150 still provides access to the blood collection status. [0037] The device 1 100 is typically used to collect a blood sample as follows. The device 1100 is initially presented in its open position, as per FIG. 2A, to provide access to the well 1104. A user, such as a patient herself or a health care professional, then uses a lancet to produce a blood sample such as from a fingertip. Drops of whole blood are then taken with the finger positioned near to, above, adjacent to, or even in contact with the well 1104 or other parts of the sample port 1102 to minimize blood spillage.

[0038] Blood is then eventually drawn into the rest of the device 1100 in one or more different ways. As will be explained in more detail below for one embodiment, blood flows and/or is first drawn from the well 1104 by one or more collection capillaries 1105 adjacent the sample port via capillary action. The capillaries may be visibly transparent so that the user can confirm that blood is being properly drawn into the device 1100. The capillaries 1105 can optionally be pre-coated with reagents such as heparin and/or EDTA for subsequent stabilization and preservation of the sample. The capillaries 1105 can also have a known and predetermined volume, in which case the incoming sample is precisely metered. The collection capillaries 1105 then direct the metered sample to a media inside the device housing 1101.

[0039] The user, who can be the patient himself/herself or a healthcare professional, then manually closes the device 1100 by pushing the two housing pieces 1101-A, 1101-B together, resulting in the housing position shown in FIG. 2B. As more fully explained below, the motion associated with closing the housing may then optionally enact one or more mechanisms that further process the sample, and to securely store it inside the device 1100.

[0040] The window 1150 may include a transparent piece of material that enables the user to view the state of the sample port 1102, the well 1104, and/or collection capillaries 1105. In that way, an indication of whether a sufficient sample of blood is being drawn into the device 1100 (when the housing 1101 is in the open position of FIG. 2A) or was drawn into the device (when the housing 1101 is in the closed position as in FIG. 2B).

[0041] FIG. 2C is a more detailed, exploded view of the components of the device 1100. The first housing piece 1101-A consists of a top case 1201-A-l and bottom case 1201-A-2, and second housing piece 1101-B consists of a top case 1201-B-l and bottom case 1201-B-2.

[0042] A backbone structure 1203 provides a support for the two housing pieces 1101- A, 1101-B. The inside vertical walls of the housing pieces 1201 -A, 1201-B may engage elongated slots or other structures formed in the backbone 1203, thus enabling at least second housing piece 1101-B to slide back and forth along the backbone, and to thus move the housing into the open or closed position. In one arrangement, first housing piece 1101-A remains fixed in position on backbone 1203. However other embodiments are possible where first housing piece 1101-A slides on backbone 1203 and second housing piece 1101-B remains fixed, or where both housing pieces 1101-A, 1101-B can slide with respect to one another.

[0043] The backbone 1203 also supports other components of the device 1100. For example, the backbone 1203 provides a location for the sample collection port 1102, as formed from an inlay part (also referred to as a capillary support element) 1252. A plunger rack 1202 is also supported by the backbone 1203. The backbone 1203 may further include a ribbed section 1230 to support a desiccant tablet (not shown in FIG. 2C) to further dry the collected sample. The backbone 1203 may also have tines at an end that provide a ratcheting closure 1240, which is activated when the two housing pieces 1101-A, 1101-B are pushed together.

[0044] Capillaries 1204 (also referred to with reference number 1105 in other figures) are inserted into and held in place by longitudinal holes (not shown in FIG. 2C) formed in the inlay 1252. The capillaries and may be formed as a rigid tube of precisely defined volume, in which case they also serve a metering function. The capillaries 1204 extract a defined quantity of blood by engagement with the blood in the sample collection port 1102 through capillary action. The inlay 1252 may fit into a hole 1221 in backbone 1203. As explained in further detail below, the inlay 1252 defines the location of a well 1104 into which the patient's blood is introduced.

[0045] The capillaries 1204 can optionally be pre-coated with reagents, heparin, EDTA, or other substances.

[0046] One or more capillaries 1204 may also store a predetermined amount of a liquid reagent. Such a reagent may then be dispensed together or in parallel with the blood sample when the housing is moved from the open to the closed position. However, reagents of other types may also be in a storage region within the housing. The storage region (not designated in the figures), may hold a first type of reagent such as a solid surface or substrate, and a second type being a liquid storage chamber, each of which are placed in the path of the blood sample collected by the device 1100.

[0047] In one arrangement, the one or more plungers 1202 firmly engage with the inner diameter of the capillaries 1204, creating a shutoff that blocks off any excess blood sample while also pushing the metered sample volume to the subsequent downstream processing steps. [0048] A base 1206 may also fit into the backbone 1203 to provide additional mechanical support for a blood collection element 1250. The collection element 1250 may comprise a sample medium (also called a membrane herein) 1209 that is supported and/or held in place by other components that assist with handling the sample medium 1209 when it is removed from the device 1101 for processing by a laboratory. These other parts of the collection element 1250 may include the base 1206, a top frame 1208, media support 1210, and bottom frame 1211. The top 1208 and bottom 1211 frame may have extensions 1222-A, 1222-B on an outboard end. The extensions 1222 further assist with handling the collection element 1250 during and after its removal from the housing 1101.

[0049] The sample medium 1209 may be a plasma separation membrane or fdter of various types located at or near an exit port of the capillaries 1105. For example, a mixed-cellulose ester membrane such as the Pall Vivid Plasma Separation available from Pall™ Corporation. The membrane 1209 may also be an LF1 glass fiber membrane (sold by General Electric™ Company) or some other media designed to receive serum or whole blood which it then separates into a blood portion and a plasma portion. A medium such as LF1 paper has a fibrous structure that causes differential migration of the sample, with a slower rate for red cells, resulting in a gradual separation of plasma sample as it migrates down the paper. The membrane 1209 can optionally be previously impregnated with heparin, EDTA, sugars, or other stabilization agents. LF1 paper, which separates plasma from red blood cells through a fiber matrix, is preferred in some embodiments, because it causes a slower migration rate for the blood cells. However, other types of separation membranes for blood either liquid or dried may be used. In embodiments, more than one sample medium may be contained in the fluid sampling device 1100.

[0050] The kit may comprise a package configured to contain a fluid collection device configured to collect a urine sample from the subject; a urine reservoir configured to releasably engage the fluid collection device and receive the urine sample; and a closure for the reservoir to contain the urine sample; and a label for the urine reservoir. The fluid collection device may comprise a urine cup. Depending on the amount of sample needed, the urine collected from the subject may be kept in the urine cup and a closure lid may be engaged to the urine cup to contain the sample for shipment. In such embodiments, the lid may be engaged to the urine cup by snap fit or screw-thread engagement features. In alternate embodiments, a portion of the urine collected in the urine cup can be transferred to a smaller sample tube using a disposable dropper provided in the kit. The sample tube can be closed with a snap-fit or screw cap closure for shipment. The package may also contain a urine sample label to be affixed to the urine cup or sample tube after collection of the sample. The label may be positioned across the junction between the closure and the container so that it can serve as a tamper evidence feature.

[0051] The package may further comprise a biohazard bag. The package may further comprise one or more additional components selected from the group consisting of a disposable dropper, absorbent pad, and instructions for collecting and handling the urine sample.

[0052] In embodiments, the kit comprises a fluid collection device for collecting a sample of blood from the subject and a fluid collection device for collecting a sample of urine from the subject.

[0053] The kit may further comprise swabs for obtaining oral, rectal and/or vaginal samples, labels for oral, rectal and/or vaginal samples, containers for the oral, rectal and/or vaginal samples, instructions for obtaining oral, rectal and/or vaginal samples. In some embodiments, these items may be packaged together with the urine collection device.

[0054] The kit may further comprise a container for shipping the collected sample or samples to a laboratory for testing and/or analysis. The kit may further comprise a package configured to contain shipping materials for sending the samples to the laboratory, wherein the shipping material may include items selected from the group consisting of a biohazard bag, a return package, a shipping label, and return instructions. The return package is configured to contain a sample collection device such as shown in Figures 1A-C and 2A-C and any additional samples (e.g. urine samples) to be sent to the laboratory. The return package may comprise a prelabeled shipping bag. The return package may comprise a shipping box.

[0055] Additional items in the kit may include one or more of the following selected from the group consisting of a blood spot card, blood spot card instructions, additional biohazard bag, silica gel desiccant packet, lancets, bandages, sterile gauze, alcohol swab, and instructions for use.

[0056] A representative kit comprises an outer shipping box for providing the fluid collection device to a subject and the other components of the kit. The outer shipping box may include a return shipping box for the subject to return the fluid collection device, with a collected sample, to a testing laboratory.

[0057] In a specific embodiment shown in Figures 3A and 3B, the kit comprises an outer box 300 and three inner boxes 301, 302 and 303. Figure 3A shows the top flap of the outer box 300 open to show the inner boxes 301, 302 and 303. Figure 3B shows the kit in exploded view, showing that the inner boxes 301, 302 and 303 can be removed from the outer box to access their contents (not shown). A first inner box 301 contains a urine sample collection kit comprising a urine sample vial, a disposable pipette, a collapsible urine cup, and sample swabs. A second inner box 302 contains a fluid collection device 100 and a blood container tube 104. A third box 303 comprises a return box for returning samples to the laboratory. Other items in the kit may include secondary containment bags, alcohol wipes, bandages, gauze pads, an instant chemical heat pack, sample labels, zip lock bags, shipping labels, instructions, and polymailer bags.

[0058] In embodiments, a health care professional may use the kit to obtain samples from a subject in an office setting and ship the samples to a laboratory for testing. In other embodiments, a subject may receive the kit, either in a professional office or by delivery to the subject’s home address, collect sample(s) by self-administration and use the enclosed return package to send the samples to a laboratory for testing.

[0059] While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. Various alternatives to the specific embodiments of the invention described herein may be employed in practicing the invention. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents are covered thereby.

Claims

1. A kit for one or more fluid collection devices, wherein the kit is configured to provide a fluid collection device to a subject to collect a sample of a bodily fluid from the subject in the fluid collection device and ship the sample of the bodily fluid to a laboratory for testing and/or analysis.

2. The kit of claim 1 comprising a fluid collection device for collecting a sample of blood from the user.

3. The kit of claim 1 comprising a package configured to contain a fluid collection device configured to collect a blood sample from the subject; a blood reservoir configured to releasably engage the fluid collection device and receive the blood sample; a closure for the reservoir to contain the blood sample; and a label for the blood reservoir.

4. The kit of claim 3 wherein the package further comprises a biohazard bag.

5. The kit of claim 3 wherein the package further comprises one or more additional components selected from the group consisting of a heat pack, alcohol swab, bandage, absorbent pad, instructions for using the fluid collection device and instructions for handling the blood sample.

6. The kit of claim 1 wherein the fluid collection device comprises a housing; an actuator movable relative to the housing; a skin piercing feature at least partially within the housing and operably coupled to the actuator, wherein movement of the actuator toward skin of the subject is configured to cause the skin piercing feature to move toward the skin of the subject and cause a flow of blood from the subject; a collection site positioned to receive the skin piercing feature; and a conduit disposed within the housing configured to convey a sample of the blood from the subject to a collection reservoir, the conduit comprising a first end in fluid communication with the collection site; a second end configured to releasably engage the collection reservoir.

7. The kit of any of claims 1 through 6 further comprising a fluid collection device for collecting a sample of urine from the subject.

8. The kit of claim 1 comprising a package configured to contain a fluid collection device configured to collect a urine sample from the subject; a urine reservoir configured to releasably engage the fluid collection device and receive the blood sample; and a closure for the reservoir to contain the blood sample; and a label for the urine reservoir.

9. The kit of claim 8 wherein the fluid collection device comprises a urine cup.

10. The kit of claim 8 or claim 9 wherein the package further comprises a biohazard bag.

11. The kit of any of claims 8, 9 or 10 wherein the package further comprises one or more additional components selected from the group consisting of a disposable dropper, absorbent pad, and instructions for collecting and handling the urine sample.

12. The kit of claim 1 comprising a fluid collection device for collecting a sample of blood from the subject and a fluid collection device for collecting a sample of urine from the subject.

13. The kit of any of claims 1 through 12 further comprising swabs for obtaining oral, rectal and/or vaginal samples, labels for oral, rectal and/or vaginal samples, containers for the oral, rectal and/or vaginal samples, and instructions for obtaining oral, rectal and/or vaginal samples.

14. The kit of any of claims 1 through 13 further comprising a container for shipping the collected sample or samples to a laboratory for testing and/or analysis.

15. The kit of claim 14 further comprising a package configured to contain shipping materials for sending the samples to the laboratory, wherein the shipping materials include one or more items selected from the group consisting of a biohazard bag, a return package, a shipping label and packager and return instructions.

16. The kit of claim 15 wherein the return package comprises a prelabeled shipping bag.

17. The kit of any of claims 1 through 16 comprising one or more of the following selected from the group consisting of a blood spot card, blood spot card, additional biohazard bag, silica gel desiccant packet, lancets, bandages, sterile gauze, alcohol swab, and instructions for use.