Device and method for biological fluid sample collection and transfer

Abstract

A device for collecting and transferring a biological fluid for detection includes a housing defining an upstream end and a downstream end and a passage therebetween. The transfer element is movably connected to the housing along the channel and includes an upstream portion thereof for projecting outwardly from an upstream opening formed at an upstream end of the housing. A collection element at an upstream portion of the transfer element collects the biological fluid. A compression element along the channel is used to compress the collection element when engaged, thereby releasing the collected biological fluid. Movement of the transfer element in a direction from the upstream end towards the downstream end causes the upstream portion and the collection element and the collected biological fluid to move into the housing through an upstream opening providing engagement of the collection element with the at least one compression element to compress the collection element, and at the same time release the biological fluid from the collection element to detect it within the housing.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 527,680, filed July 19, 2023, and incorporated herein by reference in its entirety. Technical Field

[0002] This disclosure generally relates to the collection, detection, and analysis of bodily fluid (biofluid) samples. More specifically, but not exclusively, this disclosure relates to a biofluid sample (e.g., saliva) collection and transfer apparatus and method for the detection and analysis of such samples. Background Technology

[0003] Biofluid sample collection (such as saliva sampling) is a common step in many analytical tests. This spans many technical fields, particularly in medical diagnostic testing. Human fluid samples can consist of various fluid types (saliva, blood, urine, mucus, etc.). Sample collection is performed in various ways by healthcare professionals who collect samples from patients or by patients provided with the necessary tools to obtain samples themselves. This can be done using swabs, containers, or other similar instruments. For example, patients may be instructed to collect urine in a container, which can then be transported to a laboratory for analysis. Samples are typically analyzed using laboratory-grade tools and equipment, which are often expensive and difficult to obtain. Laypeople often lack access to specialized equipment and need to visit a clinic or hospital to receive fluid sample testing and analysis results.

[0004] Point-of-care medicine is increasing access to medical results for the general public. This field focuses on simple medical tests that can be performed by laypeople. Home-based liquid sample collection devices will reduce the cost and wait time for sample analysis, and further reduce the risk of sample contamination during transportation and storage, which is typically required for standard laboratory testing methods.

[0005] A common approach to point-of-care medicine is through lateral flow arrays (LFAs), a known technology for detecting the presence of specific reactants in the body (i.e., Covid-19 test strips, pregnancy tests, etc.). These tests are inexpensive to manufacture, can be customized for very specific testing purposes, and do not require large liquid samples to produce results.

[0006] The main problem with these tests is that they are fragile and must be protected from environmental factors, and the liquid sample dispensed onto the test strip must be within a precise volume range to avoid flooding the test strip and invalidating the test. Summary of the Invention

[0007] Purpose One object of this disclosure is to provide an apparatus for collecting, transferring and detecting biological fluids.

[0008] One object of this disclosure is to provide a kit for collecting, transferring, and detecting biological fluids.

[0009] One object of this disclosure is to provide a method for collecting, transferring, and detecting biological fluids.

[0010] summary According to one aspect of this disclosure, an apparatus is provided for collecting and transferring a biological fluid for detection therefrom, the apparatus comprising: a housing defining an upstream end and a downstream end therefrom and a channel therebetween, an opening formed at the upstream end in fluid communication with the channel; a transfer element movably connected to the housing along the channel and including an upstream portion for projecting outward from the upstream opening; a collection element positioned at the upstream portion of the transfer element for collecting the biological fluid; and at least one compression element positioned along the channel for compressing the collection element upon engagement, thereby releasing the collected biological fluid; wherein movement is transmitted to the transfer element in a direction from the upstream end toward the downstream end, causing the upstream portion, the collection element, and the collected biological fluid to move together through the upstream opening into the housing, the upstream opening providing engagement of the collection element with the at least one compression element for compressing the collection element and simultaneously releasing the biological fluid therefrom for detection within the housing.

[0011] In one embodiment, the housing includes a display for displaying detection results generated by the detection. In another embodiment, the display is configured to show the movement position of the transfer element.

[0012] In one embodiment, the device further includes a detection element located within the housing to receive biofluid released from the collection element.

[0013] In one embodiment, the device further includes at least one detection element positioned within the housing to receive biofluid released from the collection element.

[0014] In one embodiment, the detection element is positioned below and at least close to the collection element during the compression of the collection element.

[0015] In one implementation, the detection element is positioned to engage with the collection element during compression of the collection element.

[0016] In one embodiment, the released biofluid is released onto a region of the housing, with a detection element adjacent to that region to receive the released biofluid.

[0017] In one embodiment, the detection element includes a detection area for generating a detection result, and the housing includes a display for displaying the detection result. In another embodiment, the detection element includes a sideflow array.

[0018] In one embodiment, the housing includes a downstream opening at a downstream end, and the transfer element includes a downstream portion that projects outwardly from the downstream opening. In one embodiment, the downstream portion allows a user to grip it to transmit motion to the transfer element. In one embodiment, the transfer element includes a break line for breaking the downstream end of the transfer element under a predetermined tensile force.

[0019] In one embodiment, the transfer element includes a longitudinal configuration. In another embodiment, the movement of the transfer element is linear.

[0020] In one embodiment, the transfer element includes a body portion that provides a gap opening for at least one compression element to protrude therefrom and allow engagement of a collection element with the compression element. In one embodiment, a detection element is positioned within a housing to receive biofluid released from the collection element; the detection element includes a detection area for generating a detection result, and the housing includes a display for displaying the detection result, through which the gap opening makes the detection result visible. In one embodiment, the transfer element includes another body portion for concealing the detection area when an upstream portion protrudes outward from an upstream opening.

[0021] In one embodiment, the transfer element and the housing include mutually engaging elements to hold the transfer element in place while moving in a downstream direction against compressive resistance of the collection element.

[0022] In one embodiment, the transfer element and housing element include adjacent elements for stopping the movement of the transfer element at a predetermined position.

[0023] In one embodiment, the housing includes a detachably assembled top portion and a bottom portion. In one embodiment, the top and bottom portions are movably connected to each other for relative movement. In one embodiment, the bottom portion defines an inner side that includes a transfer element.

[0024] In one embodiment, the device includes a motion transmission element connected to a transfer element for being actuated to transmit motion to the transfer element.

[0025] In one embodiment, the housing and the transfer element each include a longitudinal configuration.

[0026] In one embodiment, the housing and the transfer element each have a circular configuration.

[0027] In one embodiment, the collecting element includes an absorbent pad.

[0028] In one embodiment, at least one compression element is used to compress the collecting element along its length.

[0029] In one embodiment, at least one compression element is used to compress the collecting element along its height.

[0030] In one embodiment, at least one compression element is used to stop the movement of the transfer element when the collection element is compressed.

[0031] According to one aspect of this disclosure, a kit for collecting, transferring, and detecting biological fluids is provided, comprising: means as described in any of the preceding paragraphs; and a reader for reading detection results provided by the detection.

[0032] According to one aspect of this disclosure, an apparatus is provided for collecting and transferring biological fluid for detection therein, the apparatus comprising: a housing defining a longitudinal channel therein and a front opening and a rear opening in fluid communication with the longitudinal channel at respective front and rear ends of the housing, the housing encapsulating a detection element therein; a transfer element movably positioned within the housing along the longitudinal channel and including a front portion and a rear portion projecting outward from the front opening and the rear opening, respectively; a collection element positioned at the front portion of the transfer element for collecting the biological fluid; and at least one compression element positioned within the housing for compressing the collection element upon engagement, thereby releasing the collected biological fluid; wherein linear motion is transmitted to the transfer element in a direction from the front end toward the rear end, such that the front portion moves together with the collection element into the housing via the front opening, the front opening providing engagement of the collection element with the at least one compression element for compression, and simultaneously releasing the biological fluid to the detection element for detection and providing a detection result.

[0033] In one embodiment, the housing includes a display for displaying detection results provided by the detection element.

[0034] According to one aspect of this disclosure, a method for collecting, transferring, and detecting biological fluid is provided, the method comprising: collecting biological fluid using a collecting element positioned on a transferring element movably connected to a housing defining a channel, the collecting element extending outward from the housing; transmitting continuous motion along the channel to the transferring element for inserting the collecting element and the collected biological fluid into the housing; simultaneously engaging the collecting element with at least one compression element within the housing using the continuous motion for compressing the collecting element and releasing the biological fluid therefrom; and capturing the biological fluid using a detection element within the housing as the biological fluid is released from the collecting element for detecting the biological fluid and providing a detection result.

[0035] In one implementation, continuous motion is linear motion.

[0036] The apparatus, kit, and method disclosed herein provide a series of steps for collecting biological fluid on a collection element, releasing the collected biological fluid by compressing the collection element, capturing the released biological fluid on a detection element, detecting the biological fluid, and displaying the detection results.

[0037] Other objects, advantages, and features of this disclosure will become more apparent after reading the following non-limiting description of illustrative embodiments of the present disclosure, which are given by way of example only with reference to the accompanying drawings. Attached Figure Description

[0038] In the attached diagram: Figure 1 These are top and side perspective views of a device for collecting, transferring, and detecting biological fluid at a biological fluid collection position, according to a non-limiting illustrative embodiment of the present disclosure. Figure 2 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 1 Top and side perspective views of the device at the biofluid transfer position; Figure 3 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 1 Top and side perspective views of the device at the biofluid detection position; Figure 4 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 1 Top and side perspective views of the device in another biofluid detection position; Figure 5 It is a non-limiting illustrative embodiment of this disclosure positioned within the reader. Figure 1 A perspective view of the device; Figure 6 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 1 Top and side perspective views of the bottom housing portion of the device; Figure 7 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 1 Bottom and side perspective views of the bottom housing of the device; Figure 8 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 1 Top and side perspective views of the top housing portion of the device; Figure 9 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 1The device's top housing portion is viewed from below and from the side. Figure 10 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 1 A cross-sectional view of the device; Figure 11 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 1 A top perspective view of the transfer element of the device; Figure 12 Installation according to a non-limiting illustrative embodiment of this disclosure Figure 5 The bottom shell part Figure 11 Top and side perspective views of the transfer element; Figure 13 These are top and side perspective views of an apparatus for collecting, transferring, and detecting biological fluids according to another non-limiting illustrative embodiment of this disclosure; Figure 14 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 13 The device's top housing portion is viewed from below and from the side. Figure 15 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 13 Top and side perspective views of the bottom housing portion of the device; Figure 16 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 13 A cross-sectional view of the device; Figure 17 These are top and side perspective views of an apparatus for collecting, transferring, and detecting biological fluids according to another non-limiting illustrative embodiment of this disclosure; Figure 18 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 17 The device is viewed from below and from the side. Figure 19 This is a top and side perspective view of an apparatus for collecting, transferring, and detecting biological fluid at a biological fluid collection position, according to another non-limiting illustrative embodiment of this disclosure. Figure 20 This is a non-limiting illustrative embodiment of the present disclosure located at a biofluid detection position. Figure 19 Top and side perspective views of the device; Figure 21 These are top and side perspective views of an apparatus for collecting, transferring, and detecting biological fluids according to yet another non-limiting illustrative embodiment of this disclosure; Figure 22These are top and side perspective views of an apparatus for collecting, transferring, and detecting biological fluids according to another non-limiting illustrative embodiment of this disclosure; Figure 23 This is a top and side perspective view of an apparatus for collecting, transferring, and detecting biological fluid at a biological fluid collection position, according to another non-limiting illustrative embodiment of this disclosure. Figure 24 This is a non-limiting illustrative embodiment of the present disclosure located at the biofluid transfer site. Figure 23 Top and side perspective views of the device; Figure 25 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 23 An exploded perspective view of the device; Figure 26A This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 23 The device is shown in front, top, and side perspective views. Figure 26B This is according to another non-limiting illustrative embodiment of the present disclosure. Figure 23 The device is shown in front, top, and side perspective views. Figure 27 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 23 The device in Figure 26A and Figure 26B Another sectional perspective view of the downstream section, including front, top, and side views; Figure 28 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 23 Cross-sectional side and top perspective views of the device at the biofluid collection location; Figure 29 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 23 The apparatus in cross-sectional side and top perspective views at the initial transfer position; Figure 30 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 23 Cross-sectional side and top perspective views of the device in the transfer and compression positions; and Figure 31 This is based on a non-limiting illustrative embodiment of the present disclosure. Figure 23 The apparatus in cross-sectional side and top perspective views in the transferred and fully compressed positions. Detailed Implementation

[0039] Generally speaking, and according to one aspect of this disclosure, an apparatus for collecting and transferring biological fluid for detection is provided. The apparatus includes a housing defining an upstream end and a downstream end and a channel therebetween. An opening communicating with the channel is formed at the upstream end. A transfer element is movably connected to the housing along the channel and includes an upstream portion for projecting outward from the upstream opening. A collection element is positioned at the upstream portion of the transfer element for collecting the biological fluid. At least one compression element is positioned along the channel for compressing the collection element upon engagement, thereby releasing the collected biological fluid. The transfer element moves in a direction from the upstream end toward the downstream end such that the upstream portion, together with the collection element and the collected biological fluid, moves into the housing through the upstream opening, which provides engagement of the collection element with the at least one compression element that compresses the collection element and simultaneously releases the biological fluid therefrom for detection within the housing.

[0040] In one embodiment, the housing includes a display for showing the detection results generated by the detection. In another embodiment, the display is used to show the movement position of the transfer element.

[0041] In one embodiment, the device further includes a detection element located within the housing to receive biofluid released from the collection element.

[0042] According to one aspect of this disclosure, an apparatus for collecting and transferring biological fluid for detection is provided. The apparatus includes a housing defining a longitudinal channel therein, and a front opening and a rear opening located at respective front and rear ends of the housing, communicating with the longitudinal channel. A detection element is encapsulated within the housing. A transfer element is movably positioned within the housing along the longitudinal channel and includes a front portion and a rear portion projecting outward from the front and rear openings, respectively. A collection element is positioned at the front portion of the transfer element for collecting the biological fluid. At least one compression element is positioned within the housing for compressing the collection element upon engagement, thereby releasing the collected biological fluid. Linear movement of the transfer element in a direction from the front end toward the rear end causes the front portion, together with the collection element, to move into the housing through the front opening, which provides engagement of the collection element with the at least one compression element for compression and simultaneous release of the biological fluid to the detection element for detection and providing a detection result.

[0043] In one embodiment, the housing includes a display for showing the detection results provided by the detection element.

[0044] According to one aspect of this disclosure, a method for collecting, transferring, and detecting biological fluid is provided. The biological fluid is collected using a collecting element positioned on a transferring element, the transferring element being movably connected to a housing defining a channel. The collecting element extends outward from the housing. Continuous movement of the transferring element along the channel inserts the collecting element and the collected biological fluid into the housing, simultaneously engaging the collecting element with at least one compression element within the housing to compress the collecting element and simultaneously release the biological fluid. Upon release, the biological fluid is captured by a detection element within the housing for detection and to provide a detection result.

[0045] Reference Figures 1 to 4 The present invention illustrates an apparatus 10 for collecting biological fluid samples from a subject and transferring such biological fluid samples therein for detection / analysis.

[0046] Device 10 includes a housing 12 having a generally longitudinal body and defining an upstream or front end 14A and a downstream or rear end 14B, respectively, and a top surface 16 and a bottom surface 18 connected together by circumferential walls 17 therebetween (see Figure 7 The front end 14A and rear end 14B of the housing 12 define corresponding front opening 20A and rear opening 20B (see...). Figure 10 They are in fluid communication with the internal channel 50 (see...) Figure 10 The transfer element 22, which is in the form of a longitudinal body or a vertical strip, is movably positioned within the housing 12 and defines a front portion 24 that protrudes outward through a front opening 20A and a rear portion 26 that protrudes outward through a rear opening 20B.

[0047] The front portion 24 of the transfer element 22 carries a biofluid collection element 28 in a fixed position for collecting biofluid. In the non-limiting example shown here, the biofluid element 28 is an absorbent pad conveniently configured for collecting, for example, saliva samples. The rear portion 26 allows the user to pull the transfer element 22, thereby moving it at arrow A (see arrow 24). Figure 10 The transfer element is moved along a linear path within the channel 50 in the direction shown, thus moving the front portion 24 inwardly into the housing 12 through the inlet opening 20A. In the example shown here, the rear portion 26 includes a gripping ridge 30 for easy manual gripping.

[0048] exist Figure 1 In the middle, the front portion 24 is shown in its most outwardly protruding position, where the absorbent pad 28 is fully exposed to receive a biofluid sample from the subject. Once the biofluid sample has been collected, the transfer element 22 is pulled, thereby moving the front portion 24 together with the absorbent pad 28 inwardly into the housing 12 through the inlet opening 20A, as... Figure 2 As shown, until the absorbent pad 28 has been completely transferred into the housing 12, as Figure 3As shown. When the user continues to pull on portion 26, portion 26 disconnects from the rest of the transfer element 22, thereby preventing any further inward movement of the absorbent pad 28, as... Figure 4 As shown. In fact, Figure 4 The device 10 is shown without any part protruding / extending outward from the housing 12.

[0049] As will be further described below, housing 12 contains the detection element (see Figure 10 Element 56), during the linear movement of transfer element 22 (as indicated by arrow A), absorbent pad 28 is compressed by a compression mechanism located within housing 12 (see element 56). Figure 10 The element 58 is compressed in contact with the detection element, thereby releasing the collected biological fluid onto the detection element. The detection results are displayed via a display 32 (e.g., an observation window) formed in the top surface 16 of the housing 12.

[0050] like Figure 5 As shown, device 10 can be inserted into optical reader 34 to further read test results via display 32. For example, the detection element is a test strip that generates a result line displayed via display window 32 when collected saliva is received. Reader 34 reads the intensity of the line and determines, for example, the subject's hormone levels. In one example, reader 34 takes a photograph of the results displayed via display window 32 for analysis.

[0051] Therefore, the biological fluid sample can be collected by a portion 24 of the transfer element 22 and directly transferred to the detection element inside the housing 12 by a single linear motion of the transfer element 22, thereby compressing the collection element 28 inside the housing 12 along the linear motion, so that the biological fluid sample is simultaneously released onto the detection element to provide the detection results displayed via the display 32.

[0052] In one embodiment, housing 12 includes a bottom housing portion 36 (see...) Figure 6 and Figure 7 ) and top shell portion 38 (see Figure 8 and Figure 9 These components are assembled together to provide housing 12. In one embodiment, housing 12 is reusable, so device 10 can have multiple detection elements. A user can open housing 12 by disassembling said portions 36 and 38 and replace the used detection element with a new one. In one embodiment, housing 12 is for single use only and is therefore discarded after use. In one embodiment, housing 12 is sealed to prevent spills, leaks, or escape of biohazardous liquids.

[0053] like Figure 6As shown, the bottom housing portion 36 includes a cup-shaped body that defines a bottom base plate 40, which is surrounded by a circumferential wall portion 17' extending upward therefrom. The bottom base plate 40 is Figure 7 The opposite inner side of the bottom outer surface 18 is shown. In one embodiment, the bottom surface 18 includes a positioning element 42 for easy insertion into a reader (such as an optical reader 34).

[0054] Go to Figure 9 The top shell portion 38 is dome-shaped, and its top wall or ceiling 44 is... Figure 8 The top outer surface 16 is shown as the opposite inner side. The top wall 44 is surrounded by a circumferential wall portion 17” extending downward therefrom. The top circumferential wall portion 17” and the bottom circumferential wall portion 17’ are respectively connected together to form the circumferential wall 17, thereby assembling the top housing portion 38 and the bottom housing portion 36 respectively to form the housing 12. In one embodiment, the top circumferential wall portion 17” includes a snap-fit ​​insert 46 extending downward therefrom for snap-fitting into a corresponding groove 48 formed in the bottom circumferential wall 17’.

[0055] like Figure 6 As shown, the bottom circumferential wall portion 17' defines a front notch or recess 20A' at the front end 14A and a rear notch or recess 20B' at the rear end 14B. Accordingly, as Figure 9 As shown, the top circumferential wall portion 17” defines a front recess 20A” at the front end 14A and a rear recess 20B” at the rear end 14B. Therefore, when assembling the housing portions 36 and 38, adjacent front recesses 20A' and 20A” define a front opening 20A, and adjacent rear recesses 20B' and 20B” define a rear opening 20B. The front inlet opening 20A provides sufficient clearance for the absorbent pad 28 to enter the housing 12 at its maximum volume retention size without being structurally disturbed by the circumferential wall 17 surrounding the opening 20A, thereby allowing a sufficient amount of biofluid to be absorbed and transferred to the housing 12 for detection.

[0056] Reference Figure 10 When the portions 36 and 38 are assembled, the housing 12 defines an internal longitudinal cavity 50 in fluid communication with the front opening 20A and the rear opening 20B, which defines a longitudinal channel for the linear movement of the transfer element 22 in the direction indicated by arrow A.

[0057] Return to Figure 6 The bottom housing portion 36 includes a support structure 52 that extends upward from the bottom base plate 40 and defines a space 54 for receiving and holding a detection element in place on the bottom base plate 40. The detection element is, for example, a detection strip 56, and the detection strip 56 is, for example, an LFA strip (see...). Figure 10 ).

[0058] The housing 12 includes a compression mechanism 57 near its inlet opening 20A for compressing the absorbent pad 28 to release the absorbed biological fluid.

[0059] like Figure 6 As shown, the compression mechanism 57 includes spaced-apart, ramp-shaped bottom compression elements 58 that extend upward from the bottom plate 40 into the channel 50. (See reference...) Figure 7 The compression mechanism 57 also includes a pair of top compression elements 60 in the form of tabs, which extend downward from the top wall 44 into the channel 50. (Go to...) Figure 10 When the rear portion 26 is pulled outward through the opening 20B, the front portion 24, together with the absorbent pad 28, moves into the housing 12 through the opening 20A. At this point, the absorbent pad 28 engages with compression elements 58 and 60, which provide a gradually narrowing gap 51 between them, preventing the absorbent pad 28 from moving further along the channel 50. Therefore, the absorbent pad 28 is compressed between the top protrusion 60 and the bottom ramp 58, and shortens due to the blocking gap 51 when it is pulled in the direction indicated by arrow A. Thus, the absorbent pad 28 is compressed vertically (i.e., squeezed) and axially (i.e., shortened) to increase the amount of biofluid released.

[0060] In fact, the compression mechanism 57 acts as a limiter, restricting the linear movement of the transfer element 22, so that the stroke of the absorption pad 28 is within the sample collection portion 56' of the detection strip 56 located in the bottom housing portion 36 (see...). Figure 10 Stop above.

[0061] Go to Figure 11 The front portion 26 of the transfer element defines a frame 62 having an opening 63 for positioning the absorbent pad 28 passing through it. (See reference...) Figure 6 and Figure 10 The detection strip 56 is positioned below the transfer element 22 and the compression mechanism 56 so that it receives the released biofluid. When the absorbent pad 28 is compressed and has its exposed lower side provided by the opening 63, the biofluid overflows directly onto the detection strip 56.

[0062] In one implementation, the sample collection section 56' is positioned between the ramps 58 and held in place between the segments 59 of the support structure 52 (see...). Figure 6 The compressed absorbent pad 28 is positioned directly above the sample collection portion 56', thereby facilitating the release of biofluid that falls directly onto said portion 56'. In one embodiment and with reference to Figure 9 The top protrusion 60 is inclined, guiding the absorption pad 28 downwards closer to the detection strip 56 and centered towards its axis of symmetry. In one embodiment, and as in... Figure 6As shown, the bottom housing portion 36 includes a guide element 64 that extends upward from the base plate 40 and is positioned near the inlet opening 20A to help guide the absorbent pad 28 to the compression mechanism 56.

[0063] The biofluid is absorbed by the detection strip 56 and travels along the detection strip 56 toward the detection result portion 56'' (see Figure 10 As you proceed, the detection result is conveniently located at the bottom of window 32 for easy viewing. Go to... Figure 11 and Figure 12 The transfer element 22 provides an observation opening 65 to avoid obstructing the detection result portion 56''. In one embodiment, and as shown... Figure 8 As shown, an indicator 66 (including stickers, markings, etc.) is provided on the top surface 16 for recording, for example, unique information about a single housing.

[0064] In one embodiment and referring to Figure 9 A cantilever-shaped contact element 67, extending downward from the top wall 44 into the channel 50, engages the detection strip 56 on the base plate 40 within the space 54 to prevent movement of the detection strip 56 and to guide the flow of biological fluid through the detection strip 56. Figure 11 As shown, the contact element 67 engages with the detection strip 56 through the gap opening 68 provided by the transfer element 22.

[0065] In one embodiment and as in Figure 6 As shown, the support structure 52 includes a longitudinal frame 70 with circumferential walls 72 and support ribs 74 for nesting the test strip 56 thereon, slightly higher than the base plate 40. The frame 70 facilitates the suction of liquid stencils through the test strip 56 without causing sample buildup or submersion around the strip. Furthermore, the frame 70 serves as a structural and transport support for the test strip 56, preventing damage before and during use.

[0066] Now go to Figure 11 and Figure 12 The linear movement of the transfer element 22 is influenced by a wing-shaped abutment 76 extending laterally from it and a mating side barrier 78 extending inwardly from the inside of the wall portion 17' of the bottom housing portion 36 (see also...). Figure 6The limitations imposed by the rear portion 26 stop the linear movement of the transfer element 22 in the direction indicated by arrow A when the rear portion 26 is pulled. These measures prevent the rear portion 26 of the transfer element 22 from over-extending beyond the housing 12 and the front portion 24 from over-inserting into the housing 12. In one embodiment, the transfer element 22 includes a connector 80 that interconnects its lateral sides 82i and 82ii and provides them with structural integrity, as well as indicating to the user via a display window 34 the remaining distance of the linear movement of the transfer element through the housing 12. In one embodiment, the transfer element 22 also includes a tear line 84 that allows the user to remove excess material from the transfer element 22 when compression of the pad 28 is complete.

[0067] The front portion 24 of the transfer element 22 includes a support wall 86 surrounding the opening 63 to maintain the integrity of the absorbent pad 28 as it travels through the housing 12. The support wall 86 prevents the absorbent pad 28 from breaking upon contact with the housing 12, thereby allowing the absorbent pad 28 to enter the housing 12 for compression and preventing damage before compression.

[0068] In one embodiment, the material of the absorbent pad 28 is selectively chosen for its absorbency. A suitable material is capable of absorbing and releasing the correct amount of fluid for the detection strip 56 used within the device 10. In one embodiment, this material is compact when dry and expands upon contact with the biofluid sample, providing stability and durability during transport and storage of the device 10. In one embodiment, the amount of biofluid sample released from the absorbent pad 28 is from about 0.5 μL to about 500 μL of fluid.

[0069] Now go to Figures 13 to 16 The diagram shows a device 100 similar to device 10; therefore, for the sake of brevity only, the differences between them will be discussed in detail.

[0070] The device 100 includes a housing 112 through which a movable transfer element 122 is movably positioned. The transfer element 122 has 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 a collection element 128. After biological fluid collection, the collection element 124 moves linearly through the opening 120A (e.g., ...). Figure 16 (As indicated by arrow A) Move into housing 112 to engage compression mechanism 156.

[0071] Compression mechanism 156 includes, for example Figure 15 and Figure 16 The bottom compression element 158 ​​within the bottom housing portion 136 shown includes spaced-apart walls having a proximal ramp portion 158' and a distal track portion 158''. Figure 14As shown, the compression mechanism 156 also includes a top compression element 160 comprising a series of fins extending downward from the top housing portion 138. The pad 128 is compressed between the fins 160 and the spaced-out walls 158. The fins are flexible; during the movable engagement of the pad 128, one or more fins 160 may bend inward, but linear movement is ultimately prevented, thus stopping the pad 128 in a compressed state (vertical compression and horizontal shortening) to release the biofluid directly onto the detection strip beneath it.

[0072] The device disclosed optimizes the release of biological fluid samples from the collection element by eliminating the need for the user to identify the amount of sample to be dispensed onto the test strip. The collection element is autonomously compressed upon entering the device housing, and the fluid sample is dispensed onto the test strip through this travel motion.

[0073] The device components described herein can be made from any desired material. In one embodiment, the device is made of plastic material and manufactured using additive manufacturing or injection molding.

[0074] refer to Figure 17 and Figure 18 The diagram illustrates an apparatus 200 for collecting, transferring, and detecting biological fluids. The apparatus 200 includes a housing 202 defining an upstream end 204, a downstream end 206, and a channel 208 therebetween. An opening 210 is formed at the upstream end 204. A transfer element 212 is movably connected to the housing 202 and positioned along the channel 208. The transfer element 212 includes an upstream portion 214 configured to project outward from the opening 210. This upstream portion 214 carries a collection element (now shown) for collecting the biological fluid. The transfer element 212 moves from the upstream position to the downstream position, as indicated by arrow A. The transfer element 212 is moved by pushing a tab 216 projecting along the length of a longitudinal slot 218 along the direction of arrow A. The apparatus 200 includes a compression element (now shown) positioned along the channel 208 for compressing the collection element after the biological fluid has been collected, thereby releasing the biological fluid onto a detection element engaged with the compressed collection element, thus providing a detection result displayed via a display window 218.

[0075] Figure 19 and Figure 20A device 250 for collecting, transferring, and detecting biological fluids is shown. The device 250 includes a housing 252 defining an upstream end 254, a downstream end 256, and a channel 258 therebetween. An opening 260 is formed at the upstream end 254. The housing 252 defines lateral edges 262 and includes a top housing portion 264 and a bottom housing portion 266, which are slidably interconnected with each other along the lateral edges 262. Thus, the top housing portion 264 and the bottom housing portion 266 slide relative to each other. In other words, the bottom housing portion 266 slides along the top body 264, and the top body portion 264 slides relative to the bottom body portion 266.

[0076] The top portion 264 and the bottom portion 266 each have mutually engaging inner sides spaced apart, thereby defining a channel 268 formed within the housing 252. The inner side of the bottom housing portion 266 defines a transfer element 270, which can be moved by relative movement between portions 264 and 266. Therefore, the transfer element 270 is movably connected to the housing 252 along the channel 268 from the upstream end 254 to the downstream end 256 (as indicated by arrow A). The transfer element 270 has an upstream portion 272 that carries a collecting element 274. When the transfer element 270 is in… Figure 19 In the first position shown, by sliding the top portion 264 and the bottom portion 266 relative to each other, motion is transmitted to the transfer element 270 in the downstream direction (arrow A), thereby inserting the collection element 274 into the housing 252 through the opening 260 to compress the collection element (as previously described along the channel 268 through the compression element), thereby simultaneously releasing the collected biofluid onto the detection element (as previously described) positioned within the bottom housing portion 266 to provide detection results, which can be viewed through the display window 276 formed within the top housing portion.

[0077] Figure 21A device 300 for collecting, transferring, and detecting biological fluids is shown. The device 300 includes a housing 302 with a semi-circular configuration, defining an upstream end 304, a downstream end 306, and a channel 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 channel 308. A circular transfer element 314 is movably positioned along the channel 308 through the housing 302. The circular transfer element 314 has a portion 316 on which a collecting element 318 is mounted. This portion 316 is located outside the housing and upstream of the opening 310, thus forming an upstream outwardly projecting portion 316. The housing 302 and the transfer element 314 are movable relative to each other, thereby allowing the transfer element 314 to move in a direction from the upstream end 304 to the downstream end 306, as indicated by arrow B. In this manner and after the biological fluid is collected, the collection element 318 moves into the housing 302 via the opening 310, where it is compressed by a compression element (not shown) positioned within the housing 302 along the channel 308, thereby releasing the biological fluid onto a detection element (now shown) positioned within the housing 302 along the channel 308 to provide detection results displayed through a display window 320 formed in the housing 302.

[0078] Figure 22 A device 350 for collecting, transferring, and detecting biological fluids is shown. The device 350 includes a disc-shaped housing 352 defining a top surface 354, an opposing bottom surface 356, and a peripheral edge 358 therebetween. The disc 352 defines a slit portion 360 that defines a longitudinal opening 362 leading to a cavity 364 formed within the disc housing 352. A disc-shaped transfer element 366 is movably positioned within the cavity 364 of the housing 352. A central portion of the disc-shaped transfer element 366 is connected to a handle 368 that extends upward from the housing 352 via a top opening 370 for rotating the disc-shaped transfer element 366 within the housing 352. The handle 368 includes a rod 372 connected to the disc-shaped transfer element 366, with a knob 374 at its free end. Rod 372 defines the axis of rotation of disc transfer element 366, causing disc transfer element 366 to rotate in the direction indicated by arrow 376, which is an opening formed in housing 352, allowing the user to observe the rotation of disc 366 within disc 352.

[0079] A portion 378 of the disc-shaped transfer element 366 protrudes outward from the longitudinal opening 362. This portion 378 defines its outer edge portion 380, which moves along an inner edge portion 382 formed near the peripheral edge and defining a channel for the outer edge portion 380. The outer edge portion 380 carries a collecting element 383. The longitudinal opening 362 is defined by a mouth portion 384 defining opposing edges 386 and 388. The longitudinal opening defines its edge opening portions 390 and 392 at the respective mouth portions 386 and 388.

[0080] When a rotational motion is applied to the disc 366 in the direction of arrow 376, the outer edge portion 380 moves within the inner edge channel 382 in a direction from the mouth edge 386 to the mouth edge 386, thereby defining an upstream end and a downstream end having corresponding upstream edge opening portions 390 and downstream edge opening portions 392, respectively. Therefore, the collecting element 383 moves through the upstream opening 390 into the housing 352 to move along the channel 382, ​​thereby being compressed along the channel 382 within the housing 352 by a compression element (not shown) to release the collected biofluid to a detection element (not shown) along the channel and engaged with the compressed collecting element, providing a detection result, which is displayed via a display window 394 formed within the top surface 354 of the housing 352.

[0081] refer to Figures 23 to 31 The illustration shows an apparatus 400 for collecting biological fluid samples from a subject and transferring the biological fluid samples therein for detection / analysis.

[0082] Special Reference Figure 24 and 24 The device 400 includes a housing 402 having a generally longitudinal body and defining an upstream or front end 404A and a downstream or rear end 404B, respectively, and defining a top surface 406 and a bottom surface 408, respectively, which are curved toward each other to form lateral surfaces 410' and 410' (see Figures 26A-27 The front end 404A and rear end 404B of housing 402 define corresponding front opening 412A and rear opening 412B (see...). Figure 29 and Figure 31 ), they are related to internal channel 414 (see Figure 28-31 Fluid communication is maintained. The transfer element 416 is movably positioned within the housing 12 and defines a front portion 418 protruding outward via a front opening 412A and a rear portion 420 protruding outward via a rear opening 412B.

[0083] The front portion 418 of the transfer element 416 carries the biofluid collection element 422 in a fixed position for collecting biofluid samples (e.g., saliva). The rear portion 420 of the transfer element includes a clamping disc 424 that allows the user to pull the transfer element 416, thereby moving the transfer element 416 along a linear path within the channel 414 in the direction indicated by arrow A. Figures 29-31 ), and thus the front portion 418 and the collecting element 420 move together inward through the front inlet opening 412A into the housing 402 (e.g. Figure 29 (As shown).

[0084] Reference Figure 25 The transfer element 416 is in the form of a longitudinal body, including a first body portion 426 and a second body portion 428. The first body portion 426 defines an elongated elliptical opening 430, thereby providing a pair of lateral arms 432' and 434'', which are connected at the front end 436 and at the rear end 438 to the second body portion 428. The elongated elliptical opening 430 provides clearance space during the linear movement of the transfer element 416 so as not to interfere with the internal compression and stop element 440 (see...). Figures 28-31 This will be discussed further below.

[0085] As described 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.

[0086] In one embodiment and as Figure 26A As shown, the collection pad 420 is positioned within the elongated elliptical opening 430 at the front portion 418 of the transfer element 416 and is connected to the arms 432' and 432'' via connecting elements 442' and 442''. The collection pad 422 includes an upper portion 422i extending upward over the transfer element 416 and a lower portion 422ii extending downward below the transfer element 416. The above example can provide more sample collection.

[0087] In one embodiment and as Figure 26A As shown, the front portion 418 of the transfer element 416 includes a base plate 444 integral with the lateral arms 432' and 434'' for positioning the absorbent pad 420 thereon to hold it in place. In one embodiment, the length of the base plate 444 may be shorter than that of the absorbent pad 422, so that the rear leading edge portion 446 of the pad 422 (see...) Figure 29 The lower side of the base plate 444 is exposed through an elongated elliptical opening 430. The exposed edge 446 can help distribute more biofluid during compression, as will be discussed below. In another embodiment, the base plate 444 may include an opening instead of an exposed edge to allow biofluid to be distributed through the opening during compression.

[0088] In another embodiment, the base plate 444 does not span between arms 432' and 432'', providing only an inwardly supporting portion extending into the elongated elliptical opening 430, or may also include a narrow bridge between arms 432' and 432'', where the remaining area of ​​the front portion 418 between arms 432' and 432'' is open. The collection pad 422 is located only on top of arms 432' and 432'' and any additional supporting portions therebetween; no portion of the collection pad 422 extends further downward from the transfer element, but exposes the majority of the pad 422 for collecting biological fluid.

[0089] Return to Figure 25 The absorbent pad 422 is held in place by retaining hook elements 448 extending from the lateral arms 432' and 432'' for engaging the sides 450 and top surface 452 of the absorbent pad 424, and the front arcuate end 436 of the front portion 418. Thus, the retaining element 448 holds the absorbent pad 422 in place during sample collection.

[0090] The second body portion 428 defines a flat, continuous material piece 454 without any openings to protect the detection area (which will be described further below). The second body portion 428 defines its rear end 456, which has outwardly flared wings 458' and 458'' and a central connecting tab 460 for mounting within a slot 462 of the clamping disc 428 for connection thereto.

[0091] The housing 402 includes an upper portion or sheath 464 and a lower portion or sheath 466 that snap together. The upper portion 466 includes a front end 404A of the housing 402 that defines a front inlet opening 412A, which is in the form of an elongated elliptical aperture defined by a front wall 468. The opening 412A is configured and sized such that the front portion 418 and the absorbent pad 422 (including any external protrusions of the first body portion 426 of the transfer element 416) can be inserted therein without any interference, such as... Figure 26A and Figure 26B As shown.

[0092] The lower portion 468 defines a front end 470 that snaps onto the rear of a chin 472 defined by the front end 404A of the upper portion. The upper portion 464 and the lower portion 466 have corresponding curved lateral edges (474', 474'') (476', 476'') that define the lateral surfaces 410' and 410'' of the housing 402 when snapped together.

[0093] The respective rear ends 478 and 480 of each portion 464 and 466 are curved inward to provide an inwardly curved rear end 404B when abutted, which defines a rear opening 412B in the form of a slit, providing clearance space for the second body portion 428 of the transfer element 416 to move through the clearance space without any interference. The rear slit 412B is formed by a rearwardly curved wall 482 (see...). Figure 28 The rear inwardly curved wall is defined by the circular outer wall 484 of the disk 424 (see...). Figure 29 Complementary configuration, and mating disk 424 onto transfer element 416 when it is in the fully outwardly projecting position, for example, as Figure 23 As shown.

[0094] Reference Figure 26A and Figure 26B The internal passage 414 is defined by the top wall 486, the lateral side walls 488' and 488'', and the bottom wall 490 (see also...) Figure 25 The upper portion 464 includes guides 492' and 492'' extending downward from the top wall 486 to slidably engage the top surfaces 494' and 494'' of the lateral arms 432' and 432'' (see...). Figure 23 The lower portion 464 includes guides 496' and 496'' extending upward 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 portion 426 of the transfer element 416 is held in place between the top guides 492', 492'' and the bottom guides 496', 498'' to hold the pad 422 in place during inward linear movement as provided herein.

[0095] Special Reference Figure 25 The device 400 includes a detection element 500, such as an LFA strip. In a non-limiting illustrative embodiment, the LFA strip 500 includes the sideflow array device described in U.S. Provisional Patent Application Serial No. 63 / 667,547, filed July 3, 2024, the entire contents of which are incorporated herein by reference. The device 500 includes a pad 502 defining an upstream end 504A and an opposing downstream end 504B. An upstream pad element 506 is mounted on the pad 502 from the upstream end 504B and extends downstream thereon. A detection region 508 is located downstream of the upstream pad element 506 and includes detection lines 510 (e.g., test lines and / or control lines). Finally, a downstream pad element 512 is positioned downstream of the detection region 508 and extends to the downstream end 504B.

[0096] The detection element 500 is positioned on the bottom wall or base plate 490 of the housing 402. The detection element 500 is positioned between support elements extending upward from the base plate 490. These support elements include longitudinally abutting elements 512' and 512'', which provide space between them for the detection element 500 positioned on first guide supports 514' and 514'', which extend along the length of the base plate 492 and space the detection element 500 from the base plate 492. (Reference) Figure 25 and Figure 27 The additional three pairs of support elements (516' and 516'') extend along the width of the base plate 490 at three regions along the length of the base plate 490 to hold the detection element 500 in the proper position between them. Figure 27 As shown, support elements 516' and 516'' also have top edges to hold transfer element 416 in place when it slides on the top edges during linear movement. Furthermore, turning back... Figure 25 In addition to the support guides 514', 514'', the detection element 500 is placed on an additional support structure 518 extending upward from the base plate 492. These supports or spacers 514', 514'' and 518 maintain space between the detection element 500 and the base plate 490, so that the detection element 500 is not saturated or submerged by excessive biofluid.

[0097] Reference Figures 28 to 31 The device 400 will now be described in operation. Figure 28 In the middle, the transfer element 416 is in its most outwardly extended position, with the disc 28 abutting against the rear curved wall 482. Further forward movement of the transfer element 416 extending out of the opening 412B is stopped by the disc 28 abutting against the wall 482 and the rear end 438 of the elongated elliptical opening 430 abutting against the compression stop element 440 extending downward from the top wall 486.

[0098] The collecting element 422 collects the biological fluid. The user holds the tray 424 and pulls the first main body portion 426 of the transfer element 416 inward. The collecting element 422 moves into the channel 414, as shown. Figure 29 As shown, the second main body portion 428 moves outward from the rear opening 412B. The inward movement of the collecting element 422 is stopped by a compression element and a stop element 440 extending downward from the top wall 486 into the elongated elliptical opening 430.

[0099] like Figure 30 and Figure 31As shown, the user continues to pull the disc 424, further moving the collection element 422 inward onto the compression stop 440, thereby compressing the collection element 422 against the compression stop 440 and causing it to release the collected biofluid. As the collection pad 422 is compressed against the compression element 440, the biofluid 520 is released onto region 522 of the bottom plate 490 of the housing 402. The detection element 500 is adjacent to region 522, so the biofluid flows toward the detection element 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 prevent contact between them that could cause backflow of the biofluid.

[0100] refer to Figure 25 and Figure 26B A central rib support 524, extending upward from the base plate 490 and directly adjacent to the opening 412A, slidably engages with the collection element 422 and / or the front portion 418 (including the base plate 444) to keep the collection element 420 upwardly spaced from the region 522 to avoid contact with the base plate 490 or the detection element 500, thereby preventing backflow of the biofluid. In one embodiment, a portion of the detection element 500 extends into the region 522 for collecting released biofluid.

[0101] In practice, the detection element 500 is positioned within the housing 402 such that it collects the biofluid from the collection element 424 upon release. Thus, it can be located in region 522, near region 522, adjacent to region 522, below, near, or adjacent to the compression element 440, as given in several non-limiting examples, providing a convenient location for collecting the released biofluid.

[0102] Go to Figure 25 and Figure 31 When the user extends fully backward, the collection pad 420 is compressed to its limit; if released, it will expand back to its original shape. This is why, in order to maintain maximum compression, the transfer element 416 must remain in place. Figure 31 The wings 526' and 526'' at the joint area 528 between the first body 430 and the second body 432 are respectively configured to clamp the clamping elements or ribs 530' and 530'' to hold them in place against the re-expansion force of the collection pad 424. Additional force is required to release the wings 526' and 526'' from the ribs 530' and 530''.

[0103] Reference Figures 23-25 and Figures 29-31The top surface 406 of the housing 402 includes a display window 532, which is conveniently positioned above the detection area 508 of the detection element 500. When the transfer element 416 extends outward from the front opening 412A, as... Figure 28 In the initial position, the material 454 of the second main body 428 covers the detection area 508, protecting the area and the detection line 510 from contamination.

[0104] When the transfer element 416 is in such a state Figure 31 When fully retracted, the elongated elliptical opening 430 makes the detection area 508 visible through the display window 532. The display window 532 may be an opening or include transparent material.

[0105] In one embodiment, the test results displayed via display window 532 are captured by, for example, a laboratory result image capture and analysis system or method as described in U.S. Provisional Patent Application Serial No. 63 / 667,453, filed July 3, 2024, the entire contents of which are incorporated herein by reference.

[0106] In one implementation and reference Figure 23 The top surface 406 of the housing 402 includes a region 534, which can be engraved or provide space for markings such as QR codes.

[0107] The various features described herein can be combined in various ways within the context of this disclosure to provide other implementations. Therefore, these implementations are not mutually exclusive. Furthermore, the implementations discussed herein do not need to include all features and elements described and / or illustrated, and therefore partial combinations of features are also contemplated. Additionally, implementations with fewer features than those described are also contemplated. It should be understood that this disclosure is not limited in its application to the details of the constructions and components shown in the drawings and described above. This disclosure is capable of other implementations and can be carried out in various ways. It should also be understood that the wording or terminology used herein is for descriptive purposes only and not for limitation. Therefore, although this disclosure has been provided above by way of non-limiting illustrative embodiments, modifications may be made thereto without departing from the scope, spirit, and nature of this disclosure and the appended claims.

Claims

1. An apparatus for collecting and transferring biological fluids for detection thereon, the apparatus comprising: A shell that defines its upstream and downstream ends and the channel between them, with an opening formed at the upstream end that is in fluid communication with the channel; A transfer element, which is movably connected to the housing along a channel and includes its upstream portion for projecting outward from an upstream opening; A collection element, located upstream of the transfer element, is used to collect biological fluids; and At least one compression element, positioned along the channel, is used to compress the collection element upon engagement, thereby releasing the collected biological fluid; In this process, the transfer element is moved in a direction from the upstream end to the downstream end, causing the upstream portion, together with the collection element and the collected biofluid, to move into the housing through an upstream opening. The upstream opening provides engagement between the collection element and at least one compression element to compress the collection element and simultaneously release the biofluid from the collection element for detection within the housing.

2. The apparatus according to any one of claims 1 to 6, wherein the housing includes a display for displaying the detection results generated by the detection.

3. The apparatus according to claim 2, wherein the display is used to display the movement position of the transfer element.

4. The apparatus of claim 1 further includes a detection element located within the housing to receive biofluid released from the collection element.

5. The apparatus of claim 1 further comprises at least one detection element positioned within the housing to receive biofluid released from the collection element.

6. The apparatus according to any one of claims 4 or 5, wherein the detection element is positioned below and at least near the collection element during compression of the collection element.

7. The apparatus according to any one of claims 4 or 5, wherein the detection element is positioned to engage with the collection element during compression of the collection element.

8. The apparatus according to any one of claims 4 or 5, wherein the released biofluid is released onto a region of the housing, and a detection element is adjacent to said region to receive the released biofluid.

9. The apparatus according to any one of claims 4 to 8, wherein the detection element includes its detection area for generating a detection result, and the housing includes a display for displaying the detection result.

10. The apparatus according to any one of claims 4 to 9, wherein the detection element comprises a sideflow array.

11. The apparatus of claim 1, wherein the housing includes a downstream opening at a downstream end, and the transfer element includes a downstream portion of itself projecting outward from the downstream opening.

12. The apparatus of claim 11, wherein the downstream portion allows a user to grasp in order to transmit motion to the transfer element.

13. The apparatus of claim 12, wherein the transfer element includes a fracture line for breaking the downstream end of the transfer element under a predetermined tensile force.

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

15. The apparatus according to any one of claims 11 to 14, wherein the movement of the transfer element is linear.

16. The apparatus according to any one of claims 11 to 15, wherein the transfer element includes its body portion which provides a gap opening therefrom for at least one compression element and allows the compression element to engage with the collection element.

17. The apparatus of claims 11 to 16, further comprising a detection element positioned within the housing to receive biological fluid released from the collection element, the detection element including a detection area for generating a detection result, the housing including a display for displaying the detection result, the gap opening allowing the detection result to be seen therethrough.

18. The apparatus of claim 17, wherein the transfer element includes another body portion for shielding the detection area when the upstream portion protrudes outward from the upstream opening.

19. The apparatus according to any one of claims 1 to 18, wherein the transfer element and the housing include mutually engaging elements to engage the transfer element in a suitable position as the transfer element moves downstream against the resistance of the collecting element to compression.

20. The apparatus according to any one of claims 1 to 19, wherein the transfer element and the housing element include adjacent elements thereto for stopping the movement of the transfer element at a predetermined position.

21. The device of claim 1, wherein the housing comprises a detachably assembled top portion and a bottom portion.

22. The apparatus of claim 21, wherein the top portion and the bottom portion are movably connected to move relative to each other.

23. The device of claim 22, wherein the bottom portion defines the inner side of the transfer element.

24. The apparatus of claim 1, wherein the apparatus includes a motion transmission element connected to a transfer element for being actuated to transmit motion to the transfer element.

25. The apparatus according to any one of claims 1 to 24, wherein the housing and the transfer element each comprise a longitudinal configuration.

26. The device of claim 1, wherein the housing and the transfer element comprise corresponding circular configurations.

27. The apparatus according to any one of claims 1 to 26, wherein the collecting element comprises an absorbent pad.

28. The apparatus according to any one of claims 1 to 27, wherein at least one compression element is used to compress the collecting element along its length.

29. The apparatus according to any one of claims 1 to 28, wherein at least one compression element is used to compress the collecting element along the height of the collecting element.

30. The apparatus according to any one of claims 1 to 29, wherein at least one compression element is used to stop the movement of the transfer element when compressing the collection element.

31. A kit for collecting, transferring, and detecting biological fluids, comprising: The apparatus according to any one of claims 1 to 30; and A reader is used to read the detection results provided by the detection.

32. An apparatus for collecting and transferring biological fluids for detection thereon, the apparatus comprising: A housing that defines a longitudinal channel therein and a front opening and a rear opening at respective front and rear ends of the housing that are in fluid communication with the longitudinal channel, the housing enclosing the detection element therein; The transfer element is movably positioned within the housing along a longitudinal channel and includes a front portion and a rear portion that protrude outward from a front opening and a rear opening, respectively. A collection element, located at the front part of the transfer element, is used to collect biological fluids; and At least one compression element, positioned within the housing, is used to compress the collection element upon engagement, thereby releasing the collected biofluid; In this process, a linear motion is applied to the transfer element in a direction from the front end toward the rear end, which causes the front portion to move together with the collection element into the housing through a front opening. The front opening provides engagement between the collection element and at least one compression element for compressing the collection element and simultaneously releasing the biological fluid to the detection element for detection and providing detection results.

33. The apparatus of claim 30, wherein the housing includes a display for displaying detection results provided by the detection element.

34. A method for collecting, transferring, and detecting biological fluids, the method comprising: Biological fluids are collected using a collection element positioned on a transfer element, the transfer element being movably connected to a housing defining a channel, the collection element extending outward from the housing; Continuous motion is transmitted along the channel to the transfer element, which is used to insert the collection element and the collected biological fluid into the shell; During continuous motion, the collecting element is engaged with at least one compression element within the housing to compress the collecting element, thereby simultaneously releasing the biofluid from the collecting element; When the biological fluid is released from the collection element, the biological fluid is captured by the detection element inside the housing to detect the biological fluid and provide detection results.

35. The method of claim 34, wherein the continuous motion is linear motion.

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