Apparatus for testing a biological sample and method of determining a characteristic of a biological sample

Abstract

The present invention relates to a device for testing a biological sample and a method for determining a characteristic of a biological sample. The device for testing a biological sample comprises a receiving mechanism to receive a carrier, the carrier comprising holding areas, wherein the holding areas carry or have been exposed to the biological sample; a camera module configured to capture a collective image of the holding areas; and a processor configured to utilize the camera module to (1) identify visual cues located on the carrier from the captured collective image of the holding areas, and (2) based on the identification of the visual cues, perform an analysis process on the captured collective image; the analysis process comprising: dividing the captured collective image into a plurality of blocks, selecting a plurality of candidate blocks from the plurality of blocks, and determining a characteristic of the biological sample by analyzing the plurality of selected candidate blocks. The present invention can obtain the result of the test immediately and at a low cost.

Description

TECHNICAL FIELD

[0001] The present invention relates to an apparatus for testing a biological sample, and more particularly, to an apparatus for testing a biological sample and a method of determining characteristics of a biological sample. BACKGROUND

[0002] Currently, testing of liquid contents is usually entrusted to professional testing agencies, which perform the testing using expensive microscope equipment with high magnification. Since the general public does not have a microscope device, the testing activity cannot be performed by the general public.

[0003] However, in some of today's testing categories, periodic testing is required to be performed; thus, the need for frequent testing places a heavy burden in terms of time and expense. For example, a category of long-term testing includes testing of semen of infertile patients. The semen testing mainly involves observation of the number of sperm, its motility, and morphology.

[0004] The method of semen testing includes leaving the semen of a male subject at room temperature for a period of time, and taking a drop of the sample and dropping the sample on a glass slide, and observing the sample under a microscope. The observations include not only high magnification observation of individual sperm to identify the external appearance of individual sperm, but also observation of a large number of total sperm, its motility, morphology, and quantity per unit area. However, individuals cannot perform the semen testing by themselves, since the industry has not yet developed technology that allows individuals to perform the testing via a simple auxiliary device. SUMMARY

[0005] The present invention provides an apparatus for testing a biological sample and a method of determining characteristics of a biological sample, the apparatus for testing a biological sample comprising: a receiving mechanism to receive a carrier, wherein the carrier includes a holding area, wherein the holding area carries or has been exposed to the biological sample; a camera module configured to capture a collective image of the holding area, resulting in a captured collective image; and a processor configured to utilize the camera module to (1) identify a visual cue on the carrier from the captured collective image of the holding area, and (2) based on a result of the identification of the visual cue, perform a set of analysis processing procedures on the captured collective image; wherein the set of analysis processing procedures includes: segmenting the captured collective image into a plurality of blocks; selecting a plurality of candidate blocks from the plurality of blocks for analysis, wherein the selection of the candidate blocks is based on (1) a degree of focus of the blocks, and (2) normality of the blocks, and determining one or more characteristics of the biological sample through the plurality of candidate blocks (selected candidate blocks).

[0006] Preferably, the collective image is one or more images.

[0007] The device for testing biological samples of the present invention is inexpensive, requires less labor for testing, and is easy to use compared to known testing devices. The technology can be applied to semen testing as well as other testing fields such as water containing microorganisms, water quality, blood, urine, bodily fluids, feces, and skin surface tissue / cells. The technology provides a simple testing product with significantly lower cost of use compared to existing technologies using laboratory microscopy equipment.

[0008] The device for testing biological samples disclosed herein provides a simple structure that can significantly reduce the cost of sample magnification testing structures for testing such as sperm testing, urine analysis, or other bodily fluid analysis compared to existing technologies. The technology disclosed herein can be used in a wide range of applications via a carrier designed with a sample holding area, a magnification assembly, and a unique innovative setup. For example, the device for testing biological samples can be applied to detect the count, motility, and morphology of a sperm sample.

[0009] The device for testing biological samples of the present invention is suitable for performing testing at home. The results of the testing can be obtained immediately and at a low cost. For example, the device for testing biological samples provides a way for a couple trying to conceive to assess the male fertility of the couple at home so that the couple can make an informed decision as to whether medical intervention is needed.

[0010] The disclosed technology can be conveniently integrated with existing smart communication devices such as smart phones or single board computers and is capable of using existing smart communication devices to capture magnified test images and perform subsequent operations such as storing and transferring the images. The cost of these devices is low so that they can be implemented as disposable devices or reusable devices.

[0011] At least some embodiments of the present invention are directed to a device (e.g., a test cartridge or test strip) for testing biological samples. The device includes a sample carrier and a detachable cover. The sample carrier includes a sample holding area. The detachable cover is placed on top of the sample holding area. The detachable cover includes a magnification assembly configured to align with the sample holding area. The focal length of the magnification assembly is 0.1 millimeters (mm) to 8.5 mm. The magnification assembly has a linear magnification ratio of at least 1.0.

[0012] At least some implementations of the invention relate to a system for testing biological samples. The system includes the above-mentioned device for testing biological samples and a base assembly. The base assembly includes an insertion port for inserting the device for testing biological samples into the base assembly. The base assembly further includes a camera assembly for capturing images of the sample holding area or a form fitting frame for securing a mobile device including the camera assembly for capturing images of the sample holding area. The base assembly can further include a supplemental lens placed below the camera assembly. The combination of the magnification assembly and the supplemental lens can have an effective linear magnification ratio of at least 1.0.

[0013] At least some implementations of the invention relate to a method of testing sperm using a device for testing biological samples. The method includes the steps of obtaining the device for testing the above-mentioned biological samples, applying a sample of sperm to the sample holding area, recording a video or image of the sample of sperm; determining a number of sperm in the sample of sperm based on at least one frame of the recorded video or the recorded image; and determining sperm motility of the sample of sperm based on the recorded video or the recorded image.

[0014] At least some implementations of the invention relate to a system for testing biological samples. The system includes a disposable device for testing biological samples and a base assembly. The disposable device includes a sample carrier including a sample holding area and a detachable cover placed on top of the sample holding area. The base assembly includes an insertion port for inserting the disposable device into the base assembly and a camera. The camera, including an image sensor and an optical lens module, captures one or more images of the sample holding area.

[0015] Some implementations of the invention include a device for testing biological samples. The device can include a housing having an opening. A receiving mechanism can receive a carrier inserted via the opening. A holding area of the carrier can include an adjacent first holding area and a second holding area. The first holding area and the second holding area can carry a biological sample or have been exposed to a biological sample.

[0016] In some implementations, the device can include two camera modules. The camera modules are a first camera module configured to capture one or more images of a first holding region, and a second camera module configured to capture one or more images of a second holding region. Additionally, some specific examples include a main circuit board carrying a processor configured to perform a first analysis process on the captured images of the first holding region. The processor can be configured to perform a second analysis process on the captured images of the second holding region that is different from the first analysis process. In some specific examples, the processor can determine a result regarding the biological sample based on results of both the first analysis process and the second analysis process. According to one or more specific examples, the receiving mechanism, the first and second camera modules, and the main circuit board are all encapsulated within a housing.

[0017] Further, in some specific examples, when the processor identifies that the first holding region is in a first shape, the processor is configured to perform a certain analysis process. For example, if the first shape indicates that the biological sample includes sperm from a male subject, the process can determine one or more characteristics of the sperm. The characteristics that can be determined can include: cell count (e.g., sperm count), concentration of sperm, motility of sperm, and / or morphology of sperm. In some examples, the determination of one or more characteristics of the sperm can be performed using the second camera module. In some of these examples, the processor further determines at least one additional characteristic of the sperm using the first camera module. This additional characteristic can include the acidity of the sperm. For example, the carrier can include a pH indicator in the first holding region that indicates the acidity of the sperm with a color, and the processor can recognize the color for identifying the acidity.

[0018] In some examples, when the processor identifies that the first holding region is in a second shape that can indicate that the biological sample includes urine from a female subject, the processor is configured to determine one or more characteristics of the urine. The characteristics that can be determined can include: luteinizing hormone (LH) level, follicle-stimulating hormone (FSH) level, and / or human chorionic gonadotropin (HCG) level. As with the acidity, the determination of one or more characteristics of the urine can be performed using the first camera module. Similarly, the carrier can include an LH indicator, an FSH indicator, and / or an HCG indicator in the first holding region.

[0019] In some specific examples, the first camera module has a lower magnification ratio and / or a lower camera resolution compared to the second camera module.

[0020] In some embodiments, the processor can be configured to (1) identify, with the first camera module, a shape of a first holding region on the carrier; and (2) select, based on the shape of the first holding region, a set of analysis processing procedures to be performed. The shape of the first holding region can identify gender information of the biological sample. Then, in response to the shape of the first holding region being a first shape, the set of analysis processing procedures selected by the processor can determine fertility of the reproductive cells with respect to a first gender. In addition, in response to the shape of the first holding region being a second shape, the set of analysis processing procedures selected by the processor can determine fertility of the reproductive cells with respect to a second gender.

[0021] The present disclosure also provides a device for testing a biological sample, the device comprising:

[0022] a housing comprising an opening; a receiving mechanism to receive a carrier, the receiving mechanism receiving the carrier inserted via the opening; wherein the carrier comprises a holding region, wherein the holding region carries or has been exposed to the biological sample; a camera module configured to capture one or more images of the holding region, resulting in a captured image; and a circuit board carrying a processor, the processor configured to utilize the camera module to (1) identify, from the captured image of the holding region, a visual cue in or near the holding region on the carrier, and (2) based on a result of the identification of the visual cue, selectively perform a set of analysis processing procedures on the captured image of the holding region; wherein the processor is further configured to determine, after the set of analysis processing procedures is performed, a final result with respect to the biological sample based on a result of the set of analysis processing procedures; wherein the receiving mechanism, the camera module, and the circuit board are enclosed within the housing.

[0023] Preferably, in the above device, the visual cue is a size that is not perceptible by a human, and the size is identified by the camera module after being magnified via a microscopic lens.

[0024] Preferably, in the above device, an outer dimension of the housing is less than 27000 cubic centimeters.

[0025] Preferably, in the above device, further comprising: a second camera module, wherein the processor is further configured to utilize the second camera module to identify a shape of a second holding region on the carrier.

[0026] The present invention further provides a method for determining the characteristics of a biological sample, comprising: using the apparatus as described above, operating a processor to utilize a camera module to (1) identify a visual cue on the carrier from the captured set of images of the holding region, and (2) selectively performing a set of analysis processing procedures on the captured set of images based on a result of the identification of the visual cue; wherein the set of analysis processing procedures includes: segmenting the captured set of images into multiple blocks; selecting multiple candidate blocks from the multiple blocks for analysis, wherein the selection of candidate blocks is based on (1) the focus of the blocks and (2) the normality of the blocks, and determining one or more characteristics of the biological sample through the multiple selected candidate blocks.

[0027] This invention provides immediate test results at a low cost. Attached Figure Description

[0028] FIG. 1A An exploded view of an apparatus for testing biological samples according to a specific embodiment of the present invention.

[0029] FIG. 1B for FIG. 1A An assembly view of the test setup.

[0030] FIG. 2A for FIG. 1A A cross-sectional view of the test apparatus.

[0031] FIG. 2B A cross-sectional view of another specific example of the test apparatus.

[0032] FIG. 3 This is a flowchart illustrating the testing of a testing apparatus according to a specific embodiment of the present invention.

[0033] FIG. 4 This is a cross-sectional view of an apparatus for testing biological samples according to another specific embodiment of the present invention.

[0034] FIG. 5 This is a cross-sectional view of an apparatus for testing biological samples according to another specific embodiment of the present invention.

[0035] FIG. 6 For use FIG. 5 A schematic diagram of the testing apparatus.

[0036] FIG. 7 This is a schematic diagram of an apparatus for testing biological samples according to another specific embodiment of the present invention.

[0037] FIG. 8 This is a schematic diagram of an apparatus for testing biological samples according to another specific embodiment of the present invention.

[0038] FIG. 9 Schematic view of a device for testing a biological sample according to another embodiment of the application.

[0039] FIG. 10 Schematic view of a device for testing a biological sample according to another embodiment of the application.

[0040] FIG. 11 to FIG. 13 Views of a device for testing a biological sample according to three further embodiments of the application. FIG. 14A Schematic view of a test strip inserted into a meter device according to another embodiment of the application.

[0041] FIG. 14B Schematic view of an assembly of a meter device according to another embodiment of the application.

[0042] FIG. 15A Sample processing procedure for a semen test by a device such as a meter device or a smart communication device is shown.

[0043] FIG. 15B Sample processing procedure for a semen test by a device such as a meter device or a smart communication device is shown. FIG. 15A Sample step 1515 of the processing procedure shown in

[0044] FIG. 15C Sample processing procedure for a semen test by a device such as a meter device or a smart communication device is shown. FIG. 15A Sample step 1520 of the processing procedure shown in

[0045] FIG. 15D Sample processing procedure for a semen test by a device such as a meter device or a smart communication device is shown. FIG. 15A Sample step 1530 of the processing procedure shown in

[0046] FIG. 15E Sample processing procedure for a semen test by a device such as a meter device or a smart communication device is shown. FIG. 15A Sample step 1550 of the processing procedure shown in

[0047] FIG. 15F Sample processing procedure for a semen test by a device such as a meter device or a smart communication device is shown. FIG. 15A Sample step 1555 of the processing procedure shown in

[0048] FIG. 16 Sample processing procedure for determining sperm concentration is shown.

[0049] FIG. 17 Sample sperm and sample sperm trajectory are shown.

[0050] FIG. 18 Sample processing procedure for determining sperm trajectory and motility is shown.

[0051] FIG. 19 Schematic view of a test device including a collection bottle.

[0052] FIG. 20 Schematic view of a test device not including a collection bottle.

[0053] FIG. 21A 、 FIG. 21B and FIG. 21C is a cross-sectional schematic view of a test device of various specific examples of test strip devices.

[0054] FIG. 22 is a cross-sectional schematic view of a test device of a test strip device having two sample holding areas.

[0055] FIG. 23 is a schematic view of components of a test device having an autofocus function.

[0056] FIG. 24 is a schematic view of components of another test device having an autofocus function.

[0057] FIG. 25A and FIG. 25B are cross-sectional schematic views of a test device including a switch and a motor.

[0058] FIG. 26A and FIG. 26B are cross-sectional schematic views of a test device including a flexible element.

[0059] FIG. 27 is a flowchart of a process for analyzing a semen sample of a male client or patient.

[0060] FIG. 28 is a flowchart of a process for analyzing LH or HCG of a female client or patient.

[0061] FIG. 29 shows an example of a carrier that can be adapted for a test device having a multi-camera setup, such as the test device shown in FIG. 22 .

[0062] FIG. 30 is a flowchart of a process for analyzing fertility of both male and female subjects with the test devices disclosed herein.

[0063] FIG. 31 shows an additional example that the carrier can be used for an analysis process performed with a control test device having a visual cue (e.g., in or near a holding area).

[0064] FIG. 32 is a flowchart of an additional example process that can be adaptively performed by the disclosed test devices based on a visual cue.

[0065] FIG. 33 is an example flowchart of a process that can be implemented by the disclosed test devices.

[0066] FIG. 34 An instance image showing a region that has been divided into many blocks.

[0067] FIG. 35 An example image illustrating a portion of the candidate block selection process.

[0068] FIG. 36 Example images illustrating the results of image processing procedures (e.g., polarization) and cell count determination.

[0069] FIG. 37 A flowchart illustrating an example of a calibration procedure that can be implemented using the disclosed test apparatus.

[0070] FIG. 38 The test carrier carries example images of visual cues and / or image patterns that can be used to correct or enable the test device.

[0071] FIG. 39 For captured by the revealed test apparatus FIG. 38 Example images of visual cues in the middle.

[0072] FIG. 40A and FIG. 40B illustrate FIG. 39 The different image qualities of different blocks in the extracted image.

[0073] FIG. 41 The test carrier carries an image of a test sample instance that can be used to calibrate or enable the test device.

[0074] FIG. 42A and FIG. 42B illustrate FIG. 41 The different image qualities of different blocks in the extracted image. Detailed Implementation

[0075] Reference will now be made in detail to presently preferred embodiments of the invention, examples of which are shown in the accompanying drawings.

[0076] FIG. 1A and FIG. 1B An apparatus for testing biological samples according to a specific example of the invention is shown. The specific examples disclosed herein are for illustrative purposes and should not be construed as limiting the invention. The apparatus A1 for testing biological samples includes: a carrier 10 having a sample holding region 11 formed on the top of a carrier 10, an outer cover 20 stacked on the top of the carrier 10, and at least one magnifying member 30 (also referred to as a magnifying assembly or magnifying glass) including a convex lens-type surface formed on the outer cover 20.

[0077] The amplification component 30 in this specific example includes, for example: FIG. 1AThe planar convex lens shown is not included. However, other types of magnifying lenses (e.g., biconvex lenses) may be included as the magnifying element 30. The magnifying element 30 is positioned to align with and cover the sample holding region 11 of the carrier 10. The magnifying element 30 may have various magnification ratios based on the testing requirements of various tests. For example, the tests may include semen tests, urine tests, synovial fluid tests, skin tests, water tests, or other bodily fluid tests, etc.

[0078] The testing using the apparatus A1 for testing biological samples in this specific example does not require expensive and time-consuming additional magnifying lenses or laboratory microscopes. Furthermore, it is not necessary to align the sample holding area with the magnifying lens or laboratory microscope.

[0079] like FIG. 1A As shown, the sample holding region 11 of the carrier 10 can be formed with a recessed structure. The recessed structure is designed to provide a stable and large storage space containing the sample 40. The recessed structure allows the sample to stand for a required period of time before performing the test. For example, before performing a motility test on a semen sample, it is necessary to allow the semen sample to stand at room temperature for a required period of time before performing the motility test.

[0080] Sample 40 can first be dripped into the recessed structure (i.e., the sample holding area 11 of the carrier 10) and left to stand for a period of time. For example... FIG. 1B As shown, the total area of ​​the outer cover 20 may be smaller than the total area of ​​the carrier 10. A sample receiving port 12, exposed outside the outer cover 20, is formed on one side of the sample holding region 11. The sample receiving port 12 may be designed to have an outwardly expanding shape, which facilitates smooth sample dispensing.

[0081] FIG. 2A An air channel 13 is shown extending beyond the other side of the outer casing 20 and formed on the other side of the sample holding region 11. The air channel 13 prevents air from filling the interior of the sample holding region 11, which would prevent the reception of the sample if the sample is in a liquid state.

[0082] like FIG. 2A As shown, a lateral illumination device 50 may be positioned on one side of the carrier 10 of the test apparatus A1. The lateral illumination device 50 provides illumination to the sample 40 in the sample holding area 11, thereby improving the resolution of the captured test image of the sample 40. In some specific instances, the sample holding area 11 may receive illumination from a light source located at the top or bottom of the test apparatus A1.

[0083] like FIG. 1AAs shown in FIG. 1, the magnification component 30 and the housing 20 can be integrally formed, i.e., the magnification component 30 and the housing 20 can be a single assembly. In other embodiments (such as the embodiment shown in FIG. 2), the detachable housing 20 and the magnification component 30 disposed in the upwardly facing concave portion of the detachable housing 20, i.e., the recess 21, can each be separate assemblies adapted to be integrated together. In other words, the same type of detachable housing 20 can be integrated with different magnification components 30 of various magnification ratios. FIG. 2B

[0084] In some embodiments, the distance between the bottom of the detachable housing 20 and the sample holding area 11 is between 0.005 mm and 10 mm. In some embodiments, the distance between the bottom of the detachable housing 20 and the sample holding area 11 is about 0.01 mm. The test device can include one or more spacers (not shown) to ensure the distance between the bottom of the detachable housing 20 and the sample holding area 11. The spacers can be integrally formed with the detachable housing 20 or the sample holding area 11 of the carrier 10.

[0085] In some embodiments, the strip including the carrier 10 and the housing 20 is used for sperm testing. In some embodiments, the optimal angular magnification ratio for determining sperm concentration and motility is about 100 to 200. In some embodiments, the optimal angular magnification ratio for determining sperm morphology is about 200 to 300. The thinner the magnification assembly, the higher the angular magnification ratio.

[0086] The focal length of the magnification assembly can also be related to the angular magnification ratio. In some embodiments, a magnification assembly having an angular magnification ratio of 100 has a focal length of 2.19 mm. A magnification assembly having an angular magnification ratio of 156 has a focal length of 1.61 mm. A magnification assembly having an angular magnification ratio of 300 has a focal length of 0.73 mm. In some embodiments, the magnification assembly has an angular magnification ratio of at least 30, and preferably at least 50. In some embodiments, the focal length of the magnification assembly is between 0.1 mm and 3 mm.

[0087] FIG. 3 FIG. 1 shows the use of a magnification assembly having an angular magnification ratio of 100. FIG. 1B ​The apparatus A1 shown for testing biological samples performs a sample processing procedure for testing. In step S110, the sample 40 to be tested is placed in the sample holding area 11. In step S110, the outer cover 20 is stacked on top of the carrier 10, and then the sample 40 to be tested is placed in the sample holding area 11 from the sample receiving port 12. Alternatively, the sample 40 to be tested can be placed directly in the sample holding area 11 first, and then the outer cover 20 is stacked on top of the carrier 10. In step S120, the sample 40 is left to stand in the sample holding area 11 according to the testing requirements of the sample 40, selectively for a period of time. In step S130, a smart communication device (e.g., a mobile phone) is attached to the outer cover 20, and the camera of the mobile phone is aligned with the magnifying component 30 to capture an image or video of the sample using the camera of the mobile phone via the magnifying component 30. In step S140, an application (APP) running on a mobile phone or other analysis device can be used to perform analysis on images or videos to obtain test results.

[0088] like FIG. 4 As shown, a support side (such as protrusion 14) may be further formed on the top of the outer casing 20 of the test device A2 at the boundary of the magnifying member 30. In some specific instances, the protruding support structure can be formed on the top of the outer casing 20 by adding protrusion 14. When a user attempts to capture images or videos of the sample using a smart communication device 60 (e.g., a mobile device such as a smartphone or a single-board computer), one side of the smart communication device 60 with camera 61 can be fixed to the protrusion 14 (in the direction indicated by arrow L1). Therefore, the test device A2 allows the user to capture images or videos of the sample using the smart communication device 60 without requiring expensive test equipment to record images or videos. Furthermore, for optimal observation distance, the height of the protrusion 14 can be predetermined based on the specifications of the camera 61 and the test device A2.

[0089] like FIG. 5 and FIG. 6 As shown, the test apparatus A3 may include an instrumentation unit 70 (also referred to as a base assembly). The instrumentation unit 70 includes a lower barrel base 71 and an upper barrel body 72 that can rise or fall relative to the lower barrel base 71. The lower barrel base 71 has an insertion port 73 that provides an insertion position for the stacked outer casing 20 and carrier 10. An upward-facing light-emitting device (also referred to as a light source) 80 is disposed on the bottom of the lower barrel base 71 to provide illumination from the bottom to the combination of the outer casing 20 and carrier 10. The upper barrel body 72 may include at least one additional magnifying lens 74, for example, for further magnification.

[0090] A threaded mechanism can be used to attach the upper barrel body 72 to the lower barrel base 71 so that the upper barrel body 72 can be raised or lowered relative to the lower barrel body 71 like a screw. In other words, the upper barrel body 72 can be rotated relative to the lower barrel base 71 in the direction of arrow L2 so that the upper barrel body 72 moves up and down relative to the lower barrel base 71 in the direction of arrow L3. By adjusting the height of the upper barrel body 72 relative to the lower barrel body 71, the system adjusts the height of the magnification lens 74 (changes the magnification ratio) and the height of the camera 61.

[0091] An assembly frame 75 (also referred to as a form-fit frame) can be disposed at the upper end of the upper barrel body 72. The assembly frame 75 secures the smart communication device 60 at a predetermined position. The assembly frame 75 has a camera alignment hole 76. The camera 61 of the smart communication device 60 can receive light from the sample via the camera alignment hole 76.

[0092] The camera 61 disposed on the current smart communication device 60 typically only has a digital zoom function. Generally, high-precision testing requires an optical zoom lens. However, the user using the testing device A3 does not need a camera 61 with an optical zoom lens. The height adjustment function of the testing device A3 provides a flexible solution for aligning the sample, the magnification lens, and the camera 61.

[0093] FIG. 6 The smart communication device 60 is shown assembled and secured to the assembly frame 75, which is disposed on the upper barrel body 72. The enclosure 20 and the carrier 10 containing the sample 40 are inserted via the insertion port 73. The upward light emitting device 80 can provide illumination to the sample and increase the brightness of the sample.

[0094] FIG. 6 The smart communication device 60 is shown assembled and secured to the assembly frame 75, which is disposed on the upper barrel body 72. The enclosure 20 and the carrier 10 containing the sample 40 are inserted via the insertion port 73. The upward light emitting device 80 can provide illumination to the sample and increase the brightness of the sample.

[0095] The upper barrel body 72 or the instrument device 70 can be rotated along the direction L2 to adjust the height of the magnification lens 74 and the camera 61 upward or downward along the direction L3. The height adjustment mechanism enables the function of adjusting the magnification ratio. The camera 61 can capture dynamic video or static test images of the sample 40 after magnification. In addition, the smart communication device 60 can store the captured video or images, deliver test images or video, and perform subsequent processing using its original equipment function.

[0096] As FIG. 7As shown, the apparatus A4 for testing biological samples includes multiple amplification components 30, 30B, and 30C with different magnification ratios mounted on an outer casing 20. The user can offset the outer casing 20 to align the sample holding area 11 of the carrier 10 with any of the amplification components 30, 30B, and 30C with different magnification ratios, thereby obtaining test results with different magnification ratios. With this design, the testing apparatus A4, with its single-module amplification function, can be applied to meet the amplification requirements of multiple testing protocols without requiring changes to the amplification components or the outer casing.

[0097] like FIG. 8 As shown, the apparatus A5 for testing biological samples includes a flexible transparent film 15. The flexible transparent film 15 is disposed between the carrier 10 and the magnifying component 30, and covers the sample holding area 11. The flexible transparent film 15 covers the sample 40 (in a liquid state) so that the sample 40 is confined within a restricted space. Therefore, external influences caused by air, dust, and contaminants are minimized. Furthermore, the focal length of the testing apparatus A5 can be adjusted by changing the thickness of the flexible transparent film 15.

[0098] like FIG. 9 As shown, the magnifying component 30 of the device A6 for testing biological samples is a planar convex lens, and the surface of the magnifying component 30 facing the carrier 10 is a protruding surface. Therefore, an upward-facing concave hollow component, i.e., a groove 21, is formed on the surface of the magnifying component 30 facing the carrier 10. The focal length parameter H1 is defined by the thickness of the thickest part of the magnifying component 30 through the planar convex lens. FIG. 10 As shown, the focal length parameter H2 of the device A7 used for testing biological samples is different from that of the device A7 used for testing biological samples. FIG. 9 The focal length parameter H1.

[0099] The focal lengths H1 and H2 can be adjusted by changing the thickness of the outer casing 20 or the curvature of the magnifying component 30. For example, FIG. 10 The focal length H2 shown is greater than FIG. 9 The focal length H1 shown is achieved by changing the curvature of the magnifying element 30. In this way, various focal length test requirements can be met by using different magnifying elements 30.

[0100] In some specific instances, the magnifying element 30 may be transparent and the remainder of the outer casing 20 may be opaque. Additionally, the carrier 10 may include a transparent sample holding region 11. The remainder of the carrier 10 may be opaque. When testing is performed on the testing apparatus, light can propagate through the sample holding region 11 and the magnifying element 30 to suppress the chance of light interference from other components of the apparatus.

[0101] See FIG. 11In the device A8 for testing biological samples, the carrier 10 of the testing device A8 further comprises a light beam assisted guiding structure 16 formed at the bottom surface of the carrier 10. The carrier 10 can be made of transparent or translucent material. The light beam assisted guiding structure 16 can be opaque or comprise a particle structure, a rough pattern, an engraved pattern or other suitable structure that scatters the light beam reaching the guiding structure 16. The light beam assisted guiding structure 16 can provide a specific pattern to the whole or part of the surface of the housing and carrier. The light beam assisted guiding structure 16 can also be formed all around the side surface of the carrier 10.

[0102] When the housing 20 and the carrier 10 are stacked and attached to the smart communication device 60 (e.g. as shown in FIG. 4 The magnifying component 30 is aligned with the camera 61 of the smart communication device 60. In addition, a supplemental light (not shown) can be disposed near the camera 61 on the surface of the smart communication device 60. The light beam provided by the supplemental light can be guided to the carrier 10 to illuminate the sample holding area 11 through the housing 20. Meanwhile, the light beam assisted guiding structure 16 of the carrier 10 can scatter the light beam provided by the supplemental light, thereby improving the brightness and illumination uniformity of the sample holding area 11.

[0103] By disposing the light beam assisted guiding structure 16, the testing device does not need an additional supplemental light source to illuminate the carrier 10. Therefore, the housing 20 comprises a light transmissive material so that the supplemental light of the smart communication device 60 can pass through the housing 20 to reach the sample. In some alternative embodiments, the device does not comprise the housing 20 and the supplemental light directly reaches the carrier 10 without propagating through the housing 20.

[0104] The device A8 for testing biological samples can comprise an anti-slip film 92, a release paper 96 and a pH test paper 94. The anti-slip film 92 is attached on the supporting side (such as the top side) of the housing 20 and is used to stably dispose the housing 20 to the camera 61 of the smart communication device 60, as shown in FIG. 4 , so that the magnifying component 30 is aligned with the camera 61 of the smart communication device 60. Using the anti-slip film 92, the positioning of the smart communication device 60 relative to the testing device A8 is fixed to a predetermined structure.

[0105] The anti-slip film 92 can have an opening aligned with the magnifying component 30 so that the anti-slip film 92 does not block the light transmitted from the sample through the magnifying component 30 to the camera 61. The anti-slip film 92 can comprise a material such as silicon, and the surface of the anti-slip film 92 can be protected with the release paper 96 to maintain the paper tackiness. The pH test paper 94 can be disposed on the sample holding area 11 of the carrier 10 to provide an indication of the pH value of the sample. The pH test paper 94 can be replaced after use.

[0106] In addition, the magnification component 30 and the housing 20 can be designed to be removable. Thus, a user can replace the original magnification component 30 with another magnification component 31 that is different from the magnification component 30 based on testing requirements. Various magnification components that can be assembled with the housing 20 are assembled to achieve different magnification ratios or other optical characteristics.

[0107] Referring now to FIG. 12 , the device A9 for testing a biological sample can further include a sample collection sheet 42 disposed in the sample holding region 11. The sample collection sheet 42, for example, has a sample collection region 42A. The sample collection region 42A can collect sperm, subcutaneous tissue / cells, parasite eggs, and similar solid test subjects using adhesion or other methods. In some embodiments, the sample collection sheet 42 can be used as a spacer to maintain the distance between the housing 20 and the sample holding region 11.

[0108] Referring now to FIG. 13 , the device A10 for testing a biological sample can include an isolation component 98 disposed at the sample holding region 11 between the carrier 10 and the housing 20. The isolation component 98 can isolate the magnification component 30 from a test liquid in the sample holding region 11 and prevent the test liquid from contaminating the magnification component 30. In some embodiments, the isolation component 98 can be used as a spacer to maintain the distance between the housing 20 and the sample holding region 11. The isolation component 98 can be integrated with the housing 20 as a single component. Alternatively, the isolation component 98 can be integrated with the carrier 10 as a single component.

[0109] FIG. 14A A schematic view of a test strip inserted into a meter device according to another embodiment of the present disclosure. The test strip 5 (also referred to as a test cartridge) includes a removable housing 20 and a carrier 10. In other words, the combination of the removable housing 20 and the carrier 10 (e.g., as shown in FIG. 1B ) forms the test strip 5. The test strip 5 is inserted into a meter device 70 (also referred to as a base assembly) via an insertion port. The insertion port can be, for example, a lateral or vertical insertion port. The meter device 70 can include, for example, components for capturing images of a sample collected in the test strip 5.

[0110] FIG. 14BFIG. 15 shows a schematic view of components of a meter device according to another specific example of the present disclosure. The meter device 70 includes an insertion port 73 that provides an insertion location for a test strip 5. The test strip 5 includes a carrier 10 and a removable cover 20. The removable cover includes a magnification component 30. The meter device 70 includes a camera 61 for capturing an image or video of a sample holding region of the carrier 10. The camera 61 is aligned with the magnification component 30. The meter device further includes a light source 80 for providing illumination to the sample holding region from the bottom. In some specific examples, a parallel light tube (e.g., a parallel light tube lens or a light reflector; not shown) can be placed on top of the light source 80 for collimating the light beam. A ring-shaped aperture can further be placed between the light source 80 and the parallel light tube so that the light beam traveling through the parallel light tube forms a hollow cone-shaped light beam. The carrier 10 can include a transparent or translucent material for light propagation.

[0111] In some specific examples, the meter device 70 can further include a phase plate that shifts the phase of light rays emitted from the sample holding region. As light rays propagate through a sample, the speed of the light rays increases or decreases. Thus, the light rays that propagate through the sample are out of phase (about 90 degrees) with the remaining light rays that do not propagate through the sample. The out-of-phase light rays interfere with each other and enhance the contrast between bright and dark portions of the sample image.

[0112] The phase plate can further shift the phase of the light rays that propagate through the sample by about 90 degrees so as to further enhance the contrast resulting from the interference of the out-of-phase light rays. Thus, the light rays that propagate through the sample are out of phase by about 180 degrees with the remaining light rays that do not propagate through the sample. This destructive interference between the light rays enhances the contrast of the sample image by darkening objects in the image and brightening the boundaries of the objects.

[0113] In some alternative specific examples, this phase plate can be disposed on top of the removable cover 20 of the test strip 5. In other words, the phase plate can be part of the test strip 5 rather than part of the meter device 70.

[0114] FIG. 15 shows a schematic view of components of a meter device according to another specific example of the present disclosure. The meter device 70 includes an insertion port 73 that provides an insertion location for a test strip 5. The test strip 5 includes a carrier 10 and a removable cover 20. The removable cover includes a magnification component 30. The meter device 70 includes a camera 61 for capturing an image or video of a sample holding region of the carrier 10. The camera 61 is aligned with the magnification component 30. The meter device further includes a light source 80 for providing illumination to the sample holding region from the bottom. In some specific examples, a parallel light tube (e.g., a parallel light tube lens or a light reflector; not shown) can be placed on top of the light source 80 for collimating the light beam. A ring-shaped aperture can further be placed between the light source 80 and the parallel light tube so that the light beam traveling through the parallel light tube forms a hollow cone-shaped light beam. The carrier 10 can include a transparent or translucent material for light propagation. FIG. 5and the instrument device 70 or the smart communication device 60 shown in FIG. 14. In step 1505, the device obtains an image (frame) of the sample. In step 1510, the device determines the sperm concentration based on the image. In step 1515, the device can further determine the pH value of the sample by analyzing the color or grayscale of the pH strip. For example, the device can include a processor to identify the color of a portion of the image captured by the camera (corresponding to the pH strip) and determine the biochemical property (e.g., pH level) of the biological sample contained in the strip. In some other specific examples, the light source of the device can provide illumination with at least one color. For example, the light source can include light emitters with different colors (e.g., red, green, and blue) to form light of various colors. The camera of the device can further capture at least one (or more) images of the sample illuminated with light. The processor can compare the color of a particular region (e.g., the pH strip region) of the image to determine the property of the biological sample or the quantification of the analyte. In some specific examples, the processor only needs the color of a particular region of one image to determine the property of the biological sample. For example, the device (e.g., the test device) can include a color correction module for correcting the color of the image. The processor then analyzes the corrected image to determine the property of the biological sample. Alternatively, the test strip can include a color correction region with a known color. The processor performs a color correction operation on the image based on the color correction region and then analyzes the corrected image to determine the property of the biological sample or the quantification of the analyte. In some specific examples, the reagent in the pH strip (or other types of biochemical test strips) reacts with the biological sample, after which a particular region (e.g., the pH strip region) of the image shows a particular color. In some specific examples, the particular region for color detection necessarily requires magnification of the image captured by the camera. Therefore, in at least some specific examples, there is no magnification component or supplement over the particular region (e.g., the pH strip region) of the strip for color detection. For example, some types of biochemical test strips contain photochemical reagents. When the photochemical reagents react with a particular analyte in the biological sample, the reaction causes a color change in the sample holding region of the strip. The processor can analyze the image (captured by the camera) of the test strip to detect the color change and quantify the particular analyte in the biological sample. In addition, the device can determine sperm morphology (1520), sperm volume (1525), and sperm total number (1530). In step 1540, the device obtains a series of multiple frames of the sample. In steps 1545, 1550, and 1555, the device can determine sperm motility parameters based on sperm trajectories and determine sperm motility. FIG. 16 A sample processing procedure to determine sperm concentration is shown. In 1605, the device obtains an image (frame) of the sample. In 1610, the device determines the sperm concentration based on the image. In 1615, the device can further determine the pH value of the sample by analyzing the color or grayscale of the pH strip. For example, the device can include a processor to identify the color of a portion of the image captured by the camera (corresponding to the pH strip) and determine the biochemical property (e.g., pH level) of the biological sample contained in the strip. In some other specific examples, the light source of the device can provide illumination with at least one color. For example, the light source can include light emitters with different colors (e.g., red, green, and blue) to form light of various colors. The camera of the device can further capture at least one (or more) images of the sample illuminated with light. The processor can compare the color of a particular region (e.g., the pH strip region) of the image to determine the property of the biological sample or the quantification of the analyte. In some specific examples, the processor only needs the color of a particular region of one image to determine the property of the biological sample. For example, the device (e.g., the test device) can include a color correction module for correcting the color of the image. The processor then analyzes the corrected image to determine the property of the biological sample. Alternatively, the test strip can include a color correction region with a known color. The processor performs a color correction operation on the image based on the color correction region and then analyzes the corrected image to determine the property of the biological sample or the quantification of the analyte. In some specific examples, the reagent in the pH strip (or other types of biochemical test strips) reacts with the biological sample, after which a particular region (e.g., the pH strip region) of the image shows a particular color. In some specific examples, the particular region for color detection necessarily requires magnification of the image captured by the camera. Therefore, in at least some specific examples, there is no magnification component or supplement over the particular region (e.g., the pH strip region) of the strip for color detection. For example, some types of biochemical test strips contain photochemical reagents. When the photochemical reagents react with a particular analyte in the biological sample, the reaction causes a color change in the sample holding region of the strip. The processor can analyze the image (captured by the camera) of the test strip to detect the color change and quantify the particular analyte in the biological sample. In addition, the device can determine sperm morphology (1520), sperm volume (1525), and sperm total number (1530). In step 1540, the device obtains a series of multiple frames of the sample. In steps 1545, 1550, and 1555, the device can determine sperm motility parameters based on sperm trajectories and determine sperm motility. FIG. 5and a camera of the meter device 70 or the smart communication device 60 ("the device") shown in FIG. 14 captures an enlarged image of the sperm sample. The captured image is the raw image for determining the sperm concentration. The device then converts the digital color image to a digital grayscale image, and further divides the digital grayscale image into a plurality of regions.

[0115] In step 1610, the device performs an adaptive thresholding binary computation on each region based on the mean and standard deviation of the grayscale values of the region. The goal of the adaptive thresholding binary computation is to identify objects that are candidates for sperm as foreground objects, and to identify the rest of the region as background.

[0116] The foreground objects in the binary-computed image can still include impurities that are not actually sperm. Those impurities are smaller than or larger than the sperm. The method can set upper and lower boundary values for the size of the sperm. In step 1615, the device performs a denoising operation on the image by removing impurities that are larger than the upper boundary value or smaller than the lower boundary value of the sperm. After the denoising operation, the foreground objects in the image represent sperm.

[0117] The method counts the number of sperm in the image based on the head portion of the sperm. In steps 1620 and 1625, the device performs a distance transform operation to compute the minimum distance between the foreground objects and the background, and also identifies the locations of local maxima. Those locations are candidates for the head locations of the sperm.

[0118] In step 1630, the device performs an ellipse fitting operation on each sperm candidate object to reduce false positive candidates that do not have an elliptical shape and thus are not the head of a sperm. Then, the device counts the total number of remaining positive candidates of sperm, and computes the concentration of the sperm based on the volume represented by the image. The volume can be, for example, the area of the captured sample holding region multiplied by the distance between the sample holding region and the bottom of the outer cover.

[0119] In some embodiments, the device can use multiple images of the sample and compute concentration values based on the images, respectively. Then, the device computes the average of the concentration values to minimize the measurement error of the sperm concentration.

[0120] Using a series of images (e.g., video frames) of the sample, the device can further determine the trajectories and motilities of the sperm. For example, FIG. 17 A sample sperm such as sperm 1705 and sample sperm trajectories such as trajectory 1710 and trajectory 1720 are shown.

[0121] FIG. 18 A sample processing procedure for determining sperm trajectories and motilities is shown. As shown in FIGS. 17A and 17B, respectively, FIG. 5The device, as shown in Figure 14, uses a camera to capture a series of images (e.g., video frames) of the sperm sample. The device uses this series of captured images to determine parameters of sperm motility. To determine these parameters, the device needs to track the trajectory of each sperm in the series of images.

[0122] The device converts digital color images into digital grayscale images. The device first identifies the head position of sperm in the first image of the series (e.g., using...). FIG. 16 (The method shown). The identified head position of the sperm in the first image is the initial position of the sperm trajectory to be tracked. In some specific instances, the device may use a two-dimensional Kalman filter to estimate the trajectory of the sperm movement.

[0123] In some specific instances, it is used to track values ​​with a measurement z. j (k) sperm s j Two-dimensional Kalman filtering includes the following steps:

[0124] 1: Calculate the predicted state and error covariance matrix

[0125]

[0126]

[0127] 2: Using predicted states Measured value z j (k) and error covariance matrix Calculate the predicted measurement value Measurement residuals and residual covariance matrix

[0128]

[0129]

[0130]

[0131] 3: If and Then calculate the Kalman filter gain. Updated state estimate and the updated error covariance matrix

[0132]

[0133]

[0134]

[0135] (k|k-1) represents the prediction of image k based on image k-1. This represents the position and velocity of the j-th sperm. Let Q(k-1) be the covariance matrix for estimating the error, Q(k-1) be the covariance matrix for processing noise, N(k) be the covariance matrix for the noise vector at the white position, and γ be the gate threshold value and V max To maximize the possible sperm speed.

[0136] When tracking multiple trajectories of multiple sperm, the method can use joint probability data association filtering to determine the trajectory path. This joint probability data association filtering identifies feasible joint association events between the detection target and the measurement target. Feasible joint association events (A... js The relative probability value between sperm s and sperm j is used for detection. Next, the method makes a path allocation decision based on the optimal specification method. js Defined as:

[0137]

[0138] λ is a parameter. Let be the Gaussian probability density function for these sperm detections.

[0139] Based on the series of frames over a time period, the method identifies the trajectory of each sperm, such as... FIG. 18 The trajectory 1805 is shown in the diagram. Next, the method determines various parameters of sperm motility based on these trajectories. These parameters include, for example, curvilinear velocity (VCL), straight-line velocity (VSL), linearity (LIN), and amplitude of lateral head displacement (ALH). Curvilinear velocity (VCL) 1810 is defined as the sum of the distances traveled per unit time. Straight-line velocity (VSL) 1815 is defined as the straight-line distance traveled per unit time. Linearity (LIN) is defined as VSL divided by VCL. Amplitude of lateral head displacement (ALH) 1820 is defined as twice the amplitude of the lateral displacement of the sperm head relative to the average path 1825.

[0140] In some embodiments, the curvilinear velocity (VCL) 1810 can be used to determine sperm motility. The method can set a velocity cutoff. Any sperm with a VCL higher than or equal to the velocity cutoff is identified as a motile sperm. The remaining sperm with a VCL lower than the velocity cutoff is identified as a non-motile sperm. The level of motility is the number of motile sperm divided by the total number of sperm identified from the image.

[0141] The method can further analyze sperm morphology. A camera of the instrument device 70 or the smart communication device 60 ("the device") captures an enlarged image of the sperm sample. The captured image is the raw image used to determine sperm morphology.

[0142] The method detects the shape of sperm candidates based on segmentation. The method uses the location of the head of the sperm as an initial point. Using a segmentation algorithm related to shape, the method segments the image of the sperm into a head portion, a neck portion, and a tail portion. For example, the method can segment the sperm using a method such as active contour model.

[0143] Based on the portions, the method calculates parameters (such as length and width) of each portion. A classifier (such as a support vector machine, a neural network, a convolutional neural network, or an AdaBoost algorithm) can be trained using a training data set that includes labeled samples. After training, the parameters of each portion of the sperm can be fed into the classifier to determine whether the sperm has the proper morphology. In some embodiments, the classifier can be used for other applications such as detecting characteristics of cells and microorganisms.

[0144] FIG. 19 A schematic of a test device including a collection vial according to at least one embodiment of the present application. A test strip device 1905 can be inserted into a test device 1900 via an insertion port. The test strip device 1905 can include a collection vial 1910 for collecting a sample (e.g., a sperm sample) or include a slot that houses the collection vial. The test device 1900 can include a sensor (not shown) to detect whether the collection vial 1910 is inserted into the test device 1900.

[0145] The test device 1900 can have a timer mechanism to determine the time period that the collection vial 1910 is inserted into the test device 1900. After the collection vial 1910 containing the sample is inserted, the test device 1900 can wait for a predetermined time period (e.g., 30 minutes) to liquefy the sample before prompting the user to transfer the sample from the collection vial 1910 to the test strip device 1905. In some embodiments, the test device 1900 can include a camera or a sensor to determine whether the sample has been liquefied.

[0146] Further, the testing device can include a moving mechanism to apply mechanical force to the collection bottle 1910 so as to mix the sample in the collection bottle 1910. For example, the moving mechanism can shake, vibrate, or rotate the collection bottle 1910. In some other specific examples, the testing device can include a rod to be inserted into the collection bottle 1910 and stir the sample in the collection bottle 1910.

[0147] The testing device 1900 can optionally include a display (e.g., screen 1920) for displaying information. For example, the screen 1920 can show instructions or prompts on how to operate the testing device 1900. The screen 1920 can also show the test results after the testing device 1900 performs a test. Additionally or alternatively, the testing device 1900 can include a known communication module so that it can communicate with a user's computing device (e.g., a smart phone with a mobile software application, or a traditional personal computer such as a laptop) (e.g., analyze the results and / or images acquired by the camera module). The testing device 1900 can be operable to receive instructions from a user (e.g., from the screen 1920 and / or from the aforementioned communication module), and perform a selected number of automated analysis processes based on the instructions. The testing device 1900 can also display the results and / or images of the sample on the screen 1920 or on the user's computer (e.g., via the aforementioned communication module), or both.

[0148] Similar to the testing device shown in FIG. 14A and FIG. 14B The testing device 1900 can include a camera (not shown) for capturing images or videos of the test strip device 1905. The testing device 1900 can further include a processor (not shown) for processing the images or videos for determining the test results (e.g., via the processing procedure shown in FIG. 16 ).

[0149] In some specific examples, the magnification component 2110 is a magnifying lens, for example. The magnification capability of the magnification component 2110 can be represented by an angular magnification ratio or a linear magnification ratio. The angular magnification ratio is the ratio between the angular size of an object as seen through an optical system and the angular size of the object as seen directly at the near point distance (i.e., 250 mm from the human eye). The linear magnification ratio is the ratio between the size of the image of an object projected on an image sensor and the size of the actual object.

[0150] For example, the magnifying lens can have a focal length of 6 mm, a thickness of 1 mm, and a diameter of 2 mm. Assuming that 250 mm is the near point distance of a human eye (i.e., the closest distance that a human eye can focus), the angular magnification ratio is 250 mm / 6 mm = 41.7 times. The distance between the magnifying assembly 2110 and the sample holding region 2115 can be, for example, 9 mm. Thus, the linear magnification ratio can be close to 2. In other words, the size of the image of the object on the image sensor caused by the magnifying assembly is 2 times the size of the actual object underneath the magnifying assembly.

[0151] In some embodiments, the magnifying assembly has a focal length of 0.1 mm to 8.5 mm. In some embodiments, the linear magnification ratio of the magnifying assembly is at least 1. In some embodiments, the linear magnification ratio of the magnifying assembly is 0.5 to 10.0.

[0152] In some embodiments, a supplemental lens 2135 is placed underneath the camera module 2130 for further magnifying the image and reducing the distance between the magnifying assembly 2110 and the sample holding region 2115. The effective linear magnification ratio of the entire optical system can be, for example, 3. In other words, the size of the image of the object captured by the camera module 2130 is 3 times the size of the actual object in the sample holding region 2115. In some embodiments, the effective linear magnification ratio of the entire optical system of the test device is 1.0 to 100.0, preferably 1.0 to 48.0.

[0153] In some embodiments, the image sensor of the camera module has a pixel size of 1.4 μιη. Typically, the captured image of an object needs to have at least 1 pixel in order to properly analyze the shape of the object. Thus, the size of the captured image of the object needs to be at least 1.4 μιη. If the linear magnification ratio of the test device is 3, then the test device can properly analyze the shape of an object having a size of at least 0.47 μιη.

[0154] In some embodiments, the image sensor of the camera module has a pixel size of 1.67 μιη. Then, the size of the captured image of the object needs to be at least 1.67 μιη in order to properly analyze the shape of the object. If the linear magnification ratio of the test device is 3, then the test device can properly analyze the shape of an object having a size of at least 0.56 μιη.

[0155] In some embodiments, the length of the entire optical system can be, for example, 24 mm. The distance between the bottom of the magnifying assembly and the top of the sample holding region 2115 can be, for example, 1 mm. In some embodiments, the length of the entire optical system of the test device is 2 mm to 100 mm, preferably 5 mm to 35 mm.

[0156] FIG. 20FIG. 1 is a schematic view of a testing device according to at least one embodiment of the present disclosure. The testing device 100 includes a collection bottle 105, a test strip device 110, and a camera module 115. The collection bottle 105 is configured to receive a sample from a user or operator. The test strip device 110 is configured to receive the sample from the collection bottle 105. The camera module 115 is configured to capture an image or video of a sample holding area 1115 of the test strip device 110.

[0157] FIG. 21B FIG. 2 is a schematic view of a testing device according to at least one embodiment of the present disclosure. The testing device 2000 includes a test strip device 2105 and a camera module 2130. The test strip device 2105 includes a sample holding area 2115. The camera module 2130 is configured to capture an image or video of the sample holding area 2115 of the test strip device 2105. FIG. 21A FIG. 3 is a schematic view of a cross-section A-A of a testing device according to at least one embodiment of the present disclosure. The cross-section A-A of the testing device 3000 shows a camera module 3130 above a test strip device 3105. The test strip device 3105 includes a sample holding area 3115. The camera module 3130 is configured to capture an image or video of the sample holding area 3115 of the test strip device 3105.

[0158] In some embodiments, the test strip device 3105 can include a test strip in or near the sample holding area 3115. For example, the test strip can be a pH test strip, an HCG (human chorionic gonadotropin) test strip, an LH (luteinizing hormone) test strip, or a fructose test strip. When an analyte of a sample in the sample holding area interacts with a chemical or biochemical reagent in the test strip, some optical properties (e.g., color or light intensity) of the test strip can change. The camera module 3130 can capture the color or intensity of the test strip to determine a test result, such as a pH level, an HCG level, an LH level, or a fructose level. In some embodiments, the magnifying assembly 3110 above the test strip can be replaced with a transparent or translucent cover. Thus, the testing device can simultaneously test for an analyte in a sample and perform another analysis of the sample via one or more magnified images of the sample.

[0159] FIG. 21C FIG. 4 is a schematic view of a cross-section A-A of a testing device according to at least one embodiment of the present disclosure. The cross-section A-A of the testing device 4000 shows a camera module 4130 below a test strip device 4105. The test strip device 4105 includes a sample holding area 4115. The camera module 4130 is configured to capture an image or video of the sample holding area 4115 of the test strip device 4105. FIG. 21AA-A cross-sectional view of another specific example of a testing device 1900. The A-A cross-section of the testing device 1900 shows a camera module 2130 on top of the testing strip device 2105 for capturing images or video of the sample holding area 2115 of the testing strip device 2105, which includes a sensor and one or more lenses 2135 (also referred to as supplemental lenses or optical lens modules). A light source 2140 below (or disposed elsewhere) of the testing strip device 2105 provides illumination for the sample holding area 2115. A magnification assembly 2110 can be attached to the bottom of the lenses 2135, rather than on top of the sample holding area 2115 as shown in FIG. 21A FIG. 1. In some specific examples, if the lenses 2135 provide sufficient magnification capability, the element 2110 can be a flat light transmissive cover without magnification capability. In some other specific examples, if the lenses 2135 provide sufficient magnification capability (e.g., if the linear magnification ratio of the lenses 2135 is at least 1.0), the testing device 1900 does not include the magnification assembly 2110.

[0160] FIG. 22 A schematic view of a testing device for a testing strip device with two sample holding areas. FIG. 29 An example of a carrier that can be suitable for a testing device with a multi-camera configuration, such as the testing device shown in FIG. 22 FIG. 1. Referring to both FIG. 19 and FIG. 20 , FIG. 22 The testing device shown in FIG. 1 can be another variant of the testing device 1900 (i.e., with a collection bottle) or the testing device 2000 (i.e., without a collection bottle). As shown in FIG. 22 The receiving mechanism is included in the testing device to receive one or more carriers (e.g., a testing strip device such as the testing strip device 2205, or a collection bottle such as the bottle 1910), which can be inserted via an opening on the housing of the testing device.

[0161] In some specific examples, a single carrier can include a first holding area and a second holding area, such as shown by the testing strip device 2205 in FIG. 22 FIG. 1. As shown in FIG. 22As shown in the middle, at least two camera modules can be included in the testing device. The two camera modules include a first camera module 2230A and a second camera module 2230B configured to capture images and / or videos of a first holding area 2215A and a second holding area 2215B, respectively. More specifically, the test strip device 2205 can include a sample holding area 2215A and another sample holding area 2215B. In some examples, a transparent or semi-transparent cover 2210A is placed on top of the sample holding area 2215A. A light source 2240A can be controllable and can provide illumination on the sample holding area 2215A. The first camera module 2230A is positioned to capture images or videos of the sample holding area 2215A. As an optional implementation, a magnification assembly 2210B can be placed on top of the sample holding area 2215B. In addition, in some specific examples, a light source 2240B can be operable to provide illumination on the sample holding area 2215B. The second camera module 2230B is positioned to capture images or videos of the sample holding area 2215B. The first holding area and the second holding area can carry biological samples directly or have been exposed to biological samples. Similar to the description above, the test strip device 2205 can include a phase plate between the sample holding area and at least one of the camera modules for phase shifting light rays reflected by the sample holding area. FIG. 14B With the introduced structure, in some specific examples, the testing device can include a collimator for collimating a light beam emitted by the light source into at least one of the holding areas. In some specific examples, an annular diaphragm can be further included between the light source and the collimator for forming a hollow cone light beam that travels through the collimator and then reaches the sample holding area. In some additional specific examples, a phase plate can be included between the sample holding area and at least one of the camera modules for phase shifting light rays reflected by the sample holding area.

[0162] As an alternative to a single carrier with multiple holding areas, multiple carriers can be inserted into the testing device via their individual openings, ports, or slots. For example, two independent test strip devices can include sample holding areas 2215A and 2215B, respectively. Depending on the needs of the test, the locations of the sample holding areas 2215A and 2215B in the test strip can be designed to align with the first camera module 2230A and the second camera module 2230B. In some specific examples, the two test strip devices are inserted into the testing device via two independent insertion ports.

[0163] Among other benefits, the convenience and ease of use of the testing apparatus disclosed herein are two significant advantages. According to specific examples herein, users of the disclosed testing apparatus do not need any expertise on how to perform various types of analysis on biological samples before they can utilize the apparatus to generate results. Therefore, the testing apparatus can include a processor for performing automated analytical processing on the sample and determining the results regarding the sample. The processor can be carried via a main circuit board (i.e., a known component, not shown for simplicity). Furthermore, the testing apparatus is preferably small and not as bulky as conventional testing apparatuses commonly found in laboratories. Therefore, in some specific examples, such as FIG. 19 and FIG. 20 As shown, the receiving mechanism, camera module, and main circuit board of the carrier can all be encapsulated within the housing of the test device. The test device can have a small external size, such as less than 30 cm × 30 cm × 30 cm, i.e., 27,000 cm². 3 In some specific instances, the test apparatus may further include a battery compartment enclosed within a housing, such that a battery can be installed in the battery compartment to power the test apparatus.

[0164] In some specific instances, a processor included in a testing apparatus can perform different analyses on different held regions and can derive results based on a combination of the results of the analyses performed on different regions. In other words, the processor can be configured to perform a first analytical process on a captured image of a first held region, perform a second analytical process on a captured image of a second held region (different from the first analytical process), and determine the outcome regarding the biological sample based on the results of both the first and second analytical processes. As used herein, the term "analytic process" means a process that evaluates one or more fragments of information (e.g., images of held regions) collected from a number of sources and produces results, conclusions, final results, estimates, or similar information about the sources.

[0165] According to some examples, the test device can use a combination of the first camera module 2230A, the light source 2240A, and the housing 2210A to quantitatively analyze an analyte or determine a characteristic of a sample (e.g., a pH level, an LH level, an HCG level, or a fructose level). Additionally, the test device can further use a combination of the second camera module 2230B, the light source 2240B, and the magnification assembly 2210B to analyze a magnified image of the sample to determine a characteristic of the sample (e.g., sperm count, sperm motility, sperm morphology, etc.). Depending on the requirements of various types of biochemical tests, different combinations or configurations of light sources can be used to illuminate the biochemical sample. The multi-camera configuration is particularly beneficial since different analysis processes can be performed via different camera modules without requiring the user to change the carrier (e.g., test strip device), thereby speeding up result generation and reducing the complexity of necessary human operations. The light sources 2240A and 2240B are encapsulated inside the housing and configured to illuminate the biological sample for at least one of the camera modules. According to one or more specific examples, the processor is configured to control the light source based on the analysis process that the processor is currently configured to perform.

[0166] Furthermore, in some specific examples, the processor can perform different analysis processes based on visual cues on the carrier. For example, some specific examples can perform image recognition and processing on an image of the holding region, and can perform different analysis processes according to visual cues from the results of the image recognition. Example carriers 2905(1) to 2905(4) are shown in FIG. 29

[0167] FIG. 22 FIG. 29 ​​​In some specific instances, when the processor identifies (e.g., via the first camera module 2230A) a first holding region (e.g., region 2215A or region 2915A of carrier 2905(1)) as having a first shape (e.g., circular), the processor is configured to execute a certain analysis procedure (e.g., fertility of a male subject, such as based on various characteristics of his sperm sample), and when the first holding region (region 2215A or region 2915A of carrier 2905(2)) is in a second shape (e.g., oval), the processor will execute a different analysis procedure (e.g., analysis of fertility of a female subject, such as based on hormone levels in her urine sample). In this way, the testing device is not limited to performing only one type of test (e.g., sperm fertility), but it can also switch analysis procedures accordingly based on the carrier (e.g., test strip device) inserted into the machine.

[0168] More specifically, according to some implementations, when the shape represents a biological sample including sperm from a male subject, the processing procedure can determine one or more characteristics of the sperm, such as those introduced herein. In some instances, the determination of one or more characteristics of the sperm can be performed using a second camera module 2230B. For some specific instances, the characteristics that can be determined may include: sperm concentration, sperm motility, and / or sperm morphology. According to some specific instances, the processor is configured to (1) determine sperm concentration and / or sperm morphology based on a single image in the captured images, and (2) determine sperm motility based on two or more images in the captured images.

[0169] In view of the above, FIG. 30 For use with the test apparatus disclosed herein (e.g., in FIG. 22 (Chinese) Flowchart of the case processing procedure 3000 for analyzing the fertility of both male and female subjects. Continue referring to... FIG. 29 The processing procedure 3000 is described below. Note that in the following example, the male samples are applied first, followed by the female samples, but the reverse order (i.e., females followed by males) can be performed without affecting the accuracy of the results.

[0170] First, in step 3002, the user applies a biological sample (e.g., sperm) from the male subject to a first holding region (e.g., region 2915A) and a second holding region (region 2915B) of a first carrier (e.g., carrier 2905(1)). Next, in step 3004, the user inserts the first carrier into the testing device (e.g., FIG. 22As shown in FIG. 29, the test device can automatically acquire knowledge that the current sample contains sperm from a male and accordingly select an analysis process because the shape of the first holding region 2915A of the carrier 2905(1) is circular. Then, in step 3006, the user can use the test device to determine one or more properties of the sperm. For example, as discussed herein, the processor in the test device can use the first camera module 2230A to acquire an image of the first holding region 2915A of the carrier 2905(1) which can include a test strip that shows different colors in response to different acidity, and identify the color of the test strip to determine the acidity of the sperm. In addition, in step 3006, the processor in the test device can use the second camera module 2230B to determine one or more properties of the sperm selected from the group consisting of cell number (e.g., sperm number), concentration of sperm, motility of sperm, and morphology of sperm.

[0171] Then, in step 3008, the user can apply urine from a female subject to the holding region 2915A of the second carrier (e.g., carrier 2905(2)). In step 3010, the user inserts the second carrier into the test device, and because the shape of the first holding region 2915A of the carrier 2905(2) is oval, the test device can automatically acquire knowledge that the current sample contains urine from a female and accordingly select an analysis process. In step 3012, the test device determines one or more properties of the urine, for example, by using the second camera module 2230B. For example, the test strip can be adapted to enable the test device to determine the concentration level of one or more types of female hormones (e.g., FSH, LH, or HCG). Finally, in step 3014, the user uses the test device to automatically analyze the results of the male and female biological samples and determine a final result regarding the fertility of the subject.

[0172] In some particular examples, the first camera module 2230A can have a lower camera resolution compared to the second camera module 2230B, and therefore the two cameras are used by the processor to perform different analysis processes. In addition, the first camera module 2230A can have a lower magnification ratio compared to the second camera module 2230B. Some examples of the first camera module 2230A can not have a magnification function at all, while the second camera module 2230B can have a fixed magnification ratio. In addition or as an alternative to the second camera module 2230B which has a higher magnification ratio by itself, the housing 2210B of the second holding region 2215B can include a magnification assembly, such as FIG. 22The camera modules can be configured to capture images of the first holding region 2215A and the second holding region 2215B, respectively. In some implementations, the magnification ratio of the camera modules can be adjustable (e.g., controlled by the processor). Some examples of the testing device provide that the first camera module 2230A has a camera resolution of 2 megapixels or higher, and the second camera module 2230B has a camera resolution of 13 megapixels or higher. In some examples, the second camera module 2230B can include a linear magnification ratio of at least 4.8x or higher.

[0173] In some of these examples, the processor further determines at least one additional characteristic of the sperm using the first camera module 2230A. This additional characteristic can include the acidity of the sperm. For example, the carrier can include a pH indicator in the first holding region 2215A that uses a color to indicate the acidity of the sperm, which the processor can recognize to identify the acidity. Similarly, some examples provide that the processor can determine a biochemical characteristic of the biological sample based on a color of a region in one or more images of the first or second holding region.

[0174] Continuing with the above testing device examples having a multi-camera configuration in FIG. 22 and the carrier examples in FIG. 29 In some implementations, when the processor identifies that the first holding region (e.g., region 2215A or region 2915A of carrier 2905(2)) exhibits a second shape (such as an oval shape) that can indicate that the biological sample includes urine from a female subject, the processor is configured to determine one or more characteristics of the urine. The characteristics that can be determined can include: LH level, FSH level, and / or HCG level. As with the acidity, the determination of the one or more characteristics of the urine can be performed using the first camera module. Similarly, the carrier can include an LH indicator (e.g., as shown in carrier 2905(3)), an FSH indicator (e.g., as shown in carrier 2905(2)), and / or an HCG indicator (e.g., as shown in carrier 2905(4)) in the first holding region (e.g., region 2915A of the individual carriers).

[0175] Further, in some specific examples, the processor can utilize at least one of the two camera modules (e.g., the first camera module 2230A) or another sensor (e.g., a light sensor 2690 introduced below with respect to FIG. 26) to determine a readiness state or validity of the biological sample prior to performing the analysis process. In some implementations, the readiness state or validity of the testing sample can be determined based on identifying whether a first visual marker is displayed in a particular region (e.g., where line 2916 is shown in FIG. 29 This example of the first visual marker can be a line displayed in a certain designated region on the test strip, such as in FIG. 29a red line 2916. The red line 2916 can be a quality control feature that can indicate that the test is valid or that the results are ready. Additionally, the first holding region 2915A can include another region that displays a second visual indicia (e.g., where a line 2917 is shown in FIG. 29 ) that indicates the test results regarding the characteristics of the biological sample. An example of this second visual indicia can be a line displayed in another certain designated region on the test strip that is ready status, such as in FIG. 29 ) is shown as a red line 2917.

[0176] In some embodiments, the test device can perform an action in response to a determination that the biological sample is not ready. In some embodiments, the action performed by the processor includes implementing a timer having a duration determined by the analysis process to be performed. In some other embodiments, the test device further includes a moving mechanism, and the processor in the test device can utilize the moving mechanism to apply a mechanical force to the carrier to increase the readiness of the biological sample. More details of the actions and mechanisms that can be implemented in the test device are introduced below with respect to FIG. 25 FIG. 25A and FIG. 25B ) and FIG. 26 FIG. 26A and FIG. 26B ).

[0177] The positions of the magnification components (e.g., the magnification components of the camera modules or the magnification components of the test strip) and the positions of the light sources can be adjusted or selected depending on the requirements of various types of analyte analysis. In variations, the camera modules can have adjustable magnification ratios. In at least some of these embodiments, the processor is further configured to adjust the magnification ratio of at least one of the two camera modules based on the analysis process that the processor is currently configured to perform. As introduced above, when the biological sample includes sperm, the test device can configure the appropriate camera module (e.g., the second camera module 2230B) to different magnification ratios for determining the motility of the sperm and the morphology of the sperm.

[0178] It should be noted that the optimal distance between the camera module and the magnification component can have a low error margin. For example, even a slight deviation of 0.01 mm from the optimal distance can prevent the camera module from capturing a clear image of the sample holding region. To fine-tune the distance between the camera module and the magnification component, the test device can include an auto-focus (AF) function. The auto-focus function is a function that automatically adjusts the optical system (e.g., adjusts the distance between the components of the optical system) so that the object being imaged (e.g., the semen) is within the focal plane of the optical system. At least one or more embodiments also provide a mechanical focusing mechanism that can be controlled by the processor to focus at least one of the two camera modules on the individual holding region. More details are introduced below with respect to FIG. 23 and FIG. 24The mechanical focusing mechanism is discussed in more detail. The mechanical focusing mechanism can be controllable to adjust the position of the lens in at least one of the two camera modules (e.g., as generally shown in FIG. 23 Additionally or alternatively, the mechanical focusing mechanism can be controllable to adjust the position of the carrier (e.g., as generally shown in FIG. 24

[0179] FIG. 23 is a schematic view of components of a test device with autofocus functionality. As shown in FIG. 23 the test device can move the camera module up or down along the Z-axis (e.g., by a motorized track, an ultrasonic motor drive, or a stepper motor). By adjusting the vertical position of the camera module, the test device can adjust the distance between the camera module and the magnification assembly.

[0180] FIG. 24 is a schematic view of components of another test device with autofocus functionality. As shown in FIG. 24 the test device can move the test strip device up or down along the Z-axis. By adjusting the vertical position of the test strip device, the test device can adjust the distance between the camera module and the magnification assembly.

[0181] During the autofocus operation as shown in FIG. 23 or FIG. 24 the camera module and the supplemental lens remain as a single module. In other words, the distance between the camera module and the supplemental lens remains unchanged during the autofocus operation as shown in FIG. 23 or FIG. 24

[0182] FIG. 25B is a B-B cross-sectional view of a test device including a switch and a motor. FIG. 25A The B-B cross-section of the test device 1900 in FIG. 25B shows various components of the test device. The test device 1900 includes a switch 2550 to detect a collection vial 2510 inserted into the test device 1900. When the collection vial 2510 is inserted, the switch 2550 is activated. The collection vial 2510 is then informed to the test device 1900 via the switch 2550. Based on the time period that the switch 2550 is activated, the test device can determine the time period that the collection vial 2510 remains inserted.

[0183] The test device 1900 further includes a motor 2560 to shake, vibrate, or rotate the collection vial 2510 in order to mix the sample in the collection vial 2510. The test device 1900 can include a camera 2570 to determine whether the sample has been liquefied based on a captured image of the sample in the collection vial 2510.

[0184] FIG. 26B is a​​FIG. 26A C-C cross-sectional view of a test device comprising a flexible element. FIG. 26B A B-B cross-section of the test device 1900 in FIG. 19B shows various components of the test device. The test device 1900 comprises a mobile element 2680 (e.g., a resilient component) at the bottom of a slot for movably receiving a collection vial 2610. For example, the mobile element 2680 can comprise a spring that can spontaneously return to its normal shape after being contracted or deformed. When the collection vial 2610 is inserted into the slot, the mobile element 2680 is compressed. A light sensor 2690 (or other type of distance sensor) is responsible for detecting the distance between the light sensor 2690 and the bottom of the collection vial 2610. Based on the distance between the light sensor 2690 and the bottom of the collection vial 2610, the test device 1900 can determine the weight or volume of the sample contained in the collection vial 2610. For example, the distance between the light sensor 2690 and the bottom of the collection vial 2610 can be inversely proportional to the weight or volume of the sample contained in the collection vial 2610.

[0185] In some other embodiments, the test device 1900 can comprise a sensor on the top of the collection vial 2610. The sensor can be responsible for detecting the distance between the sensor and the top of the collection vial 2610. The weight or volume of the sample contained in the collection vial 2610 can be determined based on the distance, since the volume or the weight can be, for example, directly proportional to the distance between the sensor and the top of the collection vial 2610. In turn, based on the weight or volume of the sample, the test device 1900 can determine the time period for which the sample in the collection vial 2610 is to be liquefied. The test device 1900 further comprises a motor 2660 for shaking, vibrating, or rotating the collection vial 2610 in order to mix the sample in the collection vial 2610.

[0186] In some embodiments, the camera module of the test device can comprise a light field camera (not shown) that captures the intensity and direction of light rays. The light field camera can comprise a microlens array or a multi-camera array in front of an image sensor to detect directional information. Using the directional information of the light rays, the camera module can capture sharp images at a wide range of focal planes. Thus, the test device using the light field camera can not need an autofocus function to finely adjust the distance between the camera module and the magnification component.

[0187] In view of the above, the device of the present invention is suitable for testing male fertility and / or female fertility.

[0188] This invention provides a method for testing male fertility using the device of this application. The method includes the following steps: applying a biological sample from a male subject to a first holding region and a second holding region of a carrier; inserting the carrier into the device; determining the acidity of sperm according to a first analysis procedure; determining one or more characteristics of sperm selected from a group consisting of the following according to a second analysis procedure: sperm concentration, sperm motility, and sperm morphology; and using the analysis results to determine male fertility.

[0189] The present invention also provides a method for testing female reproductive hormones using the device of this application. The method includes the following steps: applying a biological sample from a female subject to a first holding region of a carrier; inserting the carrier into the device; and determining the concentration level of one or more types of female hormones, such as luteinizing hormone (LH), follicle-stimulating hormone (FSH), or human chorionic gonadotropin (HCG).

[0190] The present invention further provides a method for testing the fertility of a male and female pair of subjects. The method includes the following steps: applying a biological sample from the male subject to a first and second holding regions of a first carrier; inserting the first carrier into a device; determining sperm acidity according to a first analytical procedure; determining one or more characteristics of sperm selected from a group consisting of sperm concentration, sperm motility, and sperm morphology according to a second analytical procedure; applying a biological sample from the female subject to a holding region of a second carrier; inserting the second carrier into the device; determining the concentration levels of one or more types of estrogen; and analyzing the results of the male and female biological samples.

[0191] FIG. 27 This is a flowchart of a procedure for processing semen samples used to analyze male clients or patients. Systems used for analyzing semen samples may include testing machines (e.g., testing device 1900), mobile devices, and cloud servers. FIG. 28 This is a flowchart of a procedure for analyzing LH or HCG in female clients or patients. Systems used for analyzing LH or HCG may include testing machines (e.g., testing device 1900), mobile devices, and cloud servers. FIG. 27 and FIG. 28 The flowchart illustrates the steps performed through the test machine, mobile device, and cloud server, as well as the information transmitted between the test machine, mobile device, and cloud server.

[0192] In some embodiments, a method for testing sperm comprises the steps of obtaining a device for testing a biological sample, applying a sperm sample to a sample holding area, recording a video or image of the sperm sample; determining a sperm count of the sperm sample based on at least one frame of the recorded video or recorded image; and determining sperm motility of the sperm sample based on the recorded video or recorded image.

[0193] In related embodiments, the method further comprises waiting for a predetermined period of time for liquefaction of the sperm sample prior to applying the sperm sample to the sample holding area.

[0194] In another related embodiment, the method further comprises positioning a mobile device comprising a camera assembly on a top portion of the device such that the camera assembly is aligned with the magnification assembly and the sample holding area; and receiving, by the mobile device, light signals from the sperm sample in the sample holding area via magnification by the magnification assembly.

[0195] In yet another related embodiment, the method further comprises illuminating the sample holding area by a lateral illumination device disposed on a side of a carrier of the device or a vertical illumination device disposed on a top portion or below a carrier of the device.

[0196] In still another related embodiment, the method further comprises directing a light beam from the lateral illumination device through a carrier made of a transparent or translucent material; and reflecting the light beam to the sample holding area by a plurality of light reflecting patterns included in the carrier.

[0197] In yet another related embodiment, the method further comprises inserting a disposable testing device into a base comprising a camera assembly for recording a video of the sperm sample or a form fitting frame for securing a mobile device comprising a camera assembly for recording a video of the sperm sample.

[0198] In still another related embodiment, the method further comprises extracting at least one frame from the recorded video of the biological sample; identifying a plurality of sperm from the at least one frame; and calculating a sperm count based on a number of the identified sperm and an area recorded by the at least one frame.

[0199] In yet another related embodiment, the method further comprises analyzing a shape of the identified sperm; and determining a morphology level based on the shape of the identified sperm.

[0200] In yet another relevant specific example, the method further includes: extracting a series of video frames from a recorded video of a sperm sample; identifying multiple sperm from the series of video frames; identifying the movement trajectory of the sperm based on the series of video frames; determining the movement speed of the sperm based on the movement trajectory of the sperm and the time period captured from the series of video frames; and calculating sperm motility based on the movement speed of the sperm.

[0201] In yet another relevant specific example, the method further includes: further magnifying a video or image of a sperm sample via a magnifying lens.

[0202] In some specific instances, a method for testing sperm using a system for testing biological samples includes: inserting a device into a base assembly; recording a video of a sperm sample in a sample holding region via a movable device fixed in a shape-fitting frame of the base assembly; determining the sperm count of the sperm sample based on at least one frame of the recorded video; and determining the sperm motility of the sperm sample based on the recorded video.

[0203] In a specific example, the method further includes: further magnifying the video of the sperm sample via a magnifying lens.

[0204] In some specific examples, the system for testing biological samples includes a disposable device and a base assembly for testing the biological samples. The disposable device includes a sample carrier containing a sample holding region and a removable outer cover placed on top of the sample holding region. The base assembly includes an insertion port for inserting the disposable device into the base assembly and a camera assembly for capturing images of the sample holding region, the camera assembly including an image sensor and an optical lens module. In relevant specific examples, the optical lens module may have a linear magnification ratio of at least 0.1.

[0205] FIG. 31 An additional instance carrier 3105 is shown to have one or more visual symbols 3117(1)-3117(5) (or may be collectively referred to as visual cues 3117) available to control the analysis processing procedures performed by the measuring device (e.g., FIG. 21C or FIG. 22 (The test apparatus shown). FIG. 31 As shown, visual cue 3117 may be in or near the holding region of carrier 3105 (e.g., holding region 3115B, in some other or alternative embodiments).

[0206] As mentioned above (for example, regarding...) FIG. 29), the processor can execute different analysis processes based on the visual cues on the carrier. For example, in some specific embodiments, image recognition can be performed and the image of the holding area can be processed and different analysis processes can be executed based on the results from the image recognition. In some embodiments, the visual cues of the carrier can be a shape of a particular holding area. Further visual cue embodiments can include graphical patterns, visual markers, one-dimensional barcodes, multi-dimensional pattern codes (e.g., QR codes), etc.

[0207] In some specific embodiments, as shown in FIG. 31, the visual markers (e.g., visual markers 3117(1)) can be a particular small graphical pattern that can be imprinted, attached, or marked on the holding area 3115B in the carrier 3105. FIG. 31 FIG. 31 In the example of FIG. 31, the visual markers 3117(1)-3117(5) are all the same or substantially similar patterns, however, in other examples (not shown for simplicity), they do not have to be exactly the same and each visual marker can have a unique shape, size, pattern, etc. In one or more embodiments, the visual cues 3117 (e.g., visual markers 3117(1)-3117(5)) are of a size that is not perceptible by a human but can be recognized by a camera module (e.g., camera module 2130 of FIG. 21) via a microscope lens (e.g., microscope lens 2132 of FIG. 21) that magnifies the visual cues 3117. FIG. 22 FIG. 21C In some embodiments, the visual markers 3117(1)-3117(5) are less than 15 micrometers (pm) in size. In addition, the visual markers 3117(1)-3117(5) can be configured such that their positions collectively form a pattern (e.g., a predetermined configuration). In addition or as an alternative to the unique characteristics of the visual markers (e.g., size, shape, color, and / or position), this collective pattern formed by the positions of each visual marker can be an identifiable cue that can be used to control the functionality of the testing device (e.g., whether and, in turn, which analysis process to execute). This collective pattern can be based on the absolute positions of the visual markers (e.g., in the holding area) and / or the relative positions of the visual markers (e.g., from their respective neighboring markers). FIG. 31 In the example of FIG. 31, the collective pattern shown by the visual markers 3117(1)-3117(5) is that each of the visual markers 3117(1)-3117(4) is positioned at a corner (of the camera-captured image) and the visual marker 3117(5) is positioned at the center, each of the visual markers is evenly distributed. Some additional or alternative embodiments provide that each (or each group of) particular visual marker (or marker) of the visual cues can represent a different analysis function to be executed.

[0208] ​​In view of the above, the test device herein can utilize visual cues on the carrier (e.g., in or near the holding area) to control the functionality of the test device and adaptively perform an analysis processing procedure based on the visual cues. In some embodiments, the visual cues can be used to confirm whether the carrier is an authorized carrier (e.g., properly authorized and manufactured in compliance with certain specifications and according to applicable quality standards). In other examples, the visual cues can be used to control the test device to perform the calculations in which mode (e.g., male or female, lab or home, high accuracy or short time, use battery or plug-in). Moreover, providing visual cues in some embodiments can be used to control access to certain functionality of the test device, which provides the ability to flexibly tailor the services provided by the test device according to the identity of the customer, geographic location, etc.

[0209] FIG. 32 The test device disclosed herein (e.g., in FIG. 21C or FIG. 22 ) adaptively performs an analysis processing procedure based on visual cues can implement a processing procedure 3200 further example flowchart. With continued reference to FIG. 31 , the processing procedure 3200 is explained below. It should be noted that in the following example of the processing procedure 3200, the visual cues are applied to perform a carrier authentication application, however the processing procedure can equally be adapted to perform other applications (e.g., as described with respect to FIG. 30 ). For example, in some applications that are not carrier verification, the processor can perform a different set of analysis processing procedures based on different visual cues.

[0210] First, at step 3202, a carrier inserted through the opening is received by the receiving mechanism of the test device, a sensor (not shown for simplicity) can notify the processor, which will cause the camera module built-in the test device to capture one or more images of the carrier holding area. At step 3204, the processor can identify the visual cues in the carrier (e.g., based on known image analysis techniques or those disclosed herein) using the captured images. As discussed above, the visual cues can include some visual marks, each of which can be the same or different size, shape, pattern, color, etc. (as in the example shown in FIG. 31 ). The visual marks can further collectively present a pattern (e.g., from their positions). Then, the processor can compare the visual cues (e.g., the specific size, shape, position, or collective pattern) with predetermined visual cues (e.g., stored in the local memory and / or a cloud database (which can be operated or controlled by the manufacturer of the test device or other administrator)).

[0211] In step 3206, the processor selectively performs a set of analytical processing procedures on the captured image of the holding region based on the recognition result of the visual cues. If the recognition result of the visual cues is positive (e.g., responding to a carrier holding region with a predetermined visual cue), the processor then proceeds to subsequent steps, which may include selectively capturing additional images (or videos) for analysis (step 3208) and performing a corresponding set of analytical processing procedures on the images (step 3210). On the other hand, if the recognition result is negative (e.g., responding to a carrier holding region without a predetermined visual cue), the processor performs an alternative action (e.g., displaying an error code) to reflect the unrecognizable visual cues and does not perform any analytical processing procedures on the images (step 3212). After the set of analytical processing procedures has been executed, the processor may continue to determine the results regarding the biological sample based on the results of the analytical processing procedures as described above.

[0212] Furthermore, it is worth noting that traditional computer-assisted sperm analyzers (CASA) rely on large microscopes and the experience of operators to determine sperm parameters. Some computer software programs exist to supplement the experience of technicians and to standardize analytical results. However, due to differences in lenses and sensing modules, blurred images often severely affect the effectiveness of the software, leading to inaccuracies in related functions (such as sperm count).

[0213] Furthermore, regulatory authorities such as the World Health Organization (WHO) publish laboratory manuals for the examination and processing of human semen, which specify the minimum sample size (e.g., 200 sperm) required to assess sperm concentration, motility, and morphology. Existing computer-aided sperm analysis based on images generally lacks automated sampling or requires manual operation to obtain multiple fields of view to meet WHO standards and reduce sampling errors. Alternatively, if sampling is performed repeatedly using a single field of view, the time required for repeated procedures to achieve a satisfactory low sampling error often becomes too long to be implemented on a large scale.

[0214] FIG. 33 It is a device that can be tested here (e.g., FIG. 21C or FIG. 22 The flowchart of an example of a processing procedure 3300 implemented for better results (e.g., better analytical accuracy or efficiency). Processing procedure 3300 may be located here (e.g.) FIG. 16 Alternative or supplementary processing procedures to the processing procedures shown.

[0215] First, at step 3310 (e.g., upon insertion of a carrier cassette carrying the biological sample or having been exposed to the biological sample (as introduced above)), the introduced device can utilize a camera module to capture one or more images (or collectively, imagery) of the carrier cassette holding area. In some alternative embodiments (e.g., with respect to the FIG. 29 or 31), the device can identify (step 3320) visual cues on the carrier from the captured imagery of the holding area. In these alternative embodiments, the device can perform a set of analysis processes on the captured imagery based on the identification of the visual cues.

[0216] At step 3330, the device can segment the captured imagery into a plurality of tiles. In certain embodiments, the tiles can be polygons. More particularly, some embodiments indicate that the tiles can be triangles, rectangles, squares, pentagons, hexagons, etc. The shape of these (tiles) can have at least one side that is 0.05 mm. In one or more embodiments, the tiles are squares and have a size of 0.05 mm by 0.05 mm. Notably, depending on the implementation, the number and size of the tiles can be adjusted according to the resolution of the camera module. In FIG. 34 An example of an image of a holding area segmented into a plurality of tiles (e.g., tiles 3402) is illustrated. It should be noted that, for the purposes of facilitating the discussion of the disclosed technology herein, the captured imagery is considered to be "segmented" into tiles; however, in one or more implementations it should be appreciated that the processor need not actually perform a mathematical division operation to implement the technology during computer runtime (or while normally operating); rather, the resulting tiles or grid can be predetermined, logically pre-associated, programmatically preset, or pre-configured on the camera controller and / or processor of the device, such that the need for performing the operation of segmenting the imagery into tiles can be reduced, or in some instances eliminated altogether.

[0217] At step 3340, the example device selects from the plurality of tiles, candidate tiles for analysis. According to one or more embodiments, the selection of the candidate tiles is based on a number of factors, such as the focus of a tile and / or the normality of a tile.

[0218] More particularly, in many embodiments, the device can determine (step 3342) the focus of each of the plurality of tiles, such that each tile can have a corresponding focus measurement. The focus can be determined based on one or more focus measurement functions. Depending on the implementation, the focus measurement function(s) that are employed can include one or more of: a variance type, a coefficient of variation sum type, a Laplacian energy image type, and / or a side gradient intensity maximization type.

[0219] After determining the focus level of each block, in some embodiments, the device compares the focus level of a block with a minimum focus level threshold. In one or more embodiments, a block can be selected as a candidate block only if its focus level meets (e.g., reaches or exceeds) the minimum focus level threshold. Furthermore, the device can also tag or label blocks. In one or more embodiments, the device indicates that blocks are tagged or labeled only if they meet the minimum focus level threshold (e.g., for further analysis or tracking identification). Tagging or labeling can be done sequentially or randomly. FIG. 35 The description describes a selection process for a portion of the candidate blocks. Here, blocks are randomly labeled, and blocks that exceed the minimum focal length threshold are initially selected as candidate blocks 3510.

[0220] Next, the device can perform image processing on multiple selected blocks to determine the characteristics of the selected blocks (step 3344) to determine the normality of a block, such as whether the block is "sufficiently normal" to grant further analysis. In some instances, the blocks selected for normality determination are those that have been initially selected as candidate blocks (e.g., those that meet the minimum focus threshold, as explained above). In some instances, the characteristic used at this stage to determine normality is cell count (e.g., sperm count). In specific instances, the device can perform image processing on blocks that meet the minimum focus threshold (i.e., they are sufficiently focused) to determine the cell (sperm) count within each sufficiently focused block. This image processing may include binarization (and in some implementations, combined with adaptive constraints) to identify objects in the block that may be sperm as foreground and the remainder of the block as background. After image processing, the device can determine the cell (sperm) count. In one or more embodiments, the number of cells in a candidate block can be determined based on the ratio of areas with sperm to areas without sperm (e.g., by extrapolation using a table associated with a known ratio of cell counts).

[0221] Afterwards, the device can calculate statistics (e.g., mean and standard deviation) for all remaining candidate blocks (e.g., those that satisfy the minimum focus level threshold). After the statistics are calculated, the device can determine (step 3344) the normality of the particular block by statistically comparing one or more characteristics (e.g., sperm count) of the particular block to those of all remaining candidate blocks. In some embodiments, a particular block is only continued to be considered as a candidate block if it satisfies a normality condition. Using sperm count as an example, in various embodiments, a block is considered "sufficiently normal" (e.g., satisfies the normality condition) when the sperm count in the block is within a pre-determined number of standard deviations from the mean of the sperm counts in the blocks. In one or more implementations, the normality requirement is within two standard deviations from the mean. In other implementations, the normality requirement is within one or three standard deviations, or other suitable statistical technique that reflects the comparison of a block to the group of blocks for normality. In FIG. 36 In FIG. 6B, the result of the image processing procedure (e.g., adaptive thresholding binarization) and cell count determination is shown. Note that in FIG. 36 In FIG. 6B, the result of the image processing procedure (e.g., adaptive thresholding binarization) and cell count determination is shown. Note that in

[0222] In addition, the device can determine (step 3346) whether a target number of cells to be analyzed has been reached. In particular, one or more embodiments of the disclosed device can maintain a total cell count, and for each block selected as a candidate block, the device adds the corresponding cell count of the block to the total cell count. The device can use this target number of cells to be analyzed to control the amount of biological sample to be analyzed, and this amount can be configurable depending on the implementation. This amount (number) can be made according to laboratory manuals and standards for testing particular biological samples. In some embodiments, the target number of cells to be analyzed is two hundred (200). In certain instances, the selection of candidate blocks is complete when the total cell count reaches the target number of cells to be analyzed. That is, according to at least certain embodiments disclosed herein, the selection of candidate blocks can be performed (e.g., in a random manner) on blocks that satisfy the focus level threshold and the normality requirement that the total cell count reaches the target number of cells to be analyzed.

[0223] At step 3350, after a candidate region is selected, the introduced device can determine one or more characteristics of the biological sample by analyzing the selected candidate region (e.g., by one or more techniques introduced herein). In at least some embodiments, the biological sample is semen, and the one or more characteristics of the biological sample that are to be determined in the one or more candidate regions include one or more of: cell count (or concentration, which can be inferred from cell count), motility, or morphology. In some instances, the device is further configured to determine a result (e.g., fertility) about the biological sample based on the results of the set of analysis processes after the set of analysis processes are performed.

[0224] Further, it is observed herein that it is often difficult to manufacture lens assemblies perfectly (especially in large quantities and when cost control is a concern), such as microscopic lens assemblies and / or magnifying lens assemblies that are mounted on the test devices introduced herein. Lens imperfections exist in a variety of forms, such as impurities, or imperfections in the lens itself (e.g., clarity, refraction, focus, and others), and these imperfections can adversely affect the accuracy of the test devices. Accordingly, introduced herein are calibration and qualification techniques to mitigate lens imperfections and further improve the analytical accuracy of the test devices disclosed herein.

[0225] FIG. 37 An example flowchart 3700 of a calibration process can be implemented by a test device disclosed herein (e.g., the test device of FIG. 21C or FIG. 22 ) to obtain improved results. This process 3700 can be an alternative or supplemental process to the processes disclosed herein, such as the processes described in FIG. 16 .

[0226] First, at step 3710 (e.g., after the carrier cassette is inserted), the introduced device can use the camera module to capture one or more images (or collectively, imagery) of the holding area of the carrier cassette. In some optional embodiments (e.g., those described with respect to FIG. 29 or 31, the device can identify (step 3720) the visual cues on the carrier from the captured imagery of the holding area. In these optional embodiments, the device can perform a set of analysis processes on the captured imagery based on the results of the identification of the visual cues.

[0227] More specifically, in some implementations, the carrier cassette herein can serve as a special virtual cassette that can be used to trigger the calibration process. For example, the special virtual cassette can have one or more special graphical patterns (e.g., those described with respect to FIG. 38As described below, the test device can be triggered to enter a calibration mode after the visual cue recognition process (e.g., in step 3720). In another example, a special virtual cartridge can carry a special test sample (e.g., a special dye or other substance) that can trigger the calibration mode. FIG. 41 As described below, and using the test device, a user can manually cause (e.g., through a user interface on the test device or a remote control) the test device to enter a calibration mode. In many examples, the virtual cartridge can include an electronic (e.g., a radio frequency identification (RFID)) or a mechanical feature (e.g., a special shape or mechanical protrusion) that can trigger the calibration mode.

[0228] FIG. 38 A test cartridge carrying a visual cue or image pattern can be used to calibrate or verify the test device disclosed herein. In one or more embodiments, the visual cue includes an image pattern that the test device can recognize as a trigger to enter a calibration mode. The test device can then use the camera module to capture an image of the image pattern and perform a self-diagnostic to self-correct from the results in the captured image. The visual pattern should be easily recognizable (and not easily mistaken). As explained in FIG. 38 the example described in FIG. 6, the visual pattern includes repeating (e.g., every 0.08 mm, i.e., a repeat rate or "pitch"), larger (e.g., 0.02 mm by 0.02 mm) and generally regular shapes. The visual cue can further include one or more repeating linear patterns. In FIG. 38 the example described in FIG. 7, the linear pattern includes a set (e.g., three) of horizontal lines and a set (e.g., three) of vertical lines. In some embodiments, the lines have a resolution of 200 line pairs per mm (LP / mm) or higher. In FIG. 38 a particular example, the lines have a resolution of 500 LP / mm. It should be noted that the horizontal and / or vertical lines are examples of visual linear patterns suitable to assist the test device in performing a self-diagnostic of the optical characteristics and performance of a particular optical instrument (e.g., a microscope lens) installed in the test device itself; other suitable visual patterns can be substituted for the example described in FIG. 38 FIG. 7. For example, in some embodiments, an "E" shape pattern or equivalent can be substituted for the parallel lines as the visual linear pattern. For example, in some embodiments, solid and dashed lines can be used for the visual linear pattern.

[0229] Continuing with process 3700, despite the fact that the calibration mode has been initiated at step 3730, after the collective image of the carrier is captured (e.g., at step 3710), the apparatus can segment the captured collective image into a plurality of tiles (similar to step 3330, discussed above). In some embodiments, the tiles can be polygonal. More specifically, some embodiments indicate that the tiles can be triangular, rectangular, square, pentagonal, hexagonal, etc. These shapes (of the tiles) can have at least one side of 0.05 mm. In one or more embodiments, the tiles are square and have a size of 0.05 mm by 0.05 mm. Notably, the number and size of the tiles can be adjusted depending on the resolution of the camera module, according to the particular implementation. In one or more embodiments, the pitch (e.g., the regularity at which the visual pattern repeats itself) mentioned above can correspond to the number of tiles into which the collective image can be segmented. In some embodiments, the pitch can be consistent with the number of tiles into which the collective image can be segmented by the testing apparatus.

[0230] At step 3740, the apparatus in the example can perform a calibration / self-diagnostic procedure, e.g., at each tile. The calibration procedure, which can be one or more steps, can enable the testing apparatus to autonomously self-diagnose the quality of the optical module (e.g., including the microlenses, the camera module) currently installed on the testing apparatus itself. In one or more embodiments, the testing apparatus can determine (at step 3742) the degree of focus of each tile, e.g., by using one or more focus measurement functions. Examples of focus measurement functions can include the variance type, the sum of differences of coefficients type, the Laplacian energy image type, and / or the side gradient intensity maximization type. Next, at step 3744, the testing apparatus can determine whether a tile satisfies the degree of focus, e.g., the minimum degree of focus threshold discussed above. Additionally or alternatively, the testing apparatus can compare the captured results with one or more expected results (at step 3746). For example, the processor of the testing apparatus has access to one or more pre-installed images in the memory (e.g., not captured using the camera, e.g., delivered or pre-installed by the program), compares the captured image with the pre-installed image, and determines whether the questionable captured image quality in the tile satisfies the minimum standard. The pre-installed image(s) should be representative of the visual pattern applied for calibration. At step 3746, the testing apparatus can compare and review example image quality parameters, including color distortion, pattern distortion, sharpness defects, and / or other image defects.

[0231] FIG. 39 is an example image of a visual cue FIG. 38 captured by the testing apparatus disclosed herein, the image quality is generally better in the lower left corner and worse in the upper right corner. FIG. 40A and 40B are two images of a visual cue FIG. 39Specific examples of different image qualities of images captured in different zones are illustrated. In some embodiments, for example, where the pitch is consistent with the number of zones that can be divided from a collective image, images 40A and 40B can represent one zone each. As illustrated, FIG. 40A the image quality in the zone is better FIG. 40B because the image is clearer and more in focus.

[0232] Returning to process 3700, in step 3750, the results of step 3740 (e.g., whether the zone meets the minimum image quality requirements, such as a minimum degree of focus) are recorded in a computer readable storage medium (e.g., which can be non-transitory, such as flash memory) associated with the testing device (which, for simplicity, is not further described). The knowledge gained from the correction process can be used, for example, when the testing device is utilized in later normal operation. In one or more embodiments, the testing device can automatically skip or ignore those zones that failed to meet the minimum image quality requirements during the correction or self-diagnostic at this time in normal operation (e.g., in step 3340, as discussed above). In this way, the testing device disclosed herein can mitigate the effects of lens imperfections and increase the accuracy of the analysis.

[0233] FIG. 41 It is disclosed that a test carrier carries an example image of a test sample that can be used to correct or verify the testing device disclosed herein. This technique can be applied in one or more of the previously described embodiments, a special virtual cartridge can carry a special test sample and the correction mode can be initiated by a trigger other than a visual pattern (e.g., manually initiated by a user, or by a mechanical feature or a radio frequency identification (RFID) on the virtual cartridge). Some embodiments indicate that the test sample should be in the form of an aqueous medium (e.g., a liquid solution) containing small test particles, such as test particles 4102, which are illustrated in FIG. 41 FIG. 4. The particles can be made of any suitable material, including, for example, a polymer. A particular particle 4102 example material is latex. The size of the particles can be adapted to the particular application. In some implementations, the size of the particles can be similar to the size of those cells, such as sperm. An example size range of the particles can be from 0.5 microns to 50 microns in diameter. In an example, the particles are 5 microns in diameter. When the test particles are used as a sample, the testing device can perform the correction / self-diagnostic as in process 3700 without step 3720 and self-diagnose the quality of the optical module currently installed in itself. In some of these implementations, the testing device can pre-install images of the test particles (e.g., not captured by the camera, such as by being transmitted or otherwise programmed to be installed) in the memory, such as discussed above, for comparison and correction purposes.

[0234] FIG. 42Aand 42B illustrate different image qualities in different tiles of an image captured in FIG. 41 As illustrated, FIG. 42A image quality in the tiles is FIG. 42B better because the image is sharper and more in focus. Similar to the discussion above, knowledge of the baseline image quality of each tile can be used, for example, when the testing device is utilized during normal operation thereafter, with respect to step 3750. For example, some testing instrument embodiments can automatically skip or ignore tiles that failed to achieve the minimum image quality conditions at calibration or self-diagnose. In this way, the testing devices disclosed herein can mitigate the effects of lens imperfections and improve analysis accuracy.

[0235] While some of the specific examples disclosed herein apply the disclosed technology to sperm testing, those skilled in the art will readily appreciate that the disclosed technology can be applied to testing various types of biological samples, such as semen, urine, synovial fluid, surface tissue or cells, tumor cells, water samples, etc.

[0236] It will be apparent to those skilled in the art that various modifications and variations can be made in the structure of the present application without departing from the scope or spirit of the application. In view of the foregoing, it is intended that the present application cover modifications and variations of this application provided they come within the scope of the claims and their equivalents.

Claims

1. A device for testing biological samples, characterized in that, The device includes: A housing having an opening, wherein an external dimension of the housing is less than 27,000 cubic centimeters; A receiving mechanism for receiving a carrier, the receiving mechanism receiving the inserted carrier via the opening, wherein the carrier includes a holding region, wherein the holding region carries the biological sample or has been exposed to the biological sample; A camera module configured to capture a set of images of the fixed region, resulting in a captured set of images; the set of images may be one or more images. and A circuit board carrying a processor configured to utilize the camera module to (1) identify a visual cue on the carrier from the captured set of images of the holding region, and (2) perform a set of analytical processing procedures on the captured set of images based on a result of the identification of the visual cue; the processor is further configured to determine a final result regarding the biological sample based on the result of the set of analytical processing procedures after the set of processing procedures are executed; the visual cue is located in or near the holding region on the carrier; The receiving mechanism, the camera module, and the circuit board are encapsulated within the housing. The analysis and processing procedures in this group include: The extracted image set is divided into multiple blocks; A focus level is determined for each of the plurality of blocks, wherein the focus level is determined based on one or more focal length measurement functions, and the one or more focal length measurement functions include one or more types of variant, sum of difference coefficients, Laplacian energy image, or lateral gradient intensity maximization. Multiple candidate blocks are selected from the plurality of blocks for analysis, wherein the selection of the candidate blocks is based on (1) the focus of the block, wherein the focus of the block is compared with a focus threshold, and the block is selected only if the focus of the block meets the focus threshold, and (2) the normality of the block, wherein the normality of the block is determined by statistically comparing one or more characteristics of the block and the plurality of blocks, and the block is selected as a candidate block only if the block meets a normality requirement; the selection of the candidate blocks is a random execution of satisfying the focus threshold and the normality requirement, wherein the normality requirement is until a total number of cells reaches a target number of cells to be analyzed; Maintain the total cell count; and sum the corresponding cell counts of each selected candidate block to the total cell count, wherein the selection of the candidate block is completed when the total cell count reaches the target number of cells to be analyzed; Furthermore, one or more characteristics of the biological sample are determined by analyzing the multiple selected candidate blocks.

2. The apparatus as claimed in claim 1, characterized in that, The visual cue is a size that is not perceived by humans.

3. The apparatus as described in claim 2, characterized in that, The dimensions are identified by the camera module after being magnified by a microscope lens.

4. The apparatus as claimed in claim 1, characterized in that, One or more characteristics of the block include the number of cells in the block, and the normality requirement is a preset value of a standard deviation of the plurality of blocks.

5. The apparatus as described in claim 4, characterized in that, The preset value for the standard deviation is two standard deviations.

6. The apparatus as claimed in claim 1, characterized in that, The analysis and processing procedure further includes: for each block that meets the focus threshold, performing an image processing procedure to determine the number of cells.

7. The apparatus as claimed in claim 6, characterized in that, The image processing procedure includes adaptive constrained binarization.

8. The apparatus as claimed in claim 6, characterized in that, This set of analytical processing procedures further includes: (1) the average number of cells and (2) the standard deviation of the number of cells are calculated from all blocks that satisfy the focus threshold.

9. The apparatus as claimed in claim 1, characterized in that, The selection of the candidate blocks is further based on the total number of cells, which controls the number of biological samples to be analyzed.

10. The apparatus as claimed in claim 1, characterized in that, The target number of cells to be analyzed is 200.

11. The apparatus as claimed in claim 1, characterized in that, The shapes of the multiple blocks are polygons.

12. The apparatus as claimed in claim 1, characterized in that, The plurality of blocks are triangular, square, pentagonal or hexagonal in shape, and one side of the plurality of blocks is at least 0.05 mm.

13. The apparatus as claimed in claim 1, characterized in that, The biological sample was semen.

14. The apparatus as claimed in claim 1, characterized in that, The biological sample's one or more characteristics include one or more of the following: cell number, motility, or morphology.

15. An apparatus for testing biological samples, characterized in that, The device includes: A housing having an opening, wherein an external dimension of the housing is less than 27,000 cubic centimeters; A receiving mechanism for receiving a carrier, the receiving mechanism receiving the inserted carrier via the opening; The carrier includes a holding region, wherein the holding region carries the biological sample or has been exposed to the biological sample; A camera module configured to capture one or more images of the fixed region to obtain a captured image; and A circuit board carrying a processor configured to use the camera module to (1) identify a visual cue in or near the holding region on the carrier from the captured image of the holding region, wherein the visual cue is a size imperceptible to humans and less than 15 micrometers, and the size is identified by the camera module after being magnified by a microlens, and (2) selectively perform a set of analysis processing procedures on the captured image of the holding region based on a result of the identification of the visual cue, the processor performing the set of analysis processing procedures if the result of the identification returns to positive. If the identification result is negative, the processor will not execute the set of analysis and processing procedures; The analysis and processing procedures in this group include: The extracted image set is divided into multiple blocks; A focus level is determined for each of the plurality of blocks, wherein the focus level is determined based on one or more focal length measurement functions, and the one or more focal length measurement functions include one or more types of variant, sum of difference coefficients, Laplacian energy image, or lateral gradient intensity maximization. Multiple candidate blocks are selected from the plurality of blocks for analysis, wherein the selection of the candidate blocks is based on (1) the focus of the block, wherein the focus of the block is compared with a focus threshold, and the block is selected only if the focus of the block meets the focus threshold, and (2) the normality of the block, wherein the normality of the block is determined by statistically comparing one or more characteristics of the block and the plurality of blocks, and the block is selected as a candidate block only if the block meets a normality requirement; the selection of the candidate blocks is a random execution of satisfying the focus threshold and the normality requirement, wherein the normality requirement is until a total number of cells reaches a target number of cells to be analyzed; Maintain the total cell count; and sum the corresponding cell counts of each selected candidate block to the total cell count, wherein the selection of the candidate block is completed when the total cell count reaches the target number of cells to be analyzed; Furthermore, one or more characteristics of the biological sample are determined by analyzing the multiple selected candidate blocks; The processor is further configured to determine a final result about the biological sample based on the results of the set of analytical processing procedures after the set of analytical processing procedures are executed. The receiving mechanism, the camera module, and the circuit board are encapsulated within the housing.

Images