Patent Publication Number: US-2022212189-A1

Title: Oral fluid, saliva and sputum collection device and method

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation-in-part of International Application No. PCT/US2020/029209, titled “Oral Fluid, Saliva and Sputum Collection Device and Method” and filed on Apr. 22, 2020, which claims priority to U.S. Non-provisional patent application Ser. No. 16/842,220, titled “Oral Fluid, Saliva and Sputum Collection Device and Method” and filed on Apr. 7, 2020, which claims priority to U.S. Provisional Patent Application No. 62/928,406 titled “Filtered Neat Oral Fluid Split Specimen Collection Device” and filed on Oct. 31, 2019, the contents of each of these patent applications being incorporated herein by reference in their entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates to devices for collecting oral fluids, saliva and sputum. Throughout this disclosure such fluids are collectively referred to as “oral fluids” or “specimens.” All three of these fluids generated by the human body have long been found useful for determining the health of people and in particular, for the diagnosis of disease, such as severe acute respiratory syndrome coronavirus 2 (also known as SARS-CoV-2 and, commonly referred to as COVID-19), prediction of disease progression, monitoring of therapeutic drug levels and detection of illicit drugs. In particular, the present disclosure relates to an oral fluids collection device wherein the donor can discharge oral fluids directly from the donor&#39;s mouth into a container and wherein the oral fluids can be filtered and drawn into removable vacuum tubes, ready for laboratory transport, point of collection screening, testing, or diagnostic analysis while the oral fluid specimen is still in the transparent vacuum tube. 
     BACKGROUND 
     Saliva samples are commonly collected by intra-oral sponge absorption and by direct expectoration into a container. An example of intra-oral sponge absorption is disclosed in U.S. Pat. No. 4,580,577, which describes an absorbent mass (collection paddle) that is masticated by the donor until saturated. The mass is placed in a squeezing device to expel saliva into a holding chamber, out of which a test aliquot can be removed. The problem with the currently marketed collection paddle systems is that the absorbent collection paddle is placed in a particular place in the donor&#39;s mouth, is subjected to touching by the donor, comes into contact with the interior of the donor&#39;s mouth and tongue and any particulates that may remain in the donor&#39;s mouth, and collects from one region of the mouth. In addition, the donor has to place a saturated paddle in the transport tube that contains transport buffer. The transport tube may be subject to spillage and leakage during transportation to the laboratory. Some absorbent collection paddle systems may contain a cotton swab with chemicals to help excite the donor&#39;s salivary glands. These chemicals and the cotton swabs add more volume to the saliva sample and may contaminate the sample so that it may be unknown how much of the sample is actually oral fluid. In many cases the cotton swab deteriorates or separates from a plastic portion of the paddle, both while in the donor&#39;s mouth and otherwise prior to use, and the volume from one collection to the next can vary depending on how much the cotton has deteriorated. The cotton can also trap particulates from the donor&#39;s mouth, therefore adding more volume that is not saliva and could be a contaminant. Foaming and bubbling of oral fluid specimens in this process can compromise laboratory testing. Intra-oral sponge absorption does not provide a split specimen collection nor a mixed saliva specimen. The absorbent materials can cause discomfort for the donor, perhaps even precipitating a biological reaction. 
     The shortcomings of the current intra-oral sponge absorption were addressed by the Department of Health and Human Services&#39; (DHHS) in its “Mandatory Guidelines for Federal Workplace Drug Testing Programs” (published in the Federal Register at 2019-22684, issued on Oct. 25, 2019, and went into effect on Jan. 1, 2020, the “DHHS Regulation”), which is applicable to all federal employees. This DHHS Regulation allowed for the use of neat oral fluid collection devices. The DHHS Regulation defined the term “undiluted (neat) oral fluid” as “an oral fluid specimen to which no other solid or liquid has been added. For example, see Section 2.4: “a collection device that uses a diluted (or other compartment, process, or method that modifies the volume of the testable specimen) must collect at least one (1) mL of undiluted (neat) oral fluid.” 
     Voiding into an open container eliminates the drawbacks of oral absorption methods but may produce a specimen having unwanted particulates from the mouth and the open container can be prone to spillage. What is needed is an open container method that avoids these problems and is able to meet the regulatory requirements for a “neat oral fluid” specimen. 
     SUMMARY 
     The present disclosure describes a device for collecting oral fluids, saliva, or sputum. The device has a tubular housing having a top end and a bottom end. A collection cup having a top end and a bottom end is attached to the top end of the tubular housing. The bottom end of the cup has one or more hollow needles or hollow, pointed, sharp tubes extending from the bottom end of the cup into an interior of the top end of the tubular housing. The bottom end of the cup has one or more openings that open into the one or more hollow needles or hollow, pointed, sharp tubes. The hollow needles or hollow, pointed sharp tubes are covered with a penetrable sleeve to prevent unwanted drainage. One or more vacuum tubes are positioned in the housing. The vacuum tubes have a top end with a penetrable seal and a bottom end. When one or more vacuum tubes are pushed towards the top end of the housing the penetrable seals of the vacuum tubes are penetrated by the hollow needles or hollow, pointed, sharp tubes. 
     A base is attached to the bottom end of the housing. The base has a vacuum tube holder for the vacuum tubes. In one embodiment the base is constructed to screw into and off of the bottom end of the housing. When the base is screwed into the bottom end of the housing the vacuum tubes are moved upward towards the top of the housing, and the hollow needles or hollow, pointed, sharp tubes are pushed through the penetrable seal of the vacuum tubes. In another embodiment, the base is constructed such that the base slides upward relative to the housing. When the base is slid upward into the bottom end of the housing, the vacuum tubes are pushed upward towards the top of the housing, and the hollow needles or hollow, pointed, sharp tubes are pushed through the penetrable seal of the vacuum tubes. The device can include a removeable tab that is positioned to restrict the base from moving upward into the bottom end of the housing. This tab is kept in place during initial shipping and storage of the device and during the initial collection of a specimen. Once the specimen has been deposited into the collection cup, the tab is removed, which facilitates the movement of the base upward relative to the housing. 
     A filter may be positioned in an interior of the collection cup to filter the oral fluids to remove bubbles, foam, particulates and other undesirable substances. Additionally, a fill control line may be positioned on the collection cup as a guide when a donor is depositing a specimen into the device. 
     An advantage of the oral fluid, saliva, and sputum collection device is the collection of a specimen ready for laboratory transport, point of collection screening, testing, or diagnostic analysis while the oral fluid specimen is still in the transparent vacuum tube. 
     Another advantage is a collection of an oral fluid specimen in a transparent vacuum tube which allows for the use of lasers, fluorescence, and all nanotechnology diagnostic and molecular imaging of nanoparticle options currently in existence or which might exist in the future. 
     Another advantage is an oral fluid collection device that will reduce overall cost of oral fluid drug testing, human factor errors, opportunities for collector error, opportunities for specimen adulteration by the donor, and incidents of specimen leakage in transport. 
     Another advantage is a collection of an oral fluid specimen that will provide superior drug recovery characteristics for laboratory testing and/or point of collection screening in accordance with DHHS Regulations and in any application where oral fluid testing is conducted. 
     Another advantage is that the device allows for a self-collection by donors of their oral fluids in their homes, workplaces, physician&#39;s offices, clinics, as well as a collector directed or an observed collection, all without ever requiring the collector to come in contact with the oral fluid specimen. 
     Another advantage is that the device allows for the collection of an oral fluid sample from a donor, where that oral fluid sample is filtered to remove unwanted particulates and other substances and split into two neat specimens useful in testing and analysis. Such undiluted neat split specimens allow for confirmation of analyses (such as a positive or negative diagnosis or results), as a backup specimen in case of an error in testing or inconclusive result, if a donor disputes the results of the initial test, and other such circumstances. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         FIG. 1  is a top, side, perspective view of an exemplary embodiment of an oral fluid collection device of the present disclosure. 
         FIG. 2  is an exploded perspective view of the oral fluid collection device of  FIG. 1 . 
         FIG. 3  is a side elevation view of the oral fluid collection device of  FIG. 1  in an oral fluid sampling configuration. 
         FIG. 4  is a side elevation view of the oral fluid collection device of  FIG. 1  in a vacuum tube collection configuration. 
         FIG. 5  is a top, side, perspective view of another embodiment of an oral fluid collection device of the present disclosure. 
         FIG. 6  is an exploded perspective view of the oral fluid collection device of  FIG. 5 . 
         FIG. 7  is a side elevation view of the oral fluid collection device of  FIG. 5  in an oral fluid sampling configuration. 
         FIG. 8  is a side elevation view of the oral fluid collection device of  FIG. 5  in a vacuum tube collection configuration. 
         FIG. 9  is a side cross-sectional view of a portion of the exemplary oral fluid collection device using a luer lock mechanism to connect a hollow needle to a collection cup. 
         FIG. 10  is a schematic illustration of another exemplary embodiment of an oral fluid collection device of the present disclosure. 
         FIG. 11  is a schematic illustration of the oral fluid collection device of  FIG. 10  in preparation for use by a donor. 
         FIG. 12  is a schematic illustration of the oral fluid collection device of  FIG. 10  in use by a donor. 
         FIG. 13  is a schematic illustration of the oral fluid collection device of  FIG. 10  in use by a donor. 
         FIG. 14  is a schematic illustration of the oral fluid collection device of  FIG. 10  in use by a donor. 
         FIG. 15  is a schematic illustration of the oral fluid collection device of  FIG. 10  in use by a donor. 
         FIG. 16  is a schematic illustration of the oral fluid collection device of  FIG. 10  in use by a donor. 
         FIG. 17  is a schematic illustration of the oral fluid collection device of  FIG. 10  in use by a donor. 
         FIG. 18  is a schematic illustration of the oral fluid collection device of  FIG. 10  in use by a donor. 
         FIG. 19  is a schematic illustration of the oral fluid collection device of  FIG. 10  in use by a donor. 
         FIG. 20  is a schematic illustration of the oral fluid collection device of  FIG. 10  in use by a donor. 
         FIG. 21  is a schematic illustration of the oral fluid collection device of  FIG. 10  in use by a donor. 
         FIG. 22  is a schematic illustration of an exemplary base for use with an oral fluid collection device with a vacuum tube engaged with the base. 
         FIG. 23  is a schematic illustration of the exemplary base of  FIG. 22 , with another vacuum tube engaged with the base. 
         FIG. 24  is a schematic illustration of an exemplary collection cup and related accessories for use with an oral fluid collection device. 
         FIG. 25  is a schematic illustration of the exemplary collection cup of  FIG. 24  in use with the exemplary base of  FIG. 22 . 
         FIG. 26  is a schematic illustration of the exemplary collection cup of  FIG. 24  in use with the exemplary base of  FIG. 22 . 
         FIG. 27  is a schematic illustration of the exemplary collection cup of  FIG. 24  in use with the exemplary base of  FIG. 22 . 
         FIG. 28  is a schematic illustration of the exemplary collection cup of  FIG. 24  in use with the exemplary base of  FIG. 22 . 
         FIG. 29  is a schematic illustration of the exemplary collection cup of  FIG. 24  in use with the exemplary base of  FIG. 22 . 
         FIG. 30  is a schematic illustration of the exemplary collection cup of  FIG. 24  in use with the exemplary base of  FIG. 22 . 
         FIG. 31  is a schematic illustration of the exemplary collection cup of  FIG. 24  in use with the exemplary base of  FIG. 22 . 
     
    
    
     DETAILED DESCRIPTION OF THE DISCLOSURE 
     While the following description details the preferred embodiments of the present disclosure, it is to be understood that the disclosure is not limited in its application to the details of arrangement of the devices, parts, components, and methods described and illustrated in the accompanying figures, since the disclosure is capable of applying to other embodiment of oral fluid collection devices, parts, components, and methods of practice. 
     The present disclosure provides a rapid, safe, secure, and simultaneous split specimen collection device, for self-collection (or collector observed collection) of neat filtered saliva, oral fluid, and sputum specimens, which are transported into test tubes ready for prompt diagnostic screening and testing of a virus such as COVID-19, and of any other substances of interest in these specimens. This oral fluid collection device can provide a neat simultaneous split oral fluid specimen in full compliance with the DHHS Regulations. The due process value in regulated workplace testing (including eventually testing under U.S. Department of Transportation rules and regulations) is to allow the donor who disagrees with the result of a test to demand confirmation testing at a second Substance Abuse and Mental Health Services Administration (“SAMHSA”) certified laboratory using the untested split sample. Additionally, in a non-regulated testing situation, the split specimen tube can be used for the analysis of other substances of interest, such as DNA, to prove that the specimen was actually the claimed donor&#39;s specimen where a self-collection is conducted, or similar to a situation where numerous vacuum blood tubes are simultaneously taken for diagnostic analysis. 
       FIG. 1  is a top, side, perspective view of an exemplary oral fluid collection device  100  of the present disclosure, and  FIG. 2  is an exploded perspective view of the oral fluid collection device. The collection device  100  has a hollow tubular housing  101  with a top end  102  and a bottom end  103  and a collection cup  104  with a top end  105  and a bottom end  106 . The collection cup  104  has an interior  107  and an opening  108  at the top end  105  that provides access into the interior  107  of the collection cup  104 . The top end  105  of the collection cup  104  has threads  109  around the opening  108  that are arranged to engage a screw-on cap  110  with corresponding threads  111 . 
     The bottom end  106  of the collection cup  104  has an opening  113  for insertion of a hollow needle  114 , to facilitate the drainage of liquid through the opening  113  and into the hollow needle  114 . The hollow needle  114  extends downward beyond the underside  115  of the bottom end  106  of the collection cup  104  and is covered with a flexible, compressible, penetrable sleeve  116  that prevents unwanted drainage through the hollow needle  114 . The hollow needle  114  can take on other arrangements, such as a hollow, pointed, sharp tube; a shard of hollow metal or plastic; or any arrangement that can facilitate the flow of fluids from one location of the other. However for convenience, such components will be referred to as hollow needles throughout this disclosure. 
     The collection device  100  includes a base  117 , where the base  117  includes a stem  119 . The base  117  further includes a vacuum tube holder  118  formed by the interior surface of the stem  119  and located generally in the center of the base  117 . The bottom end  103  of the housing  101  includes a threaded section  121  along the interior of the housing  101 . The exterior of the stem  119  includes corresponding threads  120  for engaging with the threads  121  at the bottom end  103  of the housing  101 . The threads  120  of the base  117  can be engaged with the threads  121  of the base  117 , and as the threads ( 120  and  121 ) engaged and the base  117  is screwed into the housing  101 , the vacuum tube holder  118  advances upwards towards the top end  102  of the housing  101 . As will be further described, when a vacuum tube  125  is positioned within the vacuum tube holder  118 , the vacuum tube  125  will advance upward toward the top end  102  of the housing  101  and toward the hollow needle  114 . 
     The oral fluid collection device  100  has a sieve or filter  122  which has an open end  123  that opens into an interior  124  of the filter  122 . The filter  122  is placed inside the interior  107  of the collection cup  104  and, preferably, has a shape which conforms to the shape of the collection cup  104 . The open end  123  of the filter  122  is adjacent to the opening  108  of the collection cup  104  at the top end  105  of the collection cup  104 . The filter  122  is made of a non-absorbent material such as plastic or metal but paper can also be used. Preferably, the filer is a microfilter. The microfilter is a micro-filtration screen made from a specific weave type, wire diameter, and mesh count for the filtration of suspended solid particles, bubbles and viscous matter in order to provide the ideal fluid specimen. For example, a type  304  stainless steel mesh is used having 0.0098 inch openings with a 0.0037 inch wire diameter. The microfilter is precisely cut and formed to fit the collection cup  104 . 
     A vacuum tube  125  is positioned in the interior of the housing  101 . The vacuum tube  125  has a top end  126  and a bottom end  127 . The top end  126  is open and has a cap  128  which covers the top end  126 . The cap  128  has a flexible penetrable membrane  129  which can be punctured by the hollow needle  114 . The compressible sleeve  116  on the hollow needle  114  can also be punctured by the hollow needle  114 . Vacuum tubes for collection fluid samples are well known in the art and can be obtained commercially. Flexible, compressive sleeves for the hollow needle  114  can also be obtained commercially. 
       FIG. 3  is side elevation view of the oral fluid collection device in an oral fluid sampling configuration.  FIG. 4  is side elevation view of the oral fluid collection device in a vacuum tube collection configuration. In use, the cap  110  is unscrewed from the top of the collection cup  104  and a donor voids his or her oral fluids into the filter  122  that is in the collection cup  104 . The oral fluids will drain through the anti-foaming filter  122  to the bottom of the collection cup  104  and collect there. The collection cup  104  can have a control fill line (for example, as illustrated in  FIGS. 7 and 8  as reference number  530 ) to guide the donor to provide a sufficient and precise amount of oral fluid. The oral fluid will also drain into the hollow needle  114  but will not flow out of the hollow needle  114  because of the blocking action of the sleeve  116  that is placed over and attached to the hollow needle  114 . Sputum can also be collected in this manner but it may be necessary for the donor or the collector to first remove the filter, which can be done manually. 
     After the oral fluids sample is provided, the cap  110  is replaced on the collection cup  104  and the base  117  of the housing  101  is screwed into the housing  101 . As the base  117  is screwed inward, the vacuum tube  125  will move upward and engage the hollow needle  114 . As the base  117  is further screwed inward, the cap  128  of the vacuum tube  125  engages the sleeve  116  and the hollow needle  114 , and such upward movement results in a force being applied between the hollow needle  114  and the cap  128  of the vacuum tube  125 , resulting in the hollow needle  114  penetrating both the sleeve  116  and the membrane  129  in the cap  128  of the vacuum tube  125 . The sleeve  116  compress and moves away from the tip of the hollow needle  114 , and the vacuum in the vacuum tube  125  pulls the oral fluids into the vacuum tube  125  until the vacuum is dissipated. 
     Once the vacuum tube  125  is properly filled, the base  117  and the housing  101  are unscrewed, causing the vacuum tube  125  to move downward relative to the housing  101 , causing the hollow needle  114  to be removed from the vacuum tube  125 . Once the hollow needle  114  is removed, the membrane  129  of the cap  128  of the vacuum tube  125  reseals the vacuum tube  125 . The sleeve  116  uncompresses, returns to its original configuration, and again covers the tip of the hollow needle  114 . Thus providing users with protection from the sharp portion of the hollow needle  114 . The vacuum tube  125  can then be removed from the housing  101  and the vacuum tube holder  118 . In one embodiment, the vacuum tube  125  can be held in the vacuum tube holder  118  using a friction fit that is arranged to retain the vacuum tube  125  in the vacuum tube holder  118 , while allowing the user to apply a reasonable force to remove the vacuum tube  125  from the vacuum tube holder  118 . The vacuum tube  125  containing the sample of oral fluids can then be transferred to a laboratory for analysis. 
     In another embodiment, the oral fluid collection device can accommodate a plurality of vacuum tubes.  FIG. 5  is a top, side, perspective view of such an embodiment of an oral fluid collection device  500  with two vacuum tubes  525 .  FIG. 6  is an exploded perspective view of the oral fluid collection device  500  with two vacuum tubes  525 . The oral fluid collection device  500  has a hollow tubular housing  501  with a top end  502  and a bottom end  503  and a collection cup  504  with a top end  505  and a bottom end  506 . The collection cup  504  has an interior  507  and the top end  505  forms an opening  508  into the interior  507 . The top end  505  of the collection cup  504  has threads  509  around the opening  508  engaging a screw-on cap  510  having corresponding threads  511 . 
     The bottom end  506  of the collection cup  504  has an pair of openings  513  for insertion of a pair of hollow needles  514  for drainage of liquid. The hollow needles  514  extend downward beyond the underside  515  of the bottom end  506  and are each covered with a flexible, compressible sleeve  516  that prevents unwanted drainage through the hollow needles  514 . 
     The collection device  500  includes a base  517 , where the base  517  includes a stem  519 . The base  517  further includes a vacuum tube holder  518  formed by the interior surface of the stem  519  and located generally in the center of the base  517 . The bottom end  503  of the housing  501  includes a threaded section  521  along the interior of the housing  501 . The exterior of the stem  519  includes corresponding threads  520  for engaging with the threads  521  at the bottom end  503  of the housing  501 . The threads  520  of the base  517  can be engaged with the threads  521  of the base  517 , and as the threads ( 520  and  521 ) are engaged and the base  517  is screwed into the housing  501 , the vacuum tube holder  518  advances upwards towards the top end  502  of the housing  501 . When a pair of vacuum tubes  525  are positioned within the vacuum tube holder  518 , the vacuum tubes  525  will advance upward toward the top end  502  of the housing  501  and toward the hollow needles  514 . 
     The oral fluid collection device  500  has a sieve or filter  522  which has an open end  523  that opens into an interior  524  of the filter  522 . The filter  522  is placed inside the interior  507  of the collection cup  504  and, preferably, has a shape which conforms to the shape of the collection cup  504 . The open end  523  of the filter  522  is adjacent to the opening  508  of the collection cup  504  at the top end  505  of the collection cup  504 . 
     Vacuum tubes  525  are positioned in the interior  519  of the housing  501 . Each vacuum tube  525  has a top end  526  and a bottom end  527 . The top end  526  is open and has a cap  528  which covers the top end  525 . The cap  528  has a flexible membrane  529 , which can be punctured by the hollow needle  514 . The compressible sleeve  516  on the hollow needle  514  can also be punctured by the hollow needles  514 . A fill control line  530  is located on the cup  504 , vacuum tube guides  531  are positioned at the bottom  512  of the collection cup  504 , and a vacuum tube tray  532  is shown for insertion into the vacuum tube holder  518 . The vacuum tube guides  531  and the vacuum tube tray  532  prevent the vacuum tubes  525  from rotating as the base  517  is screwed into and off of the bottom end  503  of the housing  501 . The vacuum tubes  525  may also have control fill lines to verify accuracy. 
       FIG. 7  is side elevation view of the oral fluid collection device  500  in an oral fluid sampling configuration.  FIG. 8  is side elevation view of the oral fluid collection device  500  in a vacuum tube collection configuration. The oral fluid collection device  500  is used in a similar manner as described for the oral fluid collection device  100 . 
       FIG. 9  is a side elevation view of an exemplary subassembly for use in an oral fluid collection device. This embodiment uses a luer lock mechanism to connect a hollow needle to a collection cup. The subassembly  900  has a collection cup  901  with a top end  902  and a bottom end  903 . The collection cup  901  has an interior  904  and the top end  902  forms an opening  905  into the interior  904 . The top end  902  of the collection cup  901  has threads  906  around the opening  905  engaging a screw-on cap  907  having threads  908 . The underside  909  of the bottom end  903  has an opening  910  and a luer lock mechanism  911  to attach a hollow needle to the opening  910 . A hollow female receptacle  912  of the luer lock mechanism  911  is attached to the opening  910 . A hollow male insert  913  of the luer lock mechanism  911  is insertable into the hollow female receptacle  912  and can be locked thereto with a locking mechanism  914 , as is well known in the art. A hollow needle  915  is attached to the hollow male insert  913  so that fluid in the collection cup  901  will flow from the collection cup  901 , through the opening  910 , through the hollow female receptacle  912 , through the hollow male insert  913 , through the hollow needle  915 , and into a vacuum tube. The subassembly  900  functions similar to the description of the oral fluid collection devices  100  and  500  for obtaining a specimen in a clear vacuum tube. In the devices  100 ,  500  and subassembly  900 , the vacuum tubes can be pushed manually onto the hollow needle and can be made of any suitable plastic or metal or combination thereof. 
     The oral fluid collection devices  100 ,  500  and subassembly  900  provide for useful methods for collecting oral fluids, saliva, or sputum. A collection cup is provided having a top end and a bottom end. The bottom end of the cup has one or more hollow needles extending from the bottom end of the cup. One or more vacuum tubes are provided. Each vacuum tube has a top end with a penetrable seal. The vacuum tubes are placed beneath the hollow needles. Oral fluids, saliva, or sputum from a donor are collected into the collection cup. The hollow needles are pushed through the penetrable seal of the vacuum tubes. The oral fluids, saliva, or sputum from the collection cup are drawn through the hollow needles and into the vacuum tubes. Preferably, the fluids, saliva, or sputum are collected up to a control line on the collection cup. If desired, a filter is placed in the collection cup and the oral fluids, saliva, or sputum are filtered before pushing the hollow needles through the penetrable seal of the vacuum tubes. A compressible sleeve can be placed over the hollow needles to prevent unwanted drainage prior to pushing the hollow needles through the penetrable seal of the vacuum tubes. 
     These oral fluid collection devices  100 ,  500  and subassembly  900  are used to collect oral fluids, such as mixed saliva, directly from a mouth of a donor. Mixed saliva is considered a gold standard for testing saliva because it provides the purest specimen by the donor. The use of mixed saliva is in compliance with the DHHS Regulations. The oral fluid collection device  500  with a pair of vacuum tubes  525  can also provide split specimen collection. 
     The specimen can be initially filtered through a non-absorbent material screen at the top of the oral fluid collection cup to remove bubbles, foam, particulates, and donor induced adulterants. The collection cup can have a scratch and a sniff food grade scent sticker on its side, or supplied to the collector, to excite the donor&#39;s salivary glands so that a sufficient volume of oral fluid may be obtained to reach a control line within 5 to 10 minutes. The vacuum tubes come pre-vacuumed to draw in a precise amount of oral fluid from the cup. The precise amount is defined by laboratory requirements and/or accrediting agencies including but not limited to the DHHS Regulations and other similar regulations, such as, for example, regulations of the Federal Department of Transportation (“DOT”) and similar federal and state agencies. The vacuum tubes may be prefilled with a transport and stabilizing buffer to preserve the integrity of the specimen for a number of days stated by the buffer manufacturer in an un-refrigerated state. The vacuum tubes also preserve the integrity of the specimen for transport for laboratory testing, in compliance with proposed DHHS and/or DOT split specimen collection regulations. The filtered oral fluid specimen or split specimen contained in the leak proof vacuum tubes is optimized for immediate laboratory processing or frozen storage. The vacuum tube may also be used for point of collection (POCT) screening by placement of color-coded activated reagents in the vacuum test tube. The reagents react quickly to multiple possible substances in the donor&#39;s oral fluid as the oral fluid is vacuumed from the collection cup into analytical laboratory equipment. 
     Advances in nanotechnology, diagnostic and molecular imaging of nanoparticles, such as by use of gold nanoparticles, quantum dots, magnetic nanoparticles, etc. combined with mobile fluorescence devices, are especially well suited to use transparent vacuum tube delivered neat oral fluid specimens. The oral fluid specimen in the transparent vacuum tube allows for the use of lasers, fluorescence, and all nanotechnology diagnostic and molecular imaging of nanoparticle options which currently exist or which might exist in the future for a true solution (“Fluorometric virus detection platform using quantum dots-gold nanocomposites optimizing the linker links variation,” published in ScienceDirect Volume 1109, 1 May 2020, pages 148-157, found at https://doi.org/10.1016/j.aca.2020.02.039). Oral fluid has long been understood to be useful as a diagnostic tool in medicine. Technological advances over the past decades have enabled oral fluid to expand its usefulness in the diagnosis of disease, prediction of disease progression, monitoring of therapeutic drug levels and detection of illicit drugs. The easy non-invasive nature of collection and the relationship between oral fluid and plasma levels make oral fluid a valuable clinical tool. (“Oral fluid as a diagnostic tool,” published in Clin Chem Lab Med 2004; 42(11):1273-1287, found at. DOI 10.1515/CCLM.2004.248). 
     For purposes of COVID-19 or other virus testing, the oral fluid collection devices  100 ,  500  and subassembly  900 , for example, allow for the safe and secure self-collection and secure transport of either saliva, oral fluids and/or sputum collected from a donor. Recently, sputum has been shown in scientific studies to have a higher recovery rate of the COVID-19 markers compared to a nasal swab, which has a higher than expected false negative rate and which is extremely invasive. (“Detection of SARS-CoV-2 in Different Types of Clinical Specimens,” JAMA Research Letter published Mar. 11, 2020 found at: 25 doi:10.1001/jama.2020.3.3786 and “SARS-CoV-2 more readily detected in induced sputum than in throat swabs of convalescent COVID-19 patients,” Mar. 12, 2020 in The Lancet Infectious Diseases found at DOI: http://doi.org/10.1016/S1473-3099(20)30174-2). Likewise, there is a recent medical study showing that a saliva specimen is a consistent detection option for COVID-19 patients. The 2019 novel coronavirus (2019-nCoV) was detected in the self-collected saliva of 91.7% (11/12) of patients. Serial saliva viral load monitoring generally showed a declining trend. Live virus was detected in saliva by viral culture. Saliva is a promising noninvasive specimen for diagnostic, monitoring, and 35 infectious control in patients with 2019-nCoV. (“Consistent Detection of  2019  Novel Coronavirus in Saliva,” published 30 Feb. 12, 2020 in the Journal for Infectious Diseases Society of America found at DOI: 10.1093/cid/ciaa149). 
     Because the oral fluid collection devices  100 ,  500  and subassembly  900  are self-collection devices, collection of specimens can be conducted without placing a healthcare worker at risk of contracting COVID-19. The devices allow for multiple oral fluid collection possibilities based upon compliance with various pre-collection protocols and instructions from the collector. Multiple oral fluid collections make the devices ideal for collection of oral fluid specimens to measure the donor&#39;s antibody production following a bout with COVID-19. The devices are also useful following vaccination (once discovered) to determine the donor&#39;s level of immunity protection against a subsequent outbreak and to provide clearance to go safely back to work and play in a non-social distancing society. 
       FIGS. 10-21  schematically illustrate another embodiment of an oral fluid collection device  1000 . The fluid collection device  1000  operates generally on the same principles as described herein for other oral fluid collection devices  100  and  500  and includes a pair of vacuum tubes that collect split samples. However, the oral fluid collection device  1000  illustrated in  FIGS. 10-21  includes a sliding or plunger mechanism for facilitating relative linear movement between the vacuum tubes and hollow needles to collect samples in the vacuum tubes. As illustrated in  FIG. 10 , the oral fluid collection device  1000  includes a base  1002 , a collection cup  1004 , and a cap  1006 . The cap  1006  is connected to the collection cup  1004  by a hinge  1008  and a user can selectively open or close the cap  1006  to gain access to or secure the collection cup  1004 . Such cap  1006  is secured to the collection cup  1004  by a reversible protrusion and snap mechanism  1010 . Positioned in the collection cup  1004  is an anti-foaming filter funnel  1012  for filtering oral fluids deposited in the collection cup  1004  by a donor. A collection cup  1004  includes a thin walled body  1014  that defines the inner volume or the collection cup  1004 . A collection cup fill line  1016  can be scribed on the collection cup body  1014  to assist a user in determining when a sufficient amount of oral fluid has been deposited in the collection cup  1004 . The collection cup  1004  further includes a pair of hollow needles  1018  that are secured in a vertical position at least partially within the collection cup  1004  and in fluid communication with oral fluid deposited into the collection cup  1004 . As previously described, a flexible, compressible, penetrable sleeve  1019  can be positioned over each hollow needle  1018  to prevent unwanted drainage through the hollow needle  1018  and to offer protection to a user or donor handling the oral fluid collection device  1000  from injury from the sharp end of the hollow needle  1018 . 
     The base  1002  includes a thin walled body  1020  that defines the inner volume of the base  1006 . The thin walled body  1014  of the collection cup  1004  and the thin walled body  1020  of the base  1002  are reversibly secured together by a removeable seal. During the collection of oral fluids, the thin walled body  1014  of the collection cup  1004  and the thin walled body  1020  of the base  1002  remain secured together. After the collection of oral fluids is complete and the oral fluids are fully moved to and stored in vacuum tubes, the removeable seal can be removed, the collection cup  1004  and the base  1002  separated, and the vacuum tubes accessed and removed by the donor or other user of the oral fluid collection device  1000 . 
     The base  1002  includes a pedestal  1022 , which forms the bottom portion of the base  1002 . The pedestal  1022  includes an upper surface  1025  and a lower surface  1027 has and a recessed section  1024  located between the upper surface  1025  and lower surface  1027  (as best illustrated in  FIG. 17 ). As illustrated in  FIG. 10 , a removable tab  1026  is positioned within the recessed section  1024  and, as will be subsequently described, the removeable tab  1026  engages with the recessed section  1024  in a manner that maintains a static positional relationship between the vacuum tubes  1028  and the hollow needles  1018 . Such a static positional relationship prevents the vacuum tubes  1028  from interaction with the hollow needles  1018  prematurely (i.e., prevents accidental piercing of the membrane sealing the vacuum tubes prior to the oral fluid being in proper position to fill the vacuum tubes). As illustrated in the figures, positioned within the base  1002  are a pair of vacuum tubes  1028 , which can be optionally reversibly secured in place with a vacuum tube holder  1030 . Each vacuum tube  1028  can also include a vacuum tube fill line  1032  to inform a user whether a sufficient amount of oral fluid has been deposited into the vacuum tubes  1028 . 
       FIGS. 11-21  illustrate an exemplary method of using the oral fluid collection device  1000 . As illustrated in  FIG. 11 , when a donor is ready to use the oral fluid collection device  1000 , the donor will unsecure the protrusion and snap mechanism  1010  and rotate the cap  1006  about the hinge  1008  to open the oral fluid collection device  1000 . As illustrated in  FIG. 12 , the donor deposits oral fluid into the opening in the oral fluid collection device  1000 . As the oral fluid is deposited into the oral fluid collection device  1000 , it engages the filter funnel  1012  (as illustrated in  FIG. 13 ), where the filter funnel  1012  filters out unwanted materials from the oral fluid. The oral fluid then progresses through filter funnel  1012  downward into a collection area  1034  (as illustrated in  FIG. 14 ). As all the oral fluid filters through the filter funnel  1012  and into the collection area  1034 , the collected fluid may surpass the fill line  1016  on the collection cup  1004  (as illustrated in  FIG. 15 ). If the oral fluid in the collection area  1034  does not surpass the fill line  1016  of the collection cup  1004  with the first oral fluid deposit from the donor, the donor can again deposit oral fluid into the oral fluid collection device  1000  until the oral fluid surpasses the fill line  1016 . 
     Once the fill line  1016  on the collection cup  1004  is surpassed, the cap  1006  is closed and latched (as illustrated in  FIG. 16 ) and the removable tab  1026  is removed from the recessed section  1024  of the pedestal  1022  (as illustrated in  FIG. 17 ). The oral fluid collection device  1000  is now in condition to fill the vacuum tubes  1028  with oral fluid in the collection area  1034 . As illustrated in  FIG. 18 , with the removable tab  1016  removed, the collection cup  1004  and thin walled body  1020  of the base  1002  can move downward relative to the vacuum tubes  1028 . Such movement moves the hollow needles  1018  downward and engages the hollow needles  1018  with the vacuum tubes  1028 ; thus, facilitating the flow of oral fluid from the collection area  1034  into the vacuum tubes  1028 . As all the oral fluid flows from the collection area  1034  into the vacuum tubes  1028 , the oral fluid will surpass the vacuum tube fill lines  1032  (as illustrated in  FIG. 19 ). 
     One method of moving the collection cup  1004  and thin walled body  1020  of the base  1002  downward relative to the vacuum tubes  1028  is to place the oral fluid collection device  1000  on a flat surface, such as a table top, with the lower surface  1027  of the pedestal  1022  in contact with the flat surface, and apply downward pressure on the top of the oral fluid collection device  1000  until the hollow needles  1018  engage with the vacuum tubes  1028  and oral fluid flows into the vacuum tubes  1028 . Once the vacuum tubes  1028  are filled, the oral fluid collection device  1000  can be returned to its original position (as illustrated in  FIG. 20 ), any seal or mechanism joining the collection cup  1004  to the base  1002  is removed and the collection cup  1004  can be separated from the base  1002  (as illustrated in  FIG. 21 ). The vacuum tubes  1028  can now be removed from the base  1002  and secured and packaged for shipping or transport to a laboratory for testing. Once the vacuum tubes are removed and secured, both the base  1002  and the collection cup  1004  can be discarded. 
     In other embodiments of oral fluid collection devices, a base of such a device can include features that provide for accommodating vacuum tubes of different sizes. Additionally, components and features can be incorporated into an oral fluid collection device to facilitate the engagement and disengagement of vacuum tubes and hollow needles and to protect users from the hollow needles. Such components and features include the use of a force generated by the compression of a resilient material to manage the engagement of the hollow needle with the vacuum tube and the use of a force generated by the release of a compressed material to manage the disengagement of the hollow needle from the vacuum tube.  FIGS. 22-31  illustrate exemplary components that add such features and functionality, which can be used with any of the embodiments disclosed herein. 
     In one example of a base  1100 , schematically illustrated in  FIGS. 22 and 23 , the base  1100  can include a feature to accommodate different sized vacuum tubes. The exemplary base  1100  includes a cone shaped feature  1102  that can form a friction fit with a vacuum tube inserted into the base  1100 . As illustrated in  FIG. 22 , a vacuum tube  1104  with a relatively small diameter is accommodated by the cone-shaped feature  1102  in the base  1100 . As illustrated in  FIG. 23 , a vacuum tube  1106  with a relatively large diameter is accommodated by the cone shaped feature  1102  in the base  1100 . In addition to a cone shaped feature, the base can include a funnel shaped feature, a wedge shaped feature or any other shape that facilitates the insertion of a vacuum tube, including vacuum tubes of varying sizes. 
       FIG. 24  schematically illustrates an exemplary collection cup  1200  with an integrated hollow needle  1202  and a tube guide  1204  extending downward from the collection cup  1200  and enclosing the hollow needle  1202 . Positioned within the tube guide  1204 , and surrounding the hollow needle  1202 , is a compressible and resilient sleeve  1206 . The sleeve  1206  consists of a material that can be deformed by an applied force, but will return to its original shape upon the removal of the force. Once such material is polypropylene; however, it will be understood that many materials can be used for the sleeve  1206 . As illustrated in  FIG. 24 , the sleeve  1206  occupies the available volume of the tube guide  1204  and extends beyond the hollow needle  1202 ; thus, protecting both the hollow needle  1202  and any user or donor that handles the oral fluid collection device. Similar to the flexible, compressible, penetrable sleeves  116 ,  1019  described above, the compressible and resilient sleeve  1206  illustrated in  FIGS. 24-31  can prevent unwanted drainage through the hollow needle  1202 . 
       FIGS. 25-31  schematically illustrate the combination of the base  1100  of  FIGS. 22 and 23 , and the collection cup  1200  and related components of  FIG. 24 . When the base  1100  and collection cup  1200  (and related components) are to be used together, a user positions the collection cup  1200  over the base  1100 , with a vacuum tube  1104  positioned in the base  1100 . As illustrated in  FIG. 26 , the collection cup  1200  is lowered toward the base  1100 , and the tube guide  1204  is slid over the vacuum tube  1104  and into the base  1100 . The collection cup  1200  is lowered until the top of the vacuum tube  1104  is positioned near the bottom of the sleeve  1206 . Once in such a position, as illustrated in  FIG. 27 , the donor can deposit a specimen in the collection cup  1200 . Once a sufficient volume of oral fluid is deposited in the collection cup  1200 , the user or donor can further move the collection cup  1200  downward, applying enough force to overcome the resilient nature of the sleeve  1206  (as illustrated in  FIG. 28 ). The force generated by the compression of the sleeve  1206  provides for smooth and controlled downward movement of the collection cup  1200 . As the sleeve  1206  compresses, the hollow needle  1202  engages the vacuum tube  1104  (i.e., pierces the membrane sealing the vacuum tube  1104 ) and the vacuum within the vacuum tube  1104  draws the specimen into the vacuum tube  1104  through the hollow needle  1202  (as illustrated in  FIG. 29 ). 
     Once the user or donor releases the downward pressure on the collection cup  1200 , the resilient nature of the sleeve  1206  returns to its original shape and applies a force on the vacuum tube  1104 . As illustrated in  FIG. 30 , such a force applied by the sleeve  1206  moves the collection cup  1200  upward, and the hollow needle  1202  is moved upward and withdrawn from the membrane sealing the vacuum tube  1104 . Once the hollow needle  1202  and vacuum tube  1104  are disengaged, the collection cup  1200  can then be removed from the base  1100  (as illustrated in  FIG. 31 ), and the user or donor can remove the vacuum tubes  1104  from the base  1100  and secure and package the vacuum tube  1104  for shipping or transport to a laboratory for testing. The sleeve  1206  once again covers the hollow needle  1202  to protect the user or donor when handling the oral fluid collection device. Once the vacuum tube  1104  is removed and secured, both the base  1100  and the collection cup  1200  can be discarded. 
     The foregoing description illustrates and describes the disclosure. Additionally, the disclosure shows and describes only the preferred embodiments but, it is to be understood that the preferred embodiments are capable of being formed in various other combinations, modifications, and environments and are capable of changes or modifications within the scope of the invention concepts as expressed herein, commensurate with the above teachings and/or the skill or knowledge of the relevant art. The embodiments described herein above are further intended to explain the best modes known by applicant and to enable others skilled in the art to utilize the disclosure in such, or other, embodiments and with the various modifications required by the particular applications or uses thereof. Accordingly, the description is not intended to limit the invention to the form disclosed herein. Also, it is intended that the appended claims be construed to include alternative embodiments. It will be further understood that various changes in the details, materials, and arrangements of the parts which have been described and illustrated above in order to explain the nature of this invention may be made by those skilled in the art without departing from the principle and scope of the invention as recited in the following claims.