TWI699532B - Equipment for testing biological specimens - Google Patents
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Abstract
Description
本發明係關於用於測試生物樣本之設備,且尤其係關於具有放大功能或分析物量化功能之測試設備。 The present invention relates to equipment for testing biological samples, and particularly relates to testing equipment with amplification function or analyte quantification function.
目前,液體內含物的測試通常會委託給專業測試機構,利用具有高放大比率之昂貴顯微鏡設備來執行測試。由於一般人不具有顯微鏡裝置,故無法由一般人執行測試活動。 At present, the testing of liquid content is usually entrusted to a professional testing organization, which uses expensive microscope equipment with high magnification to perform the test. Since the average person does not have a microscope device, it cannot be performed by the average person.
然而,在一些當今測試類別中是需要執行定期測試;因此對於需要頻繁測試之需求而言,在時間及費用方面造成負擔過重。舉例而言,長期測試的類別包括不孕的患者精液測試。該精液測試主要係針對精子數目、其活動力及形態執行觀測。 However, in some of today's test categories, it is necessary to perform regular tests; therefore, for requirements that require frequent tests, it is too burdensome in terms of time and cost. For example, the category of long-term testing includes semen testing for infertile patients. The semen test is mainly based on the observation of the number, motility and morphology of sperm.
精液測試方法包含:將男性受試者的精液在室溫下靜置一段時間,及取得一滴所述樣本並將所述樣本滴注於載玻片上,以及在顯微鏡下觀測所述樣本。該等觀測不僅包括對個別精子執行高放大之觀測以識別個別精子之外部形貌,而且包括對大量的全部精子、其活動力、形態及每單位面積的數量執行觀測。然而,個人不能自己執行精液測試,此係由於業界尚未研發出允許個人經由簡單輔助裝置執行測試的技術。 The semen test method includes: leaving the semen of a male subject at room temperature for a period of time, taking a drop of the sample and instilling the sample on a glass slide, and observing the sample under a microscope. These observations include not only performing high-magnification observations on individual sperm to identify the external appearance of individual sperm, but also performing observations on a large number of all sperm, their motility, morphology, and quantity per unit area. However, individuals cannot perform semen tests by themselves. This is because the industry has not yet developed a technology that allows individuals to perform tests via simple auxiliary devices.
本發明提供一種用於測試生物樣本的裝置及判定生物樣本特性的方法,所述用於測試生物樣本的裝置包含:一接收機構,以接收一載體,其中所述載體包括一固持區域,其中固持區域攜帶所述生物樣本或已暴露所述生物樣本;一相機模組,其經配置以擷取固持區域的一集合圖像,得到一經擷取集合圖像;及一處理器,所述處理器經配置以利用相機模組來(1)從所述固持區域的所述經擷取集合圖像識別在所述載體上的一視覺提示,且(2)基於所述視覺提示的所述識別的一結果,對所述經擷取集合圖像執行一組分析處理程序;其中該組分析處理程序包括:將所述經擷取集合圖像分割為複數區塊;自所述複數區塊選擇複數候選區塊以分析,其中所述候選區塊的選擇是基於(1)區塊的聚焦程度,及(2)區塊的正常性,且藉由所述複數候選區塊(經選擇候選區塊)判定所述生物樣本的一或多個特性。 The present invention provides a device for testing biological samples and a method for determining characteristics of biological samples. The device for testing biological samples includes: a receiving mechanism to receive a carrier, wherein the carrier includes a holding area, wherein the holding The area carries the biological sample or the biological sample has been exposed; a camera module configured to capture a set of images of the holding area to obtain a captured set of images; and a processor, the processor Is configured to use a camera module to (1) recognize a visual cue on the carrier from the captured set image of the holding area, and (2) the recognized based on the visual cue As a result, a set of analysis processing procedures is performed on the captured set image; wherein the set of analysis processing procedures includes: dividing the captured set image into a plurality of blocks; selecting a plurality of blocks from the plurality of blocks Candidate blocks are analyzed, wherein the selection of the candidate blocks is based on (1) the focus of the block, and (2) the normality of the block, and by the plurality of candidate blocks (selected candidate blocks ) Determine one or more characteristics of the biological sample.
本發明之用於測試生物樣本的裝置與習知的測試裝置相比較便宜、需要較少勞動用於測試且易於使用。所述技術可應用於精液測試以及其他測試領域,諸如含微生物之水、水品質、血液、尿液、體液、大便及皮膚表層組織/細胞。所述技術與使用實驗室顯微鏡設備之現有技術相比提供具有顯著較低使用成本之簡單測試產品。 The device for testing biological samples of the present invention is cheaper than conventional testing devices, requires less labor for testing, and is easy to use. The technology can be applied to semen testing and other testing fields, such as water containing microorganisms, water quality, blood, urine, body fluids, stool, and skin surface tissues/cells. The technology provides a simple test product with a significantly lower use cost than the prior art using laboratory microscope equipment.
相較於現有技術,本文中所公開的用於測試生物樣本的裝置提供可顯著降低樣本放大測試結構之成本的簡單結構,用於諸如精子測試、尿分析或其他體液分析的測試。本文中所公開的技術經由設計具有樣本固持區域、放大組件及獨特創新設置的載體而可用於廣泛範圍之應用中。舉例而言,用於測試生物樣本的裝置可應用於檢測精子樣本的計數、活動力及形態。 Compared with the prior art, the device for testing biological samples disclosed herein provides a simple structure that can significantly reduce the cost of the sample amplification test structure, and is used for tests such as sperm testing, urinalysis or other body fluid analysis. The technology disclosed herein can be used in a wide range of applications by designing a carrier with a sample holding area, amplifying components, and unique innovative settings. For example, the device for testing biological samples can be applied to detect the count, motility, and morphology of sperm samples.
本發明的用於測試生物樣本的裝置適合於在家執行測試。可即刻獲得測試的結果且成本低。舉例而言,用於測試生物樣本的裝置提供一種在 家評定設法懷孕之夫妻的男性生育力的方式,以使得夫妻可作出是否需要醫學干預的知情決策。 The device for testing biological samples of the present invention is suitable for performing tests at home. The test results can be obtained immediately and the cost is low. For example, a device for testing biological samples provides a The way in which homes assess the male fertility of couples trying to conceive so that couples can make informed decisions about whether medical intervention is needed.
所揭示的技術可與現有智慧通信裝置(諸如智能電話或單板計算機)便利地整合,且能夠使用現有智慧通信裝置擷取經放大測試圖像及執行後續操作,諸如儲存及傳遞圖像。該等裝置的成本低,使得該等裝置可實施為一次性裝置或可重複使用的裝置。 The disclosed technology can be easily integrated with existing smart communication devices (such as smart phones or single-board computers), and can use the existing smart communication devices to capture enlarged test images and perform subsequent operations, such as storing and transferring images. The low cost of these devices allows them to be implemented as disposable devices or reusable devices.
本發明的至少一些具體實例係關於一種用於測試生物樣本的裝置(例如,測試盒或測試條帶)。所述裝置包括樣本載體及可拆卸外罩。樣本載體包括樣本固持區域。可拆卸外罩置放於所述樣本固持區域的頂部上。可拆卸外罩包括經設置以與樣本固持區域對準的放大組件。放大組件之焦距為0.1毫米(mm)至8.5mm。放大組件具有至少為1.0的線性放大比率。 At least some specific examples of the present invention relate to a device (for example, a test cartridge or a test strip) for testing biological samples. The device includes a sample carrier and a detachable cover. The sample carrier includes a sample holding area. The detachable cover is placed on the top of the sample holding area. The detachable housing includes an amplifying component that is configured to align with the sample holding area. The focal length of the magnifying unit is 0.1 millimeter (mm) to 8.5mm. The amplification component has a linear amplification ratio of at least 1.0.
本發明的至少一些具體實例係關於一種用於測試生物樣本的系統。所述系統包括上文所提及之用於測試生物樣本的裝置及基座組件。基座組件包括用於將測試生物樣本的裝置插入至基座組件中的插入埠。基座組件進一步包括用於擷取樣本固持區域之圖像的相機組件,或用於固定包括用於擷取樣本固持區域之圖像之相機組件的行動裝置的形狀配合框架。基座組件可進一步包括置放於相機組件下方之補充透鏡。放大組件與該補充透鏡之組合可具有至少為1.0的有效線性放大比率。 At least some specific examples of the present invention relate to a system for testing biological samples. The system includes the aforementioned device and base assembly for testing biological samples. The base assembly includes an insertion port for inserting the device for testing biological samples into the base assembly. The base assembly further includes a camera assembly for capturing an image of the sample holding area, or a form-fitting frame for fixing a mobile device including a camera assembly for capturing an image of the sample holding area. The base assembly may further include a supplementary lens placed under the camera assembly. The combination of the magnifying component and the supplementary lens may have an effective linear magnification ratio of at least 1.0.
本發明的至少一些具體實例係關於一種使用用於測試生物樣本的裝置來測試精子的方法。所述方法包括以下步驟:獲得用於測試上文所提及之生物樣本的裝置,將精子樣本施加至樣本固持區域,記錄所述精子樣本的視訊或圖像;基於所記錄視訊或所記錄圖像的至少一個圖框來判定所述精子樣本的精子數;以及基於所記錄視訊或所記錄圖像判定所述精子樣本的精子活動力。 At least some specific examples of the present invention relate to a method of testing sperm using a device for testing biological samples. The method includes the following steps: obtaining a device for testing the biological sample mentioned above, applying the sperm sample to the sample holding area, and recording the video or image of the sperm sample; based on the recorded video or image At least one frame of the image to determine the sperm count of the sperm sample; and determine the sperm motility of the sperm sample based on the recorded video or the recorded image.
本發明的至少一些具體實例係關於一種用於測試生物樣本的系統。所述系統包括用於測試生物樣本之一次性裝置及基座組件。所述一次性裝置包括含樣本固持區域的樣本載體及置放於所述樣本固持區域之頂部上的可拆卸外罩。所述基座組件包括將一次性裝置插入至基座組件中之插入埠及相機。包括圖像感測器及光學透鏡模組之相機擷取樣本固持區域之一或多個圖像。 At least some specific examples of the present invention relate to a system for testing biological samples. The system includes a disposable device and a base assembly for testing biological samples. The disposable device includes a sample carrier containing a sample holding area and a detachable cover placed on the top of the sample holding area. The base assembly includes an insertion port for inserting the disposable device into the base assembly and a camera. A camera including an image sensor and an optical lens module captures one or more images of the sample holding area.
本發明的一些具體實例包括用於測試生物樣本的裝置。所述裝置可包括具有開口之殼體。接收機構可接收經由所述開口插入之載體。所述載體的固持區域可包括相鄰的第一固持區域及第二固持區域。第一固持區域及第二固持區域可攜載生物樣本或已暴露於生物樣本。 Some specific examples of the invention include devices for testing biological samples. The device may include a housing with an opening. The receiving mechanism can receive the carrier inserted through the opening. The holding area of the carrier may include adjacent first holding areas and second holding areas. The first holding area and the second holding area can carry biological samples or have been exposed to biological samples.
在一些實施中,所述裝置可包括兩個相機模組。所述相機模組為經配置以擷取第一固持區域之一或多個圖像的第一相機模組,及經配置以擷取第二固持區域之一或多個圖像的第二相機模組。另外,一些具體實例包括攜帶處理器之主電路板,所述處理器經配置以對第一固持區域之經擷取圖像執行第一分析處理程序。所述處理器可經配置以對第二固持區域之經擷取圖像執行不同於第一分析處理程序之第二分析處理程序。在一些具體實例中,所述處理器可基於第一分析處理程序及第二分析處理程序兩者之結果判定關於生物樣本之結果。根據一或多個具體實例,所述接收機構、所述第一、二相機模組以及所述主電路板全部封裝於殼體內。 In some implementations, the device may include two camera modules. The camera module is a first camera module configured to capture one or more images of a first holding area, and a second camera configured to capture one or more images of a second holding area Module. In addition, some specific examples include a main circuit board carrying a processor configured to execute a first analysis processing program on the captured image of the first holding area. The processor may be configured to execute a second analysis processing procedure different from the first analysis processing procedure on the captured image of the second holding area. In some specific examples, the processor may determine the result of the biological sample based on the results of both the first analysis processing program and the second analysis processing program. According to one or more specific examples, the receiving mechanism, the first and second camera modules, and the main circuit board are all encapsulated in a housing.
此外,在一些具體實例中,當所述處理器識別第一固持區域呈第一形狀時,所述處理器經配置以執行某一分析處理程序。舉例而言,若第一形狀表示生物樣本包括來自男性受試者之精子,則所述處理程序可判定精子之一或多個特性。可判定之特性可包括:細胞數(例如精子數)、精子之濃度、精子之活動力及/或精子之形態。在一些實例中,可藉由使用第二相機模組執行對精子之一或多個特性的判定。在此等實例中之一些中,處理器進一步藉由使用 第一相機模組來判定精子之至少一個額外特性。此額外特性可包括精子之酸度。舉例而言,載體可包括在第一固持區域中用色彩表示精子之酸度的酸鹼值(pH)指示器,且處理器可辨識用於識別酸度之色彩。 In addition, in some specific examples, when the processor recognizes that the first holding area is in the first shape, the processor is configured to execute a certain analysis processing program. For example, if the first shape indicates that the biological sample includes sperm from a male subject, the processing program can determine one or more characteristics of the sperm. The determinable characteristics may include: cell number (for example, sperm count), sperm concentration, sperm motility, and/or sperm morphology. In some examples, the determination of one or more characteristics of the sperm can be performed by using the second camera module. In some of these instances, the processor further uses The first camera module determines at least one additional characteristic of the sperm. This additional characteristic may include the acidity of the sperm. For example, the carrier may include a pH indicator that indicates the acidity of the sperm in a color in the first holding region, and the processor may recognize the color for identifying the acidity.
在一些實例中,當所述處理器識別第一固持區域呈可指示生物樣本包括來自女性受試者之尿液的第二形狀時,所述處理器經配置以判定尿液之一或多個特性。可判定之特性可包括:黃體激素(LH)水平、濾泡刺激激素(FSH)水平及/或人絨毛膜促性腺激素(HCG)水平。如同酸度,可藉由使用第一相機模組執行對尿液之一或多個特性的判定。類似地,載體可包括第一固持區域中之LH指示器、FSH指示器及/或HCG指示器。 In some examples, when the processor recognizes that the first holding area is in a second shape that can indicate that the biological sample includes urine from a female subject, the processor is configured to determine one or more of urine characteristic. The determinable characteristics may include: Luteinizing Hormone (LH) Level, Follicle Stimulating Hormone (FSH) Level, and/or Human Chorionic Gonadotropin (HCG) Level. Like acidity, the judgment of one or more characteristics of urine can be performed by using the first camera module. Similarly, the carrier may include the LH indicator, the FSH indicator and/or the HCG indicator in the first holding area.
在一些具體實例中,第一相機模組與第二相機模組相比具有更低放大比率及/或更低的相機分辨率。 In some specific examples, the first camera module has a lower magnification ratio and/or a lower camera resolution than the second camera module.
在一些具體實例中,處理器可經配置以(1)利用第一相機模組識別載體上之第一固持區域之形狀;及(2)基於第一固持區域之形狀選擇將被執行之一組分析處理程序。第一固持區域之形狀可識別生物樣本之性別資訊。接著,回應於第一固持區域之形狀為第一形狀,由處理器選擇之該組分析處理程序可判定關於第一性別之生殖細胞的生育力。另外,回應於第一固持區域之形狀為第二形狀,由處理器選擇之該組分析處理程序可判定關於第二性別之生殖細胞的生育力。 In some specific examples, the processor may be configured to (1) use the first camera module to recognize the shape of the first holding area on the carrier; and (2) select a set of to be executed based on the shape of the first holding area Analysis processing program. The shape of the first holding area can identify the gender information of the biological sample. Then, in response to the shape of the first holding region being the first shape, the set of analysis processing programs selected by the processor can determine the fertility of the germ cells of the first sex. In addition, in response to the shape of the first holding region being the second shape, the set of analysis processing programs selected by the processor can determine the fertility of the germ cells of the second sex.
本發明另提供一種用於測試生物樣本的裝置,所述裝置包含:一殼體,所述殼體包含一開口;一接收機構,以接收一載體,所述接收機構係經由所述開口接收插入的所述載體;其中所述載體包括一固持區域,其中固持區域攜帶所述生物樣本或已暴露所述生物樣本;一相機模組,其經配置以擷取固持區域的一或多個圖像,得到一經擷取圖像;及一攜帶一處理器的電路板,所述處理器經配置以利用相機模組來(1)從所述固持區域的所述經擷取圖像識別 在所述載體上的所述固持區域中或附近一視覺提示,且(2)基於所述視覺提示所述識別的一結果,選擇性地對所述固持區域的所述經擷取圖像執行一組分析處理程序;其中所述處理器更進一步經配置以在該組分析處理程序被執行後,基於該組分析處理程序的結果判定關於所述生物樣本的一最終結果;其中所述接收機構、所述相機模組及所述電路板封裝於所述殼體內。 The present invention also provides a device for testing biological samples. The device includes: a housing, the housing includes an opening; a receiving mechanism for receiving a carrier, the receiving mechanism receives insertion through the opening The carrier; wherein the carrier includes a holding area, wherein the holding area carries the biological sample or the biological sample has been exposed; a camera module configured to capture one or more images of the holding area , Obtain a captured image; and a circuit board carrying a processor configured to use a camera module to (1) recognize the captured image from the holding area A visual cue in or near the holding area on the carrier, and (2) based on a result of the recognition of the visual cue, selectively executing on the captured image of the holding area A set of analysis processing procedures; wherein the processor is further configured to determine a final result of the biological sample based on the results of the set of analysis processing procedures after the set of analysis processing procedures are executed; wherein the receiving mechanism , The camera module and the circuit board are packaged in the casing.
較佳的,上述裝置中,所述視覺提示是一不被人類感知的尺寸,且所述尺寸被所述相機模組經由一顯微透鏡放大後識別。 Preferably, in the above device, the visual cue is a size that is not perceived by humans, and the size is recognized by the camera module after being enlarged by a micro lens.
較佳的,上述裝置中,所述殼體的一外觀尺寸是小於27000立方公分。 Preferably, in the above-mentioned device, an external dimension of the housing is less than 27,000 cubic centimeters.
較佳的,上述裝置中進一步包含:一第二相機模組,其中所述處理器進一步經配置以利用所述第二相機模組來識別所述載體上的一第二固持區域的一形狀。 Preferably, the above-mentioned device further comprises: a second camera module, wherein the processor is further configured to use the second camera module to recognize a shape of a second holding area on the carrier.
本發明另提供一種判定生物樣本特性的方法,包括:使用如前述之裝置,操作處理器以利用相機模組來(1)從所述固持區域的所述經擷取集合圖像識別在所述載體上的一視覺提示,且(2)基於所述視覺提示所述識別的一結果,對所述經擷取集合圖像選擇性地執行一組分析處理程序;其中該組分析處理程序包括:將所述經擷取集合圖像分割為複數區塊;自所述複數區塊選擇複數候選區塊以分析,其中所述候選區塊的選擇是基於(1)區塊的聚焦程度,及(2)區塊的正常性,且藉由所述複數經選擇候選區塊判定所述生物樣本的一或多個特性。 The present invention also provides a method for determining the characteristics of a biological sample, including: using the device as described above, operating a processor to use a camera module to (1) recognize from the captured collection image of the holding area in the A visual cue on the carrier, and (2) based on a result of the recognition of the visual cue, a set of analysis processing procedures is selectively executed on the captured set image; wherein the set of analysis processing procedures includes: Divide the captured set image into a plurality of blocks; select a plurality of candidate blocks from the plurality of blocks for analysis, wherein the selection of the candidate block is based on (1) the focus of the block, and ( 2) The normality of the block, and one or more characteristics of the biological sample are determined by the plurality of selected candidate blocks.
5:測試條帶 5: Test strip
10:載體 10: Carrier
11:樣本固持區域 11: Sample holding area
12:樣本接收埠 12: Sample receiving port
13:空氣通道 13: Air channel
14:突起部件 14: Protruding parts
15:可撓性透明薄膜 15: Flexible transparent film
16:光束輔助導引結構 16: beam assisted guiding structure
20:外罩 20: outer cover
21:凹槽 21: Groove
30:放大部件 30: Enlarged parts
30B:放大部件 30B: Enlarged parts
30C:放大部件 30C: Enlarged parts
31:放大部件 31: Enlarged parts
40:樣本 40: sample
42:樣本收集片 42: Sample collection sheet
42A:樣本收集區域 42A: Sample collection area
50:側向照明器件 50: Side lighting device
60:智慧通信裝置 60: Smart communication device
61:相機 61: Camera
70:儀表裝置 70: Instrumentation
71:下部機筒基座 71: Lower barrel base
72:上部機筒主體 72: Upper barrel body
73:插入埠 73: plug into port
74:放大透鏡 74: Magnifying lens
75:組裝框架 75: Assemble the frame
76:相機對準孔 76: Camera alignment hole
80:光源 80: light source
92:防滑薄膜 92: non-slip film
94:pH試紙 94: pH test paper
96:離型紙 96: Release paper
98:隔離組件 98: isolation components
1505:步驟 1505: step
1510:步驟 1510: step
1515:步驟 1515: step
1520:步驟 1520: step
1525:步驟 1525: step
1530:步驟 1530: step
1540:步驟 1540: step
1545:步驟 1545: step
1550:步驟 1550: step
1555:步驟 1555: step
1605:步驟 1605: step
1610:步驟 1610: step
1615:步驟 1615: step
1620:步驟 1620: step
1625:步驟 1625: step
1630:步驟 1630: steps
1705:精子 1705: sperm
1710:軌跡 1710: track
1720:軌跡 1720: Track
1805:軌跡 1805: Track
1810:曲線速度 1810: curve speed
1815:直線速度 1815: linear speed
1820:橫向頭部位移幅度 1820: Horizontal head displacement amplitude
1825:平均路徑 1825: average path
1900:測試設備 1900: test equipment
1905:測試條帶器件 1905: Test strip devices
1910:收集瓶 1910: collection bottle
1920:螢幕 1920: screen
2000:測試裝置 2000: Test device
2005:測試條帶裝置 2005: Test strip device
2105:測試條帶裝置 2105: Test strip device
2110:放大組件 2110: Amplification component
2115:樣本固持區域 2115: Sample holding area
2130:相機模組 2130: camera module
2135:透鏡 2135: lens
2140:光源 2140: light source
2205:測試條帶裝置 2205: Test strip device
2210A:外罩 2210A: Cover
2210B:放大組件 2210B: Amplifying components
2215A:第一固持區域 2215A: The first holding area
2215B:第二固持區域 2215B: The second holding area
2230A:第一相機模組 2230A: The first camera module
2230B:第二相機模組 2230B: Second camera module
2240A:光源 2240A: light source
2240B:光源 2240B: light source
2510:收集瓶 2510: collection bottle
2550:開關 2550: switch
2560:馬達 2560: Motor
2570:相機 2570: camera
2610:收集瓶 2610: collection bottle
2660:馬達 2660: Motor
2680:移動元件 2680: moving components
2690:光感測器 2690: Light Sensor
2905(1):載體 2905(1): Carrier
2905(2):載體 2905(2): Carrier
2905(3):載體 2905(3): Carrier
2905(4):載體 2905(4): Carrier
2915A:第一固持區域 2915A: The first holding area
2915B:第二固持區域 2915B: second holding area
3000:處理程序 3000: handler
3002:步驟 3002: Step
3004:步驟 3004: step
3006:步驟 3006: step
3008:步驟 3008: step
3010:步驟 3010: steps
3012:步驟 3012: steps
3014:步驟 3014: steps
3105:載體 3105: carrier
3117(1):視覺標誌 3117(1): visual sign
3117(2):視覺標誌 3117(2): Visual Sign
3117(3):視覺標誌 3117(3): visual sign
3117(4):視覺標誌 3117(4): visual sign
3117(5):視覺標誌 3117(5): visual sign
3115B:固持區域 3115B: Holding area
3200:處理程序 3200: handler
3202:步驟 3202: step
3204:步驟 3204: step
3206:步驟 3206: step
3208:步驟 3208: step
3210:步驟 3210: steps
3212:步驟 3212: steps
3300:處理程序 3300: handler
3310:步驟 3310: step
3320:步驟 3320: steps
3330:步驟 3330: steps
3340:步驟 3340: steps
3342:步驟 3342: step
3344:步驟 3344: step
3346:步驟 3346: step
3350:步驟 3350: step
3402:區塊 3402: block
3510:候選區塊 3510: candidate block
3700:校正處理程序 3700: Calibration process
3710:步驟 3710: steps
3720:步驟 3720: step
3730:步驟 3730: steps
3740:步驟 3740: step
3742:步驟 3742: step
3744:步驟 3744: steps
3746:步驟 3746: step
3750:步驟 3750: steps
4102:測試粒子 4102: test particles
A1:測試裝置 A1: Test device
A2:測試裝置 A2: Test device
A3:測試裝置 A3: Test device
A4:測試裝置 A4: Test device
A5:測試裝置 A5: Test device
A6:測試裝置 A6: Test device
A7:測試裝置 A7: Test device
A8:測試裝置 A8: Test device
A9:測試裝置 A9: Test device
A10:測試裝置 A10: Test device
H1:焦距參數 H1: Focal length parameter
H2:焦距參數 H2: Focal length parameter
L1:箭頭 L1: Arrow
L2:箭頭 L2: Arrow
L3:箭頭 L3: Arrow
S110:步驟 S110: Step
S120:步驟 S120: Step
S130:步驟 S130: Step
S140:步驟 S140: Step
圖1A為根據本發明之一具體實例之用於測試生物樣本的用於測試生物樣本的裝置的分解視圖。 Fig. 1A is an exploded view of a device for testing biological samples according to a specific example of the present invention.
圖1B為圖1A之測試裝置之組裝視圖。 Figure 1B is an assembled view of the testing device of Figure 1A.
圖2A為圖1A之測試裝置之橫截面視圖。 Figure 2A is a cross-sectional view of the testing device of Figure 1A.
圖2B為測試裝置之另一具體實例之橫截面視圖。 Fig. 2B is a cross-sectional view of another specific example of the test device.
圖3為根據本發明之一具體實例之測試裝置的測試之流程圖。 Fig. 3 is a flow chart of testing of a testing device according to a specific example of the present invention.
圖4為根據本發明之另一具體實例之用於測試生物樣本的裝置的橫截面視圖。 4 is a cross-sectional view of a device for testing biological samples according to another specific example of the present invention.
圖5為根據本發明之另一具體實例之用於測試生物樣本的裝置的橫截面視圖。 Fig. 5 is a cross-sectional view of a device for testing biological samples according to another embodiment of the present invention.
圖6為正在使用之圖5之測試裝置的示意圖。 Figure 6 is a schematic diagram of the test device of Figure 5 in use.
圖7為根據本發明之另一具體實例之用於測試生物樣本的裝置的示意圖。 Fig. 7 is a schematic diagram of a device for testing biological samples according to another embodiment of the present invention.
圖8為根據本發明之另一具體實例之用於測試生物樣本的裝置的示意圖。 Fig. 8 is a schematic diagram of a device for testing biological samples according to another embodiment of the present invention.
圖9為根據本發明之另一具體實例之用於測試生物樣本的裝置的示意圖。 FIG. 9 is a schematic diagram of a device for testing biological samples according to another specific example of the present invention.
圖10為根據本發明之另一具體實例之用於測試生物樣本的裝置的示意圖。 Fig. 10 is a schematic diagram of a device for testing biological samples according to another specific example of the present invention.
圖11至圖13為根據本發明之另三個具體實例之用於測試生物樣本的裝置的視圖。 11 to 13 are views of the apparatus for testing biological samples according to another three specific examples of the present invention.
圖14A為根據本發明之另一具體實例之插入至儀表裝置中的測試條帶之示意圖。 14A is a schematic diagram of a test strip inserted into the meter device according to another specific example of the present invention.
圖14B為根據本發明之另一具體實例之儀表裝置之組件的示意圖。 Fig. 14B is a schematic diagram of components of a meter device according to another embodiment of the present invention.
圖15A示出藉由諸如儀表裝置或智慧通信裝置之裝置進行的精液測試之樣本處理程序。 FIG. 15A shows a sample processing procedure of a semen test performed by a device such as a meter device or a smart communication device.
圖15B示出圖15A中所示之處理程序之樣本步驟1515。
Figure 15B shows a
圖15C示出圖15A中所示之處理程序之樣本步驟1520。
Figure 15C shows a
圖15D示出圖15A中所示之處理程序之樣本步驟1530。
Figure 15D shows a
圖15E示出圖15A中所示之處理程序之樣本步驟1550。
Figure 15E shows a
圖15F示出圖15A中所示之處理程序之樣本步驟1555。
Figure 15F shows a
圖16示出判定精子濃度之樣本處理程序。 Figure 16 shows a sample processing procedure for determining sperm concentration.
圖17示出樣本精子及樣本精子軌跡。 Figure 17 shows sample sperm and trajectories of sample sperm.
圖18示出判定精子軌跡及活動力之樣本處理程序。 Figure 18 shows a sample processing program for determining sperm trajectory and motility.
圖19為包括收集瓶之測試裝置之示意圖。 Figure 19 is a schematic diagram of a testing device including a collection bottle.
圖20為不包括收集瓶之測試裝置之示意圖。 Figure 20 is a schematic diagram of the test device without the collection bottle.
圖21A、圖21B及圖21C為測試裝置之各種具體實例之截面示意圖。 21A, 21B, and 21C are schematic cross-sectional views of various specific examples of the test device.
圖22為具有兩個樣本固持區域之測試條帶裝置之測試裝置的截面示意圖。 Fig. 22 is a schematic cross-sectional view of a test device having a test strip device with two sample holding areas.
圖23為具有自動聚焦功能之測試裝置之組件的示意圖。 Figure 23 is a schematic diagram of the components of a test device with autofocus function.
圖24為具有自動聚焦功能之另一測試裝置之組件的示意圖。 Fig. 24 is a schematic diagram of the components of another test device with auto-focus function.
圖25A及圖25B為包括開關及馬達之測試裝置的截面示意圖。 25A and 25B are schematic cross-sectional views of a test device including a switch and a motor.
圖26A及圖26B為包括可撓性元件之測試裝置的截面示意圖。 26A and 26B are schematic cross-sectional views of a testing device including a flexible element.
圖27為用於分析男性客戶或患者之精液樣本的處理程序之流程圖。 Figure 27 is a flowchart of a processing procedure for analyzing a semen sample of a male client or patient.
圖28為用於分析女性客戶或患者之LH或HCG的處理程序之流程圖。 Fig. 28 is a flowchart of a processing procedure for analyzing LH or HCG of female clients or patients.
圖29示出可適合於具有多相機設置之測試裝置(諸如圖22中所示之測試裝置)的載體之實例。 Figure 29 shows an example of a carrier that can be adapted to a test device with a multi-camera setup, such as the test device shown in Figure 22.
圖30為用於利用本文所揭示之測試裝置來分析男性受試者及女性受試者兩者之生育力的處理程序之流程圖。 FIG. 30 is a flowchart of a processing procedure for analyzing the fertility of both male and female subjects using the testing device disclosed herein.
圖31示出額外實例具有視覺提示(例如,在固持區域中或附近)載體可被 用於利用控制測試裝置執行的分析處理程序。 Figure 31 shows additional examples with visual cues (for example, in or near the holding area) that the carrier can be It is used to control the analysis processing program executed by the test device.
圖32為可被所揭示之測試裝置基於視覺提示適應性地執行分析處理程序所實施的處理程序額外實例流程圖。 FIG. 32 is a flowchart of an additional example of a processing program implemented by the disclosed testing device to adaptively execute an analysis processing program based on visual cues.
圖33為可被所揭示之測試裝置實施的處理程序的實例流程圖。 Figure 33 is an example flow chart of a processing procedure that can be implemented by the disclosed testing device.
圖34為固持區域被分割為許多區塊的實例圖像。 Fig. 34 is an example image in which the holding area is divided into many blocks.
圖35為說明一部分的候選區塊的選擇處理程序實例圖像。 Fig. 35 is an example image explaining a part of the candidate block selection processing procedure.
圖36為說明圖像處理程序(例如,二極化)及細胞數判定後的結果的實例圖像。 FIG. 36 is an example image illustrating the result of an image processing program (for example, two polarization) and the determination of the number of cells.
圖37為可被所揭示之測試裝置實施的校正程序實例流程圖。 Fig. 37 is a flowchart of an example calibration procedure that can be implemented by the disclosed testing device.
圖38測試載體攜帶可用於校正或使測試裝置生效的視覺提示及/或圖像圖案的實例圖像。 Figure 38 The test carrier carries example images of visual cues and/or image patterns that can be used to calibrate or validate the test device.
圖39為被所揭示之測試裝置擷取的圖38中視覺提示的實例圖像。 FIG. 39 is an example image of the visual cue in FIG. 38 captured by the disclosed testing device.
圖40A及圖40B說明圖39的經擷取圖像中不同區塊的不同的圖像品質。 40A and 40B illustrate different image qualities of different regions in the captured image of FIG. 39.
圖41為測試載體攜帶可用於校正或使測試裝置生效的測試樣本實例圖像。 Fig. 41 is an example image of a test sample carried by the test carrier that can be used to calibrate or validate the test device.
圖42A及圖42B說明圖41的經擷取圖像中不同區塊的不同的圖像品質。 42A and 42B illustrate different image qualities of different regions in the captured image of FIG. 41.
現將詳細參考本發明之當前較佳具體實例,其實例示出於隨附圖式中。 Reference will now be made in detail to the presently preferred specific examples of the present invention, which examples are shown in the accompanying drawings.
圖1A及圖1B示出根據本發明之具體實例的用於測試生物樣本的裝置。本文中所揭示之具體實例用於說明目的且不應視為對本發明之所需限制。用於測試生物樣本的裝置A1包括:具有形成於載體10之頂部上之樣本固持
區域11的載體10、堆疊於載體10之頂部上之外罩20及包括形成於外罩20上之凸透鏡型表面的至少一個放大部件30(亦被稱作放大組件或放大鏡)。
Figures 1A and 1B show a device for testing a biological sample according to a specific example of the present invention. The specific examples disclosed herein are for illustrative purposes and should not be regarded as necessary limitations to the present invention. The device A1 for testing biological samples includes: a sample holder formed on the top of the
本具體實例之放大部件30包括如圖1A中所示之平面凸透鏡。然而,可包括其他類型之放大透鏡(例如,雙面雙凸透鏡)作為放大部件30。放大部件30經安置以與載體10之樣本固持區域11對準且覆蓋所述樣本固持區域11。放大部件30可基於各種測試之測試要求而具有各種放大比率。舉例而言,所述測試可包括精液測試、尿液測試、滑液關節液測試、皮膚測試、水測試或其他體液測試等等。
The magnifying
使用本具體實例之用於測試生物樣本的裝置A1的測試不需要昂貴且操作耗時的額外放大透鏡或實驗室顯微鏡。此外,不需要使樣本固持區域與所述放大透鏡或實驗室顯微鏡對準。 The test using the apparatus A1 for testing biological samples of this specific example does not require an expensive and time-consuming additional magnifying lens or laboratory microscope. In addition, there is no need to align the sample holding area with the magnifying lens or laboratory microscope.
如圖1A中所示,載體10之樣本固持區域11可經形成具有凹陷結構。所述凹陷結構設計提供含有樣本40之穩定且大的儲存空間。所述凹陷結構允許在執行測試之前將所述樣本靜置一所需時間段。舉例而言,在對精液樣本執行活動力測試之前,有必要在執行活動力測試之前使精液樣本於室溫下靜置一所需時間段。
As shown in FIG. 1A, the
樣本40可首先經滴注於凹陷結構(亦即,載體10之樣本固持區域11)中以靜置一段時間。如圖1B中所示,外罩20之總面積可小於載體10之總面積。暴露在外罩20外部之樣本接收埠12形成於樣本固持區域11之一側上。樣本接收埠12可經設計以具有朝外擴展之形狀,所述形狀可有助於平穩地滴注樣本。
The
圖2A示出延伸超出外罩20之另一側且形成於樣本固持區域11之另一側上的空氣通道13。空氣通道13可阻止空氣填充樣本固持區域11之內部,該填充在樣本呈液體狀態時阻止對樣本之接收。
FIG. 2A shows the
如圖2A中所示,側向照明裝置50可安置於測試裝置A1之載體10之一側處。所述側向照明裝置50可為樣本固持區域11中之樣本40提供照明且因此改良樣本40之經擷取測試圖像之分辨率。在一些具體實例中,樣本固持區域11可接收在測試裝置A1之頂部或底部上之光源的照明。
As shown in FIG. 2A, the
如圖1A中所示,放大部件30及外罩20可一體地形成,亦即,放大部件30及外罩20可為單一組件。在其他具體實例(諸如圖2B中所示之具體實例)中,可拆卸外罩20及安置於可拆卸外罩20之朝上凹型部件,即凹槽21中之放大部件30可各自為適於經整合在一起的獨立組件。換言之,相同類型之可拆卸外罩20可與各種放大比率之不同放大部件30整合。
As shown in FIG. 1A, the amplifying
在一些具體實例中,所述可拆卸外罩20之底部與所述樣本固持區域11之間的距離為0.005mm至10mm。在一些具體實例中,所述可拆卸外罩20之底部與所述樣本固持區域11之間的距離約為0.01mm。測試裝置可包括一或多個間隔件(圖未示)以確保可所述拆卸外罩20之底部與樣本固持區域11之間的距離。所述間隔件可與可拆卸外罩20或載體10之樣本固持區域11一體地形成。
In some specific examples, the distance between the bottom of the
在一些具體實例中,包括載體10及外罩20之條帶係用於精子測試。在一些具體實例中,用於判定精子濃度及活動力之最佳角度放大比率約為100至200。在一些具體實例中,用於判定精子形態之最佳角度放大比率為約200至300。放大組件愈薄,角度放大比率則愈高。
In some specific examples, the strip including the
放大組件之焦距亦可與角度放大比率相關。在一些具體實例中,具有100之角度放大比率的放大組件具有2.19mm之焦距。具有角度放大比率為156的放大組件具有1.61mm的焦距。具有300之角度放大比率的放大組件具有0.73mm的焦距。在一些具體實例中,放大組件具有的角度放大比率至少 為30、較佳地至少為50。在一些具體實例中,放大組件的焦距為0.1mm至3mm。 The focal length of the magnifying component can also be related to the angular magnification ratio. In some specific examples, the magnifying component with an angular magnification ratio of 100 has a focal length of 2.19 mm. The magnifying assembly with an angular magnification ratio of 156 has a focal length of 1.61 mm. The magnifying unit with an angular magnification ratio of 300 has a focal length of 0.73 mm. In some specific examples, the magnification component has an angular magnification ratio of at least It is 30, preferably at least 50. In some specific examples, the focal length of the magnifying component is 0.1 mm to 3 mm.
圖3示出使用圖1B中所示之用於測試生物樣本的裝置A1執行測試的樣本處理程序。在步驟S110中,將待測試之樣本40設置於樣本固持區域11中。在步驟S110中,使外罩20堆疊於載體10之頂部上,之後自樣本接收埠12將待測試之樣本40設置於樣本固持區域11中。替代地,可首先將待測試之樣本40直接設置於樣本固持區域11中,之後使外罩20堆疊於載體10之頂部上。在步驟S120中,根據樣本40之測試要求使樣本40靜置於樣本固持區域11中,選擇性地持續一段時間。在步驟S130中,智慧通信裝置(例如,行動電話)附接在外罩20上,且使行動電話之相機與放大部件30對準,以使用行動電話之相機經由放大部件30擷取樣本之圖像或視訊。在步驟S140中,在行動電話或其他分析裝置處運行之應用程式(APP)可用於對圖像或視訊執行分析,從而獲得測試結果。
Fig. 3 shows a sample processing procedure for performing a test using the apparatus A1 for testing biological samples shown in Fig. 1B. In step S110, the
如圖4中所示,支撐側(諸如突起部件14)可進一步形成於測試裝置A2之外罩20之頂部上放大部件30之邊界處。在一些具體實例中,突起型支撐結構可藉由添加突起部件14形成於外罩20之頂部上。當使用者試圖使用智慧通信裝置60(例如,諸如智能型電話或單板計算機之行動裝置)擷取樣本之圖像或視訊時,具有相機61之智慧通信裝置60之一側可固定至突起部件14(沿箭頭L1示出之方向)。因此,測試裝置A2允許使用者使用智慧通信裝置60擷取樣本之圖像或視訊,且不需要昂貴測試裝置記錄圖像或視訊。此外,為了最佳觀測距離,可基於相機61及測試裝置A2之規格預定突起部件14之高度。
As shown in FIG. 4, a supporting side (such as the protruding member 14) may be further formed at the boundary of the magnifying
如圖5及圖6中所示,測試裝置A3可包括儀表裝置70(亦被稱作基座組件)。儀表裝置70包括下部機筒基座71及可相對於下部機筒基座71上升或下降之上部機筒主體72。下部機筒基座71具有為堆疊在一起之外罩20及載體10提供插入位置之插入埠73。朝上發光裝置(亦被稱作光源)80安置於下部機筒基座
71之底部上,以自底部向外罩20及載體10之組合提供照明。上部機筒主體72可包括例如用於進一步放大之至少一個額外放大透鏡74。
As shown in FIGS. 5 and 6, the test device A3 may include an instrument device 70 (also referred to as a base assembly). The
可使用螺紋機構將上部機筒主體72附接至下部機筒基座71以使得上部機筒主體72可如同螺釘相對於下部機筒主體71上升或下降。換言之,上部機筒主體72可相對於下部機筒基座71沿箭頭L2方向旋轉以使得上部機筒主體72沿箭頭L3方向相對於下部機筒基座71向上及向下移動。藉由調整上部機筒主體72相對於下部機筒主體71之高度,所述系統調整放大透鏡74之高度(改變放大比率)及相機61之高度。
A screw mechanism may be used to attach the upper barrel
組裝框架75(亦被稱作形狀配合框架)可安置於上部機筒主體72之上端處。組裝框架75將智慧通信裝置60固定在預定位置處。組裝框架75具有相機對準孔76。智慧通信裝置60之相機61可經由相機對準孔76接收來自樣本的光。
The assembly frame 75 (also referred to as a form-fitting frame) may be disposed at the upper end of the
安置於當前智慧通信裝置60上之相機61典型地僅具有數字變焦功能。一般而言,高精確度之測試需要光學變焦透鏡。然而,使用測試裝置A3之使用者不需要具有光學變焦透鏡之相機61。測試裝置A3之高度調整功能為對準樣本、放大透鏡及相機61提供靈活的解決方案。
The
圖6示出已組裝且固定至組裝框架75上之智慧通信裝置60,所述組裝框架75安置於上部機筒主體72上。外罩20及含有樣本40之載體10經由插入埠73插入。朝上發光裝置80可向樣本提供照明且增加樣本之亮度。
FIG. 6 shows the
圖6示出已組裝且固定至組裝框架75上之智慧通信裝置60,所述組裝框架75安置於上部機筒主體72上。外罩20及含有樣本40之載體10經由插入埠73插入。朝上發光裝置80可向樣本提供照明且增加樣本之亮度。
FIG. 6 shows the
上部機筒主體72或儀表裝置70可沿著方向L2旋轉,以沿方向L3朝上或向下調整放大透鏡74及相機61之高度。高度調整機構實現調整放大比率
之功能。相機61可在放大之後擷取樣本40之動態視訊或靜態測試圖像。此外,智慧通信裝置60可使用其原始裝備功能儲存經擷取視訊或圖像、傳遞測試圖像或視訊及進行後續處理。
The
如圖7中所示,用於測試生物樣本的裝置A4包括安置於外罩20上之具有不同放大比率之複數個放大部件30、30B、30C。使用者可使外罩20偏移以使載體10之樣本固持區域11與具有不同放大比率之放大部件30、30B、30C中之任一者對準,以便獲得具有不同放大比率之測試結果。藉由此設計,具有單一模組之放大功能的測試裝置A4可應用於滿足多個測試協定之放大要求,而不需要改變放大部件或外罩。
As shown in FIG. 7, the apparatus A4 for testing biological samples includes a plurality of amplifying
如圖8中所示,用於測試生物樣本的裝置A5包括可撓性透明薄膜15。可撓性透明薄膜15安置於載體10與放大部件30之間,且覆蓋樣本固持區域11。可撓性透明薄膜15覆蓋樣本40(呈液態)以使得樣本40在受限空間中。因此,將由空氣、灰塵及污物所致之外部影響約束至最低程度。此外,測試裝置A5可藉由改變可撓性透明薄膜15之厚度來調整焦距。
As shown in FIG. 8, the device A5 for testing biological samples includes a flexible
如圖9中所示,用於測試生物樣本的裝置A6之放大部件30為平面凸透鏡,且面向載體10之放大部件30之表面為突起表面。因此,朝上凹型空心部件,即凹槽21形成於面向載體10之放大部件30之表面處。藉由平面凸透鏡之放大部件30之最厚部分之厚度定義焦距參數H1。如圖10中所示,用於測試生物樣本的裝置A7之焦距參數H2不同於圖9之焦距參數H1。
As shown in FIG. 9, the magnifying
可藉由改變外罩20之厚度或放大部件30之曲率大小來調整焦距H1及H2。舉例而言,圖10中所示之焦距H2大於圖9中所示之焦距H1,且藉由改變放大部件30之曲率大小來達成。以此方式,可藉由採用不同放大部件30來滿足各種焦距之測試要求。
The focal lengths H1 and H2 can be adjusted by changing the thickness of the
在一些具體實例中,放大部件30可為透明的且外罩20之其餘部分可不透明。另外,載體10可包括透明之樣本固持區域11。載體10之剩餘部分可為不透明的。當在測試裝置上執行測試操作時,光可傳播穿過樣本固持區域11、放大部件30以抑制裝置之其他部件中之光干擾的機會。
In some specific examples, the magnifying
參見圖11,在用於測試生物樣本的裝置A8中,測試裝置A8之載體10進一步包括形成於載體10之底部表面處的光束輔助導引結構16。載體10可由透明的或半透明的材料製成。光束輔助導引結構16可為不透明的或包括顆粒結構、粗糙圖案、雕刻圖案或散射到達導引結構16之光束的其他合適結構。光束輔助導引結構16可為外罩及載體之整個表面或部分表面提供特定圖案。光束輔助導引結構16亦可全部圍繞載體10之側表面形成。
Referring to FIG. 11, in the device A8 for testing biological samples, the
當外罩20及載體10經堆疊且附接至智慧通信裝置60(例如,如圖4中所示)時,放大部件30與智慧通信裝置60之相機61對準。另外,補充光(圖未示)可安置在智慧通信裝置60之表面上之相機61附近處。由補充光提供之光束可經導引至載體10以穿過外罩20照亮樣本固持區域11。同時,載體10之光束輔助導引結構16可使由補充光提供之光束散射,進而改良樣本固持區域11之亮度及照明均勻性。
When the
藉由安置光束輔助導引結構16,測試裝置不需要額外的補充光源來照亮載體10。因此,外罩20包括光透射性材料以使得智慧通信裝置60之補充光可穿過外罩20到達樣本。在一些替代具體實例中,裝置不包括外罩20且補充光直接到達載體10而不傳播穿過外罩20。
By arranging the auxiliary
用於測試生物樣本的裝置A8可包括防滑薄膜92、離型紙96及pH試紙94。防滑薄膜92附接在外罩20之支撐側(諸如頂部側)上,且用於將外罩20穩定安置至智慧通信裝置60之相機61,如圖4中所示,以使得放大部件30與智
慧通信裝置60之相機61對準。使用防滑薄膜92,智慧通信裝置60相對於測試裝置A8之定位經固定至預定結構。
The device A8 for testing biological samples may include a
防滑薄膜92可具有與放大部件30對準之開口,以使得防滑薄膜92不阻斷穿過放大部件30自樣本傳輸至相機61之光。防滑薄膜92可包括(例如)矽之材料,利用離型紙96可保護防滑薄膜92表面,以維持紙黏性。pH試紙94可安置於載體10之樣本固持區域11上,以提供對樣本之pH值之指示。pH試紙94可在使用之後經替換。
The
另外,放大部件30及外罩20可採用可拆卸設計。因此,使用者可基於測試要求選擇不同於放大部件30之另一放大部件31來替換原始放大部件30。可與外罩20組裝之各種放大部件經組裝以達成不同的放大比率或其他光學特徵。
In addition, the amplifying
現參見圖12,用於測試生物樣本的裝置A9可進一步包括安置於樣本固持區域11中之樣本收集片42。樣本收集片42(例如)具有樣本收集區域42A。樣本收集區域42A可使用黏著或其他方法收集精子、皮下組織/細胞、寄生蟲卵及類似固體測試主體。在一些具體實例中,樣本收集片42可用作維持外罩20與樣本固持區域11之間的距離的間隔件。
Referring now to FIG. 12, the device A9 for testing biological samples may further include a
接著,參見圖13,用於測試生物樣本的裝置A10可包括安置於載體10與外罩20之間的樣本固持區域11處的隔離組件98。隔離組件98可使放大部件30與樣本固持區域11中之測試液隔離,且防止測試液污染放大部件30。在一些具體實例中,隔離組件98可用作維持外罩20與樣本固持區域11之間的距離之間隔件。隔離組件98可與外罩20整合為單一組件。替代地,隔離組件98可與載體10整合為單一組件。
Next, referring to FIG. 13, the device A10 for testing biological samples may include an
圖14A為根據本發明之另一具體實例之插入至儀表裝置中的測試條帶之示意圖。測試條帶5(亦稱為測試盒)包括可拆卸外罩20及載體10。換言
之,可拆卸外罩20與載體10之組合(例如,如圖1B中所示)形成測試條帶5。測試條帶5經由插入埠插入至儀表裝置70(亦被稱作基座組件)中。插入埠可為例如側向或豎直插入埠。儀表裝置70可包括例如用於擷取測試條帶5中所收集之樣本之圖像的組件。
14A is a schematic diagram of a test strip inserted into the meter device according to another specific example of the present invention. The test strip 5 (also called a test box) includes a
圖14B為根據本發明之另一具體實例之儀表裝置之組件的示意圖。儀表裝置70包括提供測試條帶5之插入位置的插入埠73。測試條帶5包括載體10及可拆卸外罩20。可拆卸外罩包括放大部件30。儀表裝置70包括用於擷取載體10之樣本固持區域之圖像或視訊的相機61。相機61與放大部件30對準。儀表裝置進一步包括用於自底部為樣本固持區域提供照明之光源80。在一些具體實例中,平行光管(例如,平行光管透鏡或光反射器;現示出)可置放於光源80之頂部上以用於準直光束。環狀光圈可進一步置放於光源80與平行光管之間以使得行進穿過平行光管之光束形成空心錐形之光束。載體10可包括用於光傳播之透明或半透明材料。
Fig. 14B is a schematic diagram of components of a meter device according to another embodiment of the present invention. The
在一些具體實例中,儀表裝置70可進一步包括使自樣本固持區域發射之光線之相位偏移的相位板。當光線傳播穿過樣本時,光線之速度增大或減小。因此,傳播穿過樣本之光線與未傳播穿過樣本之剩餘光線異相(約90度)。異相光線彼此干擾且增強樣本圖像之明亮部分與黑暗部分之間的對比度。
In some specific examples, the
相位板可進一步使傳播穿過樣本之光線的相位偏移約90度,以便進一步增強由異相光線之干擾所致的對比度。因此,傳播穿過樣本之光線與未傳播穿過樣本之剩餘光線異相共約180度。光線之間的此破壞性干擾藉由暗化圖像中之對象且亮化該等對象之邊界來增強樣本圖像之對比度。 The phase plate can further shift the phase of the light propagating through the sample by about 90 degrees to further enhance the contrast caused by the interference of out-of-phase light. Therefore, the light propagating through the sample and the remaining light not propagating through the sample are approximately 180 degrees out of phase. This destructive interference between lights enhances the contrast of the sample image by darkening the objects in the image and brightening the boundaries of those objects.
在一些替代具體實例中,此相位板可安置於測試條帶5之可拆卸外罩20之頂部上。換言之,相位板可為測試條帶5之部分,而非儀表裝置70之部分。
In some alternative specific examples, the phase plate can be placed on the top of the
圖15示出藉由諸如分別在圖5及圖14中所示之儀表裝置70或智慧通信裝置60的裝置對精液測試進行之樣本處理程序。在步驟1505中,裝置獲得樣本之圖像(圖框)。在步驟1510中,裝置基於該圖像判定精子濃度。在步驟1515中,藉由分析pH條帶之色彩或灰度,裝置可進一步判定樣本的pH值。舉例而言,裝置可包括用以識別由相機擷取之圖像之部分(對應於pH條帶)的色彩及判定包含於該條帶中之生物樣本之生化特性(例如,pH水平)的處理器。在一些其他具體實例中,裝置之光源可提供具有至少一個色彩之照明。舉例而言,光源可包括具有不同色彩(例如,紅色、綠色及藍色)之光發射器來形成各種色彩之光。裝置之相機可進一步擷取用光照亮之樣本之至少一個(或更多)圖像。處理器可比較圖像之特定區域(例如,pH條帶區域)之色彩以判定生物樣本之特性或分析物之量化。在一些具體實例中,處理器僅需要一個圖像之特定區域之色彩來判定生物樣本之特性。舉例而言,裝置(例如,測試裝置)可包括用於校正圖像之色彩的色彩校正模組。處理器接著分析經校正圖像以判定生物樣本之特性。替代地,測試條帶可包括具有已知色彩之色彩校正區域。處理器基於色彩校正區域對圖像進行色彩校正操作,且接著分析經校正圖像以判定生物樣本之特性或分析物之量化。在一些具體實例中,pH條帶(或其他類型之生化測試條帶)中之試劑與生物樣本反應,之後圖像之特定區域(例如,pH條帶區域)示出特定色彩。在一些具體實例中,用於色彩偵測之特定區域必定需要對由相機擷取之圖像的放大。因此,至少在一些具體實例中,在用於色彩偵測之條帶之特定區域(例如,pH條帶區域)上方不存在放大組件或補充物。舉例而言,一些類型之生化測試條帶含有光化學試劑。當光化學試劑與生物樣本中之特定分析物反應時,該反應造成條帶之樣本固持區域中之色彩變化。處理器可分析測試條帶之圖像(由相機擷取)以偵測色彩變化且量化生物樣本中之特定分析物。此外,裝置可判定精子形態(1520)、精子容量(1525)及精子總數(1530)。在步驟
1540中,裝置獲得樣本之一系列多個圖框。在步驟1545、1550及1555中,裝置可基於精子軌跡判定精子活動力參數且判定精子活動力。圖16示出判定精子濃度之樣本處理程序。在1605中,如分別在圖5及圖14中所示之儀表裝置70或智慧通信裝置60(「所述裝置」)之相機擷取精子樣本之經放大圖像。經擷取圖像為用於判定精子濃度之原始圖像。所述裝置接著將數字色彩圖像轉換成數字灰度圖像,且進一步將數字灰度圖像劃分成多個區域。
FIG. 15 shows a sample processing procedure for a semen test performed by a device such as the
在步驟1610中,所述裝置基於每一區域之灰度值之均值及標準差對彼區域進行自適應定限二進制計算。該自適應定限二進制計算之目標為將為精子之候選者的對象識別為前景對象,且將區域之其餘部分識別為背景。
In
在二進制計算之後的圖像中之前景對象可仍包括實際上不為精子的雜質。彼等雜質小於該等精子或大於該等精子。所述方法可為精子之大小設置上邊界值及下邊界值。在步驟1615中,所述裝置藉由移除大於精子之上邊界值或小於精子之下邊界值的雜質來對圖像進行降噪操作。在降噪操作之後,圖像中之前景對象表示精子。
The foreground object in the image after the binary calculation may still include impurities that are not actually sperm. Their impurities are smaller or larger than the sperm. The method can set an upper boundary value and a lower boundary value for the size of sperm. In
所述方法基於精子之頭部部分對圖像中之精子數目進行計數。在步驟1620及1625中,所述裝置進行距離變換操作以計算前景對象與背景之間的最小距離,且亦識別局部最大值之位置。彼等位置為精子頭部位置之候選者。
The method counts the number of sperm in the image based on the head part of the sperm. In
在步驟1630中,所述裝置對每一精子候選對象進行橢圓擬合操作以減少不具有橢圓形狀且因此不為精子頭部之偽陽性候選者。接著,所述裝置對精子之剩餘陽性候選者之總數進行計數,且基於由圖像所表示之體積計算所述精子之濃度。該體積可為(例如)經擷取樣本固持區域之面積乘以樣本固持區域與外罩之底部之間的距離。
In
在一些具體實例中,所述裝置可使用樣本之多個圖像且分別基於該等圖像計算濃度值。接著,所述裝置計算該等濃度值之平均值以使得精子濃度之量測誤差最小化。 In some specific examples, the device may use multiple images of the sample and calculate the concentration value based on the images respectively. Then, the device calculates the average value of the concentration values to minimize the measurement error of the sperm concentration.
使用樣本之一系列圖像(例如,視訊圖框),所述裝置可進一步判定精子之軌跡及活動力。舉例而言,圖17示出諸如精子1705之樣本精子及諸如軌跡1710及軌跡1720之樣本精子軌跡。
Using a series of images of the sample (for example, a video frame), the device can further determine the trajectory and motility of the sperm. For example, FIG. 17 shows sample sperm such as
圖18示出判定精子軌跡及活動力之樣本處理程序。如分別在圖5及圖14中所示之儀表裝置70或智慧通信裝置60(「所述裝置」)之相機擷取精子樣本之一系列圖像(例如,視訊圖框)。所述裝置使用經擷取之一系列圖像判定精子活動力之參數。為判定精子活動力之參數,所述裝置需要追蹤該系列圖像中之每一精子之軌跡。
Figure 18 shows a sample processing program for determining sperm trajectory and motility. For example, the camera of the
所述裝置將數字色彩圖像轉換成數字灰度圖像。所述裝置首先識別所述系列之第一圖像中之精子之頭部位置(例如,使用圖16中所示之方法)。第一圖像中之精子之經識別頭部位置為待追蹤之精子軌跡之初始位置。在一些具體實例中,所述裝置可使用二維卡爾曼過濾(Kalman filter)來估計該等精子之運動的軌跡。 The device converts digital color images into digital grayscale images. The device first identifies the position of the sperm's head in the first image of the series (for example, using the method shown in FIG. 16). The identified head position of the sperm in the first image is the initial position of the sperm trajectory to be tracked. In some specific examples, the device can use a two-dimensional Kalman filter to estimate the trajectory of the sperm.
在一些具體實例中,用於追蹤具有量測值z j (k)之精子s j 的二維卡爾曼過濾包括以下之步驟: In some specific examples, the two-dimensional Kalman filter used to track sperm s j with the measured value z j ( k ) includes the following steps:
1:計算預測狀態(k|k-1)及誤差共變數矩陣(k|k-1):
2:使用預測狀態(k|k-1)、量測值z j (k)及誤差共變數矩陣(k|k-1),計算經預測量測值(k|k-1)、量測值殘差(k)及殘差共變數矩陣(k):
3:若(k) T (k)-1 (k)<γ及∥(k)∥/T V max,則計算卡爾曼過濾增益
(k)、經更新狀態估計值(k|k)及經更新誤差共變數矩陣(k|k):
(k|k-1)表示基於圖像k-1對圖像k之預測,為第j個精子的位置及速度的狀態。為估計誤差的共變數矩陣,Q(k-1)為處理雜訊共變數矩陣,N(k)為白色位置雜訊向量之共變數矩陣,γ為閘極臨限值且V max為最大可能精子速度。 ( k | k -1) represents the prediction of image k based on image k -1, Is the position and velocity of the jth sperm. Is the covariate matrix of the estimation error, Q ( k -1) is the covariate matrix for processing noise, N ( k ) is the covariate matrix of the white position noise vector, γ is the gate threshold and V max is the maximum possible Sperm speed.
當追蹤多個精子之多個軌跡時,所述方法可使用聯合概率資料關聯過濾來決定軌跡路徑。該聯合概率資料關聯過濾判定偵測目標與量測目標之間的可行聯合關聯事件。可行聯合關聯事件(A js )為偵測精子s與量測精子j之間的相對概率值。接著,所述方法基於最佳指定方法進行路徑分配決策。Ajs定義為:
λ為參數,[z j (k)]為該等偵測精子之高斯概率密度函數。 λ is the parameter, [ z j ( k )] is the Gaussian probability density function of the detected sperm.
基於一時間段內之所述系列圖框,所述方法識別每一精子之軌跡,諸如如圖18中所示之軌跡1805。接著,所述方法基於該等軌跡判定精子活動力之各種參數。該等參數包括:例如,曲線速度(curvilinear velocity;VCL)、直線速度(straight-line velocity;VSL)、線性度(linearity;LIN)及橫向頭部位移幅度(amplitude of lateral head displacement;ALH)。曲線速度(VCL)1810
經定義為在單位時間內之運動距離的總和。直線速度(VSL)1815經定義為在單位時間內之直線運動距離。線性度(LIN)經定義為VSL除以VCL。橫向頭部位移幅度(ALH)1820經定義為精子頭部相對於平均路徑1825之橫向位移之幅度的兩倍。
Based on the series of frames within a time period, the method identifies the trajectory of each sperm, such as the
在一些具體實例中,曲線速度(VCL)1810可用於判定精子活動力。所述方法可設定速度臨限值。具有高於或等於速度臨限值之VCL的任何精子經識別為活躍精子。具有低於速度臨限值之VCL的其餘精子經識別為非活躍精子。活動力之水平為經識別活躍精子之數目除以自圖像辨識之精子之總數。 In some specific examples, curve velocity (VCL) 1810 can be used to determine sperm motility. The method can set the speed threshold. Any sperm with a VCL higher than or equal to the velocity threshold is identified as active sperm. The remaining sperm with a VCL below the velocity threshold were identified as inactive sperm. The level of motility is the number of identified active sperm divided by the total number of sperm identified from the image.
所述方法可進一步分析精子形態。儀表裝置70或智慧通信裝置60(「所述裝置」)之相機擷取精子樣本之經放大圖像。經擷取圖像為判定精子形態之原始圖像。
The method can further analyze sperm morphology. The camera of the
所述方法基於分段偵測精子候選者之形狀。所述方法將該等精子之頭部之位置用作初始點。使用與形狀相關之分段演算法,所述方法將精子之圖像分割成頭部部分、頸部部分及尾部部分。舉例而言,所述方法可使用諸如主動輪廓模型之方法分割該等精子。 The method is based on segmented detection of the shape of sperm candidates. The method uses the position of the head of the sperm as the initial point. Using a segmentation algorithm related to shape, the method divides the image of the sperm into a head part, a neck part and a tail part. For example, the method may use methods such as active contour models to segment the sperm.
基於各部分,所述方法計算各種部分之參數(諸如長度及寬度)。可使用包括已經標記之樣本的訓練資料集合來訓練分類器(諸如支援向量機、神經網路、迴旋神經網路或AdaBoost算法)。在訓練之後,可將精子之各種部分之參數饋入至分類器以判定精子是否具有恰當的形態。在一些具體實例中,分類器可用於諸如偵測細胞及微生物之特性的其他應用。 Based on each part, the method calculates the parameters (such as length and width) of the various parts. A training data set including labeled samples can be used to train a classifier (such as a support vector machine, neural network, convolutional neural network, or AdaBoost algorithm). After training, the parameters of various parts of the sperm can be fed to the classifier to determine whether the sperm has an appropriate morphology. In some specific examples, the classifier can be used for other applications such as detecting the characteristics of cells and microorganisms.
圖19為根據本發明之至少一個具體實例之包括收集瓶之測試裝置的示意圖。測試條帶裝置1905可經由插入埠插入至測試裝置1900中。測試條帶裝置1905可包括用於收集樣本(例如,精子樣本)之收集瓶1910或包括容納
收集瓶之槽孔。測試裝置1900可包括感測器(圖未示)以偵測收集瓶1910是否插入至測試裝置1900中。
Fig. 19 is a schematic diagram of a test device including a collection bottle according to at least one specific example of the present invention. The
測試裝置1900可具有用於判定收集瓶1910插入至測試裝置1900中所歷經之時間段的計時器機構。在插入含有樣本之收集瓶1910之後,測試裝置1900可等待預定時間段(例如,30分鐘)來液化樣本,之後促使使用者將樣本自收集瓶1910轉移至測試條帶裝置1905。在一些具體實例中,測試裝置1900可包括相機或感測器以判定樣本是否已經液化。
The
此外,測試裝置可包括移動機構以將機械力施加至收集瓶1910以便將樣本混合於收集瓶1910中。舉例而言,移動機構可(例如)搖動、振動或旋轉收集瓶1910。在一些其他具體實例中,測試裝置可包括待插入至收集瓶1910中且攪拌收集瓶1910中之樣本的桿。
In addition, the testing device may include a moving mechanism to apply mechanical force to the
測試裝置1900視情況可包括用於顯示資訊的顯示器(例如,螢幕1920)。舉例而言,螢幕1920可示出關於如何操作測試裝置1900的指令或提示。螢幕1920亦可示出在測試裝置1900進行測試之後的測試結果。另外或替代地,測試裝置1900可包括已知通信模組以使得其可與使用者的計算裝置(例如,具有移動軟件應用程式之智能電話,或諸如膝上型計算機之傳統個人計算機)通信(例如,分析結果及/或藉由相機模組獲取之圖像)。測試裝置1900可操作以接收來自使用者(例如,來自螢幕1920及/或來自前述通信模組)的指令,且基於指令執行選定數目之自動化分析處理程序。測試裝置1900亦可將結果及/或樣本之圖像顯示於螢幕1920上或使用者的計算機(例如,經由前述通信模組)上,或兩者上。
The
類似於在圖14A及圖14B中所示之測試裝置,測試裝置1900可包括用於擷取測試條帶裝置1905之圖像或視訊的相機(圖未示)。測試裝置1900可
進一步包括用於處理用於判定測試結果之圖像或視訊(例如,經由圖16中所示的處理程序)的處理器(圖未示)。
Similar to the test device shown in FIGS. 14A and 14B, the
在一些具體實例中,舉例而言,放大組件2110為放大透鏡。放大組件2110之放大能力可由角度放大比率或線性放大比率表示。角度放大比率為如經由光學系統所見的對象的角度大小與如直接在最近明視距離處(亦即,距人眼250mm)所見的對象的角度大小之間的比率。線性放大比率為將投射在圖像感測器上的對象的圖像的大小與實際對象的大小之間的比率。
In some specific examples, for example, the
舉例而言,所述放大透鏡可具有6mm之焦距、1mm之厚度及2mm之直徑。假設250mm為人眼之近點距離(亦即,人眼可聚焦之最近距離),則角度放大比率為250mm/6mm=41.7倍。放大組件2110與樣本固持區域2115之間的距離可為(例如)9mm。因此,線性放大比率可接近於2。換言之,由放大組件造成的圖像感測器上的對象的圖像之大小為在放大組件下方的實際對象的大小的2倍。
For example, the magnifying lens may have a focal length of 6 mm, a thickness of 1 mm, and a diameter of 2 mm. Assuming that 250mm is the near point distance of the human eye (that is, the shortest distance at which the human eye can focus), the angle magnification ratio is 250mm/6mm=41.7 times. The distance between the magnifying
在一些具體實例中,放大組件具有0.1mm至8.5mm之焦距。在一些具體實例中,放大組件的線性放大比率為至少1。在一些具體實例中,放大組件之線性放大比率為0.5至10.0。 In some specific examples, the magnifying component has a focal length of 0.1 mm to 8.5 mm. In some specific examples, the linear amplification ratio of the amplification component is at least 1. In some specific examples, the linear amplification ratio of the amplification component is 0.5 to 10.0.
在一些具體實例中,補充透鏡2135置放於相機模組2130下方以用於進一步放大圖像及減小放大組件2110與樣本固持區域2115之間的距離。整個光學系統的有效線性放大比率可為(例如)3。換言之,由相機模組2130擷取的對象之圖像的大小為樣本固持區域2115中的實際對象的大小的3倍。在一些具體實例中,測試裝置的整個光學系統的有效線性放大比率為1.0至100.0,較佳為1.0至48.0。
In some specific examples, the
在一些具體實例中,相機模組的圖像感測器具有1.4μm的像素大小。典型地,對象之經擷取圖像需要獲取至少1像素以便恰當地分析對象的 形狀。因此,對象之經擷取圖像之大小需要為至少1.4μm。若測試裝置的線性放大比率為3,則測試裝置可恰當地分析具有至少0.47μm之大小的對象的形狀。 In some specific examples, the image sensor of the camera module has a pixel size of 1.4 μm. Typically, the captured image of the object needs to acquire at least 1 pixel in order to properly analyze the object’s shape. Therefore, the size of the captured image of the object needs to be at least 1.4 μm. If the linear amplification ratio of the test device is 3, the test device can properly analyze the shape of an object with a size of at least 0.47 μm.
在一些具體實例中,相機模組的圖像感測器具有1.67μm的像素大小。接著,對象之經擷取圖像的大小需要為至少1.67μm以便恰當地分析對象的形狀。若測試裝置的線性放大比率為3,則測試裝置可恰當地分析具有至少0.56μm之大小的對象的形狀。 In some specific examples, the image sensor of the camera module has a pixel size of 1.67 μm. Next, the size of the captured image of the object needs to be at least 1.67 μm in order to properly analyze the shape of the object. If the linear amplification ratio of the test device is 3, the test device can properly analyze the shape of an object with a size of at least 0.56 μm.
在一些具體實例中,舉例而言,整個光學系統的長度可為(例如)24mm。放大組件的底部與樣本固持區域2115之頂部之間的距離可為(例如)1mm。在一些具體實例中,測試裝置的整個光學系統之長度為2mm至100mm,較佳為5mm至35mm。
In some specific examples, for example, the length of the entire optical system may be, for example, 24 mm. The distance between the bottom of the magnifying component and the top of the
圖20為根據本發明的至少一個具體實例之不包括收集瓶的測試裝置的示意圖。不同於測試裝置1900,測試裝置2000不包括收集瓶或用於插入收集瓶的槽孔。由使用者或操作員將樣本直接施加至測試條帶裝置2005,而不收集在收集瓶中。
Fig. 20 is a schematic diagram of a test device that does not include a collection bottle according to at least one specific example of the present invention. Unlike the
圖21B為圖21A測試裝置1900之具體實例的A-A截面示意圖。測試裝置1900的A-A截面示出在測試條帶裝置2105之頂部上用於擷取測試條帶裝置2105的樣本固持區域2115的圖像或視訊的相機模組2130。測試條帶裝置2105包括在樣本固持區域2115的頂部上的放大組件2110。在測試條帶裝置2105下方的光源2140為樣本固持區域2115提供照明。在一些其他具體實例中,光源可置放於測試條帶裝置的頂部上或橫向置放於測試條帶裝置的一側。可存在用於在測試條帶裝置上提供照明之多個光源或光源陣列。在一些具體實例中,可視分析物類型而切換、調整或選擇光源之不同組合,以使得分析物由具有恰當色彩之光照亮。
FIG. 21B is a schematic diagram of the A-A cross section of the specific example of the
在一些具體實例中,測試條帶裝置2105可包括在樣本固持區域2115中或附近之測試條帶。舉例而言,測試條帶可為pH測試條帶、HCG(人絨毛膜促性腺激素)測試條帶、LH(黃體激素)測試條帶或果糖測試條帶。當樣本固持區域中之樣本的分析物與測試條帶中的化學或生化試劑相互作用時,測試條帶的一些光學特性(例如,色彩或光強度)可改變。相機模組2130可擷取測試條帶的色彩或強度以判定測試結果,諸如pH水平、HCG水平、LH水平或果糖水平。在一些具體實例中,在測試條帶上方的放大組件2110可用透明的或半透明的外罩替換。因此,測試裝置可同時對樣本中的分析物進行檢核及經由樣本的一或多個放大圖像對樣本進行另一分析。
In some embodiments, the
圖21C為圖21A測試裝置1900的另一具體實例之A-A截面示意圖。測試裝置1900的A-A截面示出在測試條帶裝置2105的頂部上之用於擷取測試條帶裝置2105的樣本固持區域2115的圖像或視訊的相機模組2130,其包括感測器及一或多個透鏡2135(亦被稱作補充透鏡或光學透鏡模組)。在測試條帶裝置2105下方(或安置於其他地方)的光源2140為樣本固持區域2115提供照明。放大組件2110可附接至透鏡2135之底部,而非如圖21A中所示在樣本固持區域2115的頂部上。在一些具體實例中,若透鏡2135提供足夠的放大能力,則元件2110可為不具有放大能力的平坦光透射性外罩。在一些其他具體實例中,若透鏡2135提供足夠的放大能力(例如,若透鏡2135的線性放大比率為至少1.0),則測試裝置1900不包括放大組件2110。
FIG. 21C is a schematic cross-sectional view of A-A of another specific example of the
圖22為具有兩個樣本固持區域的測試條帶裝置的測試裝置的示意圖。圖29示出可適合於具有多相機配置的測試裝置(諸如圖22中所示的測試裝置)的載體之實例。同時參照圖19及圖20,圖22中所示的測試裝置可為測試裝置1900(亦即,具有收集瓶)或測試裝置2000(亦即,不具有收集瓶)之另一變體。如圖22中所示,接收機構包括於測試裝置中以接收一或多個載體(例如,諸如測試
條帶裝置2205之測試條帶裝置,或諸如瓶子1910之收集瓶),所述載體可經由測試裝置之殼體上的開口插入。
Figure 22 is a schematic diagram of a test device having a test strip device with two sample holding areas. FIG. 29 shows an example of a carrier that can be adapted to a test device having a multi-camera configuration, such as the test device shown in FIG. 22. 19 and 20 at the same time, the test device shown in FIG. 22 may be another variation of the test device 1900 (that is, with a collection bottle) or the test device 2000 (that is, without a collection bottle). As shown in FIG. 22, the receiving mechanism is included in the test device to receive one or more carriers (for example, such as test
The test strip device of the
在一些具體實例中,單一載體可包括第一固持區域及第二固持區域,諸如由圖22中的測試條帶裝置2205所示。如圖22中所示,至少兩個相機模組可包括於測試裝置中。兩個相機模組包括經配置以分別擷取第一固持區域2215A及第二固持區域2215B之圖像及/或視訊的第一相機模組2230A及第二相機模組2230B。更特定言之,測試條帶裝置2205可包括樣本固持區域2215A及另一樣本固持區域2215B。在一些實例中,透明的或半透明的外罩2210A置放於樣本固持區域2215A之頂部上。光源2240A可為可控制的且可在樣本固持區域2215A上提供照明。第一相機模組2230A經定位以擷取樣本固持區域2215A的圖像或視訊。作為一可選實施,放大組件2210B可置放於樣本固持區域2215B的頂部上。另外,在一些具體實例中,光源2240B可操作以在樣本固持區域2215B上提供照明。第二相機模組2230B經定位以擷取樣本固持區域2215B的圖像或視訊。第一固持區域及第二固持區域可直接攜帶生物樣本或已暴露於生物樣本。類似於關於圖14B引入的結構,在一些具體實例中,測試裝置可包括用於將光源發射的光束準直至固持區域中的至少一者的平行光管。在一些具體實例中,環狀光圈可進一步包括在光源與平行光管之間以用於形成行進穿過平行光管且接著到達樣本固持區域的空心錐形光束。在一些額外具體實例中,相位板可包括在樣本固持區域與相機模組中的至少一者之間以用於相移由樣本固持區域反射的光線。
In some specific examples, a single carrier may include a first holding area and a second holding area, such as shown by the
作為具有多個固持區域的單一載體的替代方案,多個載體可經由其個別開口、埠或槽孔插入至測試裝置中。舉例而言,兩個獨立測試條帶裝置可分別包括樣本固持區域2215A及2215B。視測試的需要而定,樣本固持區域2215A及2215B在測試條帶中的位置可經設計以與第一相機模組2230A及第二相
機模組2230B對準。在一些具體實例中,兩個測試條帶裝置經由兩個獨立插入埠插入至測試裝置中。
As an alternative to a single carrier with multiple holding areas, multiple carriers can be inserted into the test device through its individual openings, ports or slots. For example, two independent test strip devices may include
除其他益處之外,測試的便利性及容易度為本文所揭示的測試裝置可提供的兩個顯著益處。根據本文具體實例,所揭示的測試裝置之使用者不必在該使用者可利用測試裝置產生結果之前具備關於如何對生物樣本執行各種類型的分析的任何專業知識。因此,測試裝置可包括用於對樣本執行自動化分析處理程序的處理器且判定關於樣本的結果。所述處理器可藉由主電路板(亦即,已知組件,為簡單起見未示出)攜帶。另外,測試裝置較佳地為較小的且不與在實驗室中常見的傳統測試裝置一樣龐大。因此,在一些具體實例中,諸如圖19及圖20中所示之彼等,載體的接收機構、相機模組及主電路板可全部封裝於測試裝置的殼體內。測試裝置可具有較小的外觀尺寸,諸如小於30厘米(cm)×30cm×30cm,亦即27,000cm3。在一些具體實例中,測試裝置可進一步包括封裝於殼體內的電池隔室,以使得電池可安裝在電池隔室中為測試裝置供電。 In addition to other benefits, the convenience and ease of testing are two significant benefits that the testing device disclosed herein can provide. According to specific examples herein, the user of the disclosed testing device does not need to have any professional knowledge on how to perform various types of analysis on biological samples before the user can use the testing device to generate results. Therefore, the testing device may include a processor for executing an automated analysis processing program on the sample and determining the result about the sample. The processor may be carried by a main circuit board (ie, known components, not shown for simplicity). In addition, the test device is preferably small and not as bulky as the traditional test device commonly found in laboratories. Therefore, in some specific examples, such as those shown in FIGS. 19 and 20, the receiving mechanism of the carrier, the camera module, and the main circuit board may all be packaged in the housing of the test device. The test device may have a small external size, such as less than 30 centimeters (cm)×30 cm×30 cm, that is, 27,000 cm 3 . In some specific examples, the test device may further include a battery compartment encapsulated in the housing, so that the battery can be installed in the battery compartment to power the test device.
在一些具體實例中,包括於測試裝置中的處理器可對不同固持區域執行不同分析,且可基於對不同區域執行之分析的結果的組合導出結果。換言之,處理器可經配置以對第一固持區域的經擷取圖像執行第一分析處理程序、對第二固持區域的經擷取圖像執行不同於第一分析處理程序的第二分析處理程序,且基於第一分析處理程序及第二分析處理程序兩者之結果判定關於生物樣本的結果。如本文所使用,術語「分析處理程序(analytic process)」意謂可評估自許多來源收集的資訊(例如,固持區域的圖像)的一或多個片段,且產生關於來源之結果、結論、最終結果、估計值或其類似者的處理程序。 In some specific examples, the processor included in the test device may perform different analyses on different holding areas, and may derive results based on a combination of the results of the analyses performed on the different areas. In other words, the processor may be configured to perform a first analysis process on the captured image of the first holding area, and perform a second analysis process that is different from the first analysis process on the captured image of the second holding area Procedures, and based on the results of both the first analysis processing program and the second analysis processing program to determine the result of the biological sample. As used herein, the term “analytic process” means that one or more pieces of information collected from many sources (for example, images of holding areas) can be evaluated, and results, conclusions, and conclusions about the sources can be generated. Final result, estimated value or similar processing procedure.
根據一些實例,測試裝置可使用第一相機模組2230A、光源2240A及外罩2210A之組合來定量分析物或判定樣本之特性(例如,pH水平、LH水平、HCG水平或果糖水平)。另外,測試裝置可進一步使用第二相機模組
2230B、光源2240B及放大組件2210B的組合來分析樣本之經放大圖像以判定樣本的特性(例如,精子數量、精子活動力、精子形態等)。視各種類型的生化測試的要求而定,不同組合或配置的光源可用於照亮生化樣本。多相機配置尤其有益,此係由於不同分析處理程序可經由不同相機模組執行而不需要使用者更換載體(例如,測試條帶裝置),由此加速結果生成且降低必要人類操作的複雜度。光源2240A及2240B封裝於殼體內部且經配置以為相機模組中的至少一者照亮生物樣本。根據一或多個具體實例,處理器經配置以基於處理器當前經配置以執行之分析處理程序來控制光源。
According to some examples, the testing device may use a combination of the
此外,在一些具體實例中,處理器可基於載體上之視覺提示執行不同的分析處理程序。舉例而言,一些具體實例可對固持區域的圖像執行圖像辨識及處理,且可根據來自圖像辨識的結果的視覺提示執行不同的分析處理程序。實例載體2905(1)至2905(4)示出於圖29中,其中載體2905(1)用於關於男性受試者之生殖細胞的生育力測試(例如,經由其精子),且載體2905(2)、2905(3)及2905(4)用於關於女性受試者之生殖細胞的生育力測試(例如,經由其尿液)。如所示,載體2905(1)至2905(4)全部具有對應於第一相機模組2230A之位置的第一固持區域2915A,但僅載體2905(1)包括第二固持區域2915B。在一些實例中,載體上之視覺提示可為特定固持區域(例如,固持區域2215A)的形狀。對於本文中之論述,固持區域的形狀意謂固持區域的整體邊緣(或外部周邊)。舉例而言,所述形狀可為圓形、卵形、三角形、矩形,或藉由利用已知圖像處理技術的處理器在如由個別相機模組(例如,第一相機模組2230A)所擷取之固持區域的圖像上可識別的任何適合的形狀。視覺提示的額外實例可包括圖形圖案、視覺標誌、一維條碼、多維圖案碼(例如,QR碼)等。
In addition, in some specific examples, the processor may execute different analysis processing programs based on visual cues on the carrier. For example, some specific examples may perform image recognition and processing on the image of the holding area, and may perform different analysis processing procedures according to the visual cues from the result of the image recognition. Example vectors 2905(1) to 2905(4) are shown in Figure 29, where the vector 2905(1) is used for fertility testing on the germ cells of a male subject (e.g., via its sperm), and the vector 2905( 2), 2905(3) and 2905(4) are used for the fertility test on the germ cells of female subjects (for example, via their urine). As shown, the carriers 2905(1) to 2905(4) all have a
同時參照圖22及圖29,在一些具體實例中,當處理器識別(例如,經由第一相機模組2230A)第一固持區域(例如,載體2905(1)的區域2215A或
區域2915A)呈第一形狀(例如,圓形)時,處理器經配置以執行某一分析處理程序(例如,男性受試者之生育力,諸如根據其精子樣本之各種特性),且當第一固持區域(載體2905(2)之區域2215A或區域2915A)呈第二形狀(例如,卵形)時,處理器將執行不同的分析處理程序(例如,對女性受試者的生育力的分析,諸如根據其尿液樣本的激素水平)。以此方式,測試裝置不僅不限於執行僅一種類型之測試(例如,精子的生育力),而且其亦可基於插入至機器中的載體(例如,測試條帶裝置)相應地切換分析處理程序。
Referring to FIGS. 22 and 29 at the same time, in some specific examples, when the processor recognizes (for example, via the
更特定言之,根據一些實施,當形狀表示生物樣本包括來自男性受試者的精子時,則處理程序可判定精子的一或多個特性,諸如本文中所引入的彼等特性。在一些實例中,可藉由使用第二相機模組2230B執行對精子的一或多個特性的判定。對於一些特定實例,可判定的特性可包括:精子的濃度、精子的活動力及/或精子的形態。根據一些具體實例,處理器經配置以(1)基於經擷取圖像中的單一圖像判定精子的濃度及/或精子的形態,且(2)基於經擷取圖像中的兩個或多於兩個圖像判定精子的活動力。
More specifically, according to some implementations, when the shape indicates that the biological sample includes sperm from a male subject, the processing procedure may determine one or more characteristics of the sperm, such as those introduced herein. In some examples, the determination of one or more characteristics of sperm can be performed by using the
鑒於以上情況,圖30為用於利用本文所揭示之測試裝置(例如,在圖22中)分析男性受試者及女性受試者兩者之生育力的實例處理程序3000之流程圖。繼續參照圖29,在下文說明處理程序3000。應注意,以下實例首先施加男性的樣本,接著為女性的樣本,但可執行反向次序(亦即,女性及接著男性),而對結果的精確度無影響。
In view of the above situation, FIG. 30 is a flowchart of an
首先在步驟3002中,使用者可將男性受試者的生物樣本(例如,精子)施加至第一載體(例如,載體2905(1))之第一固持區域(例如,區域2915A)及第二固持區域(區域2915B)。接著,在步驟3004中,使用者將第一載體插入至測試裝置(例如,圖22中所示之一者),且因為載體2905(1)之第一固持區域2915A的形狀為圓形,測試裝置可自動獲取當前樣本含有來自男性的精子的知
識且相應地選擇分析處理程序。接著,在步驟3006中,使用者可使用測試裝置判定精子的一或多個特性。舉例而言,如此處所論述,測試裝置中的處理器可利用第一相機模組2230A來獲取載體2095(1)之第一固持區域2915A的圖像(所述載體2095(1)可包括回應於不同酸度而示出不同色彩之測試條帶),且識別測試條帶的色彩以判定精子的酸度。另外,在步驟3006中,測試裝置中的處理器可利用第二相機模組2230B來判定選自由以下組成的群組的精子的一或多個特性:細胞數(例如精子數)、精子的濃度、精子的活動力及精子的形態。
First, in
接著,在步驟3008中,使用者可將來自女性受試者之尿液施加至第二載體(例如,載體2905(2))的固持區域2915A。在步驟3010中,使用者將第二載體插入至測試裝置,且由於載體2905(2)的第一固持區域2915A的形狀為卵形,測試裝置可自動地獲取當前樣本含有來自女性的尿液的知識且相應地選擇分析處理程序。在步驟3012中,測試裝置例如藉由利用第二相機模組2230B判定尿液的一或多個特性。舉例而言,測試條帶可適合於使測試裝置能夠判定一或多個類型之女性激素(例如,FSH、LH或HCG)的濃度水平。最後,在步驟3014中,使用者利用測試裝置自動地分析男性及女性生物樣本的結果且判定關於受試者的生育力的最終結果。
Next, in
在一些特定實例中,第一相機模組2230A與第二相機模組2230B相比可具有較低的相機分辨率,且因此所述兩個攝像機由處理器用以執行不同的分析處理程序。另外,第一相機模組2230A與第二相機模組2230B相比可具有較低的放大比率。第一相機模組2230A的一些實例可根本不具有放大功能,而第二相機模組2230B可具有固定的放大比率。另外或作為本身具有較高放大比率的第二相機模組2230B的替代方案,第二固持區域2215B的外罩2210B可包括放大組件,諸如圖22中所示。在一些實施中,所述相機模組的放大比率可為可調整的(例如,由處理器控制)。測試裝置的一些實例規定第一相機模組2230A具
有2百萬像素或更高之相機分辨率,且第二相機模組2230B具有13百萬像素或更高之相機分辨率。在一些實例中,第二相機模組2230B可包括至少4.8倍或更高的線性放大比率。
In some specific examples, the
在此等實例中之一些中,處理器進一步藉由使用第一相機模組2230A來判定精子的至少一個額外特性。此額外特性可包括精子的酸度。舉例而言,載體可包括在第一固持區域2215A中使用色彩表示精子之酸度的pH指示器,處理器可辨識該色彩以識別酸度。類似地,一些實例規定處理器可基於第一或第二固持區域的一或多個圖像中的一區域之色彩來判定生物樣本的生化特性。
In some of these examples, the processor further determines at least one additional characteristic of the sperm by using the
繼續在圖22中的具有多相機配置之以上測試裝置實例及圖29中的載體實例的情況下,在一些實施中,當處理器識別第一固持區域(例如,區域2215A或載體2905(2)之區域2915A)呈可指示生物樣本包括來自女性受試者的尿液的第二形狀(諸如卵形)時,處理器經配置以判定尿液的一或多個特性。可判定的特性可包括:LH水平水平、FSH水平及/或HCG水平。如同酸度,可藉由使用第一相機模組執行對尿液的一或多個特性的判定。類似地,載體可包括第一固持區域(例如,個別載體之區域2915A)中的LH指示器(例如,如載體2905(3)中所示)、FSH指示器(例如,如載體2905(2)中所示)及/或HCG指示器(例如,如載體2905(4)中所示)。
Continuing in the case of the above test device example with a multi-camera configuration in FIG. 22 and the carrier example in FIG. 29, in some implementations, when the processor identifies the first holding area (eg,
此外,在一些具體實例中,處理器可利用兩個相機模組中之至少一者(例如,第一相機模組2230A)或另一感測器(例如,下文關於圖26引入的光感測器2690)來在執行分析處理程序之前判定生物樣本的準備狀態或有效性。在一些實施中,可基於識別第一視覺標誌是否顯示在第一固持區域(例如,區域2915A)中的特定區域(例如,其中線2916示出於圖29中)中來判定測試樣本的準備狀態或有效性。此第一視覺標誌之實例可為測試條帶上之某一指定區域中所
顯示的線,諸如在圖29中示出為紅線2916。紅線2916可用作品質控制構件,其可指示測試為有效的或結果準備好了。另外,第一固持區域2915A可包括顯示表示關於生物樣本之特性之測試結果的第二視覺標誌的另一區域(例如,其中線2917示出於圖29中)。此第二視覺標誌之實例可為測試條帶上準備狀態另一某一指定區域中所顯示的線,諸如在圖29中示出為紅線2917。
In addition, in some specific examples, the processor may utilize at least one of the two camera modules (for example, the
在一些具體實例中,測試裝置可回應於生物樣本未準備好的判定執行動作。在一些實例中,藉由處理器執行的動作包括實施具有藉由待執行的分析處理程序判定的持續時間的計時器。在一些其他實例中,測試裝置進一步包括移動機構,且測試裝置中的處理器可利用移動機構將機械力施加至載體以提高生物樣本的準備度。在下文關於圖25(圖25A及圖25B)及圖26(圖26A及圖26B)引入可在測試裝置中實施的動作及機構的更多細節。 In some specific examples, the testing device may perform actions in response to the determination that the biological sample is not ready. In some examples, the action performed by the processor includes implementing a timer with a duration determined by the analysis processing program to be executed. In some other examples, the testing device further includes a moving mechanism, and the processor in the testing device can use the moving mechanism to apply mechanical force to the carrier to improve the preparation of the biological sample. More details on the actions and mechanisms that can be implemented in the test device are introduced below with respect to Figure 25 (Figure 25A and Figure 25B) and Figure 26 (Figure 26A and Figure 26B).
該等放大組件(例如,相機模組之放大組件或測試條帶之放大組件)的位置及該等光源的位置可視各種類型的分析物分析的要求而經調整或選擇。在變體中,該等相機模組可具有可調整放大比率。在此等實例中的至少一些中,處理器經進一步配置以基於所述處理器當前經配置以執行的分析處理程序來調整兩個相機模組中的至少一者的放大比率。如上文引入,當生物樣本包括精子時,測試裝置可配置合適相機模組(例如,第二相機模組2230B)達到不同的放大比率以用於判定精子的活動力及精子的形態。
The positions of the magnifying components (for example, the magnifying components of the camera module or the magnifying components of the test strip) and the positions of the light sources can be adjusted or selected according to the requirements of various types of analyte analysis. In a variant, the camera modules may have adjustable magnification ratios. In at least some of these examples, the processor is further configured to adjust the magnification ratio of at least one of the two camera modules based on the analysis processing program that the processor is currently configured to execute. As introduced above, when the biological sample includes sperm, the testing device can be equipped with a suitable camera module (for example, the
應注意,相機模組與放大組件之間的最佳距離可具有低誤差界限。舉例而言,甚至與最佳距離之0.01mm之微小偏差可阻止相機模組擷取樣本固持區域之清晰圖像。為了精細調節相機模組與放大組件之間的距離,測試裝置可包括自動聚焦(AF)功能。自動聚焦功能為自動地調整光學系統(例如,調整光學系統的組件之間的距離)以使得正成像的對象(例如,精液)在光學系統的焦平面內的功能。至少一或多個具體實例亦提供可藉由處理器控制的機械聚焦 機構以使得兩個相機模組中的至少一者聚焦於個別固持區域上。在下文關於圖23及圖24更詳細地論述機械聚焦機構。所述機械聚焦機構可為可控制的以調整透鏡在兩個相機模組中之至少一者中的位置(例如,圖23中大體所示)。另外或替代地,所述機械聚焦機構可為可控制的以調整載體的位置(例如,圖24中大體所示)。 It should be noted that the optimal distance between the camera module and the magnifying component can have a low error margin. For example, even a slight deviation of 0.01 mm from the optimal distance can prevent the camera module from capturing a clear image of the sample holding area. In order to finely adjust the distance between the camera module and the magnifying assembly, the testing device may include an auto focus (AF) function. The autofocus function is a function of automatically adjusting the optical system (for example, adjusting the distance between components of the optical system) so that the object being imaged (for example, semen) is in the focal plane of the optical system. At least one or more specific examples also provide mechanical focusing that can be controlled by a processor The mechanism enables at least one of the two camera modules to focus on the individual holding area. The mechanical focus mechanism is discussed in more detail below with respect to FIGS. 23 and 24. The mechanical focusing mechanism may be controllable to adjust the position of the lens in at least one of the two camera modules (for example, as shown generally in FIG. 23). Additionally or alternatively, the mechanical focusing mechanism may be controllable to adjust the position of the carrier (e.g., generally shown in FIG. 24).
圖23為具有自動聚焦功能的測試裝置的組件的示意圖。如圖23中所示,測試裝置可沿Z軸朝上或朝下移動相機模組(例如,藉由機動軌、超音波馬達驅動或步進馬達)。藉由調整相機模組的豎直位置,測試裝置可調整相機模組與放大組件之間的距離。 Figure 23 is a schematic diagram of the components of a test device with an autofocus function. As shown in FIG. 23, the testing device can move the camera module upward or downward along the Z axis (for example, by a motorized track, an ultrasonic motor drive, or a stepping motor). By adjusting the vertical position of the camera module, the testing device can adjust the distance between the camera module and the magnifying component.
圖24為具有自動聚焦功能的另一測試裝置的組件的示意圖。如圖24中所示,測試裝置可沿Z軸朝上或朝下移動測試條帶裝置。藉由調整測試條帶裝置的豎直位置,測試裝置可調整相機模組與放大組件之間的距離。 Figure 24 is a schematic diagram of the components of another test device with an autofocus function. As shown in Figure 24, the test device can move the test strip device up or down along the Z axis. By adjusting the vertical position of the test strip device, the test device can adjust the distance between the camera module and the magnifying component.
在如圖23或圖24中所示之自動聚焦操作期間,相機模組及補充透鏡保持為單一模組。換言之,相機模組與補充透鏡之間的距離在如圖23或圖24中所示之自動聚焦操作期間保持不變。 During the autofocus operation as shown in FIG. 23 or FIG. 24, the camera module and the supplementary lens remain as a single module. In other words, the distance between the camera module and the supplementary lens remains constant during the auto-focus operation as shown in FIG. 23 or FIG. 24.
圖25B為圖25A包括開關及馬達的測試裝置的B-B截面示意圖。圖25B中的測試裝置1900之B-B橫截面示出所述測試裝置的各種組件。測試裝置1900包括用以偵測插入至測試裝置1900中的收集瓶2510的開關2550。當插入了收集瓶2510時,開關2550被激活。接著經由開關2550將收集瓶2510告知測試裝置1900。基於開關2550處於被激活的時間段,測試裝置可判定收集瓶2510保持插入的時間段。
Fig. 25B is a B-B cross-sectional schematic diagram of the test device of Fig. 25A including a switch and a motor. The B-B cross section of the
測試裝置1900進一步包括用於搖動、振動或旋轉收集瓶2510以便在收集瓶2510中混合樣本的馬達2560。測試裝置1900可包括相機2570以基於收集瓶2510中的樣本之經擷取圖像來判定樣本是否已經液化。
The
圖26B為圖26A包括可撓性元件之測試裝置的C-C截面示意圖。圖26B中的測試裝置1900的B-B橫截面示出所述測試裝置的各種組件。測試裝置1900包括在用於以移動方式容納收集瓶2610之槽孔之底部的移動元件2680(例如,彈性組件)。舉例而言,移動元件2680可包括在收縮或變形之後可自發地恢復其正常形狀的彈簧。當收集瓶2610插入至槽孔中時,移動元件2680經壓縮。光感測器2690(或其他類型之距離感測器)負責偵測光感測器2690與收集瓶2610的底部之間的距離。基於光感測器2690與收集瓶2610的底部之間的距離,測試裝置1900可判定收集瓶2610中所含樣本的重量或體積。舉例而言,光感測器2690與收集瓶2610的底部之間的距離可與收集瓶2610中所含樣本的重量或體積成反比。
Fig. 26B is a C-C cross-sectional schematic diagram of the testing device of Fig. 26A including a flexible element. The B-B cross section of the
在一些其他具體實例中,測試裝置1900可包括在收集瓶2610的頂部上的感測器。感測器可負責偵測感測器與收集瓶2610的頂部之間的距離。可基於所述距離判定收集瓶2610中所含樣本的重量或體積,此係由於所述體積或所述重量可(例如)同感測器與收集瓶2610的頂部之間的距離成正比。繼而,基於樣本的重量或體積,測試裝置1900可判定等待收集瓶2610中的樣本液化的時間段。測試裝置1900進一步包括用於搖動、振動或旋轉收集瓶2610以便在收集瓶2610中混合樣本的馬達2660。
In some other specific examples, the
在一些具體實例中,測試裝置之相機模組可包括擷取光線的強度以及方向之光場相機(圖未示)。光場相機可包括在圖像感測器的前方的微透鏡陣列或多相機陣列以偵測方向資訊。使用光線的方向資訊,相機模組可在廣泛範圍的焦平面處擷取清晰圖像。因此,使用光場相機的測試裝置可不需要自動聚焦功能來精細調整相機模組與放大組件之間的距離。 In some specific examples, the camera module of the test device may include a light field camera (not shown) that captures the intensity and direction of light. The light field camera may include a micro lens array or a multi-camera array in front of the image sensor to detect direction information. Using the direction information of the light, the camera module can capture clear images at a wide range of focal planes. Therefore, the test device using the light field camera may not need the autofocus function to finely adjust the distance between the camera module and the magnifying component.
鑒於以上情況,本發明的裝置適用於測試男性生育力及/或女性生殖力。 In view of the above, the device of the present invention is suitable for testing male fertility and/or female fertility.
本發明提供一種使用本申請案的裝置測試男性生育力的方法。所述方法包含以下步驟:將來自男性受試者的生物樣本施加至載體的第一固持區域及第二固持區域;將載體插入至裝置中;根據第一分析處理程序判定精子的酸度;根據第二分析處理程序判定選自由以下組成之群組的精子的一或多個特性:精子的濃度、精子的活動力及精子的形態;以及分析結果以判定男性生育力。 The present invention provides a method for testing male fertility using the device of the present application. The method includes the following steps: applying a biological sample from a male subject to the first holding area and the second holding area of the carrier; inserting the carrier into the device; determining the acidity of the sperm according to the first analysis and processing program; The second analysis processing program determines one or more characteristics of sperm selected from the group consisting of: sperm concentration, sperm motility, and sperm morphology; and analysis results to determine male fertility.
本發明亦提供一種使用本申請案的裝置測試女性生殖激素的方法。所述方法包含以下步驟:將來自女性受試者的生物樣本施加至載體的第一固持區域;將載體插入至裝置中;以及判定一或多個類型的女性激素的濃度水平,所述女性激素諸如黃體激素(LH)、濾泡刺激激素(FSH),或人絨毛膜促性腺激素(HCG)。 The present invention also provides a method for testing female reproductive hormones using the device of the present application. The method includes the following steps: applying a biological sample from a female subject to the first holding area of the carrier; inserting the carrier into the device; and determining the concentration level of one or more types of female hormones. Such as luteinizing hormone (LH), follicle stimulating hormone (FSH), or human chorionic gonadotropin (HCG).
本發明進一步提供一種用於測試一對男性受試者與女性受試者之生育力的方法。所述方法包含以下步驟:將來自男性受試者之生物樣本施加至第一載體之第一固持區域及第二固持區域;將第一載體插入至裝置中;根據第一分析處理程序判定精子的酸度;根據第二分析處理程序判定選自由以下組成之群組的精子的一或多個特性:精子的濃度、精子的活動力及精子的形態;將來自女性受試者的生物樣本施加至第二載體的固持區域;將第二載體插入至裝置中;判定一或多個類型的雌性激素的濃度水平;以及分析男性與女性生物樣本的結果。 The present invention further provides a method for testing the fertility of a pair of male subjects and female subjects. The method includes the following steps: applying a biological sample from a male subject to the first holding area and the second holding area of the first carrier; inserting the first carrier into the device; determining the sperm status according to the first analysis and processing program Acidity; According to the second analysis and processing program, determine one or more characteristics of sperm selected from the group consisting of: sperm concentration, sperm motility and sperm morphology; apply biological samples from female subjects to the first The holding area of the two carriers; inserting the second carrier into the device; determining the concentration level of one or more types of female hormones; and analyzing the results of male and female biological samples.
圖27為用於分析男性客戶或患者的精液樣本的處理程序之流程圖。用於分析精液樣本之系統可包括測試機(例如,測試裝置1900)、行動裝置及雲端伺服器。圖28為用於分析女性客戶或患者的LH或HCG的處理程序的流程圖。用於分析LH或HCG的系統可包括測試機(例如,測試裝置1900)、行動裝 置及雲端伺服器。圖27及圖28之流程圖示出藉由測試機、行動裝置及雲端伺服器執行的步驟及在測試機、行動裝置及雲端伺服器之間傳遞的資訊。 Fig. 27 is a flowchart of a processing procedure for analyzing a semen sample of a male client or patient. The system for analyzing semen samples may include a testing machine (for example, the testing device 1900), a mobile device, and a cloud server. Fig. 28 is a flowchart of a processing procedure for analyzing LH or HCG of a female client or patient. The system for analyzing LH or HCG may include a test machine (for example, the test device 1900), a mobile device And cloud server. The flowcharts of FIGS. 27 and 28 show the steps performed by the test machine, the mobile device and the cloud server and the information transmitted between the test machine, the mobile device and the cloud server.
在一些具體實例中,用於測試精子的方法包含以下步驟:獲得用於測試生物樣本的裝置,將精子樣本施加至樣本固持區域,記錄精子樣本的視訊或圖像;基於經記錄視訊或經記錄圖像的至少一個圖框來判定精子樣本的精子數;以及基於經記錄視訊或經記錄圖像判定精子樣本的精子活動力。 In some specific examples, the method for testing sperm includes the following steps: obtaining a device for testing a biological sample, applying the sperm sample to the sample holding area, recording the video or image of the sperm sample; based on the recorded video or recorded At least one frame of the image is used to determine the sperm count of the sperm sample; and the sperm motility of the sperm sample is determined based on the recorded video or the recorded image.
在相關具體實例中,所述方法進一步包含:在將精子樣本施加至樣本固持區域之前等待用於精子樣本的液化的預定時間段。 In a related specific example, the method further includes: waiting for a predetermined period of time for the liquefaction of the sperm sample before applying the sperm sample to the sample holding area.
在另一相關具體實例中,所述方法進一步包含:置放包括在裝置的頂部上的相機組件的行動裝置以使得所述相機組件與放大組件及樣本固持區域對準;及藉由行動裝置接收樣本固持區域中經由放大組件之放大來自精子樣本的光信號。 In another related specific example, the method further includes: placing a mobile device including a camera assembly on the top of the device so that the camera assembly is aligned with the magnifying assembly and the sample holding area; and receiving by the mobile device The optical signal from the sperm sample is amplified in the sample holding area through the amplification component.
在又一相關具體實例中,所述方法進一步包含:藉由安置於裝置的載體之一側的側向照明裝置或安置於裝置的載體之頂部或下方的豎直照明裝置來照亮樣本固持區域。 In another related specific example, the method further includes: illuminating the sample holding area by a side illuminating device placed on one side of the carrier of the device or a vertical illuminating device placed on top or under the carrier of the device .
在再一相關具體實例中,所述方法進一步包含:導引來自側向照明裝置的光束穿過由透明的或半透明材料製成的載體;及藉由包括於載體中的複數個光反射圖案將光束反射至樣本固持區域。 In still another related embodiment, the method further includes: guiding the light beam from the side lighting device through a carrier made of a transparent or translucent material; and by including a plurality of light reflection patterns in the carrier The beam is reflected to the sample holding area.
在又一相關具體實例中,所述方法進一步包含:將一次性測試裝置插入至基座中,該基座包括用於記錄精子樣本的視訊的相機組件或用於固定行動裝置的形狀配合框架,所述行動裝置包括用於記錄精子樣本的視訊的相機組件。 In another related specific example, the method further includes: inserting the disposable testing device into a base, the base including a camera assembly for recording video of sperm samples or a form-fitting frame for fixing the mobile device, The mobile device includes a camera component for recording video of the sperm sample.
在再一相關具體實例中,所述方法進一步包含:自生物樣本之經記錄視訊提取至少一個圖框;自至少一個圖框識別複數個精子;以及基於經識別精子之數目及由至少一個圖框記錄之面積計算精子數。 In still another related specific example, the method further includes: extracting at least one frame from the recorded video of the biological sample; identifying a plurality of sperm from the at least one frame; and based on the number of identified sperm and the at least one frame Calculate the sperm count from the recorded area.
在又一相關具體實例中,所述方法進一步包含:分析經識別精子的形狀;及基於經識別精子的形狀判定形態水平。 In yet another related specific example, the method further includes: analyzing the shape of the identified sperm; and determining the morphological level based on the shape of the identified sperm.
在再一相關具體實例中,所述方法進一步包含:自精子樣本之經記錄視訊提取一系列視訊圖框;自該系列視訊圖框識別複數個精子;基於所述系列視訊圖框識別精子的移動軌跡;基於精子的移動軌跡及由所述系列視訊圖框擷取的時間段判定精子的移動速度;以及基於精子的移動速度計算精子活動力。 In still another related specific example, the method further includes: extracting a series of video frames from the recorded video of the sperm sample; identifying a plurality of sperm from the series of video frames; identifying the movement of the sperm based on the series of video frames Trajectory; determine the movement speed of the sperm based on the movement trajectory of the sperm and the time period captured by the series of video frames; and calculate the sperm motility based on the movement speed of the sperm.
在又一相關具體實例中,所述方法進一步包含:經由放大透鏡進一步放大精子樣本的視訊或圖像。 In another related specific example, the method further includes: further magnifying the video or image of the sperm sample through a magnifying lens.
在一些具體實例中,一種用於使用測試生物樣本的系統來測試精子的方法,其包含:將裝置插入至基座組件中;藉由行動裝置記錄樣本固持區域中的精子樣本的視訊,所述行動裝置固定在基座組件的形狀配合框架中;基於經記錄視訊之至少一個圖框判定精子樣本的精子數;以及基於經記錄視訊判定精子樣本的精子活動力。 In some specific examples, a method for testing sperm using a system for testing biological samples includes: inserting a device into a base assembly; recording a video of the sperm sample in the sample holding area by a mobile device, the The mobile device is fixed in the shape-matching frame of the base assembly; the sperm count of the sperm sample is determined based on at least one frame of the recorded video; and the sperm motility of the sperm sample is determined based on the recorded video.
在相關具體實例中,所述方法進一步包含:經由放大透鏡進一步放大精子樣本的視訊。 In a related specific example, the method further includes: further magnifying the video of the sperm sample through a magnifying lens.
在一些具體實例中,用於測試生物樣本的系統包含用於測試生物樣本的一次性裝置及基座組件。一次性裝置包括含樣本固持區域的樣本載體及置放於該樣本固持區域的頂部上的可拆卸外罩。基座組件包括用於將一次性裝置插入至基座組件中的插入埠,及用於擷取樣本固持區域之圖像的相機組 件,所述相機組件包括圖像感測器及光學透鏡模組。在相關具體實例中,光學透鏡模組可具有至少為0.1的線性放大比率。 In some specific examples, the system for testing biological samples includes a disposable device for testing biological samples and a base assembly. The disposable device includes a sample carrier containing a sample holding area and a detachable cover placed on the top of the sample holding area. The base assembly includes an insertion port for inserting the disposable device into the base assembly, and a camera set for capturing images of the sample holding area The camera assembly includes an image sensor and an optical lens module. In related specific examples, the optical lens module may have a linear magnification ratio of at least 0.1.
圖31示出一額外實例載體3105有一或多的視覺標誌3117(1)-3117(5)(或可以被共同地稱為視覺提示3117)可用以控制測式裝置執行的分析處理程序(例如,圖21C或圖22示出之測試裝置)。如圖31中所示,視覺提示3117可以在載體3105固持區域(例如固持區域3115B)中(或附近,在一些另外或替代之實施例)。
Figure 31 shows an
如同前述(例如有關於圖29),處理器可基於一載體上之視覺提示執行不同的分析處理程序。例如在一些特定的實施例可以執行圖像辨識並處理固持區域的圖像並可根據來自圖像辨識的結果的視覺提示執行不同的分析處理程序。在一些實施例中,載體的視覺提示可為一特定固持區域的一形狀。另外的視覺提示實施例可包括圖形圖案、視覺標誌、一維條碼、多維圖案碼(例如,QR碼)等。 As mentioned above (for example, in relation to FIG. 29), the processor can execute different analysis processing procedures based on visual cues on a carrier. For example, in some specific embodiments, image recognition can be performed and the image of the holding area can be processed, and different analysis processing procedures can be performed according to the visual cues from the result of the image recognition. In some embodiments, the visual cue of the carrier may be a shape of a specific holding area. Other visual cue embodiments may include graphic patterns, visual signs, one-dimensional bar codes, multi-dimensional pattern codes (eg, QR codes), and the like.
在一些特定實例如圖31所示,任一視覺標誌(例如視覺記號3117(1))可為一特定小型的圖形圖案可被刻印、被附接再者或被標記在載體3105中的固持區域3115B上。圖31之實例中,視覺標誌3117(1)-3117(5)是全部相同或實質上相似的圖案,然而在其他實例中(為簡單起見未示出),它們不必完全相同且每一視覺標誌可有特有的形狀、尺寸、圖案等。在一或多的實施中,視覺提示3117(例如視覺標誌3117(1)-3117(5))是一不被人類感知的尺寸但可以被一相機模組經由顯微透鏡放大後識別(例如,圖22中之第二相機模組2230B或圖21C的相機模組2130)。在其中一些實施中,視覺標誌3117(1)-3117(5)是小於15微米(μm),此外,視覺標誌3117(1)-3117(5)可經配置以使得它們的位置共同地形成一圖案(例如一預定的配置)。另外或作為視覺標誌特有的特性的替代方案(例如尺寸、形狀、顏色及/或位置),此由每一視覺記號的位置形成的集合
圖案可為可識別的提示以被用來控制測試裝置的功能(例如,是否且接續地執行何種分析處理程序)。此集合圖案可基於視覺標誌(例如在固持區域)的絕對位置及/或視覺標誌的相對位置(例如,從它們各別的鄰近標誌)。圖31中,由視覺標誌3117(1)-3117(5)所示的集合圖案是視覺標誌3117(1)-3117(4)每一被設置在(相機捕捉的影像)四個角落之一且視覺記號3117(5)被設置在中心,每一視覺標誌是被均勻的分佈。一些另外或替代地實施例提供在視覺提示的每一(或每一組)特別的視覺記號(或標誌)可代表一個不同的分析功能以被執行。
In some specific examples, as shown in Figure 31, any visual mark (such as visual mark 3117(1)) can be a specific small graphic pattern that can be engraved, attached, or marked in the holding area of the
鑒於以上狀況,此處之測試裝置可利用載體上之視覺提示(例如,在固持區域中或附近)以控制測試裝置之功能且適應性地基於視覺提示執行分析處理程序。在某些實施例中,視覺提示可用來確認是否載體為一授權的載體(例如,適當的被授權且在符合某一規範下並根據適用的品質標準製造)。在其他實例中,視覺提示可被用於控制測試裝置以在何種模式(例如,男性或女性、實驗室或家庭、高準確度或短時間、使用電池或插電)下執行計算。此外,在一些實施例中提供視覺提示可用於控制存取測試設備的某一功能,這根據客戶身分、地理位置等提供彈性訂製由測試設備提供的服務的能力。 In view of the above situation, the test device here can use visual cue on the carrier (for example, in or near the holding area) to control the function of the test device and adaptively execute the analysis processing program based on the visual cue. In some embodiments, the visual cue can be used to confirm whether the carrier is an authorized carrier (for example, appropriately authorized and manufactured in accordance with a certain specification and in accordance with applicable quality standards). In other examples, visual cues can be used to control the test device in which mode (for example, male or female, laboratory or home, high accuracy or short time, use battery or plug in) to perform calculations. In addition, in some embodiments, providing a visual cue can be used to control access to a certain function of the test device, which provides the ability to flexibly customize the service provided by the test device according to the customer's identity and geographic location.
圖32是在此揭露的測試裝置(如在圖21C或圖22)基於視覺提示適應性的執行一分析處理程序可實施的處理程序3200另外實例流程圖。繼續參照圖31,在下文說明處理程序3200。應注意,以下處理程序3200的實例中,視覺提示是被應用於執行一載體認證應用,然而處理程序可同樣地被適用於執行其他應用(例如,有關於圖30之敘述)。例如在一些不是載體驗證的應用,處理器可以基於不同視覺提示執行不同組的分析處理程序。
FIG. 32 is a flowchart of another example of a
首先,步驟3202,在測試裝置的接收機構接收經由開口插入之載體,感測器(簡單起見未示出)可通知處理器,而處理器將造成測試裝置內建的相機模組以擷取一或多個載體固持區域的圖像。在步驟3204,處理器可利用
經擷取圖像識別(例如基於已知圖像分析技術或揭露於此的那些)在載體中的視覺提示。如上討論,視覺提示可包括一些視覺標誌,每一視覺標誌可以是相同或不同尺寸、形狀、圖案、顏色等(如圖31所示之實例)或他們可能不相同。視覺標誌可共同進一步呈現一個圖案(例如,從他們的位置)。接著,處理器可將視覺提示(例如特有的尺寸、形狀、位置或集合圖案)與預定的視覺提示(例如,儲存在本機記憶體及/或雲端資料庫(可藉由測試裝置的製造商或其他管理員操作或控制)進行比較。
First, in
步驟3206,處理器選擇性地對固持區域的經擷取圖像基於視覺提示的識別結果執行一組分析處理程序。如果視覺提示的識別結果回覆正向(例如,回應具有預定的視覺提示的載體固持區域),接著處理器繼續進行可包括選擇性的擷取額外的圖像(或視訊)以用於分析(步驟3208)及對經圖像執行分析處理程序的相對應組(步驟3210)的後續步驟。另一方面,若識別結果回覆負向(例如,回應不具有預定的視覺提示的載體固持區域),則處理器造成替代性的動作(例如,顯示錯誤代碼)反映視覺提示的不可識別,且不對圖像執行任何分析處理程序(步驟3212)。在所述的分析處理程序組被執行後,處理器可如前述基於分析處理程序的結果繼續判定關於生物樣本的結果。
此外,值得注意的是傳統的電腦輔助精子分析(computer-assisted sperm analyzers,CASA)依賴大型顯微鏡及操作技術人員的經驗以判定精子的參數。有一些電腦軟體輔助以補充技術人員的經驗及使標準化分析結果。然而,由於透鏡及感測模組的不同,模糊圖像時常會嚴重影響輔助軟體的有效性,導致相關功能(例如精子數計算)的不精確。 In addition, it is worth noting that traditional computer-assisted sperm analyzers (CASA) rely on large microscopes and the experience of operating technicians to determine sperm parameters. There are some computer software to supplement the experience of the technicians and standardize the analysis results. However, due to the difference between the lens and the sensing module, blurred images often seriously affect the effectiveness of the auxiliary software, resulting in inaccurate related functions (such as sperm count calculation).
另外,主管機關例如世界衛生組織(World Health Organization,WHO)發佈人類精液檢查與處理實驗室手冊,手冊中明訂被評估用以決定精子的濃度、精子的活動力及精子的形態的樣本最低量(例如,200個精子)。現有的 基於電腦輔助精子分析圖像的分析一般缺乏自動採樣或需要手動操作以取得多個視野以達到世界衛生組織規範及降低分析中的採樣誤差,替代地,如果採樣僅用單一視野重複的執行,為了達到令人滿意的低採樣誤差,而重複程序所花費的時間往往變得過長而無法大規模地實現。 In addition, competent authorities such as the World Health Organization (WHO) issued a human semen examination and processing laboratory manual. The manual clearly stipulates the minimum amount of samples to be evaluated to determine the concentration of sperm, the motility of sperm, and the morphology of sperm. (For example, 200 sperm). current The analysis based on computer-aided sperm analysis images generally lacks automatic sampling or requires manual operation to obtain multiple fields of view to meet the World Health Organization specifications and reduce the sampling error in the analysis. Alternatively, if sampling is performed repeatedly with only a single field of view, To achieve a satisfactory low sampling error, the time it takes to repeat the procedure often becomes too long to be implemented on a large scale.
圖33是可被此處測試裝置(例如,圖21C或圖22)為了較佳的結果(例如較佳的分析精確性或效率)實施的處理程序3300實例流程圖。處理程序3300可為此處(例如圖16示出的處理程序)的處理程序的替代性或補充性處理程序。
FIG. 33 is a flowchart of an
首先,步驟3310(例如,在攜帶所述生物樣本或已暴露於所述生物樣本之載體盒插入後(如上文引入)),此被引入的裝置可利用相機模組以擷取載體盒固持區域的一或多個圖像(或共同地稱為,集合圖像(imagery))。在一些選擇性的實施例(例如,關於圖29或31的形容),裝置可從固持區域的經擷取集合圖像識別(步驟3320)載體上的視覺提示。在這些選擇性的實施例中,此裝置可基於視覺提示的識別結果對經擷取集合圖像執行一組分析處理程序。 First, in step 3310 (for example, after the carrier box carrying the biological sample or has been exposed to the biological sample is inserted (as introduced above)), the introduced device can use a camera module to capture the carrier box holding area One or more images of (or collectively, imagery). In some alternative embodiments (for example, as described with respect to FIG. 29 or 31), the device can recognize (step 3320) the visual cue on the carrier from the captured set image of the holding area. In these alternative embodiments, the device can perform a set of analysis processing procedures on the captured set of images based on the recognition result of the visual cue.
於步驟3330,此裝置可將經擷取集合圖像分割為複數的區塊。在某些實施例中,區塊可以是多邊形的。更特定地來說,一些實施指出區塊可以是三角形、矩形、正方形、五邊形、六邊形等等。這些(區塊的)形狀可能至少有一邊常為0.05毫米。在一個或多個實施例中,區塊為正方形且尺寸為0.05毫米乘以0.05毫米。值得注意的是,依據特定的實施,區塊的數量及尺寸可根據相機模組的解析度調整。在圖34中說明指出一個固持區域的圖像實例分割為數個區塊(例如,區塊3402)。應注意到,為了在此促進所揭示的技術的討論,經擷取集合圖像被認為「分割」成區塊;然而,在一個或多個實施中應該要了解到,處理器在電腦運作時間(或在正常操作時)並不需要實際上進行數學上的劃分運作來執行此技術;而是,所得到的區塊或網格可以被預定、邏
輯上預接、程式預設,或是預先配置在裝置的相機控制器及/或處理器上,如此與集合圖像為分割為區塊的相關運算執行的需求可以被減少,或在某些實例中完全被消除。
In
於步驟3340,實例裝置從複數區塊、候選區塊中選取以做分析。根據一個或更多實施例,候選區塊的選取是基於很多因素,舉例來說某一區塊的聚焦程度及/或某一區塊的正常性。
In
更特定言之,在許多實施中,此裝置可判定(步驟3342)每一複數的區塊的聚焦程度,以至於每一區塊能夠有相對應的聚焦程度測量。此聚焦程度可基於一或多個焦距測量功能判定。依據實施,被採納的焦距測量功能可包括一或多個:變異型、差異係數總和型、拉普拉斯能量圖像型、及/或側梯度強度最大化型。 More specifically, in many implementations, the device can determine (step 3342) the focus degree of each complex number of blocks, so that each block can have a corresponding focus degree measurement. The degree of focus can be determined based on one or more focal length measurement functions. Depending on the implementation, the adopted focal length measurement function may include one or more: variant type, sum of difference coefficients type, Laplacian energy image type, and/or lateral gradient intensity maximization type.
在判定每個區塊的聚焦程度後,在一些實施例中,此裝置會將一區塊的聚焦程度與最小聚焦程度閾值進行比較。在一或多個實施中,一個區塊只有在聚焦程度滿足(例如,達到或超過)最小聚焦程度閾時可以被選擇為候選區塊。此外,此裝置亦可標記或標號區塊。此裝置在一個或多個實施例中指出,區塊只有在滿足最小聚焦程度閾值時會被標記或標號(例如,為了進一步的分析或追蹤識別)。標記或標號可以是連續的或隨機的完成。在圖35中說明是一部分的候選區塊的選取過程,在此,區塊是隨機地經標號,且超過最小焦距程度閾值的區塊被初步的選取為候選區塊3510。 After determining the focus degree of each block, in some embodiments, the device compares the focus degree of a block with the minimum focus degree threshold. In one or more implementations, a block can be selected as a candidate block only when the focus degree meets (for example, reaches or exceeds) the minimum focus degree threshold. In addition, the device can also mark or label blocks. In one or more embodiments of this device, it is pointed out that the block will be marked or labeled only when the minimum focus degree threshold is met (for example, for further analysis or tracking identification). The marking or labeling can be done continuously or randomly. The selection process of a part of the candidate blocks is illustrated in FIG. 35. Here, the blocks are randomly labeled and the blocks that exceed the minimum focal length threshold are preliminarily selected as candidate blocks 3510.
接下來,此裝置可對於數個被選取的區塊執行圖像處理程序,以判定被選取之區塊的特性(步驟3344),以判定一區塊之正常性,例如查看此區塊是否「足夠正常」以授予更進一步的分析。在一些實例中,被選取做正常性判定的區塊是那些已經被初步的選取為候選區塊(例如,那些滿足最小聚焦程度閾值,如上文說明)。在一些實例中,此階段被用於判定正常性的特性是 細胞數(如精子數)。在特定的實例中,此裝置可對滿足最小聚焦程度的區塊(意即它們是足夠聚焦的)執行圖像處理程序以對每一足夠聚焦的區塊判定區塊內細胞(精子)數。此圖像處理程序可包括二值化(binarization)(且在一些實施中,搭配適應定限)以識別區塊中部分可能是精子的對象為前景,並識別區塊的剩餘部份為背景,經圖像處理程序後,此裝置可判定細胞(精子)數。在一或多個實施例中,候選區塊的細胞數可基於有精子與沒有精子的面積比例被判定(例如,利用與已知細胞數比例相關的表格進行外插法)。 Next, the device can perform image processing on several selected blocks to determine the characteristics of the selected blocks (step 3344), to determine the normality of a block, for example, to check whether the block is " Normal enough" to grant further analysis. In some instances, the blocks selected for normality determination are those that have been preliminarily selected as candidate blocks (for example, those that meet the minimum focus degree threshold, as described above). In some instances, the characteristic used to determine normality at this stage is Number of cells (such as sperm count). In a specific example, the device can perform image processing on the blocks that meet the minimum degree of focus (meaning that they are sufficiently focused) to determine the number of cells (sperm) in the block for each sufficiently focused block. This image processing procedure may include binarization (and in some implementations, with adaptation limits) to identify some objects in the block that may be sperm as the foreground, and identify the remaining part of the block as the background. After image processing procedures, this device can determine the number of cells (sperm). In one or more embodiments, the number of cells in the candidate block can be determined based on the ratio of the area with sperm to the area without sperm (for example, using a table related to the known cell number ratio for extrapolation).
之後,此裝置能夠計算所有剩餘候選區塊(例如,這些滿足最小聚焦程度閾值的區塊)的統計數據(例如,平均值和標準差)。統計數據經計算後,此裝置能夠藉由統計上比較特定區塊和所有剩餘候選區塊的一或多個特性(例如,精子數)判定(步驟3344)特定區塊的正常性。在一些實施例中,只有在特定區塊的正常性滿足一個正常性條件,才會被繼續的選取為候選區塊。以精子數為例,在多個實施例中,一區塊被認為「足夠正常」(例如,滿足正常性條件),是當區塊中的精子數在複數區塊的以平均值而言的標準差預設數值中。在一或多個實施中,正常性的要求是(以平均值而言)在兩個標準差之內。在其他的實施之中,正常性要求以是一個或三個標準差,或其他適合的的統計技術,能夠反映一個區塊與其他區塊組的正常性之比較。在圖36中說明,此圖為在圖像處理程序後的結果(例如,適應限定二值化(adaptive thresholding binarization))和細胞數判定。應注意,在圖36中,顯示每一個候選區塊的估計細胞數替代它的標誌。 After that, the device can calculate statistics (for example, average and standard deviation) of all remaining candidate blocks (for example, these blocks that meet the minimum focus degree threshold). After the statistical data is calculated, the device can determine (step 3344) the normality of the specific block by statistically comparing one or more characteristics (for example, sperm count) of the specific block and all remaining candidate blocks. In some embodiments, only when the normality of a specific block satisfies a normality condition, it will continue to be selected as a candidate block. Take the number of sperm as an example. In many embodiments, a block is considered "sufficiently normal" (for example, it satisfies the normality condition), when the sperm count in the block is the average of the plural blocks The standard deviation is in the preset value. In one or more implementations, the requirement for normality is (in terms of average) within two standard deviations. In other implementations, the normality requirement is one or three standard deviations, or other suitable statistical techniques, which can reflect the comparison of normality between a block and other block groups. It is illustrated in FIG. 36, which is the result (for example, adaptive thresholding binarization) and cell number determination after the image processing procedure. It should be noted that in Fig. 36, the estimated cell number of each candidate block is displayed instead of its mark.
此外,此裝置可判定(步驟3346)是否已達到欲被分析細胞的目標數量。特定地來說,所揭示的裝置的一或多個實施例能夠維持總細胞數,且針對被選取為候選區塊的每一區塊,此裝置將該區塊的相應細胞數加至總細胞數。此裝置可用此該目標數量的分析細胞去控制欲被分析生物樣本的數量, 且根據實施此數量是可配置的。此數量(數目)可依實驗室手冊和測試特定生物樣本之標準訂做。在一些實施例中,欲被分析細胞的目標數量是兩百(200)。在某些實例中,當總細胞量達到欲被分析細胞的目標數量時,選取候選區塊即完成。也就是說,根據至少某些揭示於此的實施例,在滿足聚焦程度閾值和總細胞數達到欲被分析細胞的目標數量的正常性要求的區塊上,候選區塊的選取能夠被執行(例如,以隨機的方式)。 In addition, the device can determine (step 3346) whether the target number of cells to be analyzed has been reached. Specifically, one or more embodiments of the disclosed device can maintain the total cell count, and for each block selected as a candidate block, the device adds the corresponding cell count of the block to the total cell number. This device can use the target number of analysis cells to control the number of biological samples to be analyzed. And according to the implementation this number is configurable. This quantity (number) can be customized according to the laboratory manual and the standards for testing specific biological samples. In some embodiments, the target number of cells to be analyzed is two hundred (200). In some instances, when the total cell amount reaches the target number of cells to be analyzed, the selection of the candidate block is completed. That is, according to at least some of the embodiments disclosed herein, the selection of candidate blocks can be performed on blocks that meet the threshold of the degree of focus and the normality requirement that the total number of cells reach the target number of cells to be analyzed ( For example, in a random manner).
於步驟3350,在選取候選區塊後,此引入的裝置可以藉由分析選取的候選區塊(例如,藉由此處所引入的一個或更多技術),判定生物樣本一或多個特性。在至少數個實施例中,此生物樣本為精液,且在候選區塊中一或多的生物樣本特性欲被判定,其包括一或多的:細胞數量(或濃度,可以從細胞數量推斷)、活動力、或形態。在一些實例中,此裝置更配置了,在該組分析處理程序執行後,可基於分析處理程序的結果判定關於此生物樣本的結果(例如,生育力)。
In
此外,在此觀察到完美地製造鏡片的組合件通常是困難的(尤其是量大時和須控制成本時)諸如安裝在在此引入之測試裝置上的顯微的透鏡組合件和/或放大透鏡組合件。透鏡的瑕疵以各式各樣的形式存在著,諸如雜質,或透鏡本身的不完美(例如,清楚程度、折射度、焦點及其他),而這些瑕疵可以對測試裝置的精確性做出不利的影響。因此在此介紹,是校正和合格檢查的技術以減輕透鏡瑕疵並且更進一步改善於此所揭示的測試裝置之分析精確性。 In addition, it is observed here that it is often difficult to perfectly manufacture the lens assembly (especially when the quantity is large and the cost must be controlled) such as the microscopic lens assembly and/or magnification installed on the test device introduced here. Lens assembly. The defects of the lens exist in various forms, such as impurities, or imperfections of the lens itself (for example, clarity, refraction, focus, and others), and these defects can adversely affect the accuracy of the test device influences. Therefore, the techniques introduced here are calibration and qualification inspection techniques to reduce lens defects and further improve the analytical accuracy of the test device disclosed here.
圖37是一例校正處理程序的實例流程圖3700,可以由一個在此揭示的測試裝置實施(例如,圖21C或圖22)以獲得改進的結果。此處理程序3700可以是在此揭示的過程之替代的或是補充的處理程序,例如在圖16中說明的處理程序。
FIG. 37 is an
首先,在步驟3710中(舉例來說,載體盒插入後),此引入之裝置能夠利用相機模組以擷取於載體盒固持區域的一個或多個圖像(或共同地稱為,集合圖像(imagery))。在一些選擇性的實施例中(例如,那些有關於圖29或31的敘述,此裝置可以,從固持區域擷取之集合圖像識別(步驟3720)載體上的視覺提示。在這些選擇性的實施例中,此裝置可以根據上述視覺提示的識別之結果對經擷取集合圖像執行一組的分析過程。 First, in step 3710 (for example, after the carrier box is inserted), the introduced device can use the camera module to capture one or more images (or collectively referred to as the collection image) in the holding area of the carrier box. Like (imagery)). In some optional embodiments (for example, those described in relation to Figure 29 or 31, the device can recognize (step 3720) the visual cues on the carrier from the collective image captured from the holding area. In these optional In an embodiment, the device can perform a set of analysis processes on the captured set images according to the recognition results of the above-mentioned visual cues.
更特定地來說,在一些實施中,在此的載體盒可以作為一個專門的虛擬盒,可用以觸發校正處理程序。舉例來說,專門的虛擬盒可能帶有一或更多的專門的圖形圖案(例如,關於圖38如下介紹),在視覺提示識別處理程序後(例如,在步驟3720中),能夠觸發測試裝置進入校正模式。另一實例中,一個專門的虛擬盒能夠攜帶專門的測試樣本(例如,關於圖41如下介紹),且使用者可以手動造成(例如,透過面板上的使用者介面或遙控測試裝置)測試裝置進入校正模式中。在許多實例中,虛擬盒可以包括一個電子的(例如,一個無線射頻辨識(RFID))或一個機械的特徵(例如,一個特殊的形狀或是機械的凸出物),能夠觸發校正模式。 More specifically, in some implementations, the carrier box here can be used as a dedicated virtual box that can be used to trigger the correction processing program. For example, a special virtual box may have one or more special graphic patterns (for example, as described below with respect to FIG. 38). After the visual prompt recognition processing procedure (for example, in step 3720), the test device can be triggered to enter Correction mode. In another example, a special virtual box can carry special test samples (for example, as described below with respect to Figure 41), and the user can manually cause the test device to enter (for example, through the user interface on the panel or remote test device) In calibration mode. In many instances, the virtual box may include an electronic (e.g., a radio frequency identification (RFID)) or a mechanical feature (e.g., a special shape or a mechanical protrusion) that can trigger the calibration mode.
圖38是一測試載體攜帶一視覺提示或一個圖像圖案,能夠用於校正或驗證在此揭露的測試裝置。在一個或更多的實施例中,視覺提示包括一個圖像圖案,使測試裝置能夠識別作為一觸發器以進入校正模式。之後,此測試裝置能利用相機模組擷取圖像圖案之圖像,且執行自我診斷以從經擷取圖像中之結果自行校正。視覺圖案應要易於識別(且不容易誤認)。如同在圖38中說明,實例中的視覺圖案包含重複的(例如,每0.08毫米,也就是重複率或「間距(pitch)」)、更大的(例如,0.02毫米乘以0.02毫米)和一般地有規則的形狀。此視覺提示可以更進一步包含一個或更多重複的線性樣式。在圖38說明的例子中,此線性樣式包含一組(例如,三個)水平線條和一組(例如,三 個)垂直線條。在一些實施例中,這些線條有200線對/毫米(LP/mm)或是更高的解析度。在圖38特定的例子中,線條有500LP/mm的解析度。應注意到,水平和/或垂直線條是的視覺線性圖案的實例,適合輔助測試裝置以執行特定安裝於測試裝置本身的光學儀器(例如,顯微透鏡)的光學特性與性能之自我診斷;其他適合的視覺圖案可取代圖38中的說明例。舉例來說,在一些實施列中,一個「E」形狀圖案或同等物可取代平行線條用作視覺線性圖案。舉例來說,在一些實施列中,實線和虛線能夠用於視覺線性圖案。 Figure 38 is a test carrier carrying a visual cue or an image pattern that can be used to calibrate or verify the test device disclosed herein. In one or more embodiments, the visual cue includes an image pattern that enables the test device to be recognized as a trigger to enter the calibration mode. After that, the test device can use the camera module to capture the image of the image pattern, and perform self-diagnosis to self-calibrate the results from the captured image. The visual pattern should be easy to recognize (and not easy to misunderstand). As illustrated in Figure 38, the visual pattern in the example includes repetitive (for example, every 0.08 mm, which is the repetition rate or "pitch"), larger (for example, 0.02 mm by 0.02 mm) and general The ground has a regular shape. This visual cue can further include one or more repeating linear patterns. In the example illustrated in Figure 38, this linear pattern includes a set (for example, three) of horizontal lines and a set of (for example, three) A) Vertical lines. In some embodiments, these lines have a resolution of 200 line pairs per millimeter (LP/mm) or higher. In the specific example of Figure 38, the line has a resolution of 500LP/mm. It should be noted that the horizontal and/or vertical lines are examples of visual linear patterns, which are suitable for assisting the test device to perform self-diagnosis of the optical characteristics and performance of the optical instrument (for example, microlens) installed in the test device itself; others Suitable visual patterns can replace the illustrative example in FIG. 38. For example, in some embodiments, an "E" shaped pattern or equivalent can replace parallel lines as a visual linear pattern. For example, in some embodiments, solid lines and dashed lines can be used for visual linear patterns.
繼續處理程序3700,儘管於步驟3730校正模式已被引發,在載體的集合圖像被擷取後(例如,於步驟3710),此裝置能分割經擷取集合圖像為複數區塊(此與步驟3330相似,如上討論)。在一些實施例中,區塊可以是多邊形的。更特定言之,一些實施中指出區塊能為三角形、矩形、正方形、五邊形、六邊形等等。這些(區塊的)這些形狀可能至少有一邊為0.05毫米。在一個或多個實施例中,區塊為正方形且尺寸為0.05毫米乘以0.05毫米。值得注意的是,根據特定的實施,區塊的數量與尺寸能依據相機模組的解析度調整。在一個或更多的實施中,上文提到的間距(例如,視覺圖案規律地自行重複率)能夠對應到集合圖像能被分割的區塊的數量。在一些實施例中,間距可以與集合圖像能被測試裝置分割的區塊數量一致。
Continuing with the
於步驟3740,實例中的裝置能執行校正/自我診斷程序,例如於每一區塊。校正程序通常應為一或更多步驟,能夠使測試裝置能夠自主地自我診斷當前安裝在測試裝置自身上的光學模組(例如,包括顯微透鏡、相機模組)品質。在一或多個實施例中,測試裝置可以判定(於步驟3742)每個區塊的聚焦程度,例如,藉由使用一或更多焦距測量函數。焦距測量函數的例子可以包含變異型、差異係數總和型、拉普拉斯能量圖像型、和/或側梯度強度最大化型。接著,於步驟3744,此測試儀器可判定一區塊是否滿足聚焦程度,例
如,上文討論之最小聚焦程度閾值。另外或替代地,此測試裝置能將經擷取之結果與一或多個期望結果做比較(於步驟3746)。舉例來說,此測試儀器之處理器存取到一或多個預先安裝在記憶體中的圖像(例如,非使用相機擷取,例如,被傳遞或被程式預設安裝),與經擷取的圖像做出比較,並判定在區塊中之有疑慮之經擷取圖像品質是否滿足最低標準。預先安裝的一個或多個圖像應為應用於校正之視覺圖案的代表。於步驟3746,測試裝置能夠比較並檢視示例圖像品質參數,包括顏色失真、圖案變形、清晰程度瑕疵及/或其他圖像瑕疵。
In
圖39是一個視覺提示圖38的示例圖像,經此處所揭示的測試裝置擷取,此圖像品質一般而言往左下角較佳,往右上角則較差。圖40A及40B為兩個在圖39中在不同區塊中經擷取圖像的不同圖像品質的特定實例說明。在一些實施例中,例如,其中間距與可以分割集合圖像的區塊數量一致,圖像40A及40B能分別代表一個區塊。如圖說明,圖40A的區塊中圖像品質較圖40B良好,因為圖像較為清晰且更加聚焦。 FIG. 39 is an example image of the visual cue of FIG. 38. The image quality is generally better in the lower left corner and worse in the upper right corner after being captured by the test device disclosed herein. 40A and 40B are two specific example illustrations of different image qualities of the captured images in different regions in FIG. 39. In some embodiments, for example, where the pitch is the same as the number of blocks that can be divided into the collective image, the images 40A and 40B can each represent one block. As illustrated, the image quality in the block in FIG. 40A is better than that in FIG. 40B because the image is clearer and more focused.
回溯到處理程序3700,於步驟3750中,步驟3740的結果(例如,區塊是否滿足最小圖像品質要求,例如最低聚焦程度)被記錄在結合於測試裝置(簡易起見不多加贅述)的電腦可讀取儲存媒體中(例如,可以是非暫態的,例如快速記憶(flash memory))。從校正處理程序獲得的知識可以,舉例來說,當測試裝置在之後的正常操作中被利用。在一個或更多實施例中,在正常的操作中(例如,於步驟3340中,如上討論)此時測試裝置可以自動地跳過或忽略那些在校正或自我診斷時未能達到最小圖像品質要求的區塊。這樣一來,在此揭示的測試裝置能減輕透鏡瑕疵的不良反應並增加分析精確性。
Back to the
圖41所揭示的是一測試載體攜帶一測試樣本的示例圖像,其可用於校正或驗證揭露於此的測試裝置。此技術可被應用在一或多個前述的實施例中,一個專門的虛擬盒能攜帶專門的測試樣本且校正模式能被視覺圖案以外
的觸發器啟動(例如使用者手動啟動,或由機械的特徵或是虛擬盒上的無線射頻辨識(RFID))。某一些實施例指出測試樣本應為水介質型式(例如,液態溶液)包含小型的測試粒子,例如在圖41中說明的測試粒子4102。這些微粒子可以被任何適合的物質所製成,包括,舉例來說聚合物。一特定的粒子4102實例物質為乳膠。粒子的尺寸可適合於特定的應用。在某些實施中,粒子的尺寸能與那些細胞,例如精子,的尺寸相似。粒子的實例尺寸範圍可從直徑0.5微米至50微米。在實例中,粒子為直徑5微米。當測試粒子作為樣本,此測試裝置可以如3700處理程序執行校正/自我診斷而不需步驟3720,且自我診斷當前安裝於自身的光學模組的品質。在這些當中的一些實施,此測試裝置可以預先安裝測試粒子的圖像(例如,非經相機擷取,例如,透過被傳輸或被其他方式程式安裝)於記憶體中,例如上述討論,以做出比較和校正目的。
Figure 41 shows an example image of a test sample carried by a test carrier, which can be used to calibrate or verify the test device disclosed herein. This technology can be applied to one or more of the aforementioned embodiments. A special virtual box can carry special test samples and the correction mode can be changed from the visual pattern.
The trigger is activated (for example, manually activated by the user, or by mechanical features or radio frequency identification (RFID) on the virtual box). Some embodiments indicate that the test sample should be in the form of an aqueous medium (for example, a liquid solution) containing small test particles, such as the
圖42A及42B說明在圖41中經擷取圖像的不同區塊中不同圖像品質。如同說明,圖42A中區塊中圖像品質較圖42B佳,因為圖像較為清晰且更加聚焦。與上述討論相似,關於步驟3750,每一區塊的基線圖像品質的知識可以用來,例如,當測試裝置在之後的正常操作時被利用。舉例來說,一些測試儀器的實施例可以自動地跳過或忽略那些在校正時未能達成最小圖像品質條件的區塊或自我診斷。這樣一來,在此揭露的測試裝置能減輕透鏡瑕疵的不良反應並改進分析準確性。
42A and 42B illustrate different image qualities in different regions of the captured image in FIG. 41. As explained, the image quality in the block in FIG. 42A is better than that in FIG. 42B because the image is clearer and more focused. Similar to the above discussion, with regard to
儘管本文所揭示之具體實例中之一些將所揭示之技術應用於精子測試,但一般熟習此項技術者容易瞭解,所揭示之技術可應用於測試各種類型之生物樣本,諸如精液、尿液、滑動關節液、表層組織或細胞、腫瘤細胞、水樣本等。 Although some of the specific examples disclosed in this article apply the disclosed technology to sperm testing, it is easy for those familiar with the technology to understand that the disclosed technology can be applied to test various types of biological samples, such as semen, urine, Sliding joint fluid, surface tissue or cells, tumor cells, water samples, etc.
熟習此項技術者將顯而易見,在不脫離本發明之範疇或精神之情況下可對本發明之結構進行各種修改及變化。鑒於前述內容,意欲本發明涵 蓋本發明的修改以及變化,只要其屬於以下申請專利範圍以及其等效內容的範疇。 It will be obvious to those familiar with the art that various modifications and changes can be made to the structure of the present invention without departing from the scope or spirit of the present invention. In view of the foregoing, it is intended that the present invention encompasses Cover the modifications and changes of the present invention as long as they fall within the scope of the following patent applications and their equivalent content.
2205:測試條帶器件 2205: test strip device
2210A:外罩 2210A: Cover
2210B:放大組件 2210B: Amplifying components
2215A:第一固持區域 2215A: The first holding area
2215B:第二固持區域 2215B: The second holding area
2230A:第一相機模組 2230A: The first camera module
2230B:第二相機模組 2230B: Second camera module
2240A:光源 2240A: light source
2240B:光源 2240B: light source
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US16/101,336 | 2018-08-10 | ||
US16/101,336 US10324022B2 (en) | 2016-05-11 | 2018-08-10 | Analysis accuracy improvement in automated testing apparatus |
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US20150078642A1 (en) * | 2012-04-24 | 2015-03-19 | The General Hospital Corporation | Method and system for non-invasive quantification of biologial sample physiology using a series of images |
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US20100050131A1 (en) * | 2003-04-08 | 2010-02-25 | Thomas Weise | Interface And Method For Exploring A Collection of Data |
US20150078642A1 (en) * | 2012-04-24 | 2015-03-19 | The General Hospital Corporation | Method and system for non-invasive quantification of biologial sample physiology using a series of images |
US20150300957A1 (en) * | 2014-04-22 | 2015-10-22 | Nanoscopia (Cayman), Inc. | Sample holder and system for using |
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