Device and method for biofluid sample collection and transfer

Abstract

A device for collecting and transferring biofluids for testing comprises a housing defining upstream and downstream ends and a passage therebetween. A transfer element is movably connected to the housing along the passage and comprises an upstream portion thereof for outwardly protruding from the upstream opening formed at the upstream end of the housing. A collection element at the upstream portion of the transfer element collects biofluid. A compression element along the passage for compresses the collection element when engaged thereby to release the collected biofluid. Movement of the transfer element in a direction from the upstream end towards the downstream end moves the upstream portion with the collection element and collected biofluid into the housing via the upstream opening providing engagement of the collection element by the at least one compression element for compression thereof and concurrent release of the biofluid therefrom for testing thereof within the housing.

Description

TITLEDEVICE AND METHOD FOR BIOFLUID SAMPLE COLLECTION AND TRANSFERCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] The present application claims priority on United States Provisional Patent Application Serial Number 63 / 527,680 filed on July 19, 2023 and incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present disclosure generally relates to bodily fluid (biofluid) sample collection, testing and analysis. More particularly, but not exclusively, the present disclosure relates to a biofluid sample (e.g. saliva) collection and transfer device for sample testing and analysis thereof and a method therefor.BACKGROUND

[0003] Biofluid sample collection, such as saliva sampling, is a common step for many analytical tests. This spans across a number of technical fields and is notably used in medical diagnostic tests. Human fluid samples may consist of a number of fluid types (saliva, blood, urine, mucus, etc.). Sample collection is conducted in a number of ways, whether by a medical professional sampling a patient or the patient being given the necessary tools to retrieve the sample themselves. This may be done with a swab, a container, or other similar instruments. For example, a patient may be instructed to deposit urine into a container, which can be transported to a laboratory for analysis. Samples are often analyzed using laboratory-grade tools and equipment, which are typically expensive and difficult toacquire. The common layperson does not usually have access to specialized equipment and is required to visit a clinic or hospital in order to receive a liquid sample test and analysis results.

[0004] Point of care medicine is increasing the common person’s access to medical results. This field of medicine focuses on simple medical testing that can be conducted by a layperson. At-home liquid sample collection devices will reduce the cost and wait time of a sample analysis, and additionally reduce risk of contaminating the sample during transportation and storage usually required for standard laboratory testing methods.

[0005] A common method of applying point of care medicine is through lateral flow assays (LFA), a known technology for the testing of the presence of a specific reactant within the human body (ie. Covid-19 test strips, pregnancy tests etc.). These tests are low-cost to manufacture, can be customized for very specific testing purposes, and do not require large liquid samples in order to generate a result.

[0006] The main concerns with these tests are that they are fragile and must be protected from environmental factors, and that the liquid sample dispensed onto the strip must be within a precise volume range, in order to not flood the strip and nullify the test.OBJECTS

[0007] An object of the present disclosure is to provide a device for collecting, transferring, and testing biofluids.

[0008] An object of the present disclosure is to provide a kit for collecting, transferring, and testing biofluids.

[0009] An object of the present disclosure is to provide a method for collecting, transferring and testing biofluids.SUMMARY

[0010] In accordance with an aspect of the present disclosure, there is provided a device for collecting and transferring biofluids for testing thereof, the device comprising: a housing defining upstream and downstream ends thereof and a passage therebetween, an opening formed at the upstream end in fluid communication with the passage; a transfer element movably connected to the housing along the passage and comprising an upstream portion thereof for outwardly protruding from the upstream opening; a collection element positioned at the upstream portion of the transfer element for collecting a biofluid; and at least one compression element positioned along the passage for compressing the collection element when engaged thereby to release the collected biofluid; wherein imparting a movement to the transfer element in a direction from the upstream end towards the downstream end moves the upstream portion with the collection element and collected biofluid into the housing via the upstream opening providing engagement of the collection element by the at least one compression element for compression thereof and concurrent release of the biofluid therefrom for testing thereof within the housing.

[0011] In an embodiment, the housing comprises a display for displaying test results produced by the testing. In an embodiment, the display provides for displaying a movement position of the transfer element.

[0012] In an embodiment, the device further comprises a testing element positioned within the housing to receive the biofluid released from the collection element.

[0013] In an embodiment, the device further comprises at least one testing element for being positioned within the housing to receive the biofluid released from the collection element.

[0014] In an embodiment, the testing element is positioned beneath and at least in proximity of the collection element during compression thereof.

[0015] In an embodiment, the testing element is positioned to interface with the collection element during compression thereof.

[0016] In an embodiment, the released biofluid is released onto an area of the housing, the testing element being adjacent the area in order to receive the released biofluid.

[0017] In an embodiment, the testing element comprises a testing area thereof for producing test results, the housing comprising a display for displaying the test results. In an embodiment, the testing element comprises a lateral flow array.

[0018] In an embodiment, the housing comprises a downstream opening at the downstream end, the transfer element comprising a downstream portion thereof outwardly protruding from the downstream opening. In an embodiment, the downstream portion thereof provides for a user to grip in order to impart the movement to the transfer element. In an embodiment, the transfer element comprises break lines for breaking the downstream end of the transfer element at a predetermined pulling force thereof.

[0019] In an embodiment, the transfer element comprises a longitudinal configuration. In an embodiment, the movement of the transfer element is a linear movement.

[0020] In an embodiment, the transfer element comprises a body portion thereof providing a clearance opening for the at least one compression element to protrude therethrough and aloe the engagement of the compression element by the collection. In an embodiment, a testing element positioned within the housing to receive the biofluid released from the collection element, the testing element comprising a testing area for producing test results, the housing comprising a display for displaying the test results, the clearance opening providing for the test results to be visible therethrough. In an embodiment, the transferring element comprises another body portion thereof for concealing the test area when the upstream portion outwardly protrudes from the upstream opening.

[0021] In an embodiment, the transferring element and the housing comprise mutually engaging elements to removably maintain the transferring element in position when moved in the downstream direction against a resistance force to compression by the collection element.

[0022] In an embodiment, the transfer element and the housing element comprise mutually abutting elements thereof for stopping the movement of the transfer element at a predetermined position.

[0023] In an embodiment, the housing comprises top and bottom portions that are removably assembled. In an embodiment, the top and bottom portions are movably connected for relative movement to each other. In an embodiment, the bottom portion defines an inner side thereof comprising the transfer element.

[0024] In an embodiment, the device comprises a movement imparting element connected to the transfer element for being actuated to impart the movement to the transfer element.

[0025] In an embodiment, the housing and the transfer element comprise respective longitudinal configurations.

[0026] In an embodiment, the housing and the transfer element comprise respective circular-like configurations.

[0027] In an embodiment, the collection element comprises an absorptive pad.

[0028] In an embodiment, the at least one compression element provides for compressing the collection element along a length thereof.

[0029] In an embodiment, the at least one compression element provides for compressing the collection element along a height thereof.

[0030] In an embodiment, the at least one compression elements provide for stopping the movement of the transfer element when compressing the collection element.

[0031] In accordance with an aspect of the present disclosure, there is provided a kit for collecting, transferring, and testing of biofluids comprising: the device of any one of the preceding paragraphs; and a reader for reading test results provided by the testing.

[0032] In accordance with an aspect of the present disclosure, there is provided a device for collecting and transferring biofluids for testing thereof, the device comprising: a housing defining a longitudinal passage therein and front and rear openings at respective front end and rear ends of the housing in fluid communication with the longitudinal passage, the housing enclosing a testing element therein; a transfer element movably positioned within the housing along the longitudinal passage and comprising front and rear portions thereof, respectivelyoutwardly protruding from the front and rear openings; a collection element positioned at the front portion of the transfer element for collecting a biofluid; and at least one compression element positioned within the housing for compressing the collection element when engaged thereby to release the collected biofluid; wherein imparting a linear movement to the transfer element in a direction from the front end towards the rear end moves the front portion with the collection element into the housing via the front opening providing engagement of the collection element by the at least one compression elements for compression thereof and concurrent release of the biofluid to the testing element for testing and providing test results.

[0033] In embodiment, the housing comprises a display for displaying the test results provided by the testing element.

[0034] In accordance with an aspect of the present disclosure, there is provided a method for collecting, transferring, and testing biofluids, the method comprising: collecting a biofluid with a collection element positioned on a transfer element movably connected to a housing defining a passage, the collection element outwardly extending from the housing; mparting a contiguous movement to the transfer element along the passage for inserting the collection element and collected biofluid into the housing; simultaneously with the contiguous movement, engaging the collection element with at least one compression element within the housing for compression of the collection element providing concurrent releasing of the biofluid therefrom; capturing the biofluid upon release thereof from the collection element with a testing element in the housing for testing of the biofluid and providing test results.

[0035] In an embodiment, the contiguous movement is a linear movement.

[0036] The devices, kits and methods of the disclosure provide for a one contiguous step providing collecting biofluid on a collection element, releasing the collected biofluid by compressing the collection element and capturing the released biofluid on a testing element for testing thereof and displaying the test results.

[0037] Other objects, advantages and features of the present disclosure will become more apparent upon reading of the following non-restrictive description of illustrative embodiments thereof, given by way of example only with reference to the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0038] In the appended drawings:

[0039] Figure 1 is a top and side perspective view of a device for collecting, transferring and testing biofluids in a biofluid collecting position in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0040] Figure 2 is a top and side perspective view of the device of Figure 1 in a biofluid transferring position in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0041] Figure 3 is a top and side perspective view of the device of Figure 1 in a biofluid testing position in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0042] Figure 4 is a top and side perspective view of the device of Figure 1 in another biofluid testing position in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0043] Figure 5 is a perspective view of the device of Figure 1 positioned within a reader in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0044] Figure 6 is a top and side perspective view of the bottom housing portion of the device of Figure 1 in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0045] Figure 7 is a bottom and side perspective view of the bottom housing portion of the device of Figure 1 in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0046] Figure 8 is a top and side perspective view of the top housing portion of the device of Figure 1 in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0047] Figure 9 is a bottom and side perspective view of the top housing portion of the device of Figure 1 in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0048] Figure 10 is a sectional view of the device of Figure 1 in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0049] Figure 11 is a top perspective view of the transfer element of the device of Figure 1 in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0050] Figure 12 is top and perspective view of the transfer element of Figure 11 mounted to the bottom housing portion of Figure 5 in accordance with a non- restrictive illustrative embodiment of the present disclosure;

[0051] Figure 13 is a top and side perspective view of a device for collecting, transferring, and testing biofluids in accordance with another non-restrictive illustrative embodiment of the present disclosure;

[0052] Figure 14 is a bottom and side perspective view of the top housing portion of the device of Figure 13 in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0053] Figure 15 is a top and side perspective view of the bottom housing portion of the device of Figure 13 in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0054] Figure 16 is a sectional view of the device of Figure 13 in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0055] Figure 17 is a top and side perspective view of a device for collecting, transferring, and testing biofluids in accordance with a further non-restrictive illustrative embodiment of the present disclosure;

[0056] Figure 18 is a bottom and side perspective view of the device of Figure 17 in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0057] Figure 19 is a top and side perspective view of a device for collecting, transferring, and testing biofluids in a biofluid collecting position in accordance with yet another non-restrictive illustrative embodiment of the present disclosure;

[0058] Figure 20 is a top and side perspective view of the device of Figure 19 in a biofluid testing position in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0059] Figure 21 is a top and side perspective view of a device for collecting, transferring, and testing biofluids in accordance with yet a further non-restrictive illustrative embodiment of the present disclosure;

[0060] Figure 22 is a top and side perspective view of a device for collecting, transferring, and testing biofluids in accordance with still another non-restrictive illustrative embodiment of the present disclosure;

[0061] Figure 23 is a top and side perspective view of a device for collecting, transferring and testing biofluids in a biofluid collecting position in accordance with another non-restrictive illustrative embodiment of the present disclosure;

[0062] Figure 24 is a top and side perspective view of the device of Figure 23 in a biofluid transferring position in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0063] Figure 25 is an exploded perspective view of the device of Figure 23 in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0064] Figure 26A is a sectional, front, top and side perspective view of the device of Figure 23 in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0065] Figure 26B is a sectional, front, top and side perspective view of the device of Figure 23 in accordance with another non-restrictive illustrative embodiment of the present disclosure;

[0066] Figure 27 is a further sectional, front, top and side perspective view of the device of Figure 23 sectioned further downstream to Figures 26A and 26B in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0067] Figure 28 is a sectional lateral and top perspective view of the device of Figure 23 at a biofluid collecting position in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0068] Figure 29 is a sectional lateral and top perspective view of the device of Figure 23 at an initial transferring position in accordance with a non-restrictive illustrative embodiment of the present disclosure;

[0069] Figure 30 is a sectional lateral and top perspective view of the device of Figure 23 at a transferring and compressing position in accordance with a non- restrictive illustrative embodiment of the present disclosure; and

[0070] Figure 31 is a sectional lateral and top perspective view of the device of Figure 23 at a transferred and fully compressed position in accordance with a non-restrictive illustrative embodiment of the present disclosure.DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0071] Generally stated and in accordance with an aspect of the present disclosure, there is provided a device for collecting and transferring biofluids for testing. The device comprises a housing defining upstream and downstream ends and a passage therebetween. An opening is formed at the upstream communicating with the passage. A transfer element is movably connected to the housing along the passage and comprises an upstream portion thereof for outwardly protruding from the upstream opening. A collection element is positioned at the upstream portion of the transfer element for collecting biofluid. At least one compression element is positioned along the passage for compressing the collection element when engaged thereby to release the collected biofluid. Movement of the transfer element in a direction from the upstream end towards the downstream end moves the upstream portion with the collection element and collected biofluid into thehousing via the upstream opening providing engagement of the collection element by the at least one compression element for compression thereof and concurrent release of the biofluid therefrom for testing thereof within the housing.

[0072] In an embodiment, the housing comprises a display for displaying test results produced by the testing. In an embodiment, the display provides for displaying a movement position of the transfer element.

[0073] In an embodiment, the device further comprises a testing element positioned within the housing to receive the biofluid released from the collection element.

[0074] In accordance with an aspect of the present disclosure, there is provided a device for collecting and transferring biofluids for testing. The device comprises a housing defining a longitudinal passage therein and front and rear openings at respective front end and rear ends of the housing communicating with the longitudinal passage. The housing encloses a testing element therein. A transfer element is movably positioned within the housing along the longitudinal passage and comprises front and rear portions, respectively outwardly protruding from the front and rear openings. A collection element is positioned at the front portion of the transfer element for collecting biofluid. At least one compression element is positioned within the housing for compressing the collection element when engaged thereby to release the collected biofluid. Linear movement of the transfer element in a direction from the front end towards the rear end moves the front portion with the collection element into the housing via the front opening providing engagement of the collection element by the at least one compression elements for compression thereof and concurrent release of the biofluid to the testing element for testing and providing test results.

[0075] In embodiment, the housing comprises a display for displaying the test results provided by the testing element.

[0076] In accordance with an aspect of the present disclosure, there is provided a method for collecting, transferring, and testing biofluids. Biofluid is collected with a collection element positioned on a transfer element movably connected to a housing defining a passage. The collection element outwardly extends from the housing. A contiguous movement of the transfer element along the passage inserts the collection element and collected biofluid into the housing and simultaneously engages the collection element with at least one compression element within the housing for compression of the collection element providing concurrent releasing of the biofluid. The biofluid is captured upon release the with a testing element in the housing for testing of the biofluid and providing test results.

[0077] With reference to 1 to 4, there is shown a device 10 for collecting a biofluid sample from a subject and for transferring this biofluid sample therein for testing / analysis thereof.

[0078] The device 10 comprises a housing 12 having a generally longitudinal body and defining upstream or front and downstream or rear ends, 14A and 14B respectively, and top and bottom surfaces, 16 and 18 (see Figure 7) respectively joined together by a peripheral wall 17 therebetween. The front and rear ends 14A and 14B of the housing 12 define respective front and rear openings 20A and 20B (see Figure 10) in fluid communication with an internal passage 50 (see Figure 10). A transfer element 22 in the form of a longitudinal body or straight strip is movably positioned within the housing 12 and defines a front portion 24 thereof protruding outwardly via the front opening 20A and a rear portion 26 thereof protruding outwardly via the rear opening 20B.

[0079] The front portion 24 of the transfer element 22 carries a biofluid collection element 28 in a fixed position for collecting a biofluid. In the non-limiting example shown here, the biofluid element 28 is an absorbent pad conveniently configured for collecting a saliva sample for example. The rear portion 26 provides for a user to pull on the transfer element 22 thereby moving the transfer element along a linear path within passage 50 in the direction shown by arrow A (see Figure 10) and consequently moving the front portion 24 inwardly into the housing 12 via the inlet opening 20A. In the example shown here, the rear portion 26 includes gripping ridges 30 facilitating manual gripping.

[0080] In Figure 1 , the front portion 24 is shown in its most outwardly protruding position with the absorbent pad 28 being fully exposed to receive a biofluid sample from a subject. Once the biofluid sample has been collected the transfer element 22 is pulled to move the front portion 24 with the absorbent pad 28 inwardly into the housing 12 via the inlet opening 20A as shown in Figure 2 until the absorbent pad 28 has been fully transferred within the housing 12, as shown in Figure 3. As the user continues to pull on portion 26, this portion 26 is broken from the rest of the transfer element 22 thereby preventing any further inward movement of the absorbent pad 28 as shown in Figure 4. Indeed, Figure 4 shows the device 10 without any portions outwardly protruding / extending from the housing 12.

[0081] As will be further described below, the housing 12 houses a testing element (see element 56 in Figure 10) therein and the absorbent pad 28 is compressed therein via contact with a compression mechanism (see element 58 in Figure 10) positioned inside the housing 12 during linear movement (as shown by arrow A) of the transfer element 22 thereby releasing the collected biofluid onto the testing element. The test results are displayed via a display 32 (such as a viewing window for example) formed in the top surface 16 of the housing 12.

[0082] As shown in Figure 5, the device 10 can be inserted into an optical reader 34 for further reading of the test results via the display 32. For example, the testing element is a test strip and produces result lines when receiving collected saliva which are displayed via the display window 32. The reader 34 reads the intensity of the lines and determines, for example, hormone levels of the subject. In one example, the reader 34 takes a photograph of the results displayed via the display window 32 for analysis thereof.

[0083] As such, a biofluid sample can be collected by one portion 24 of the transfer element 22 and transferred directly onto a testing element within the housing 12 by way of a single linear movement of the transfer element 22 thereby compressing the collection element 28 within the housing 12 along this linear movement for concurrent release of the biofluid sample onto the testing element to provide test results displayed via the display 32.

[0084] In an embodiment, the housing 12 comprises a bottom housing portion 36 (see Figures 6 and 7) and a top housing portion 38 (see Figures 8 and 9) assembled together to provide the housing 12. In an embodiment, the housing 12 is reusable and as such the device 10 can be provided with a plurality of testing elements. The user can open the housing 12 by disassembling portions 36 and 38 and replace the user testing element with a new one. In an embodiment, the housing 12 is for single use only and thus discarded after use. In an embodiment, the housing 12 is sealed thereby preventing spills, leaks, or biologically hazardous liquid to escape therefrom.

[0085] As shown in Figure 6, the bottom housing portion 36 comprises a cupshaped body defining a bottom floor 40 being circumscribed by a peripheral wall portion 17’ upwardly extending therefrom. The bottom floor 40 is the opposite inner side of the bottom outer surface 18 shown in Figure 7. In an embodiment, thebottom surface 18 includes locating elements 42 for convenient insertion into a reader (such as optical reader 34).

[0086] Turning to Figure 9, the top housing portion 38 is dome-like with a top wall or ceiling 44 being the opposite inner side of the top outer surface 16 shown in Figure 8. The top wall 44 is circumscribed by a peripheral wall portion 17” downwardly extending therefrom. The top and bottom peripheral wall portions 17” and 17’, respectively, are connected together forming the peripheral wall 17 and thereby assembling the top and bottom housing portions, 38 and 36 respectively, to form the housing 12. In an embodiment, the top peripheral wall portion 17” includes snap inserts 46 downwardly extending therefrom for being snap fitted within corresponding grooves 48 formed in the bottom peripheral wall 17’.

[0087] As shown in Figure 6, the bottom peripheral wall portion 17’ defines a front cut-out or recess 20A’ at front end 14A and a rear cut-out recess 20B’ at rear end 14B. Correspondingly, and as shown in Figure 9, the top peripheral wall portion 17” defines a front recess 20A” at front end 14A and a rear recess 20B” at rear end 14B. Accordingly, when assembling the housing portions 36 and 38, the adjoined front recesses 20A’ and 20A” define the front opening 20A and the adjoined rear recesses 20B’ and 20B” define the rear opening 20B. The front inlet opening 20A provides a sufficient clearance space for the absorbent pad 28 to enter the housing 12 when at its maximum volume retention size without structural interference from the peripheral wall 17 circumscribing the opening 20A thereby providing a sufficient amount of biofluid to be absorbed and transferred into the housing 12 for testing.

[0088] With reference to Figure 10, when the portions 36 and 38 are assembled, the housing 12 defines an inner longitudinal cavity 50 in fluid communication with the front and rear openings 20A and 20B defining thelongitudinal passage for the linear movement of the transfer element 22 in the direction shown by arrow A.

[0089] Turning back to Figure 6, the bottom housing portion 36 comprises a support structure 52 upwardly extending from the bottom floor 40 and defining a space 54 for receiving and maintaining a testing element such as a test strip 56 such as an LFA strip (see Figure 10) in position on the bottom floor 40.

[0090] The housing 12 includes a compression mechanism 57 therein near the inlet opening 20A for compressing the absorbent pad 28 to release the absorbed biofluid.

[0091] As shown in Figure 6, the compression mechanism 57 comprises bottom compression elements 58 in the form of spaced apart ramps upwardly extending from the bottom floor 40 into the passage 50. Referring to Figure 7, the compression mechanism 57 also comprises top compression elements 60 in the form of a pair of tabs downwardly extending from the top wall 44 into the passage 50. T urning to Figure 10, as the front portion 24 together with the absorbent pad 28 are moved into the housing 12 via the opening 20A when pulling the rear portion 26 outwardly of the opening 20B, the absorbent pad 28 engages the compression elements 58 and 60 which provide a small and progressively narrowing gap 51 therebetween that blocks the absorbent pad 28 from further movement along the passage 50. Consequently, the absorbent pad 28 is compressed between the top tabs 60 and the bottom ramps 58 and is also shortened due to clogging the gap 51 as it is pulled in the direction shown by arrow A. As such, the absorbent pad 28 is compressed both vertically (i.e. squeezed) and axially (i.e. shortened) in order to increase the biofluid released thereby.

[0092] Indeed, the compression mechanism 57 acts as a stopper that limits the linear movement of the transfer element 22, such that the absorbent pad 28 travel is stopped over a sample collection portion 56’ (see Figure 10) of the test strip 56 positioned within the bottom housing portion 36.

[0093] Turning to Figure 11 , the front portion 26 of the transfer element defines a frame 62 with an opening 63 for positioning the absorbent pad 28 therethrough. With reference to both Figures 6 and 10, the testing strip 56 is positioned beneath the transferring element 22 and the compression mechanism 56 such that it receives released biofluid. As the absorbent pad 28 is compressed and has an exposed underside provided by opening 63, the biofluid spills directly on the testing strip 56.

[0094] In an embodiment, the sample collection portion 56’ is positioned between the ramps 58 and held in position between segments 59 of the support structure 52 (see Figure 6) with the compressed absorbent pad 28 being positioned directly above the sample collection portion 56’ thereby facilitating the released biofluid falling directly on portion 56’. In an embodiment and with reference to Figure 9, the top tabs 60 are angled guiding the absorbent pad 28 down closer to the test strip 56, and centrally towards its symmetrical axis. In an embodiment and as shown in Figure 6, the bottom housing portion 36 includes a guide element 64 upwardly extending from the floor 40 and being positioned near the inlet opening 20A to assist in the guidance of the absorbent pad 28 to the compression mechanism 56.

[0095] The biofluid is absorbed by and travels along the testing strip 56 towards a test result portion 56” (see Figure 10) conveniently positioned beneath the window 32 for viewing thereof. Turning to Figures 11 and 12, the transfer element 22 provides a viewing opening 65 for not blocking the test result portion56”. In an embodiment and as shown in Figure 8, indication 66 (including stickers, markings, etc.) are provided on the top surface 16 for the recording of unique information about the individual housing for example.

[0096] In an embodiment and with reference to Figure 9, a contact element 67 in the form of a flap downwardly extending from the top wall 44 into the passage 50 provides for engaging the test strip 56 on the floor 40 within space 54 in order to prevent movement of the test strip 56 as well as to guide the flow of the biofluid through the test strip 56. As shown in Figure 11 , the contact element 67 engages the test strip 56 via a clearance opening 68 provided by the transfer element 22.

[0097] In an embodiment and as shown in Figure 6, the support structure 52 comprises a longitudinal frame 70 with a peripheral wall 72 and support ribs 74 therein for nesting the testing strip 56 thereon slightly above floor 40. Frame 70 assists in the wicking of liquid through the test strip 56 without causing pooling or flooding of sample around a strip. In addition, frame 70 acts as structural and transportation support for a test strip 56, preventing damage prior to and during use.

[0098] T urning now to Figures 11 and 12, the linear movement of the transfer element 22 is limited by wing abutments 76 laterally extending therefrom and engaging side barriers 78 (see also Figure 6) inwardly extending from the inner sides of wall portion 17’ of the bottom housing portion 36 thereby stopping the linear movement of the transfer element 22 in the direction shown by arrow A when pulling on the rear portion 26. The foregoing avoids over-extension of the rear portion 26 of transfer element 22 out of the housing 12 and an over-insertion into the housing 12 of the front portion 24. In an embodiment, the transfer element 22 comprises connectors 80 interconnecting its lateral sides 82i and 82ii and providing structural integrity thereto as well as indicating to user via the display window 34 the remaining distance of the transfer element linear movement through the housing 12. In anembodiment, the transfer element 22 further comprises tear-away break lines 84 which permit the user to remove excess material transfer element 22 the compression of the pad 28 is complete.

[0099] The front portion 24 of the transfer element 22 includes support walls 86 about the opening 63 for preserving the integrity of the absorbent pad 28 as it travels through the housing 12. The support walls 80 prevent the absorbent pad 28 from breaking up on contact with the housing 12 thereby providing for absorbent pad 28 to enter the housing 12 for compression thereof and avoiding damage prior to compression.

[0100] In an embodiment, the absorbent pad 28 material is selectively chosen for its absorbent properties. An appropriate material is capable of absorbing and releasing the correct amount of fluid for the test strip 56 implemented within the device 10. In an embodiment, this material is compact when dry and expands on contact with a biofluid sample, providing stability and durability through transportation and storage of the device 10. In an embodiment, the amount of biofluid sample released from the absorbent pad 28 from about 0.5uL to about 500uL of fluid.

[0101] Turning now to Figures 13 to 16, there is shown a device 100 that is similar to device 10 and as such only the differences therewith will be discussed in detail for concision purposes only.

[0102] The device 100 includes a housing 112 with a moveable transfer element 122 movably positioned therethrough and having a front portion 124 extending outwardly from a front opening 120A and a rear portion extending outwardly from a rear opening 120B. The front portion 124 carries collection element 128. Following biofluid collection, the collection element 124 is moved intothe housing 112 via the opening 120A along a linear movement (shown by arrow A in Figure 16) to engage a compression mechanism 156.

[0103] The compression mechanism 156 includes bottom compression elements 158 within the bottom housing portion 136 and shown in Figures 15 and 16 and comprising spaced apart walls having a proximal ramp portion 158’ thereof and a distal rail portion 158” thereof. As shown in Figure 14, the compression mechanism 156 also includes top compression elements 160 comprising a series of fins downwardly extending from the top housing portion 138. The pad 128 is compressed between the fins 160 and the spaced apart walls 158. The fins are flexible and one or more of the fins 160 may be caused to bend inwardly during movable engagement by the pad 128 yet linear movement will be eventually arrested thereby stopping the pad 128 in a compressed (vertically squeezed and horizontally shortened) to release the biofluid directly on the testing strip thereunder.

[0104] The device of the disclosure optimizes the release of a biofluid sample from a collection element by removing the need for a user to identify the amount of sample to dispense onto a test strip. The collection is autonomously compressed upon entry into the device housing and the fluid sample is dispensed onto the test strip through this travel motion.

[0105] The device components herein can be made in any desired material. In an embodiment, the device is made of plastic material, manufactured through additive techniques or injection molding.

[0106] With reference to Figures 17 and 18, there is shown a device 200 for collecting, transferring, and testing biofluids. The device 200 comprises a housing 202 defining an upstream end 204, a downstream end 206 and a passage 208 therebetween. An opening 210 is formed at the upstream end 204. A transferelement 212 is movably connected to the housing 202 and positioned along the passage 208. The transfer element 212 includes an upstream portion 214 that is provided to protrude outwardly of the opening 210. This upstream portion 214 carries a collection element (now shown) for collecting biofluid. The transfer element 212 is moved from the upstream position to a downstream position as shown by arrow A. The transfer element 212 is moved by pushing a tab 216 protruding from a longitudinal slot 218 along a length of the slot 218 in the direction of arrow A. The device 200 comprises compression elements (now shown) positioned along the passage 208 for compressing the collection element following biofluid collection in order to release the biofluid on a testing element interfacing with the compressed collection element thereby providing test results which are displayed via a display window 218.

[0107] Figures 19 and 20 show a device 250 for collecting, transferring, and testing biofluids. The device 250 comprises a housing 252 defining an upstream end 254, a downstream end 256 and a passage 258 therebetween. An opening 260 is formed at the upstream end 254. The housing 252 defines lateral edges 262 and comprises top and bottom housing portions 264 and 266, respectively, which are mutually and slidably interconnected along the lateral edges 262. Thus, the top and bottom housing portions 264 and 266 mutually slide along each other. In other words, the bottom housing portion 266 slides along the top body 264 and top body portion 264 mutually slides along the bottom body portion 266.

[0108] The top and bottom portions 264 and 266, respectively, have mutually interfacing inner sides thereof that are spaced apart thereby defining a passage 268 formed within the housing 252. The inner side of the bottom housing portion 266 defines a transfer element 270 which is movable by the relative movement between portions 264 and 266. The transfer element 270 is thus movably connected to the housing 252 along passage 268 from the upstream end 254 to the downstream end256 as shown by arrow A. The transfer element 270 has an upstream portion 272 that carries a collection element 274. By sliding the top and bottom portions 264 and 266 relative to each other when the transfer element 270 is in a first position shown in Figure 19, a movement is imparted to the transfer element 270 along a downstream direction (arrow A) thereby inserting the collection element 274 via the opening 260 into the housing 252 for compression thereof (by compression elements along the passage 268 as previously discussed) thereby concurrently releasing collected biofluid onto a testing element (as previously described) positioned within the bottom housing portion 266 to provide test results which can be viewed via a display window 276 formed in the top housing portion.

[0109] Figure 21 shows a device 300 for collecting, transferring, and testing biofluids. The device 300 comprises a housing 302 having a semicircular configuration and defining an upstream end 304, a downstream end 306 and a passage 308 therebetween. An upstream opening 310 is formed at the upstream end 304 and a downstream opening 312 is formed at the downstream end 306. Openings 310 and 312 are in fluid communication with the passage 308. A circular transfer element 314 is movably positioned through the housing 302 along the passage 308. The circular transfer element 314 has a portion 316 thereof with a collection element 318 mounted thereto. This portion 316 is positioned outside the housing and upstream the opening 310 thereby forming an upstream outwardly protruding portion 316. The housing 302 and the transfer element 314 are movable relative to each other thereby providing the transfer element 314 to move in the direction from the upstream end 304 to the downstream end 306 as shown by arrow B. In this way and following biofluid collection, the collection element 318 is moved into the housing 302 via opening 310 where it is compressed by compression elements (not shown) positioned within the housing 302 along the passage 308 thereby releasing the biofluid onto a testing element (now shown) positioned withinthe housing 302 along the passage 308 in order to provide test results displayed via a display window 320 formed in the housing 302.

[0110] Figure 22 shows a device 350 for collecting, transferring, and testing biofluids. The device 350 comprises a housing 352 in the form of a circular disk defining a top face 354, an opposite bottom face 356 and peripheral edge 358 therebetween. The disk 352 defines a cut-out part 360 defining a longitudinal opening 362 leading to cavity 364 formed within the disk housing 352. A transfer element 366 in the form of disk is movably positioned within the cavity 364 of the housing 352. A central portion of the transfer disk element 366 is connected to a handle 368 upwardly extending from the housing 352 via a top opening 370 for turning the transfer disk element 366 within the housing 352. The handle 368 comprises a stem 372 connected to the transfer disk element 366 with a knob 374 at its free end. The stem 372 defines the axis of rotation of the transfer disk element 366 providing for the transfer disk element 366 to rotate in the direction shown by arrow 376 which is an opening formed in the housing 352 allowing the user to view the rotation of the disk 366 within the disk 352.

[0111] A portion 378 of the transfer disk element 366 outwardly protrudes from the longitudinal opening 362. The portion 378 defines an outer edge portion 380 thereof that moves along an inner edge part 382 formed near the peripheral edge and defining a passage for the outer edge portion 380. The outer edge portion 380 carries a collection element 383. The longitudinal opening 362 is circumscribed by a mouth 384 defining opposite edges 386 and 388. The longitudinal opening defines edge opening portion thereof 390 and 392 at respective mouth edges 386 and 388 respectively.

[0112] When imparting a rotational movement to disk 366 in the direction of arrow 376, the outer edge portion 380 moves within the inner edge passage 382from in the direction from mouth edge 386 to mouth edge 386 thereby respectively defining upstream and downstream ends with respective upstream and downstream edge openings portions 390 and 392, respectively. As such, the collection element 383 is moved into the housing 352 via the upstream opening 390 to move along the passage 382 so as to be compressed by compression elements (not shown) along the passage 382 inside the housing 352 to release collected biofluid on a testing element (not shown) along the passage and interfacing with the compressed collection element to provide test results displayed via a display window 394 formed in the top face 354 of the housing 352.

[0113] With reference to 23 to 31 , there is shown a device 400 for collecting a biofluid sample from a subject and for transferring this biofluid sample therein for testing / analysis thereof.

[0114] With particular reference to Figures 24 and 24, tsahe device 400 comprises a housing 402 having a generally longitudinal body and defining upstream or front and downstream or rear ends, 404A and 404B respectively, and top and bottom surfaces, 406 and 408 respectively curving towards each for form lateral surfaces 410’ and 410’ (see Figures 26A-27). The front and rear ends 404A and 404B of the housing 402 define respective front and rear openings 412A and 412B (see Figures 29 and 31 ) in fluid communication with an internal passage 414 (see Figures 28-31 ). A transfer element 416 in is movably positioned within the housing 12 and defines a front portion 418 thereof protruding outwardly via the front opening 412A and a rear portion 420 thereof protruding outwardly via the rear opening 412B.

[0115] The front portion 418 of the transfer element 416 carries a biofluid collection element 422 in a fixed position for collecting a biofluid sample (e.g. saliva). The rear portion 420 of the transfer element comprises a gripping disc 424 whichprovides for a user to pull on the transfer element 416 thereby moving the transfer element 416 along a linear path within passage 414 in the direction shown by arrow A (in Figures 29-31 ) and consequently moving the front portion 418 with the collection element 420 inwardly into the housing 402 via the front inlet opening 412A (as shown in Figure 29). .

[0116] With reference to Figure 25, the transfer element 416 is in the form of a longitudinal body comprising a first body part 426 and a second part 428. The first body part 426 defines an oblong opening 430 thereby providing a pair of lateral arms 432’ and 434” connected at a front end 436 and connected at a rear end 438 to the second body part 428. The oblong opening 430 provides a clearance space during linear movement of the transfer element 416 to not interfere with the an internal compression and stopper element 440 (see Figures 28-31 ) as will be discussed further below.

[0117] As mentioned above, the front portion 418 of the transfer element 416 carries the biofluid collection element 420 which is shown in the form of a rectangular and longitudinal absorbent pad.

[0118] In one embodiment, and as shown in Figure 26A, the collection pad 420 is positioned within the oblong opening 430 at the front portion 418 of the transferring element 416 and is connected to the arms 432’ and 432” via connecting elements 442’, 442”. The collection pad 422 includes an upper part 422i upwardly extending above the transferring element 416 and a lower part 422ii downwardly extending beneath the transferring element 416. The foregoing example may provide greater sample collection.

[0119] In one embodiment and as exemplified in Figure 26A, the front portion 418 of the transferring element 416 includes a floor 444 integral to the lateral arms432’ and 434” for positioning the absorbent pad 420 thereon to maintain it in position. In an embodiment, the floor 444 may be shorter in length than the absorbent pad 422 to provide for a rear leading edge portion 446 (see Figure 29) of the pad 422 to have its underside exposed via the oblong opening 430. The exposed edge 446 may assist dispensing more biofluid during compression as will be discussed below. In another embodiment, instead of an exposed edge, the floor 444 may include openings for allowing biofluid to be dispensed therethrough during compression.

[0120] In another embodiment, the floor 444 does not span between the arms 432’ and 432” and only provides inward support portions that extend into the oblong opening 430 or may also include narrow bridges between the arms 432’ and 432” with the remainder of the area of the front portion 418 between the arms 432’ and 432” being open. The collection pad 422 merely sits on top of the arms 432’ and 432” and any additional support portions therebetween without any part of the collection pad 422 extending further downwardly of the transferring element but exposing most of the pad 422 for collecting biofluid.

[0121] Turning back to Figure 25, the absorbent pad 422 is maintained in position by holding hook elements 448 extending from the lateral arms 432’ and 432” and the front arcuate end 436 of the front portion 418 to engage the sides 450 and the top surface 452 of the absorbent pad 424. As such, the holding elements 448 keep the absorbent pad 422 in place during sample collection.

[0122] The second body part 428 defines a flat contiguous piece of material 454 without any openings that protects the testing area as will be further described below and defines a rear end 456 thereof with outwardly flaring wings 458’ and 458” and a central connecting tab 460 for being fitted within the slot 462 of the gripping disc 428 for connection therewith.

[0123] The housing 402 comprises an upper and lower parts or sheaths 464 and 466 that are snapped together. The upper part 466 comprises the front end 404A of the housing 402 which defines the front inlet opening 412A which is in the form of an oblong aperture circumscribed by a front wall 468. The opening 412A is configured and sized so as to allow the front portion 418 and the absorbent pad 422 including any externally protruding portion of the first body part 426 of the transfer element 416 to be inserted therethrough without any interference as shown in Figures 26A and 26B.

[0124] The lower part 468 defines a front end 470 that is snapped fitted behind a chin 472 defined by the front end 404A of the upper part. The upper and lower parts 464 and 466 have respective curved lateral edges (474’, 474”) (476’, 476”) that when snapped fitted define the lateral surfaces 410’ and 410” of the housing 402.

[0125] The respective rear ends 478 and 480 of each part 464 and 466 are inwardly curved to provide the inwardly curved rear end 404B when adjoined which defines the rear opening 412B in the form of a slit that allows a clearance space for the second body part 428 of the transfer element 416 to move therethrough without any interference. The rear slit 412B is circumscribed by a rear inwardly curved wall 482 (see Figure 28) which is complementarily configured to the circular peripheral wall 484 (see Figure 29) of the disc 424 and provides for docking the disc 424 thereon when the transfer element 416 is in fully outwardly protruding position as shown in Figure 23 for example.

[0126] With reference to Figures 26A and 26B, the inner passage 414 is delimited by a top wall 486, lateral side walls 488’ and 488” and a bottom wall 490 (see also Figure 25). The upper part 464 includes guides 492’ and 492” downwardly extending from the top wall 486 to slidably engage the top surfaces 494’ and 494”(see Figure 23) of the lateral arms 432’ and 432”. The lower part 464 includes guides 496’ and 496” upwardly extending from the bottom wall 490 to slidably engage the bottom surfaces 498’ and 498” of the lateral arms 432’ and 432”. In this way, the front part 426 of the transferring element 416 is maintained in position between the top guides 492’, 492” and the bottom guides 496’ and 468” to maintain the pad 422 in position during inward linear movement as provided herein.

[0127] With particular reference to Figure 25, the device 400 comprises a testing element 500 such as a LFA strip. In one non-limiting illustrative embodiment, the LFA strip 500 comprises the lateral flow array device described in United States Provisional Patent Application Serial Number 63 / 667,547 filed on July 3, 2024 and incorporated herein by reference in its entirety. The device 500 comprises a backing 502 defining an upstream end 504A and an opposite downstream end 504B. An upstream pad element 506 is mounted on the backing 502 from the upstream end 504B and extending downstream thereon. A testing area 508 is positioned downstream the upstream pad element 506 and includes detection lines 510 (such as test lines and / or control lines). Finally, a downstream pad element 512 is positioned downstream the testing area 508 and runs to the downstream end 504B.

[0128] The testing element 500 is positioned on the bottom wall or floor 490 of the housing 402. The testing element 500 is positioned between support elements extending upwardly from the floor 490. These support elements include longitudinal abutment elements 512’ and 512” providing a space therebetween for the testing element 500 which is positioned on first guide supports 514’ and 514”running along a length of the floor 492 and spacing the testing element 500 from the floor 492. Referencing both Figures 25 and 27, three additional pairs support elements (516’ and 516”) run along a width of the floor 490 at three areas along the length of the floor 490 for maintaining the testing element 500 in position therebetween. As shown in Figure 27, the support elements 516’ and 516” alsohave top edges to maintain the transferring element 416 in position as it slides thereon during linear movement. Moreover, and turning back to Figure 25, in addition to support guides 514’, 514”, the testing element 500 rests on an additional support structures 518 upwardly extending from the floor 492. These supports or spacers 514’, 514” and 518 maintain a space between the testing element 500 and the floor 490 so that the testing element 500 does not get saturated or flooded by excess biofluid.

[0129] With reference to Figures 28 to 31 , the device 400 will now be described in operation. At Figure 28, the transferring element 416 is in its most outwardly extending position with the disc 28 abutting the rear curved wall 482. The further forward movement of the transferring element 416 out of the opening 412B is stopped by the abutment of the disc 28 on wall 482 and the rear end 438 of the oblong opening 430 abutting the compressor and stopper element 440 downwardly extending from the top wall 486.

[0130] The collection element 422 collects biofluid and the user grips the disc 424 pulling the first body part 426 of the transferring element 416 inwardly with the collection element 422 moving into the passage 414 as shown in Figure 29 as the second body part 428 is moved outwardly of rear opening 412B. The inward movement of the collection element 422 is stopped by a compression element and stopper element 440 downwardly extending from the top wall 486 into the oblong opening 430.

[0131] As shown in Figures 30 and 31 , the user continues pulling on the disc 424 and further moving the collection element 422 inwardly onto the compressor stopper 440 thereby compressing the collection element 422 against the compressor stopper 440 and causing it to release the collected biofluid therefrom. As the collection pad 422 is compressed against compression element 440 thebiofluid 520 is released onto an area 522 of the floor 490 of the housing 402. The testing element 500 is adjacent the area 522 and as such biofluid flows thereto and is absorbed by the upstream absorption pad 504. The compression element 440 also acts as a spacer between the absorption pad 504 and the collection pad 422 to avoid contact therebetween which may result in biofluid backflow.

[0132] With reference to Figures, 25 and 26B, a central rib support 524 upwardly extending from the floor 490 and being directly adjacent the opening 412A is slidably engaged by the collection element 422 and / or the front portion 418 (including the floor 444) to maintain the collection element 420 upwardly spaced apart from area 522 so as not to come into contact with the floor 490 or with the testing element 500 thereby avoiding backflow of the biofluid. In an embodiment, a portion of the testing element 500 extends into area 522 for collection of released biofluid.

[0133] Indeed, the testing element 500 is so positioned within the housing 402 to collect biofluid from the collection element 424 when released. As such, it could be in the area 522, in proximity to the area 522, adjacent to the area 522, beneath the compression element 440, in proximity to the compression element 440 or adjacent to the compression element 440 to give but a few non-limiting examples that provide a positioning of the testing element convenient for released biofluid collection.

[0134] Turning to Figures 25 and 31 , when the user has fully rearwardly extended, the collection pad 420 is compressed at is maximum and if released will re-expand to its original shape, this is why in order to maintain the maximum compression, the transferring element 416 must be maintained in the fully rearward position of Figure 31 . As such, lateral wings 526’ and 526” at the junction area 528 between the first and second bodies 430, 432 are provided to be respectivelyclipped clipping elements or ribs 530’ and 530” respectively so as to be secured into place against the re-expansion force of the collection pad 424. One would need additional force to unclip the wings 526’, 526” from the ribs 530’, 530”.

[0135] With reference to Figures 23-25 and 29-31 , the top surface 406 of the housing 402 includes a display window 532 conveniently positioned above the testing area 508 of the testing element 500. When the transferring element 416 is outwardly extending from the front opening 412A as in the initial position in Figure 28, the material 454 of the second body part 428 covers the testing area 508 protecting this area and the detection lines 510 from contamination.

[0136] When the transferring element 416 is in the fully retracted position as in Figure 31 , the oblong opening 430 provides for the testing area 508 to be visible via the display window 532. The display window 532 may be an opening or include transparent material.

[0137] In an embodiment, the test results shown via the display window 532 are captured by an assay result image capturing and analysis system or method as described for example in United States Provisional Patent Application Serial Number 63 / 667,453 filed on July 3, 2024 and incorporated herein by reference in its entirety.

[0138] In an embodiment and with reference to Figure 23, the top surface 406 of the housing 402 includes an area 534 which can be engraved or which can provide a space for markings such as QR code and the like.

[0139] The various features described herein can be combined in a variety of ways within the context of the present disclosure so as to provide still other embodiments. As such, the embodiments are not mutually exclusive. Moreover, the embodiments discussed herein need not include all of the features and elementsillustrated and / or described and thus partial combinations of features can also be contemplated. Furthermore, embodiments with less features than those described can also be contemplated. It is to be understood that the present disclosure is not limited in its application to the details of construction and parts illustrated in the accompanying drawings and described hereinabove. The disclosure is capable of other embodiments and of being practiced in various ways. It is also to be understood that the phraseology or terminology used herein is for the purpose of description and not limitation. Hence, although the present disclosure has been provided hereinabove by way of non-restrictive illustrative embodiments thereof, it can be modified, without departing from the scope, spirit and nature thereof and of the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A device for collecting and transferring biofluids for testing thereof, the device comprising: a housing defining upstream and downstream ends thereof and a passage therebetween, an opening formed at the upstream end in fluid communication with the passage; a transfer element movably connected to the housing along the passage and comprising an upstream portion thereof for outwardly protruding from the upstream opening; a collection element positioned at the upstream portion of the transfer element for collecting a biofluid; and at least one compression element positioned along the passage for compressing the collection element when engaged thereby to release the collected biofluid; wherein imparting a movement to the transfer element in a direction from the upstream end towards the downstream end moves the upstream portion with the collection element and collected biofluid into the housing via the upstream opening providing engagement of the collection element by the at least one compression element for compression thereof and concurrent release of the biofluid therefrom for testing thereof within the housing.

2. A device according to any one of claims 1 to 6, wherein the housing comprises a display for displaying test results produced by the testing.

3. A device according to claim 2, wherein the display provides for displaying a movement position of the transfer element.

4. A device according to claim 1 , further comprising a testing element positioned within the housing to receive the biofluid released from the collection element.

5. A device according to claim 1 , further comprising at least one testing element for being positioned within the housing to receive the biofluid released from the collection element.

6. A device according to any one of claims 4 or 5, wherein the testing element is positioned beneath and at least in proximity of the collection element during compression thereof.

7. A device according to any one of claims 4 or 5, wherein the testing element is positioned to interface with the collection element during compression thereof.

8. A device according to any one of claims 4 or 5, wherein the released biofluid is released onto an area of the housing, the testing element being adjacent the area in order to receive the released biofluid.

9. A device according to any one of claims 4 to 8, wherein the testing element comprises a testing area thereof for producing test results, the housing comprising a display for displaying the test results.

10. A device according to any one of claims 4 to 9, wherein the testing element comprises a lateral flow array.11 . A device according to any one of claims 1 , wherein the housing comprises a downstream opening at the downstream end, the transfer element comprising a downstream portion thereof outwardly protruding from the downstream opening.

12. A device according to claim 11 , wherein the downstream portion thereof provides for a user to grip in order to impart the movement to the transfer element.

13. A device according to claim 12, wherein the transfer element comprises break lines for breaking the downstream end of the transfer element at a predetermined pulling force thereof.

14. A device according to any one of claims 11 to 13, wherein the transfer element comprises a longitudinal configuration.

15. A device according to claim any one of claims 11 to 14, wherein the movement of the transfer element is a linear movement.

16. A device according to any one of claims 11 to 15, wherein the transfer element comprises a body portion thereof providing a clearance opening for the at least one compression element to protrude therethrough and aloe the engagement of the compression element by the collection.

17. A device according to claim 11 to 16, further comprising a testing element positioned within the housing to receive the biofluid released from the collection element, the testing element comprising a testing area for producingtest results, the housing comprising a display for displaying the test results, the clearance opening providing for the test results to be visible therethrough.

18. A device according to claim 17, wherein the transferring element comprises another body portion thereof for concealing the test area when the the upstream portion outwardly protrudes from the upstream opening.

19. A device according to any one of claims 1 to 18, wherein the transferring element and the housing comprise mutually engaging elements to snap the transferring element in position when moved in the downstream direction against a resistance force to compression by the collection element.

20. A device according to any one of claims 1 to 19, wherein the transfer element and the housing element comprise mutually abutting elements thereof for stopping the movement of the transfer element at a predetermined position.21 . A device according to claim 1 , wherein the housing comprises top and bottom portions that are removably assembled.

22. A device according to claim 21 , wherein the top and bottom portions are movably connected for relative movement to each other.

23. A device according to claim 22, wherein the bottom portion defines an inner side thereof comprising the transfer element.

24. A device according to claim 1 , wherein the device comprises a movement imparting element connected to the transfer element for being actuatedto impart the movement to the transfer element.

25. A device according to any one of claims 1 to 24, wherein the housing and the transfer element comprise respective longitudinal configurations.

26. A device according to claim 1 , wherein the housing and the transfer element comprise respective circular-like configurations.

27. A device according to any one of claims 1 to 26, wherein the collection element comprises an absorptive pad.

28. A device according to any one of claims 1 to 27, wherein the at least one compression element provides for compressing the collection element along a length thereof.

29. A device according to any one of claims 1 to 28, wherein the at least one compression element provides for compressing the collection element along a height thereof.

30. A device according to any one of claims 1 to 29, wherein the at least one compression elements provide for stopping the movement of the transfer element when compressing the collection element.

31. A kit for collecting, transferring, and testing of biofluids comprising: the device of any one of claims 1 to 30; and a reader for reading test results provided by the testing.

32. A device for collecting and transferring biofluids for testing thereof, the device comprising: a housing defining a longitudinal passage therein and front and rear openings at respective front end and rear ends of the housing in fluid communication with the longitudinal passage, the housing enclosing a testing element therein; a transfer element movably positioned within the housing along the longitudinal passage and comprising front and rear portions thereof, respectively outwardly protruding from the front and rear openings; a collection element positioned at the front portion of the transfer element for collecting a biofluid; and at least one compression element positioned within the housing for compressing the collection element when engaged thereby to release the collected biofluid; wherein imparting a linear movement to the transfer element in a direction from the front end towards the rear end moves the front portion with the collection element into the housing via the front opening providing engagement of the collection element by the at least one compression elements for compression thereof and concurrent release of the biofluid to the testing element for testing and providing test results.

33. A device according to claim 30, wherein the housing comprises a display for displaying the test results provided by the testing element.

34. A method for collecting, transferring, and testing biofluids, the method comprising: collecting a biofluid with a collection element positioned on a transfer element movably connected to a housing defining a passage, the collection element outwardly extending from the housing;SUBSTITUTE SHEET (RULE 26)imparting a contiguous movement to the transfer element along the passage for inserting the collection element and collected biofluid into the housing; simultaneously with the contiguous movement, engaging the collection element with at least one compression element within the housing for compression of the collection element providing concurrent releasing of the biofluid therefrom; capturing the biofluid upon release thereof from the collection element with a testing element in the housing for testing of the biofluid and providing test results.

35. A method according to claim 34, wherein the contiguous movement is a linear movement.

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