WO2022108815A1

WO2022108815A1 - Saliva specimen container

Info

Publication number: WO2022108815A1
Application number: PCT/US2021/058916
Authority: WO
Inventors: Peter A. Piscopo
Original assignee: Plastek Industries, Inc.
Priority date: 2020-11-23
Filing date: 2021-11-11
Publication date: 2022-05-27

Abstract

A specimen collection container or container kit (20) has: a container body (22) having a rim (46); an inlet valve body (28) mounted to the container body; an inlet valve element (30) mounted to the inlet valve body and depressable from a closed condition to an open condition; and a funnel (24) mounted to or mountable to the inlet valve body and depressable to drive the inlet valve element from the open condition to the closed condition.

Description

SALIVA SPECIMEN CONTAINER

CROSS-REFERENCE TO RELATED APPLICATION

[0001] Benefit is claimed of U.S. Patent Application No. 63/117,106, filed November 23, 2020, and entitled “Saliva Specimen Container”, the disclosure of which is incorporated by reference herein in its entirety as if set forth at length.

BACKGROUND

[0002] The disclosure relates to saliva sample (specimen) collection. More particularly, the disclosure relates to consumer-use specimen collection kits.

[0003] Saliva testing is used for various medical purposes. Large numbers of saliva specimen collection kits have been used in consumer genealogy DNA testing. Additionally, saliva testing kits have been used for testing for diseases such as COVID-19.

[0004] A number of single-specimen saliva collection devices exist. In many home-use collection devices, the consumer receives three separate items: a vial; a funnel; and a closure. The closure may include a buffer for stabilizing the saliva specimen. The vial may have level markings. To use, the consumer may open the packaging, attach the funnel to the vial, spit into the funnel with the saliva going into the vial. When sufficient saliva is introduced, the user may remove the funnel and attach the closure. The attachment of the closure and/or subsequent shaking may cause the buffer to mix with the saliva.

[0005] In others, the buffer is initially in the vial.

[0006] In US9732376 of Oyler et al., there is a capsule of stabilizing fluid sealed with a pierceable foil. The user receives the device with the funnel attached to the specimen tube. The cap initially contains the capsule and a piercing insert. After spitting into the funnel, the user removes the funnel and installs the cap. The installation causes the piercing of the capsule.

SUMMARY

[0007] One aspect of the disclosure involves a specimen collection container or container kit has: a container body having a rim; an inlet valve body mounted to the container body; an inlet valve element mounted to the inlet valve body and depressable from a closed condition to an open condition; and a funnel mounted to or mountable to the inlet valve body and depressable to drive the inlet valve element from the open condition to the closed condition.

[0008] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include a buffer in the container body. [0009] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include a closure mounted to or mountable to the funnel.

[0010] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include the container body, the inlet valve body, the inlet valve element, and the funnel each being a respective molded plastic piece.

[0011] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include the inlet valve body being threaded to the container body.

[0012] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include the funnel and valve body having features for detenting or locking the funnel in a depressed condition.

[0013] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include the inlet valve element and inlet valve body having features for detenting the closed condition.

[0014] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include the inlet valve element and inlet valve body features for detenting the closed condition also providing a seal in the closed condition.

[0015] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include the inlet valve element and inlet valve body having features for stopping valve element depression beyond the open condition.

[0016] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include the features for stopping valve element depression beyond the open condition comprising an interrupted outward flange on the inlet valve element and an inward flange on the inlet valve body.

[0017] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include the inlet valve body comprising: an internally-threaded outer sidewall; and an inner sidewall engaging the inlet valve element.

[0018] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include the funnel being mounted to the inlet valve body in a radial interference fit providing a seal.

[0019] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include a method for manufacturing the specimen collection container or container kit. The method comprises: inserting the inlet valve element into the inlet valve body in the closed condition; and threading the inlet valve body. [0020] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include inserting a root of the funnel into the inlet valve body.

[0021] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include a method for using the specimen collection container or container kit. The method comprises: depositing saliva into the funnel; depressing the funnel to depress the inlet valve element to the open condition; and installing a closure to the funnel.

[0022] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include the depositing saliva into the funnel being atop the inlet valve element; and the installing the closure to the funnel being before the depressing.

[0023] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include: removing the inlet valve body from the container body; and pipetting out the saliva.

[0024] Another aspect of the disclosure involves a method for using a saliva collection container. The method comprises: depositing saliva into a funnel atop a plunger; and depressing the funnel to shift the plunger so that the deposited saliva flows into a lower portion of a body of the container.

[0025] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include installing a closure to the funnel.

[0026] A further embodiment of any of the foregoing embodiments may additionally and/or alternatively include the flowing of the deposited saliva into the lower portion of the body of the container causing the deposited saliva to mix with a buffer.

[0027] Another aspect of the disclosure involves saliva collection container (20) comprising: a funnel for receipt of saliva; a body having a lower portion; and a plunger. The plunger is depressable via the funnel from a closed condition wherein flow of saliva from the funnel to the body lower portion is blocked to an open condition wherein saliva may flow from the funnel to the body lower portion.

[0028] The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] FIG. l is a view of an assembled saliva specimen container in an after specimen introduction and capping but before flowing of the specimen into a body of the container. [0030] FIG. 2 is a side view of the container. [0031] FIG. 3 is a top view of the container.

[0032] FIG. 4 is a central vertical sectional view of the container taken along line 4-4 of

FIG. 2.

[0033] FIG. 5 is a central vertical sectional view of the container uncapped, with funnel in place, prior to specimen introduction.

[0034] FIG. 6 is a central vertical sectional view of the container, with a capped funnel depressed, and specimen in the container body.

[0035] FIG. 7 is a view of the container body.

[0036] FIG. 8 is a central vertical sectional view of the container body, taken along line 8-8 of FIG. 7.

[0037] FIG. 9 is a view of a carrier member forming an inlet valve body.

[0038] FIG. 10 is a central vertical sectional view of the carrier member taken along line

10-10 of FIG. 9.

[0039] FIG. 11 is a first view of a plunger forming a valve element of the inlet valve.

[0040] FIG. 12 is a second view of the plunger.

[0041] FIG. 13 is a top view of the plunger.

[0042] FIG. 14 is a bottom view of the plunger.

[0043] FIG. 15 is a central vertical sectional view of the plunger taken along line 15-15 of

FIG. 13.

[0044] FIG. 16 is a view of the funnel.

[0045] FIG. 17 is a top view of the funnel.

[0046] FIG. 18 is a central vertical sectional view of the funnel taken along line 18-18 of

FIG. 17.

[0047] FIG. 19 is a central vertical sectional view of the closure (cap).

[0048] Like reference numbers and designations in the various drawings indicate like elements.

DETAILED DESCRIPTION

[0049] FIG. 1 shows an in-use basic saliva specimen collection container or container kit 20 including five molded plastic pieces: a vial (specimen container body) 22; a collection funnel 24; a closure (plug like) 26 for the collection funnel; a carrier member (carrier) 28; and a plunger 30 (FIG. 4). Example moldings of the vial is injection blow molding or just injection molding. An example molding of the remaining four pieces is injection molding. An example plastic is polypropylene. An alternative is polyethylene (all HDPE or all LDPE). Use of just a single such plastic (monoresin construction) eases recycling. Alternatively, the materials may be mixed such as an LDPE plunger used with remaining pieces of polypropylene or HDPE. HDPE is softer than polypropylene and LDPE is stiffer than HDPE. The LDPE softness makes it advantageous for forming a seal when interfacing with polypropylene or HDPE.

[0050] FIGs. 1-4 show the assembled saliva specimen container after specimen introduction and capping but before flowing of the specimen from a temporary location in the funnel 24 into the ultimate location in the vial.

[0051] The kit 20 may be used for saliva testing including genealogical or medical patient DNA testing or testing for infections, antibodies, body chemistry, drug consumption, toxins, or the like.

[0052] The vial 22 serves for specimen collection and initially contains a buffer 32 (FIG. 4) or the like in an interior chamber 40. The buffer may initially be partially captured in a foraminate media such as an open cell foam (not shown).

[0053] The carrier 28 mounts to the vial 22 and serves two further functions of providing a mounting feature for the funnel 24 (once the funnel is installed as discussed below); and providing a valve body for an inlet valve. The inlet valve functions to, at least temporarily, seal the interior chamber from an external environment.

[0054] The plunger 30 serves as the valve element of the inlet valve.

[0055] The closure 26 serves to close the upper end of the funnel upon use for transfer

(e.g., shipping) to a testing location.

[0056] The funnel 24 serves to: initially receive the specimen 34; then receive the closure 26 to close the collection device; and depress the plunger 30 to open the inlet valve.

[0057] As delivered to the consumer (user), the initial condition features a subassembly (FIG. 5) of: the vial 22 (containing buffer); the carrier 28 mounted to the vial (e.g., threaded onto); and the plunger 30 mounted in the carrier 28 in a relatively elevated/extended closed condition wherein the plunger 30 forms an interference radial seal with the carrier 28. The funnel 24 and closure 26 may be preassembled to each other or separate from each other while separate from the aforementioned subassembly. Or the funnel may be preassembled to the carrier with the closure separate. The subassembly and the funnel and/or closure may be packaged for sterility (e.g., in foil and/or plastic bags).

[0058] In use, a user opens any outer packaging (not shown), opens the packaging for the subassembly and places the subassembly upright on a support surface. The user then opens any packaging of the funnel and installs the funnel to the carrier in a downward installation. There is an interference between funnel OD and vial ID that holds the funnel to the vial and seals between the two. Eventually, the funnel contacts the plunger.

[0059] A substantial increase in force is required to move the plunger. So the plunger stops the funnel in a condition where the valve is still closed (an extended condition of the funnel and plunger).

[0060] The user may spit into the funnel until the saliva specimen 34 reaches a molded fill line 35 (shown as an internal shoulder in FIG. 4).

[0061] The user may then mate the closure 26 to the funnel 24 to close/seal the device.

[0062] With the higher level of force, the user may press on the funnel-closure combination so overcome the detented engagement of plunger and carrier so that the funnel drives the plunger downward to an open condition (FIG. 6) and the plunger enters its own detented/backlocked engagement with the carrier (e.g., circumferential OD rib 214 (FIG. 18) on the funnel becoming trapped below an ID rib 80 (FIG. 10) of the carrier (in a compressed condition of plunger and funnel). With the opening, the saliva will pass downward along a flowpath 520 through the now-open valve into the vial to mix with the buffer and form a mixture 36 (FIG. 6).

[0063] In an alternative implementation, the funnel may be preinstalled in the extended condition.

[0064] By initially mating the funnel to the carrier without depressing the plunger, it allows the user to verify that the correct amount of saliva has been deposited prior to depressing the plunger. By placing the closure on the funnel prior to depressing, cleanliness may be achieved.

[0065] Also, by leaving the funnel in place after depositing the specimen, consumer handling and disposal of the saliva contaminated funnel is eliminated.

[0066] To test, a lab may open the device by: placing the vial upright in a fixture; unscrewing the carrier from the vial: disposing of the carrier/plunger/funnel/closure combination; and pipetting out the stabilized specimen. [0067] In an alternative implementation, the user installs the funnel to the carrier in a downward installation wherein the funnel drives the plunger downward to an open condition and then enters a detented/backlocked engagement with the carrier. The user may then spit into the funnel and the saliva will pass downward through the now-open valve into the vial to mix with the buffer. The user may then mate the closure to the funnel to seal the funnel and the collection device as a whole.

[0068] Buffers may be highly specific to the particular test process to be used. One example of a buffer is a Tris-HCl EDTA buffer. The example vial 22 (FIGs. 7&8) has a sidewall 42 extending from a lower end at or near a base 44 to an upper end at a rim 46. The vial has an interior or inner surface 48 and an exterior or outer surface 50. The example vial is generally symmetric about a central longitudinal axis 500 (shared with the other components when assembled) with the exception of an external thread 52 along an upper portion of the sidewall outer surface. The example vial further includes a radial flange 56 below the thread (up and down being relative to a conventional use orientation wherein the axis 500 is vertical and the vial is supported atop a horizontal support surface (not shown)). With the example symmetry around the axis 500, the interior surface 48 along the sidewall 42 is an inner diameter (ID) surface and the exterior surface 50 is an outer diameter (OD) surface.

[0069] The vial has a lower portion having a chamber (a portion of the vial interior) for containing buffer and ultimately the saliva specimen and an upper portion that mates with the carrier (valve body). As is discussed further below, the example upper portion includes the external thread 52.

[0070] The vial may be molded in essentially final shape (e.g., subject to trimming of flash and/or gating). After any cleaning, the lower portion of the chamber may be filled with the buffer 32 (and any media).

[0071] The example carrier 28 (FIGs. 9&10) has an outer sidewall 60 with a lower portion 62 extending up from a lower rim 64 and having an inner diameter (ID) surface 66 and an outer diameter (OD) surface 68. The inner diameter surface bears a thread 70 complementary to the vial thread 52 for mating the carrier 28 to the vial. The outer sidewall 60 has an upper portion 72 extending to an upper rim 74. In the example embodiment, the outer sidewall 60 is stepped so that the upper portion 72 is slightly radially inward of the lower portion 62. As is discussed further below, the upper portion interfaces with the funnel 24. The upper portion 72 has an inner diameter (ID) surface 76 and an outer diameter (OD) surface 78. Near the upper rim 74, the outer sidewall upper portion 72 includes an inward projection 80 (e.g., a rounded bead structure or rib) that provides a detent action with the funnel in at least one condition. Alternative projections 80 may provide a more highly robust backlocking (e.g., a more barb-like cross-section). At the step in the outer sidewall 60, an annular web 84 extends radially inward to an inner sidewall 86.

[0072] The inner sidewall 86 has a lower portion 88 extending up from a lower rim 90 and an upper portion 92 extending to an upper rim 94. As is discussed further below, the lower portion 88 has an inner diameter (ID) surface 96 that cooperates with the plunger 30. As is discussed further below, the ID surface 96 has an annular recess 98 that engages a complementary feature of the plunger 30 to detent an open condition of the inlet valve. The upper portion 92 OD surface has an upper bevel 100 that helps guide funnel installation so that the upper portion can form a plug seal with a lower portion of the funnel.

[0073] The example plunger 30 (FIGs. 11-15) has a sidewall 120 (FIG. 15) extending from a lower end at a rim 122 to an upper end at a top web 124 which closes the upper end of the sidewall. The sidewall 120 has an interior or inner surface 126 and an exterior or outer surface 128. The sidewall 120 has an annular lower section 130 extending up from the rim 122 and including an annular outward projection 132. As noted above, the projection 132 is complementary to the carrier recess 98 so as to be accommodated in the carrier recess 98 in the closed condition of the inlet valve and detent said closed condition. The projection 132 and recess 98 may also cooperate to provide a seal in the closed condition.

[0074] An upper portion of the plunger has one or more radial recesses/reliefs 140. The example embodiment has three evenly circumferentially spaced radial reliefs 140 extending all the way from the projection 132 through the top web 124. Aside (circumferentially between) the reliefs 140, the top web 124 has radial projections 142. The example radial projections 142 take the form of continuations of (peripheral portions of) the top web 124 forming an interrupted outward radial flange (interrupted by the recesses/reliefs 140). Discussed further below, the underside 143 of the flange 142 can cooperate with a complementary surface 99 (FIG. 10 - e.g., an upper surface of an internal shoulder on an inward flange 97) of the carrier inner sidewall to act as a stop upon shifting of the plunger from the closed condition to the open condition. An alternative stop surface may be the rim 94.

[0075] The example funnel 24 (FIGs. 16-18) includes an outer wall (sidewall) 200 extending from a lower rim 202 to an upper rim 204. A lower portion 206 of the wall 200 is generally annular and forms a root of the funnel. The funnel sidewall 200 has an inner diameter (ID) surface 210 and an outer diameter (OD) surface 212. Along the OD surface 212, the lower portion 206 has an outward projection 214 which, as noted above and discussed further below, cooperates with the carrier inward projection 80 to eventually detent or otherwise backlock a depressed condition of the funnel relative to the carrier. The example projection 214 thus has a relatively shallow lower surface 216 and a relatively steep upper surface 218. The shallow lower surface 216 eases an overriding action upon depression while the steep upper surface 218 more robustly resists subsequent extraction.

[0076] The funnel sidewall 200 has an upper portion 232 diverging radially outward toward the upper rim 204 so as to provide a wide area and appropriate volume for saliva receipt. An uppermost portion 240 of the sidewall 200 has features for mating with the closure 26. The example uppermost portion 240 is stepped radially outward to create an upward-facing shoulder 242 to potentially stop downward movement of the closure 26. The example uppermost portion 240 further includes a circumferentially spaced group of inward projections 250 for cooperating with the closure to eventually detent or otherwise backlock the closure in place against extraction.

[0077] The funnel 24 further includes one or more features for engaging the plunger 30 so that downward motion of the funnel can shift the plunger from the inlet valve’s closed condition to the inlet valve’s open condition. The funnel’s example such feature is positioned to contact the upper surface of the top web of the plunger. The example feature is a circular cylindrical sleeve/boss 260 (e.g., annular) connected to the outer sidewall 200 lower portion 206 by a circumferentially spaced plurality of radially and vertically extending webs 262 (e.g., three shown). The open spaces circumferentially between the webs 262 provide a pathway for saliva to pass downward.

[0078] The example closure 26 (FIG. 19) is a plug-like cap comprising a sidewall 280 extending from a lower end at a rim 282 to an upper end at a transverse web 284. The example sidewall 280 has an interior or inner diameter (ID) surface 286 and an exterior or outer diameter (OD) surface 288. The OD surface 288 has a lower bevel 290 extending upward from the rim 282. The web 284 has an underside 292 and an upper surface 294. A lateral portion 296 of the web protrudes out to a rim 298.

[0079] In one example of assembly, the carrier 28 and plunger 30 are pre-assembled and assembled to the vial 22 as a unit after introduction of the buffer. To pre-assemble this carrier-plunger subassembly, the carrier may be held in a fixture and the plunger lowered into place. In the example carrier 28, the inner sidewall 86 ID surface is at a greater radius along the upper portion 92 than along the lower portion 88. This allows the plunger lower portion to freely pass into the carrier inner sidewall upper portion 92. Eventually, the plunger projection 132 reaches the carrier inner sidewall lower portion 88 where it encounters interference with the ID surface above the recess 98. However, the insertion force overcomes this resistance until the projection 132 becomes captured in the recess 98. The tooling doing the insertion may have a stop to prevent over-insertion beyond this detented closed condition. In the closed condition, the underside of the interrupted flange of the plunger is spaced above the rim 194 of the carrier inner sidewall upper portion.

[0080] The carrier-plunger subassembly may be threaded onto the vial via the respective threads of the carrier and vial with the vial upper rim eventually stopping and sealing against the underside of the annular flange 84 of the carrier.

[0081] In embodiments where the funnel is to be pre-installed, the funnel may then be downwardly installed to the carrier via tooling (not shown). The tooling may have a predetermined stroke (e.g., a stop) that does not over insert the funnel. An example insertion produces a sliding/sealing interaction of the funnel lower portion OD surface and the carrier projection 80 leaving the lower rim of the sleeve 260 in close facing or contacting relation with the plunger top web upper surface. There may also be initial sealing between the funnel rim 202 and carrier bevel 100. The resulting subassembly may then be packaged in a sterile package such as a bag or tray along with the closure (optionally separately packaged or sub-packaged).

[0082] In use, as noted above, the consumer opens any packaging and places the relevant subassembly including the vial upright on a support surface. If the funnel is not pre-installed, the user may downwardly install the funnel until the funnel contacts the plunger. The user may be provided with instructions instructing the two-stage operation wherein insertion is stopped at this point. With the funnel installed, the user then spits into the funnel. The funnel may include fill level markers such as a min. line and a max. line (molded to the funnel and/or painted). Once appropriately filled, the instructions may instruct the user to apply the closure to the funnel. The example closure application causes the closure top web outer portion 296 to snap below the funnel projections 250. Meanwhile, the closure sidewall OD surface along the bevel contacts the funnel sidewall ID surface to form a seal. In the illustrated example, this causes the closure to be recessed below the rim of the funnel thereby making accidental removal of the closure unlikely and intentional removal impractical absent use of tools.

[0083] The instructions may then instruct the user to press evenly more firmly downward on the funnel to open the inlet valve. The amount of downward force may be greater than the amount of force required for funnel installation and for closure installation. The downward force causes the funnel to bear against the upper surface of the plunger web 124 and downwardly shift the funnel, closure, and plunger as a unit. The downward shift disengages the plunger projection 132 from the carrier recess 98. Eventually, the plunger projection 132 passes below the lower rim of the carrier opening a passageway through the recesses/reliefs 140 and then between the funnel interior and the vial chamber. The saliva may then flow downward from the funnel passing between the webs 262 and then passing through the recesses/reliefs 140 into the chamber to mix with the buffer. The movement also further drives a lower portion of the funnel down further between the carrier walls 72 and 92, further sealing.

[0084] The downward motion may be stopped by one or more stop mechanisms such as via contact between the underside 143 of the flange 142 and the carrier shoulder surface 99. In the illustrated example, the stop provided by the flange underside 143 and shoulder 99 is a secondary /backup stop that supplements a primary stop involving funnel-to-carrier contact. The secondary stop may prevent further movement decoupled from the funnel such as via inertia). In the illustrated example, there is a gap (FIG. 6) between the flange underside 143 and shoulder 99 when the funnel bottoms out (contact between the funnel webs 262 (FIG. 18) and rim 94 and/or between the funnel lower rim 202 and carrier web 84). Thus the stop provided by the flange underside 143 and shoulder 99 is a secondary /backup stop that may prevent further movement decoupled from the funnel such as via inertia). At the point of stopping, the funnel projection 214 will have also over-ridden the carrier outer sidewall projection 180 so that the projections 214 and 80 resist a removal extraction of the funnel.

[0085] Example saliva volume introduced is 1.0 milliliter to 40.0 milliliter or 1.0 milliliter to 25 milliliter depending on the test. Thus, the volume below the valve (once depressed) and above (before depression) may be an example 2.0 milliliter to 50.0 milliliter to provide a margin. Yet more total container volume than the introduced sample volume below the valve may be desired to accommodate buffer and yet more above may be desired to avoid spillage.

[0086] The instructions may instruct the user to shake the container to mix the saliva and buffer. If packaged for home use, the instructions may instruct the user to place the container in a shipping package to ship back for testing.

[0087] When in the testing facility, testing may be accomplished by fixturing the vial and unscrewing the assembled funnel-closure-carrier-plunger subassembly from the vial. This may be done manually or automatedly. Similarly, for sample extraction, once opened, the sample may be manually or automatedly pipetted out of the vial for further testing. Alternatively, depending upon implementation, an in situ test may be performed such as by introducing a reagent to the specimen in the vial and observing some reaction. Yet alternatively, extraction may be otherwise such as via puncturing the vial.

[0088] One or more embodiments have been described. Nevertheless, it will be understood that various modifications may be made. For example, when applied to an existing baseline configuration, details of such baseline may influence details of particular implementations. Accordingly, other embodiments are within the scope of the following claims.

Claims

CLAIMS What is claimed is:

1. A specimen collection container or container kit (20) comprising: a container body (22) having a rim (46); an inlet valve body (28) mounted to the container body; an inlet valve element (30) mounted to the inlet valve body and depressable from a closed condition to an open condition; and a funnel (24) mounted to or mountable to the inlet valve body and depressable to drive the inlet valve element from the open condition to the closed condition.

2. The specimen collection container or container kit of claim 1 further comprising a buffer (32) in the container body.

3. The specimen collection container or container kit of claim 1 further comprising: a closure (26) mounted to or mountable to the funnel.

4. The specimen collection container or container kit of claim Iwherein the container body, the inlet valve body, the inlet valve element, and the funnel are each a respective molded plastic piece.

5. The specimen collection container or container kit of claim Iwherein: the inlet valve body is threaded to the container body.

6. The specimen collection container or container kit of claim 1 wherein: the funnel and valve body have features (80, 214) for detenting or locking the funnel in a depressed condition.

7. The specimen collection container or container kit of claim 1 wherein: the inlet valve element and inlet valve body have features (132, 198) for detenting the closed condition.

8. The specimen collection container or container kit of claim 7 wherein: the inlet valve element and inlet valve body features for detenting the closed condition also provide a seal in the closed condition.

9. The specimen collection container or container kit of claim 8 wherein: the inlet valve element and inlet valve body have features (142, 99) for stopping valve element depression beyond the open condition.

10. The specimen collection container or container kit of claim 9 wherein: the features for stopping valve element depression beyond the open condition comprise an interrupted outward flange (1 2) on the inlet valve element and an inward flange (97) on the inlet valve body.

11. The specimen collection container or container kit of claim 1 wherein the inlet valve body comprises: an internally-threaded outer sidewall (62); and an inner sidewall (86) engaging the inlet valve element.

12. The specimen collection container or container kit of claim 1 wherein: the funnel is mounted to the inlet valve body in a radial interference fit providing a seal.

13. A method for manufacturing the specimen collection container or container kit of claim 1, the method comprising: inserting the inlet valve element into the inlet valve body in the closed condition; and threading the inlet valve body .

14. The method of claim 13 further comprising: inserting a root of the funnel into the inlet valve body.

15. A method for using the specimen collection container or container kit of claim 1, the method comprising: depositing saliva (34) into the funnel; depressing the funnel to depress the inlet valve element to the open condition; and installing a closure to the funnel.

16. The method of claim 15 wherein: the depositing saliva into the funnel is atop the inlet valve element; and the installing the closure to the funnel is before the depressing. The method of claim 15 further comprising: removing the inlet valve body from the container body; and pipetting out the saliva. A method for using a saliva collection container (20), the method comprising: depositing saliva (34) into a funnel (24) atop a plunger (30); and depressing the funnel to shift the plunger so that the deposited saliva flows into a lower portion of a body (22) of the container. The method of claim 18 wherein: installing a closure (26) to the funnel. The method of claim 18 wherein: the flowing of the deposited saliva into the lower portion of the body of the container causes the deposited saliva to mix with a buffer (32). A saliva collection container (20) comprising: a funnel (24)for receipt of saliva (34); a body (22) having a lower portion; and a plunger (30) depressable via the funnel: from a closed condition wherein flow of saliva from the funnel to the body lower portion is blocked to an open condition wherein saliva may flow from the funnel to the body lower portion.

15