CN110408513A

CN110408513A - The method of device and judgement biological sample characteristic for test biological sample

Info

Publication number: CN110408513A
Application number: CN201910363406.9A
Authority: CN
Inventors: 徐振腾; 张家伟; 张志宾; 黄光立
Original assignee: Bonraybio Co Ltd
Current assignee: Bonraybio Co Ltd
Priority date: 2018-04-30
Filing date: 2019-04-30
Publication date: 2019-11-05
Also published as: TW201945731A; TWI699532B

Abstract

The present invention relates to a kind of device for test biological sample and the methods of judgement biological sample characteristic.The device for being used for test biological sample includes: receiving mechanism, with received vector, the carrier includes holding area, and wherein holding area carries the biological sample or exposed the biological sample；Camera model is configured to capture the integrated images of holding area；And processor, the processor is configured to be captured the visual cues of integrated images identification position on the carrier from the described of the holding area come (1) using camera model, and the recognition result of (2) based on the visual cues, integrated images execution analysis and processing program is captured to described；The analysis and processing program includes: to be divided into multiple blocks through acquisition integrated images for described, selects multiple candidate blocks from multiple blocks, and the characteristic of the biological sample is determined by analyzing the multiple chosen candidate block.The present invention can obtain the result of test and at low cost at once.

Description

The method of device and judgement biological sample characteristic for test biological sample

Technical field

The present invention relates to the equipment for test biological sample, and especially with respect to a kind of for test biological sample Device and the method for determining biological sample characteristic.

Background technique

Currently, the test of fluid contents would generally entrust to professional testing agency, holding high with high magnification ratio is utilized Your microscope device executes test.Since common people do not have microscopie unit, therefore test activity can not be executed by common people.

However, being to need to be implemented routine test in some current category of test；Therefore the need for needing frequently to test For asking, cause that over-burden in terms of time and expense.For example, the classification tested for a long time includes infertile patient's sperm Test.Sperm test executes observation primarily directed to sperm number, its energy and form.

Sperm test method includes: the sperm of male subject being stood a period of time at room temperature, and obtains a drop institute It states sample and the sample instils on glass slide, and observe the sample under the microscope.The grade observations not only include The observation of high amplification is executed to individual sperms to identify the external morphology of individual sperms, and including to a large amount of whole sperms, The quantity of its energy, form and per unit area executes observation.However, individual cannot oneself execute sperm test, this be by Not yet developing in industry allows the personal technology that test is executed via simple auxiliary device.

Summary of the invention

The present invention provides a kind of device for test biological sample and determines the method for biological sample characteristic, described to be used for The device of test biological sample includes: a receiving mechanism, to receive a carrier, wherein the carrier includes a holding area, Middle holding area carries the biological sample or has exposed the biological sample；One camera model is configured to capture fixing One integrated images in region are obtained once acquisition integrated images；And a processor, the processor are configured to utilize camera mould Block comes (1) and is captured the visual cues of integrated images identification on the carrier, and (2) base from the described of the holding area In the identification of the visual cues one as a result, to it is described through capture integrated images execute a group analysis processing routine；Its In the group analysis processing routine include: by it is described through capture integrated images be divided into multiple blocks；It is selected from the multiple block Multiple candidate blocks are to analyze, wherein the selection of the candidate block is the focus level based on (1) block, and (2) block Normality, and determine that the one or more of the biological sample is special by the multiple candidate block (chosen candidate block) Property.

Preferably, the integrated images are one or more images.

Device for test biological sample of the invention is relatively inexpensive compared with known test device, needs less labour For test and it is easy to use.The technology can be applied to sperm test and other testing fields, water such as containing microorganism, Water quality, blood, urine, body fluid, stool and skin surface tissue/cell.The technology and use laboratory microscope equipment The prior art compared to provide have significantly lower use cost simple test product.

Compared to the prior art, the device offer disclosed herein for test biological sample can significantly reduce sample The simple structure of the cost of amplification test structure, for the test of such as sperm, urinalysis or the test of other body fluid analysis.Herein Disclosed in technology there is sample holding area, amplifier module via design and unique create newly-installed carrier and can be used for wide In the application of general range.For example, counting, the activity of detection sperm sample be can be applied to for the device of test biological sample Power and form.

Device for test biological sample of the invention, which is suitable for being in, executes test.The result of test can be obtained at once And it is at low cost.For example, a kind of be in is provided for the device of test biological sample evaluate the male for the man and wife for trying pregnancy The mode of fertility, so that man and wife can be made whether to need the informed decision-making of medical intervention.

Revealed technology can advantageously be integrated with existing intelligent communications device (such as smart phone or single board computer), And be able to use existing intelligent communications device and capture through amplification test image and execute subsequent operation, such as storage and transmission figure Picture.The cost of the equal devices is low, so that it is disposable apparatus or reusable device that this, which waits devices implementable,.

At least some specific examples of the invention are devices about a kind of for test biological sample (for example, testing cassete Or test strip).Described device includes sample carriers and detachable outer cover.Sample carriers include sample holding area.Detachably Outer cover is placed on the top of the sample holding area.Detachable outer cover includes being arranged to be aligned with sample holding area Amplifier module.The focal length of amplifier module is 0.1 millimeter (mm) to 8.5mm.Amplifier module has the Linear Amplifer ratio for being at least 1.0 Rate.

At least some specific examples of the invention are about a kind of system for test biological sample.The system comprises Device and base assembly referred to above for test biological sample.Base assembly includes for by test biological sample Device is inserted into the insertion port in base assembly.Base assembly further comprises the image for capturing sample holding area Photomoduel, or for fixation include matching for the shape of the mobile device for the photomoduel for capturing the image of sample holding area Close frame.Base assembly can further comprise the complementary lens being placed in below photomoduel.Amplifier module and the complementary lens Combination can have at least 1.0 effective linear magnification ratio.

At least some specific examples of the invention are to test essence using the device for being used for test biological sample about a kind of The method of son.It the described method comprises the following steps: obtaining the device for testing biological sample referred to above, by sperm sample Originally it is applied to sample holding area, records the video or image of the sperm sample；Based on recorded video or recorded image At least one picture frame determine the sperm count of the sperm sample；And it is based on recorded video or recorded spectral discrimination institute State the motility of sperm of sperm sample.

At least some specific examples of the invention are about a kind of system for test biological sample.The system comprises Disposable apparatus and base assembly for test biological sample.The disposable apparatus includes the sample of the holding area containing sample Carrier and the detachable outer cover being placed on the top of the sample holding area.The base assembly includes by disposable apparatus Insertion port and the camera being inserted into base assembly.It is solid that sample is captured including the camera of image sensor and optical lens module Hold one or more images in region.

Some specific examples of the invention include the device for test biological sample.Described device may include having opening Shell.Receiving mechanism can receive the carrier via the opening insertion.The holding area of the carrier may include adjacent One holding area and the second holding area.First holding area and the second holding area can carry biological sample or be exposed to life Object sample.

In some implementations, described device may include two camera models.The camera model is to be configured to acquisition the The first camera module of one or more images of one holding area, and be configured to capture one or more of the second holding area The second camera module of a image.In addition, some specific examples include the main circuit board for carrying processor, the processor is through matching It sets and the first analysis and processing program is executed with the image that captured to the first holding area.The processor can be configured to second The second analysis and processing program for being different from the first analysis and processing program through capturing image execution of holding area.In some specific realities In example, the processor can the result judgement based on both the first analysis and processing program and the second analysis and processing program about biology The result of sample.According to one or more specific examples, the receiving mechanism, first and second camera model and the master Circuit board is all packaged in shell.

In addition, in some specific examples, when the processor identifies that the first holding area is in first shape, the place Reason device is configured to execute a certain analysis and processing program.For example, if first shape indicates that biological sample includes coming from male The sperm of subject, then the processing routine can determine that one or more characteristics of sperm.The characteristic that can determine that can include: cell Count the form of (such as sperm count), the concentration of sperm, the energy of sperm and/or sperm.It in some instances, can be by using Second camera module executes the judgement to one or more characteristics of sperm.In some in these examples, processor is into one Step determines at least one additional features of sperm by using first camera module.This additional features may include the acid of sperm Degree.For example, carrier may include pH-value (pH) indicator that the acidity of color representation sperm is used in the first holding area, And processor can recognize the color of acidity for identification.

In some instances, when the processor identifies that the first holding area is in that can indicate that biological sample includes from women When the second shape of the urine of subject, the processor is configured to determine one or more characteristics of urine.It can determine that Characteristic can include: corpus luteum hormone (LH) is horizontal, follicle stimulating hormone (FSH) is horizontal and/or human chorionic gonadotrophin (HCG) It is horizontal.Such as acidity, the judgement to one or more characteristics of urine can be executed by using first camera module.Similarly, Carrier may include LH indicator, FSH indicator and/or HCG indicator in the first holding area.

In some specific examples, first camera module compared with second camera module have lower magnification ratio and/or Lower camera resolution.

In some specific examples, processor, which can be configured, utilizes first on first camera module identification carrier with (1) The shape of holding area；And (2) select the group analysis processing routine that will be performed based on the shape of the first holding area.First The shape of holding area can recognize the gender information of biological sample.Then, the shape in response to the first holding area is the first shape Shape can determine that the fertility about the other reproduction cell of the primary by the group analysis processing routine that processor selects.In addition, returning It should be the second shape in the shape of the first holding area, can determine that by the group analysis processing routine that processor selects about second The fertility of the reproduction cell of gender.

The present invention separately provides a kind of device for test biological sample, and described device includes:

One shell, the shell include an opening；One receiving mechanism, to receive a carrier, the receiving mechanism be via The opening receives the carrier of insertion；Wherein the carrier includes a holding area, and wherein holding area carries the life Object sample has exposed the biological sample；One camera model is configured to capture one or more images of holding area, It obtains once acquisition image；And one carry a processor circuit board, the processor is configured to using camera model come (1) Described from the holding area is captured in the image recognition holding area on the carrier or a neighbouring vision mentions Show, and (2) based on identification described in the visual cues one as a result, selectively to the holding area it is described through capture scheme As executing a group analysis processing routine；Wherein the processor is further configured to the analysis and processing program and is performed Afterwards, a final result of the result judgement about the biological sample based on the analysis and processing program；The wherein receiver Structure, the camera model and the circuit board package are in the shell.

Preferably, the visual cues are one not by the size of human perception, and the size is described in above-mentioned apparatus Camera model identifies after amplifying via a microlens.

Preferably, an apparent size of the shell is less than 27000 cubic centimeters in above-mentioned apparatus.

Preferably, being further included in above-mentioned apparatus: a second camera module, wherein the processor is further configured To identify a shape of one second holding area on the carrier using the second camera module.

The present invention separately provides a kind of method for determining biological sample characteristic, comprising: uses device as the aforementioned, operation processing Device is to be captured the view of integrated images identification on the carrier from the described of the holding area come (1) using camera model Feel prompt, and (2) based on identification described in the visual cues one as a result, to it is described through capture integrated images selectively execute One group analysis processing routine；Wherein the group analysis processing routine includes: to be divided into multiple blocks through acquisition integrated images for described； Select multiple candidate blocks to analyze from the multiple block, wherein the selection of the candidate block is poly- based on (1) block Burnt degree, and the normality of (2) block, and by the multiple chosen candidate block determine one of the biological sample or Multiple characteristics.

The present invention can obtain the result of test and at low cost at once.

Detailed description of the invention

Figure 1A is the decomposition view of the device for test biological sample of a specific example according to the present invention.

Figure 1B is the assembled view of the test device of Figure 1A.

Fig. 2A is the viewgraph of cross-section of the test device of Figure 1A.

Fig. 2 B is the viewgraph of cross-section of another specific example of test device.

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

Fig. 4 is the viewgraph of cross-section of the device for test biological sample of another specific example according to the present invention.

Fig. 5 is the viewgraph of cross-section of the device for test biological sample of another specific example according to the present invention.

Fig. 6 is the schematic diagram of the test device of Fig. 5 currently in use.

Fig. 7 is the schematic diagram of the device for test biological sample of another specific example according to the present invention.

Fig. 8 is the schematic diagram of the device for test biological sample of another specific example according to the present invention.

Fig. 9 is the schematic diagram of the device for test biological sample of another specific example according to the present invention.

Figure 10 is the schematic diagram of the device for test biological sample of another specific example according to the present invention.

Figure 11 to Figure 13 is the view of the device for test biological sample of the other three specific example according to the present invention. Figure 14 A is the schematic diagram for the test strip of another specific example according to the present invention being inserted into metering device.

Figure 14 B is the schematic diagram of the component of the metering device of another specific example according to the present invention.

Figure 15 A shows the sample process of the sperm test carried out by the device of such as metering device or intelligent communications device Program.

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

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

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

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

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

Figure 16 shows the sample process program for determining sperm concentration.

Figure 17 shows sample sperm and sample sperm track.

Figure 18 shows the sample process program for determining spermatozoon track and energy.

Figure 19 be include receiving flask test device schematic diagram.

Figure 20 be do not include receiving flask test device schematic diagram.

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

Figure 22 is that there are two the schematic cross-sections of the test device of the test strip device of sample holding area for tool.

Figure 23 is the schematic diagram of the component of the test device with automatic focusing function.

Figure 24 is the schematic diagram of the component of another test device with automatic focusing function.

Figure 25 A and Figure 25 B be include switch and motor test device schematic cross-section.

Figure 26 A and Figure 26 B be include flexible element test device schematic cross-section.

Figure 27 is the flow chart for analyzing the processing routine of the semen sample of male client or patient.

Figure 28 is the flow chart for analyzing the processing routine of the LH or HCG of women client or patient.

Figure 29 shows the test device (test device shown in such as Figure 22) for being suitably adapted for having polyphaser to be arranged The example of carrier.

Figure 30 is for analyzing both male subject and female subjects using test device disclosed herein The flow chart of the processing routine of fertility.

Figure 31 shows additional examples can be used for utilizing with visual cues (for example, in holding area or near) carrier Control the analysis and processing program that test device executes.

Figure 32 is implemented can adaptively to execute analysis and processing program by the prompt of revealed test device view-based access control model Processing routine additional examples flow chart.

Figure 33 is the example flow chart for the processing routine that can be implemented by revealed test device.

Figure 34 is the example image that holding area is divided into many blocks.

Figure 35 is the selection processing routine example image for illustrating the candidate block of a part.

Figure 36 is the example image for illustrating the result after image processing program (for example, two polarization) and cell number judgement.

Figure 37 is the correction program example flow chart that can be implemented by revealed test device.

Figure 38 test carrier carries the reality of the visual cues and/or picture pattern that can be used for correcting or making test device to come into force Example diagram picture.

Figure 39 is the example image of visual cues in the Figure 38 captured by revealed test device.

The different image qualities through capturing different blocks in image of Figure 40 A and Figure 40 B explanatory diagram 39.

Figure 41 is to test carrier to carry the test sample example image that can be used for correcting or making test device to come into force.

The different image qualities through capturing different blocks in image of Figure 42 A and Figure 42 B explanatory diagram 41.

Specific embodiment

With detailed reference to currently preferred specific example of the invention, the example is illustrated in alterations.

Figure 1A and Figure 1B shows the device for test biological sample of specific example according to the present invention.It is taken off herein The specific example shown for illustration purposes and is not construed as to required limitation of the invention.Device A1 for test biological sample Include: the carrier 10 with the sample holding area 11 being formed on the top of carrier 10, be stacked on the top of carrier 10 Outer cover 20 and at least one 30 (referred to as amplifier module of amplifier unit on the lenticular lens type surface including being formed on outer cover 20 Or magnifying glass).

The amplifier unit 30 of this specific example includes planar convex lens as shown in Figure 1A.However, it may include other classes The amplifying lens (for example, two-sided biconvex lens) of type is used as amplifier unit 30.Amplifier unit 30 is disposed to the sample with carrier 10 This holding area 11 is aligned and covers the sample holding area 11.Amplifier unit 30 can the test request based on various tests and With various magnification ratios.For example, the test may include sperm test, urine test, the test of synovial joint liquid, skin Test, water test or the test of other body fluid etc..

It is not needed using the test of the device A1 for test biological sample of this specific example expensive and operation time-consuming Additional amplifying lens or laboratory microscope.Furthermore, it is not necessary that keeping sample holding area and the amplifying lens or laboratory aobvious Micro mirror alignment.

As shown in Figure 1A, the sample holding area 11 of carrier 10 can be formed with sunk structure.The sunk structure Design provides the stabilization containing sample 40 and big memory space.The sunk structure allows the sample before performing the testing One required time section of this standing.For example, before executing energy test to semen sample, it is necessary to execute energy Semen sample is set to stand a required time section at room temperature before test.

Sample 40 can be instiled in sunk structure (also that is, sample holding area 11 of carrier 10) first to stand one section Time.As shown in fig. 1b, the gross area of outer cover 20 is smaller than the gross area of carrier 10.The sample being exposed to outside outer cover 20 connects Receiving end mouth 12 is formed on the side of sample holding area 11.Sample reception port 12 may be designed to have the shape towards external expansion Shape, the shape can help to the sample that smoothly instils.

The air that Fig. 2A shows the other side for extending beyond outer cover 20 and is formed on the other side of sample holding area 11 Channel 13.Air duct 13 can prevent the inside of air filling sample holding area 11, when this is filled in sample in liquid condition Prevent the reception to sample.

As shown in Figure 2 A, lateral illumination device 50 can be placed at the side of carrier 10 of test device A1.The side Illumination can be provided for the sample 40 in sample holding area 11 to lighting device 50 and therefore improve testing through capturing for sample 40 The resolution ratio of image.In some specific examples, sample holding area 11 be can receive on the top or bottom of test device A1 Light source illumination.

As shown in Figure 1A, amplifier unit 30 and outer cover 20 may be integrally formed, also that is, amplifier unit 30 and outer cover 20 can For single component.In other specific examples (specific example shown in such as Fig. 2 B), detachable outer cover 20 and be placed in can The female part upward of outer cover 20 is dismantled, i.e., the amplifier unit 30 in groove 21, which can be respectively, is suitable for the independence through combining Component.In other words, the detachable outer cover 20 of same type can the integration of amplifier units 30 different from various magnification ratios.

In some specific examples, the distance between bottom and the sample holding area 11 of the detachable outer cover 20 For 0.005mm to 10mm.In some specific examples, the bottom of the detachable outer cover 20 and the sample holding area 11 it Between distance be about 0.01mm.Test device may include one or more spacer (not shown) so that ensure can the disassembly outer cover The distance between 20 bottom and sample holding area 11.The spacer can be solid with the sample of detachable outer cover 20 or carrier 10 Region 11 is held to be integrally formed.

In some specific examples, the band including carrier 10 and outer cover 20 is tested for sperm.In some specific examples In, for determining that the best angle magnification ratio of sperm concentration and energy is about 100 to 200.In some specific examples, use In determine sperm morphology best angle magnification ratio be about 200 to 300.Amplifier module is thinner, and angle enlargement ratio is then higher.

The focal length of amplifier module also can be related to angle enlargement ratio.In some specific examples, the angle with 100 is put The amplifier module of big ratio has the focal length of 2.19mm.The amplifier module for being 156 with angle enlargement ratio has 1.61mm's Focal length.Amplifier module with 300 angle enlargement ratio has the focal length of 0.73mm.In some specific examples, amplification group The angle enlargement ratio that part has is at least 30, preferably at least 50.In some specific examples, the focal length of amplifier module is 0.1mm to 3mm.

Fig. 3 shows the sample process journey that test is executed using the device A1 for being used for test biological sample shown in Figure 1B Sequence.In step s 110, sample 40 to be tested is set in sample holding area 11.In step s 110, make outer cover 20 It is stacked on the top of carrier 10, sample 40 to be tested is set to sample holding area 11 from sample reception port 12 later In.Alternatively, sample 40 to be tested can be directly arranged in sample holding area 11 first, is later stacked in outer cover 20 On the top of carrier 10.In the step s 120, sample 40 is made to be statically placed in sample holding area 11 according to the test request of sample 40 In, selectively continue for some time.In step s 130, intelligent communications device (for example, mobile phone) is attached at outer cover 20 On, and it is directed at the camera of mobile phone with amplifier unit 30, to use the camera of mobile phone to capture via amplifier unit 30 The image or video of sample.In step S140, the application program (APP) run at mobile phone or other analytical equipments can For executing analysis to image or video, to obtain test result.

As shown in Figure 4, support-side (such as protrusion member 14) can be further formed the outer cover 20 in test device A2 The boundary of amplifier unit 30 on top.In some specific examples, protrusion-type support construction can be by adding protrusion member 14 It is formed on the top of outer cover 20.When user attempts using intelligent communications device 60 (for example, such as smart phone or veneer meter The mobile device of calculation machine) when capturing the image or video of sample, the side of intelligent communications device 60 with camera 61 can be fixed To protrusion member 14 (along the direction shown in arrow L1).Therefore, test device A2 allows user to use intelligent communications device 60 The image or video of sample are captured, and does not need expensive test device record image or video.In addition, in order to most preferably observe away from From, can the predetermined protrusion member 14 of specification based on camera 61 and test device A2 height.

As shown in figs. 5 and 6, test device A3 may include metering device 70 (referred to as base assembly).Instrument dress Setting 70 includes lower part machine barrel pedestal 71 and can be relative to the top machine barrel main body 72 that lower part machine barrel pedestal 71 rises or falls.Lower part There is machine barrel pedestal 71 outer cover 20 and carrier 10 to be stacked to provide the insertion port 73 of insertion position.Shine dress upward It sets (referred to as light source) 80 to be placed on the bottom of lower part machine barrel pedestal 71, with the combination from bottom to outer cover 20 and carrier 10 Illumination is provided.Top machine barrel main body 72 may include at least one additional amplifying lens 74 for example for being further amplified.

Thread mechanism can be used that top machine barrel main body 72 is attached to lower part machine barrel pedestal 71 so that top machine barrel main body 72 can rise or fall such as screw relative to lower part machine barrel main body 71.In other words, top machine barrel main body 72 can be relative to lower part Machine barrel pedestal 71 rotates so that top machine barrel main body 72 along the direction arrow L3 relative to lower part machine barrel pedestal along the direction arrow L2 71 upwardly or downwardly move.Height by adjusting top machine barrel main body 72 relative to lower part machine barrel main body 71, the system tune The height (changing magnification ratio) of whole amplifying lens 74 and the height of camera 61.

Assembling frame 75 (referred to as shape cooperation frame) can be placed at the upper end of top machine barrel main body 72.Assembled frame Intelligent communications device 60 is fixed on pre-position by frame 75.Assembling frame 75 has camera alignment hole 76.Intelligent communications device 60 camera 61 can receive the light from sample via camera alignment hole 76.

The camera 61 being placed on current intelligent communications device 60 typically only has digital zoom functions.In general, The test of pinpoint accuracy needs optical zoom lens.However, not needed using the user of test device A3 with optical zoom The camera 61 of lens.The function of regulating height thereof of test device A3 is that alignment sample, amplifying lens and camera 61 provide flexible solution Certainly scheme.

Fig. 6 shows the intelligent communications device 60 for having assembled and being fixed on assembling frame 75, and the assembling frame 75 disposes In in top machine barrel main body 72.Outer cover 20 and carrier 10 containing sample 40 are inserted into via insertion port 73.Light emitting device upward 80 can provide illumination to sample and increase the brightness of sample.

Top machine barrel main body 72 or metering device 70 can be rotated along direction L2, with along direction L3, adjustment is put upward or downwards The height of big lens 74 and camera 61.Height regulating mechanism realizes the function of adjustment magnification ratio.Camera 61 can be after amplification Capture the dynamic video or static test image of sample 40.In addition, its original equipment function can be used to deposit for intelligent communications device 60 Chu Jing captures video or image, transmitting test image or video and carries out subsequent processing.

It as shown in Figure 7, include being placed on outer cover 20 that there are different amplifications for the device A4 of test biological sample Multiple amplifier units 30,30B, 30C of ratio.User can make outer cover 20 deviate so that the sample holding area 11 of carrier 10 with Any one of amplifier unit 30,30B, 30C with different magnification ratios alignment, to obtain with different magnification ratios Test result.It is designed by this, the test device A4 of the enlarging function with single module can be applied to meet multiple test associations The amplification requirement of view, without changing amplifier unit or outer cover.

It as shown in Figure 8, include flexible transparent membrane 15 for the device A5 of test biological sample.Flexible thin transparent Film 15 is placed between carrier 10 and amplifier unit 30, and Covering samples holding area 11.Flexible transparent membrane 15 covers sample This 40 (being in a liquid state) so that sample 40 in restricted clearance.Therefore, about by the external action caused by air, dust and dirt Beam is to minimum level.In addition, test device A5 can adjust focal length by changing the thickness of flexible transparent membrane 15.

It as shown in Figure 9, is planar convex lens for the amplifier unit 30 of the device A6 of test biological sample, and towards load The surface of the amplifier unit 30 of body 10 is protrusion surface.Therefore, concave hollow component, i.e. groove 21 are formed in towards carrier upward At the surface of 10 amplifier unit 30.Focal length parameter is defined by the thickness of the thick of the amplifier unit 30 of planar convex lens H1.As shown in Figure 10, the focal length parameter H1 of Fig. 9 is different from for the focal length parameter H2 of the device A7 of test biological sample.

Focal length H1 and H2 can be adjusted by the amount of curvature of the thickness or amplifier unit 30 that change outer cover 20.Citing and It says, focal length H2 shown in Figure 10 is greater than focal length H1 shown in Fig. 9, and is reached by the amount of curvature of change amplifier unit 30 At.By this method, the test request of various focal lengths can be met by using different amplifier units 30.

In some specific examples, amplifier unit 30 can be that transparent and outer cover 20 rest part can be opaque.In addition, Carrier 10 may include transparent sample holding area 11.The remainder of carrier 10 can be opaque.When in test device When executing test operation, light be may propagate through in the other component of sample holding area 11, amplifier unit 30 to inhibit device The chance of light interference.

Referring to Figure 11, in the device A8 for test biological sample, the carrier 10 of test device A8 further comprises shape Guiding structure 16 is assisted at the light beam at the bottom surface of carrier 10.Carrier 10 can be by transparent or translucent material system At.Light beam auxiliary guiding structure 16 can be opaque or lead including grain structure, coarse patterns, depiction or scattering arrival Other suitable constructions of the light beam of guiding structure 16.Light beam, which assists guiding structure 16, to be whole surface or the part of outer cover and carrier Surface provides specific pattern.Light beam auxiliary guiding structure 16 can also be formed all around the side surface of carrier 10.

When outer cover 20 and carrier 10 are stacked and when being attached to intelligent communications device 60 (for example, as shown in Figure 4), amplification Component 30 is aligned with the camera 61 of intelligent communications device 60.In addition, supplement light (not shown) can be placed in intelligent communications device 60 Surface on 61 vicinity of camera.Carrier 10 can be directed to by the light beam that supplement light provides and illuminate sample to pass through outer cover 20 Holding area 11.Meanwhile the light beam auxiliary guiding structure 16 of carrier 10 can make the beam divergence provided by supplement light, and then improve The brightness of sample holding area 11 and illumination uniformity.

Guiding structure 16 is assisted by placement light beam, test device does not need additional supplement light source to illuminate carrier 10. Therefore, outer cover 20 includes transmitance material so that the supplement light of intelligent communications device 60 may pass through the arrival sample of outer cover 20. In some substitution specific examples, device does not include outer cover 20 and supplement light directly reaches carrier 10 without propagating across outer cover 20。

Device A8 for test biological sample may include slip resistant film 92, release paper 96 and pH test paper 94.Slip resistant film 92 are attached in the support-side (such as top side) of outer cover 20, and for outer cover 20 to be stablized placement to intelligent communications device 60 Camera 61, as shown in Figure 4, so that amplifier unit 30 is aligned with the camera 61 of intelligent communications device 60.Use slip resistant film 92, intelligent communications device 60 relative to test device A8 positioning through being fixed to predetermined structure.

Slip resistant film 92 can have the opening being aligned with amplifier unit 30, so that slip resistant film 92 does not block across amplification Component 30 is from sample delivery to the light of camera 61.Slip resistant film 92 may include the material of (for example) silicon, can be protected using release paper 96 92 surface of slip resistant film is protected, to maintain paper sticky.PH test paper 94 can be placed on the sample holding area 11 of carrier 10, to provide Instruction to the pH value of sample.PH test paper 94 can be after usage through replacing.

In addition, design for disassembly can be used in amplifier unit 30 and outer cover 20.Therefore, user can be selected based on test request Original amplifier unit 30 is replaced different from another amplifier unit 31 of amplifier unit 30.The various amplifications that can be assembled with outer cover 20 Component is assembled to reach different magnification ratio or other optical signatures.

Referring now to Figure 12, the device A9 for test biological sample can further comprise being placed in sample holding area 11 Sample collection piece 42.Sample collection piece 42 (for example) has sample collection region 42A.Sample collection region 42A can be used viscous Or other methods collect sperm, subcutaneous tissue/cell, parasitic ovum and similar solid test subject.In some specific examples In, sample collection piece 42 can be used as maintaining the spacer of the distance between outer cover 20 and sample holding area 11.

Then, referring to Figure 13, the device A10 for test biological sample may include being placed between carrier 10 and outer cover 20 Sample holding area 11 at barrier assembly 98.Barrier assembly 98 can make the survey in amplifier unit 30 and sample holding area 11 Test solution isolation, and prevent test fluid from polluting amplifier unit 30.In some specific examples, barrier assembly 98 can be used as maintaining outer cover 20 and the distance between sample holding area 11 spacer.Barrier assembly 98 can be integrated into single component with outer cover 20.Substitution Ground, barrier assembly 98 can be integrated into single component with carrier 10.

Figure 14 A is the schematic diagram for the test strip of another specific example according to the present invention being inserted into metering device. Test strip 5 (also known as testing cassete) includes detachable outer cover 20 and carrier 10.In other words, detachable outer cover 20 and carrier 10 Combine (for example, as shown in fig. 1b) formation test strip 5.Test strip 5 is inserted into metering device 70 (also via insertion port Referred to as base assembly) in.Insertion port can be for example lateral or be inserted vertically into port.Metering device 70 may include for example for Capture the component of the image of collected sample in test strip 5.

Figure 14 B is the schematic diagram of the component of the metering device of another specific example according to the present invention.Metering device 70 wraps It includes and the insertion port 73 of the insertion position of test strip 5 is provided.Test strip 5 includes carrier 10 and detachable outer cover 20.It is removable Unloading outer cover includes amplifier unit 30.Metering device 70 includes the image or video for capturing the sample holding area of carrier 10 Camera 61.Camera 61 is aligned with amplifier unit 30.Metering device further comprises for providing from bottom for sample holding area The light source 80 of illumination.In some specific examples, parallel light tube is (for example, parallel light tube lens or reflective optical system；Now show) it can It is placed on the top of light source 80 for collimated light beam.Cyclic annular aperture can be further placed between light source 80 and parallel light tube So that the light beam for travelling across parallel light tube forms the light beam of conical hollow.Carrier 10 may include for the transparent of light propagation or Trnaslucent materials.

In some specific examples, metering device 70 can further comprise the phase for making the light emitted from sample holding area The phase-plate of position offset.When light propagates across sample, the speed of light is increased or reduced.Therefore, sample is propagated across Light and the residual ray out-phase (about 90 degree) for not propagating across sample.Out-phase light is interfering with each other and enhances the bright of sample image Contrast between bright part and darkness part.

Phase-plate can further make about 90 degree of phase offset of the light for propagating across sample, to further enhance by different Contrast caused by the interference of phase light.Therefore, it propagates across the light of sample and the residual ray for not propagating across sample is different Xiang Gongyue 180 degree.This destructive interference between light by darken the boundary of the object in the image and brightening equal objects come Enhance the contrast of sample image.

In some substitution specific examples, this phase-plate can be placed on the top of detachable outer cover 20 of test strip 5. In other words, phase-plate can be the part of test strip 5, rather than the part of metering device 70.

Figure 15 is shown through such as dress of metering device 70 or intelligent communications device 60 shown in Fig. 5 and Figure 14 respectively Set the sample process program carried out to sperm test.In step 1505, device obtains the image (picture frame) of sample.In step In 1510, device is based on the spectral discrimination sperm concentration.In step 1515, by analyzing the color or gray scale of pH band, dress Set the pH value that can further determine sample.For example, device may include to identify that the part of the image captured by camera is (right Should be in pH band) color and judgement be contained in the biological sample in the band biochemical characteristic (for example, pH is horizontal) processing Device.In some other specific examples, the light source of device can provide the illumination at least one color.For example, light source It may include the light for having the optical transmitting set of different color (for example, red, green and blue) to form various colors.The phase of device Machine can further capture use up the sample illuminated at least one (or more) image.Processor may compare the specific region of image The color of (for example, pH banded zone) is to determine the quantization of the characteristic or analyte of biological sample.In some specific examples, place Reason device needs the color of the specific region of an image only to determine the characteristic of biological sample.For example, device is (for example, survey Trial assembly is set) it may include color correction module for correcting the color of image.Processor analyzes corrected image then to determine The characteristic of biological sample.Alternatively, test strip may include the colour correction region with known color.Processor is based on color Correcting area carries out color correction operation to image, and analyzes corrected image then to determine the characteristic or analysis of biological sample The quantization of object.Reagent and biological sample in some specific examples, in pH band (or other kinds of biochemical test band) Reaction, the specific region (for example, pH banded zone) of image shows specific color later.In some specific examples, it to be used for color The specific region of coloured silk detection must need the amplification to the image captured by camera.Therefore, at least in some specific examples, In Amplifier module or supplement are not present above the specific region (for example, pH banded zone) of band for color detection.Citing For, some type of biochemical test band contains photochemical agent.Particular analysis in photochemical agent and biological sample When object reacts, which causes the color change in the sample holding area of band.Processor can analytical test strip band image (being captured by camera) is to detect color change and quantify the specific analyte in biological sample.In addition, device can determine that sperm shape State (1520), sperm capacity (1525) and sperm are total (1530).In step 1540, device obtains a series of multiple of sample Picture frame.In step 1545,1550 and 1555, device can be determined sperm motility force parameter based on spermatozoon track and determine that sperm is living Power.Figure 16 shows the sample process program for determining sperm concentration.In 1605, such as the instrument shown in Fig. 5 and Figure 14 respectively The camera of meter apparatus 70 or intelligent communications device 60 (" described device ") capture sperm sample through enlarged drawing.Through capturing image For for determining the original image of sperm concentration.Digital color image is then converted into gray level image by described device, and Gray level image is further divided into multiple regions.

In step 1610, the mean value and standard deviation of gray value of the described device based on each region carry out certainly that region Adapt to fixed limit binary computations.The target of the adaptive fixed limit binary computations be will be that the Object identifying of candidate of sperm is Foreground object, and the rest part in region is identified as background.

Foreground object in the image after binary computations can still include the impurity for not actually being sperm.They are miscellaneous Matter is less than this and waits sperms or be greater than the equal sperms.Upper boundary values and lower border value can be arranged for the size of sperm in the method.In In step 1615, described device is by removing the impurity of the upper boundary values greater than sperm or the lower border value less than sperm come to figure As carrying out noise reduction operation.After noise reduction operation, the foreground object in image indicates sperm.

The method counts the sperm number in image based on the head portion of sperm.In step 1620 and 1625 In, described device carries out range conversion operation to calculate the minimum range between foreground object and background, and also identification is local most The position being worth greatly.They position is the candidate of sperm head position.

In step 1630, described device carries out ellipse fitting operation to each sperm candidate target to reduce without ellipse Round and therefore be sperm head pseudo- Positive candidates.Then, described device is to the remaining Positive candidates' of sperm Sum is counted, and based on the concentration for calculating the sperm by the volume represented by image.The volume can be for (for example) through picking The area of this holding area is sampled multiplied by the distance between sample holding area and the bottom of outer cover.

In some specific examples, described device can be used sample multiple images and be based respectively on the grade images calculating it is dense Angle value.Then, described device calculates the average value of the isoconcentration value so that the measurement error of sperm concentration minimizes.

Using a series of images (for example, video picture frame) of sample, described device can further determine sperm track and Energy.For example, Figure 17 shows such as sample sperm of sperm 1705 and the sample of such as track 1710 and track 1720 Spermatozoon track.

Figure 18 shows the sample process program for determining spermatozoon track and energy.As respectively shown in Fig. 5 and Figure 14 The camera of metering device 70 or intelligent communications device 60 (" described device ") captures a series of images of sperm sample (for example, view Frequency picture frame).Described device determines the parameter of motility of sperm using a series of images through capturing.To determine motility of sperm Parameter, described device need to track the track of each sperm in the image series.

Digital color image is converted into gray level image by described device.Described device identifies the of the series first The head position (for example, using method shown in Figure 16) of sperm in one image.Sperm in first image it is identified Head position is the initial position of spermatozoon track to be tracked.In some specific examples, two-dimentional karr is can be used in described device It is graceful to filter (Kalman filter) to estimate the track of the movement of the grade sperms.

In some specific examples, there is measured value z for tracking_j(k) sperm s_jTwo-Dimensional Kalman filtering include with Under step:

1: calculating predicted stateAnd error co-variation matrix number

2: using predicted stateMeasured value z_j(k) and error co-variation matrix numberIt calculates through pre- Survey measured valueMeasured value residual errorAnd residual error co-variation matrix number

3: ifAndThen calculate Kalman filter gain It is updated state estimationAnd updated error co-variation matrix number

(k | k-1) prediction of the expression based on image k-1 to image k,For the position of j-th sperm and the state of speed.For the co-variation matrix number of evaluated error, Q (k-1) is processing noise co-variation matrix number, and N (k) is white positions noise vector Co-variation matrix number, γ are grid threshold value and V_maxFor maximum possible sperm speed.

When tracking multiple tracks of multiple sperms, the method can be used joint probability data association filtering to determine rail Mark path.Joint probability data association filtering determines detection target and measures feasible to combine correlating event between target.It can Row joint correlating event (A_js) it is to detect sperm s and measure the relative probability value between sperm j.Then, the method is based on most Good designation method carries out path allocation decision.A_jsIs defined as:

λ is parameter,For the Gaussian probability-density function of the equal detection sperm.

Based on the serial picture frame in a period, the method identifies the track of each sperm, such as in Figure 18 Shown in track 1805.Then, the method determines the various parameters of motility of sperm based on the equal tracks.The parameters packet such as this It includes: for example, curve speed (curvilinear velocity；VCL), space rate (straight-line velocity； VSL), the linearity (linearity；) and lateral head displacement amplitude (amplitude of lateral head LIN displacement；ALH).Curve speed (VCL) 1810 is defined as the summation of the move distance within the unit time.Straight line Speed (VSL) 1815 is defined as the linear motion distance within the unit time.The linearity (LIN) be defined as VSL divided by VCL.Lateral head displacement amplitude (ALH) 1820 is defined as the width of lateral displacement of the sperm head relative to average path 1825 Twice of degree.

In some specific examples, curve speed (VCL) 1810 can be used for determining motility of sperm.The method can be set Speed threshold value.Any sperm with the VCL for being greater than or equal to speed threshold value is identified as enlivening sperm.With lower than speed Remaining sperm for spending the VCL of threshold value is identified as inactive sperm.The level of energy is the identified number for enlivening sperm Divided by the sum of the sperm from image identification.

The method can further analyze sperm morphology.Metering device 70 or intelligent communications device 60 (" described device ") Camera capture sperm sample through enlarged drawing.Being captured image is the original image for determining sperm morphology.

Shape of the method based on segmentation detection sperm candidate.The method uses the position on the head of the equal sperms Make initial point.Using segmentation algorithm relevant to shape, the method is by the image segmentation of sperm at head portion, neck portion Point and tail portion.For example, the method that active contour model can be used in the method divides the grade sperms.

Based on each section, the method calculates the parameter (such as length and width) of various parts.Can be used includes The training data set of the sample of label come train classifier (such as support vector machine, neural network, convolution neural network or AdaBoost algorithm).After training, the parameter of the various parts of sperm can be fed into classifier to determine whether sperm has There is appropriate form.In some specific examples, classifier can be used for such as detecting the characteristic of cell and microorganism other answer With.

Figure 19 is the schematic diagram of the test device including receiving flask of at least one specific example according to the present invention.Test Belt device 1905 can be inserted into test device 1900 via insertion port.Test strip device 1905 may include for collecting The receiving flask 1910 of sample (for example, sperm sample) or the slot including accommodating receiving flask.Test device 1900 may include sensing Device (not shown) is to detect whether receiving flask 1910 is inserted into test device 1900.

Test device 1900 can have for determine receiving flask 1910 be inserted into test device 1900 after time The timer structure of section.After being inserted into the receiving flask 1910 containing sample, test device 1900 may wait for predetermined amount of time (example Such as, 30 minutes) come the sample that liquefies, promote user that sample is transferred to test strip device 1905 from receiving flask 1910 later. In some specific examples, test device 1900 may include camera or sensor to determine whether sample has liquefied.

In addition, test device may include that sample is mixed in by mobile mechanism with mechanical force is applied to receiving flask 1910 In receiving flask 1910.For example, mobile mechanism can (for example) shake, vibrate or rotating collection bottle 1910.In some other tools In body example, test device may include the bar for being inserted into receiving flask 1910 and stirring the sample in receiving flask 1910.

Test device 1900 optionally may include for showing the display of information (for example, screen 1920).For example, Screen 1920 can show to operate the instruction of test device 1900 or prompt.Screen 1920 can also be shown in test device 1900 tested after test result.Additionally or alternatively, test device 1900 may include known communication module so that It can be with the computing device of user (for example, having the smart phone of mobile software application, or such as laptop computer Conventional personal computer) communication (for example, analysis result and/or by camera model obtain image).Test device 1900 It can operate to receive the instruction from user's (for example, from screen 1920 and/or from aforementioned communication module), and be based on referring to Enable the automated analysis processing routine for executing selected number.Test device 1900 can also show the image of result and/or sample In on screen 1920 or on the computer of user (for example, via aforementioned communication module), or both on.

Similar to the test device shown in Figure 14 A and Figure 14 B, test device 1900 may include for capturing test-strips The camera (not shown) of image or video with device 1905.Test device 1900 can further comprise for handling for determining The processor (not shown) of the image or video (for example, via processing routine shown in Figure 16) of test result.

In some specific examples, for example, amplifier module 2110 is amplifying lens.The amplification energy of amplifier module 2110 Power can be indicated by angle enlargement ratio or Linear Amplifer ratio.Angle enlargement ratio is as via object seen in optical system Angular dimension and as directly at the nearest distance of distinct vision (also that is, between the angular dimension away from object seen in human eye 250mm) Ratio.Linear Amplifer ratio is between the size of image and the size of practical object of the object that will be incident upon on image sensor Ratio.

For example, the amplifying lens can have the diameter of the focal length of 6mm, the thickness of 1mm and 2mm.Assuming that 250mm is The anomalistic distance (also that is, minimum distance that human eye can focus) of human eye, then angle enlargement ratio is 250mm/6mm=41.7 times. The distance between amplifier module 2110 and sample holding area 2115 can be (for example) 9mm.Therefore, Linear Amplifer ratio is close to In 2.In other words, the size of the image of the object on the image sensor as caused by amplifier module is the reality below amplifier module 2 times of the size of border object.

In some specific examples, amplifier module has the focal length of 0.1mm to 8.5mm.In some specific examples, amplification The Linear Amplifer ratio of component is at least 1.In some specific examples, the Linear Amplifer ratio of amplifier module is 0.5 to 10.0.

In some specific examples, complementary lens 2135 are placed in 2130 lower section of camera model for figure to be further amplified Picture and reduction the distance between amplifier module 2110 and sample holding area 2115.Effective linear amplification ratio of entire optical system Rate can be (for example) 3.In other words, the size of the image of the object captured by camera model 2130 is in sample holding area 2115 3 times of size of practical object.In some specific examples, effective linear amplification ratio of the entire optical system of test device Rate is 1.0 to 100.0, preferably 1.0 to 48.0.

In some specific examples, the image sensor of camera model has 1.4 μm of pixel size.Typically, object The image that captured need to obtain at least 1 pixel properly to analyze the shape of object.Therefore, object through capturing image Size needs are at least 1.4 μm.If the Linear Amplifer ratio of test device is 3, test device, which can be analyzed properly, to be had extremely The shape of the object of few 0.47 μm of size.

In some specific examples, the image sensor of camera model has 1.67 μm of pixel size.Then, object The size needs for being captured image are at least 1.67 μm shapes properly to analyze object.If the Linear Amplifer of test device Ratio is 3, then test device can properly analyze the shape of the object of the size at least 0.56 μm.

In some specific examples, for example, the length of entire optical system can be (for example) 24mm.Amplifier module The distance between the top of bottom and sample holding area 2115 can be (for example) 1mm.In some specific examples, test device Entire optical system length be 2mm to 100mm, preferably 5mm to 35mm.

Figure 20 be at least one specific example according to the present invention do not include receiving flask test device schematic diagram.No It is same as test device 1900, test device 2000 does not include receiving flask or the slot for being inserted into receiving flask.By user or behaviour Sample is applied directly to test strip device 2005 by work person, without collecting in receiving flask.

Figure 21 B is the Section A-A schematic diagram of the specific example of Figure 21 A test device 1900.The A-A of test device 1900 is cut Face shows the sample holding area 2115 for being used to capture test strip device 2105 on the top of test strip device 2105 The camera model 2130 of image or video.Test strip device 2105 includes the amplification on the top of sample holding area 2115 Component 2110.Light source 2140 below test strip device 2105 is that sample holding area 2115 provides illumination.It is some its In his specific example, light source be can be placed on the top of the test strip device or lateral side for being placed in test strip device. It can exist for multiple light sources or array of source that illumination is provided on test strip device.In some specific examples, visually Types of analytes and the various combination for switching, adjusting or selecting light source, so that analyte is bright by the illumination with appropriate color.

In some specific examples, test strip device 2105 may include survey in sample holding area 2115 or neighbouring Strip band.For example, test strip can be (yellow for pH test strip, HCG (human chorionic gonadotrophin) test strip, LH Body hormone) test strip or fructose test strip.Change in the analyte and test strip of the sample in sample holding area When or biochemical reagents interact, some optical characteristics (for example, color or luminous intensity) of test strip are changeable.Camera mould The color or intensity of 2130 fechtable test strip of block are with discriminating test as a result, such as pH is horizontal, HCG is horizontal, LH is horizontal or fruit Sugar level.In some specific examples, the amplifier module 2110 above test strip can use transparent or translucent outer cover Replacement.Therefore, test device can simultaneously the analyte in sample is checked and via sample one or more enlarged drawings As carrying out another analysis to sample.

Figure 21 C is the Section A-A schematic diagram of another specific example of Figure 21 A test device 1900.Test device 1900 Section A-A shows the sample holding area for being used to capture test strip device 2105 on the top of test strip device 2105 2115 image or the camera model 2130 of video comprising sensor and one or more lens 2135 (referred to as supplement Lens or optical lens module).The light source 2140 of (or being placed in elsewhere) is sample below test strip device 2105 Holding area 2115 provides illumination.Amplifier module 2110 is attached to the bottom of lens 2135, rather than as shown in figure 21 a in sample On the top of this holding area 2115.In some specific examples, if lens 2135 provide enough amplifying powers, element 2110 can be the flat transmitance outer cover without amplifying power.In some other specific examples, if lens 2135 provide Enough amplifying powers (for example, if the Linear Amplifer ratio of lens 2135 is at least 1.0), test device 1900 does not include putting Big component 2110.

Figure 22 is that there are two the schematic diagrames of the test device of the test strip device of sample holding area for tool.Figure 29 is shown can It is suitable for the example of the carrier for the test device (test device shown in such as Figure 22) that there is polyphaser to configure.Referring concurrently to Test device shown in Figure 19 and Figure 20, Figure 22 can be test device 1900 (also that is, having receiving flask) or test device The another variant of 2000 (also that is, not having receiving flask).As shown in Figure 22, receiving mechanism is included in test device to receive One or more carriers (for example, the test strip device of such as test strip device 2205, or the collection of such as bottle 1910 Bottle), the carrier can be inserted into via the opening on the shell of test device.

In some specific examples, single carrier may include the first holding area and the second holding area, such as by Figure 22 In test strip device 2205 shown in.As shown in Figure 22, at least two camera models may include in test device.Two Camera model includes the image and/or view for being configured to capture the first holding area 2215A and the second holding area 2215B The first camera module 2230A and second camera module 2230B of frequency.In more specific words it, test strip device 2205 may include sample This holding area 2215A and another sample holding area 2215B.In some instances, transparent or translucent outer cover 2210A It is placed on the top of sample holding area 2215A.Light source 2240A can be controllable and can be in sample holding area 2215A Upper offer illumination.First camera module 2230A is located to capture the image or video of sample holding area 2215A.As one Optional implementation, amplifier module 2210B can be placed on the top of sample holding area 2215B.In addition, in some specific examples In, light source 2240B can be operated to provide illumination on the 2215B of sample holding area.Second camera module 2230B is located to pick Sample the image or video of this holding area 2215B.First holding area and the second holding area can directly carry biological sample Or biological sample has been exposed to it.Similar to the structure introduced about Figure 14 B, in some specific examples, test device may include Beam collimation for emitting light source at least one of holding area parallel light tube.In some specific examples, ring Shape aperture can further comprise travelling across parallel light tube to be used to form between light source and parallel light tube and then arriving at sample The conical hollow light beam of this holding area.In some Additional specific examples, phase-plate may include in sample holding area and phase Light between at least one of machine module to be reflected for phase shift by sample holding area.

As the alternative solution of the single carrier with multiple holding areas, multiple carriers can be via its individual apertures, end Mouth or slot are inserted into test device.For example, two independent test belt devices can respectively include sample holding area 2215A and 2215B.Depending on the needs tested, the position of sample holding area 2215A and 2215B in test strip can be through Design with first camera module 2230A and second camera module 2230B to be aligned.In some specific examples, two test-strips Band device is independently inserted port via two and is inserted into test device.

In addition to other benefits, the convenience and easness of test are disclosed herein test device available two Significant benefit.According to this paper specific example, the user of revealed test device need not can utilize test dress in the user It sets before generating result and has on how to execute any professional knowledge of various types of analyses to biological sample.Therefore, it surveys Trial assembly, which is set, may include processor for executing automated analysis processing routine to sample and determines result about sample.It is described Processor can by main circuit board (that is, it is known that component is not shown for the sake of simplicity) carry.In addition, test device is preferably For it is lesser and not as common traditional test device in the lab it is huge.Therefore, in some specific examples, such as They shown in Figure 19 and Figure 20, receiving mechanism, camera model and the main circuit board of carrier can all be packaged in test device Shell in.Test device can have a lesser apparent size, all such as less than 30 centimetres of (cm) × 30cm × 30cm, that is, 27, 000cm³.In some specific examples, test device can further comprise being packaged in the intracorporal battery compartment of shell, so that battery It is mountable to power in battery compartment for test device.

In some specific examples, can be executed to different holding areas by being included in the processor in test device by different points Analysis, and result can be exported based on the combination of the result of the analysis executed to different zones.In other words, processor can be configured with right The image that captured of first holding area executes the first analysis and processing program, executes not to the image that captured of the second holding area It is same as the second analysis and processing program of the first analysis and processing program, and based on the first analysis and processing program and the second analysis processing journey Result of the result judgement of both sequences about biological sample.As used herein, term " analysis and processing program (analytic Process the one or more segments that can assess the information (for example, image of holding area) for taking pride in multi-source collection) " are meaned, And it generates about the result in source, conclusion, final result, estimated value or the processing routine of its fellow.

According to some examples, the group of first camera module 2230A, light source 2240A and outer cover 2210A is can be used in test device Close the characteristic (for example, pH is horizontal, LH is horizontal, HCG is horizontal or fructose is horizontal) carried out quantifying analytes or determine sample.In addition, surveying Trial assembly, which is set, can further use the combination of second camera module 2230B, light source 2240B and amplifier module 2210B to analyze sample The characteristic (for example, sperm quantity, motility of sperm, sperm morphology etc.) that sample is determined through enlarged drawing.Depending on various types Biochemical test requirement depending on, the light source of various combination or configuration can be used for illuminating biochemical sample.Polyphaser configuration especially has Benefit, this be due to different analysis and processing programs can via different cameral module execute without user replace carrier (for example, Test strip device), thereby speed up the complexity that result generates and reduces necessary human manipulation.Light source 2240A and 2240B encapsulation In enclosure interior and it is configured to illuminate biological sample at least one of camera model.According to one or more specific real Example, processor are configured to the analysis and processing program for being currently configured to execute based on processor to control light source.

In addition, processor can execute different analysis processing based on the visual cues on carrier in some specific examples Program.For example, some specific examples can execute image identification and processing to the image of holding area, and can be according to from figure As the visual cues of the result of identification execute different analysis and processing programs.Exemplary carrier 2905 (1) to 2905 (4) are illustrated in figure In 29, wherein carrier 2905 (1) is used for the fertility test of the reproduction cell about male subject (for example, via its essence Son), and carrier 2905 (2), 2905 (3) and 2905 (4) are used for the fertility test (example of the reproduction cell about female subjects Such as, via its urine).As indicated, carrier 2905 (1) is to 2905 (4) all with the position for corresponding to first camera module 2230A The the first holding area 2915A set, but only carrier 2905 (1) includes the second holding area 2915B.In some instances, carrier On visual cues can be specific holding area (for example, holding area 2215A) shape.To discussion in this article, fixing The shape in region means the integral edge (or outer periphery) of holding area.For example, the shape can for it is round, oval, Triangle, rectangle, or by the processor using known image processing technique such as by individual camera models (for example, the first phase Machine module 2230A) identifiable any suitable shape on the image of holding area that is captured.The additional examples of visual cues It may include pictorial pattern, visual beacon, bar code, multi-dimensional pattern code (for example, QR code) etc..

Referring concurrently to Figure 22 and Figure 29, in some specific examples, when processor identifies (for example, via first camera mould Block 2230A) the first holding area (for example, region 2215A or region 2915A of carrier 2905 (1)) in first shape (for example, It is round) when, processor is configured to execute a certain analysis and processing program (for example, the fertility of male subject, such as according to it The various characteristics of sperm sample), and when the first holding area (the region 2215A or region 2915A of carrier 2905 (2)) is in second When shape (for example, oval), processor will execute different analysis and processing programs (for example, to the fertilitys of female subjects Analysis, such as according to the hormonal readiness of its urine specimen).By this method, test device is not limited to execute an only seed type Test (for example, fertility of sperm), and it also can be based on the carrier (for example, test strip device) being inserted into machine Correspondingly analysis of shift processing routine.

In more specific words it, according to some implementations, when shape representation biological sample includes the sperm from male subject, Then processing routine can determine that one or more characteristics of sperm, introduced they's characteristic such as herein.In some instances, The judgement to one or more characteristics of sperm can be executed by using second camera module 2230B.For some particular instances, The characteristic that can determine that can include: the form of the concentration of sperm, the energy of sperm and/or sperm.According to some specific examples, place Reason device is configured to (1) and determines the concentration of sperm and/or the form of sperm, and (2) based on the single image through capturing in image Based on the energy through capturing two or more spectral discrimination sperms in image.

In view of the above circumstances, Figure 30 is for analyzing male using test device (for example, in Figure 22) disclosed herein The flow chart of the instance processes program 3000 of the fertility of both property subject and female subjects.With continued reference to Figure 29, under Text illustrates processing routine 3000.It should be noted that following instance applies the sample of male first, it is then the sample of women, but can hold Row reverse order (also that is, women and then male), and on the accuracy of result without influence.

First in step 3002, the biological sample (for example, sperm) of male subject can be applied to first by user The first holding area (for example, region 2915A) and the second holding area (region of carrier (for example, carrier 2905 (1)) 2915B).Then, in step 3004, first vector is inserted into test device (for example, one shown in Figure 22 by user Person), and because the shape of the first holding area 2915A of carrier 2905 (1) is circle, test device can obtain current sample automatically This knowledge containing the sperm from male and correspondingly selection analysis processing routine.Then, in step 3006, user can One or more characteristics of sperm are determined using test device.For example, as discussed herein, the processor in test device Image (the carrier of the first holding area 2915A of carrier 2095 (1) can be obtained using first camera module 2230A 2095 (1) may include showing the test strip of different color in response to different acidity), and identify the color of test strip to sentence Determine the acidity of sperm.In addition, the processor in test device can be sentenced using second camera module 2230B in step 3006 One or more characteristics of the fixed sperm selected from the group being made up of: cell number (such as sperm count), the concentration of sperm, essence The energy of son and the form of sperm.

Then, in step 3008, user the urine from female subjects can be applied to Second support (for example, Carrier 2905 (2)) holding area 2915A.In step 3010, Second support is inserted into test device by user, and by In carrier 2905 (2) the first holding area 2915A shape be it is oval, test device can automatically obtain current sample and contain The knowledge of urine from women and correspondingly selection analysis processing routine.In step 3012, test device for example passes through benefit One or more characteristics of urine are determined with second camera module 2230B.For example, test strip is suitably adapted for filling test Set the concentration level that can determine the female sex hormone (for example, FSH, LH or HCG) of one or more types.Finally, in step In 3014, user automatically analyzes the result of male and women biological sample using test device and determines about subject's The final result of fertility.

In some particular instances, first camera module 2230A can have lower compared with second camera module 2230B Camera resolution, and therefore described two video cameras by processor to execute different analysis and processing programs.In addition, the first phase Machine module 2230A can have lower magnification ratio compared with second camera module 2230B.The one of first camera module 2230A A little examples can not have enlarging function, and second camera module 2230B can have fixed magnification ratio.Additionally or as The alternative solution of second camera module 2230B with higher magnification ratio itself, the outer cover of the second holding area 2215B 2210B may include amplifier module, all as shown in Figure 22.In some implementations, the magnification ratio of the camera model can be for can (for example, being controlled by processor) of adjustment.Some examples regulation first camera module 2230A of test device has 2,000,000 pictures Plain or higher camera resolution, and second camera module 2230B has 13 mega pixels or higher camera resolution.One In a little examples, second camera module 2230B may include at least 4.8 times or higher Linear Amplifer ratio.

In some in these examples, processor further determines sperm by using first camera module 2230A At least one additional features.This additional features may include the acidity of sperm.For example, carrier may include holding area first Using the pH indicator of the acidity of color representation sperm in the 2215A of domain, processor can recognize the color to identify acidity.It is similar Ground, some example predetermined processing devices can be based on the colors in the region in one or more images of first or second holding area To determine the biochemical characteristic of biological sample.

Continue the feelings of the above test device example with polyphaser configuration in Figure 22 and the Examples of carriers in Figure 29 Under condition, in some implementations, when processor identifies the first holding area (for example, the region of region 2215A or carrier 2905 (2) 2915A) in when can indicate that biological sample includes the second shape (such as oval) of the urine from female subjects, processor is passed through Configure one or more characteristics to determine urine.The characteristic that can determine that can include: LH is horizontal, FSH is horizontal and/or HCG It is horizontal.Such as acidity, the judgement to one or more characteristics of urine can be executed by using first camera module.Similarly, Carrier may include LH indicator in the first holding area (for example, region 2915A of individual carriers) (for example, such as carrier 2905 (3) shown in), FSH indicator (for example, as shown in carrier 2905 (2)) and/or HCG indicator be (for example, such as carrier 2905 (4) shown in).

In addition, processor is using at least one of two camera models (for example, first in some specific examples Camera model 2230A) or another sensor (for example, below with respect to Figure 26 introduce OPTICAL SENSORS 2690) come execute analysis at The preparation state or validity of biological sample are determined before managing program.It in some implementations, can be based on identification First look mark The specific region whether being shown in the first holding area (for example, region 2915A) is (for example, its middle line 2916 is illustrated in Figure 29 In) in come the preparation state or validity of discriminating test sample.The example of this First look mark can be certain on test strip Shown line, is such as shown in FIG. 29 as red line 2916 in one specified region.Red line 2916 can be used as quality control component, It can indicate test for effective or result all set.In addition, the first holding area 2915A may include that display is indicated about life Another region (for example, its middle line 2917 is illustrated in Figure 29) of second visual beacon of the test result of the characteristic of object sample. The example of this second visual beacon can such as exist to prepare line shown in another a certain specified region of state on test strip Red line 2917 is shown as in Figure 29.

In some specific examples, test device can be acted in response to the unripe Predicated execution of biological sample.One In a little examples, by the movement that processor executes include implement to have by pending analysis and processing program judgement it is lasting when Between timer.In some other examples, test device further comprises mobile mechanism, and the processor in test device can Mechanical force is applied to carrier to improve the preparation of biological sample using mobile mechanism.Below about Figure 25 (Figure 25 A and figure 25B) and Figure 26 (Figure 26 A and Figure 26 B) is introduced into the more details of the movement and mechanism that can implement in test device.

The position of equal amplifier modules (for example, the amplifier module of the amplifier module of camera model or test strip) and this etc. The position of light source visually the requirement of various types of analyte analyzations and it is adjusted or selection.In variant, the equal camera models There can be adjustable magnification ratio.In at least some of these examples, processor is further configured based on the place Reason device is configured to the analysis and processing program executed currently to adjust the magnification ratio of at least one of two camera models.Such as Introduced above, when biological sample includes sperm, test device can configure suitable camera model (for example, second camera module 2230B) reach different magnification ratio in the form of energy and the sperm for determining sperm.

It should be noted that the optimum distance between camera model and amplifier module can have low bouds on error.For example, even The clear image of camera model acquisition sample holding area can be prevented with the little deviation of the 0.01mm of optimum distance.In order to fine The distance between camera model and amplifier module are adjusted, test device may include automatic focusing (AF) function.Automatic focusing function Automatically to adjust optical system (for example, the distance between component of adjustment optical system) so that the object (example being just imaged Such as, sperm) function in the focal plane of optical system.At least one or more specific example also provides can be by processor control The mechanical focus mechanism of system is so that at least one of two camera models focus on individual holding areas.Below about Mechanical focus mechanism is discussed in more detail in Figure 23 and Figure 24.The mechanical focus mechanism can be controllable to adjust lens two Position (for example, shown generally in Figure 23) at least one of a camera model.Additionally or alternatively, the mechanical focus Mechanism can be the controllable position (for example, shown generally in Figure 24) to adjust carrier.

Figure 23 is the schematic diagram of the component of the test device with automatic focusing function.As shown in Figure 23, test device It can be faced upward or downward along Z axis and move camera model (for example, by motor-driven rail, ultrasonic motor driven or stepper motor).Pass through The vertical position of camera model is adjusted, test device can adjust the distance between camera model and amplifier module.

Figure 24 is the schematic diagram of the component of another test device with automatic focusing function.As shown in Figure 24, it tests Device can face upward or downward mobile test belt device along Z axis.By adjusting the vertical position of test strip device, test device Adjustable the distance between camera model and amplifier module.

During the auto focus operation as shown in Figure 23 or Figure 24, camera model and complementary lens remain single mould Block.In other words, the distance between camera model and complementary lens are during the auto focus operation as shown in Figure 23 or Figure 24 It remains unchanged.

Figure 25 B be Figure 25 A include switch and motor test device section B-B schematic diagram.Test device in Figure 25 B 1900 cross section B-B shows the various assemblies of the test device.Test device 1900 includes being inserted into test to detect The switch 2550 of receiving flask 2510 in device 1900.When inserting receiving flask 2510, switch 2550 is activated.Then via Receiving flask 2510 is informed test device 1900 by switch 2550.The period being activated, test device are in based on switch 2550 It can determine that receiving flask 2510 is kept for the period of insertion.

Test device 1900 further comprises for shaking, vibrating or rotating collection bottle 2510 is so as in receiving flask 2510 The motor 2560 of mixing sample.Test device 1900 may include camera 2570 with based on the sample in receiving flask 2510 through capturing Image determines whether sample has liquefied.

Figure 26 B be Figure 26 A include flexible element test device C-C schematic cross-section.Test device in Figure 26 B 1900 cross section B-B shows the various assemblies of the test device.Test device 1900 is included in for holding in a mobile fashion Receive receiving flask 2610 slot bottom moving element 2680 (for example, elastic parts).For example, moving element 2680 can Spring including can spontaneously restore its normal shape after contraction or deformation.When receiving flask 2610 is inserted into slot, Moving element 2680 is through compressing.OPTICAL SENSORS 2690 (or other kinds of proximity sensor) be responsible for detection OPTICAL SENSORS 2690 with The distance between the bottom of receiving flask 2610.The distance between bottom based on OPTICAL SENSORS 2690 Yu receiving flask 2610, test Device 1900 can determine that the weight or volume of contained sample in receiving flask 2610.For example, OPTICAL SENSORS 2690 and receiving flask The distance between 2610 bottom can be inversely proportional with the weight or volume of contained sample in receiving flask 2610.

In some other specific examples, test device 1900 may include the sensor on the top of receiving flask 2610. Sensor can be responsible for detecting the distance between the top of sensor and receiving flask 2610.It can be based on the range estimation receiving flask The weight or volume of contained sample in 2610, this is since the volume or the weight can be (for example) the same as sensors and receiving flask The distance between 2610 top is directly proportional.Then, based on the weight or volume of sample, it is due-in that test device 1900 can determine that etc. Collect the sample liquefied period in bottle 2610.Test device 1900 further comprises for shaking, vibrating or rotating collection bottle 2610 so as to the mixing sample in receiving flask 2610 motor 2660.

In some specific examples, the camera model of test device may include the intensity for capturing light and the light field in direction Camera (not shown).Light-field camera may include microlens array or polyphaser array in the front of image sensor with the side of detection To information.Using the directional information of light, camera model can capture clear image in broad range of focal plane.Therefore, make With the test device of light-field camera can not need automatic focusing function come between intense adjustment camera model and amplifier module away from From.

In view of the above circumstances, the device of the invention is suitable for test male fertility and/or female reproduction power.

The present invention provides a kind of method of device to test male fertility using present application.The method includes following Step: the biological sample from male subject is applied to the first holding area and the second holding area of carrier；By carrier It is inserted into device；The acidity of sperm is determined according to the first analysis and processing program；It is selected from according to the judgement of the second analysis and processing program One or more characteristics of the sperm for the group being made up of: the form of the concentration of sperm, the energy of sperm and sperm；With And analysis result is to determine male fertility.

The present invention also provides a kind of method of device to test female reproductive hormones using present application.The method includes Following steps: the biological sample from female subjects is applied to the first holding area of carrier；Carrier is inserted into device In；And determine the concentration level of the female sex hormone of one or more types, the female sex hormone such as corpus luteum hormone (LH), filter Bubble stimulation hormone (FSH) or human chorionic gonadotrophin (HCG).

The present invention further provides a kind of methods for testing the fertility of a pair of of male subject and female subjects. The method comprise the steps of: by the biological sample from male subject be applied to first vector the first holding area and Second holding area；First vector is inserted into device；The acidity of sperm is determined according to the first analysis and processing program；According to Two analysis and processing programs determine one or more characteristics of the sperm selected from the group being made up of: the concentration of sperm, sperm Energy and sperm form；Biological sample from female subjects is applied to the holding area of Second support；By Two carriers are inserted into device；Determine the concentration level of the female hormone of one or more types；And analysis male and female The result of biological sample.

Figure 27 is the flow chart for analyzing the processing routine of the semen sample of male client or patient.For analyzing sperm The system of sample may include test machine (for example, test device 1900), mobile device and cloud server.Figure 28 is for analyzing The flow chart of the processing routine of the LH or HCG of women client or patient.System for analyzing LH or HCG may include test machine (for example, test device 1900), mobile device and cloud server.The process of Figure 27 and Figure 28 is illustrated through test machine, is moved The step of dynamic device and cloud server execute and the information transmitted between test machine, mobile device and cloud server.

In some specific examples, the method for testing sperm comprises the steps of: acquisition for test biological sample Device, sperm sample is applied to sample holding area, records the video or image of sperm sample；Based on recorded video or At least one picture frame of recorded image determines the sperm count of sperm sample；And it is based on recorded video or recorded image Determine the motility of sperm of sperm sample.

In related embodiment, the method is further included: by sperm sample be applied to sample holding area it The liquefied predetermined amount of time for being ready to use in sperm sample such as preceding.

In another related embodiment, the method is further included: storing includes the camera on the top of device The mobile device of component is so that the photomoduel is aligned with amplifier module and sample holding area；And it is connect by mobile device It receives in sample holding area via the amplification of amplifier module from the optical signal of sperm sample.

In another related embodiment, the method is further included: the side by being placed in the carrier of device Lateral illumination device is placed in the top of carrier of device or the vertical lighting device of lower section illuminates sample holding area.

In another related embodiment, the method is further included: light beam of the guiding from lateral illumination device is worn Cross the carrier made of transparent or trnaslucent materials；And multiple smooth reflection graphic patterns by being included in carrier reflect light beam To sample holding area.

In another related embodiment, the method is further included: disposable test device is inserted into pedestal, The pedestal includes the photomoduel for recording the video of sperm sample or the shape cooperation frame for fixing mobile device, institute Stating mobile device includes the photomoduel for recording the video of sperm sample.

In another related embodiment, the method is further included: extremely from the recorded video extraction of biological sample A few picture frame；Multiple sperms are identified from least one picture frame；And number based on identified sperm and by least one figure The areal calculation sperm count of frame record.

In another related embodiment, the method is further included: analyzing the shape of identified sperm；And based on warp Identify the shape decision morphological level of sperm.

In another related embodiment, the method is further included: from the recorded video extraction one of sperm sample Series video picture frame；Multiple sperms are identified from the series video picture frame；Movement based on series video picture frame identification sperm Track；The movement speed of motion track and the period judgement sperm captured by the series video picture frame based on sperm；With And the movement speed based on sperm calculates motility of sperm.

In another related embodiment, the method is further included: sperm sample is further amplified via amplifying lens This video or image.

In some specific examples, a method of for testing sperm using the system of test biological sample, wrap Contain: inserting the device into base assembly；The video of the sperm sample in sample holding area is recorded by mobile device, it is described Mobile device is fixed in the shape cooperation frame of base assembly；At least one picture frame based on recorded video determines sperm sample This sperm count；And the motility of sperm of sperm sample is determined based on recorded video.

In related embodiment, the method is further included: sperm sample is further amplified via amplifying lens Video.

In some specific examples, the system for test biological sample includes the disposable dress for test biological sample It sets and base assembly.Disposable apparatus includes the sample carriers of the holding area containing sample and the top for being placed in the sample holding area Detachable outer cover in portion.Base assembly includes the insertion port for being inserted into disposable apparatus in base assembly, and is used In the photomoduel for the image for capturing sample holding area, the photomoduel includes image sensor and optical lens module. In related embodiment, optical lens module can have at least 0.1 Linear Amplifer ratio.

Figure 31, which shows an additional examples carrier 3105, has one or more visual beacons 3117 (1) -3117 (5) (or can To be collectively referred to as visual cues 3117) can be used to control survey formula device execution analysis and processing program (for example, Figure 21 C or Test device shown in Figure 22).As shown in Figure 31, visual cues 3117 (such as can be held in 3105 holding area of carrier Region 3115B) in (near or, in some other or alternative embodiment).

Such as aforementioned (such as about Figure 29), processor can execute different analyses based on the visual cues on a carrier Processing routine.Such as some specific embodiments can execute image identification and handle holding area image and can according to come Different analysis and processing programs is executed from the visual cues of the result of image identification.In some embodiments, the vision of carrier mentions Show to be a shape of a specific holding area.Other visual cues embodiment may include pictorial pattern, visual beacon, one-dimensional Bar code, multi-dimensional pattern code (for example, QR code) etc..

As shown in figure 31 in some particular instances, any visual beacon (such as visual cue 3117 (1)) can be specific for one Furthermore on the holding area 3115B that small-sized pictorial pattern can be marked, be attached or is marked in carrier 3105.Figure 31's In example, visual beacon 3117 (1) -3117 (5) is all identical or substantial similar pattern, however in other instances (being not shown for the sake of simplicity), they need not identical and each visual beacon can have distinctive shape, size, pattern etc.. In one or more implementation, visual cues 3117 (such as visual beacon 3117 (1) -3117 (5)) are one not felt by the mankind The size known but after being amplified by a camera model via microlens identification (for example, the second camera module in Figure 22 The camera model 2130 of 2230B or Figure 21 C).In wherein some implementations, visual beacon 3117 (1) -3117 (5) is less than 15 Micron (μm), in addition, visual beacon 3117 (1) -3117 (5) can be configured so that their position is collectively form a pattern (such as a scheduled configuration).Additionally or as alternative solution (such as size, shape, the color of the distinctive characteristic of visual beacon And/or position), this set pattern formed by the position of each visual cue can be surveyed for identifiable prompt with being used to control Function that trial assembly is set (such as, and if which kind of analysis and processing program successively executed).This set pattern can view-based access control model mark The absolute position of (such as in holding area) and/or the relative position (for example, from their other proximity tags) of visual beacon. In Figure 31, set pattern is each quilt of visual beacon 3117 (1) -3117 (4) as shown in visual beacon 3117 (1) -3117 (5) One and visual cue 3117 (5) in (image of cameras capture) four corners is set and is arranged on center, each visual beacon It is uniformly to be distributed.It is some other or alternatively embodiment provide visual cues each (or each group) special vision Mark (or mark) can represent a different analytic function to be performed.

In view of the above situation, test device herein can using on carrier visual cues (for example, in holding area or Near) to control the function of test device and be adaptively based on visual cues execution analysis and processing program.In some embodiments In, visual cues can be used to be confirmed whether that carrier is a carrier authorized (for example, appropriate be authorized to and meeting a certain specification It manufactures down and according to applicable quality standard).In other instances, visual cues can be used for controlling test device at which kind of Calculating is executed under mode (for example, sex, laboratory or family, high accuracy or short time, use battery or plug-in). In addition, providing a certain function that visual cues can be used for controlling access test equipment in some embodiments, this is according to client's body Point, geographical location etc. the ability of the customized service provided by test equipment of elasticity is provided.

Figure 32 is that the execution one of test device (such as in Figure 21 C or Figure 22) the view-based access control model prompt adaptability disclosed herein divides Analyse the other example flow chart of the enforceable processing routine 3200 of processing routine.With continued reference to Figure 31, processing routine is described below 3200.It should be noted that visual cues are to be applied to execute a carrier authentication application, so in the example of following processing routine 3200 And processing routine can similarly be applied to execute other application (for example, about narration of Figure 30).Such as it is not some The application of carrier verifying, processor can execute different groups of analysis and processing program based on different visual cues.

Firstly, step 3202, receives the carrier via opening insertion in the receiving mechanism of test device, sensor is (simple For the sake of be not shown) can notifier processes device, and processor by the camera model for causing test device built-in to capture one or more The image of carrier holding area.In step 3204, processor can utilize through capture image recognition (such as based on known image analyze Technology those of is exposed in this) visual cues in the carrier.As discussed above, visual cues may include some visual beacons, Each visual beacon can be identical or different size, shape, pattern, color etc. (example as shown in figure 31) or they may It is not identical.A pattern (for example, from their position) can be further presented in visual beacon jointly.Then, processor can will regard Feel that prompt (such as distinctive size, shape, position or set pattern) (is deposited with scheduled visual cues for example, being stored in the machine Reservoir and/or cloud database (can operate or control by the manufacturer of test device or other administrators) are compared.

Step 3206, processor selectively holds the recognition result through capturing the prompt of image view-based access control model of holding area One group analysis processing routine of row.If the recognition result of visual cues is replied positive (for example, responding has scheduled visual cues Carrier holding area), then processor continues to may include the additional image (or video) of selective acquisition to be used for Analyze (step 3208) and the subsequent step to corresponding group of (step 3210) for executing analysis and processing program through image.Another party Face, if recognition result replys negative sense (for example, responding the carrier holding area without scheduled visual cues), processor is made At alternative movement (for example, display error code), reflection visual cues not can recognize, and not execute any point to image Analyse processing routine (step 3212).After the analysis and processing program group is performed, processor can be as aforementioned based at analysis The result of reason program continues to determine the result about biological sample.

Further it should be noted that traditional computer-aided sperm analysis (computer-assisted sperm Analyzers, CASA) experience of large-scale microscope and operating technology personnel are relied on to determine the parameter of sperm.There are some computers Software auxiliary is with the experience of complementary technology personnel and makes normalized analysis result.However, due to lens and the difference of sensing module, Blurred picture can seriously affect the validity of auxiliary software often, lead to the inaccurate of correlation function (such as sperm count calculating).

In addition, such as World Health Organization, competent authority (World Health Organization, WHO) issues the mankind Semen efamination and treatment of laboratory handbook, it is bright in handbook to order the concentration, the energy of sperm and essence being evaluated to determine sperm The sample minimum flow (for example, 200 sperms) of the form of son.The existing analysis based on computer-aided sperm analysis image is general Lack sampling automatically or need to be manually operated and is reached in World Health Organization's specification and reduction analysis with obtaining multiple visuals field Sampling error, alternatively, if sampling only use the duplicate execution in the single visual field, in order to reach satisfactorily low sampling error, And repetitive routine the time it takes often becomes too long and can not realize on a large scale.

Figure 33 be can by test device herein (for example, Figure 21 C or Figure 22) in order to preferable result (such as preferably analysis Accuracy or efficiency) implement 3300 example flow chart of processing routine.Processing routine 3300 can (such as Figure 16 be shown herein Processing routine) processing routine alternative or complementarity processing routine.

Firstly, step 3310 in the carrying biological sample or the carrier box for being exposed to the biological sample (for example, insert (as introduced above) after entering), this device being introduced into can capture one or more of carrier box holding area using camera model A image (or being commonly referred to as, integrated images (imagery)).In some selective embodiments (for example, about Figure 29 or 31 Describe), device can be from holding area through capturing the visual cues on integrated images identification (step 3320) carrier.At these Selectivity embodiment in, this device can view-based access control model prompt recognition result to through capture integrated images execute a group analysis at Manage program.

In step 3330, this device can be divided into multiple blocks for integrated images are captured.In certain embodiments, area Block can be polygon.For more specifically, some implementations point out that block can be triangle, rectangle, square, five sides Shape, hexagon etc..These (block) shapes may at least often be 0.05 millimeter on one side.In one or more embodiments In, block is square and having a size of 0.05 millimeter multiplied by 0.05 millimeter.It is worth noting that, implementing according to specific, block Quantity and size can be adjusted according to the resolution of camera model.Explanation points out the image instance of a holding area in Figure 34 It is divided into multiple blocks (for example, block 3402).It should be noted that the discussion in order to promote revealed technology herein, through capturing Integrated images are considered " dividing " into block；However, it should be appreciated that, processor is transported in computer in one or more is implemented Make the division that the time (or in normal operation) does not need actually to carry out mathematically to operate to execute this technology；But institute Obtained block or grid can be scheduled, pre-terminated, program are default in logic, or be pre-configured in the camera controller of device It is so to be divided into the demand that the related operation of block executes to be reduced with integrated images, or at certain and/or on processor It is eliminated completely in a little examples.

In step 3340, example device is chosen from multiple blocks, candidate block to analyze.According to one or more realities Apply example, the selection of candidate block is based on several factors, and for example the focus level of a certain block and/or a certain block be just Perseverance.

In more specific words it, in many implementations, this device can determine that the focusing journey of each multiple block of (step 3342) Degree, so that each block can have corresponding focus level to measure.This focus level can be surveyed focal length based on one or more Function is measured to determine.According to implementation, the focometry function being adopted may include one or more: anomaly, coefficient of variation summation Type, Laplce's energy image-type and/or side gradient intensity maximization type.

After the focus level for determining each block, in some embodiments, this device can be by the focus level of a block It is compared with minimum focus level threshold value.In one or more is implemented, a block only meets (example in focus level Such as, meeting or exceeding) minimum focus level presentation time can be selected as candidate block.In addition, this device can also mark or label Block.This device points out that block can be only labeled when meeting minimum focus level threshold value in one or more embodiments Or label (for example, in order to further analyze or track identification).Label or label can be continuous or random completion.In In Figure 35 explanation be a part candidate block selection process, here, block be randomly through label, and be more than minimum focus The block of degree threshold value is chosen for candidate block 3510 by preliminary.

Next, this device can be for multiple onblock executing image processing programs being selected, to determine the area being selected Characteristic (the step 3344) of block, to determine the normality of a block, such as whether check this block " enough normal " to authorize more Further analysis.In some instances, being selected and doing the block of normal sex determination is that those are chosen for waiting by preliminary Constituency block (for example, those meet minimum focus level threshold value, as described above).In some instances, this stage be used to sentence The characteristic for determining normality is cell number (such as sperm count).In specific example, this device can be to the minimum focus level of satisfaction Block (implying that they are enough focusing) execution image processing program is thin in block to determine each block focused enough Born of the same parents' (sperm) number.This image processing program may include that (and in some implementations, collocation adapts to fixed binaryzation (binarization) Limit) using identify partially may be in block sperm object as prospect, and identify block remainder be background, at image After managing program, this device can determine that cell (sperm) number.In one or more embodiments, the cell number of candidate block can be based on There is sperm to be determined to the area ratio of not sperm (for example, carrying out extrapolation using table relevant with known cell number ratio Method).

Later, this device can calculate all remaining candidate blocks (for example, these meet the area of minimum focus level threshold value Block) statistical data (for example, average and standard deviation).After statistical data is computed, this device can be by statistically comparing One or more characteristics (for example, sperm count) of particular block and all remaining candidate blocks determine (step 3344) particular block Normality.In some embodiments, only meet a normality condition in the normality of particular block, can just continue It is chosen for candidate block.By taking sperm count as an example, in various embodiments, a block is considered " normal enough " (for example, meeting just Perseverance condition), it is the sperm count in the block in multiple blocks in the standard deviation default value for average value.At one Or in multiple implementations, the requirement of normality is (for average value) within two standard deviations.Among others are implemented, just Perseverance requires to be able to reflect a block and other blocks to be one or three standard deviations or other suitable statistical techniques The comparison of the normality of group.Illustrate in Figure 36, this figure be after image processing program result (for example, adapt to limit two-value Change (adaptive thresholding binarization)) and cell number judgement.It should be noted that being shown each in Figure 36 The estimation cell number of a candidate block substitutes its mark.

In addition, this device can determine that whether (step 3346) has reached the destination number of cell to be analyzed.Specifically come It says, one or more embodiments of revealed device are able to maintain that total cell number, and are directed to and are chosen for the every of candidate block The corresponding cell number of the block is added to total cell number by one block, this device.This device can be thin with the analysis of this destination number Born of the same parents go to control the quantity of biological sample to be analyzed, and are configurable according to this quantity is implemented.This quantity (number) can be according to reality The standard for testing room handbook and test particular organisms sample is tailor-made.In some embodiments, the destination number of cell to be analyzed is 200 (200).In some instances, when total cell amount reaches the destination number of cell to be analyzed, choosing candidate block is It completes.That is, according at least some of embodiment for being disclosed in this, meeting focus level threshold value and total cell number reaches desire On the block that the normality of the destination number of analyzed cell requires, the selection of candidate block can be performed (for example, with random Mode).

In step 3350, after choosing candidate block, this device introduced can pass through the candidate block (example of analysis selection Such as, pass through one or more technologies introduced herein), determine biological sample one or more characteristic.In at least multiple implementations In example, this biological sample is sperm, and one or more biological sample characteristics in candidate block is intended to be determined comprising one It is a or multiple: cell quantity (or concentration, can infer from cell quantity), energy or form.In some instances, this Device is more configured with, the group analysis processing routine execution after, can the result judgement based on analysis and processing program about this biology The result (for example, fertility) of sample.

In addition, it is observed that ideally manufacture eyeglass sub-assembly be often difficult (when especially measuring big and must control This when is made) such as it is mounted on micro- lens assembly and/or amplifying lens sub-assembly in the test device being incorporated herein. The flaw of lens in the form of miscellaneous there is, such as impurity or lens itself it is imperfect (for example, understand degree, folding Degree of penetrating, focus and other), and these flaws can make detrimental effect to the accuracy of test device.Therefore it introduces herein, Be correction and passed examination technology with mitigate lens flaw and further improve on this revealed test device point Analyse accuracy.

Figure 37 is the example flow chart 3700 of an example correction process program, can be real by a test device disclosed herein (for example, Figure 21 C or Figure 22) is applied to obtain improved result.This processing routine 3700 can be the substitution of the process disclosed herein Or supplement processing routine, such as the processing routine being illustrated in Figure 16.

Firstly, this device introduced can utilize camera model in step 3710 (for example, after carrier box insertion) To capture one or more images (or being commonly referred to as, integrated images (imagery)) in carrier box holding area.Some (for example, those narrations about Figure 29 or 31, this device can be with the collection captured from holding area in the embodiment of selectivity Close the visual cues on image recognition (step 3720) carrier.In the embodiment of these selectivity, this device can be according to upper The result of the identification of visual cues is stated to the analytic process for executing one group through capturing integrated images.

For more specifically, in some implementations, carrier box in this can be used as a special virtual box, can be used to Trigger correction process program.For example, special virtual box may have one or more special pictorial pattern (examples Such as, introduced as follows about Figure 38), after (for example, in step 3720) visual cues identifying processing program, test can be triggered Device enters correction mode.In another example, a special virtual box can carry special test sample (for example, about Figure 41 is introduced as follows), and user can cause (for example, by user interface or remote-controlled test device on panel) manually Test device enters in correction mode.In many instances, virtual box may include an electronics (for example, one is wirelessly penetrated Frequency identification (RFID)) or a mechanical feature (for example, projection of a special shape or machinery), school can be triggered Holotype.

Figure 38 is that a test carrier carries a visual cues or a picture pattern, can be used in correcting or verifying taking off herein The test device of dew.In one or more embodiments, visual cues include a picture pattern, and test device is enable to know Not Zuo Wei a trigger with enter correction mode.Later, this test device can capture the image of picture pattern using camera model, And self diagnosis is executed from through capturing the result self-correction in image.Visual pattern should want readily identified and (and be not easy to miss Recognize).As illustrated in Figure 38, visual pattern in example includes duplicate (for example, every 0.08 millimeter, that is, repetitive rate Or " spacing (pitch) "), bigger (for example, 0.02 millimeter multiplied by 0.02 millimeter) and generally well-regulated shape.This vision Prompt can further include one or more duplicate linear patterns.In the example that Figure 38 illustrates, this linear patterns packet Containing one group of (for example, three) horizontal line and one group of (for example, three) vertical bar.In some embodiments, these lines have 200 lines are right/millimeter (LP/mm) or higher resolution.In the specific example of Figure 38, lines have the parsing of 500LP/mm Degree.It should be noted that the example for the vision linearity pattern that horizontal and/or vertical bar is, is suitble to auxiliary test unit to execute spy The optical characteristics of optical instrument (for example, microlens) of the Dingan County loaded on test device itself and the self diagnosis of performance；Other Suitable visual pattern, which may replace in Figure 38, illustrates example.For example, in some implementation columns, " E " shape pattern or Coordinate may replace parallel lines as vision linearity pattern.For example, in some implementation columns, solid line and dotted line can be used In vision linearity pattern.

Program 3700 is continued with, although being initiated in step 3730 correction mode, is picked in the integrated images of carrier After taking (for example, in step 3710), this device can divide captured integrated images be multiple blocks (this is similar to step 3330, As discussed above).In some embodiments, block can be polygon.It, points out that block can be in more specific words in some implementations Triangle, rectangle, square, pentagon, hexagon etc..These (block) these shapes may at least be 0.05 on one side Millimeter.In one or more embodiments, block is square and having a size of 0.05 millimeter multiplied by 0.05 millimeter.It is noticeable It is to be implemented according to specific, the quantity and size of block can be adjusted according to the resolution of camera model.In one or more realities Shi Zhong, spacing mentioned above (for example, visual pattern regularly voluntarily repetitive rate), which can correspond to integrated images, to be divided Block quantity.In some embodiments, spacing can be consistent with the number of blocks that integrated images energy device being tested is divided.

Device in step 3740, example can execute correction/self diagnosis program, such as in each block.Correct journey Sequence should generally be one or more steps, and capable of enabling test device, automatically self diagnosis is presently installed at test device Optical module (e.g., including microlens, camera model) quality on itself.In one or more embodiments, test dress Setting can be determined that (in the focus level of each block of step 3742), for example, by using one or more focometry letters Number.The example of focometry function may include anomaly, coefficient of variation summation type, Laplce's energy image-type, and/or side Gradient intensity maximization type.Then, in step 3744, this test equipment can determine that whether a block meets focus level, for example, Minimum focus level threshold value discussed above.Additionally or alternatively, this test device can by through capturing result with one or more A expected result compares (in step 3746).For example, the processor access of this test equipment is preparatory to one or more The image (for example, non-captured using camera, for example, being passed or by the default installation of program) of installation in memory, and through picking The image taken, which is made, to be compared, and determine within a block have doubt through capture image quality whether meet minimum standard.In advance One or more images of installation should be the representative of the visual pattern applied to correction.In step 3746, test device can compare Relatively and inspect example image quality parameter, including cross-color, pattern deformation, readability flaw and/or other image flaws.

Figure 39 is the example image of a visual cues Figure 38, is captured through test device disclosed herein, this image product Matter is in general preferable toward the lower left corner, then poor toward the upper right corner.Figure 40 A and 40B are two and pass through in different blocks in Figure 39 Capture the particular instance explanation of the different images quality of image.In some embodiments, for example, the pitch and collection can be divided The number of blocks for closing image is consistent, and image 40A and 40B can respectively represent a block.As illustrated, scheme in the block of Figure 40 A Picture quality is good compared with Figure 40 B, because image is relatively clear and more focuses.

Processing routine 3700 is traced back to, in step 3750, the result of step 3740 is (for example, whether block meets minimum Image quality requirement, such as minimum focus level) it is recorded in the electricity for being incorporated into test device (not adding to repeat for the sake of simple) In brain readable memory medium (for example, it may be it is non-transient, such as quick storage (flash memory)).From correction process The knowledge that program obtains can be with, for example, when test device after normal operating in be utilized.In one or more realities Apply in example, in normal operation (for example, in step 3340, as discussed above) at this time test device can automatically skip or Ignore those blocks for failing to reach minimum image quality requirements in correction or self diagnosis.So, it discloses herein Test device can mitigate the adverse reaction of lens flaw and increase analysis accuracy.

It is example image that a test carrier carries a test sample that Figure 41 is revealed, can be used for correcting or verifying and take off It is exposed to this test device.This technology can be used in one or more embodiments above-mentioned, a special virtual box energy Carry special test sample and correction mode can by other than visual pattern flip-flop toggle (such as user manually boots, Or by the radio frequency identification (RFID) on mechanical feature or virtual box).Certain some embodiment points out that test sample should be Aqueous medium pattern (for example, liquid solution) includes small-sized test particle, such as the test particle 4102 illustrated in Figure 41.This Slightly particle can made by any suitable substance, including, for example polymer.One specific 4102 example object of particle Matter is latex.The size of particle is suitably adapted for specifically applying.In certain implementations, the size of particle can be with those cells, example Such as sperm, size it is similar.The example size range of particle can be 0.5 micron to 50 microns from diameter.In instances, particle is straight 5 microns of diameter.When test particle is as sample, this test device can be executed such as 3700 processing routines correction/self diagnosis without Step 3720 is needed, and self diagnosis is currently installed in the quality of the optical module of itself.Some implementations in these, this survey Trial assembly sets the image that can install test particle in advance (for example, non-capture through camera, for example, by being transmitted or by its other party The installation of formula program) in memory, for example (,) it is discussed above, compare and correct purpose to make.

Figure 42 A and 42B illustrate different images quality in the different blocks in Figure 41 through capturing image.Such as explanation, figure Image quality is good compared with Figure 42 B in block in 42A, because image is relatively clear and more focuses.To it is discussed above similar, about step Rapid 3750, the knowledge of the baseline image quality of each block can be used to, for example, when test device is in normal operating later It is utilized.For example, the embodiment of some test equipments can automatically skip or ignore those and fail to reach in timing The block or self diagnosis of minimum image quality condition.So, the test device disclosed herein can mitigate lens flaw Adverse reaction simultaneously improves precision of analysis.

Although in specific example disclosed herein it is some by revealed technology applied to sperm test, this field Technical staff is readily understood by, and revealed technology can be applied to test various types of biological samples, such as sperm, urine, cunning Movable joint liquid, textura epidermoidea or cell, tumour cell, water sample etc..

Those skilled in the art will be evident, can be to the present invention in the case where not departing from scope of the invention or spirit Structure carry out various modifications and change.In view of foregoing teachings, it is intended to the present invention covers modification and variation of the invention, as long as It belongs to claim and the scope of its equivalent.

Claims

1. a kind of device for test biological sample, which is characterized in that described device includes:

One receiving mechanism, to receive a carrier, wherein the carrier includes a holding area, wherein the holding area carries institute It states biological sample or has been exposed to the biological sample；

One camera model is configured to capture an integrated images of the holding area, obtains once acquisition integrated images；And

One processor, the processor are configured to collect from the described of the holding area through capturing using the camera model Close image recognition visual cues on the carrier, and one based on identification described in the visual cues as a result, to described It is captured integrated images and selectively executes a group analysis processing routine；

Wherein the group analysis processing routine includes:

Multiple blocks are divided into through acquisition integrated images by described；

Select multiple candidate blocks to analyze from the multiple block,

Wherein the selection of the candidate block is the normality of focus level and block based on block,

And one or more characteristics of the biological sample are determined by analyzing the multiple chosen candidate block.

2. device as described in claim 1, which is characterized in that it further includes a shell, and the shell includes an opening；

The receiving mechanism receives the carrier of insertion via the opening；

The integrated images are one or more images；

The processor is carried on a circuit board；

In the holding area that the visual cues are located on the carrier or near；

Wherein the processor is further configured to after the group analysis processing routine is performed, and is handled based on the group analysis A final result of the result judgement of program about the biological sample；

Wherein the receiving mechanism, the camera model and the circuit board package are in the shell.

3. device as claimed in claim 1 or 2, which is characterized in that the processor is further configured to based on the view Which group analysis a shape and/or the position for feeling prompt determine at the described of the holding area through acquisition integrated images Reason program will be performed.

4. device as claimed in claim 1 or 2, which is characterized in that the processor only after the visual cues are identified, The group analysis processing routine is executed through acquisition integrated images to described.

5. device as claimed in claim 4, which is characterized in that the visual cues are pre-positioned with a predetermined shape and/or one It is identified when setting.

6. device as claimed in claim 1 or 2, which is characterized in that the visual cues are one not by the size of human perception.

7. device as claimed in claim 6, which is characterized in that the size of the visual cues is passed through by the camera model By being identified after microlens amplification.

8. device as claimed in claim 1 or 2, which is characterized in that the visual cues include the one of more than one a visual beacons Scheduled configuration.

9. device as claimed in claim 2, which is characterized in that the camera model includes first camera module and second camera Module, the first camera module and the second camera module are packaged in the shell, and the holding area includes adjacent One first holding area and one second holding area；And the processor is further configured to utilize the first camera mould Block identifies a shape of first holding area on the carrier, obtains an identified shape, and utilizes described the Two camera models identify the visual cues on the carrier from second holding area, wherein the visual cues are one Not by the size of human perception.

10. device as claimed in claim 9, which is characterized in that the processor is further configured to solid to described first The image that captured for holding region executes one first group analysis processing routine.

11. device as claimed in claim 10, which is characterized in that the processor is further configured to based on identifying the The shape decision of one holding area will execute which group analysis handles journey to the image that captured of first holding area Sequence.

12. device as claimed in claim 9, which is characterized in that the processor is configured as responding to described identified Shape is a first shape, with the acid through capturing biological sample described in image recognition based on first holding area Degree.

13. device as claimed in claim 12, which is characterized in that the identification of the acidity is based on first fixing A color shown in region.

14. device as claimed in claim 9, which is characterized in that the processor is configured as responding to described identified Shape is one second shape, is swashed with one through capturing biological sample described in image recognition based on first holding area It is plain horizontal.

15. device as claimed in claim 14, which is characterized in that the hormone of the identification is based on first holding area Shown in a color.

16. device as claimed in claim 9, which is characterized in that the first camera module includes a non-microlens, and its Described in second camera module include a microlens.

17. device as claimed in claim 9, which is characterized in that the processor is configured as responding to described identified Shape is first shape, to determine a cell number of the biological sample.

18. device as claimed in claim 17, which is characterized in that the judgement of the cell number of the biological sample is It is executed using the second camera module.

19. device as claimed in claim 2, which is characterized in that it is further included: a display is packaged in the shell It is interior, wherein the processor is configured to after obtaining the final result, the judgement is shown on the display most Terminate fruit.

20. device as claimed in claim 1 or 2, which is characterized in that the processor is further configured to based on described solid Hold a biochemical characteristic of biological sample described in one or more spectral discriminations in region.

21. device as described in claim 1, which is characterized in that the group analysis processing routine further comprises:

The focus level of the block and a focus level threshold value are compared,

Wherein only meet the focus level threshold value in the focus level of the block to begin to be selected as candidate block.

22. device as described in claim 1, which is characterized in that the group analysis processing routine further comprises:

Focometry function is that each the multiple block determines a focus level based on one or more.

23. device as claimed in claim 22, which is characterized in that one or more of focometry functions include variation One or more types in type, coefficient of variation summation type, Laplce's energy image-type or side gradient intensity maximization type.

24. device as described in claim 1, which is characterized in that the group analysis processing routine further comprises:

The normal of the block is determined by one or more characteristics of the statistical block and the multiple block Property,

Wherein the block only meets normality requirement in the block, and the beginning is selected as candidate block.

25. device as claimed in claim 24, which is characterized in that one or more characteristics of the block include the block A cell number, and wherein the normality require be the multiple block a standard deviation default value.

26. device as claimed in claim 25, which is characterized in that the standard deviation default value is two standard deviations.

27. device as described in claim 1, which is characterized in that the group analysis processing routine further comprises: meeting one and focus Each block of degree threshold value executes image processing program to determine cell number.

28. device as claimed in claim 27, which is characterized in that described image processing routine includes adapting to limit binaryzation.

29. device as claimed in claim 27, which is characterized in that the group analysis processing routine further comprises:

From the whole blocks for meeting the focus level threshold value calculate the cell number an average value and the cell number one Standard deviation.

30. device as described in claim 1, which is characterized in that it is total thin that the selection of the candidate block is further based upon one Born of the same parents' number, control are intended to a quantity of analyzed biological sample.

31. device as described in claim 1, which is characterized in that the group analysis processing routine further comprises: maintenance one is total thin Born of the same parents' number；And each corresponding cell number for being selected as the candidate block is added up to total cell number, wherein candidate block The selection be that the destination number for reaching a cell to be analyzed in the total cell number is completed.

32. device as claimed in claim 31, which is characterized in that the destination number of the cell to be analyzed is 200.

33. device as described in claim 1, which is characterized in that the selection of the candidate block is to meeting a focus level Threshold value and a normality require random execution, and the normality requirement is until a total cell number reaches a cell to be analyzed Destination number.

34. device as described in claim 1, which is characterized in that the shape of the multiple block is polygon.

35. device as described in claim 1, which is characterized in that the shape of the multiple block is triangle, square, five Side shape or hexagon, and having for the multiple block is at least 0.05 millimeter on one side.

36. device as described in claim 1, which is characterized in that the biological sample is sperm.

37. device as described in claim 1, which is characterized in that one or more of characteristics of the biological sample include It is one or more: cell number, energy or form.

38. device as described in claim 1, which is characterized in that a shell is further included, wherein the receiving mechanism, the phase Machine module and the processor are packaged in the shell.

39. the device as described in Claims 2 or 38, which is characterized in that it is vertical that an apparent size of the shell is less than 27000 Fang Gongfen.

40. device as described in claim 1, which is characterized in that the processor holds the multiple block of each segmentation After one correction program of row, then carry out the analysis and processing program.

41. device as claimed in claim 40, which is characterized in that the correction program be the processor by described through capturing Integrated images are compared with one or more desired results, to determine described to be captured whether integrated images meet a lowest bid It is quasi-.

42. device as claimed in claim 41, which is characterized in that the desired result is to be pre-installed in the processor A memory in one or more images.

43. device as claimed in claim 42, which is characterized in that one or more of images in the memory are view Feel pattern.

44. device as claimed in claim 41, which is characterized in that the comparison be include relatively and inspect an image quality ginseng Number.

45. device as claimed in claim 44, which is characterized in that described image quality parameter includes: cross-color, pattern change Shape or readability flaw.

46. device as claimed in claim 40, which is characterized in that identify the vision on the carrier in the processor After prompt, the correction program is carried out.

47. device as claimed in claim 40, which is characterized in that it includes multiple tests that the holding area of the carrier, which carries one, The test sample of particle, and after the processor identifies multiple test particle in the test sample, carry out the school Positive program.

48. a kind of device for test biological sample, which is characterized in that described device includes:

One shell, the shell include an opening；

One receiving mechanism, to receive a carrier, the receiving mechanism receives the carrier of insertion via the opening；Wherein institute Stating carrier includes a holding area, wherein the holding area carries the biological sample or has been exposed to the biological sample；

One camera model is configured to capture one or more images of the holding area, obtains once acquisition image；And

One carries the circuit board of a processor, and the processor is configured to using the camera model come from the holding area It is described captured in the image recognition holding area on the carrier or a neighbouring visual cues, and be based on the view Feel and prompts the one of the identification as a result, selectively executing group analysis processing to the image that captured of the holding area Program；

Wherein the processor is further configured to after the analysis and processing program is performed, and is handled based on the analysis A final result of the result judgement of program about the biological sample；

49. device as claimed in claim 48, which is characterized in that the visual cues are one not by the size of human perception, And the size by the camera model via a microlens amplification after identify.

50. device as claimed in claim 48, which is characterized in that an apparent size of the shell is less than 27000 cubes Centimetre.

51. device as claimed in claim 48, which is characterized in that the camera model includes first camera module and the second phase Machine module, the first camera module and the second camera module are packaged in the shell, and the processor is further It is configured to identify a shape of one first holding area on the carrier using the first camera module, and utilizes institute It states second camera module and identifies the visual cues, wherein the visual cues are one not by the size of human perception.

52. a kind of method for determining biological sample characteristic characterized by comprising

Using the device as described in any claim in claim 1 to 51,

Operation processing device is to be captured integrated images identification in the load from the described of the holding area using camera model A visual cues on body, and one based on identification described in the visual cues as a result, to it is described through capture integrated images selection Execute a group analysis processing routine to property；

Wherein the group analysis processing routine includes:

Select multiple candidate blocks to analyze from the multiple block,

And one or more characteristics of the biological sample are determined by the multiple chosen candidate block.