TWI707136B - Test strip module, screen protector, protective case, and method for measuring test strip of test strip module with mobile devices - Google Patents

Abstract

A test strip module includes a case, a test strip in the case, and a position anchor extending down past a mating surface to a face of a mobile computing device. The position anchor has a shape matching a feature on the face of the mobile computing device.

Description

Test strip modules, screen protectors, protective shells suitable for mobile computing vehicles and measurement of the test Method of a test strip in a strip module [Cross-reference related applications]

This patent application claims the U.S. Provisional Patent Application No. 61/940,500 filed on February 17, 2014, the U.S. Provisional Patent Application No. 61/944,306 filed on February 25, 2014, and the U.S. Provisional Patent Application No. 61/944,306 filed on July 17, 2014. Apply for the benefits of US Provisional Patent Application No. 62/025,883 and US Provisional Patent Application No. 62/044,886 filed on September 2, 2014, the entire contents of which are incorporated herein for reference.

The content disclosed in the present invention generally relates to methods and systems for photometric analysis of analytes on test strips.

The sample test strip has a reaction zone, which contains a reagent that reacts with the analyte in the sample sample, such as cholesterol or glucose in the blood sample. The reaction zone changes color according to the nature of the analyte, such as blood cholesterol or blood glucose concentration. The sample test strip is inserted into a meter that optically determines the characteristics of the analyte.

【Introduction】

In an example of the present invention, a test strip module includes a housing; a test strip in the housing; and a positioning anchor extending downward through a mating surface to a surface of a mobile computing vehicle . The positioning anchor has a shape that matches the features on the surface of the mobile computing vehicle.

100, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, 1302 (1302-1, 1302-2, 1302-3, 1302-4, 1302-5), 1404, 1504, 2500: test Strip module

102: Mobile computing vehicle; mobile phone; portable computing vehicle

104: Camera

106: ear speaker; ear speaker hole

108: screen

110: Noodles

112: processor

114: Non-volatile memory

116: volatile memory

117: photometric test strip analyzer

118: light source area

202, 602, 702, 1002, 1201, 2502: shell

204, 708, 1202: test strip

206: bottom cover

207, 208: Mating surface

207’, 208’: bottom surface

210: positioning feature; positioning anchor

212: Optical port

214: Camera port

400, 500, 2500: Variations

410, 920: positioning anchor

510: positioning feature; positioning hole

604: inner compartment

606: Outer Compartment

610, 710, 1118, 1120: ambient light

611, 711: Interface

612, 712, 1012: peripheral wall

704, 904: Skirt

922: matching hole

924: Noodle

926: Portable Computing Vehicle

1024: bottom interface

1104: sampling channel

1106: Shell Top

1108: Ceiling

1112: high-end

1113: second end

1114: low end

1115: first end

1204: tip

1206, 1902: reaction zone

1208: storage tank

1210: Observation window

1300: test strip packaging

1400: Screen protector

1402, 1502: slot or cut

1500: Protective shell

1600, 1800, 2000: method

1702: Banner

1904: color correction area

1906 (1906-1, 1906-2, 1906-3): sub-area

1908: Section

2100: Combination chart; chart

2202: hand

2302: top of the box

2400: Chart

2504: Finger guide

2506: sample collector

2508: fluid transport membrane

2510: Lancet Cover

2602: bottom

2604: Hydrophilic layer; Hydrophilic coating

2606: Channel

T1, T2, T3: time point

C1, C2, C3: color

(C1, T1): the first point

(C2, T2): second point

The foregoing and other features of the disclosure of the present invention are combined with the accompanying drawings, which will become more apparent from the following description and the scope of the attached patent applications. These diagrams only depict the There are several specific examples of the content, so it should not be seen as a limitation of its scope. The disclosed content will be described with clear instructions and details through the use of the attached drawings.

In the accompanying drawings: the first figure illustrates the top isometric view of the test strip module to be shared with the mobile computing vehicle in the example of the present invention; the second figure illustrates the first figure in the example of the present invention The bottom isometric view of the test strip module; the third figure illustrates the cross-sectional view of the first figure on the mobile computing vehicle in the first figure in the example of the present invention; the fourth figure illustrates The variation of the test strip module in the first figure in the example of the present invention; the fifth figure illustrates the variation of the test strip module in the first figure in the example of the present invention; the sixth figure is in this example The cross-sectional view of the test strip module with inner and outer compartments in the example of the invention; the seventh figure is the cross-sectional view of the test strip module with the skirt in the example of the present invention; the eighth figure is the cross-sectional view of the test strip module with the skirt in the example of the present invention The cross-sectional view of the test strip module of the skirt; Figure 9 is the cross-sectional view of the test strip module with positioning anchors on the skirt in the example of the present invention; A cross-sectional view of a test strip module with a fine or flexible bottom interface on one side of the computing carrier; Figure 11 is a cross-sectional view of a test strip module with an inclined sampling channel in the example of the present invention; Figure 12 is The cross-sectional view of the test strip module with the sample observation window in the example of the present invention; Figure 13 is the top view of the test strip package in the example of the present invention; Figure 14 is the top view of the test strip package in the example of the present invention. Slot to accept the test strip module The top view of the screen protector; Figure 15 is a top isometric view of the protective housing with a slot to receive the test strip module in an example of the present invention; Figure 16 is an example of the present invention The flow chart of the method for determining the properties of the analyte from the test strip in the test strip module of the photometric test strip analyzer executed by the processor in the mobile computing vehicle in the first figure; the seventeenth figure is illustrated in this In the example of the invention, the notification is limited to the specific edge of the mobile computing vehicle in the first figure; the eighteenth figure is one of the examples of the invention used to implement the measurement pre-test in the method in the sixteenth figure. Flow chart of the method; Figure 19 shows a test strip in the example of the present invention; Figure 20 is a test strip in the example of the present invention for performing calibration and measurement in the method in Figure 16 Flow chart of the method; Figure 21 illustrates the combination chart of the light intensity and camera response drawn in the calibration phase and the measurement phase in the example of the present invention; Figure 22 and Figure 23 are shown in How the test strip module in the example of the present invention may be shielded; Figure 24 is a graph of color values versus ambient illuminance for different values of analyte properties in the example of the present invention; 25 The figure is an isometric view of a variation of the test strip module in the first figure in the example of the present invention; and the twenty-sixth figure is the test strip model in the twenty-fifth figure in the example of the present invention Enlarged section view of the group.

As used in this specification, the term "including" means including but not limited to, and the term "including" means including but not limited to. The term "a" is intended to indicate at least one of the specific elements. The term "based on" means based at least in part on. The term "or" means non-exclusive unless otherwise indicated, so that "A or B" includes "Yes A but not B", "Yes B not A" and "Yes A and B".

The first figure illustrates that it will be shared with the mobile computing vehicle 102 in the example of the present invention A top isometric view of the test strip module 100 of. The mobile computing vehicle 102 has a camera 104; an ear speaker 106; and a screen 108, which is located on a side 110 (such as the front) of the mobile computing vehicle 102. On the face 110, the camera 104 may be located above the ear speaker 106. The ear speaker 106 may have the form of an aperture (as shown) or a protrusion (not shown) above the face 110. The mobile computing vehicle 102 includes a processor 112, a non-volatile memory 114, and a volatile memory 116. The non-volatile memory 114 stores program codes suitable for the photometric test strip analyzer 117. The mobile computing vehicle 102 can be a mobile phone, a tablet computer, or a laptop computer. The following "mobile phone 102" is used to represent a variation of the mobile computing vehicle 102.

The second figure illustrates a bottom isometric view of the test strip module 100 in the example of the present invention. The test strip module 100 has a housing 202 with an open bottom; a test strip 204 (shown in dashed lines), which is held inside the housing 202; and a bottom cover 206, which closes the open bottom of the housing 202. The casing 202 has a bottom surface 207', and the bottom cover 206 has a bottom surface 208', which can be not flush with the bottom surface 207' of the casing 202. The bottom cover 206 also has a positioning feature 210, which can be a positioning anchor extending downward through the mating surface of the test strip module 100 to the surface 110 of the mobile phone 102. The mating surface can be the bottom surface 207' or 208'. The positioning anchor 210 has a shape that matches the corresponding feature on the face 110 of the mobile phone 102 (first image), such as the ear speaker opening 106 (first image). The positioning anchor 210 may have a rectangular or oblong shape.

The bottom cover 206 defines the optical connection port 212 and the camera connection port 214. The optical connection port 212 allows the light emitted from the light source area 118 (the first figure) of the screen 108 to enter the test strip module 100 and illuminate the inside of the test strip module 100, including a reaction area on the test strip 204. The camera connection port 214 allows the camera 104 (the first figure) of the mobile phone 102 to capture images inside the test strip module 100, including the reaction area on the test strip 204. The camera connection port 214 can be located above the positioning anchor 210 to match the structure of the camera 104 and the features of the positioning anchor 210 on the mobile phone 102, such as the ear speaker hole 106. The optical connection port 212 and the camera connection port 214 may be ports or windows.

The third figure illustrates a cross-sectional view of the test strip module 100 on the mobile phone 102 in the example of the present invention. In use, the user places the mobile phone 102 flat on a horizontal surface, and places the test strip module 100 on the surface 110 of the mobile phone 102. Then, the user slides the test strip module 100 around on the surface 110 until the positioning anchor 210 engages the corresponding feature on the surface 110, for example, is folded into the ear speaker opening 106. When the positioning anchor 210 is folded into the ear speaker When the aperture 106 is in, the mating surface 207 or 208 can be in close contact with the surface 110, and the camera connection port 214 and the optical connection port 212 become completely aligned with the camera 104 and the light source area 118, respectively. Note that the exact shape and position of the positioning anchor 210 depends on the structure of the camera 104 and the ear speaker 106 of the mobile phone 102.

The fourth figure illustrates a modification 400 of the test strip module 100 (the first figure) in the example of the present invention. The test strip module 400 is similar to the test strip module 100, except that the positioning anchor 210 has been replaced with a positioning anchor 410 in a different position to match the position of the corresponding feature, such as the ear speaker on the face of another mobile phone hole.

The fifth figure illustrates a modification 500 of the test strip module 100 (the first figure) in the example of the present invention. The test strip module 500 is similar to the test strip module 100, except that the positioning anchor 210 has been replaced with a positioning feature 510, which can be a positioning hole defined by the bottom cover 206. The positioning hole 510 matches the structure of the corresponding feature, such as a protruding ear speaker on the surface of another mobile phone. In use, the user slides the test strip module 500 around the surface of the mobile phone until the positioning hole 510 engages the corresponding feature on the surface of the mobile phone, such as receiving the ear speaker protrusion. When the positioning hole 510 receives the protruding portion of the ear speaker, the mating surface 207 or 208 can be in close contact with the surface of the mobile phone, and the camera port 214 and the optical port 212 become the same on the surface of the mobile phone. The camera and the light source area are completely aligned.

The sixth figure is a cross-sectional view of the test strip module 600 in the example of the present invention. The test strip module 600 can be a variation of another test strip module in the content disclosed in the present invention, so the test strip module 600 can share components with other test strip modules. The test strip module 600 has a housing 602 with an open bottom, an inner compartment 604 and an outer compartment 606 surrounding at least part of the inner compartment 604. The test strip 204 is located in the inner compartment 604, and the outer compartment 606 shields the test strip 204 from ambient light 610, which can penetrate through the interface 611 between the peripheral wall surface 612 of the housing 602 and the surface 110 of the mobile phone 102 Leak to the interface where the test strip module 600 is placed. The outer compartment 606 captures and absorbs the ambient light 610, so the ambient light 610 does not illuminate the test strip 204 in the inner compartment 604. The outer compartment 606 may be textured or constructed of light-absorbing material. If there is no outer compartment 606, the ambient light 610 can interfere with the expected illumination from the light source area 118 of the screen 108 on the surface 110 (the third figure).

The seventh figure is a cross-sectional view of the test strip module 700 in the example of the present invention. The test strip module 700 can be a variation of another test strip module in the disclosure of the present invention, because The test strip module 700 can share components with other test strip modules. The test strip module 700 has a housing 702 with a peripheral wall 712 and a skirt 704 surrounding at least part of the peripheral wall 712. The test strip 204 is located in the housing 702, and the skirt 704 shields the test strip 204 from ambient light 710, which can leak to the test strip module through the interface 711 between the peripheral wall surface 712 and the surface 110 of the mobile phone 102 700 is placed on the interface. The skirt 704 can lie flat against the face 110 of the mobile phone 102. The skirt 704 captures and absorbs the ambient light 710 so that the ambient light 710 does not illuminate the test strip 204. The skirt 704 may have a texture or be composed of a light-absorbing material. Without the skirt 704, the ambient light 710 can interfere with the expected illumination from the light source area 118 of the screen 108 on the surface 110 (the third figure).

In some examples of the present invention, the skirt 704 is slidingly engaged with the housing 702. The skirt 704 can initially be stored in a retracted position inside the housing 702 (shown in dashed lines). In use, the skirt 704 can slide out from the retracted position to an extended position outside the housing 702.

The eighth figure is a cross-sectional view of the test strip module 800 in the example of the present invention. The test strip module 800 is similar to the test strip module 700 except that the skirt 704 is now hinged to the peripheral wall 712 of the housing 702. The skirt 704 can be initially stored in an upright position against the peripheral wall surface 712 of the housing 702 (illustrated by a dotted line). In use, the skirt 704 can be rotated from the upright position to a horizontal position against the surface 110 of the mobile phone 102 on which the test strip module 800 is placed.

Figure 9 is a cross-sectional view of the test strip module 900 in the example of the present invention. The test strip module 900 can be a variation of another test strip module in the disclosure of the present invention, so the test strip module 900 can share components with other test strip modules. The test strip module 900 has a skirt 904 surrounding at least part of the peripheral wall 712 of the housing 702. The skirt 904 may be similar to the skirt 704 (the seventh figure or the eighth figure). The skirt 904 has a positioning anchor 920, which extends downward from the skirt 904 and is folded in a matching hole 922 on the surface 924 of the portable computing carrier 926, instead of a bottom cover with positioning anchors or positioning holes . Alternatively, the skirt 904 defines a positioning hole (not shown) that receives a matching protrusion (not shown) on the face 924.

Figure 10 is a cross-sectional view of the test strip module 1000 in the example of the present invention. The test strip module 1000 can be a variation of another test strip module in the disclosure of the present invention, so the test strip module 1000 can share components with other test strip modules. The test strip module 1000 includes a housing 1002 with a peripheral wall 1012. The peripheral wall surface 1012 has a bottom interface 1024 which is in close contact with the surface 110 of the portable computing carrier 102 to prevent ambient light from passing through the bottom Any gap between interface 1024 and face 110 enters. In some examples, the bottom interface 1024 is sanded or otherwise processed to be smooth to have a roughness of 100 microns. In other examples, the bottom interface 1024 may be a flexible material, such as a soft polyurethane coating fixed on the body of the peripheral wall 1012.

Figure 11 is a cross-sectional view of the test strip module 1100 in the example of the present invention. The test strip module 1100 can be a variation of another test strip module in the content disclosed in the present invention, so the test strip module 1100 can share components with other test strip modules. The test strip module 1100 includes a housing 202 with the open bottom; a test strip 204 supported inside the housing 202; and a bottom cover 206 which closes the open bottom of the housing 202. The housing 202 defines a sampling (such as blood) channel 1104 from the outside to the inside of the housing 202, for example from the top 1106 to the ceiling 1108. The sampling channel 1104 is inclined with respect to the mating surface 207 or 208. The sampling channel 1104 has a high end 1112 with an inlet and a low end 1114 with an outlet. The sample enters the inlet at the high end 1112, travels through the sampling channel 1104, exits through the outlet at the low end 1114, and enters the reaction zone 1116 on the test strip 204.

The sampling channel 1104 is oriented so that the low end 1114 is located in or adjacent to the first end 1115 of the test strip module 1100 with the test strip 204 and the camera port 214, and the high end 1112 is located in the test strip module 1100 with the camera port 214 The second end 1113 is in or immediately adjacent to it. The first end 1115 may be the end far away from the user, and the second end 1113 may be the immediate end close to the user. When the ambient light 1118 comes from the front (or side) of the user during use, the ambient light 1118 will not be aligned with the sampling channel 1104 and therefore cannot enter the test strip module 1100 through the sampling channel 1104. When the ambient light 1120 comes from the back of the user, the ambient light 1120 is blocked by the user, and therefore cannot enter the test strip module 1100 through the sampling channel 1104.

Figure 12 is a cross-sectional view of the test strip module 1200 in the example of the present invention. The test strip module 1200 can be a variation of another test strip module in the disclosure of the present invention, so the test strip module 1200 can share components with other test strip modules. The test strip module 1200 includes a housing 1201 having an open bottom; a test strip 1202 located inside and outside the housing 1201 at the same time; and a bottom cover 206 that closes the open bottom of the housing 1201. The test strip 1202 has a tip 1204 located outside the housing 1201 for receiving samples, and a reaction zone 1206 and a storage tank 1208 located inside the housing 1201. The sample travels to the reaction zone 1206, and some samples are more oriented Go down to the storage tank 1208. The housing 1201 includes an observation window 1210 that can reach the storage tank 1208. When the user sees the sample in the observation window 1210, the user knows that the test strip 1202 has received a sufficient sample amount.

Figure 13 is a top view of the test strip package 1300 in the example of the present invention. Test strip package 1300 includes multiple test strip modules, such as test strip modules 1302-1, 1302-2, 1302-3, 1302-4, and 1302-5 (collectively referred to as "test strip modules 1302" or individually Universal test strip module "1302"). Each test strip module 1302 can be similar to any test strip module described in the disclosure of the present invention. The test strip module 1302 can share a common casing and a common bottom cover. The housing may have multiple compartments, each of which supports the test strip. The shell can slidably engage the bottom cover. The bottom cover defines the camera connection port and the optical connection port. The bottom cover has positioning features, such as positioning anchors or openings, which engage matching features, such as ear speaker openings or protrusions, on the face 110 of the mobile phone 102 to connect the camera connection port and The optical connection port is aligned with the camera 104 (first image) and the light source area 118 (first image) on the screen 108 (first image) of the mobile phone 102.

As shown in Figure 13, the housing can slide over the bottom cover to place one compartment at a time above the camera port and the optical port. The position of the compartment above the camera connection port and the optical connection port can be defined by latch mechanisms on the housing and the bottom cover, such as fastener protrusions and recesses. When a compartment is in place, the adjacent compartment or compartments can shield the compartment from ambient light.

Figure 14 is a top view of the screen protector 1400 for the mobile phone 102 in the example of the present invention. The screen protector 1400 defines a slot or cutout 1402 for receiving and positioning the test strip module 1404 above the camera 104 (first image) and the light source area 118 (first image) on the screen 108 of the mobile phone 102. The test strip module 1404 can be any test strip module described in the disclosure of the present invention.

Figure 15 is a top isometric view of the protective housing 1500 for the mobile phone 102 in an example of the present invention. The protective housing 1500 defines a slot or cutout 1502 for receiving and positioning the test strip module 1504 above the camera 104 (first image) and the light source area 118 (first image) on the screen 108 of the mobile phone 102. The test strip module 1504 can be any of the test strip modules described in the disclosure of the present invention.

The sixteenth figure is a photometric test strip analyzer 117 (first figure) executed by the processor 112 (first figure) on the mobile phone 102 in the example of the application content of the present invention. The flow chart of the method 1600 for the test strips in the group (for example, the test strip 204 in the test strip module 100 in the first figure) to determine the properties of the analyte (for example, cholesterol or glucose concentration). The method 1600 may include one or more operations, functions, or actions, which are exemplified by one or more steps. Although the steps of the method 1600 and other methods described in the text are illustrated in a sequential order, these steps can also be performed in parallel or in a different order than described in the text. In addition, the various steps can be combined into fewer steps, divided into additional steps, or removed based on the desired implementation. The method 1600 starts at step 1602.

In step 1602, the processor 112 receives user input to run the photometric test strip analyzer 117. In response, the processor 112 executes the program code suitable for the photometric test strip analyzer 117. Step 1602 is followed by step 1604.

In step 1604, the processor 112 limits the notification (such as a banner) on the mobile phone 102 to a position away from the light source area 118 (the first image) on the screen 108 (the first image).

The seventeenth figure illustrates a banner 1702 that usually appears at the short top edge of the mobile phone 102 in the example of the present invention. It can be seen that the banner 1702 will replace the light source area 118 also located on the short top edge of the screen 108. To avoid this situation, even if the photometric test strip analyzer 117 is actually running in the vertical direction, the processor 112 will lock the mobile phone 102 in the horizontal direction, so the banner 1702 appears on the long side of the screen 108. In other examples, the processor 112 may change the banner 1702 to a warning that appears in the middle of the screen 108 instead of the short top edge of the screen 108. In other examples, when the operating system (OS) of the mobile phone 102 allows, the processor 112 may temporarily shut down or delay notification for other applications.

Please refer to Figure 16 again, step 1604 continues with step 1606.

In step 1606, the processor 112 performs a measurement pre-test to determine whether the mobile phone 102 has appropriate settings to determine the analyte properties. Step 1606 is followed by step 1608.

In step 1608, the processor 112 determines whether the mobile phone 102 has passed the measurement pre-test. If it has not passed, step 1608 continues with step 1610. Otherwise, step 1608 continues with step 1612.

In step 1610, the processor 112 suggests to display a message on the screen 108 Change the setting of the mobile phone 102.

Figure 18 is a flowchart of a method 1800 for implementing steps 1606, 1608, and 1610 of the method 1600 in an example of the present invention. The method 1800 starts at step 1802 and continues with step 1604 in the method 1600.

In step 1802, the processor 112 determines whether the mobile phone 102 is in the flight mode. In this flight mode, the wireless connection and service are closed, so the mobile phone 102 does not receive it, otherwise it will interrupt the photometric test strip analyzer 117 (first picture) and change the light provided by the light source area 118 (first picture) Color call. If the mobile phone 102 is not in the flight mode, step 1802 continues with step 1804. Otherwise, step 1802 continues with step 1806.

In step 1804, the processor 112 suggests to turn on the flight mode by displaying a message on the screen 108. The processor 112 may leave the photometric test strip analyzer 117 or loop back to step 1802 to determine whether the user has activated the flight mode. Alternatively, the processor 112 may automatically turn on the flight mode and proceed to step 1806.

In step 1806, the processor 112 determines whether the battery capacity of the mobile phone 102 is greater than the threshold. The threshold ensures that the mobile phone 102 has enough energy to determine the analyte properties. If the battery capacity of the mobile phone 102 is not greater than the threshold, step 1806 continues with step 1808. Otherwise, step 1806 continues with step 1810.

In step 1808, the processor 112 suggests charging the mobile phone 102 by displaying a message on the screen 108. The processor 112 may leave the photometric test strip analyzer 117 or loop back to step 1806 to determine whether the battery capacity is now greater than the critical value.

In step 1810, the processor 112 determines whether the mobile phone 102 is running on the internal battery. When the mobile computing vehicle 102 is plugged into a wall socket, the power fluctuations in the main power supply can change the light source area 118 (first image) of the screen 108 (first image) and the photosensitive element of the camera 104 (first image) in response to what is provided Light. If the mobile phone 102 is not running on the internal battery, step 1810 continues with step 1812. Otherwise, step 1810 continues with step 1814.

In step 1812, the processor 112 suggests to unplug the mobile phone 102 from the wall socket by displaying a message on the screen 108. The processor 112 may leave the photometric test strip analyzer 117 or loop back to step 1810 to determine whether the mobile phone 102 is now running on the internal battery.

In step 1814, the processor 112 determines whether the ambient illuminance is less than a critical value. When the ambient illuminance is high, it can leak into the test strip module 100 and interfere with the light provided by the light source area 118 of the screen 108. The processor 112 can use the camera 104 to sense the ambient illuminance, which is not covered by any test strip module at this point, and record it as needed for further use in this measurement phase. If the ambient illuminance is not less than the critical value, step 1814 continues with step 1816. Otherwise, step 1814 continues with step 1612 in method 1600.

In step 1816, the processor 112 suggests moving or blocking the mobile phone 102 by displaying a message on the screen 108. The processor 112 may leave the photometric test strip analyzer 117 or loop back to step 1814 to determine whether the ambient illuminance is now less than the critical value.

Please refer to Figure 16 again. In step 1612, the processor 112 detects the test strip 204 in the test strip module 100 after the test strip module 100 is placed on the mobile phone 102. The processor 112 uses the camera 104 to capture the internal image of the test strip module 100 and illuminate the light source area 118 inside the test strip module 100 to detect the test strip 204, and in the image based on the shape, color or color intensity Find candidates similar to test strip 204.

Figure 19 shows the test strip 204 in the example of the present invention. The test strip 204 includes a reaction zone 1902 and a color correction zone 1904. The reaction zone 1902 may include sub-zones 1906-1, 1906-2, and 1906-3 (collectively referred to as "subarea 1906"), which are directed to different numerical ranges of one or more properties of different analytes. The sub-regions 1906 may have the same color or different colors before introducing the sample. The color correction area 1904 may have a known color or color intensity, or include sub-areas of a known color or color intensity.

Once the processor 112 (the first image) finds a candidate similar to the test strip 204 in the image, the processor 112 obtains the section 1908 of the area where the reaction area 1902 should be located on the candidate, and determines whether the section includes Different colors match the different colored parts of sub-regions 1906-1, 1906-2 and 1906-3.

Please refer to the sixteenth figure again. In step 1614, the processor 112 determines whether the test strip 204 has been correctly positioned. The test strip 204 is aligned with the camera 104 and the light source area 118 when the cross section 1908 includes the different color parts of the different colors of the matching sub-region 1906. If this is not the case, step 1614 continues with step 1616. Otherwise, step 1614 continues with step 1618.

In step 1616, the processor 112 suggests to move the test strip module 100 by displaying a message on the screen 108. The processor 112 may loop back to step 1612 to determine the test strip 204 Is it positioned correctly now?

In step 1618, the processor 112 locks the white balance setting of the camera 104 to a known value. When the OS of the mobile phone 102 does not allow the processor 112 to set the white balance setting, the processor 112 can make the camera 104 shoot the first image in low light (for example, the light source area 118 is off), and then immediately under normal lighting (If the light source area 118 is turned on) shoot a second image, and temporarily lock the white balance setting to the known value. In a short period of time immediately after the camera 104 captures the first image under low light, the white balance setting will be maintained at the known value, so the second image is also captured at this known white balance setting. For example, the white balance setting in low light can provide a 1:1:1 ratio of red, green and blue (RGB). Step 1618 is followed by step 1620.

In step 1620, the processor 112 performs the correction of the lighting conditions inside the test strip module 100. Step 1620 is followed by step 1622.

In step 1622, the processor 112 determines whether the lighting conditions inside the test strip module 100 have passed the correction. If it fails, step 1622 continues with step 1624. Otherwise, step 1622 continues with step 1626.

In step 1624, the processor 112 suggests to move the mobile phone 102 or shield the test strip module 100 by displaying a message on the screen 108. The processor 112 may loop back to step 1620 to determine whether the lighting condition inside the test strip module 100 has now passed the calibration.

In step 1626, the processor 112 performs the measurement of the test strip 204. In the measurement, the processor 112 uses the camera 104 to take an image of the reaction area on the test strip 204, determine one or more color characteristics of the reaction area, correct the one or more color characteristics, and correct the One or more past color characteristics are associated with the analyte property. Step 1626 is followed by step 1628.

In step 1628, the processor 112 displays the result on the screen 108.

Figure 20 is a flowchart of a method 2000 for implementing steps 1620, 1622, 1624, and 1626 of the method 1600 in an example of the present invention. The method 2000 may start from step 2001, which continues with step 1618 in method 1600.

In step 2001, the processor 112 enters the calibration stage, and uses the camera 104 to shoot a series of images under the light of a specific pattern and the incremental intensity provided by the light source area 118. The light source area 118 is increased from off to fully opened. In some examples, the light intensities include 0, 0.2, 0.4, 0.6, 0.8, and 0.9. In other examples, the incremental light intensities only include 0 and 0.9. The The light pattern may be a square, triangle, or another shape that uniformly illuminates the test strip 204 (as shown in the nineteenth figure) due to the internal geometry of the test strip module 100. Step 2001 is followed by step 2002.

In step 2002, the processor 112 linearizes the camera's response for all color channels based on the images captured in step 2001. The image sensor of the camera 104 may have non-linearity at these extreme values of its range. Linearize the camera's response to correct the nonlinearity to provide actual color channel values. Step 2002 is followed by step 2004.

In step 2004, the processor 112 is based on the first image taken when the light source area 118 is turned off (such as light intensity=0) and the second image taken when the light source area 118 is turned on (such as light intensity=0.9) in the image series. The color correction area 1904 of the test strip 204 taken on the image (as shown in the nineteenth figure) determines the ambient light effect. The color correction area 1904 has actual color channel values that are known to the processor 112.

The twenty-first figure illustrates a combination chart 2100 with an upper chart plotting light intensity over time in the calibration phase and the measurement phase and a lower chart plotting the camera response for the color channel over the same time in the example of the present invention. The values in chart 2100 are provided for illustrative purposes. The camera response may be the average of the color channel values in the regions in the first and the second images corresponding to the color correction area 1904 with known color channel values.

In the calibration phase of this example, the camera responds with the color channel value of C _OFF when the light source area 118 is closed due to the ambient light leaking into the test strip module 100 (for example, light intensity=0). The camera response has a value of C _on when the light source area 118 is on (for example, the light intensity is 0.9). The following formula can be used to determine the corrected color channel value without the ambient light effect:

or

Where C _off is the detected color channel value of the color correction area 1904 when the light source area 118 is turned _off during the correction phase, and C _on is the detected color channel value of the color correction area 1904 when the light source area 118 is turned _on during the correction phase C _actual is the actual color channel value of the color correction area 1904, and C _detected is the _detected area (such as the reaction area 1902 in Figure 19) when the light source area 118 is turned on during the measurement phase The measured color channel value, and C _corrected is the _corrected color channel value for the desired area during the measurement phase.

Please refer to the twentieth diagram again, step 2004 continues step 2006.

In step 2006, the processor 112 determines whether the ambient light effect is greater than a critical value. The ambient light effect is represented by the color channel value C _detected when the light source area 118 is turned off during the calibration phase. High ambient light effects can result in detected color channel values that cannot be corrected. When the ambient light effect is greater than the critical value, step 2006 continues to step 2008, otherwise step 2006 continues to step 2010.

In step 2008, the processor 112 suggests to move the mobile phone 102 or shield the test strip module 100 by displaying a message on the screen 108.

Figures 22 and 23 show how the test strip module 100 can be shielded in the example of the present invention. In the twenty-second figure, the user places the hand 2202 above the test strip module 100 to shield it from ambient light. In the twenty-third figure, the user places the box top 2302 above the test strip module 100. The top 2302 of the box may be part of the test strip module 100 package.

Please refer to the twentieth figure again, and the processor 112 may loop back to step 2001 to calibrate the camera 104 again.

In step 2010, the processor 112 enters the measurement phase and causes the mobile phone 102 to vibrate after the sample is introduced into the sample inlet on the test strip module 100. The vibration helps to move the sample to the test strip 204 through the sampling channel 1104 (Figure 11). Step 2010 is continued from step 2012.

In step 2012, the processor 112 captures at least one image of the reaction area 1902 on the test strip 204 when the light source area 118 is turned on, and detects at least one color characteristic of the reaction area. In some examples of the present invention, as shown in FIG. 21, the processor 112 captures two images of the reaction area 1902 at time points T1 and T2, and detects the two colors C1, C2 of the reaction area 1902. Step 2012 continues with step 2014. In some examples, as shown in FIG. 21, the processor 112 captures an image of the reaction area 1902 at T3, and detects the color C3 of the reaction area 1902.

In step 2014, the processor 112 corrects the detected one or more colors to remove the ambient light effect in the value. Step 2014 continues with step 2016.

In step 2016, the processor 112 turns off the corrected one or more colors Link to the analyte properties. In these examples with two corrected colors, the processor 112 determines the slope of the line between the first point (C1, T1) and the second point (C2, T2), and maps the slope to The graph of the analyte property value correlates the slope to the analyte property.

In some examples of the present invention, the processor 112 does not correct the color of the reaction area by removing the ambient light effect. Instead, the processor 112 uses the known one or more colors of the color correction area 1904 and the detected one or more colors of the correction area 1904 to readjust the detected colors of the reaction area 1902 colour. The re-adjusted color of the reaction zone 1902 will include the ambient light effect. Then, the processor 112 uses a chart that maps the re-adjusted color value and ambient illuminance to the properties of the analyte, and the re-adjusted color and the ambient illuminance detected in step 1814 (Figure 18) The degree is related to the properties of the analyte. The twenty-fourth diagram illustrates a diagram 2400 in the example of the present invention. In the graph 2400, multiple lines representing different analyte properties (such as blood glucose concentration) are drawn with color values relative to the ambient illuminance. This chart can be tested experimentally for different mobile phones, and stored with the photometric test strip analyzer 117 or downloaded as required.

Please refer to the twentieth figure again, and step 2016 follows step 1628 in method 1600.

Figure 25 shows a variation 2500 of the test strip module 100 (Figure 1) in the example of the present invention. Figure 26 shows a partial cross-section of the test strip module 100 in the example of the present invention. The test strip module 2500 has a housing 2502. The top of the housing 2502 defines a finger guide 2504 and a sample collector 2506. A fluid transport membrane 2508 is fixed on the top of the housing 2502 adjacent to the sample collector 2506. A lancet cover 2510 can be folded into the housing 2502 to seal and protect the lancet inside the housing 2502.

The sample collector 2506 may have the shape of a half funnel. The finger guide 2504 may be a V-shaped inclined surface with a side wall that shrinks toward the round edge of the sample collector 2506, and the inclined surface slopes downward toward the round edge of the sample collector 2506. The fluid transport membrane 2508 abuts against the opening half of the funnel-shaped sample collector 2506. In use, the user slides his finger along the finger guide 2504 toward the sample collector 2506, and then leaves the sample in the sample collector 2506. Please refer to Figure 26, the sample will be collected at the bottom 2602 of the sample collector 2506. The position of the hydrophilic layer 2604 on the back of the fluid transport membrane 2508 is adjacent to the bottom 2602 of the sample collector 2506, The sample is transported laterally from the bottom 2602 to the channel 2606 in the housing 2502. The channel 2606 is defined by the housing 2502 between the hydrophilic layer 2604 and the test strip 204. The sample travels from the hydrophilic layer 2604 down the channel 2606 to the test strip 204. The fluid transport film 2508 may be a polyester film (Mylar) with a hydrophilic coating 2604 on one side.

It should be understood from the foregoing that various specific embodiments of the present invention are only described in this specification, and various modifications can be made without departing from the scope and spirit of the present invention. Therefore, the various specific embodiments disclosed in this specification are not intended to be limited to the actual scope and spirit indicated by the scope of the patent application later.

100: Test strip module

202: shell

204: Test Strip

206: bottom cover

207, 208: Mating surface

210: positioning anchor

212: Optical port

214: Camera port

Claims (19)

A test strip module, which is positioned above a part of a screen of a camera and a mobile phone, includes: a housing; a test strip in the housing, the test strip includes a reaction zone, and A reagent that is in contact with the sample and will react with an analyte of the sample; and a positioning anchor extending downwards through a mating surface to a surface of a mobile computing vehicle, wherein the positioning anchor includes a shape, which Match a feature on the surface of the mobile computing vehicle. For example, the test strip module of item 1 of the scope of patent application further includes a bottom cover to close an open bottom of the housing, the housing includes a first bottom surface and the bottom cover includes a second bottom surface, the mating surface Is the first bottom surface or the second bottom surface. For example, the test strip module of item 2 of the scope of patent application, wherein the positioning anchor bolt extends downward from the second bottom surface. For example, the test strip module of item 3 of the scope of patent application, in which the bottom cover defines: a camera connection port, which is opposite to the test strip; and an optical connection port. For example, the test strip module of item 1 of the scope of patent application, wherein the positioning anchor includes a rectangular or oblong protrusion. For example, the test strip module of item 1 of the scope of patent application, wherein the shell includes an inner compartment; and an outer compartment, which surrounds the inner compartment, and the test strip is located in the inner compartment and the outer compartment Shield the test strip from an ambient light. For example, the test strip module of item 1 in the scope of patent application, wherein the feature includes an ear speaker hole and the mobile computing vehicle includes a mobile phone. For example, the test strip module of item 1 of the scope of patent application further includes a skirt part surrounding the housing, and the skirt part shields the test strip from an ambient light. For example, the test strip module of item 8 of the scope of patent application, wherein the skirt includes a sliding member that is engaged with the housing, and the skirt can move from a retracted position inside the housing to a position outside the housing An extended position. For example, the test strip module of item 8 in the scope of patent application, wherein the skirt is hinged to the shell, and the skirt can rotate to a horizontal position against the upright position of the shell. For example, the test strip module of item 8 of the scope of patent application, wherein the positioning anchor bolt protrudes downward from the skirt. For example, the test strip module of item 1 in the scope of patent application, the mating surface is easy to twist. For example, the test strip module of item 1 in the scope of the patent application, wherein the mating surface includes a roughness of 100 microns. For example, the test strip module of item 1 of the scope of patent application, wherein the shell defines a sampling channel of the test strip, and the sampling channel is inclined with respect to the mating surface. For example, the test strip module of item 14 of the scope of patent application, in which the sampling channel is oriented so that a lower end of the sampling channel is located in a first end of the test strip module having a test strip 204 and a camera port or It is adjacent to it, and a high end of the sampling channel is located in or adjacent to a second end of the test strip module with a camera port. For example, the test strip module of item 1 of the scope of patent application, wherein: the test strip includes a reaction zone and a storage tank, which downwardly from the reaction zone to receive a part of the sample flowing through the reaction zone; and the shell Contains a top, which defines an observation window that opens to the tank. For example, the test strip module of item 2 of the scope of patent application, wherein the housing includes multiple compartments, each of which has a test strip, and the housing can slidably engage the bottom cover. For example, the test strip module of item 1 of the scope of patent application, wherein the housing defines a sample collector and a finger-shaped guide, which guides the sample collector; and the test strip module further includes a fluid transport membrane , Which is on the housing adjacent to the sample collector. For example, the test strip module of item 18 of the scope of patent application, wherein: the sample collector has a shape of a half-cut funnel; the finger guide has an inclined side wall, which shrinks toward a round edge of the sample collector, and the inclined surface The rounded side of the sample collector is inclined downward; the fluid transport membrane is adjacent to an opening half of the sample collector, and the fluid transport membrane has A hydrophilic layer adjacent to a bottom of the sample collector; and the shell defines a channel between the hydrophilic layer and the test strip.

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