Abstract:
A device for collecting oral fluid includes a mouthpiece with a fluid inlet connected to a collection chamber. The collection chamber includes a collecting vessel, a venting outlet, and an access port. The venting outlet may be covered by a liquid-impervious or resistant membrane, such as a hydrophobic membrane, and the access port is suitable for removing some or all of the collected fluid. This arrangement allows a saliva donor to continuously spit saliva and blow air into the closed collection chamber, without pressure build-up in the collection chamber, and without the need for the donor to release from the device until the desired oral fluid volume is collected. A valve, including a check valve may be in the saliva flow stream and baffles and structure creating a tortuous path may be utilized to keep saliva away from the membrane.

Description:
RELATED APPLICATIONS 
     The present application claims the benefit of U.S. Provisional Application No. 61/375,685 filed Aug. 20, 2010, and U.S. Provisional Application No. 61/489,221, filed May 23, 2011, which applications are hereby incorporated by reference herein in their entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to devices for collecting saliva. In particular, the present invention relates to a saliva collection device wherein the donor can discharge saliva directly and continuously into a closed collection container. The present invention also relates to systems for collecting and chemically analyzing saliva. 
     BACKGROUND OF THE INVENTION 
     Bodily fluids are collected for various reasons, including diagnosing illness, simple therapeutic removal, determining pregnancy, confirming or establishing levels of therapeutic agents, determining drug abuse, and profiling DNA composition. Blood, urine, and saliva are among the commonly collected bodily fluids for some or all of these purposes. 
     Collecting blood and urine is routine in health care environments for any of the aforementioned reasons. However, collecting these fluids has some negative characteristics for some purposes such as, for example, determining drug abuse, especially in environments outside of traditional health care settings. 
     Screening for drugs of abuse is performed by health professionals, law enforcement personnel, and government or private employers, among others. Sample collection occurs in numerous different venues, including roadside stops, corporate offices, clinical labs, medical clinics, and in donors&#39; homes. These venues are commonly classified as in-home, point-of-care, or laboratory. Substances of abuse that are commonly screened for include alcohol, cannabis, barbiturates, opioids, cocaine, amphetamines, and hallucinogens. 
     Obtaining a blood sample requires vascular access with a venipuncture needle, which is highly invasive and potentially dangerous to both donor and administrator. Urine, although less invasive to obtain than blood, brings up issues of privacy that limit its usefulness for drug testing in many environments. Moreover, urine samples are more easily adulterated if continuous donor observation is prevented by privacy requirements. For many such tests and testing environments, blood or urine collection is difficult, if not impossible, making saliva collection an appealing alternative. Saliva is less invasive to obtain than either blood or urine, and does not invoke privacy concerns to the same extent as does urine. 
     DNA testing is used for purposes of paternity, genealogy, disease susceptibility, and forensics, among others. Blood samples, buccal swabs, and saliva are commonly used for DNA tests. Collecting saliva is less invasive than collecting blood, and saliva collection can provide a larger, and therefore perhaps more reliable sample than buccal swabs. 
     Saliva samples are commonly collected by one of two methods: intra-oral sponge absorption and direct expectoration. An example of the first is U.S. Pat. No. 4,580,577 to O&#39;Brien, et al, which discloses an absorbent mass 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. Sponge or sponge-like absorption methods are disclosed in numerous other patents, teaching variations such as added reagents, salivation promoters, preservatives, flavorings, chemical stabilizers, and a plurality of samples, among others.
     U.S. Pat. No. 4,817,632 to Schramm   U.S. Pat. No. 5,339,829 to Thieme, et al.   U.S. Pat. No. 5,260,031 to Seymour   U.S. Pat. No. 5,393,496 to Seymour   U.S. Pat. No. 5,981,293 to Charlton   U.S. Pat. No. 6,150,178 to Cesarczyk, et al.   U.S. Pat. No. 6,416,715 to Gambert, et al.   U.S. Pat. No. 7,114,403 to Wu, et al.   U.S. Pat. No. 7,374,723 to Wuske, et al.   U.S. Pat. No. 7,387,899 to D&#39;Angelo   U.S. Pat. No. 7,544,324 to Tung, et al.   U.S. Pat. No. 7,850,922 to Gallagher, et al.   U.S. Patent App. No. 20090117665 to Tung, et al.   U.S. Patent App. No. 20060057027 to Hudak, et al.
 
are some examples of prior art saliva absorption patents.
   

     An example of a commercially available saliva collector using intra-oral absorption is the Salivette® made by Sarstedt AG &amp; Co. The donor removes a cylindrical cotton or synthetic swab from the tube-like container, inserts the swab into the mouth, chews it until it becomes saliva-saturated, then returns it to the tube. A cap is applied that seals the saliva inside the tube. 
     An example of a sample collection device based on direct expectoration is disclosed in U.S. Pat. No. 3,518,164 to Andelin, et al. This device includes a tube-like collector, an attached funnel, a stabilizing base, and a threaded sealing cap. The donor spits into the funnel, saliva collects in the tube to the desired volume, the funnel is removed, and the donated sample is sealed with the cap. 
     Other prior art example patents teaching variations of direct saliva expectoration collection include:
     U.S. Pat. No. 4,741,346 to Wong, et al.   U.S. Pat. No. 4,283,498 to Schlesinger   U.S. Pat. No. 4,589,548 to Fay   U.S. Pat. No. 4,761,379 to Williams, et al.   U.S. Pat. No. 4,768,238 to Kleinberg, et al.   U.S. Pat. No. 4,932,081 to Bums   U.S. Patent App. No. 200500965693 to Liang U.S.   Patent App. No. 20090216213 to Muir et al.   

     Additional References Cited 
     
         
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         U.S. Pat. No. 4,411,163 to White 
         U.S. Pat. No. 5,050,616 to Wolff, et al. 
         U.S. Pat. No. 5,238,655 to Laible, et al. 
         U.S. Pat. No. 5,562,639 to Lynn, et al. 
         U.S. Pat. No. 6,152,887 to Blume 
         U.S. Pat. No. 6,718,563 to Kreiensieck 
         U.S. Patent App. No. 20040133128 to Guan, et al. 
         U.S. Patent App. No. 20080017577 to Vi, et al. 
         U.S. Patent App. No. 20090093064 to Kolesnychenko 
         U.S. Patent App. No. 20090305315 to Gandola, et al. 
         U.S. Patent App. No. 20090306610 to Van Den Heuvel, et al. 
         UltraSal-2™ Saliva Collection Device by Oasis Diagnostics Corporation 
       
    
     More generally, there is a wide range of devices for collecting bodily fluids, with configurations dependent on the bodily fluid collected and the intended subsequent use of the fluid. For example, U.S. Pat. No. 4,813,931 to Hauze discloses a suction device for aspirating matter for disposal from the mouth and throat of pediatric patients. One embodiment of this invention is a typical vacuum collection vessel with an inlet, an outlet, and an air gap. In the U.S. Pat. No. 4,813,931 invention, the physician applies vacuum by mouth to the outlet tube and thereby to the collecting chamber, and a tube connected to the chamber transfers vacuum for aspiration to the aspiration site. An in-line, hydrophobic, liquid-impervious filter prevents the aspirated matter from reaching the physician. Another example, in this case for collecting blood, is disclosed in U.S. Pat. No. 5,238,655 to Laible, et al. This invention shows a similar arrangement of components, i.e. an inlet for capillary blood, a collection chamber, and an outlet, the outlet connected to a vacuum source. A hydrophobic membrane filter isolates the collected fluid from the outlet, thus allowing air to be withdrawn from the collecting chamber by the vacuum source, yet preventing blood from being removed through the outlet. 
     Returning now specifically to the prior art for saliva collection, the prior art methods have several drawbacks. Intra-oral saliva absorption requires sponge or spongelike materials. These can adsorb saliva constituents, which may cause errors in subsequent analysis. The absorbent materials can cause discomfort for the donor, perhaps even precipitating a biological reaction. Expectoration into an open container avoids the drawbacks of oral absorption methods, but is a clumsy, unsanitary process. Donors may miss the funnel or container when spitting, may dribble sputum onto themselves or the administrator, and may spill the container, all with negative consequences. The requirement for repetitious and sequential positioning and spitting is cumbersome and exhausting. Although the oral absorption devices generally avoid the clumsiness of the prior art direct collection devices, they have their own aforementioned drawbacks. Expectorating into a closed container though an inlet tube, or straw-like mouthpiece, would be an improvement for collecting saliva, but doing so continuously would be impossible because of pressure build-up within the collection chamber. Creating a vent hole would vent the pressure, but would also allow inadvertent or intentional escape of the collected fluid. Having the donor repeatedly release from and recouple to the mouthpiece would again be clumsy and would result in dribbling of sputum from the mouthpiece during release. 
     There remains a need for an improved saliva collection device. 
     SUMMARY OF THE INVENTION 
     The present invention is a device for collecting oral fluid that includes a mouthpiece with a fluid inlet connected to a collection chamber. The collection chamber includes a collecting vessel, a venting outlet, and an access port. The venting outlet may be covered by a liquid-impervious membrane, and the access port is suitable for removing some or all of the collected fluid. This arrangement allows a saliva donor to continuously spit saliva and blow air into the closed collection chamber, without pressure build-up in the collection chamber, and without the need for the donor to release from the device until the desired oral fluid volume is collected. 
     Embodiments of the present invention can also include additional advantageous features. For example, a one-way check valve or a tester- or user-operated valve in line with the fluid inlet can prevent fluid from coming back out of the collection chamber into the fluid inlet, even if the device is tipped. Thus, the valve captures the fluid inside the device, preventing accidental leaking, until fluid removal is desired. 
     Embodiments of the present invention can also include various physically, chemically, and biologically active agents. For example, anti-foaming or de-foaming compounds can be added to the device to reduce the foaming propensity of the collected fluid. Also, preservatives can be used to preserve the collected fluid, and test reagents can be added for preconditioning or direct chemical analysis. 
     The present invention can be a component of any system requiring a saliva sample. For example, a plurality of lateral flow immunoassay strips can be included in a test system for which the present invention can be a part. For example, the disclosed saliva collection device can be physically separated from the test system for saliva collection, then coupled or recoupled to the test system for assay. Alternatively, the present invention can include a transfer container that allows some or all of the collected saliva to be transferred from the collection device to a lateral flow assay system. 
     Alternatively, the present invention can be incorporated as an integral sub-system of an assay test system. Saliva can be accumulated and held separate from the assaying portion, if necessary, until an adequate volume is collected, then be allowed to enter the assaying portion. 
     It is therefore a feature and advantage of embodiments of the invention to provide an improved saliva collection device for use whenever oral fluid must be collected. It is also a feature and advantage of embodiments of the invention to collect oral fluid without using absorbent sponges or swabs, either in or outside the mouth. It is also an object of this invention to provide a saliva collection device wherein the saliva is collected in a closed container. It is also a feature and advantage of embodiments of the invention to provide a saliva collection device for collecting saliva in a closed container for which the donor may remain joined to the device throughout the donation. It is also a feature and advantage of embodiments of the invention to provide a device for which the donor may decouple from and recouple to the device without substantial loss of any accumulated saliva. It is also a feature and advantage of embodiments of the invention to provide a saliva collection device wherein the saliva is collected in a closed container that can be accessed for saliva removal. 
    
    
     
       DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of a preferred embodiment of the present invention. 
         FIG. 2  is an exploded perspective view of the embodiment shown in  FIG. 1 . 
         FIG. 3  is a cross-section view of the embodiment shown in  FIG. 1  drawn through the common symmetric center lines of the assembly. 
         FIG. 4  is a detail perspective view of the inside surface of cover  212 . 
         FIG. 5  is a multiple perspective view showing one typical use of the embodiment shown in  FIG. 1 . 
         FIG. 6  is a multiple perspective view of an example system using the present invention. 
         FIG. 7  is a perspective view showing an alternate embodiment of the present invention. 
         FIG. 7A  is a perspective view showing additional functional details of the embodiment shown in  FIG. 7 . 
         FIG. 7B  is a perspective view of an example use of the embodiment shown in  FIG. 7 . 
         FIG. 8  is a multiple perspective view of an alternate example system using the present invention. 
         FIG. 9  is a perspective view of an alternate example system using the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     Referring to  FIG. 1 , there is shown a saliva collection device  100 , which is an example embodiment of the present invention. This embodiment comprises a collection vessel  102  and a header assembly  104 . Header assembly  104  includes a mouthpiece  106  and a header housing  108 , that includes a receptacle portion  202 . The mouthpiece  106  includes a saliva inlet  110 , a mouthguard  112 , and bulbous region  114  and a saliva passageway  115 . Header assembly  104  also includes vent holes  116 . The collection vessel  102 , which is transparent in this embodiment, has gradations  118  showing the volume of fluid contained therein. 
     The device has an axis a which is coextensive with axis of the vessel  102 . The header housing includes an upper chamber wall  122  with a upwardly oriented vent face portion  126 , a converging portion  128 . 
     Now referring to  FIG. 2 , which is an exploded view of  FIG. 1  showing the components comprising the  FIG. 1  embodiment of saliva collection device  101 . Header assembly  104  in eludes a receptacle portion  202  into which collection vessel  102  is removably attached. In this case, receptacle portion  202  includes internal threads (not shown) to removably mate with threads  204  of collection vessel  102 . Header housing  108  includes an inlet  206 . A valve  208 , such as a one-way check valve, here shown as a duckbill-style valve, is assembled into inlet  206 . Header assembly  104  also includes venting membrane  210  and cover  212 . Cover  212  includes the aforementioned vent holes  116 . 
     The area of the filter membrane  202 , that is, its “footprint”, is larger than the largest cross sectional area of the header chamber taken at a plane p normal to the device axis a and is twice as large as the area a 2  of the cross section of the vessel. 
       FIG. 3  is a cross section view, which shows additional details of construction of collection device  101 . Collection vessel  102  is shown with a collected volume of saliva  302 . Salival foam  304  may also be expectorated by an oral fluid donor along with the air and oral fluid. This salival foam  304  will sit atop saliva  302  in either collection vessel  102  or in the header chamber  306  (described below). Collection vessel  102  is removably attached to housing  108  of header assembly  104 . Header assembly  104  includes a head space  306 , which is enclosed on its upper end by venting membrane  210  and cover  212 . Cover  212  and venting membrane  210  are attached to housing  108 . Any of various bonding methods known in the art can be used to sandwich-bond venting membrane between housing  108  and cover  212 . One suitable method, used in this embodiment, is ultrasonic welding. Referring briefly to  FIG. 4 , cover  212  includes a plurality of vent holes  116  as well as a maze-like pattern of ribs  402  on its inner side. 
     Returning to  FIG. 3 , valve  208  is shown in its assembled position within inlet  206  of housing  108  in header assembly  104 . Valve  208  is held in place by a cylindrical portion  214  (also see  FIG. 2 ) of mouthpiece  106 . Mouthpiece  106  is bonded to inlet  206  using any suitable bonding method. One such suitable method, used in this embodiment, is solvent bonding using, for example, methyl ethyl ketone. Once valve  208  is captured by mouthpiece  106 , a cylindrical ring  216  (also see  FIG. 2 ) of valve  208  forms a leak-free seal with housing  108 , which is the common method of seal used with valves of this style. Mouthpiece  106  includes saliva inlet  110 , which is in fluid communication through valve  208  with head space  306 , collection vessel  102 , and also venting membrane  210  and, in turn, vent holes  116  of cover  212 . Mouthpiece  106  includes enlargement configured as a bulbous portion  114 , which comprises a smooth bulb-like structure. 
     Mouthguard  112  is a convenient stop or marker for proper insertion into the mouth of the donor. Mouthguard  112  also separates the saliva-contaminated region from the non-contaminated portions of oral fluid collection device  101 , thereby allowing a test administrator to avoid touch contact with saliva. Enlargement  114  provides a tactile structure for a donor&#39;s lips and tongue, and aids in proper positioning and retention in the mouth. In one preferred embodiment, mouthpiece  106 , along with mouthguard  112  and enlargement  114  are formed from a soft, pliable material to reduce the likelihood of dental damage during residence in the mouth. One suitable material, used in this embodiment, is flexible polyvinyl chloride (PVC). 
     Saliva, driven by the donor&#39;s spitting action and blowing action, enters saliva inlet  110  of mouthpiece  106 . Saliva and air flow through valve  208  by this action, then enter head space  306  through inlet  206 . Valve  208  prevents reverse flow of any expectorant, and assures that oral fluid and air is captured by the saliva collection device  101  once expelled by the donor. Valve  208  can be any configuration of one-way flow valve known in the art that meets the needed performance requirements for flow and crack pressure. Examples of suitable configurations include duck-bill style valves, rubber disk valves, and spring-loaded ball valves. Alternatively, valve  208  can be an active valve selectively opened and closed on demand by the donor or administrator by, for example, a push button actuator. 
     As the expelled oral fluid enters head space  306  the liquid component flows by gravity into collection vessel  102 . Any expelled salival foam  304  resides atop the liquid saliva  302 . 
     Air expelled by the donor (and air displaced by the collected oral fluid) is vented though the vent holes  116 , thus avoiding pressure build-up inside the saliva collection device  100 , which would prevent further flow of oral fluid. Venting membrane  210  can be a hydrophobic filter membrane, which will readily allow air to pass with little impediment, yet block liquids from passing under pressures encountered in normal use. A suitable example membrane is a hydrophobic pTFE filter media with a 1.0 micron pore size. Another suitable example membrane, used in this preferred embodiment, is known by the trade name Versapore® R, and is available from Pall Corporation. A suitable pore size of this membrane is, for example, 3.0 microns. Cover  212 , as previously explained, includes vent holes  116  and maze-like ribs  402  ( FIG. 4 ). Cover  212  supports venting membrane  210 , preventing damage from outward bowing due to internal pressure or from contact from outside by fingers or other objects. Ribs  402  of cover  212  provide a flow path to vent holes  116  from all locations of venting membrane  210 . 
     The volume of head space  306 , the surface area of venting membrane  210 , the location and orientation of venting membrane  210 , and the characteristics of venting membrane  210  are all important considerations for robust function of saliva collection device  100 . It is imperative for proper function that venting membrane  210  remains unblocked so that it is able to vent expired air and relieve internal pressure. If venting membrane  210  is liquid-covered over its entire surface area, air will not pass through it. Typical hydrophobic membranes are not easily wetted by water and by many other aqueous solutions. Non-wetting liquids will bead up and roll off the surface of a hydrophobic material. Saliva, however, can exhibit much more aggressive wetting than does water, and can more easily compromise venting performance of a hydrophobic membrane. Moreover, salival foam also accumulates when oral fluid is collected. This salival foam, generally, contains an inadequate volume of saliva for subsequent use. A foam-covered hydrophobic membrane will not properly vent, just as if it were liquid-covered. 
     Referring still to  FIG. 3 , it is clear that head space  306  provides volume to accommodate foam even as collection vessel  102  becomes filled with saliva and salival foam. Furthermore, the non-horizontal slope of venting membrane  210  allows saliva to flow away from the surface of venting membrane  210  when saliva collection device  100  is in the normal saliva donation orientation, which is approximately represented in  FIG. 3 . Even if saliva collection device  100  is inadvertently or purposely reoriented, dropped, or shaken, any of which could cause saliva to contact the surface of venting membrane  210 , saliva will flow away from venting membrane  210  in this shown donation orientation due to gravity and the membrane&#39;s hydrophobic nature. In addition, venting membrane  210  has a relatively large surface area, first to allow unimpeded flow of air during saliva donation, and second to reduce the likelihood that saliva or salival foam will block the entire surface of venting membrane  210 . In this embodiment then, the components&#39; orientation, volumetric capacities, and membrane surface areas are sized so that a suitable volume of saliva  302  can be obtained with minimal risk of venting membrane  210  becoming blocked by saliva  302  or salival foam  304  when collecting the target volume. Also, air generating by the donor&#39;s spitting and blowing action can pass relatively unimpeded, thus minimizing the effort required by the donor to an acceptable level. 
     In use, referring now to  FIG. 5 , a donor inserts mouthpiece  106  into the mouth, leaving mouthguard  112  outside the mouth. Enlargement  114  provides tactile feedback to aid in proper positioning and retention of saliva collection device  100 . The donor spits and blows into mouthpiece  106  so that oral fluid, driven by spitting action and blowing action, enters saliva inlet  110 . Expectorated saliva accumulates in collection vessel  102 , and the accompanying air and potential pressure buildup is relieved through vent holes  116 . Saliva entering saliva inlet  110  is captured inside saliva collection device  100  due to the valve disposed within inlet  206  and due to the venting membrane, which will not allow saliva to pass through it. Valve  208  prevents saliva from flowing or dribbling back out of saliva inlet  110 , and venting membrane  210  (see  FIG. 2 ) prevents saliva from exiting out vent holes  116 , even if saliva collection device  100  is dropped, reoriented, or shaken. 
     The volume of accumulated saliva can be observed, typically by a test administrator or by the donor, and can be judged adequate by gradations  118 . Once adequate saliva has been donated, collection vessel  102  is removed from header assembly  104 . The saliva in collection vessel  102  can then be used for whatever purpose is desired, one example of which is to forward it to a testing laboratory for analysis. In that case, seal cap  502  can be applied to collection vessel  102 , as shown in  FIG. 5 , allowing the saliva to be safely stored or transported as required for subsequent use. 
     In any case, opening  504 , which is included in collection vessel  102  provides access to the accumulated saliva, either immediately upon removal from header assembly  104 , or later upon removal of seal cap  502 . 
     The present embodiment ( FIGS. 1-5 ) also provides an easy method to collect multiple or additional aliquots of saliva, if desired or needed. This could be necessary, for example, if an instant read, point-of-collection test for drugs of abuse showed a positive result, and a confirmation test, with additional saliva, is required to be performed. In that case, another (or the same) collection vessel  102  can be attached to header assembly  104 , and the donation procedure can be repeated. 
     Referring now to  FIG. 6 , an example embodiment is shown wherein the present invention is incorporated into an instant read test system, for example, for drugs of abuse. 
     Instant read system  600  includes a test housing  604  and a plurality of lateral flow immunoassay test strips  606  internal to test housing  604 , and visible to an observer. Collection vessel  102  of saliva collection device  100  is separated from header assembly  104  after collection of the required volume of saliva. Collection vessel  102  is then sealably attached to test housing  604  by inserting one into the other. Test housing  604  includes suitable mating geometry such as connections, seals, and channels (not shown) to accept collection vessel  102  and manage the flow of saliva. Instant read system  600 , with the attached collection vessel  102 , is then inverted. Inversion allows the saliva held by collection vessel  102  to flow by gravity to make contact with test strips  606 . Test methodology and reading of results is performed in accordance with normal practice for lateral flow immunoassay strip use. 
       FIG. 7  shows an alternative embodiment of the present invention. Saliva collection device  700  includes a header assembly  704  and a collection vessel  702 , which in this case need not be removably attached to header assembly  704 . Mouthpiece  706  is attached to header assembly  704 . Mouthpiece  706  includes saliva inlet  710 , a mouthguard  712 , and an enlargement  714 , all of which function similarly to the embodiment shown in  FIG. 1 . Likewise, the embodiment of  FIG. 7  may include a valve (not shown) as disclosed in the embodiment of  FIG. 1 , as well as gradations  718 . Header assembly  704  has vent holes  716  and a venting membrane (not shown), also analogous to similar features in the embodiment of  FIG. 1 . 
     The embodiment of  FIG. 7  includes seal cap  720 , which allows access to the collected saliva in collection vessel  702 . So, for example, seal cap  720  can be removed as shown in  FIG. 7  A after a successful saliva donation. Saliva can then be poured or pipetted out, for example. Alternatives to removable seal cap  720  to allow access to the collected saliva exist, and include a puncturable septum similar to a medicament vial with a rubber closure; a commonly available needle less connector, as is now typically used in intravenous infusion systems; a Luer taper fitting, onto which a removable plug is fitted; a frangible tip that can be snapped off to provide access; and a peelable or puncturable, sealed-foil covering. One such example, shown in  FIG. 7B , is a puncture port accessible with syringe and needle or a pipette. In this case, seal cap  720  includes an access port  722 . Regardless, the purpose of seal cap  720  is to provide access to collection vessel  702  through access port  722  for removing saliva. 
     The embodiment shown in  FIG. 7  can be used, for example as a component of an instant-read test for drugs of abuse. One such instant read system is shown in  FIG. 8 . Instant read system  800  includes a housing  802 , which includes a plurality of lateral flow immunoassay test strips  804  internal to test housing  802 , and visible to an observer. Saliva collection device  700 , with features as previously described according to  FIG. 7  includes an access port  722  (see  FIG. 7B ). Access port  722  can be, for example, a needleless connector, puncturable septum, or pierceable foil. A saliva collection device  700  that has been adequately filled with saliva is inserted into housing  802 , which causes a fluid connection allowing test strips  804  to be exposed to saliva. Test methodology and reading of results is performed in accordance with normal practice for lateral flow immunoassay strip use. 
     Another alternative embodiment of a system for instant-read drugs of abuse testing that employs the present invention is shown in  FIG. 9  as instant read system  900 . In this embodiment, a housing  908  includes a plurality of lateral flow immunoassay test strips  902  internal to test housing  908 , and visible to an observer. Integrally attached to housing  908  is a mouthpiece  906 , which includes a saliva inlet  910 . It can also include a mouthguard  912  and enlargement  914 , which are analogous to structures previously described. Housing  908  includes vent holes  916 , which vent expectorated air as in previously described embodiments. Also, as previously described, instant read system  900  includes an internal collection vessel (not shown), and may include a valve between the saliva inlet  910  and the collection vessel. As before, collected saliva is allowed to communicate with the test strips  902 , and the test methodology and reading of results is performed in accordance with normal practice for lateral flow immunoassay strip use. 
     The above disclosure is related to the detailed technical contents and inventive futures thereof. People skilled in this field may proceed with a variety of modifications and replacements based on the disclosures and suggestions of the invention as described without departing from the characteristics thereof. Nevertheless, although such modifications and replacements are not fully disclosed in the above descriptions, they have substantially been covered by the spirit and technical theory of the subject invention.