Fluid sample collection devices and methods of collecting fluid samples

Abstract

Provided herein are fluid sample collection devices, particularly, saliva sample collection devices, and methods of using them. In certain embodiments, the fluid sample collection device comprises: a first portion and a second portion, the two portions removably joined together, wherein each of the first portion and the second portion comprises a casing configured to removably accommodate an adsorbent sample collection pad. Each adsorbent sample collection pad comprises a sample collection element and a longitudinal element, which fits in a longitudinal groove of the casing. The casings removably connect with each other via connection elements to form the fluid sample collection device. In some embodiments, the adsorbent sample collection pad comprises an indicator dye, which provides a signal when contacted with a sample. In some cases, the first and / or the second portion comprise a holding element for a user. Methods of collecting saliva samples using the collection devices are also described.

Description

FLUID SAMPLE COLLECTION DEVICES AND METHODS OF COLLECTING FLUID SAMPLESCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims benefit under 35 U.S.C. § 119(e) of provisional application 63 / 726,089, filed November 27, 2024, which application is hereby incorporated by reference in its entirety.INTRODUCTION

[0002] Fluid samples, such as saliva or urine samples are often used for diagnostic purposes. Therefore, fluid sample collection devices that are convenient and comfortable for use are desirable. Also, fluid sample collection devices that allow ease of dividing collected fluid samples are also desirable.SUMMARY

[0003] The disclosure provides fluid sample collection devices and methods of collecting fluid samples using such devices. In certain aspects, a fluid sample collection device comprises: a first portion and a second portion, the two portions being removably joined together to form the collection device, wherein each of the first portion and the second portion comprises a casing configured to removably accommodate an adsorbent sample collection pad, each adsorbent sample collection pad comprising a sample collection element and a longitudinal element, wherein the longitudinal element fits in a longitudinal groove of the casing, and wherein the casings removably connect with each other via connection elements to form the fluid sample collection device.

[0004] Certain aspects of the disclosure also provide methods of collecting fluid samples, such as saliva or urine samples, using the fluid sample collection devices described herein. In some embodiments, a method of collecting a fluid sample of a subject using a fluid sample collection device disclosed herein comprises: i) positioning an adsorbent sample collection pad of a fluid sample collection device in contact with a fluid sample to be collected, ii) allowing for an appropriate time the fluid sample to be adsorbed in the sample collection element thereby collecting the fluid sample of the subject. In specific embodiments, the fluid sample is a saliva sample and the method comprises positioning the adsorbent sample collection pad of the fluid sample collection device under the subject’s tongue to contact saliva to be collected.BRIEF DESCRIPTION OF THE DRAWINGS

[0005] FIG. 1 shows an example of assembling a portion of the fluid sample collection devices described in this disclosure.

[0006] FIG. 2 shows an example of an assembled portion of the fluid sample collection devices described in this disclosure.

[0007] FIG. 3 shows an example of assembling two portions of the fluid sample collection devices described in this disclosure.

[0008] FIG. 4 shows an example of an assembled fluid sample collection device disclosed in this disclosure.

[0009] FIG. 5 describes adsorbent sample collection pad used in the fluid sample collection devices disclosed in this disclosure.DETAILED DESCRIPTION

[0010] Provided herein are devices for fluid sample collection and methods of using the devices described herein. In certain embodiments, a fluid sample collection device comprising: a first portion and a second portion, the two portions being removably joined together to form the collection device, wherein each of the first portion and the second portion comprises a casing configured to removably accommodate an adsorbent sample collection pad, each adsorbent sample collection pad comprising a sample collection element and a longitudinal element, wherein the longitudinal element fits in a longitudinal groove of the casing, and wherein the casings removably connect with each other via connection elements to form the fluid sample collection device.

[0011] In some cases, the adsorbent sample collection pad comprises an indicator dye, which provides a signal when contacted with the sample, thus, indicating sample collection. In some cases, each portion comprises a holding element for holding and manipulation by a user. In some embodiments, the two portions are removably joined together via mechanically engaging elements, such as depressions and protrusions in the casings. The two portions can be separated from each other to thereby separate the two adsorbent sample collection pads. In certain cases, the disclosure provides methods of collecting fluid samples, such as saliva or urine samples, using the collection devices disclosed herein.

[0012] Before the present disclosure is described in greater detail, it is to be understood that this disclosure is not limited to particular embodiments described, as such may vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

[0013] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.

[0014] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present disclosure, some potential and exemplary methods and materials may now be described. Any and all publications mentioned herein are incorporated herein by reference to disclose and describe the methods and / or materials in connection with which the publications are cited. It is understood that the present disclosure supersedes any disclosure of an incorporated publication to the extent there is a contradiction.

[0015] It must be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a device” includes a plurality of such devices. It is further noted that the claims may be drafted to exclude any element, e.g., any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely”, “only” and the like in connection with the recitation of claim elements, or the use of a “negative” limitation.

[0016] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed. To the extent the definition or usage of any term herein conflicts with a definition or usage of a term in an application or reference incorporated by reference herein, the instant application shall control.

[0017] As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present disclosure. Any recitedmethod can be carried out in the order of events recited or in any other order which is logically possible.FLUID SAMPLE COLLECTION DEVICES

[0018] As described above, provided herein are fluid sample collection devices, such as saliva or urine sample collection devices. In certain aspects, a fluid sample collection device comprises: a first portion and a second portion, the two portions being removably joined together to form the collection device, wherein each of the first portion and the second portion comprises a casing configured to removably accommodate an adsorbent sample collection pad, each adsorbent sample collection pad comprising a sample collection element and a longitudinal element, wherein the longitudinal element fits in a longitudinal groove of the casing, and wherein the casings removably connect with each other via connection elements to form the fluid sample collection device.

[0019] In some cases, the adsorbent sample collection pad comprises an indicator dye, which provides a signal when contacted with the sample. In certain cases, the indicator dye is present at the junction of the longitudinal element and the sample collection element. This location indicates saturation of the sample collection element with the fluid sample but indicates that the rest of the longitudinal element is free of the sample at the moment the indicator dye provides the signal. Such indication also denotes that sufficient sample is collected. In certain embodiments, the casing comprises a window through which the indicator dye is visible.

[0020] In some cases, the adsorbent sample collection elements from the two portions are flush with each other. This ensures that the collected sample is equally distributed between the two sample collection elements thereby reducing variation in the two samples collected in the sample collection elements.

[0021] In some embodiments the weight of the adsorbent collection pad is between 240 mg to 300 mg, such as 240, 245, 250, 255, 260, 265, 270, 275, or 280 mg. In some cases, the weight of the two adsorbent collection pads in the two portions is different from each other by less than 5 mg, such as less than 4, 3, 2, or 1 mg.

[0022] In some cases, the fluid sample collection device is designed to collect saliva. Thus, the indicator dye is selected such that it provides a signal, for example, a change in color when contacted with saliva. Suitable dyes that can be used to indicate the presence of saliva are well known in the art and use of such dyes are within the purview of the disclosure.

[0023] In some cases, the casing for the first portion and / or the second portion comprise a holding element for holding and manipulation of the fluid sample collection device by a user. Theholding elements can be used by a user to carry the devices. The holding elements can also be used to separate the first portion and the second portion by prying the two portions.

[0024] In certain embodiments, the first portion and the second portion are removably joined together via engaging protrusions and depressions on the first portion and the second portion.

[0025] Non-limiting example of certain fluid sample collection devices, particularly, saliva sample collection devices, described herein are provided in FIGS. 1 to 5. FIG. 1 shows an adsorbent sample collection pad (combination of 2 and 7) and the casing 3. The casing can have the holding element 1. The adsorbent sample collection pad comprises sample collection element 2 and an elongated element 7, which is designed to fit in a groove 8 in the casing 3. The elongated element also has a color indicator 4, which is visible from beneath the adsorbent sample collection pad in the point of view shown in FIGS. 1 and 2.

[0026] The casing of a first portion can comprise a protrusion 5 and a depression 6. These two elements are designed to reversible engage with corresponding protrusion and depression on the casing for the second portion of the fluid sample collection device. This is described below in more detail.

[0027] A user can place the adsorbent sample collection pad into the casing to produce a first portion of the collection device, as shown in FIG. 2. The adsorbent sample collection element sticks out of the casing while the elongated element fits into the groove 8 of the casing thereby mechanically holding the adsorbent sample collection element.

[0028] FIG. 3 shows assembly of two portions of the fluid sample collection devices. The assembly for each portion is as described in FIGS. 1 and 2 and the preceding paragraphs.

[0029] FIG. 4 describes an assembled collection device. In the assembled device, the holding elements can be used by a user to hold and manipulate the collection pad and the adsorbent sample collection elements are designed to be placed under the tongue of a subject.

[0030] When the subject holds the adsorbent sample collection element under the tongue for an appropriate period of time, for example, 3 to 5 minutes, the adsorbent sample collection element adsorbs the saliva thereby collecting the sample. As the saliva is adsorbed in the sample collection pad, it reaches the area connecting the sample collection element and the longitudinal element. A dye deposited in this connection point changes color indicating that sufficient sample is adsorbed in the sample collection element. Suitable dyes that can be used to indicate the presence of saliva are well known in the art and use of such dyes are within the purview of the disclosure. In some cases, one or both casings of the two portions comprise windows from which the indicator dye can be observed.

[0031] The size of the adsorbent sample collection pad can be varied depending on the size of a subject’s mouth. For example, a shorter sample collection pad can be used for a child whereas a longer sample collection pad can be used for an adult.

[0032] An adsorbent sample collection pad can be made of any adsorbent suitable material, for example, any suitable porous material, such as polymeric material. Non-limiting examples include filter-paper, cotton, other cellulosic material, and the like.

[0033] Because an adsorbent sample collection element touches a subject’s tongue when used to collect saliva, the adsorbent sample collection pad can be configured to avoid unpleasant taste / flavor and / or to provide a pleasant taste / flavor. For example, an adsorbent sample collection element can be flavored, for example, by incorporating flavored substances into the materials used to produce the adsorbent sample collection element. When an adsorbent sample collection element touches a subject’s tongue, such flavored material can dissolve into the subject’s saliva and provide pleasant taste to the subject. In particular, adsorbent sample collection element with pleasant taste would facilitate obtaining saliva samples from children as children may be distracted from the unpleasant experience of taking the sample and instead enjoy the pleasant taste.

[0034] In some cases, an adsorbent sample collection element is marked to indicate the appropriate location of the adsorbent sample collection element in a subject’s mouth. An appropriate location of an adsorbent sample collection pad is such that when it is placed under a subject’s tongue, the adsorbent sample collection element can properly absorb and collect a saliva sample from the subject.

[0035] Once a saliva sample is collected from a subject, a user can separate the two portions by disengaging the two portions from each other. This can be facilitated by the holding elements. Such separation of the two portions then provides two adsorbent sample collection elements, each with a portion of a saliva sample of a subject. These samples can then be used in separate tests.METHODS OF COLLECTING FLUID SAMPLES

[0036] Also provided herein are methods of collecting fluid samples, for example, saliva or urine samples, using the fluid sample collection devices described herein.

[0037] Accordingly, certain embodiments provide a method comprising:

[0038] i) positioning an adsorbent sample collection pad of a fluid sample collection device in contact with a fluid sample to be collected,

[0039] ii) allowing for an appropriate time the fluid sample to be adsorbed in the sample collection element thereby collecting the fluid sample of the subject.

[0040] In some cases, the methods further comprise collecting the sample collection element to obtain the fluid sample from the subject.

[0041] In some cases, the fluid sample is a saliva sample. Accordingly, in methods of collecting saliva, the method comprises positioning the adsorbent sample collection pad of the fluid sample collection device under the subject’s tongue to contact saliva to be collected.UTILITY

[0042] The fluid samples, particularly, saliva devices and methods of collecting fluid samples, such as saliva as disclosed herein can be typically used in medical testing and diagnostics. As appreciated by a person of ordinary skill in the art, a fluid sample, such as a saliva sample from a subject can be tested for infections, such as bacterial or viral infections. A fluid sample, such as a saliva sample from a subject can be tested for collecting cells from a subject for DNA based diagnostics. Cells collected from a subject can also be tested for the presence of neoplasm.

[0043] In some cases, a saliva sample from a subject can be tested for detecting an infection with a pathogen, for example, a virus, a bacterium, or a fungus.

[0044] A pathogen that can be tested in a saliva sample from a subject includes one or more of human immunodeficiency virus (HIV), Hepatitis C virus (HCV), Hepatitis B virus (HBV), Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Human papillomavirus (HPV), Cytomegalovirus (CMV), Epstein-Barr virus (EBV), Polyomavirus BK (BKV), Methicillin- resistant Staphylococcus aureus (MRSA), Clostridium difficile (C. Diff.), Vancomycin-resistant enterococci (VRE), adenovirus, Mycobacterium tuberculosis (TB), Varicella Zoster Virus (VZV), Herpes simplex virus (HSV), John Cunningham virus (JCV), enterovirus. Lymphogranuloma Venereum (LGV), viruses of a Respiratory Viral Panel (RVP), Human Herpesvirus 6 (HHV6), Trichomonas vaginalis, Mycoplasma genitalium, norovirus, zika virus, Respiratory syncytial virus (RSV), streptococcal pathogen, such as Streptococcus pyrogenes and Streptococcus agalactiae, SARS-CoV-2, and influenza virus.

[0045] A saliva sample from a subject can also be tested for toxicological screening, such as for detecting drugs or other chemicals. A drug or compound tested in a throat swab sample include alcohol, amphetamines, barbiturates, benzodiazepines, cocaine, marijuana, methamphetamine, opioids, opiates, and phencyclidine.

[0046] Although the foregoing disclosure has been described in some detail by way of illustration and example for purposes of clarity of understanding, it is readily apparent to those of ordinary skill in the art in light of the teachings of this disclosure that certain changes and modifications may be made thereto without departing from the spirit or scope of the appended claims.

[0047] Accordingly, the preceding merely illustrates the principles of the disclosure. It will be appreciated that those skilled in the art will be able to devise various arrangements which, although not explicitly described or shown herein, embody the principles of the disclosure and are included within its spirit and scope. Furthermore, all examples and conditional language recited herein are principally intended to aid the reader in understanding the principles of the disclosure and the concepts contributed by the inventors to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Moreover, all statements herein reciting principles, aspects, and embodiments of the disclosure as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents and equivalents developed in the future, i.e., any elements developed that perform the same function, regardless of structure. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.

[0048] The scope of the present disclosure, therefore, is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of present disclosure is embodied by the appended claims. In the claims, 35 U.S.C. §112(f) is expressly defined as being invoked for a limitation in the claim only when the exact phrase “means for” or the exact phrase "step for" is recited at the beginning of such limitation in the claim; if such exact phrase is not used in a limitation in the claim, then 35 U.S.C. § 112(f) is not invoked.

Claims

CLAIMSWe Claim:

1. A fluid sample collection device comprising: a first portion and a second portion, the two portions being removably joined together to form the collection device, wherein each of the first portion and the second portion comprises a casing configured to removably accommodate an adsorbent sample collection pad, each adsorbent sample collection pad comprising a sample collection element and a longitudinal element, wherein the longitudinal element fits in a longitudinal groove of the casing, and wherein the casings removably connect with each other via connection elements to form the fluid sample collection device.

2. The fluid sample collection device of claim 1, wherein the adsorbent sample collection pad comprises an indicator dye, which provides a signal when contacted with the sample.

3. The fluid sample collection device of claim 2, wherein the sample is saliva.

4. The fluid sample collection device of claim 2 or 3, wherein the casing comprises a window through which the indicator dye is visible.

5. The fluid sample collection device of any one of preceding claims, wherein the casing for the first portion and / or the second portion comprise a holding element for holding and manipulation of the fluid sample collection device by a user.

6. The fluid sample collection device of any one of preceding claims, wherein the first portion and the second portion are removably joined together via engaging protrusions and depressions on the first portion and the second portion.

7. The fluid sample collection device of any one of the preceding claims, wherein the first portion and the second portion are separable from each other to thereby separate the two adsorbent sample collection pads.

8. A method of collecting a fluid sample of a subject using a fluid sample collection device of any one preceding claims, the method comprising: i) positioning an adsorbent sample collection pad of a fluid sample collection device in contact with a fluid sample to be collected,ii) allowing for an appropriate time the fluid sample to be adsorbed in the sample collection element thereby collecting the fluid sample of the subject.

9. The method of claim 8, wherein the fluid sample is a saliva sample.

10. The method of claim 9, wherein the method comprises positioning the adsorbent sample collection pad of the fluid sample collection device under the subject’s tongue to contact saliva to be collected.

11. The method of any one of claims 8 to 10, further comprising collecting the sample collection element to obtain the fluid sample from the subject.

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