Abstract:
In an embodiment, the claimed invention includes an oral-fluid collection and testing device that. is simple to operate. The device includes a body assembly and a cap assembly that are easy to handle by a user. A collection sponge projects from an end of the body assembly for absorbing the oral fluid of a donor, A cap assembly is easily aligned with the body assembly by way of visual alignment indicators on both the body and the cap. Once the cap is aligned with the body, a user simply pushes the cap onto the &#39;body, which causes a first stage fluid, flow. More specifically, a buffer fluid is released from the cap and mixes with the oral fluid collected on the sponge—After waiting a short time* the cap is rotated, then pushed again, causing a second-stage fluid flow in which the sponge is compressed such that the buffer fluid/oral fluid exits the sponge and flows toward a. pair of test strips. A user can then easily view the test results by observing a visual indication, such as a color change of the test strips through a viewing window.

Description:
FIELD OF THE INVENTION 
       [0001]    The claimed invention relates to devices for collecting and testing oral fluid. In particular, the claimed invention relates to multi-stage oral fluid collection and testing of one or more substances. 
       BACKGROUND OF THE INVENTION 
       [0002]    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. Among these, saliva has an advantage over other fluids for ease of collection. This is especially true for drugs-of abuse-testing and for DNA testing. 
         [0003]    Screening for drugs of abuse is performed by health professionals, law enforcement personnel, and government or private employers, among others. Substances of abuse that are commonly screened for include alcohol, cannabis, barbiturates, opiods, cocaine, amphetamines, and hallucinogens. 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. 
         [0004]    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. 
         [0005]    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. 
         [0006]    However, such known saliva collection devices can be inconvenient to use, may be prone to leakage and contamination, and may yield inaccurate results due to user error. 
       SUMMARY OF THE INVENTION 
       [0007]    Embodiments of the claimed invention solve many of the problems of known collection devices and test devices by providing convenient, easy to use combined collection and testing devices that accurately test for substances in a donor&#39;s oral fluids. 
         [0008]    In an embodiment, the claimed invention includes an oral-fluid collection and testing device that is simple to operate. The device includes a body assembly and a cap assembly that are easy to handle by a user. A collection sponge projects from an end of the body assembly for absorbing the oral fluid of a donor. A cap assembly is easily aligned with the body assembly by way of visual alignment indicators on both the body and the cap. Once the cap is aligned with the body, a user simply pushes the cap onto the body, which causes a first stage fluid flow. More specifically, a buffer fluid is released from the cap and mixes with the oral fluid collected on the sponge. After waiting a short time, the cap is rotated, then pushed again, causing a second-stage fluid flow in which the sponge is compressed such that the buffer fluid/oral fluid exits the sponge and flows toward a pair of test strips. A user can then easily view the test results by observing a visual indication, such as a color change of the test strips through a viewing window. 
         [0009]    In another embodiment, the claimed invention includes an oral collection and testing device that can test for the presence or absence of multiple substances in an oral fluid, and display the results to a user, during a single test operation. In such an embodiment, the testing device includes a pair of test strips secured in a pair of test strip channels beneath a pair of viewing windows. Buffered solution mixes centrally with the collected oral fluid, and flows to both test strips. A first test strip may test for a first substance, while a second test strip tests for a second substance, the first substance being different than the first substance. 
         [0010]    In yet another embodiment, the claimed invention comprises a testing device with an improved flow path that enhances capillary rise, reduces splashing that could obscure viewing windows or suggest false results, and that ensures efficient venting without fluid leakage. A first stage flow path includes a plunger channel directing buffer fluid from a fluid container toward a collection sponge, where collected oral fluid is mixed with the buffer fluid. A second stage flow path includes a fluid reservoir adjacent the collection sponge, coupled to first and second test strip channels, holding first and second test strips, respectively. Bridges crossing the channels transversely may include projections on a top surface, and are configured to compress and secure portions of the test strips in their respective channels. The resulting restrictive nature of the bridges results in increased capillary rise and elimination of splashing in the vicinity of view windows. Each channel is in communication with a vent channel leading to a vent sponge, such that trapped air may be exhausted during operation of the device, but without fluid leakage. 
         [0011]    Other embodiments, including methods of the claimed invention, are further described throughout the specification, figures, and claims herein. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0012]    The invention can be understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which: 
           [0013]      FIG. 1  is a perspective view of a multi-stage oral-fluid collecting and testing device, according to an embodiment; 
           [0014]      FIG. 2  is an exploded view of the testing device of  FIG. 1 ; 
           [0015]      FIG. 3  is a bottom perspective view of a first body portion of a body assembly of the testing device of  FIG. 1 , according to an embodiment; 
           [0016]      FIG. 4  is a top perspective view of a second body portion of a body assembly of the testing device of  FIG. 1 , according to an embodiment; 
           [0017]      FIG. 5  is a cross-sectional view of a cap assembly of the testing device of  FIG. 1 , in an initial alignment position, according to an embodiment; 
           [0018]      FIG. 6  is a perspective view of the second body portion of  FIG. 4  with sponges and test strips; 
           [0019]      FIG. 7  is a perspective view of a body and plunger of the testing device of  FIG. 1 , the plunger aligned with the body in an initial alignment position, according to an embodiment; 
           [0020]      FIG. 8  is a cross-sectional view of the testing device of  FIG. 1  depicting a first-stage fluid flow path, according to an embodiment; 
           [0021]      FIG. 9  is a perspective view of the body and plunger of  FIG. 7 , the plunger aligned with the body in second alignment position, after rotation, according to an embodiment; 
           [0022]      FIG. 10  is a perspective view of the body and plunger of  FIGS. 7 and 9 , the plunger having been guided axially toward the body, according to an embodiment; 
           [0023]      FIG. 11  is a perspective view of the testing device of  FIG. 1  in a final engagement position, according to an embodiment; 
           [0024]      FIG. 12  is a cross-sectional view of the testing device in the final engagement position as depicted in  FIG. 11 ; and 
           [0025]      FIG. 13  is a cross-sectional view of the testing device of  FIG. 1  in a final engagement position, and depicting a second-stage flow path. 
       
    
    
     DETAILED DESCRIPTION 
       [0026]    Referring to  FIG. 1 , an embodiment of multi-stage oral-fluid collection and testing device  100  (“oral-fluid testing device”  100 ) is depicted. In an embodiment, oral-fluid testing device  100  includes collection-and-test body assembly  102  (“body assembly”  102 ) and cap assembly  104 . 
         [0027]    Referring also to  FIG. 2 , oral-fluid testing device  100  is depicted in exploded view. 
         [0028]    In an embodiment, test body  102  includes body portion  106 , test strips  108   a  and  108   b , vent sponge  110 , and oral-fluid collection sponge  112 . 
         [0029]    Body portion  106 , as depicted, includes first, or upper, body portion  114 , coupled to second, or lower, body portion  116 . First body portion  114  may be coupled to second body portion  116  in any number of ways. In an embodiment, first body portion  114  includes multiple projections  118  extending outward and away from an edge of body portion  114 . Second body portion  116  may include corresponding holes  120  adapted to receive projections  118 . After assembling first body portion  114  to second body portion  116 , the body portions may be sonically welded to secure the two body portions together. In other embodiments, projections  118  with holes  120  may form a snap fit. In further embodiments, adhesives may be also be used to join first body portion  114  to second body portion  116 . 
         [0030]    Body portion  106  may be generally cylindrical or tubular, and in some embodiments, adapted to be gripped by a user&#39;s hand. Body portion  106  may comprise any of a variety of materials, including various know injection molded polymers such as polycarbonate etc. 
         [0031]    Body portion  106  also includes cap-engagement portion  122  at first or proximal end  124 , viewing-window portion  126  with viewing windows  128   a  and  128   b , and vent portion  130  at second or distal end  132 . 
         [0032]    Cap-engagement portion  122  is generally configured to fit into cap  104 , and may define a generally cylindrical shape. In an embodiment, cap engagement portion  122  defines a plurality of grooves or channels, including visual-alignment grooves  134  and cap-guide channels  136 , and plunger-guide channels  138  (see also  FIGS. 7, 10, and 11 ). 
         [0033]    When present, visual-alignment grooves  134  extend longitudinally, or axially, along a portion of the length of body  106 , including cap engagement portion  122 . Cap-engagement portion  122  may include first visual-alignment groove  134  in first body portion as depicted in  FIGS. 1 and 2 , and may include a second corresponding groove, not depicted in  FIGS. 1 and 2 , located opposite to  134  on second body portion  116 . As will be explained further below, visual-alignment grooves  134  provide a visual marker for rotationally aligning body assembly  102  relative to cap  104 . In other embodiments, visual-alignment grooves  134  may comprise other visual indicators, such as a projection (with mating with a slot in cap assembly  104 ), a printed line, or other such alignment indicator. 
         [0034]    In an embodiment, cap-engagement portion  122  defines one or more cap-guide channels  136 . A first cap-guide channel  136  is depicted in  FIGS. 1 and 2 . A second plunger-guide channel  136  is depicted in  FIG. 9  below. In an embodiment, cap-guide channel  136  defines a first channel portion  140 , second channel portion  142 , and third channel portion  144 . First channel portion  140  and third channel portion  144  extend axially along an outside engagement surface  146  of cap-engagement portion  122 , and are linked by radially-extending second channel portion  142 . First channel portion  140  extends axially from an outermost edge of first end  124  toward second end  132 . Third channel portion  144  also extends axially, and in an embodiment, parallel to, and offset from, first channel portion  140 . In an embodiment, and as depicted, second channel portion  142  may be defined from portions of first and third channel portions  140  and  144  when such portions are adjacent one another. 
         [0035]    Channel portions  140 ,  142 , and  144  may define relatively shallow portions that in an embodiment do not define openings into an inside portion of body  106 . In other embodiments, one or more channel portions  140 ,  142 , and  144  may penetrate the wall of body  106  to define an opening into body  106 . 
         [0036]    In an embodiment, cap-engagement portion  122  includes a pair of cap-guide channels  136 , though it will be understood that only one, or more than two cap-guide channels  136  may be defined by cap-engagement portion  122 . 
         [0037]    Rather than utilizing the push-rotate-push arrangement described above, a more traditional rotation only arrangement with cooperating threads; such may be helical channels of similar proportion to what is illustrated. 
         [0038]    Referring also to  FIGS. 10 and 11 , cap-engagement portion  122  may also include one or more plunger-guide channels  140 . In an embodiment, plunger-guide channel  140  extends axially from first end  124  towards second end  132 , and defines a linear channel, groove, slot, or slit. As depicted, plunger-guide channel  140  does not penetrate a wall of body portion  106 , but in other embodiments, may penetrate body portion  106  to define a slot or opening to an interior space of body portion  106 . 
         [0039]    Cap-engagement portion  122  may also include annular ring  148  where cap-engagement portion transitions to viewing-window portion  126 . Annular ring  148  may define an outer diameter greater than an outer diameter of first end  124 , including surface  150 , thereby functioning as a stop for cap assembly  104 . 
         [0040]    In an embodiment, viewing-window portion  126 , in addition to viewing windows  128   a  and  128   b , includes view-window surface  152  and defines recess  154 . Viewing windows  128   a  and  128   b  as depicted comprise semi-cylindrical portions extending axially along surface  152  and located within associated openings in first body portion  114 . In an embodiment, surface  152  presents a generally flat, planar surface  152 . In an embodiment, and as depicted, body assembly  102  includes two viewing windows  128 , one for each test strip  108 . However, in other embodiments, only one window  128  may be present so as to view one or more test strips  108 , or more than two windows  128  may be present to view multiple test strips  108 . 
         [0041]    Viewing windows  128   a  and  128   b  may comprise a transparent or translucent material that allows a user to see into body portion  106  and view test strips  108 . As depicted, viewing windows  128   a  and  128   b  are curved, and in some cases may provide a magnifying effect so as to aid in the viewing of test trips  108 . In other embodiments, viewing windows  128  may comprise flat or planar portions that may be coplanar with surface  152 . 
         [0042]    In an embodiment, viewing-window portion  126  defines a circumference that may easily be grasped by a user&#39;s hand, a portion of which may be received by recess  154 , which is bounded by view portion  130  and ring  150 . 
         [0043]    Vent portion  130 , in an embodiment, includes beveled surface  156 , top surface  158  and end surface  160  of end wall  162 , and radial wall  164 . Vent portion  130  defines one or more vent holes  166  in end wall  162 . As depicted, vent portion  130  includes two outer vent holes  166   a  and  166   b.    
         [0044]    Referring to  FIGS. 3 and 4 , top perspective views of first body portion  114 , and second body portion  116 , are respectively depicted. As described further below, each body portion presents a contoured inner surface defining a plurality of channels and recesses. Further, in an embodiment, the inner surfaces of each body portion are substantially the same, with the exception of a few features, including pins  118  versus holes  120 . When assembled together to form body portion  106 , each body portion  114  or  116  defines one half of a channel or recess of body portion  106 . 
         [0045]    Referring specifically to  FIG. 3 , first body portion  114  includes sponge pin  170 , first proximal bridges or dividers  172   a  and  172   b , first distal bridges or dividers  174   a  and  174   b , first central wall  176 , first outer wall  178 , first collection sponge wall  180 , first vent walls  182   a  and  182   b , first vent sponge wall  184 , and presents inner contoured surface  186 . 
         [0046]    Inner contoured surface  186  includes a number of surfaces, including flat first edge surface  188  extending about a periphery of first body portion  114 , curved first collection sponge surface  190 , curved first test strip channel surfaces  192   a  and  192   b , curved first inner vent hole surfaces  194   a  and  194   b , and curved first vent sponge surface  196 . 
         [0047]    Inner contoured surface  186  and its surfaces above define a number of cavities and channels, including first collection sponge cavity  200   a , first fluid reservoir  201   a , first test strip channel  202   a , second test strip channel  204   a , first inner vent channel  206   a , second inner vent channel  208   a , first vent sponge cavity  210   a , first outer vent channel  212   a , and second outer vent channel  214   a.    
         [0048]    First collection sponge cavity  200   a  is located at first end  124 , is defined by outer wall  178 , first collection sponge wall  180  and surface  190 , and in an embodiment is shaped to receive a portion of cylindrically-shaped collection sponge  112 . 
         [0049]    Each of first and second test strip channels  202   a  and  204   a  extend axially along inner contoured surface  186 , defined by surfaces  192   a ,  192   b , and walls  182   a ,  182   b , respectively. Channels  202   a  and  204   a  define generally semi-cylindrical channels. Bridges  172   a  and  174   a  each span a width of first test strip channel  202   a , dividing the channel into three portions. Bridges  172   b  and  174  similarly span a width of second test strip channel  202   b , dividing the channel into three portions. 
         [0050]    Inner vent channels  206   a  and  206   b  are defined by curved surfaces  194   a  and  194   b , respectively, also extending axially. 
         [0051]    First vent sponge cavity  210   a  is configured to receive a portion of disc-shaped vent sponge  110 , such that it has a semi-circular shape when viewed in cross section. Cavity  210   a  is defined by wall and surface  196 . 
         [0052]    Referring to  FIG. 4 , second body portion  116  is depicted. As described above, second body portion  116  includes structure substantially the same as first body portion  114 . As such, second body portion  116  includes inner contoured surface  210  having multiple individual surfaces defining multiple cavities and channels. Contoured surface  201  defines second collection sponge cavity  200   b , second fluid reservoir  201   b , first test strip channel  202   b , second test strip channel  204   b , inner vent channels  206   b  and  208   b , second vent sponge cavity  210   b , and outer vent channels  212   b  and  214   b . In some embodiments, second body portion  116  may also define one or more material-saving voids  212 , which may be implemented via an injection-molding process. 
         [0053]    Each cavity and channel of second body portion  116  includes a counterpart cavity and channel of first body portion  114 , such that when first body portion  114  is coupled to second body portion  116  causing contoured surface  186  to contact contoured surface  210 , each of the respective cavities and channels form a cavity and channel of body portion  106 . In other words, first and second collection sponge cavities  200   a  and  200   b  combine to form collection sponge cavity  200  of body portion  106 ; first and second fluid reservoirs  201   a  and  201   b  form fluid reservoir  201 ; first test strip channels  202   a  and  202   b  form first test strip channel  202 ; second test strip channels  204   a  and  204   b  form second test strip channel  204 ; inner vent channels  206   a  and  206   b  form inner vent channel  206 ; inner vent channels  208   a  and  208   b  form inner vent channel  208 , first and second vent sponge cavities  210   a  and  210   b  form sponge cavity  210 ; outer vent channels  212   a  and  212   b  form outer vent channel  212 ; outer vent channels  214   a  and  214   b  form outer vent channel  214 . Outer vent channel  212  also defines outer vent hole  166   a , while outer vent channel  214  also defines outer vent hold  166   b  (see also  FIG. 1 ). 
         [0054]    In an embodiment, second body portion  116  also includes additional structural features, including sponge-pin receiver  216 , second proximal bridges or dividers  218   a  and  218   b , second distal bridges or dividers  220   a  and  220   b , second central portion  222  (which in an embodiment may define a central channel receiving a portion of first central wall  176 ), second outer wall  224  forming rim  225 , second collection sponge wall  226 , second vent walls  228   a  and  228   b , and second vent sponge wall  230 . 
         [0055]    In an embodiment, and as depicted, second proximal bridges  220   a  and  220   b  may include one or more projections  232  projecting radially away from top surfaces  234   a  and  234   b . Second proximal bridges  220   a  and  220   b  may include similar projections. In an embodiment, and as depicted each bridge  220  includes two projections  232 , although fewer or more projections may be present. 
         [0056]    In an embodiment, and as depicted, second distal bridges  220   a  and  220   b  include ridges  236  and define grooves  238 . 
         [0057]    Referring again to  FIGS. 1 and 2 , in an embodiment, cap assembly  102  includes cap  240 , fluid container  242 , and plunger  244 . When assembled, and as discussed further below, fluid container  242  and plunger  244  are housed within cap  240 . 
         [0058]    Referring also to  FIG. 5 , cap  240 , in an embodiment, comprises a polymer material defines a generally cylindrical or tubular shape. Cap  240  includes first end  250 , second end  252 , circumferential wall  254  with edge  255 , and end wall  256 . Cap  240  also defines outside surface  258  and inside surface  260 . In an embodiment, second end  252  also includes one or more body-cap visual alignment indicators  262 . As depicted, second end  252  includes two alignment indicators  262 , each comprising a ridge extending axially along outer surface  258 , and opposite one another. Second end  252  defines an opening into cap cavity  264 , a hollow portion of cap  240  defined by wall  254  and into which fluid container  242  and plunder  244  are inserted. In an embodiment, cap cavity  264  defines first cavity portion  266  and second cavity portion  268 . 
         [0059]    In an embodiment, cap  240  also includes one or more alignment members  270  comprising protuberances projecting radially inward from inside surface  260  ( FIG. 5 ). In an embodiment, cap  240  includes two alignment members  270 , each member  270  opposite the other within cap  240 . In an embodiment, alignment members  270  each include a beveled edge  272  and a top surface  274 . 
         [0060]    Cap  240  may also include shoulder  276  at the transition between first cavity portion  266  and second cavity portion  268 . In an embodiment, shoulder  276  forms an annular ring within cap  240 , and as will be described further below, serves as a stop for plunger  242 . 
         [0061]    In an embodiment, first end  250  may define a diameter that is slightly smaller than a diameter of second end  252 , thereby conforming to end  124  of body assembly  102 . 
         [0062]    Referring still to  FIGS. 2 and 5 , in an embodiment, fluid container  242  includes closed first end  280 , open second end  282 , body portion  284 , and flange  286 . In an embodiment, body portion  284  comprises outer circumferential wall  288  forming body portion  284 , end wall  290  forming closed first end  280 , first body portion  292 , second body portion  294 , and shoulder  296 . Shoulder  296  is adjacent first body portion  292  and second body portion  294 , at the transition between the two portions. Fluid container  242  presents outside surface  298  and inside surface  300 . 
         [0063]    Fluid container  242  defines inside cavity  302 , which defines first cavity portion  304  and second cavity portion  306 , formed by first body portion  292  and second body portion  294 , respectively. 
         [0064]    Fluid container  242  also includes barrier or membrane  310  and fluid  312  (see  FIG. 8 ). Initially, fluid  312  is contained within fluid container  242 . Fluid  312  in an embodiment comprises a buffer solution intended to be mixed with oral fluid, such as saliva, collected by testing device  100 . Membrane  310  extends across an opening into cavity  302  and membranes to surface  312  of flange  286 , thereby keeping fluid  312  within fluid container  242 . In an embodiment, membrane  310  may comprise a foil membrane or barrier, but may alternately comprise some other penetrable material, such as a plastic or polymer. 
         [0065]    In an embodiment, fluid container  242 , as depicted may form a generally cylindrical shape. Fluid container  242  is generally shaped and configured to conform with, and fit into, first cavity portion  266  of cap  240 . In other embodiments fluid container  242  may comprise other shapes configured to fit into cap  300 . 
         [0066]    Plunger  244 , in an embodiment, and as depicted, includes body portion  320 , cup portion  322 , and extensions  324 . 
         [0067]    In an embodiment, body portion  320  includes first end  326 , second end  328 , and defines fluid channel  330 . First end  326  includes penetrating tip  332  for penetrating membrane or barrier  310 . Second end  328  is adjacent cup portion  322 . Fluid channel  330  extends axially from tip  332  through body portion  320 , opening into cup  322 . In an embodiment, fluid channel  330  also extends into and through tip  332 . 
         [0068]    In an embodiment, body portion  320  is configured and shaped to conform to, or fit into, cavity  302  of fluid container  242 . 
         [0069]    Cup portion  322 , adjacent body portion  320 , in an embodiment, includes ring portion  334  with outer ring surface  336 , and end wall  338  with end surface  340 . Ring portion  334  may generally comprise a ring or disc shape; end wall  338  in an embodiment comprises a generally flat, planar surface. Together, ring portion  334  and end wall  338  form cup cavity  342 , which, in an embodiment, is configured to receive a portion of collection sponge  112 . Cup portion  322  also presents inner surface  344  comprising an inner surface of ring portion  334  and an inner surface of end wall  338 . 
         [0070]    In an embodiment, and as depicted, plunger  244  includes two extensions  324 , opposite one another, and affixed to ring portion  344 . However, in other embodiments, plunger  244  may include one, or more than two, extensions  324 . In an embodiment, each extension  324  comprises a generally flat, strip-like portion extending axially away from an edge of ring portion  334 . In other embodiments, extensions  324  may comprise other structures, such as columns, and so on, extending axially away from ring portion  334 . 
         [0071]    Referring specifically to  FIG. 5 , cap assembly  104  is depicted in an initial, or shipping, configuration, with fluid container  242  received in first cavity  266  of cap  240 , and plunger  244  received in second cavity  268 . In an embodiment, plunger  244  is not engaged, or is only minimally engaged, with fluid container  242 . In other embodiments, fluid container  242  may be integrated with plunger  244 . 
         [0072]    As depicted, plunger  244  is slidably engaged with cap  240 , such that outer ring surface  336  of plunger  244  is in contact with inner surface  260  of cap  240 . 
         [0073]    Referring again to  FIGS. 1 and 2 , body assembly  102  includes one or more test strips  108 . As depicted, body assembly  102  includes two test strips,  108   a  and  108   b . In an embodiment, each test strip  108  comprises a generally flat, planar strip including a first end  350  ( 350   a ,  350   b ) and second end  352  ( 352   a ,  352   b ), and presenting a top surface  354  ( 354   a ,  35   b ) and bottom surface  356  ( 356   a ,  356   b ). 
         [0074]    As will be understood by those of ordinary skill in the art, test strips  108  may comprise an immunoassay strip adapted to indicate the absence or presence of specific chemicals, typically pharmaceuticals or drugs. Test strips  108  typically indicate the presence of a chemical by changing color, the color being visible to a user. 
         [0075]    In an embodiment, body assembly  102  includes vent sponge  110 . In an embodiment, and as depicted, vent sponge  110  comprises an absorbent sponge material forming a disc shape. 
         [0076]    Body assembly  102  also includes oral-fluid collection sponge  112  comprising an absorbent sponge material and forming a generally cylindrical shape. In other embodiments, collection sponge  112  may comprise a disc-like shape, or other shape. Collection sponge  112  includes first end  360 , second end  362 , and in an embodiment, defines channel  364 . First end  360  of sponge  112  is received by body portion  106 , with pin  170  and pin receiver  216  being received by channel  364  to position and secure collection sponge  112  relative to body  106 . Second end  362  extends axially and away from body  106 , and includes end surface  366 . Other structural embodiments may be utilized for retaining the sponge, such as adhesives, barbs, clamp structure for compressing and securing a flange. 
         [0077]    Referring to  FIG. 6 , second body portion  116  with test strips  108   a ,  108   b , vent sponge  110  and collection sponge  112 , is depicted. Referring also to  FIG. 4 , test strips  108   a  and  108   b  are fit into test strip channels  202   b  and  204   b , respectively. First ends  350   a,b  are adjacent sponge cavity  200   b , while second ends  352   a,b , are in or adjacent to vent portion  130  of body  106 . First ends  350   a,b  are adjacent to, and in contact with bridges  218   a, b , and  220   a, b . More specifically, projections  232  and ridges  236  contact bottom surfaces  356   a,b  of test strips  108   a,b . In some embodiments, test strips  108  may be compliant enough that portions of bottom surfaces  356   a,b  also contact top surfaces  234  and grooves  238 . When first body portion  114  is coupled to second body portion  116 , test strips  108  may be compressed somewhat by bridges  218  and  220 , thereby maintaining an axial position of each test strip  108  relative to body  106 . 
         [0078]    Vent sponge  110  is received by vent sponge cavity  210 . 
         [0079]    Collection sponge  112  is received by collection sponge cavity  200 , and as described above, positioned and secured by pin  170  and pin receiver  216  (see also  FIG. 5 ). In an embodiment, and as depicted, a gap G exists between sponge  112  and first ends  350  of test strips  108 , such that sponge  112  is not in direct contact with test strips  108 . In such an embodiment, and as will be described further below, a more uniform capillary effect may be achieved by avoiding such direct contact. In other embodiments test strips  108  may directly contact collection sponge  112 . 
         [0080]    Referring generally to  FIGS. 7-14 , collecting and testing an oral fluid using oral-fluid collecting and testing device  100  is depicted. 
         [0081]    Referring to  FIGS. 1 and 5 , testing device  100  may be shipped, and/or received by a user as a two-piece item, namely body assembly  102  and cap assembly  104 . A sample of an oral fluid, such as saliva is received by first end portion  362  of collection sponge  112 . Collection sponge  112  may be swabbed inside the mouth of a person or animal whose fluid is to be tested, such a person may spit onto, or otherwise supply the oral fluid onto sponge  112 . 
         [0082]    After oral fluid is received or and absorbed by collection sponge  112 , cap assembly  102  may be aligned axially along axis A with body assembly  102  as depicted in  FIG. 1 . Cap assembly  104  and body assembly  102  may then be axially moved towards one another. Alignment indicators  262  may be aligned with visual-alignment grooves  134  so as to rotationally align cap assembly  104  with body assembly  102 , thereby positioning cap assembly  104  at body assembly  102  in preparation for body assembly  102  receiving cap assembly  104 . 
         [0083]    Referring to  FIG. 7 , body assembly  102 , without collection sponge  112  and plunger  244  are depicted in an initial position. Alignment of visual indicators  262  ( FIG. 1 ) with grooves  134  results in the depicted rotational orientation of plunger  244  relative to cap engagement portion  122 . In this initial position, an end of each of extensions  324  of plunger  244  are adjacent, and in some embodiments, in contact with, rim or edge  225 . Rim  225 , in an embodiment, may include a beveled edge. 
         [0084]    In this initial engagement position, in an embodiment, extensions  224  are not yet aligned with plunger-guide channels  138 , such that even if an axial force is applied to plunger  244 , extensions  224  merely contact rim  225 , and are generally unable to move axially relative to body  106 . As described further below, plunger  244  must be rotated so as to align channels  138  with extensions  224  before plunger  244  may be moved axially onto cap-engagement portion  122  of body  106 . 
         [0085]    Referring to  FIG. 8 , cap assembly  104  is depicted in a second position relative to body assembly  103 . In this second engagement position, cap assembly  104  has moved axially relative to body assembly  104 , and has received a portion of cap-engagement portion  122 . Alignment members  270  are received by first channel portions  140  of cap-guide channels  136  (see also  FIG. 7 ), having “traveled” along channel portion  140 . Fluid container  242  remains seated in first cavity  266  of cap  250 . A gap H remains between cap edge  255  of cap  240  and ring  148 , which serves as a stop for cap  240 . 
         [0086]    Cap assembly  104  is prevented from being moved further in an axial direction not only due to the contact of extensions  324  with body  106 , but also because, in an embodiment, engagement members  270  have traveled the entire length of axial channel  140 , arriving at radial channel  142  (see also  FIG. 7 ). Until cap assembly  102  is rotated into another alignment position, cap assembly  102  cannot move further axially onto body  106 . 
         [0087]    A portion of plunger  244  is received by fluid container  242 . More specifically, tip  332  (see  FIG. 5  also), after penetrating membrane  310 , has traveled along with first end  326  into cavity  302  of fluid container  242 , so as to be in the depicted position. The arrow indicates a direction of movement of plunger  242  relative fluid container  242 . 
         [0088]    Fluid  312  flows from fluid container  242  into and through plunger fluid channel  330 , out of plunger  244 , and onto collection sponge  112 , as indicated by the multiple smaller arrows, and as caused by the movement of cap assembly  104  onto body assembly  102 . Fluid  312  from fluid container  242  is absorbed by collection sponge  112  and mixes with oral fluid already absorbed by collection sponge  112  to form oral-fluid mixture  313 . 
         [0089]    Simultaneously, air that may have become trapped between cap assembly  104  and body assembly  102  is expelled from body assembly  102 . More specifically, an exhaust air flow path is formed by the combination of collection sponge  112  with sponge cavity  200 , fluid reservoir  201 , test strips  108  with test strip channels  204 , inner exhaust channels  206 , vent sponge  110  with sponge cavity  210 , and outer exhaust channels  212 . Vent sponge  110  functions to trap and absorb any stray fluid that should migrate all the way to vent portion  130 , so as to prevent any unwanted release of fluid from testing device  100 . 
         [0090]    In this second engagement position, collection sponge  112  is not yet compressed by plunger  244 , such that oral-fluid mixture  313  is generally contained on and within collection sponge  112 , rather than at test strips  108 . 
         [0091]    The above release of fluid  312  onto oral-fluid soaked collection sponge  112 , and simultaneous air exhaustion, describes another stage of the multi-stage collection and test procedure. As described above, in an embodiment, collection of oral fluid may comprises a first stage or step. Another stage or step may include the alignment of cap assembly  104  with body assembly  102 . 
         [0092]    At the next stage or step, cap assembly  104  and its plunger  244  are rotated relative to body assembly  102 , such that cap assembly  104  with plunger  244  may be moved further in an axial direction along cap-engagement portion  122 . 
         [0093]    In an embodiment, a user waits a period of time, which may be predetermined, before proceeding with the rotation step so as to allow time for fluid  312  to be fully absorbed into sponge  112  and to mix with the oral fluid to form oral-fluid mixture  313 . 
         [0094]    Referring to  FIG. 9 , plunger  244  is depicted after being rotated relative to body  106 . Referring also to  FIG. 7 , in an embodiment, cap assembly  104  and plunger  244  are depicted as being rotated approximately 22 degrees in a clockwise direction. In other embodiments, the degree of rotation may vary. In one such embodiment, plunger  244  is rotated approximately 44 degrees. In another embodiment, plunge  244  may be rotated from 20 degrees to 50 degrees; in another embodiment plunger  244  may be rotated from 10 to 90 degrees. Other embodiments may allow for other rotational ranges. 
         [0095]    In this rotated position, extensions  324  are axially aligned with plunger-guide channels  138 . Although not depicted, it will be understood that during rotation, alignment members  170  travel radially within radial channels  142  to become aligned with axial channels  144  (see also  FIGS. 7 and 8 ). In this position, cap assembly  104  is capable of travelling further in an axial direction toward ring  148  when an axial force is applied to cap assembly  104 . Further, plunger  144  will travel simultaneously with cap  240  as cap assembly  104  travels axially. 
         [0096]    Referring to  FIG. 10 , after such an axial force is applied, plunger  244 , guided by extensions  324  traveling in plunger-guide channels  138  seats on cap-engagement portion  122  of body  106  as depicted. 
         [0097]    Referring also to  FIG. 11 , cap assembly  104  engaged with body assembly  102  in a final engagement position is depicted in a perspective view. In this position, second end  252  and edge  255  of cap  240  are seated against ring  148 . Plunger  244  is engaged with body  106  as depicted in  FIG. 10 . Some trapped air has been exhausted out of body assembly  102 , and as depicted and described below, collection sponge  112  is compressed, causing oral-fluid mixture  313  to flow into fluid reservoir  201 , and be absorbed by test strips  108 . 
         [0098]    Referring to  FIG. 12 , cap assembly  104  engaged with body assembly  102  in a final engagement position is depicted in cross section (fluid container  242  is not depicted in a cross-sectional view). In this final position, cup portion  322  at end wall  338  engages collection sponge  112  in a compressed position. The compression of collection sponge  112  causes oral-fluid mixture  313  to flow from sponge  112  and into fluid reservoir  201 , as depicted in  FIG. 13 . 
         [0099]    In an embodiment, cap-engagement portion  122  of body  106  may include a snap ring to engage inside surface  260  of cap  240  to hold cap assembly  104  in a final engagement position. This may be a locked position such that the cap assembly is not readily removable without tools. Attempt to remove same will be at least difficult and may, in particular embodiments, requiring breaking the device if specialized tools are not used. 
         [0100]    Referring to  FIG. 13 , a flow diagram of oral-fluid mixture  313  is depicted in testing device  100 . As discussed above with respect to  FIG. 12 , collection sponge  112  is compressed due to the axial translation of cap  240  in a direction indicated by the arrows, causing oral-fluid mixture  313  to exit sponge  112  in a generally axial direction into reservoir  201  and toward test strips  108 . As fluid reservoir  201  fills, oral-fluid mixture  313  comes into contact with test strips  108 . Oral-fluid mixture is drawn through channels  202  and  204  and test strips  108  in a generally axial direction from reservoir  201  toward distal end  132 , as indicated by the arrows on test strips  108 . Flow of oral-fluid mixture  313  is aided by wicking and capillary effects. Capillary rise may be improved with the compression of test strips  108  by bridges  172 ,  174 ,  218  and  220  (see also  FIGS. 4 and 5 ). Further bridges  172 ,  174 ,  218  and  220  also prevent incidental splashing of oral-fluid mixture  313  onto viewing windows  126  or in the general vicinity thereof. 
         [0101]    As oral-fluid mixture  313  travels or migrates along test strips  108 , an appropriate chemical reaction occurs, indicating the presence (or absence) of a particular chemical in oral-fluid mixture  313 . As described briefly above, and as will be understood, the presence of a tested-for chemical is typically indicated by a display or change of color. 
         [0102]    In an embodiment, first test strip  108   a  tests for a first substance, and second test strip  108   b  tests for a second substance. In one such embodiment, first and second substances comprise different substances. In another embodiment, first and second substances comprise the same substance. 
         [0103]    As portions of test strips  108  are generally visible through viewing windows  126 , when strips  108  present a color or other indication, such an indication will be visible to a user looking at viewing windows  126 , such that the absence or presence of the tested-for chemical or substance in the oral fluid of a donor is indicated to the user. 
         [0104]    In accordance with the above description, in an embodiment, methods of the claimed invention include a method for testing for a substance using a testing device that includes a cap assembly  104  having a plunger  244  and a fluid container  242  with a reservoir, as well as a body assembly  102  that includes a body portion with test strips  108  and a collection sponge  112 , the method including collecting an oral-fluid sample onto the collection sponge  112 , rotationally aligning the cap assembly  104  with the body assembly  102  by aligning visual indicators  162 ,  134  on both the cap assembly and body assembly, applying a first axial force to the cap assembly  102  causing it to move axially toward the body assembly  102 , thereby causing the plunger  244  to penetrate a membrane of the fluid container  242  such that in a first-stage fluid flow process, a fluid  312  in the fluid container  242  flows to the sponge  112  which is in an uncompressed state. 
         [0105]    In an embodiment, the above method also includes waiting for a predetermined period of time, then rotating the cap assembly  104  to align extension portions  324  of the plunger to align with plunger guide channels  138 , followed by applying a second axial force to the cap assembly  104  causing the plunger  244  and cap  240  to move axially further toward a distal end of the body assembly  102  and causing the collection sponge  112  to be compressed such that it releases its oral-fluid mixture  313  into a reservoir  201  of the body assembly  102 , and to contact a test strip  108 . 
         [0106]    In a further embodiment, the above method may also include viewing a visual indicator presented by the test strip  108  through a viewing window  128 , thereby indicating the presence of a substance under test. 
         [0107]    The embodiments above are intended to be illustrative and not limiting. Additional embodiments are within the claims. In addition, although aspects of the present invention have been described with reference to particular embodiments, those skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the invention, as defined by the claims. 
         [0108]    Persons of ordinary skill in the relevant arts will recognize that the invention may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the invention may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the invention may comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. 
         [0109]    Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein. 
         [0110]    For purposes of interpreting the claims for the present invention, it is expressly intended that the provisions of Section 112, sixth paragraph of 35 U.S.C. are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.