TWI699532B - Equipment for testing biological specimens - Google Patents

Abstract

The invention relates to an apparatus for testing a biological specimen, the apparatus comprising: a receiving mechanism to receive a carrier, wherein the carrier includes a holding area, wherein the holding area carriers or has been exposed to the biological specimen; a camera module arranged to capture imagery of the holding area; a processor that is configured to utilize the camera module to (1) identify, from the captured imagery of the holding area, a visual cue on the carrier, and (2) perform, based on a result of said identification of the visual cue, a set of analytic processes on the captured imagery, wherein the set of analytic processes includes: dividing the captured imagery into a plurality of segments; selecting, from the plurality of segments, candidate segments for analysis; and determining one or more properties of the biological specimen by analyzing the selected candidate segments.

Description

Device for testing biological samples

The present invention relates to equipment for testing biological samples, and particularly relates to testing equipment with amplification function or analyte quantification function.

At present, the testing of liquid content is usually entrusted to a professional testing organization, which uses expensive microscope equipment with high magnification to perform the test. Since the average person does not have a microscope device, it cannot be performed by the average person.

However, in some of today's test categories, it is necessary to perform regular tests; therefore, for requirements that require frequent tests, it is too burdensome in terms of time and cost. For example, the category of long-term testing includes semen testing for infertile patients. The semen test is mainly based on the observation of the number, motility and morphology of sperm.

The semen test method includes: leaving the semen of a male subject at room temperature for a period of time, taking a drop of the sample and instilling the sample on a glass slide, and observing the sample under a microscope. These observations include not only performing high-magnification observations on individual sperm to identify the external appearance of individual sperm, but also performing observations on a large number of all sperm, their motility, morphology, and quantity per unit area. However, individuals cannot perform semen tests by themselves. This is because the industry has not yet developed a technology that allows individuals to perform tests via simple auxiliary devices.

The present invention provides a device for testing biological samples and a method for determining characteristics of biological samples. The device for testing biological samples includes: a receiving mechanism to receive a carrier, wherein the carrier includes a holding area, wherein the holding The area carries the biological sample or the biological sample has been exposed; a camera module configured to capture a set of images of the holding area to obtain a captured set of images; and a processor, the processor Is configured to use a camera module to (1) recognize a visual cue on the carrier from the captured set image of the holding area, and (2) the recognized based on the visual cue As a result, a set of analysis processing procedures is performed on the captured set image; wherein the set of analysis processing procedures includes: dividing the captured set image into a plurality of blocks; selecting a plurality of blocks from the plurality of blocks Candidate blocks are analyzed, wherein the selection of the candidate blocks is based on (1) the focus of the block, and (2) the normality of the block, and by the plurality of candidate blocks (selected candidate blocks ) Determine one or more characteristics of the biological sample.

The device for testing biological samples of the present invention is cheaper than conventional testing devices, requires less labor for testing, and is easy to use. The technology can be applied to semen testing and other testing fields, such as water containing microorganisms, water quality, blood, urine, body fluids, stool, and skin surface tissues/cells. The technology provides a simple test product with a significantly lower use cost than the prior art using laboratory microscope equipment.

Compared with the prior art, the device for testing biological samples disclosed herein provides a simple structure that can significantly reduce the cost of the sample amplification test structure, and is used for tests such as sperm testing, urinalysis or other body fluid analysis. The technology disclosed herein can be used in a wide range of applications by designing a carrier with a sample holding area, amplifying components, and unique innovative settings. For example, the device for testing biological samples can be applied to detect the count, motility, and morphology of sperm samples.

The device for testing biological samples of the present invention is suitable for performing tests at home. The test results can be obtained immediately and the cost is low. For example, a device for testing biological samples provides a The way in which homes assess the male fertility of couples trying to conceive so that couples can make informed decisions about whether medical intervention is needed.

The disclosed technology can be easily integrated with existing smart communication devices (such as smart phones or single-board computers), and can use the existing smart communication devices to capture enlarged test images and perform subsequent operations, such as storing and transferring images. The low cost of these devices allows them to be implemented as disposable devices or reusable devices.

At least some specific examples of the present invention relate to a device (for example, a test cartridge or a 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 the top of the sample holding area. The detachable housing includes an amplifying component that is configured to align with the sample holding area. The focal length of the magnifying unit is 0.1 millimeter (mm) to 8.5mm. The amplification component has a linear amplification ratio of at least 1.0.

At least some specific examples of the present invention relate to a system for testing biological samples. The system includes the aforementioned device and base assembly for testing biological samples. 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 an image of the sample holding area, or a form-fitting frame for fixing a mobile device including a camera assembly for capturing an image of the sample holding area. The base assembly may further include a supplementary lens placed under the camera assembly. The combination of the magnifying component and the supplementary lens may have an effective linear magnification ratio of at least 1.0.

At least some specific examples of the present invention relate to a method of testing sperm using a device for testing biological samples. The method includes the following steps: obtaining a device for testing the biological sample mentioned above, applying the sperm sample to the sample holding area, and recording the video or image of the sperm sample; based on the recorded video or image At least one frame of the image to determine the sperm count of the sperm sample; and determine the sperm motility of the sperm sample based on the recorded video or the recorded image.

At least some specific examples of the present invention relate to a system for testing biological samples. The system includes a disposable device and a base assembly for testing biological samples. The disposable device includes a sample carrier containing a sample holding area and a detachable cover placed on the 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. A camera including an image sensor and an optical lens module captures one or more images of the sample holding area.

Some specific examples of the invention include devices for testing biological samples. The device may include a housing with an opening. The receiving mechanism can receive the carrier inserted through the opening. The holding area of the carrier may include adjacent first holding areas and second holding areas. The first holding area and the second holding area can carry biological samples or have been exposed to biological samples.

In some implementations, the device may include two camera modules. The camera module is a first camera module configured to capture one or more images of a first holding area, and a second camera configured to capture one or more images of a second holding area Module. In addition, some specific examples include a main circuit board carrying a processor configured to execute a first analysis processing program on the captured image of the first holding area. The processor may be configured to execute a second analysis processing procedure different from the first analysis processing procedure on the captured image of the second holding area. In some specific examples, the processor may determine the result of the biological sample based on the results of both the first analysis processing program and the second analysis processing program. According to one or more specific examples, the receiving mechanism, the first and second camera modules, and the main circuit board are all encapsulated in a housing.

In addition, in some specific examples, when the processor recognizes that the first holding area is in the first shape, the processor is configured to execute a certain analysis processing program. For example, if the first shape indicates that the biological sample includes sperm from a male subject, the processing program can determine one or more characteristics of the sperm. The determinable characteristics may include: cell number (for example, sperm count), sperm concentration, sperm motility, and/or sperm morphology. In some examples, the determination of one or more characteristics of the sperm can be performed by using the second camera module. In some of these instances, the processor further uses The first camera module determines at least one additional characteristic of the sperm. This additional characteristic may include the acidity of the sperm. For example, the carrier may include a pH indicator that indicates the acidity of the sperm in a color in the first holding region, and the processor may recognize the color for identifying the acidity.

In some examples, when the processor recognizes that the first holding area 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 of urine characteristic. The determinable characteristics may include: Luteinizing Hormone (LH) Level, Follicle Stimulating Hormone (FSH) Level, and/or Human Chorionic Gonadotropin (HCG) Level. Like acidity, the judgment of one or more characteristics of urine can be performed by using the first camera module. Similarly, the carrier may include the LH indicator, the FSH indicator and/or the HCG indicator in the first holding area.

In some specific examples, the first camera module has a lower magnification ratio and/or a lower camera resolution than the second camera module.

In some specific examples, the processor may be configured to (1) use the first camera module to recognize the shape of the first holding area on the carrier; and (2) select a set of to be executed based on the shape of the first holding area Analysis processing program. The shape of the first holding area can identify the gender information of the biological sample. Then, in response to the shape of the first holding region being the first shape, the set of analysis processing programs selected by the processor can determine the fertility of the germ cells of the first sex. In addition, in response to the shape of the first holding region being the second shape, the set of analysis processing programs selected by the processor can determine the fertility of the germ cells of the second sex.

The present invention also provides a device for testing biological samples. The device includes: a housing, the housing includes an opening; a receiving mechanism for receiving a carrier, the receiving mechanism receives insertion through the opening The carrier; wherein the carrier includes a holding area, wherein the holding area carries the biological sample or the biological sample has been exposed; a camera module configured to capture one or more images of the holding area , Obtain a captured image; and a circuit board carrying a processor configured to use a camera module to (1) recognize the captured image from the holding area A visual cue in or near the holding area on the carrier, and (2) based on a result of the recognition of the visual cue, selectively executing on the captured image of the holding area A set of analysis processing procedures; wherein the processor is further configured to determine a final result of the biological sample based on the results of the set of analysis processing procedures after the set of analysis processing procedures are executed; wherein the receiving mechanism , The camera module and the circuit board are packaged in the casing.

Preferably, in the above device, the visual cue is a size that is not perceived by humans, and the size is recognized by the camera module after being enlarged by a micro lens.

Preferably, in the above-mentioned device, an external dimension of the housing is less than 27,000 cubic centimeters.

Preferably, the above-mentioned device further comprises: a second camera module, wherein the processor is further configured to use the second camera module to recognize a shape of a second holding area on the carrier.

The present invention also provides a method for determining the characteristics of a biological sample, including: using the device as described above, operating a processor to use a camera module to (1) recognize from the captured collection image of the holding area in the A visual cue on the carrier, and (2) based on a result of the recognition of the visual cue, a set of analysis processing procedures is selectively executed on the captured set image; wherein the set of analysis processing procedures includes: Divide the captured set image into a plurality of blocks; select a plurality of candidate blocks from the plurality of blocks for analysis, wherein the selection of the candidate block is based on (1) the focus of the block, and ( 2) The normality of the block, and one or more characteristics of the biological sample are determined by the plurality of selected candidate blocks.

5: Test strip

10: Carrier

11: Sample holding area

12: Sample receiving port

13: Air channel

14: Protruding parts

15: Flexible transparent film

16: beam assisted guiding structure

20: outer cover

21: Groove

30: Enlarged parts

30B: Enlarged parts

30C: Enlarged parts

31: Enlarged parts

40: sample

42: Sample collection sheet

42A: Sample collection area

50: Side lighting device

60: Smart communication device

61: Camera

70: Instrumentation

71: Lower barrel base

72: Upper barrel body

73: plug into port

74: Magnifying lens

75: Assemble the frame

76: Camera alignment hole

80: light source

92: non-slip film

94: pH test paper

96: Release paper

98: isolation components

1505: step

1510: step

1515: step

1520: step

1525: step

1530: step

1540: step

1545: step

1550: step

1555: step

1605: step

1610: step

1615: step

1620: step

1625: step

1630: steps

1705: sperm

1710: track

1720: Track

1805: Track

1810: curve speed

1815: linear speed

1820: Horizontal head displacement amplitude

1825: average path

1900: test equipment

1905: Test strip devices

1910: collection bottle

1920: screen

2000: Test device

2005: Test strip device

2105: Test strip device

2110: Amplification component

2115: Sample holding area

2130: camera module

2135: lens

2140: light source

2205: Test strip device

2210A: Cover

2210B: Amplifying components

2215A: The first holding area

2215B: The second holding area

2230A: The first camera module

2230B: Second camera module

2240A: light source

2240B: light source

2510: collection bottle

2550: switch

2560: Motor

2570: camera

2610: collection bottle

2660: Motor

2680: moving components

2690: Light Sensor

2905(1): Carrier

2905(2): Carrier

2905(3): Carrier

2905(4): Carrier

2915A: The first holding area

2915B: second holding area

3000: handler

3002: Step

3004: step

3006: step

3008: step

3010: steps

3012: steps

3014: steps

3105: carrier

3117(1): visual sign

3117(2): Visual Sign

3117(3): visual sign

3117(4): visual sign

3117(5): visual sign

3115B: Holding area

3200: handler

3202: step

3204: step

3206: step

3208: step

3210: steps

3212: steps

3300: handler

3310: step

3320: steps

3330: steps

3340: steps

3342: step

3344: step

3346: step

3350: step

3402: block

3510: candidate block

3700: Calibration process

3710: steps

3720: step

3730: steps

3740: step

3742: step

3744: steps

3746: step

3750: steps

4102: test particles

A1: Test device

A2: Test device

A3: Test device

A4: Test device

A5: Test device

A6: Test device

A7: Test device

A8: Test device

A9: Test device

A10: Test device

H1: Focal length parameter

H2: Focal length parameter

L1: Arrow

L2: Arrow

L3: Arrow

S110: Step

S120: Step

S130: Step

S140: Step

Fig. 1A is an exploded view of a device for testing biological samples according to a specific example of the present invention.

Figure 1B is an assembled view of the testing device of Figure 1A.

Figure 2A is a cross-sectional view of the testing device of Figure 1A.

Fig. 2B is a cross-sectional view of another specific example of the test device.

Fig. 3 is a flow chart of testing of a testing device according to a specific example of the present invention.

4 is a cross-sectional view of a device for testing biological samples according to another specific example of the present invention.

Fig. 5 is a cross-sectional view of a device for testing biological samples according to another embodiment of the present invention.

Figure 6 is a schematic diagram of the test device of Figure 5 in use.

Fig. 7 is a schematic diagram of a device for testing biological samples according to another embodiment of the present invention.

Fig. 8 is a schematic diagram of a device for testing biological samples according to another embodiment of the present invention.

FIG. 9 is a schematic diagram of a device for testing biological samples according to another specific example of the present invention.

Fig. 10 is a schematic diagram of a device for testing biological samples according to another specific example of the present invention.

11 to 13 are views of the apparatus for testing biological samples according to another three specific examples of the present invention.

14A is a schematic diagram of a test strip inserted into the meter device according to another specific example of the present invention.

Fig. 14B is a schematic diagram of components of a meter device according to another embodiment of the present invention.

FIG. 15A shows a sample processing procedure of a semen test performed by a device such as a meter device or a smart communication device.

Figure 15B shows a sample step 1515 of the processing program shown in Figure 15A.

Figure 15C shows a sample step 1520 of the processing program shown in Figure 15A.

Figure 15D shows a sample step 1530 of the processing program shown in Figure 15A.

Figure 15E shows a sample step 1550 of the processing program shown in Figure 15A.

Figure 15F shows a sample step 1555 of the processing program shown in Figure 15A.

Figure 16 shows a sample processing procedure for determining sperm concentration.

Figure 17 shows sample sperm and trajectories of sample sperm.

Figure 18 shows a sample processing program for determining sperm trajectory and motility.

Figure 19 is a schematic diagram of a testing device including a collection bottle.

Figure 20 is a schematic diagram of the test device without the collection bottle.

21A, 21B, and 21C are schematic cross-sectional views of various specific examples of the test device.

Fig. 22 is a schematic cross-sectional view of a test device having a test strip device with two sample holding areas.

Figure 23 is a schematic diagram of the components of a test device with autofocus function.

Fig. 24 is a schematic diagram of the components of another test device with auto-focus function.

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

26A and 26B are schematic cross-sectional views of a testing device including a flexible element.

Figure 27 is a flowchart of a processing procedure for analyzing a semen sample of a male client or patient.

Fig. 28 is a flowchart of a processing procedure for analyzing LH or HCG of female clients or patients.

Figure 29 shows an example of a carrier that can be adapted to a test device with a multi-camera setup, such as the test device shown in Figure 22.

FIG. 30 is a flowchart of a processing procedure for analyzing the fertility of both male and female subjects using the testing device disclosed herein.

Figure 31 shows additional examples with visual cues (for example, in or near the holding area) that the carrier can be It is used to control the analysis processing program executed by the test device.

FIG. 32 is a flowchart of an additional example of a processing program implemented by the disclosed testing device to adaptively execute an analysis processing program based on visual cues.

Figure 33 is an example flow chart of a processing procedure that can be implemented by the disclosed testing device.

Fig. 34 is an example image in which the holding area is divided into many blocks.

Fig. 35 is an example image explaining a part of the candidate block selection processing procedure.

FIG. 36 is an example image illustrating the result of an image processing program (for example, two polarization) and the determination of the number of cells.

Fig. 37 is a flowchart of an example calibration procedure that can be implemented by the disclosed testing device.

Figure 38 The test carrier carries example images of visual cues and/or image patterns that can be used to calibrate or validate the test device.

FIG. 39 is an example image of the visual cue in FIG. 38 captured by the disclosed testing device.

40A and 40B illustrate different image qualities of different regions in the captured image of FIG. 39.

Fig. 41 is an example image of a test sample carried by the test carrier that can be used to calibrate or validate the test device.

42A and 42B illustrate different image qualities of different regions in the captured image of FIG. 41.

Reference will now be made in detail to the presently preferred specific examples of the present invention, which examples are shown in the accompanying drawings.

Figures 1A and 1B show a device for testing a biological sample according to a specific example of the present invention. The specific examples disclosed herein are for illustrative purposes and should not be regarded as necessary limitations to the present invention. The device A1 for testing biological samples includes: a sample holder formed on the top of the carrier 10 The carrier 10 of the area 11, the outer cover 20 stacked on the top of the carrier 10, and at least one magnifying part 30 (also referred to as magnifying assembly or magnifying glass) including a convex lens-shaped surface formed on the outer cover 20.

The magnifying part 30 of this specific example includes a plane convex lens as shown in FIG. 1A. However, other types of magnifying lenses (for example, biconvex lenses) can be included as the magnifying part 30. The magnifying part 30 is arranged to be aligned with the sample holding area 11 of the carrier 10 and cover the sample holding area 11. The amplifying part 30 can have various amplification ratios based on the test requirements of various tests. For example, the test may include a semen test, a urine test, a synovial fluid test, a skin test, a water test or other body fluid tests, and so on.

The test using the apparatus A1 for testing biological samples of this specific example does not require an expensive and time-consuming additional magnifying lens or laboratory microscope. In addition, there is no need to align the sample holding area with the magnifying lens or laboratory microscope.

As shown in FIG. 1A, the sample holding area 11 of the carrier 10 may be formed to have a recessed structure. The recessed structure design provides a stable and large storage space containing the sample 40. The recessed structure allows the sample to stand for a desired period of time before performing the test. For example, before performing a mobility test on a semen sample, it is necessary to allow the semen sample to stand at room temperature for a desired period of time before performing the mobility test.

The sample 40 may first be dripped into the recessed structure (ie, the sample holding area 11 of the carrier 10) to be allowed to stand for a period of time. As shown in FIG. 1B, the total area of the outer cover 20 may be smaller than the total area of the carrier 10. The sample receiving port 12 exposed to the outside of the cover 20 is formed on one side of the sample holding area 11. The sample receiving port 12 may be designed to have an outwardly expanding shape, which may help to instill the sample smoothly.

FIG. 2A shows the air channel 13 extending beyond the other side of the outer cover 20 and formed on the other side of the sample holding area 11. The air channel 13 can prevent air from filling the inside of the sample holding area 11, and the filling prevents the sample from being received when the sample is in a liquid state.

As shown in FIG. 2A, the side illuminating device 50 can be placed at one side of the carrier 10 of the test device A1. The lateral illumination device 50 can provide illumination for the sample 40 in the sample holding area 11 and thus improve the resolution of the captured test image of the sample 40. In some specific examples, the sample holding area 11 may be illuminated by a light source on the top or bottom of the test device A1.

As shown in FIG. 1A, the amplifying part 30 and the outer cover 20 may be integrally formed, that is, the amplifying part 30 and the outer cover 20 may be a single component. In other specific examples (such as the specific example shown in FIG. 2B), the detachable cover 20 and the upwardly concave member disposed in the detachable cover 20, that is, the enlarged member 30 in the groove 21 may each be adapted to be integrated Independent components together. In other words, the same type of detachable cover 20 can be integrated with different magnifying parts 30 of various magnification ratios.

In some specific examples, the distance between the bottom of the detachable cover 20 and the sample holding area 11 is 0.005 mm to 10 mm. In some specific examples, the distance between the bottom of the detachable cover 20 and the sample holding area 11 is about 0.01 mm. The testing device may include one or more spacers (not shown) to ensure the distance between the bottom of the detachable cover 20 and the sample holding area 11. The spacer can be formed integrally with the sample holding area 11 of the detachable cover 20 or the carrier 10.

In some specific examples, the strip including the carrier 10 and the outer cover 20 is used for sperm testing. In some specific examples, the best angle magnification ratio for determining sperm concentration and motility is about 100 to 200. In some specific examples, the optimal angular magnification ratio for determining sperm morphology is about 200 to 300. The thinner the magnifying component, the higher the angle magnification ratio.

The focal length of the magnifying component can also be related to the angular magnification ratio. In some specific examples, the magnifying component with an angular magnification ratio of 100 has a focal length of 2.19 mm. The magnifying assembly with an angular magnification ratio of 156 has a focal length of 1.61 mm. The magnifying unit with an angular magnification ratio of 300 has a focal length of 0.73 mm. In some specific examples, the magnification component has an angular magnification ratio of at least It is 30, preferably at least 50. In some specific examples, the focal length of the magnifying component is 0.1 mm to 3 mm.

Fig. 3 shows a sample processing procedure for performing a test using the apparatus A1 for testing biological samples shown in Fig. 1B. In step S110, the sample 40 to be tested is set in the sample holding area 11. In step S110, the cover 20 is stacked on the top of the carrier 10, and then the sample 40 to be tested is set in the sample holding area 11 from the sample receiving port 12. Alternatively, the sample 40 to be tested can be directly placed in the sample holding area 11 first, and then the cover 20 is stacked on the top of the carrier 10. In step S120, the sample 40 is statically placed in the sample holding area 11 according to the test requirements of the sample 40 for a period of time selectively. In step S130, a smart communication device (for example, a mobile phone) is attached to the cover 20, and the camera of the mobile phone is aligned with the magnifying part 30, so that the camera of the mobile phone is used to capture the image of the sample through the magnifying part 30 Or video. In step S140, an application program (APP) running on a mobile phone or other analysis device can be used to perform analysis on the image or video to obtain the test result.

As shown in FIG. 4, a supporting side (such as the protruding member 14) may be further formed at the boundary of the magnifying member 30 on the top of the outer cover 20 of the test device A2. In some specific examples, the protruding support structure can be formed on the top of the outer cover 20 by adding protruding parts 14. When a user tries to use the smart communication device 60 (for example, a mobile device such as a smart phone or a single board computer) to capture images or videos of a sample, one side of the smart communication device 60 with the camera 61 can be fixed to the protruding part 14 (in the direction shown by arrow L1). Therefore, the test device A2 allows the user to use the smart communication device 60 to capture images or videos of the sample, and does not require expensive test devices to record images or videos. In addition, for the best observation distance, the height of the protrusion 14 can be predetermined based on the specifications of the camera 61 and the testing device A2.

As shown in FIGS. 5 and 6, the test device A3 may include an instrument device 70 (also referred to as a base assembly). The instrument device 70 includes a lower barrel base 71 and an upper barrel main body 72 that can be raised or lowered relative to the lower barrel base 71. The lower barrel base 71 has an insertion port 73 that provides an insertion position for the outer cover 20 and the carrier 10 to be stacked together. The upward light emitting device (also known as the light source) 80 is placed on the base of the lower barrel On the bottom of 71, the combination of the cover 20 and the carrier 10 from the bottom is provided with illumination. The upper barrel body 72 may include, for example, at least one additional magnifying lens 74 for further magnification.

A screw mechanism may be used to attach the upper barrel main body 72 to the lower barrel base 71 so that the upper barrel main body 72 can be raised or lowered with respect to the lower barrel main body 71 like a screw. In other words, the upper barrel main body 72 is rotatable in the arrow L2 direction relative to the lower barrel base 71 so that the upper barrel main body 72 moves upward and downward relative to the lower barrel base 71 in the arrow L3 direction. By adjusting the height of the upper barrel body 72 relative to the lower barrel body 71, the system adjusts the height of the magnifying lens 74 (changes the magnification ratio) and the height of the camera 61.

The assembly frame 75 (also referred to as a form-fitting frame) may be disposed at the upper end of the upper barrel body 72. The assembly frame 75 fixes 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 through the camera alignment hole 76.

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

FIG. 6 shows the smart communication device 60 that has been assembled and fixed to an assembly frame 75 that is disposed on the upper barrel body 72. The cover 20 and the carrier 10 containing the sample 40 are inserted through the insertion port 73. The upward light emitting device 80 can provide illumination to the sample and increase the brightness of the sample.

FIG. 6 shows the smart communication device 60 that has been assembled and fixed to an assembly frame 75 that is disposed on the upper barrel body 72. The cover 20 and the carrier 10 containing the sample 40 are inserted through the insertion port 73. The upward light emitting device 80 can provide illumination to the sample and increase the brightness of the sample.

The upper barrel body 72 or the instrument device 70 can rotate along the direction L2 to adjust the height of the magnifying lens 74 and the camera 61 upward or downward along the direction L3. Height adjustment mechanism realizes adjustment of magnification ratio The function. The camera 61 can capture dynamic video or static test images of the sample 40 after zooming in. In addition, the smart communication device 60 can use its original equipment function to store the captured video or image, transmit the test image or video, and perform subsequent processing.

As shown in FIG. 7, the apparatus A4 for testing biological samples includes a plurality of amplifying parts 30, 30B, 30C with different magnification ratios arranged on the outer cover 20. The user can offset the cover 20 to align the sample holding area 11 of the carrier 10 with any one of the magnifying parts 30, 30B, 30C with different magnification ratios, so as to obtain test results with different magnification ratios. With this design, the test device A4 with a single module's amplification function can be applied to meet the amplification requirements of multiple test protocols without changing the amplification components or the outer cover.

As shown in FIG. 8, the device 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 part 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 in a confined space. Therefore, the external influences caused by air, dust and dirt are restrained to a minimum. In addition, the testing device A5 can adjust the focal length by changing the thickness of the flexible transparent film 15.

As shown in FIG. 9, the magnifying part 30 of the apparatus A6 for testing biological samples is a plane convex lens, and the surface of the magnifying part 30 facing the carrier 10 is a convex surface. Therefore, the upward concave hollow member, that is, the groove 21 is formed at the surface of the enlarged member 30 facing the carrier 10. The focal length parameter H1 is defined by the thickness of the thickest part of the magnifying part 30 of the plane convex lens. As shown in FIG. 10, the focal length parameter H2 of the device A7 for testing biological samples is different from the focal length parameter H1 of FIG.

The focal lengths H1 and H2 can be adjusted by changing the thickness of the outer cover 20 or the curvature of the magnifying part 30. For example, the focal length H2 shown in FIG. 10 is greater than the focal length H1 shown in FIG. 9 and is achieved by changing the curvature of the magnifying part 30. In this way, different magnifying components 30 can be used to meet various focal length test requirements.

In some specific examples, the magnifying part 30 may be transparent and the rest of the cover 20 may be opaque. In addition, the carrier 10 may include a transparent sample holding area 11. The remainder of the carrier 10 may be opaque. When the test operation is performed on the test device, light can propagate through the sample holding area 11 and the amplifying part 30 to suppress the chance of light interference in other parts of the device.

Referring to FIG. 11, in the device A8 for testing biological samples, the carrier 10 of the test device A8 further includes a beam auxiliary guiding structure 16 formed at the bottom surface of the carrier 10. The carrier 10 may be made of a transparent or translucent material. The beam-assisted guiding structure 16 may be opaque or include granular structures, rough patterns, engraved patterns, or other suitable structures that scatter the light beam reaching the guiding structure 16. The beam auxiliary guiding structure 16 can provide a specific pattern for the entire surface or part of the surface of the cover and the carrier. The beam auxiliary guiding structure 16 can also be formed all around the side surface of the carrier 10.

When the cover 20 and the carrier 10 are stacked and attached to the smart communication device 60 (for example, as shown in FIG. 4), the magnifying part 30 is aligned with the camera 61 of the smart communication device 60. In addition, supplementary light (not shown) can be placed near the camera 61 on the surface of the smart communication device 60. The light beam provided by the supplementary light can be guided to the carrier 10 to pass through the cover 20 to illuminate the sample holding area 11. At the same time, the beam auxiliary guiding structure 16 of the carrier 10 can scatter the beam provided by the supplementary light, thereby improving the brightness and illumination uniformity of the sample holding area 11.

By arranging the auxiliary beam guiding structure 16, the test device does not require an additional supplementary light source to illuminate the carrier 10. Therefore, the cover 20 includes a light-transmissive material so that the supplementary light of the smart communication device 60 can pass through the cover 20 to reach the sample. In some alternative specific examples, the device does not include the outer cover 20 and the supplementary light directly reaches the carrier 10 without propagating through the outer cover 20.

The device A8 for testing biological samples may include a non-slip film 92, a release paper 96, and a pH test paper 94. The non-slip film 92 is attached to the support side (such as the top side) of the cover 20, and is used to stably mount the cover 20 to the camera 61 of the smart communication device 60, as shown in FIG. 4, so that the magnifying part 30 and the smart The camera 61 of the smart communication device 60 is aligned. Using the non-slip film 92, the positioning of the smart communication device 60 relative to the test device A8 is fixed to a predetermined structure.

The non-slip film 92 may have an opening aligned with the magnifying part 30 so that the non-slip film 92 does not block the light transmitted from the sample to the camera 61 through the magnifying part 30. The non-slip film 92 may include, for example, a silicon material, and the release paper 96 can protect the surface of the non-slip film 92 to maintain the adhesiveness of the paper. The pH test paper 94 can be placed 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.

In addition, the amplifying part 30 and the outer cover 20 may adopt a detachable design. Therefore, the user can select another amplifying part 31 different from the amplifying part 30 to replace the original amplifying part 30 based on the test requirements. Various magnification components that can be assembled with the outer cover 20 are assembled to achieve different magnification ratios or other optical characteristics.

Referring now to FIG. 12, the device A9 for testing biological samples may further include a sample collection sheet 42 arranged in the sample holding area 11. The sample collection sheet 42 has a sample collection area 42A, for example. The sample collection area 42A can use adhesion or other methods to collect sperm, subcutaneous tissue/cells, parasite eggs, and similar solid test subjects. In some specific examples, the sample collection sheet 42 may be used as a spacer to maintain the distance between the outer cover 20 and the sample holding area 11.

Next, referring to FIG. 13, the device A10 for testing biological samples may include an isolation component 98 disposed at the sample holding area 11 between the carrier 10 and the outer cover 20. The isolation component 98 can isolate the amplifying component 30 from the test liquid in the sample holding area 11 and prevent the test liquid from contaminating the amplifying component 30. In some specific examples, the isolation component 98 can be used as a spacer for maintaining the distance between the outer cover 20 and the sample holding area 11. The isolation component 98 can be integrated with the outer cover 20 as a single component. Alternatively, the isolation component 98 may be integrated with the carrier 10 as a single component.

14A is a schematic diagram of a test strip inserted into the meter device according to another specific example of the present invention. The test strip 5 (also called a test box) includes a detachable cover 20 and a carrier 10. In other words Otherwise, the combination of the detachable cover 20 and the carrier 10 (for example, as shown in FIG. 1B) forms a test strip 5. The test strip 5 is inserted into the meter device 70 (also referred to as the base assembly) through the insertion port. The insertion port may be, for example, a lateral or vertical insertion port. The meter device 70 may include, for example, a component for capturing an image of the sample collected in the test strip 5.

Fig. 14B is a schematic diagram of components of a meter device according to another embodiment of the present invention. The meter device 70 includes an insertion port 73 for providing an insertion position of the test strip 5. The test strip 5 includes a carrier 10 and a detachable cover 20. The detachable cover includes an enlarged part 30. The meter device 70 includes a camera 61 for capturing an image or video of the sample holding area of the carrier 10. The camera 61 is aligned with the magnifying part 30. The meter device further includes a light source 80 for illuminating the sample holding area from the bottom. In some specific examples, a collimator (eg, collimator lens or light reflector; now shown) may be placed on top of the light source 80 for collimating the light beam. The ring-shaped aperture may be further placed between the light source 80 and the collimator so that the light beam traveling through the collimator forms a hollow cone-shaped light beam. The carrier 10 may include a transparent or translucent material for light propagation.

In some specific examples, the meter device 70 may further include a phase plate that shifts the phase of the light emitted from the sample holding area. As the light travels through the sample, the speed of the light increases or decreases. Therefore, the light that travels through the sample is out of phase (about 90 degrees) from the remaining light that does not travel through the sample. The out-of-phase light interferes with each other and enhances the contrast between the bright and dark parts of the sample image.

The phase plate can further shift the phase of the light propagating through the sample by about 90 degrees to further enhance the contrast caused by the interference of out-of-phase light. Therefore, the light propagating through the sample and the remaining light not propagating through the sample are approximately 180 degrees out of phase. This destructive interference between lights enhances the contrast of the sample image by darkening the objects in the image and brightening the boundaries of those objects.

In some alternative specific examples, the phase plate can be placed on the top of the detachable cover 20 of the test strip 5. In other words, the phase plate can be part of the test strip 5 instead of part of the meter device 70.

FIG. 15 shows a sample processing procedure for a semen test performed by a device such as the meter device 70 or the smart communication device 60 shown in FIGS. 5 and 14 respectively. 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, by analyzing the color or gray scale of the pH band, the device can further determine the pH value of the sample. For example, the device may include processing for identifying the color of a part of the image captured by the camera (corresponding to the pH band) and determining the biochemical characteristics (for example, pH level) of the biological sample contained in the band Device. In some other specific examples, the light source of the device can provide illumination with at least one color. For example, the light source may include light emitters with different colors (for example, 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 specific area of the image (for example, the pH band area) to determine the characteristics of the biological sample or the quantification of the analyte. In some specific examples, the processor only needs the color of a specific area of an image to determine the characteristics of the biological sample. For example, the device (e.g., test device) may include a color correction module for correcting the color of the image. The processor then analyzes the corrected image to determine the characteristics of the biological sample. Alternatively, the test strip may include color correction areas with known colors. The processor performs color correction operations on the image based on the color correction area, and then analyzes the corrected image to determine the characteristics 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, and then a specific area of the image (for example, the pH strip area) shows a specific color. In some specific examples, the specific area used for color detection must be magnified on the image captured by the camera. Therefore, at least in some specific examples, there are no magnifying components or supplements above a specific area of the band used for color detection (for example, the pH band area). For example, some types of biochemical test strips contain photochemical reagents. When the photochemical reagent reacts with a specific analyte in a biological sample, the reaction causes a color change in the sample holding area of the strip. The processor can analyze the image of the test strip (captured by the camera) to detect color changes and quantify specific analytes in the biological sample. In addition, the device can determine sperm morphology (1520), sperm volume (1525) and total number of sperm (1530). In steps In 1540, the device obtained multiple frames of a series of samples. In steps 1545, 1550, and 1555, the device can determine sperm motility parameters and determine sperm motility based on the sperm trajectory. Figure 16 shows a sample processing procedure for determining sperm concentration. In 1605, the camera of the meter device 70 or the smart communication device 60 ("the device") shown in FIG. 5 and FIG. 14 respectively captures an enlarged image of the sperm sample. The captured image is the original image used to determine the sperm concentration. The device then converts the digital color image into a digital grayscale image, and further divides the digital grayscale image into multiple regions.

In step 1610, the device performs an adaptive bounding binary calculation for each region based on the mean and standard deviation of the gray value of that region. The goal of this adaptive bounded binary calculation is to recognize the object that is the candidate of the sperm as the foreground object and the rest of the area as the background.

The foreground object in the image after the binary calculation may still include impurities that are not actually sperm. Their impurities are smaller or larger than the sperm. The method can set an upper boundary value and a lower boundary value for the size of sperm. In step 1615, the device performs a noise reduction operation on the image by removing impurities larger than the upper boundary value of the sperm or smaller than the lower boundary value of the sperm. After the noise reduction operation, the foreground object in the image represents sperm.

The method counts the number of sperm in the image based on the head part of the sperm. In steps 1620 and 1625, the device performs a distance transformation operation to calculate the minimum distance between the foreground object and the background, and also identifies the location of the local maximum. Their positions are candidates for the position of the sperm head.

In step 1630, the device performs an ellipse fitting operation on each sperm candidate to reduce false positive candidates that do not have an elliptical shape and therefore are not sperm heads. Then, the device counts the total number of remaining positive candidates of sperm, and calculates the concentration of the sperm based on the volume represented by the image. The volume can be, for example, the area of the sample holding area multiplied by the distance between the sample holding area and the bottom of the cover.

In some specific examples, the device may use multiple images of the sample and calculate the concentration value based on the images respectively. Then, the device calculates the average value of the concentration values to minimize the measurement error of the sperm concentration.

Using a series of images of the sample (for example, a video frame), the device can further determine the trajectory and motility of the sperm. For example, FIG. 17 shows sample sperm such as sperm 1705 and sample sperm trajectories such as trajectory 1710 and trajectory 1720.

Figure 18 shows a sample processing program for determining sperm trajectory and motility. For example, the camera of the meter device 70 or the smart communication device 60 ("the device") shown in FIGS. 5 and 14 respectively captures a series of images (eg, video frames) of the sperm sample. The device uses a series of images captured to determine sperm motility parameters. In order to determine the parameters of sperm motility, the device needs to track the trajectory of each sperm in the series of images.

The device converts digital color images into digital grayscale images. The device first identifies the position of the sperm's head in the first image of the series (for example, using the method shown in FIG. 16). 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 examples, the device can use a two-dimensional Kalman filter to estimate the trajectory of the sperm.

In some specific examples, the two-dimensional Kalman filter used to track sperm s _j with the measured value z _j ( k ) includes the following steps:

(k|k-1)及誤差共變數矩陣

(k|k-1)：

1: Calculate the prediction status

( k | k -1) and error covariate matrix

( k | k -1):

(k|k-1)、量測值z _j (k)及誤差共變數矩陣

(k|k-1)，計算經預測量測值

(k|k-1)、量測值殘差

(k)及殘差共變數矩陣

(k)：

2: Use prediction status

( k | k -1), measured value z _j ( k ) and error covariate matrix

( k | k -1), calculate the predicted measured value

( k | k -1), residual of measured value

( k ) and residual covariate matrix

( k ):

(k) T

(k)-1

(k)<γ及∥

(k)∥/T

V _max，則計算卡爾曼過濾增益

(k)、經更新狀態估計值

(k|k)及經更新誤差共變數矩陣

(k|k)：

3: If

( k ) T

( k ) -1

( k )< γ and ∥

( k )∥/ T

V _max , calculate the Kalman filter gain

( k ), updated state estimate

( k | k ) and the updated error covariate matrix

( k | k ):

為第j個精子的位置及速度的狀態。

為估計誤差的共變數矩陣，Q(k-1)為處理雜訊共變數矩陣，N(k)為白色位置雜訊向量之共變數矩陣，γ為閘極臨限值且V _max為最大可能精子速度。 ( k | k -1) represents the prediction of image k based on image k -1,

Is the position and velocity of the jth sperm.

Is the covariate matrix of the estimation error, Q ( k -1) is the covariate matrix for processing noise, N ( k ) is the covariate matrix of the white position noise vector, γ is the gate threshold and V _max is the maximum possible Sperm speed.

When tracking multiple trajectories of multiple sperm, the method can use joint probability data association filtering to determine the trajectory path. The joint probability data association filtering determines feasible joint association events between the detection target and the measurement target. The feasible joint association event ( A _js ) is the relative probability value between the detected sperm s and the measured sperm j . Next, the method makes path allocation decisions based on the best specified method. A _{js is} defined as:

[z _j (k)]為該等偵測精子之高斯概率密度函數。 λ is the parameter,

[ z _j ( k )] is the Gaussian probability density function of the detected sperm.

Based on the series of frames within a time period, the method identifies the trajectory of each sperm, such as the trajectory 1805 shown in FIG. 18. Next, the method determines various parameters of sperm motility based on the trajectories. These parameters include, for example, curvilinear velocity (VCL), straight-line velocity (VSL), linearity (LIN), and amplitude of lateral head displacement (ALH). Curve speed (VCL) 1810 It is defined as the sum of movement distance in unit time. Linear speed (VSL) 1815 is defined as the linear movement distance per unit time. Linearity (LIN) is defined as VSL divided by VCL. The 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.

In some specific examples, curve velocity (VCL) 1810 can be used to determine sperm motility. The method can set the speed threshold. Any sperm with a VCL higher than or equal to the velocity threshold is identified as active sperm. The remaining sperm with a VCL below the velocity threshold were identified as inactive sperm. The level of motility is the number of identified active sperm divided by the total number of sperm identified from the image.

The method can further analyze sperm morphology. The camera of the meter device 70 or the smart communication device 60 ("the device") captures an enlarged image of the sperm sample. The captured image is the original image for determining the sperm morphology.

The method is based on segmented detection of the shape of sperm candidates. The method uses the position of the head of the sperm as the initial point. Using a segmentation algorithm related to shape, the method divides the image of the sperm into a head part, a neck part and a tail part. For example, the method may use methods such as active contour models to segment the sperm.

Based on each part, the method calculates the parameters (such as length and width) of the various parts. A training data set including labeled samples can be used to train a classifier (such as a support vector machine, neural network, convolutional neural network, or AdaBoost algorithm). After training, the parameters of various parts of the sperm can be fed to the classifier to determine whether the sperm has an appropriate morphology. In some specific examples, the classifier can be used for other applications such as detecting the characteristics of cells and microorganisms.

Fig. 19 is a schematic diagram of a test device including a collection bottle according to at least one specific example of the present invention. The test strip device 1905 can be inserted into the test device 1900 through the insertion port. The test strip device 1905 may include a collection bottle 1910 for collecting a sample (for example, a sperm sample) or include The slot of the collection bottle. The testing device 1900 may include a sensor (not shown) to detect whether the collection bottle 1910 is inserted into the testing device 1900.

The testing device 1900 may have a timer mechanism for determining the period of time that the collection bottle 1910 has been inserted into the testing device 1900. After inserting the collection bottle 1910 containing the sample, the testing device 1900 may wait for a predetermined period of time (for example, 30 minutes) to liquefy the sample, and then prompt the user to transfer the sample from the collection bottle 1910 to the test strip device 1905. In some specific examples, the testing device 1900 may include a camera or a sensor to determine whether the sample has liquefied.

In addition, the testing device may include a moving mechanism to apply mechanical force to the collection bottle 1910 in order to mix the sample in the collection bottle 1910. For example, the moving mechanism can shake, vibrate or rotate the collection bottle 1910, for example. In some other specific examples, the testing device may include a rod to be inserted into the collection bottle 1910 and stir the sample in the collection bottle 1910.

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

Similar to the test device shown in FIGS. 14A and 14B, the test device 1900 may include a camera (not shown) for capturing images or videos of the test strip device 1905. Test device 1900 can It further includes a processor (not shown) for processing images or videos used to determine test results (for example, via the processing program shown in FIG. 16).

In some specific examples, for example, the magnifying component 2110 is a magnifying lens. The magnification capability of the magnifying 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 the object as seen through the optical system and the angular size of the object as seen directly at the closest photopic distance (that is, 250 mm from the human eye). The linear magnification ratio is the ratio between the size of the image of the object to be projected on the image sensor and the size of the actual object.

For example, the magnifying lens may have a focal length of 6 mm, a thickness of 1 mm, and a diameter of 2 mm. Assuming that 250mm is the near point distance of the human eye (that is, the shortest distance at which the human eye can focus), the angle magnification ratio is 250mm/6mm=41.7 times. The distance between the magnifying component 2110 and the sample holding area 2115 may be, for example, 9 mm. Therefore, the linear amplification 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 component is twice the size of the actual object under the magnifying component.

In some specific examples, the magnifying component has a focal length of 0.1 mm to 8.5 mm. In some specific examples, the linear amplification ratio of the amplification component is at least 1. In some specific examples, the linear amplification ratio of the amplification component is 0.5 to 10.0.

In some specific examples, the supplementary lens 2135 is placed under the camera module 2130 to further magnify the image and reduce the distance between the magnifying component 2110 and the sample holding area 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 area 2115. In some specific examples, 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.

In some specific examples, the image sensor of the camera module has a pixel size of 1.4 μm. Typically, the captured image of the object needs to acquire at least 1 pixel in order to properly analyze the object’s shape. Therefore, the size of the captured image of the object needs to be at least 1.4 μm. If the linear amplification ratio of the test device is 3, the test device can properly analyze the shape of an object with a size of at least 0.47 μm.

In some specific examples, the image sensor of the camera module has a pixel size of 1.67 μm. Next, the size of the captured image of the object needs to be at least 1.67 μm in order to properly analyze the shape of the object. If the linear amplification ratio of the test device is 3, the test device can properly analyze the shape of an object with a size of at least 0.56 μm.

In some specific examples, for example, the length of the entire optical system may be, for example, 24 mm. The distance between the bottom of the magnifying component and the top of the sample holding area 2115 may be, for example, 1 mm. In some specific examples, the length of the entire optical system of the test device is 2 mm to 100 mm, preferably 5 mm to 35 mm.

Fig. 20 is a schematic diagram of a test device that does not include a collection bottle according to at least one specific example of the present invention. Unlike the test device 1900, the test device 2000 does not include a collection bottle or a slot for inserting the collection bottle. The sample is directly applied to the test strip device 2005 by the user or operator, and is not collected in a collection bottle.

FIG. 21B is a schematic diagram of the A-A cross section of the specific example of the test device 1900 of FIG. 21A. The A-A section of the test device 1900 shows a camera module 2130 on the top of the test strip device 2105 for capturing an image or video of the sample holding area 2115 of the test strip device 2105. The test strip device 2105 includes an amplifying assembly 2110 on top of the sample holding area 2115. The light source 2140 under the test strip device 2105 provides illumination for the sample holding area 2115. In some other specific examples, the light source can be placed on the top of the test strip device or placed laterally on one side of the test strip device. There may be multiple light sources or light source arrays used to provide illumination on the test strip device. In some specific examples, different combinations of light sources can be switched, adjusted or selected depending on the type of the analyte, so that the analyte is illuminated by light with an appropriate color.

In some embodiments, the test strip device 2105 may include a test strip in or near the sample holding area 2115. For example, the test strip may be a pH test strip, a HCG (human chorionic gonadotropin) test strip, an LH (luteinizing hormone) test strip, or a fructose test strip. When the analyte of the sample in the sample holding area interacts with the chemical or biochemical reagent in the test strip, some optical characteristics (for example, color or light intensity) of the test strip may change. The camera module 2130 can capture the color or intensity of the test strip to determine the test result, such as pH level, HCG level, LH level, or fructose level. In some specific examples, the magnifying component 2110 above the test strip can be replaced with a transparent or translucent cover. Therefore, the testing device can simultaneously check the analytes in the sample and perform another analysis on the sample through one or more enlarged images of the sample.

FIG. 21C is a schematic cross-sectional view of A-A of another specific example of the testing device 1900 of FIG. 21A. The AA section of the test device 1900 shows a camera module 2130 on the top of the test strip device 2105 for capturing images or video of the sample holding area 2115 of the test strip device 2105, which includes a sensor and a Or a plurality of lenses 2135 (also called supplementary lenses or optical lens modules). The light source 2140 under the test strip device 2105 (or placed elsewhere) provides illumination for the sample holding area 2115. The magnifying assembly 2110 may be attached to the bottom of the lens 2135 instead of on the top of the sample holding area 2115 as shown in FIG. 21A. In some specific examples, if the lens 2135 provides sufficient magnification, the element 2110 may be a flat light transmissive cover without magnification. In some other specific examples, if the lens 2135 provides sufficient magnification (for example, if the linear magnification ratio of the lens 2135 is at least 1.0), the test device 1900 does not include the magnifying component 2110.

Figure 22 is a schematic diagram of a test device having a test strip device with two sample holding areas. FIG. 29 shows an example of a carrier that can be adapted to a test device having a multi-camera configuration, such as the test device shown in FIG. 22. 19 and 20 at the same time, the test device shown in FIG. 22 may be another variation of the test device 1900 (that is, with a collection bottle) or the test device 2000 (that is, without a collection bottle). As shown in FIG. 22, the receiving mechanism is included in the test device to receive one or more carriers (for example, such as test The test strip device of the strip device 2205, or the collection bottle such as the bottle 1910), the carrier can be inserted through an opening in the housing of the test device.

In some specific examples, a single carrier may include a first holding area and a second holding area, such as shown by the test strip device 2205 in FIG. 22. As shown in FIG. 22, at least two camera modules may be included in the test 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 the first holding area 2215A and the second holding area 2215B, respectively. More specifically, the test strip device 2205 may include a sample holding area 2215A and another sample holding area 2215B. In some examples, a transparent or translucent cover 2210A is placed on top of the sample holding area 2215A. The 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, the amplifying component 2210B can be placed on the top of the sample holding area 2215B. Additionally, in some specific examples, the light source 2240B is 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 directly carry the biological sample or have been exposed to the biological sample. Similar to the structure introduced with respect to FIG. 14B, in some specific examples, the test device may include a collimator for collimating the light beam emitted by the light source to at least one of the holding areas. In some specific examples, an annular aperture may be further included between the light source and the collimator to form a hollow cone beam that travels through the collimator and then reaches the sample holding area. In some additional specific examples, a phase plate may be included between at least one of the sample holding area and the camera module for phase shifting the light reflected by the sample holding area.

As an alternative to a single carrier with multiple holding areas, multiple carriers can be inserted into the test device through its individual openings, ports or slots. For example, two independent test strip devices may include sample holding areas 2215A and 2215B, respectively. Depending on the needs of the test, the position of the sample holding areas 2215A and 2215B in the test strip can be designed to be in line with the first camera module 2230A and the second camera module 2230A and the second camera module. Machine module 2230B is aligned. In some specific examples, two test strip devices are inserted into the test device via two independent insertion ports.

In addition to other benefits, the convenience and ease of testing are two significant benefits that the testing device disclosed herein can provide. According to specific examples herein, the user of the disclosed testing device does not need to have any professional knowledge on how to perform various types of analysis on biological samples before the user can use the testing device to generate results. Therefore, the testing device may include a processor for executing an automated analysis processing program on the sample and determining the result about the sample. The processor may be carried by a main circuit board (ie, known components, not shown for simplicity). In addition, the test device is preferably small and not as bulky as the traditional test device commonly found in laboratories. Therefore, in some specific examples, such as those shown in FIGS. 19 and 20, the receiving mechanism of the carrier, the camera module, and the main circuit board may all be packaged in the housing of the test device. The test device may have a small external size, such as less than 30 centimeters (cm)×30 cm×30 cm, that is, 27,000 cm ³ . In some specific examples, the test device may further include a battery compartment encapsulated in the housing, so that the battery can be installed in the battery compartment to power the test device.

In some specific examples, the processor included in the test device may perform different analyses on different holding areas, and may derive results based on a combination of the results of the analyses performed on the different areas. In other words, the processor may be configured to perform a first analysis process on the captured image of the first holding area, and perform a second analysis process that is different from the first analysis process on the captured image of the second holding area Procedures, and based on the results of both the first analysis processing program and the second analysis processing program to determine the result of the biological sample. As used herein, the term “analytic process” means that one or more pieces of information collected from many sources (for example, images of holding areas) can be evaluated, and results, conclusions, and conclusions about the sources can be generated. Final result, estimated value or similar processing procedure.

According to some examples, the testing device may use a combination of the first camera module 2230A, the light source 2240A, and the housing 2210A to quantify the analyte or determine the characteristics of the sample (eg, pH level, LH level, HCG level, or fructose level). In addition, the test device can further use a second camera module The combination of 2230B, light source 2240B, and magnifying component 2210B analyzes the magnified image of the sample to determine the characteristics of the sample (eg, 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 biochemical samples. The multi-camera configuration is particularly beneficial because different analysis and processing procedures can be executed through different camera modules without requiring the user to replace the carrier (for example, a test strip device), thereby speeding up the result generation and reducing the complexity of necessary human operations. The light sources 2240A and 2240B are packaged 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 processing program that the processor is currently configured to execute.

In addition, in some specific examples, the processor may execute different analysis processing programs based on visual cues on the carrier. For example, some specific examples may perform image recognition and processing on the image of the holding area, and may perform different analysis processing procedures according to the visual cues from the result of the image recognition. Example vectors 2905(1) to 2905(4) are shown in Figure 29, where the vector 2905(1) is used for fertility testing on the germ cells of a male subject (e.g., via its sperm), and the vector 2905( 2), 2905(3) and 2905(4) are used for the fertility test on the germ cells of female subjects (for example, via their urine). As shown, the carriers 2905(1) to 2905(4) all have a first holding area 2915A corresponding to the position of the first camera module 2230A, but only the carrier 2905(1) includes a second holding area 2915B. In some examples, the visual cue on the carrier may be the shape of a specific holding area (eg, holding area 2215A). For the discussion in this article, the shape of the holding area means the overall edge (or outer periphery) of the holding area. For example, the shape can be a circle, an oval, a triangle, a rectangle, or a processor using a known image processing technology can be used for example by an individual camera module (for example, the first camera module 2230A). Any suitable shape that can be recognized on the captured image of the holding area. Additional examples of visual cues may include graphic patterns, visual signs, one-dimensional bar codes, multi-dimensional pattern codes (e.g., QR codes), and the like.

Referring to FIGS. 22 and 29 at the same time, in some specific examples, when the processor recognizes (for example, via the first camera module 2230A) the first holding area (for example, the area 2215A of the carrier 2905(1) or When the region 2915A) has a first shape (for example, a circle), the processor is configured to perform a certain analysis processing procedure (for example, the fertility of a male subject, such as according to various characteristics of the sperm sample), and when the When a holding area (area 2215A or area 2915A of carrier 2905(2)) is in a second shape (for example, oval), the processor will execute different analysis processing procedures (for example, analysis of the fertility of female subjects) , Such as based on the hormone levels in their urine samples). In this way, the test device is not limited to performing only one type of test (for example, sperm fertility), but it can also switch the analysis processing program accordingly based on the carrier inserted into the machine (for example, the test strip device).

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

In view of the above situation, FIG. 30 is a flowchart of an example processing procedure 3000 for analyzing the fertility of both male and female subjects using the testing device disclosed herein (for example, in FIG. 22). Continuing to refer to FIG. 29, the processing program 3000 will be described below. It should be noted that the following example applies male samples first, followed by female samples, but the reverse order (ie, female and then male) can be performed without affecting the accuracy of the result.

First, in step 3002, the user may apply the biological sample (for example, sperm) of the male subject to the first holding area (for example, area 2915A) and the second holding area of the first carrier (for example, carrier 2905(1)). Holding area (area 2915B). Next, in step 3004, the user inserts the first carrier into the test device (for example, the one shown in FIG. 22), and because the shape of the first holding area 2915A of the carrier 2905(1) is circular, the test The device can automatically obtain the knowledge that the current sample contains sperm from a male Recognize and select the analysis processing program accordingly. Then, in step 3006, the user can use the testing device to determine one or more characteristics of the sperm. For example, as discussed herein, the processor in the test device may use the first camera module 2230A to obtain an image of the first holding area 2915A of the carrier 2095(1) (the carrier 2095(1) may include responding to Different acidity shows different color test strips), 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 may use the second camera module 2230B to determine one or more characteristics of sperm selected from the group consisting of: cell number (for example, sperm number), sperm concentration , Sperm motility and sperm morphology.

Next, in step 3008, the user can apply urine from the female subject to the holding area 2915A of the second carrier (for example, carrier 2905(2)). In step 3010, the user inserts the second carrier into the test device, and since the shape of the first holding area 2915A of the carrier 2905(2) is oval, the test device can automatically obtain the current sample containing urine from a woman Knowledge and choose the analysis process accordingly. In step 3012, the testing device determines one or more characteristics of urine, for example, by using the second camera module 2230B. For example, the test strip may be adapted to enable the test device to determine the concentration level of one or more types of female hormones (eg, FSH, LH, or HCG). Finally, in step 3014, the user uses the testing device to automatically analyze the results of the male and female biological samples and determine the final result regarding the fertility of the subject.

In some specific examples, the first camera module 2230A may have a lower camera resolution than the second camera module 2230B, and therefore the two cameras are used by the processor to execute different analysis processing procedures. In addition, the first camera module 2230A may have a lower magnification ratio than the second camera module 2230B. Some examples of the first camera module 2230A may not have a magnification function at all, while the second camera module 2230B may have a fixed magnification ratio. In addition or as an alternative to the second camera module 2230B having a higher magnification ratio, the outer cover 2210B of the second holding area 2215B may include magnifying components, such as shown in FIG. 22. In some implementations, the magnification ratio of the camera module may be adjustable (for example, controlled by a processor). Some examples of test devices specify that the first camera module 2230A has It 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 may include a linear magnification ratio of at least 4.8 times or higher.

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

Continuing in the case of the above test device example with a multi-camera configuration in FIG. 22 and the carrier example in FIG. 29, in some implementations, when the processor identifies the first holding area (eg, area 2215A or carrier 2905(2) When the area 2915A) is in a second shape (such as an oval) 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 determinable characteristics may include: LH level, FSH level, and/or HCG level. Like acidity, the determination of one or more characteristics of urine can be performed by using the first camera module. Similarly, the carrier may include an LH indicator (e.g., as shown in carrier 2905(3)), FSH indicator (e.g., as shown in carrier 2905(2)) in the first holding area (e.g., area 2915A of the individual carrier) Shown in) and/or the HCG indicator (e.g., as shown in carrier 2905(4)).

In addition, in some specific examples, the processor may utilize at least one of the two camera modules (for example, the first camera module 2230A) or another sensor (for example, the light sensor introduced below in relation to FIG. 26). 2690) to determine the preparation status or validity of the biological sample before executing the analysis processing program. In some implementations, the preparation state of the test sample may be determined based on identifying whether the first visual mark is displayed in a specific area (for example, where line 2916 is shown in FIG. 29) in the first holding area (for example, area 2915A) Or effectiveness. An example of this first visual mark can be a designated area on the test strip. The displayed line, such as the red line 2916 shown in FIG. 29. The red line 2916 can be used as a quality control component, which can indicate that the test is valid or the result is ready. In addition, the first holding area 2915A may include another area displaying a second visual mark indicating the test result on the characteristic of the biological sample (for example, the line 2917 is shown in FIG. 29). An example of this second visual mark may be a line displayed in another designated area of the ready state on the test strip, such as the red line 2917 shown in FIG. 29.

In some specific examples, the testing device may perform actions in response to the determination that the biological sample is not ready. In some examples, the action performed by the processor includes implementing a timer with a duration determined by the analysis processing program to be executed. In some other examples, the testing device further includes a moving mechanism, and the processor in the testing device can use the moving mechanism to apply mechanical force to the carrier to improve the preparation of the biological sample. More details on the actions and mechanisms that can be implemented in the test device are introduced below with respect to Figure 25 (Figure 25A and Figure 25B) and Figure 26 (Figure 26A and Figure 26B).

The positions of the magnifying components (for example, the magnifying components of the camera module or the magnifying components of the test strip) and the positions of the light sources can be adjusted or selected according to the requirements of various types of analyte analysis. In a variant, the camera modules may have adjustable magnification ratios. In at least some of these examples, the processor is further configured to adjust the magnification ratio of at least one of the two camera modules based on the analysis processing program that the processor is currently configured to execute. As introduced above, when the biological sample includes sperm, the testing device can be equipped with a suitable camera module (for example, the second camera module 2230B) to achieve different magnification ratios for determining the motility of the sperm and the morphology of the sperm.

It should be noted that the optimal distance between the camera module and the magnifying 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 area. In order to finely adjust the distance between the camera module and the magnifying assembly, the testing device may include an auto focus (AF) function. The autofocus function is a function of automatically adjusting the optical system (for example, adjusting the distance between components of the optical system) so that the object being imaged (for example, semen) is in the focal plane of the optical system. At least one or more specific examples also provide mechanical focusing that can be controlled by a processor The mechanism enables at least one of the two camera modules to focus on the individual holding area. The mechanical focus mechanism is discussed in more detail below with respect to FIGS. 23 and 24. The mechanical focusing mechanism may be controllable to adjust the position of the lens in at least one of the two camera modules (for example, as shown generally in FIG. 23). Additionally or alternatively, the mechanical focusing mechanism may be controllable to adjust the position of the carrier (e.g., generally shown in FIG. 24).

Figure 23 is a schematic diagram of the components of a test device with an autofocus function. As shown in FIG. 23, the testing device can move the camera module upward or downward along the Z axis (for example, by a motorized track, an ultrasonic motor drive, or a stepping motor). By adjusting the vertical position of the camera module, the testing device can adjust the distance between the camera module and the magnifying component.

Figure 24 is a schematic diagram of the components of another test device with an autofocus function. As shown in Figure 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 magnifying component.

During the autofocus operation as shown in FIG. 23 or FIG. 24, the camera module and the supplementary lens remain as a single module. In other words, the distance between the camera module and the supplementary lens remains constant during the auto-focus operation as shown in FIG. 23 or FIG. 24.

Fig. 25B is a B-B cross-sectional schematic diagram of the test device of Fig. 25A including a switch and a motor. The B-B cross section of the test device 1900 in FIG. 25B shows various components of the test device. The testing device 1900 includes a switch 2550 for detecting the collection bottle 2510 inserted into the testing device 1900. When the collection bottle 2510 is inserted, the switch 2550 is activated. Then, the collection bottle 2510 is notified to the testing device 1900 via the switch 2550. Based on the time period during which the switch 2550 is activated, the testing device can determine the time period during which the collection bottle 2510 remains inserted.

The testing device 1900 further includes a motor 2560 for shaking, vibrating, or rotating the collection bottle 2510 to mix the sample in the collection bottle 2510. The testing device 1900 may include a camera 2570 to determine whether the sample has been liquefied based on the captured image of the sample in the collection bottle 2510.

Fig. 26B is a C-C cross-sectional schematic diagram of the testing device of Fig. 26A including a flexible element. The B-B cross section of the test device 1900 in FIG. 26B shows various components of the test device. The testing device 1900 includes a moving element 2680 (for example, an elastic component) at the bottom of the slot for movably receiving the collection bottle 2610. For example, the moving element 2680 may include a spring that can spontaneously return to its normal shape after being contracted or deformed. When the collection bottle 2610 is inserted into the slot, the moving element 2680 is compressed. The light sensor 2690 (or other types of distance sensors) is responsible for detecting the distance between the light sensor 2690 and the bottom of the collection bottle 2610. Based on the distance between the light sensor 2690 and the bottom of the collection bottle 2610, the testing device 1900 can determine the weight or volume of the sample contained in the collection bottle 2610. For example, the distance between the light sensor 2690 and the bottom of the collection bottle 2610 may be inversely proportional to the weight or volume of the sample contained in the collection bottle 2610.

In some other specific examples, the testing device 1900 may include a sensor on the top of the collection bottle 2610. The sensor may be responsible for detecting the distance between the sensor and the top of the collection bottle 2610. The weight or volume of the sample contained in the collection bottle 2610 can be determined based on the distance, because the volume or the weight can, for example, be proportional to the distance between the sensor and the top of the collection bottle 2610. Then, based on the weight or volume of the sample, the testing device 1900 can determine the time period to wait for the sample in the collection bottle 2610 to liquefy. The testing device 1900 further includes a motor 2660 for shaking, vibrating, or rotating the collection bottle 2610 to mix the sample in the collection bottle 2610.

In some specific examples, the camera module of the test device may include a light field camera (not shown) that captures the intensity and direction of light. The light field camera may include a micro lens array or a multi-camera array in front of the image sensor to detect direction information. Using the direction information of the light, the camera module can capture clear images at a wide range of focal planes. Therefore, the test device using the light field camera may not need the autofocus function to finely adjust the distance between the camera module and the magnifying component.

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

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

The present invention also provides a method for testing female reproductive hormones using the device of the present application. The method includes the following steps: applying a biological sample from a female subject to the first holding area of the 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).

The present invention further provides a method for testing the fertility of a pair of male subjects and female subjects. The method includes the following steps: applying a biological sample from a male subject to the first holding area and the second holding area of the first carrier; inserting the first carrier into the device; determining the sperm status according to the first analysis and processing program Acidity; According to the second analysis and processing program, determine one or more characteristics of sperm selected from the group consisting of: sperm concentration, sperm motility and sperm morphology; apply biological samples from female subjects to the first The holding area of the two carriers; inserting the second carrier into the device; determining the concentration level of one or more types of female hormones; and analyzing the results of male and female biological samples.

Fig. 27 is a flowchart of a processing procedure for analyzing a semen sample of a male client or patient. The system for analyzing semen samples may include a testing machine (for example, the testing device 1900), a mobile device, and a cloud server. Fig. 28 is a flowchart of a processing procedure for analyzing LH or HCG of a female client or patient. The system for analyzing LH or HCG may include a test machine (for example, the test device 1900), a mobile device And cloud server. The flowcharts of FIGS. 27 and 28 show the steps performed by the test machine, the mobile device and the cloud server and the information transmitted between the test machine, the mobile device and the cloud server.

In some specific examples, the method for testing sperm includes the following steps: obtaining a device for testing a biological sample, applying the sperm sample to the sample holding area, recording the video or image of the sperm sample; based on the recorded video or recorded At least one frame of the image is used to determine the sperm count of the sperm sample; and the sperm motility of the sperm sample is determined based on the recorded video or the recorded image.

In a related specific example, the method further includes: waiting for a predetermined period of time for the liquefaction of the sperm sample before applying the sperm sample to the sample holding area.

In another related specific example, the method further includes: placing a mobile device including a camera assembly on the top of the device so that the camera assembly is aligned with the magnifying assembly and the sample holding area; and receiving by the mobile device The optical signal from the sperm sample is amplified in the sample holding area through the amplification component.

In another related specific example, the method further includes: illuminating the sample holding area by a side illuminating device placed on one side of the carrier of the device or a vertical illuminating device placed on top or under the carrier of the device .

In still another related embodiment, the method further includes: guiding the light beam from the side lighting device through a carrier made of a transparent or translucent material; and by including a plurality of light reflection patterns in the carrier The beam is reflected to the sample holding area.

In another related specific example, the method further includes: inserting the disposable testing device into a base, the base including a camera assembly for recording video of sperm samples or a form-fitting frame for fixing the mobile device, The mobile device includes a camera component for recording video of the sperm sample.

In still another related specific example, the method further includes: 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 based on the number of identified sperm and the at least one frame Calculate the sperm count from the recorded area.

In yet another related specific example, the method further includes: analyzing the shape of the identified sperm; and determining the morphological level based on the shape of the identified sperm.

In still another related specific example, the method further includes: extracting a series of video frames from the recorded video of the sperm sample; identifying a plurality of sperm from the series of video frames; identifying the movement of the sperm based on the series of video frames Trajectory; determine the movement speed of the sperm based on the movement trajectory of the sperm and the time period captured by the series of video frames; and calculate the sperm motility based on the movement speed of the sperm.

In another related specific example, the method further includes: further magnifying the video or image of the sperm sample through a magnifying lens.

In some specific examples, a method for testing sperm using a system for testing biological samples includes: inserting a device into a base assembly; recording a video of the sperm sample in the sample holding area by a mobile device, the The mobile device is fixed in the shape-matching frame of the base assembly; the sperm count of the sperm sample is determined based on at least one frame of the recorded video; and the sperm motility of the sperm sample is determined based on the recorded video.

In a related specific example, the method further includes: further magnifying the video of the sperm sample through a magnifying lens.

In some specific examples, the system for testing biological samples includes a disposable device for testing biological samples and a base assembly. The disposable device includes a sample carrier containing a sample holding area and a detachable cover placed on the 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 set for capturing images of the sample holding area The camera assembly includes an image sensor and an optical lens module. In related specific examples, the optical lens module may have a linear magnification ratio of at least 0.1.

Figure 31 shows an additional example carrier 3105 with one or more visual signs 3117(1)-3117(5) (or can be collectively referred to as visual cues 3117) that can be used to control the analysis processing program (for example, Figure 21C or Figure 22 shows the test device). As shown in FIG. 31, the visual cue 3117 may be in (or near, in some additional or alternative embodiments) the holding area of the carrier 3105 (eg, holding area 3115B).

As mentioned above (for example, in relation to FIG. 29), the processor can execute different analysis processing procedures based on visual cues on a 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 processing procedures can be performed according to the visual cues from the result of the image recognition. In some embodiments, the visual cue of the carrier may be a shape of a specific holding area. Other visual cue embodiments may include graphic patterns, visual signs, one-dimensional bar codes, multi-dimensional pattern codes (eg, QR codes), and the like.

In some specific examples, as shown in Figure 31, any visual mark (such as visual mark 3117(1)) can be a specific small graphic pattern that can be engraved, attached, or marked in the holding area of the carrier 3105 On 3115B. In the example of Figure 31, the visual signs 3117(1)-3117(5) are all the same or substantially similar patterns, but in other examples (not shown for simplicity), they do not have to be exactly the same and each visual The logo may have a unique shape, size, pattern, etc. In one or more implementations, the visual cue 3117 (for example, the visual signs 3117(1)-3117(5)) is a size that is not perceived by humans but can be recognized by a camera module after being magnified by a microlens (for example, The second camera module 2230B in FIG. 22 or the camera module 2130 in FIG. 21C). In some of these implementations, the visual signs 3117(1)-3117(5) are less than 15 microns (μm). In addition, the visual signs 3117(1)-3117(5) can be configured so that their positions collectively form a Pattern (for example, a predetermined configuration). In addition or as an alternative to the unique characteristics of the visual sign (such as size, shape, color, and/or position), this is a set formed by the position of each visual sign The pattern can be an identifiable prompt to be used to control the function of the test device (for example, whether and which analysis processing program is executed successively). This collective pattern may be based on the absolute position of the visual sign (e.g., in the holding area) and/or the relative position of the visual sign (e.g., from their respective adjacent signs). In Figure 31, the set patterns shown by the visual signs 3117(1)-3117(5) are visual signs 3117(1)-3117(4) each set in one of the four corners of the (camera captured image) and The visual mark 3117(5) is set in the center, and each visual mark is evenly distributed. Some additional or alternative embodiments provide that each (or each group) of special visual signs (or signs) in the visual cue can represent a different analysis function to be performed.

In view of the above situation, the test device here can use visual cue on the carrier (for example, in or near the holding area) to control the function of the test device and adaptively execute the analysis processing program based on the visual cue. In some embodiments, the visual cue can be used to confirm whether the carrier is an authorized carrier (for example, appropriately authorized and manufactured in accordance with a certain specification and in accordance with applicable quality standards). In other examples, visual cues can be used to control the test device in which mode (for example, male or female, laboratory or home, high accuracy or short time, use battery or plug in) to perform calculations. In addition, in some embodiments, providing a visual cue can be used to control access to a certain function of the test device, which provides the ability to flexibly customize the service provided by the test device according to the customer's identity and geographic location.

FIG. 32 is a flowchart of another example of a processing program 3200 that can be implemented by the testing device (such as FIG. 21C or FIG. 22) adaptively executing an analysis processing program based on visual cues. With continued reference to FIG. 31, the processing procedure 3200 will be described below. It should be noted that in the following example of the processing procedure 3200, the visual cue is applied to execute a carrier authentication application, but the processing procedure can also be applied to execute other applications (for example, as described in relation to FIG. 30). For example, in some applications that are not carrier verification, the processor can execute different sets of analysis processing programs based on different visual cues.

First, in step 3202, the receiving mechanism of the test device receives the carrier inserted through the opening, the sensor (not shown for simplicity) can notify the processor, and the processor will cause the built-in camera module of the test device to capture One or more carriers hold the image of the area. In step 3204, the processor can use The captured image identifies the visual cue in the carrier (for example, based on known image analysis techniques or those disclosed herein). As discussed above, the visual cues may include some visual signs, and each visual sign may be the same or different in size, shape, pattern, color, etc. (as shown in the example in FIG. 31) or they may be different. The visual signs can collectively further present a pattern (for example, from their location). Then, the processor can combine visual cues (such as a unique size, shape, position, or collection pattern) with predetermined visual cues (such as stored in the local memory and/or cloud database (which can be obtained by the manufacturer of the test device) Or other administrator operations or control) for comparison.

Step 3206, the processor selectively executes a set of analysis processing procedures on the recognition result of the captured image of the holding area based on the visual cue. If the recognition result of the visual cue responds to the positive direction (for example, responding to the carrier holding area with a predetermined visual cue), then the processor continues to proceed, which may include selectively capturing additional images (or videos) for analysis (step 3208) and the subsequent steps of the corresponding group (step 3210) that executes the analysis processing program on the image. On the other hand, if the recognition result responds in a negative direction (for example, responding to a carrier holding area that does not have a predetermined visual cue), the processor causes an alternative action (for example, displaying an error code) to reflect that the visual cue is unrecognizable and incorrect. The image executes any analysis processing program (step 3212). After the analysis processing program group is executed, the processor can continue to determine the result of the biological sample based on the result of the analysis processing program as described above.

In addition, it is worth noting that traditional computer-assisted sperm analyzers (CASA) rely on large microscopes and the experience of operating technicians to determine sperm parameters. There are some computer software to supplement the experience of the technicians and standardize the analysis results. However, due to the difference between the lens and the sensing module, blurred images often seriously affect the effectiveness of the auxiliary software, resulting in inaccurate related functions (such as sperm count calculation).

In addition, competent authorities such as the World Health Organization (WHO) issued a human semen examination and processing laboratory manual. The manual clearly stipulates the minimum amount of samples to be evaluated to determine the concentration of sperm, the motility of sperm, and the morphology of sperm. (For example, 200 sperm). current The analysis based on computer-aided sperm analysis images generally lacks automatic sampling or requires manual operation to obtain multiple fields of view to meet the World Health Organization specifications and reduce the sampling error in the analysis. Alternatively, if sampling is performed repeatedly with only a single field of view, To achieve a satisfactory low sampling error, the time it takes to repeat the procedure often becomes too long to be implemented on a large scale.

FIG. 33 is a flowchart of an example processing procedure 3300 that can be implemented by the testing device (for example, FIG. 21C or FIG. 22) for better results (for example, better analysis accuracy or efficiency). The processing program 3300 may be an alternative or supplementary processing program of the processing program here (for example, the processing program shown in FIG. 16).

First, in step 3310 (for example, after the carrier box carrying the biological sample or has been exposed to the biological sample is inserted (as introduced above)), the introduced device can use a camera module to capture the carrier box holding area One or more images of (or collectively, imagery). In some alternative embodiments (for example, as described with respect to FIG. 29 or 31), the device can recognize (step 3320) the visual cue on the carrier from the captured set image of the holding area. In these alternative embodiments, the device can perform a set of analysis processing procedures on the captured set of images based on the recognition result of the visual cue.

In step 3330, the device can divide the captured set image into a plurality of blocks. In some embodiments, the block may be polygonal. More specifically, some implementations indicate that blocks can be triangles, rectangles, squares, pentagons, hexagons, and so on. These (block) shapes may have at least one side often 0.05 mm. In one or more embodiments, the block is square and has a size of 0.05 mm by 0.05 mm. It is worth noting that, according to a specific implementation, the number and size of the blocks can be adjusted according to the resolution of the camera module. It is illustrated in FIG. 34 that an example of an image indicating a holding area is divided into several blocks (for example, block 3402). It should be noted that, in order to promote the discussion of the disclosed technology here, the captured collection image is considered to be "segmented" into blocks; however, it should be understood in one or more implementations that the processor is in the operating time of the computer (Or during normal operation) does not actually need to perform mathematical division operations to perform this technology; instead, the resulting block or grid can be predetermined, logically It is pre-installed on the editor, preset by the program, or pre-configured on the camera controller and/or processor of the device, so that the need for performing operations related to the collection of images divided into blocks can be reduced, or in some cases The instance is completely eliminated.

In step 3340, the example device selects from a plurality of blocks and candidate blocks for analysis. According to one or more embodiments, the selection of the candidate block is based on many factors, for example, the focus degree of a block and/or the normality of a block.

More specifically, in many implementations, the device can determine (step 3342) the focus degree of each complex number of blocks, so that each block can have a corresponding focus degree measurement. The degree of focus can be determined based on one or more focal length measurement functions. Depending on the implementation, the adopted focal length measurement function may include one or more: variant type, sum of difference coefficients type, Laplacian energy image type, and/or lateral gradient intensity maximization type.

After determining the focus degree of each block, in some embodiments, the device compares the focus degree of a block with the minimum focus degree threshold. In one or more implementations, a block can be selected as a candidate block only when the focus degree meets (for example, reaches or exceeds) the minimum focus degree threshold. In addition, the device can also mark or label blocks. In one or more embodiments of this device, it is pointed out that the block will be marked or labeled only when the minimum focus degree threshold is met (for example, for further analysis or tracking identification). The marking or labeling can be done continuously or randomly. The selection process of a part of the candidate blocks is illustrated in FIG. 35. Here, the blocks are randomly labeled and the blocks that exceed the minimum focal length threshold are preliminarily selected as candidate blocks 3510.

Next, the device can perform image processing on several selected blocks to determine the characteristics of the selected blocks (step 3344), to determine the normality of a block, for example, to check whether the block is " Normal enough" to grant further analysis. In some instances, the blocks selected for normality determination are those that have been preliminarily selected as candidate blocks (for example, those that meet the minimum focus degree threshold, as described above). In some instances, the characteristic used to determine normality at this stage is Number of cells (such as sperm count). In a specific example, the device can perform image processing on the blocks that meet the minimum degree of focus (meaning that they are sufficiently focused) to determine the number of cells (sperm) in the block for each sufficiently focused block. This image processing procedure may include binarization (and in some implementations, with adaptation limits) to identify some objects in the block that may be sperm as the foreground, and identify the remaining part of the block as the background. After image processing procedures, this device can determine the number of cells (sperm). In one or more embodiments, the number of cells in the candidate block can be determined based on the ratio of the area with sperm to the area without sperm (for example, using a table related to the known cell number ratio for extrapolation).

After that, the device can calculate statistics (for example, average and standard deviation) of all remaining candidate blocks (for example, these blocks that meet the minimum focus degree threshold). After the statistical data is calculated, the device can determine (step 3344) the normality of the specific block by statistically comparing one or more characteristics (for example, sperm count) of the specific block and all remaining candidate blocks. In some embodiments, only when the normality of a specific block satisfies a normality condition, it will continue to be selected as a candidate block. Take the number of sperm as an example. In many embodiments, a block is considered "sufficiently normal" (for example, it satisfies the normality condition), when the sperm count in the block is the average of the plural blocks The standard deviation is in the preset value. In one or more implementations, the requirement for normality is (in terms of average) within two standard deviations. In other implementations, the normality requirement is one or three standard deviations, or other suitable statistical techniques, which can reflect the comparison of normality between a block and other block groups. It is illustrated in FIG. 36, which is the result (for example, adaptive thresholding binarization) and cell number determination after the image processing procedure. It should be noted that in Fig. 36, the estimated cell number of each candidate block is displayed instead of its mark.

In addition, the device can determine (step 3346) whether the target number of cells to be analyzed has been reached. Specifically, one or more embodiments of the disclosed device can maintain the 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 number. This device can use the target number of analysis cells to control the number of biological samples to be analyzed. And according to the implementation this number is configurable. This quantity (number) can be customized according to the laboratory manual and the standards for testing specific biological samples. In some embodiments, the target number of cells to be analyzed is two hundred (200). In some instances, when the total cell amount reaches the target number of cells to be analyzed, the selection of the candidate block is completed. That is, according to at least some of the embodiments disclosed herein, the selection of candidate blocks can be performed on blocks that meet the threshold of the degree of focus and the normality requirement that the total number of cells reach the target number of cells to be analyzed ( For example, in a random manner).

In step 3350, after the candidate block is selected, the introduced device can determine one or more characteristics of the biological sample by analyzing the selected candidate block (for example, by one or more techniques introduced here). In at least several embodiments, the biological sample is semen, and one or more biological sample characteristics in the candidate block are to be determined, including one or more: the number of cells (or concentration, which can be inferred from the number of cells) , Activity, or form. In some examples, the device is further configured to determine the result (for example, fertility) of the biological sample based on the result of the analysis processing procedure after the set of analysis processing procedures are executed.

In addition, it is observed here that it is often difficult to perfectly manufacture the lens assembly (especially when the quantity is large and the cost must be controlled) such as the microscopic lens assembly and/or magnification installed on the test device introduced here. Lens assembly. The defects of the lens exist in various forms, such as impurities, or imperfections of the lens itself (for example, clarity, refraction, focus, and others), and these defects can adversely affect the accuracy of the test device influences. Therefore, the techniques introduced here are calibration and qualification inspection techniques to reduce lens defects and further improve the analytical accuracy of the test device disclosed here.

FIG. 37 is an example flow chart 3700 of an example of a calibration processing program, which can be implemented by a test device disclosed herein (for example, FIG. 21C or FIG. 22) to obtain improved results. This processing program 3700 may be an alternative or supplementary processing program of the process disclosed herein, such as the processing program illustrated in FIG. 16.

First, in step 3710 (for example, after the carrier box is inserted), the introduced device can use the camera module to capture one or more images (or collectively referred to as the collection image) in the holding area of the carrier box. Like (imagery)). In some optional embodiments (for example, those described in relation to Figure 29 or 31, the device can recognize (step 3720) the visual cues on the carrier from the collective image captured from the holding area. In these optional In an embodiment, the device can perform a set of analysis processes on the captured set images according to the recognition results of the above-mentioned visual cues.

More specifically, in some implementations, the carrier box here can be used as a dedicated virtual box that can be used to trigger the correction processing program. For example, a special virtual box may have one or more special graphic patterns (for example, as described below with respect to FIG. 38). After the visual prompt recognition processing procedure (for example, in step 3720), the test device can be triggered to enter Correction mode. In another example, a special virtual box can carry special test samples (for example, as described below with respect to Figure 41), and the user can manually cause the test device to enter (for example, through the user interface on the panel or remote test device) In calibration mode. In many instances, the virtual box may include an electronic (e.g., a radio frequency identification (RFID)) or a mechanical feature (e.g., a special shape or a mechanical protrusion) that can trigger the calibration mode.

Figure 38 is a test carrier carrying a visual cue or an image pattern that 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 enables the test device to be recognized as a trigger to enter the calibration mode. After that, the test device can use the camera module to capture the image of the image pattern, and perform self-diagnosis to self-calibrate the results from the captured image. The visual pattern should be easy to recognize (and not easy to misunderstand). As illustrated in Figure 38, the visual pattern in the example includes repetitive (for example, every 0.08 mm, which is the repetition rate or "pitch"), larger (for example, 0.02 mm by 0.02 mm) and general The ground has a regular shape. This visual cue can further include one or more repeating linear patterns. In the example illustrated in Figure 38, this linear pattern includes a set (for example, three) of horizontal lines and a set of (for example, three) A) Vertical lines. In some embodiments, these lines have a resolution of 200 line pairs per millimeter (LP/mm) or higher. In the specific example of Figure 38, the line has a resolution of 500LP/mm. It should be noted that the horizontal and/or vertical lines are examples of visual linear patterns, which are suitable for assisting the test device to perform self-diagnosis of the optical characteristics and performance of the optical instrument (for example, microlens) installed in the test device itself; others Suitable visual patterns can replace the illustrative example in FIG. 38. For example, in some embodiments, an "E" shaped pattern or equivalent can replace parallel lines as a visual linear pattern. For example, in some embodiments, solid lines and dashed lines can be used for visual linear patterns.

Continuing with the processing procedure 3700, although the calibration mode has been triggered in step 3730, after the collective image of the carrier is captured (for example, in step 3710), the device can divide the captured collective image into a plurality of blocks (this is the same as Step 3330 is similar, as discussed above). In some embodiments, the block may be polygonal. More specifically, some implementations indicate that the blocks can be triangles, rectangles, squares, pentagons, hexagons, and so on. These (blocks) of these shapes may have at least one side of 0.05 mm. In one or more embodiments, the block is square and has a size of 0.05 mm by 0.05 mm. It is worth noting that, according to a specific implementation, the number and size of the blocks can be adjusted according to the resolution of the camera module. In one or more implementations, the above-mentioned pitch (for example, the regular repetition rate of the visual pattern) can correspond to the number of blocks that can be divided into the collective image. In some embodiments, the spacing may be consistent with the number of blocks that can be divided by the test device in the collective image.

In step 3740, the device in the example can perform calibration/self-diagnosis procedures, for example, in each block. The calibration procedure should usually consist of one or more steps, which enables the testing device to self-diagnose the quality of the optical modules (for example, including microlenses and camera modules) currently installed on the testing device itself. In one or more embodiments, the testing device can determine (at step 3742) the degree of focus of each zone, for example, by using one or more focal length measurement functions. Examples of the focal length measurement function may include a variation type, a sum of difference coefficients type, a Laplacian energy image type, and/or a lateral gradient intensity maximization type. Then, in step 3744, the test instrument can determine whether a block meets the focus degree, for example For example, the minimum focus degree threshold discussed above. Additionally or alternatively, the test device can compare the retrieved results with one or more expected results (in step 3746). For example, the processor of this test instrument accesses one or more images pre-installed in memory (for example, captured without a camera, for example, transferred or installed by a program), and The captured images are compared, and it is determined whether the quality of the suspected captured image in the block meets the minimum standard. The pre-installed image or images should be representative of the visual pattern to be corrected. In step 3746, the test device can compare and view the example image quality parameters, including color distortion, pattern distortion, clarity defects, and/or other image defects.

FIG. 39 is an example image of the visual cue of FIG. 38. The image quality is generally better in the lower left corner and worse in the upper right corner after being captured by the test device disclosed herein. 40A and 40B are two specific example illustrations of different image qualities of the captured images in different regions in FIG. 39. In some embodiments, for example, where the pitch is the same as the number of blocks that can be divided into the collective image, the images 40A and 40B can each represent one block. As illustrated, the image quality in the block in FIG. 40A is better than that in FIG. 40B because the image is clearer and more focused.

Back to the processing procedure 3700, in step 3750, the result of step 3740 (for example, whether the block meets the minimum image quality requirements, such as the minimum focus) is recorded on the computer integrated with the test device (for simplicity, no more details) Readable storage media (for example, it may be non-transitory, such as flash memory). The knowledge gained from the calibration process can be used, for example, when the test device is used in normal operation afterwards. In one or more embodiments, in normal operation (for example, in step 3340, as discussed above) at this time, the test device can automatically skip or ignore those that fail to reach the minimum image quality during calibration or self-diagnosis. The requested block. In this way, the testing device disclosed herein can reduce the adverse effects of lens defects and increase the accuracy of analysis.

Figure 41 shows an example image of a test sample carried by a test carrier, which can be used to calibrate or verify the test device disclosed herein. This technology can be applied to one or more of the aforementioned embodiments. A special virtual box can carry special test samples and the correction mode can be changed from the visual pattern. The trigger is activated (for example, manually activated by the user, or by mechanical features or radio frequency identification (RFID) on the virtual box). Some embodiments indicate that the test sample should be in the form of an aqueous medium (for example, a liquid solution) containing small test particles, such as the test particles 4102 illustrated in FIG. 41. These microparticles can be made of any suitable substance, including, for example, polymers. An example material for a particular particle 4102 is latex. The size of the particles can be adapted to the specific application. In some implementations, the size of the particles can be similar to the size of those cells, such as sperm. Example sizes of particles can range from 0.5 microns to 50 microns in diameter. In the example, the particles are 5 microns in diameter. When the test particles are used as samples, the test device can perform calibration/self-diagnosis as in the 3700 processing procedure without step 3720, and self-diagnose the quality of the optical module currently installed in itself. In some of these implementations, the test device can be pre-installed with images of test particles (for example, not captured by a camera, for example, by being transmitted or program-installed by other means) in the memory, as discussed above, to do For comparison and correction purposes.

42A and 42B illustrate different image qualities in different regions of the captured image in FIG. 41. As explained, the image quality in the block in FIG. 42A is better than that in FIG. 42B because the image is clearer and more focused. Similar to the above discussion, with regard to step 3750, the knowledge of the baseline image quality of each block can be used, for example, when the test device is subsequently used in normal operation. For example, some embodiments of the test instrument can automatically skip or ignore those areas that fail to meet the minimum image quality condition during calibration or self-diagnosis. In this way, the testing device disclosed herein can reduce the adverse effects of lens defects and improve the accuracy of analysis.

Although some of the specific examples disclosed in this article apply the disclosed technology to sperm testing, it is easy for those familiar with the technology to understand that the disclosed technology can be applied to test various types of biological samples, such as semen, urine, Sliding joint fluid, surface tissue or cells, tumor cells, water samples, etc.

It will be obvious to those familiar with the art that various modifications and changes can be made to the structure of the present invention without departing from the scope or spirit of the present invention. In view of the foregoing, it is intended that the present invention encompasses Cover the modifications and changes of the present invention as long as they fall within the scope of the following patent applications and their equivalent content.

2205: test strip device

2210A: Cover

2210B: Amplifying components

2215A: The first holding area

2215B: The second holding area

2230A: The first camera module

2230B: Second camera module

2240A: light source

2240B: light source

Claims (50)

A device for testing biological samples, the device comprising: a receiving mechanism to receive a carrier, wherein the carrier includes a holding area, wherein the holding area carries the biological sample or has been exposed to the biological sample ; A camera module configured to capture a set of images of the holding area to obtain a captured set of images; and a processor configured to use the camera module to ( 1) Recognizing a visual cue on the carrier from the captured set image of the holding area, and (2) Based on a result of the recognition of the visual cue, comparing the captured set The image executes a set of analysis processing procedures; the set of analysis processing procedures includes: dividing the captured set image into a plurality of blocks; selecting a plurality of candidate blocks from the plurality of blocks to analyze, wherein the candidate The selection of the block is based on (1) the focus of the block and (2) the normality of the block, and one or more characteristics of the biological sample are determined by analyzing the plurality of selected candidate blocks. The device according to claim 1, further comprising a housing, the housing comprising an opening; the receiving mechanism receives the inserted carrier through the opening; the collective image is one or more Image; the processor is carried on a circuit board; the visual cue is located in or near the holding area on the carrier; wherein the processor is further configured to be executed in the set of analysis processing procedures Then, based on the results of the set of analysis processing procedures, determine a final result about the biological sample; The receiving mechanism, the camera module and the circuit board are packaged in the casing. The device of claim 1 or 2, wherein the processor is further configured to determine which of the captured set images of the holding area based on a shape and/or a position of the visual cue A set of analysis processing procedures will be executed. The device according to claim 1 or 2, wherein the processor executes the set of analysis processing procedures on the captured set images only after the visual cue is recognized. The device according to claim 4, wherein the visual cue is recognized in a predetermined shape and/or a predetermined position. The device according to claim 1 or 2, wherein the visual cue is a size that is not perceived by humans. The device according to claim 6, wherein the size of the visual cue is recognized by the camera module after being enlarged by a microlens. The device according to claim 1 or 2, wherein the visual cue includes a predetermined configuration of a plurality of visual signs. The device according to claim 2, wherein the camera module includes a first camera module and a second camera module, and the first camera module and the second camera module are packaged in the housing, The holding area includes a first holding area and a second holding area that are adjacent; and the processor is further configured to use the first camera module to identify the first holding area on the carrier To obtain a recognized shape, and use the second camera module to recognize the visual cue on the carrier from the second holding area, wherein the visual cue is a size that is not perceived by humans . The device of claim 9, wherein the processor is further configured to execute a first analysis processing procedure on the captured image of the first holding region. The device of claim 10, wherein the processor is further configured to Identify the shape of the first holding area to determine which set of analysis processing procedures will be performed on the captured image of the first holding area. The device of claim 9, wherein the processor is configured to identify the first shape based on the captured image of the first holding area in response to the recognized shape being a first shape The acidity of a biological sample. The device according to claim 12, wherein the recognition of the acidity is based on a color shown in the first holding area. The device of claim 9, wherein the processor is configured to, in response to the recognized shape being a second shape, to recognize the image based on the captured image of the first holding area A hormone level in a biological sample. The device according to claim 14, wherein the identified hormone is based on a color shown in the first holding area. The device according to claim 9, wherein the first camera module includes a non-microlens, and wherein the second camera module includes a microlens. The apparatus according to claim 9, wherein the processor is configured to determine a cell number of the biological sample in response to the recognized shape being the first shape. The device according to claim 17, wherein the determination of the number of cells of the biological sample is performed by using the second camera module. The device according to claim 2, further comprising: a display packaged in the casing, wherein the processor is configured to display the final result of the determination on the display after obtaining the final result . The device of claim 1 or 2, wherein the processor is further configured to determine the biochemical characteristics of the biological sample based on one or more images of the holding area. The device according to claim 1, wherein the set of analysis processing procedures further includes Including: comparing the focus degree of the block with a focus degree threshold, wherein the block is selected as a candidate block only when the focus degree of the block meets the focus degree threshold. The device according to claim 1, wherein the set of analysis processing procedures further comprises: determining a focus degree for each of the plurality of blocks based on one or more focal length measurement functions. The device according to claim 22, wherein the one or more focal length measurement functions include one or more of a variation type, a sum of difference coefficient type, a Laplacian energy image type, or a lateral gradient intensity maximization type . The device according to claim 1, wherein the set of analysis processing procedures further comprises: determining the normality of the block by statistically comparing one or more characteristics of the block and the plurality of blocks, wherein The block is selected as a candidate block only when the block meets a normality requirement. The device according to claim 24, wherein the one or more characteristics of the block include a number of cells in the block, and wherein the normality requirement is a predetermined value of the standard deviation of the complex number block . The device according to claim 25, wherein the preset value of the standard deviation is two standard deviations. The device according to claim 1, wherein the group of analysis processing procedures further includes: for each block meeting a threshold degree of focus, an image processing procedure is executed to determine the number of cells. The device according to claim 27, wherein the image processing program includes adaptive limit binarization. The device according to claim 27, wherein the set of analysis processing procedures further comprises: calculating (1) an average value of the number of cells and (2) an average value of the number of cells from all blocks satisfying the threshold of the focus degree One standard deviation. The device according to claim 1, wherein the selection of the candidate block is further based on a total number of cells, which controls a number of biological samples to be analyzed. The device according to claim 1, wherein the set of analysis processing procedures further includes: maintaining a total cell count; and summing each corresponding cell count selected as the candidate block to the total cell count, wherein the candidate The selection of the block is completed when the total number of cells reaches a target number of cells to be analyzed. The device according to claim 31, wherein the target number of cells to be analyzed is 200. The device according to claim 1, wherein the selection of the candidate block is performed randomly on a block that meets a focus degree threshold and a normality requirement, and the normality requirement is until a total cell count reaches a desired The target number of cells being analyzed. The device according to claim 1, wherein the shape of the plurality of blocks is a polygon. The device according to claim 1, wherein the shape of the plurality of blocks is triangle, square, pentagon or hexagon, and one side of the plurality of blocks is at least 0.05 mm. The device according to claim 1, wherein the biological sample is semen. The device according to claim 1, wherein the one or more characteristics of the biological sample include one or more: cell number, activity or morphology. The device according to claim 1, further comprising a housing, wherein the receiving mechanism, the camera module, and the processor are packaged in the housing. The device according to claim 2 or 38, wherein an external dimension of the casing is less than 27,000 cubic centimeters. According to the device described in claim 1, the processor executes a calibration procedure for each of the divided plural blocks, and then executes the set of analysis processing procedures. For the device according to claim 40, the calibration procedure is for the processor to compare the captured set image with one or more expected results to determine whether the captured set image satisfies A minimum standard. In the device according to claim 41, the desired result is one or more images pre-installed in a memory of one of the processors. The device according to claim 42, wherein the one or more images in the memory are visual patterns. According to the device described in claim 41, the comparison includes comparing and checking an image quality parameter. According to the device according to claim 44, the image quality parameter includes: color distortion, pattern distortion, or clarity defect. The device according to claim 40, after the processor recognizes the visual cue on the carrier, performs the calibration procedure. In the device according to claim 40, the holding area of the carrier carries a test sample containing a plurality of test particles, and after the processor recognizes the test particles in the test sample, the calibration procedure is performed. A device for testing biological samples, the device comprising: a housing, the housing comprising an opening, wherein an external dimension of the housing is less than 27000 cubic centimeters; a receiving mechanism to receive a carrier, The receiving mechanism receives the inserted all through the opening The carrier; wherein the carrier includes a holding area, wherein the holding area carries the biological sample or has been exposed to the biological sample; a camera module configured to capture one or more of the holding area Images to obtain a captured image; and a circuit board carrying a processor configured to use the camera module to (1) obtain a captured image from the holding area Image recognition is a visual cue in or near the holding area on the carrier, and (2) based on a result of the recognition of the visual cue, selectively checking the captured image of the holding area Like executing a set of analysis processing procedures; wherein the processor is further configured to determine a final result of the biological sample based on the results of the set of analysis processing procedures after the set of analysis processing procedures are executed; wherein The receiving mechanism, the camera module and the circuit board are packaged in the casing. The device according to claim 48, wherein the visual cue is a size that is not perceived by humans, and the size is recognized by the camera module after being magnified by a micro lens. The device according to claim 48, wherein the camera module includes a first camera module and a second camera module, and the first camera module and the second camera module are packaged in the housing, And the processor is further configured to use the first camera module to recognize a shape of a first holding area on the carrier, and to use the second camera module to recognize the visual cue, wherein The visual cue is a size that is not perceived by humans.

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