U.S. patent application number 16/161073 was filed with the patent office on 2019-04-11 for assistive sample collection and storage assembly.
The applicant listed for this patent is General Electric Company. Invention is credited to Erin Jean Finehout, Weston Blaine Griffin, Ian Hart, Ying Mao.
Application Number | 20190105020 16/161073 |
Document ID | / |
Family ID | 51844670 |
Filed Date | 2019-04-11 |
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United States Patent
Application |
20190105020 |
Kind Code |
A1 |
Mao; Ying ; et al. |
April 11, 2019 |
ASSISTIVE SAMPLE COLLECTION AND STORAGE ASSEMBLY
Abstract
An assistive sample collection and storage assembly for
collecting, transferring and storing a biological sample includes a
sample collection device having a first portion and a second
portion. The first portion is configured to receive a sample
collection member. The assembly includes a sample storage device
comprising a sample substrate to receive at least a portion of the
biological sample from the sample collection member. The assembly
is configured to exist in a first and second state. The sample
collection member is disposed at a determined distance from the
sample substrate in the first state. At least a portion of the
sample collection member is in physical contact with at least a
portion of the sample substrate in the second state. The sample
collection member is configured to apply a determined amount of
contact force between the collection member and the sample
substrate in the second state of the assembly.
Inventors: |
Mao; Ying; (Niskayuna,
NY) ; Griffin; Weston Blaine; (Niskayuna, NY)
; Finehout; Erin Jean; (Clifton Park, NY) ; Hart;
Ian; (Nassau, NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
General Electric Company |
Schenectady |
NY |
US |
|
|
Family ID: |
51844670 |
Appl. No.: |
16/161073 |
Filed: |
October 16, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14035085 |
Sep 24, 2013 |
10130258 |
|
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16161073 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
B01L 2300/043 20130101;
B01L 2300/0822 20130101; A61B 10/0096 20130101; A61B 10/0045
20130101; A61B 10/0038 20130101; B01L 3/5029 20130101 |
International
Class: |
A61B 10/00 20060101
A61B010/00; B01L 3/00 20060101 B01L003/00 |
Goverment Interests
[0002] This invention was made with Government support under grant
number HR0011-11-C-0127 awarded by the Defense Advanced Research
Projects Agency (DARPA). The Government has certain rights in the
invention.
Claims
1. A method for collecting a biological sample using an assistive
sample collection and storage assembly, comprising: providing a
sample collection member; collecting the sample using the sample
collection member; providing a sample storage device comprising a
sample substrate; providing an assistive sample collection and
storage assembly comprising the sample collection device and the
sample storage device; switching a state of the assistive sample
collection and storage assembly to a second state such that at
least a portion of the sample collection member is in physical
contact with at least a portion of the sample substrate; bending
the sample collection member at an optimal angle against a surface
of the sample substrate; applying a force at a head of the sample
collection member to transfer the biological sample from the sample
collection member to the surface of the sample substrate in the
second state of the assembly; rotating the sample collection member
to facilitate transfer of at least a portion of the sample from the
sample collection member to the sample substrate; de-coupling the
sample storage device from the sample collection device; and
storing the sample.
2. The method of claim 1, wherein the step of providing an
assistive sample collection and storage assembly comprises coupling
the sample collection member to the sample collection device after
collecting the sample.
3. The method of claim 1, wherein the step of providing an
assistive sample collection and storage assembly comprises
releasably coupling the sample collection device having the sample
collection member to the sample storage device.
4. The method of claim 1, wherein the step of bending further
comprises applying a determined force while rotating the sample
collection member to facilitate transfer of the sample.
5. The method of claim 1, wherein the step of providing the sample
storage device comprises providing a stabilizing agent on the
surface of the sample substrate.
6. The method of claim 4, further comprising rotating the sample
collection member for a determined number of turns.
7. The method of claim 1, further comprising switching the assembly
to the first state prior for decoupling the sample storage device
from the sample collection device.
Description
[0001] This is a division of U.S. patent application Ser. No.
14/035,085, filed Sep. 24, 2013, now co-pending, the entire
disclosure of which is incorporated herein by reference.
BACKGROUND
[0003] The invention relates to collection and storage of
biological samples, and more particularly to devices configured to
collect, transfer and store the biological samples.
[0004] The collection of biological samples (such as blood) and
extracting DNA for genetic analysis from the sample have been
widely used by the forensics and medical community for
identification purposes such as, but not limited to, paternity
testing, genetic diagnostic testing in new born screening programs,
genetic typing for predisposition to a particular disease, and
genetic characterization for drug susceptibility. Typically,
collected biological samples are stored in a dried state on an
absorbant material. By way of example, dried blood spots are
commonly stored on substrates.
[0005] Typically, for sample storage of the biological samples, it
is desirable to use substrates that facilitate efficient and
reproducible transfer of the collected samples to a substrate card.
However, typically, the success of the transfer of the collected
samples depends on skills of the user. Accordingly, the sample
transfer process is adversely affected in point-of-care type
settings where the person (e.g., a nurse, or a patient) collecting
the sample may have inadequate training in the sample collection
and transfer. Moreover, when compared to other samples, such as
substrate based samples, the sample transfer success rate is
relatively lower for swabbed samples (such as a buccal swab, nasal
swab, or swab of a wound area) as the user needs to apply the
sample to the correct location for sample collection and use the
right amount of force to transfer the sample from the swab to the
sample substrate. For example, if less than a desirable force is
applied to transfer the sample from the swab to the sample
substrate, the sample may not be efficiently transferred to the
sample substrate. On the other hand, if the force applied to the
swab is more than the desirable force, the storage substrate may
suffer damages.
BRIEF DESCRIPTION
[0006] In one embodiment, an assistive sample collection and
storage assembly for collecting, transferring and storing a
biological sample is provided. The assembly includes a sample
collection device and a sample storage device. The sample
collection device includes a first portion and a second portion,
where the first portion of the sample collection device is
configured to receive a sample collection member, wherein the
second portion is connected to the first portion by a rotating
element. Further, the sample collection device is configured to
rotate the sample collection member about a longitudinal axis of
the sample collection member. The sample storage device includes a
sample substrate configured to receive at least a portion of the
biological sample from the sample collection member. The assembly
is configured to exist in a first state and a second state. In the
first state of the assembly, the sample collection member is
disposed at a determined distance from the sample substrate.
Whereas, in the second state, at least a portion of the sample
collection member is in physical contact with at least a portion of
the sample substrate. Moreover, in the second state, the sample
collection member is configured to apply a determined amount of
contact force between the sample collection member and the sample
substrate.
[0007] In another embodiment, an assistive sample collection and
storage assembly for collecting, transferring and storing a
biological sample is provided. The assembly includes a sample
collection device and a sample storage device. The sample
collection device includes a first portion and a second portion.
The first portion of the sample collection device includes a sample
collection member having a handle. The second portion of the sample
collection device is configured to be coupled to the first portion
and the sample storage device.
[0008] In yet another embodiment, a method for collecting,
transferring and storing a biological sample using an assistive
sample collection and storage assembly is provided. The method
includes providing a sample collection member, collecting the
sample using the sample collection member. Further, the method
includes providing a sample storage device having a sample
substrate, and providing the assistive sample collection and
storage assembly comprising the sample collection device and the
sample storage device. Moreover, the method includes switching a
state of the assistive sample collection and storage assembly such
that at least a portion of the sample collection member is in
physical contact with at least a portion of the sample substrate,
where the sample collection member is in physical contact with the
sample substrate at a determined angle. Moreover, the method
includes rotating the sample collection member to facilitate
transfer of at least a portion of the sample from the sample
collection member to the sample substrate.
DRAWINGS
[0009] These and other elements and aspects of embodiments of the
present disclosure will become better understood when the following
detailed description is read with reference to the accompanying
drawings in which like characters represent like parts throughout
the drawings, wherein:
[0010] FIG. 1 is a perspective view of an example assistive sample
collection and storage assembly, in accordance with aspects of the
present disclosure:
[0011] FIG. 2 is a perspective view of the example assistive sample
collection and storage assembly of FIG. 1 in a first state, where a
sample collection member is disposed at a distance from a sample
substrate:
[0012] FIG. 3 is a perspective view of the example assistive sample
collection and storage assembly of FIG. 1 in a second state, where
at least a portion of a sample collection member is in physical
contact with at least a portion of a sample substrate;
[0013] FIG. 4 is a block diagram of an example method of using an
assistive sample collection and storage assembly for collecting,
transferring and storing a biological sample, in accordance with
aspects of the present disclosure:
[0014] FIG. 5 is a perspective view of a first portion of a sample
collection device in use, in accordance with aspects of the present
disclosure;
[0015] FIG. 6 is a perspective view of the first portion of the
sample device of FIG. 5;
[0016] FIG. 7 is an exploded view of an assistive sample collection
and storage assembly, in accordance with aspects of the present
disclosure;
[0017] FIG. 8 is a perspective view of the assistive sample
collection and storage assembly of FIG. 7 in a first state:
[0018] FIG. 9 is a perspective view of the assistive sample
collection and storage assembly of FIGS. 7-8 in a second state:
[0019] FIGS. 10(a)-10(b) are cross-sectional views of an
experimental set-up configured to assess an effect of a bending
angle of a swab on a location and amount of sample transferred on a
sample substrate, in accordance with aspects of the present
disclosure; and
[0020] FIG. 11 is a schematic representation of overlapping images
of a sample transferred from a swab to a sample substrate.
DETAILED DESCRIPTION
[0021] Embodiments relate to assistive sample collection assemblies
configured to assist in collection, transfer and storage of a
biological sample in a controlled manner. By way of example, the
assistive sample collection assemblies are configured to transfer
the biological sample to a desirable location on a sample substrate
in a reproducible manner. It should be noted that the terms
"sample" and "biological sample" may be used interchangeably
throughout the application. In certain embodiments, the assistive
sample collection and storage assembly may be used to collect
degradable biologically sourced analytes such as nucleic acids,
proteins, and respective fragments thereof. Non-limiting examples
of the biological sample may include saliva, blood, serum, lymph
fluids, buccal cells, mucosal cells, cerebrospinal fluid, semen,
feces, plasma, urine, a suspension of cells, or a suspension of
cells and viruses. In addition, the biological samples may include
samples from flora and fauna. In a non-limiting example, the
biological samples may include plant or fungal samples for the
study of population genetics. Also, in one example, the assembly
may be used for collection of the biological samples for purposes,
such as, but not limited to, collection of buccal cell samples for
criminal databases, collection of crime scene samples (i.e.,
rehydrated blood, semen, saliva and liquid samples of the same);
collection of sexual assault samples; collection of buccal samples
for population genetics or pharmacogenomics studies; collection of
nasal samples for respiratory infection diagnosis; collection of
bacterial or parasite samples from food sources; collection of
blood from meat at a slaughterhouse for meat traceability; or
collection of biological samples from animals for veterinary
diagnostics. It should be noted that at the time of collection, the
biological samples may or may not exist in a biological body from
where the sample originated. By way of example, the biological
sample may include a blood sample splattered on a floor of a crime
scene.
[0022] In certain embodiments, the assistive sample collection and
storage assembly may include a sample collection device and a
sample storage device. As used herein, the terms "assistive sample
collection and storage assembly," "assistive assembly," and
"assembly" may be used interchangeably. The sample collection
device is configured to receive at least one sample collection
member. The sample collection member is configured to collect a
biological sample. In some embodiments, the sample collection
member may include an analyte collection surface. The analyte
collection surface may include an analyte collection medium. In
certain embodiments, the sample collection member may be disposed
outside the sample collection device while collecting the sample.
In these embodiments, the sample collection member is coupled to
the sample collection device after collecting the sample. In
certain other embodiments, the sample collection member may be
disposed, at least in part, in the sample collection device while
collecting the sample. The sample storage device includes a sample
substrate. The sample substrate may be configured to receive and
store the sample from the sample collection member.
[0023] For analysis of the biological sample, the sample collection
device and the sample storage device are operated so as to transfer
at least a portion of the sample from the sample collection member
to the sample storage device. By way of example, the sample
collection device containing a sample collection member is coupled
to a sample storage device such that a portion of the sample
collection member having the sample is brought in physical contact
with a portion of the sample storage device to facilitate the
transfer of the sample from the sample collection member to the
sample storage device.
[0024] In one embodiment, the sample collection device may be
releasably coupled to the sample storage device. By way of example,
the sample collection device may be releasably coupled to the
sample storage device at least during transfer of at least a
portion of the sample from the sample collection member to the
sample storage device. In one example, the sample substrate may be
configured to receive the sample from the sample collection member
upon physical contact between the sample collection member of the
sample collection device and the sample substrate of the sample
storage device. The portion of the sample transferred from the
sample collection member to the sample storage device may be stored
on the sample substrate. In certain embodiments, the sample storage
device may include a storage medium suitable for collecting and
storing the biological sample. The storage medium may be disposed
on a surface of the sample substrate of the sample storage device.
In some embodiments, a surface of the sample substrate may be a
volume of a foam pad, for example, and not just a contact surface
area of the sample substrate. As used herein, the phrase "store the
sample" or "storing the sample" may encompass the steps of
disposing the sample on the sample substrate and drying the
sample.
[0025] One or more parts of the assistive sample collection and
storage assembly may be configured for one time use to reduce or
prevent contamination or spreading of infection via the sample
collection and storage assembly. In one example, the sample
collection device may be a disposable device. In some embodiments,
the design of the assistive sample collection and storage assembly
facilitates collection, transfer and storage of the sample, while
preventing any undesirable contact of the user with the sample
while transferring the sample from the sample collection member to
the sample storage device, or while storing the sample.
Advantageously, in some embodiments, the assistive sample
collection and storage assembly may be configured to receive
off-the shelf sample collection members, such as, but not limited
to, swabs, for collection of the biological samples. Furthermore,
the assembly may be used by any person, including a patient, and
may not necessarily need a technician or skilled operator to
collect, transfer or store the sample. In certain embodiments, the
assistive sample collection and storage assembly may be configured
for consistent and reproducible collection, transfer and storage of
biological samples. In certain embodiments, a percentage of the
biological sample transferred from the sample collection member to
the sample storage device may be reproducible. In certain
embodiments, the position of biological sample on the sample
substrate transferred from the sample collection member to the
sample storage device is reproducible.
[0026] In certain embodiments, for analysis of the biological
sample after collection, a suitable storage medium may be selected
so as to remove at least a portion of a biologically sourced
analyte present on the storage medium. Non-limiting examples of
suitable storage media may include cellulose, such as #903.RTM.
brand paper (GE Healthcare) or chemically impregnated celluloses,
such as FTA.RTM. and FTA.RTM. Elute brand paper (also from GE
Healthcare). These storage media provide a simple method for
collection, shipping and storage of biological samples. These
storage media also contain chemistries which facilitate easy
isolation of DNA from complex samples such as blood. Samples
collected on treated or untreated storage media are dried for
storage and can be stored at room temperature for long periods of
time.
[0027] Moreover, in some embodiments, the storage media may include
at least one stabilizing reagent that preserves at least one
biological sample analyte for transport or storage. Non-limiting
examples of suitable reagents for the storage media may include one
or more of a weak base, a chelating agent, and, optionally, uric
acid or a urate salt or simply the addition of a chaotropic salt,
alone or in combination with a surfactant. In one embodiment, the
storage media may have a visual delineation disposed around the
transfer area of the storage medium such that, if the sample
storage device is removed from the sample collection device, an
operator may know where the material was deposited without
reference to the device.
[0028] Furthermore, in certain embodiments, the assistive sample
collection and storage assembly may use a dry solid storage and
transfer medium and a method for the collection of biological
material of interest (genetic or proteinaceous material) in a form
suitable for storage and/or subsequent analysis. The analyte
collection surface may include an analyte collection medium
suitable for collecting the sample.
[0029] In one embodiment, the sample collection member may be
pre-fitted in the sample collection device. By way of example, the
sample collection member may be a factory fit in the sample
collection device. In an alternative embodiment, the sample
collection member may be available separately, and may be coupled
to the sample collection device as required. Also, In one
embodiment, the sample collection member may be used to collect the
sample prior to being coupled to the sample collection device. In
another embodiment, the sample collection member may be coupled to
the sample collection device before collecting the sample.
Non-limiting examples of the sample collection member may include a
flocked swab, cotton-tipped applicator, foam-tipped applicator, or
combinations thereof. In one example, the sample collection member
may include an off-the-shelf swab. In another example, the swab may
be a customized swab that is designed to suit requirements (e.g.,
size, shape) of the user and the sample collection device.
Non-limiting examples of the swab designs may include cylindrical
swabs that are symmetric about their longitudinal axis. However,
other kinds of swabs, such as, but not limited to, non-symmetrical
swabs (e.g., cone shaped swabs) may also be used.
[0030] Further, the sample collection device may include elements
to dispose the sample collection member such that when the sample
collection member comes in physical contact with the surface of the
sample substrate, also referred to as "substrate surface". The
contact is at a desirable angle to facilitate transfer of the
sample to the substrate surface. In addition, the sample collection
device may be configured to provide reproducible contact force
between the sample collection member (e.g., swab) and the sample
substrate. Further, the sample collection device may be configured
to provide a reproducible transfer location for the sample on the
sample substrate. Moreover, the sample collection device may be
configured to provide determined amount of collected sample volume
as well as sample concentration (sample volume per unit area of the
sample substrate) that is compatible with downstream sample elution
and analysis. Furthermore, the sample collection device provides an
ergonomically suitable design to enable trained as well as
untrained users to operate the device in a non-clinical setting.
Advantageously, the sample collection device provides elements that
facilitate storage of the sample while preventing user contact with
the sample, or user contact with the sample substrate to prevent
the user from coming in contact with any hazardous chemicals or
materials that are not bio-compatible.
[0031] In some embodiments, the sample collection device may
include provisions to be releasably coupled to the sample storage
device. Thus, one can separate the sample storage device from the
collection device for subsequent processing or storage. In one
embodiment, a coupling element between the sample collection device
and the sample storage device may be configured to allow for manual
or automated release of the sample storage device, but not allow
for accidental loss of the sample storage device from the
assembly.
[0032] In some embodiments, the assistive sample collection and
storage assembly may have a monolithic structure. In some of these
embodiments, the sample collection device and the sample storage
device may form an integrated structure. In some other embodiments,
the assistive sample collection and storage assembly may include
two or more physically independent portions. By way of example, the
physically independent portions of the assembly may include a
sample collection device and a sample storage device. The sample
collection device and sample storage device may be releasably or
permanently coupled to one another to form the assistive sample
collection and storage assembly.
[0033] Further, in some embodiments, the sample collection device
may have a monolithic structure. In some other embodiments, the
sample collection device may include two or more portions. In one
embodiment, the two or more portions of the sample collection
device may be operatively coupled via a coupling element. In one
such embodiment, the coupling element may be a flexure between the
two or more portions of the sample collection device. In one
example, a first portion of the sample collection device may be
releasably coupled to the second portion of the sample storage
device. In another example, the first portion of the sample
collection device may be releasably coupled to the sample
collection member. Non-limiting examples of the coupling element
may include fasteners, such as, but not limited to, slots and
pins.
[0034] The sample collection device may include provisions for a
bi-state design of the assistive sample collection and storage
assembly. In a first state of the assembly, the sample collection
member may be disposed away from the sample substrate. More
particularly, in the first state of the assembly, the portion of
the sample collection device having the sample collection member
and the other portion of the sample storage device are locked such
that the sample collection member is disposed away from the sample
substrate. In a second state of the assembly, the portion of the
sample collection device having the sample collection member and
the other portion of the sample storage device are locked such that
at least a portion of the sample collection member is in physical
contact with at least a portion of the sample substrate.
[0035] In certain embodiments, the sample collection device may
include a receiver that is configured to receive the sample
collection member. The receiver may be a snap-in element, a clip
element, an adhesive based element, or any other design that is
able to receive the sample collection member (e.g., an
off-the-shelf swab). The sample collection member may be
permanently or releasably coupled to the receiver.
[0036] Additionally, in certain embodiments, an analyte collection
surface of the sample collection member may include surfaces, such
as, but not limited to, a flocked surface. The analyte collection
surface may be dimensioned and configured such that the volume of
the sample being transferred from the sample collection member to
the sample substrate is controlled. By controlling the volume of
the transferred sample, overloading of any stabilizing reagents
disposed on the storage medium with respect to the respective
protecting capacity of the stabilizing reagents may be reduced or
prevented. If used in nasal swab applications, the analyte
collection surface may be dimensioned and configured to fit within
the human nasal cavity. Accordingly, when used in buccal swab
applications, the analyte collection surface should be dimensioned
and configured to fit within the human mouth.
[0037] In some embodiments, for record keeping and traceability,
the present device may also include an identification label (such
as conventional bar coding). In one example, the identification
label may be disposed on the sample collection device and the
sample storage device.
[0038] To ensure device integrity, in some embodiments, the
assistive sample collection and storage assembly may include a
sterility envelope surrounding device elements or devices of the
assistive sample collection and storage assembly. In some
embodiments, the elements or devices of the assistive sample
collection and storage assembly may be made from medical grade
plastics. Additionally, the elements or devices of the assistive
sample collection and storage assembly may be free from
contaminates and leachable materials (e.g., USP Class VI
materials). Moreover, the elements or devices of the assistive
sample collection and storage assembly may be sterilized through
conventional techniques such as irradiation after the envelope is
sealed. Kits may be made that incorporate the above device along
with any combination of associated equipment or reagents including
purification reagents, buffers, or the like and storage systems,
containers, or the like.
[0039] In one example embodiment, the assistive sample collection
and storage assembly may include a sample collection member-bending
approach. In this sample collection member-bending approach, a
natural stiffnessflexibility of a body of sample collection member
may be used to press a head of the sample collection member against
the sample substrate to produce proper contact force and facilitate
transfer of a desirable portion of the sample from the sample
collection member to the sample substrate. In some embodiments, the
user may rotate the sample collection member (e.g., a swab) one or
more times to facilitate physical contact between the head of the
sample collection member and the sample substrate.
[0040] Advantageously, systems and methods described herein are
configured to provide and address one or more issues associated
with reliable collection, transfer, and storage of the biological
sample on the sample substrate: 1) reproducible contact force
between the sample collection member and the sample substrate 2)
reproducible transferred sample location on the sample substrate,
percentage of transferred volume and sample concentration (volume
per unit area) to be compatible with downstream sample elution and
analysis; 3) ergonomically suitable to allow a wider range of users
including untrained users in the field, or non-clinical settings.
4) safe for the user to prevent undesirable user contact with the
sample substrate that may contain hazardous chemicals.
[0041] FIG. 1 illustrates an example assistive sample collection
and storage assembly 10. The assembly 10 may include a sample
collection device 12 and a sample storage device 14. The assembly
10 may be configured to allow a trained or an untrained user to
efficiently collect and store a biological sample. By way of
example, the assistive sample collection and storage assembly 10
may be configured to collect a biological sample (not shown) from
the user, and successfully transfer and store a desirable volume of
the collected sample in a desirable location of the sample storage
device 14 with repeatability.
[0042] In the illustrated embodiment, the assistive sample
collection and storage assembly 10 is configured to collect the
biological sample using a sample collection member 16. Further, the
assembly 10 is configured to transfer the collected biological
sample from the sample collection member 16 to a sample substrate
18 of the sample storage device 14. The sample substrate 18 is
configured to chemically stabilize and store the biological sample
for further analysis. The design of the assistive assembly 10 is
configured to facilitate reproducible volume and location of the
sample on the substrate 18.
[0043] In some embodiments, the sample collection device 12 may
have a first portion 13 and a second portion 15 that are connected
by a living hinge 32. In one embodiment, the living hinge 32 is a
thin flexible hinge or a flexure. In one example, the living hinge
32 may be made from the same material as the portions 13 and 15 of
the sample collection device 12. Non-limiting examples of the
material for the portions 13 and 15 may include, plastic, metal,
rubber, or combinations thereof. In one embodiment, a sub-portion
24 of the first portion 13 may be a separate component. In this
embodiment, the sub-portion 24 may be configured to be releasably
or permanently coupled to the first portion 13. The living hinge 32
may be configured to limit the relative rotational motion between
the first portion 13 and second portion 15. Further, the living
hinge 32 is configured to provide fatigue resistance. In one
example, the living hinge 32 may be injection molded. In another
example, the entire assembly 10 including the sub-components may be
injection molded.
[0044] The sample collection member 16 includes a head 20 and a
body 22. In one embodiment, the sample collection member 16 may be
an off-the-shelf swab. In another embodiment, the sample collection
member 16 may be a customized swab. Moreover, in some embodiments,
the sample collection member 16 may form an integral part of the
sample collection device 12. In another embodiment, the sample
collection member 16 may be a physically separate entity from the
sample collection device 12. In this embodiment, the sample
collection member 16 may be coupled or decoupled from the sample
collection device 12, as needed. By way of example, the sample
collection member 16 may be coupled to the sample collection device
12 before collecting the sample. As illustrated, in some
embodiments, the body 22 of the sample collection member 16 may be
disposed on fastener 26. The fastener 26 may have a determined
height (h), generally represented by reference numeral 25. Further,
the fasteners 26 and 30 may be configured to facilitate rotation of
the sample collection member 16 along a longitudinal axis of the
sample collection member 16, represented generally by reference
numeral 28. The fasteners 26 and 30 are configured to hold the
sample collection member 16 while transferring the sample from the
head 20 of the sample collection member 16 to the sample substrate
18. The fasteners 26 and 30 may be configured to permanently or
releasably couple the sample collection member 16 to the device 12.
The fasteners 26 and 30 are configured to provide a desirable angle
33 to the swab 16 when the head 20 of the sample collection member
16 is in contact with the sample substrate 18 for transfer of the
sample. The height (h) 25 of the fastener 26 may be determined
based on an angular value that is desirable for the angle 33.
Additionally, the fastener 31 is configured to secure the head 20
of the sample collection member 16, thereby preventing the head 20
of the sample collection member 16 from moving along the plane of
the sample substrate 18, during transfer of the sample.
Non-limiting examples of the fasteners 26, 30 and 31 may include
clasps, holders, ties, closures, snaps, pins, clips, toggles, or
combinations thereof. The fasteners 26 and 30 may employ similar or
different types of fastening means. In one embodiment, the
fasteners 26, 30 and 31 may be an integral part of the sample
collection device 12. The fasteners 26, 30 and 31 may be configured
to limit the translational motion of the sample collection member
16, where the translational motion is generally represented by
reference numeral 27. Further, the fasteners 26, 30 and 31 are
configured to allow rotation of the sample collection member 16, as
represented by reference numeral 29. Moreover, the fasteners 26 and
30 are configured to hold and bend the sample collection member 16
to an optimal angle 33 for applying force at the head 20 of the
sample collection member 16 to facilitate transfer of the
biological sample from the sample collection member 16 to the
sample substrate 18.
[0045] In a non-limiting example, the detent elements 34, 36 and
the living hinge 32 enable a bi-state operation of the sample
collection and storage assembly 10. By way of example, as
illustrated in FIG. 2, the detent elements 34, 36 and the living
hinge 32 enable the assembly 10 to exist in the first state by
allowing the sample collection member 16 to be disposed away from
the sample substrate 18. Further, as illustrated in FIG. 3, the
detent elements 34, 36 and the living hinge 32 enable the assembly
10 to exist in the second state by allowing the sample collection
member 16 to be in physical contact with a surface of the sample
substrate 18 at a desirable angle 33 to facilitate the transfer of
the sample from the sample collection member 16 to the sample
substrate 18 in the second state of the assembly 10. The sample
collection and storage assembly 10 is configured to switchably
change between the first and second states.
[0046] FIGS. 2-3 provide detailed views of detent elements employed
in the assistive sample collection device 12 which enables the
bi-state operation of sample collection and storage assembly 10 of
FIG. 1. FIG. 2 illustrates an embodiment 40 of the assistive
assembly 10 of FIG. 1, where the sample collection device 12 and
the sample storage device 14 are in the first state of the bi-state
design of the assembly 10. An enlarged view of the detent mechanism
is represented by reference numeral 42. In the illustrated
embodiment of FIG. 2, the detent mechanism 42 of the assembly 10
enables the assembly 10 to be in the first state, where the head 20
of the sample collection member 16 is disposed away from the sample
substrate 18. To maintain the first state the device 12, a detent
element 34 on the sub-portion 24 of the first portion 13 is
configured to interfere with a detent element 36 having a base 38.
In one embodiment, the interference between the detent element 36
and 34 retains the sample collection member 16 away from the sample
substrate 18. The living hinge 32 is flexed such that the detent
element 36 is brought in physical contact with the detent element
34.
[0047] FIG. 3 illustrates the assembly 10 in the second state of
the bi-state design of the assembly 10. In the illustrated
embodiment, an example detent mechanism is illustrated by reference
numeral 46. The detent mechanism 46 of the assembly 10 enables the
assembly 10 to be in the second state. The detent element 36 and 34
are in a locked position to configure the sample collection member
16 to make physical contact with a surface of the sample substrate
18. In the second state, at least a portion of the sample collected
by the sample collection member 16 may be transferred to the sample
substrate 18. In the illustrated embodiment of FIG. 3, the second
state is obtained when the detent element 34 rests below an
overhanging portion of the detent element 36. The detent element 36
is configured to bend without breaking as the tab 34 is rotated
towards the base 38 of the detent element 36. In one example, a
user holding the first and second portions 13 and 15 of the sample
collection device 12 may rotate the two portions 13 and 15 relative
to one another to obtain the second state of the assembly 10. In
the second state of the assembly 10, the sample collection member
16 maintains physical contact with the sample substrate 18. In one
embodiment, in the second state, the sample collection member 16
may be configured to maintain physical contact with the sample
substrate 18 without using any external loads or pressure.
[0048] In the illustrated embodiment, the sample collection member
16 is configured to apply a determined amount of force on the
sample substrate 18 to facilitate transfer of at least a portion of
the sample from the sample collection member 16 to the sample
substrate 18. In the illustrated embodiment, the arrow 29
illustrates the rotational movement of the sample collection member
16 around the axis 28 to facilitate transfer of the sample from the
sample collection member 16 to the sample substrate 18. In certain
embodiments, an optimal bending angle 33 for the sample collection
member 16 may be in a range from about 5 degrees to about 35
degrees. The heights of the fasteners 26, 30 and 31 may be selected
to provide the optimal angle to the sample collection member 16 to
facilitate transfer of the sample from the sample collection member
16 to the sample substrate 18.
[0049] After transfer of the sample, the devices 12 and 14 may be
decoupled. In some embodiments, the devices 12 and 14 may be
decoupled while the assembly 10 is still in the second state. In
alternative embodiments, the devices 12 and 14 may be decoupled
after switching the assembly 10 from the second state to the first
state. In some of these embodiments, the head 20 of the sample
collection member 16 may be positioned away from the sample
substrate 18 to prevent any undesirable transfer of the sample from
the sample collection member 18 to the sample substrate 18 during
decoupling of the sample storage device 14 from the sample
collection device 12. Further, positioning the head 20 away from
the sample substrate 18 prevents any undesirable contact of the
head 20 with either the sample substrate 18 or any other part of
the assembly 10. In one example, the head 20 of the sample
collection member 18 may be positioned away from the sample
substrate 18 by the user by rotating the two portions 13 and 15
relative to one another to obtain the second state.
[0050] FIG. 4 is an example flow chart 60 for a method for
collecting, transferring and storing a biological sample using an
assistive sample collection and storage assembly 10 (see FIG. 1) of
the present disclosure. The method of FIG. 4 will be described with
reference to assistive assembly of FIGS. 1-3 and 5-9. At block 62,
the method commences by collecting a biological sample. In a
non-limiting example, the sample may be collected from a patient, a
criminal suspect, a victim, a scene of crime, a plant, a fungus. In
one embodiment, the user of the assembly may be a trained
technician, in an alternative embodiment, the user of the assembly
may be a person who is not a trained technician. In one embodiment,
the sample collection member may be disposed in the sample
collection device while collecting the sample. In another
embodiment, the sample may be collected using the sample collection
member, and subsequently, the sample collection member may be
coupled to the sample collection device to facilitate transfer of
at least a portion of the sample from the sample collection member
to the sample substrate. In one example, the sample collection
member may be coupled to the sample collection device using a
snap-in mechanism. However, as will be appreciated, other fastening
mechanisms, such as clipping, adhesive, and the like may also be
used to couple the sample collection member to the sample
collection device. In one example, a user may use an off-the-shelf
swab to collect the sample.
[0051] In some embodiments, the sample collection device may be
available in two or more portions. In these embodiments, one of the
portions of the sample collection device may be coupled to the
sample collection member to collect the sample. The sample
collection member may be pre-fitted in the portion. Alternatively,
the sample collection member may be coupled to the portion of the
sample collection time at the time of use.
[0052] In addition, at block 66, the sample collection and storage
assembly is provided. The sample collection and storage assembly
may be provided in a first state. In some embodiments, the step of
providing the assistive sample collection and storage assembly
includes coupling the sample collection member to the sample
collection device after collecting the sample. In these
embodiments, the sample collection device and the sample storage
devices may be already coupled to each other at the time of sample
collection.
[0053] In other embodiments, the step of providing the assistive
sample collection and storage assembly includes releasably coupling
the sample collection device having the sample collection member to
the sample storage device. In these embodiments, the sample
collection member may be already coupled to the sample collection
device at the time of sample collection.
[0054] It should be noted that in embodiments where the assistive
sample collection and storage assembly has a monolithic structure,
the step of providing the assembly may be redundant.
[0055] Furthermore, at block 68, the state of the assistive sample
collection and storage assembly may be switched from the first
state to a second state to provide physical contact between the
sample collection member and the sample substrate. The fasteners
may be used to prevent undesirable movements of the sample
collection member in the second state of the assembly. In
particular, fasteners may be used to prevent undesirable movements
of the sample collection member during transfer of the sample from
the sample collection member to the sample substrate.
[0056] At block 70, at least a portion of the sample is transferred
from the sample collection member to the sample substrate. In one
embodiment, the sample may be transferred by applying force on the
sample collection member such that the head of the sample
collection member is pressed against the sample substrate, and at
least a portion of the sample is transferred to the sample
substrate. In one embodiment, the head of the sample collection
member may be rotated along a longitudinal axis of the sample
collection member one or more times to ensure that sample is
transferred from the surface area of the head of the sample
collection member. The sample from the head of the sample
collection member may be transferred to the substrate by applying a
force on the head of the sample collection member.
[0057] Moreover, at block 72, subsequent to the transfer of the
sample, the sample collection device is decoupled from the sample
storage device. It should be noted that optionally, after transfer
of the sample, but prior to decoupling of the sample collection and
sample storage devices, the sample collection device may be
returned to the first state prior to decoupling the devices. In
certain embodiments, the assistive sample collection and storage
assembly may be made using one or more of rapid prototyping,
molding, casting, injection molding, machining, or combinations
thereof.
[0058] FIG. 5 illustrates an example embodiment 80 of a portion of
an assistive sample collection and storage assembly, such as the
assistive assembly of FIG. 1, being used by a user 84 to collect a
nasal sample. In the illustrated embodiment, the user 84 employs a
first portion 82 of a sample collection device (not shown) to
collect the sample. In the illustrated embodiment, the first
portion 82 of the sample collection device is configured to receive
a sample collection member 86 (e.g., a nasal swab). In the
illustrated embodiment, the sample collection member 86 is embedded
in a body 88 of the first portion 82. In one embodiment, the sample
collection member 86 may be coupled to the first portion 82 at the
time of use, e.g., before and during collecting the sample. In
another embodiment, the sample collection member 86 may be coupled
to the first portion 82 of the sample collection device after
collection of the sample. The sample collection member 86 may be
configured to be snapped into the first portion 82. Moreover, in
one embodiment, the sample collection member 86 may be an
off-the-shelf swab.
[0059] In the illustrated embodiment, the sample collection member
86 includes a handle 90. The handle 90 of the sample collection
member 86 provides the provision for holding the sample collection
device. By way of example, at the time of sample collection, the
user 84 may hold the sample collection member 86 using the handle
90. The sample collection member 86 may be rotated using the handle
90. As will be appreciated, rotation of the sample collection
member 86 facilitates sample collection.
[0060] FIG. 6 illustrates the first portion 82 of the sample
collection device (not shown) and the sample collection member 86.
The body 88 and handle 90 of the sample collection member 86
include detent elements 91 and 92 to track number of rotations of
the sample collection member 86. An enlarged view 96 shows detent
elements 91 and 92. Additionally, the body 88 of the first portion
82 includes a second detent element 94 configured to achieve a
bi-state design of the assembly.
[0061] The detent elements 91 and 92 provide a feedback to the user
regarding the number of rotations of the sample collection member
86 that have been completed during collection or transfer of the
sample. The feedback may be provided by using mechanical means to
produce a tactile sensation, where the detent haptic feedback is
provided at the completion of a rotation. In one example, the
feedback from the detent elements 91 and 92, may be provided using
an audible clicking sound from the detent elements 91 and 92, where
the clicking sound is provided at the completion of a rotation. In
one embodiment, controlling the number of rotations helps to
improve reproducibility of the sample transfer. Further, the detent
elements 91 and 92 also help prevent the user from rotating less
than one complete rotation, in which case some portion of the
sample collection member 86 may not come in physical contact with
the sample substrate (not shown). Further, the detent elements 91
and 92 may be provided in the first portion 82 to prevent the
sample collection member 86 from undesirably rotating while
collecting the sample (e.g., mucus sample).
[0062] As illustrated in FIG. 6, the assembly may include elements
that enhance ergonomics and user-friendliness of the assembly. In
particular, the first portion 82 may be designed to provide the
user with an ergonomically suitable grip. By way of example, a size
of element 90 of the sample collection member may be suitable for
the user to hold element 90 with the hand and rotate element 90
during sample collection or transfer.
[0063] FIG. 7 illustrates an exploded view 100 of an assistive
sample collection and storage assembly employing the sample
collection member 86 (see FIG. 5) and first portion 82 of the
sample collection device. In operation, subsequent to the
collection of the sample by the first portion 82 of the sample
collection device, the first portion 82 may be coupled to a second
portion 102 of the sample collection device to form a sample
collection device. Further, a sample storage device 104 may be
coupled to the second portion 102 of the sample collection device
to form the assistive sample collection and storage assembly. The
sample collection device having the portions 82 and 102 may include
one or more fasteners configured to couple the sample storage
device 104 to the sample collection device. The fasteners may be
configured to allow the assembly to switch between the first and
second states. In one embodiment, the first portion 82 may include
a counterpart of the fasteners to facilitate coupling of the first
portion 82 of the sample collection device to the second portion
102 of the sample collection device. Further, the second portion
102 of the sample collection device may include a detent element
107 corresponding to detent element 94.
[0064] Detent elements 94 and 107 having a double-detent design is
configured to achieve a bi-state design wherein the assembly is
able to keep the sample collection member 86 away from the sample
substrate until the user snaps the device to bend the sample
collection member 84 at the optimal angle against the sample
substrate. The detent element 107 may be moved within the detent
element 94 to enable the switch between the first and second states
of the assembly. Also, fasteners 105 and 109 may be used to couple
the portions 82 and 102 of the sample collection device.
[0065] FIG. 8 illustrates a first state of an assistive sample
collection and storage assembly 106 or a sample collection device
108. The assembly 106 includes the sample collection device 108 and
the sample storage device 104. In the first state, the portions 82
and 102 of the sample collection device 108 are disposed such that
a head 110 of the sample collection member 86 is disposed at a
distance from a sample substrate 112 of the sample storage device
104.
[0066] The assistive sample collection and storage assembly 106 is
configured to exist in two discrete states that can be transitioned
to one another by rotating the first portion 82 relative to the
second portion 102 or the sample storage device 104. In the first
state, the portions 82 and 102 of the sample collection device 108
are disposed such that the head 110 of the sample collection member
86 is disposed at a distance from a sample substrate 112 of the
sample storage device 104.
[0067] Reference numeral 113 represents an enlarged view of the
detent elements 91 and 92. As illustrated in the enlarged view 113,
the handle 90 of the sample collection member 86 includes detent
element 91 and is configured to rotate as generally represented by
reference numeral 111. An enlarged view of detent elements 94 and
107 in the first state of the assistive sample collection and
storage assembly 106 is represented generally by reference numeral
114.
[0068] FIG. 9 depicts an embodiment 115 of the assistive sample
collection and storage assembly. As illustrated in FIG. 9, in the
second state, the portions 82 and 102 of the sample collection
device 108 are disposed such that at least a portion of the head
110 of the sample collection member 86 is in direct physical
contact with a portion of a surface of the sample substrate 112 of
the sample storage device 104. In the second state, the sample
collection member 86 is bent at an optimal angle with respect to
the second portion 102 or the sample storage device 104 to maintain
an optimal contact force between the head 110 of the sample
collection member 86 and the sample substrate 112 on the sample
storage device 104. By rotating the sample collection member 86
using element 90 of the sample collection member 86, at least a
portion of the biological sample is transferred to the sample
substrate 112 of the sample storage device 104. The sample may be
transferred with reproducible location, percentage of transferred
sample and sample concentration (volume per unit area). This
transfer method is compatible with different types of collection
members (e.g., swab) with an axially-symmetric head that can
collect a sample by rotation and a relatively flexible body. The
device is designed to be easy to use and mistake-proof.
[0069] An enlarged view of the detent elements 94 and 107 in the
second state of the assistive sample collection and storage
assembly 106 is represented generally by reference numeral 116. As
illustrated, in the second state, the head 110 of the sample
collection member 86 is in physical contact with the sample
substrate 112. The detent elements 94 and 107 having a
double-detent design is configured to achieve a bi-state design. In
particular, the detent element 107 disposed within the detent
element 94 is able to switch between a first position as
illustrated in the enlarged view 114 (FIG. 8), and the second
position as illustrated in the enlarged view 116. The shifting of
the position of the detent element 107 occurs when a user snaps the
first portion 82 to bend the sample collection member 86 at the
optimal angle to the sample substrate 112.
[0070] In one embodiment, subsequent to the transfer of the sample,
the detent elements 94 and 107 are configured in the first state,
and the sample collection device 108 is decoupled from the sample
storage device 104. In another embodiment, subsequent to the
transfer of the sample, the detent element may be maintained in the
second state, and the sample collection device 108 is decoupled
from the sample storage device 104.
[0071] In certain embodiments, the assembly utilizes the
flexibility of the sample collection member to create desirable
consistent contact force by bending/flexing the sample collection
member at an optimal angle against the surface of the sample
substrate. Further, one or more elements of the sample collection
device may be configured to guide the head of the sample collection
member and ensure that the head of the sample collection member
stays in the same desirable position during a sample transfer. In
addition to features and elements described herein above, the
assistive sample collection and storage assembly may also include
one or more elements to prevent user mistakes, for example, a guide
that stops undesirable rotation of the sample collection member.
The guide may be configured to prevent the handle which includes
the sample collection member from rotating about the base, before
the handle snaps onto the base. This snapping of the handle in the
base prevents premature contact between the sample collection
member and the sample substrate. With all these elements, the
assistive sample collection and transfer assembly becomes easier to
use and mistake-proof. The assembly may also include a cover that
prevents undersirable finger contact with the substrate and so
forth. The assistive sample collection and transfer assembly
facilitates reproducible biological sample transfer in both
location and percentage of transferred volume from an off-the-shelf
or customized swab to the sample substrate by a trained or novice
user using the assembly, while making the assembly
mistake-proof.
Example 1
[0072] In one example, an arrangement 130 of an experimental set-up
is provided to determine an optimal bending angle for a sample
collection member, such as a swab. As illustrated in FIGS.
10(a)-10(b), the arrangement 130 includes a peg board 140. A swab
142 is coupled to the peg board 140 using c-clips 144 and 146. The
number and positions of the clips 144 and 146 may be varied on the
peg board 140 to obtain different bending angles 148 and 154 of the
swab 142 to facilitate contact between the swab 142 and the sample
substrate 150. Patterns 152 and 156 represent positions of the
transferred sample on the sample substrate 150. The pattern 152
corresponds to the position of the swab 142 as illustrated in FIG.
10(a). Similarly, the pattern 156 corresponds to the position of
the swab 142 as illustrated in FIG. 10(b).
[0073] Sample transfer efficiency is analyzed quantitatively to
determine the optimal bending angle. The transfer efficiency is
quantified by a volume of sample in a 3 mm diameter sample area
(the current sample isolation area). Amount of sample transferred
from the swab 142 on the sample substrate 150 is obtained by
measuring a weight change of the sample substrate 150 before and
after transfer of the sample. The optimal number of turns of the
swab required to transfer a desirable amount of the sample is also
determined with this arrangement by evaluating the transfer
efficiency and substrate damage.
[0074] The experimental procedure included disposing the swab in
place and aligning the head of the swab at a desirable location on
the substrate. In the illustrated embodiment of FIG. 11, the head
of the swab is aligned with a hole on the peg board. Next,
retaining rings are installed to prevent front and back movement of
the swab. The weight of the swab and the substrate are measured.
Furthermore, about 50 .mu.L of mucus sample is applied on an
interior of a pipette using a syringe. The swab is rolled against
the interior of the pipette to transfer the sample on the swab. The
swab with the mucus sample is weighed. Subsequently, the swab is
disposed on the peg board. In addition, a suitable surface (e.g., a
paper) is disposed on the substrate. Next, the peg board and the
substrate are arranged such that there is physical contact between
the swab head and the substrate. While in contact with the
substrate, the swab is rotated ten times to facilitate transfer of
the mucus sample from the swab head to the substrate. Subsequent to
the transfer of the sample, the swab and the substrate paper are
released and weighed. FIG. 11 illustrates images of examples of the
transferred samples and the corresponding swab angles.
[0075] The transfer efficiency is quantified by the volume of mucus
in a 3 mm circle, which equals the amount of mucus that DNA/RNA can
be eluted from in the work flow. This can be obtained by measuring
the weight change of the substrate before and after and the
computing the mucus spot size using image processing. The results
are listed in Table 1. It is observed that for a bending angle
larger than the bending angle 148 of FIG. 10(a), the transferred
volume in a 3 mm.sup.2 area does not increase as bending angle
increases.
TABLE-US-00001 TABLE 1 S. No. 1 2 3 4 5 6 7 8 9 10 11 12 13 14
Angle 0 4.7 9.5 14 18.4 22.6 26.6 5.8 10.5 15 19.1 21.5 24.2 26.8
(degrees) Vol. 1.08 1.63 1.84 1.75 1.90 1.72 1.73 1.52 1.61 1.48
1.71 1.63 1.64 1.67 per 3 mm.sup.2 (.mu.L)
[0076] An amount of food dye that is less than about 10 .mu.L in
1.5 mL mucus sample is used. A ETF31 base paper is used as a
surface of the substrate. About 50 .mu.L of mucus sample is used
for each position of the bending angle of the swab. Further, two
different locations for the front c-clip (close to the swab head)
and seven locations for the rear c-clip are evaluated. The swab is
rotated for ten turns to transfer the sample from the swab to the
substrate.
[0077] Initially, the swab is disposed parallel to a surface of the
substrate, the bending angle of the swab at this stage may be
considered to be zero degrees. For bending angles of the swab above
zero degrees, the transferred volume in a 3 mm diameter area does
not increase immediately with the increase in the bending angle in.
However, bending angles greater than about 22.6 degrees (e.g.,
config. 6) may cause excessive force on the surface of the
substrate, thereby damaging the substrate. Considering an amount of
the transferred volume of the sample and substrate damage, an
optimal bending angle in a range from about 5 degrees to about 10
degrees is determined. An average volume of the sample transferred
from the swab to the substrate in a 3 mm elution area is about 1.67
.mu.L+0.21 .mu.L. A position of the transferred sample on the
substrate is analyzed using image processing. A center position of
the transferred sample relative to the peg board has deviation of
up to about 0.8 mm in both horizontal and vertical directions
(represented by x- and y-axes, respectively). The arrangement
demonstrated reproducibility in the volume of the sample
transferred and location of the sample on the substrate.
Example 2
[0078] A volume of the biological sample transferred from the
substrate was obtained by measuring a weight of the substrate
before and after the transfer of the biological sample.
[0079] The position of the transferred mucus spot was analyzed
using image processing in Matlab. A schematic of an overlapped
image 160 of all transferred samples 162 is shown in FIG. 11. A
darker area 164 indicates the common area shared by all the mucus
samples. The darker area 164 covers the interior 3 mm.sup.2
compression seal 166, which is shown as the circle. One can wrap a
rectangle around the sample with the edges parallel to the image
edges. The center position of such rectangle referenced to the
corner of the peg booard is obtained for each sample. The results
are shown in Table 2. Mucus spot positions after transfer. The
center position has small standard deviation of 0.8 mm in both
horizontal and vertical direction.
[0080] In the illustrated embodiment of FIG. 11, the transferred
sample images are added together. The rings 164 indicate the
compression seal. The region 166 indicates a common area shared by
all samples.
[0081] Advantageously, the assembly is lightweight and compact in
size. In one example, the assembly may weigh in a range from about
15 grams to about 50 grams. Further, the assembly is injection
moldable, without need for any further processing. Hence, the
assembly may be manufactured at a low cost. Moreover, the
customized swab may also be manufactured in a cost-effective
fashion. In some embodiments, the device may be used in a
multi-analyte point-of-care diagnostic platform that encompasses
the entire sample collection to sample analysis workflow. The
assembly enables a method to transfer biological sample from a swab
to substrate paper by bending a swab. Such a method of sample
transfer is compatible with a variety of swabs and is applicable to
a wide range of biological samples. Further, the assembly is
easy-to-use and mistake proof. Accordingly, the assembly may be
used by users including untrained persons in clinical or
non-clinical settings.
[0082] While only certain elements of the invention have been
illustrated and described herein, many modifications and changes
will occur to those skilled in the art. It is, therefore, to be
understood that the appended claims are intended to cover all such
modifications and changes as fall within the scope of the
invention.
* * * * *