TWI490476B - Method and apparatus for analyte measurement - Google Patents

Description

Method and apparatus for analyte measurement

The present disclosure is generally directed to methods and systems for analyte measurement. 【Background technique】

The first figure shows a sample test strip 100 having a reaction zone 102. Reaction zone 102 contains reagents that react with analytes in a sample sample, such as glucose in a blood sample. When the sample sample reaches reaction zone 102, reaction zone 102 changes color depending on the analyte characteristics, such as glucose levels in the blood. The user visually compares the color of reaction zone 102 to chart 104 to correlate the color of reaction zone 102 with the analyte property. Alternatively, the user inserts the sample test strip 100 into a meter that optically determines the characteristics of the analyte.

[brief]

In accordance with an aspect of the present disclosure, a method of a portable computing device for reading a reaction zone on a test strip located in a peripheral device of a test strip placed over an image sensor and a light source of the portable computing device is provided. Light is provided by the source and the peripheral device directs it to the reaction zone. An image including the reaction zone is captured by the image sensor. The analyte characteristics are determined based on the color of the captured reaction zone in the image.

According to another aspect of the disclosure, the test strip peripheral device is placed above the image sensor and the light source of the portable computing device to assist the portable computing device to read the reaction zone on the test strip in the peripheral device. . The peripheral device includes a light guide for directing light from the light source to the test strip; and an alignment component to assist the image sensor and the peripheral device of the light source relative to the portable computing device Placement.

In accordance with other aspects of the present disclosure, the test strip detects analyte characteristics in a sample of the sample. The test strip includes a reaction zone to receive the sample of the sample; and a conductive gel point that is to be detected by the touch screen. Information about the test strip is communicated based on the configuration of the smart points, the orientation of the smart points, or both.

100‧‧‧Sample test strip

102‧‧‧Reaction zone

104‧‧‧Chart

200A, 200B‧‧‧ system

202‧‧‧Test strip

204‧‧‧Portable computing device; device

206A‧‧‧screen; touch screen

206B‧‧‧Flash

208‧‧‧Image sensor

210‧‧‧ Non-transitory computer readable media

212‧‧‧Application

214‧‧‧ processor

216A, 216B‧‧‧ test strip peripherals; peripherals

218A, 218B‧‧‧ Light guide

220‧‧‧ color filter

300, 400, 500‧‧‧ test strip peripherals; peripherals

302, 402, 502, 602, 702‧‧‧ test strip slots or compartments

304, 404, 504, 604, 704‧‧ ‧ light guide

306, 406, 506, 606, 706‧ ‧ aligning parts

308, 408, 508, 608, 708‧‧ color filters

310‧‧‧reflecting surface of light guide body 304

312‧‧‧ Edge of device 204

412‧‧‧Incoming surface of light guide body 404

414‧‧‧ the exit surface of the light guide

510‧‧ ‧ the first reflecting surface of the light guiding body 504; the reflecting surface

512‧‧‧the second reflecting surface of the light guiding body; reflecting surface

600, 700‧‧‧ peripheral devices

610‧‧ ‧ the first reflecting surface of the light guiding body 604; the reflecting surface

612‧‧‧the second reflecting surface of the light guiding body; reflecting surface

800‧‧‧Integrated structure test strip peripheral device; peripheral device

802‧‧‧ test strip

804‧‧‧Light guide

806‧‧‧Alignment parts

902‧‧ Alignment mark

904‧‧‧Test strip peripherals; peripherals

1000A, 1000B, 1000C, 1100A, 1100B, 1100C‧‧‧ test strips

1002, 1102‧‧‧Reaction zone

1004A, 1004B, 1004C‧‧‧ reference area

1104A, 1104B, 1104C‧‧‧ color correction area

1202‧‧‧Test strips or test strip peripherals; test strips or peripherals

1204‧‧‧Electrified machine point; smart point; coding

1400A, 1400B‧‧‧ test strips

1402‧‧‧Reaction zone

1404A‧‧‧Temperature Sensor

1404B‧‧‧ Temperature indication zone

1500‧‧‧Test strips or test strip peripherals; test strips or peripherals

1502‧‧‧ test strip

1504‧‧‧Light guide

1506‧‧‧Integrated structure lancet

1600‧‧‧Test strips or test strip peripherals; test strips or peripherals

1602‧‧‧ lancet

1700‧‧‧Test strip peripherals; peripherals

1701‧‧‧ hollow housing; housing

1702‧‧‧Slots

1704‧‧‧reflective interior

1706‧‧‧Alignment parts

1708‧‧‧Top opening

1709‧‧‧Capillary

1710‧‧‧U-shaped guide

1802‧‧‧ border

1804‧‧‧Reaction zone

1806‧‧‧ Part of screen 206A

1808‧‧‧ capture button

1900‧‧‧ method

1902, 1904, 1906, 1908, 1910‧‧‧ blocks

2002, 2004‧‧‧Parts of different strengths or colors

2006‧‧The first part of the reaction zone

2008‧‧‧Light of first intensity or color

2010‧‧The second part of the reaction zone

2012‧‧‧second intensity or color of light

2100‧‧‧Test strip peripherals; peripherals

2101‧‧‧Shell

2102‧‧‧ compartment; recessed area

2104‧‧‧reflective interior

2106‧‧‧Alignment parts

2108‧‧‧ hollow body; body

2110‧‧‧ cover; housing cover

2112‧‧‧Opening

2114‧‧‧Top opening

2116‧‧‧ Capillary

The foregoing description of the present invention and other features of the invention will be apparent from the It should be understood that the drawings are only illustrative of the specific embodiments of the invention, and therefore, Reveal the content.

In the drawings: the first figure shows a prior art sample test strip; the second and second B figures show that each of the examples disclosed herein includes a portable computing device and a test strip peripheral device A system for assisting the portable computing device to read the test strip; the third figure shows a side view of the peripheral device of the first test strip for the portable computing device in the example of the disclosure of the present invention; A side view of a second test strip peripheral device for a portable computing device in an example of the disclosed invention; a fifth diagram showing a third test strip peripheral device for a portable computing device in an example of the disclosed content a side view; a sixth view showing a side view of a fourth test strip peripheral device for a portable computing device in an example of the present disclosure; a seventh figure showing an example for carrying in an example of the disclosed content of the present invention Side view of the fifth test strip peripheral of the computing device; Figures 8A and 8B show the sixth test strip peripheral for the portable computing device in an example of the disclosed content A side view and a top view; the ninth figure shows a portable computing device screen having an alignment mark that facilitates placement of the peripherals of the test strip in an example of the disclosed content; FIGS. 10A, 10B, and 10C show Test strips having reaction and reference regions in an example of the disclosure of the present invention; panels 11A, 11B and 11C show test strips having reaction and color correction regions in an example of the disclosed subject matter ; Figure 12A shows a conductive clever point on a test strip or test strip peripheral device in an example of the disclosure of the present invention; twelfth B, twelve C, twelve D and twelve E diagrams are shown in the present invention Different types of smart points in the examples of the disclosed content; the thirteenth, thirteenth, and thirteenth Cth views show different configurations of the smart points in the examples of the present disclosure; the fourteenth A is shown in A test strip having a reaction zone and a temperature sensor in an example of the disclosure of the present invention; a fourteenth B diagram showing a test strip having a reaction and temperature indicating zone in an example of the disclosure of the present invention; A seventh test strip peripheral device for a portable computing device in an example of the disclosed content; a sixteenth graph showing an eighth test strip peripheral device for a portable computing device in an example of the disclosed content The seventeenth, seventeenth, seventeenth, seventeenth, and seventeenth Dth views show perspective, top, bottom, and side views of the ninth test strip peripheral device in an example of the disclosed content; In the scope of the disclosure of the present invention a screen of a portable computing device; a nineteenth embodiment is a method for a portable computing device to read a test strip placed in a peripheral device of a test strip placed on the portable computing device in an example of the disclosed content a flowchart showing a portable computing device in an example of the disclosed content; and a twenty-first A, twenty-one, twenty-one, twenty-one, and twenty-one A first perspective view, a second perspective view, a top view, and a side view of the tenth test strip peripheral device in an example of the present disclosure.

As used herein, the term "includes" is used to include, but not limited to, the term "including" is meant to include, but not limited to. The terms "a (a)" and "an" (an) To indicate at least one of a particular component. The term "based on" means at least partially based.

Second Panel A shows a system 200A for detecting analyte characteristics on test strip 202 in an example of the present disclosure. System 200A includes a portable computing device 204, such as a smart phone or tablet. Device 204 has a screen 206A (eg, a touch screen), a flash 206B, an image sensor 208 (shown in phantom), and a non-transitory computer readable program for storing processor executable instructions (shown in dashed lines) A media 210 (shown in phantom) and a processor 214 (shown in dashed lines) running the application are taken. Executing the application 212, the processor 214 illuminates the reaction zone on the test strip 202 with the light from the screen 206A, captures the image of the reaction zone by the image sensor 208, and determines the captured reaction zone in the image. The color determines the analyte characteristics based on the color of the captured reaction zone in the image.

System 200A includes a test strip peripheral 216A that assists device 204 in reading the reaction zone on test strip 202. Peripheral device 216A includes a light guide 218A that directs light from screen 206A to the reaction zone on test strip 202.

Second B shows a system 200B for detecting analyte characteristics on test strip 202 in an example of the disclosed invention. System 200B includes device 204 and a test strip peripheral device 216B. Executing the application 212, the processor 214 illuminates the reaction zone on the test strip 202 with light from the flash 206B (shown in phantom), captures the image of the reaction zone with the image sensor 208, and determines the location in the image. The color of the reaction zone is captured and the analyte characteristics are determined based on the color of the captured reaction zone in the image.

Peripheral device 216B includes a light guide 218B that directs light from flash 206B to the reaction zone on test strip 202. Peripheral device 216B includes a color filter 220 (shown in phantom) to control the color of the light that illuminates the reaction zone on test strip 202.

The third figure shows a test strip peripheral device 300 for the device 204 in an example of the present disclosure. Peripheral device 300 includes a test strip slot or compartment 302 to receive test strip 202; a light guide 304 to direct light from a light source, such as screen 206A or flash 206B, to a reaction zone on the test strip; An alignment component 306 is provided to aid placement of the peripheral device on the portable computing device. When the flash 206B is used as a light source, the peripheral device 300 includes a color filter 308 to control the color of the light that illuminates the reaction zone on the test strip 202.

Light is emitted upward from screen 206A or flash 206B, and filtered as needed. The 308 is reflected obliquely downward from the reflective surface 310 of the light guide 304 through the reaction zone on the test strip 202 and illuminates the image sensor 208.

In some examples, the light guide body 304 is a transparent block and the reflective surface 310 is a beveled edge of the transparent block that is reflected by total internal reflection (TIR) or reflective coating. The light guide 304 can be covered by the housing or by coating to prevent ambient light from entering, thus substantially illuminating the reaction zone on the test strip 202 by the screen 206A or flash 206B. In other examples, light guide 304 is a reflective interior in the hollow housing of peripheral device 300, and reflective surface 310 is the reflective inner surface. The hollow housing blocks ambient light such that the reaction zone on test strip 202 is substantially illuminated by screen 206A or flash 206B.

The color filter 308 is located above a portion of the screen 206A or flash 206B. In other examples, color filter 308 is located above test strip 202.

The alignment component 306 abuts the edge 312 of the device 204 to place the test strip 202 over the image sensor 208, and the reflective surface 310 of the light guide 304 is placed over a portion of the screen 206A or flash 206B. In other examples, the alignment component 306 can be received in an opening in the device 204, such as a speaker aperture or a headphone jack.

The fourth figure shows a test strip peripheral device 400 for the device 204 in an example of the present disclosure. The peripheral device 400 includes a test strip slot or compartment 402 for receiving the test strip 202; a light guide 404 for directing light from the screen 206A or flash 206B to the reaction zone on the test strip; and an alignment component 406 to assist in placement of the peripheral device on the portable computing device. When the flash 206B is used as a light source, the peripheral device 400 includes a color filter 408 to control the color of the light that illuminates the reaction zone on the test strip 202.

Light is emitted from the screen 206A or the flash 206B, passes through the color filter 408 as needed, and is transmitted from the incident surface 412 of the light guide 404 to the exit surface 414 of the light guide, and is obliquely reflected downward from the reaction zone on the test strip 202. The image sensor 208 is illuminated.

The light guide body 404 is tilted such that the entrance face 412 is located above a portion of the screen 206A or flash 206B and the exit face 414 is located below the reaction zone on the test strip 202. In some examples, light guide 404 is a transparent block that constrains light by total internal reflection (TIR) or reflective coating on its surface. In other embodiments, the light guide 404 is hollow and constrains light by reflective coating on its surface. Can cover the light guide body by coating or by coating 404 to prevent ambient light from entering, such that the reaction zone on test strip 202 is substantially illuminated by screen 206A or flash 206B.

The color filter 408 is located above a portion of the screen 206A or flash 206B. In other examples, color filter 408 is located below the reaction zone on test strip 202.

The alignment component 406 is adjacent to the edge 312 of the device 204 to place the test strip 202 over the image sensor 208 and the light guide 404 above a portion of the screen 206A or flash 206B. In other examples, the alignment component 406 can be received in an aperture in the device 204, such as a speaker aperture or a headphone jack.

The fifth figure shows a test strip peripheral device 500 for the device 204 in an example of the present disclosure. Peripheral device 500 includes a test strip slot or compartment 502 for receiving test strip 202; a light guide 504 to direct light back and forth to the image sensor 208; and an alignment component 506 to aid in carrying Placement of the peripheral device on the computing device. When the flash 206B is used as a light source, the peripheral device 500 includes a color filter 508 to control the color of the light that illuminates the reaction zone on the test strip 202.

In some examples, light is emitted upward from screen 206A or flash 206B, as desired through color filter 508, obliquely downwardly from first reflective surface 510 of light guide 504, obliquely upward from the reaction zone on test strip 202. The reflection reflects downward from the second reflecting surface 512 of the light guiding body and illuminates the image sensor 208.

In some examples, the light guide body 504 is a transparent block, and the first reflective surface 510 is a beveled edge of the transparent block, which is reflected by total internal reflection (TIR) or reflective coating, and The second reflecting surface 512 is a reflector embedded in the light guiding body. The light guide 504 can be covered by the housing or by coating to prevent ambient light from entering, so that the reaction zone on the test strip 202 is substantially illuminated by the screen 206A or flash 206B. In other examples, light guide 504 is a reflective interior in the hollow housing of peripheral device 500, and reflective surfaces 510, 512 are the reflective inner surfaces. The hollow housing blocks ambient light such that the reaction zone on test strip 202 is substantially illuminated by screen 206A or flash 206B.

Color filter 508 is located above a portion of screen 206A or flash 206B. In other examples, color filter 508 is located above test strip 202.

Alignment member 506 abuts edge 312 of device 204 to bring the second reflective surface 512 is placed over image sensor 208 and first reflective surface 510 is placed over portion of screen 206A or flash 206B. In other examples, the alignment component 506 can be received in an aperture in the device 204, such as a speaker aperture or a headphone jack.

The sixth diagram shows a peripheral device 600 for device 204 in an example of the disclosed invention. Peripheral device 600 includes a test strip slot or compartment 602 for receiving test strip 202; a light guide 604 to direct light back to the reaction zone on the test strip; and an alignment component 606 to assist the portable Placement of the peripheral device on the computing device. When flash 206B is used as the light source, peripheral device 600 includes a color filter 608 to control the color of the light that illuminates the reaction zone on test strip 202.

The light is emitted upward from the screen 206A or the flash 206B, passes through the color filter 608 as needed, and is obliquely reflected downward from the reaction zone on the test strip 202, and is obliquely reflected upward from the first reflecting surface 610 of the light guiding body 604, from which the light is guided. The second reflective surface 612 of the body reflects obliquely downward and illuminates the image sensor 208.

In some examples, light guide 604 has a transparent block that forms a portion of the test strip slot or chamfered edge of compartment 602. The first reflective surface 610 is located on the bottom of the light guide body 604 and is laterally offset from the test strip 202. The first reflective surface 610 is coated with reflected light by total internal reflection (TIR) or reflective coating. The second reflective surface 612 is embedded in the reflector in the light guide 604 and laterally offset from the first reflective surface 610. The light guide 604 can be covered by the housing or by coating to prevent ambient light from entering, so that the reaction zone on the test strip 202 is substantially illuminated by the screen 206A or flash 206B. In other examples, light guide 604 is a reflective interior in the hollow housing of peripheral device 600, and reflective surfaces 610 and 612 are the reflective inner surfaces. The hollow housing blocks ambient light such that the reaction zone on test strip 202 is substantially illuminated by screen 206A or flash 206B.

Color filter 608 is located above a portion of screen 206A or flash 206B.

The alignment component 606 is adjacent to the edge 312 of the device 204 to place the test strip 202 over a portion of the screen 206A or flash 206B and the second reflective surface 612 is placed over the image sensor 208. In other examples, the alignment component 606 can be received in an opening in the device 204, such as a speaker aperture or a headphone jack.

The seventh diagram shows the device 204 for use in an example of the disclosed invention. Peripheral device 700. Peripheral device 700 includes a test strip slot or compartment 702 for receiving test strip 202; a light guide 704 for directing light to the reaction zone on the test strip; and an alignment component 706 to aid in carrying Placement of the peripheral device on the computing device. When flash 206B is used as the light source, peripheral device 700 includes a color filter 708 to control the color of the light that illuminates the reaction zone on test strip 202.

Light is emitted upward from screen 206A or flash 206B, passes through color filter 708 as needed, scatters within light guide 704, and reflects obliquely downward from reaction zone on test strip 202 and illuminates image sensor 208.

The light guide 704 is a block of scattering material above the portion of the screen 206A or flash 206B and adjacent to the test strip 202 in the test strip slot 702, such as acrylic, polycarbonate, epoxy or glass with a doped hollow shell. The light guide 704 can be covered by the housing or by coating to prevent ambient light from entering, so that the reaction zone on the test strip 202 is substantially illuminated by the screen 206A or flash 206B.

Color filter 708 is located above a portion of screen 206A or flash 206B.

The alignment component 706 is adjacent to the edge 312 of the device 204 to place the light guide 704 over a portion of the screen 206A or flash 206B, and the test strip 202 is placed over the image sensor 208. In other examples, the alignment component 706 can be received in an aperture in the device 204, such as a speaker aperture or a headphone jack.

Figures 8A and 8B show an integral structural test strip peripheral device 800 for apparatus 204 (second A or B diagram) in an example of the present disclosure. Peripheral device 800 includes a test strip 802 that is integrated with light guide 804 and alignment component 806. Light guide 804 directs light from screen 206A or flash 206B (second A or B map) to the reaction zone on test strip 802. The light-receiving body 804 can be covered by the housing or by coating to prevent ambient light from entering, so that the reaction zone on the test strip 802 is substantially illuminated by the screen 206A or flash 206B.

Alignment member 806 is adjacent to the edge of device 204 to place light guide 804 over a portion of screen 206A or flash 206B, and test strip 802 is placed over image sensor 208 (second A and B diagrams). In other examples, the alignment component 806 can be received in an aperture in the device 204, such as a speaker aperture or a headphone jack.

The ninth diagram shows the device 204 (second in the example of the disclosure of the present invention) Screen 206A of A or B). An alignment mark 902 is created on screen 206A to facilitate placement of test strip peripheral device 904 on device 204.

In some examples, alignment marks 902 are used to properly align the peripheral device in two dimensions, such as the X and Y dimensions. In other examples, the alignment mark 902 operates in conjunction with the alignment features of the peripheral device 904. The alignment component can abut an edge of the device 204 or an aperture that is inserted into the portable computing device, such as a speaker aperture or a headphone jack. The alignment component can align the peripheral device 904 in one dimension (eg, the Y dimension), while the alignment marker 902 can align the peripheral device in another dimension (eg, the x dimension).

Figures 10A, XB and CC show test strips having reaction and reference regions in an example of the disclosure of the present invention. The reference zone is used to determine imaging conditions such as exposure time, aperture f-fetch, and film speed. Based on the color and color intensity of the reference region, processor 214 (second A or B map) executing application 212 (second A or B map) may select such imaging conditions. This reference area may be a color chart, a grayscale card, or a pure white or black block.

In the tenth A diagram, the test strip 1000A in the example of the present disclosure has a reaction zone 1002 and a reference zone 1004A in close proximity to the reaction zone. In the tenth panel B, the test strip 1000B in the example of the present disclosure has a reaction zone 1002 and a reference zone 1004B surrounding the reaction zone. In the tenth C-picture, the test strip 1000C in the example of the present disclosure has a reaction zone 1002 and a reference zone 1004C surrounded by the reaction zone.

The eleventh, eleventh, and eleventh C diagrams show test strips having reaction and color correction regions in an example of the disclosed invention. The color correction zone is used to characterize the illumination provided by a particular screen and adjust the analyte measurements accordingly. This color correction area may be a color chart, a grayscale card, or a pure black or white block.

In the eleventh A diagram, the test strip 1100A in the example of the present disclosure has a reaction zone 1102 and a color correction zone 1104A configured in a strip-shaped color chart. In the eleventh B-picture, the test strip 1100B has a reaction zone 1102 and a color correction zone 1104B configured in a strip-like gray scale chart. In the eleventh C-picture, the test strip 1100C in the example of the present disclosure has a reaction zone 1102 and a color correction zone 1104C arranged concentrically.

Figure 12A shows a conductive machine in an example of the disclosed content of the present invention Test strip 1208 or test strip peripheral 1202. The smart point 1204 has regions of different conductivity compared to the rest of the test strip or peripheral device 1202 and can therefore be detected by the touch screen on the portable computing device.

Twelfth B shows a smart point 1204 made of conductive rubber in an example of the disclosed invention. Twelfth C shows a smart point 1204 made of conductive fibers in an example of the disclosed invention. The Twelfth D-D diagram shows a smart point 1204 made of a conductive cloth in an example of the disclosed content. Twelfth E shows a smart point 1204 made of a combination of metal and plastic in an example of the disclosed invention.

The thirteenth, thirteenth and thirteenth Cth diagrams show different configurations (i.e., patterns) of the smart points 1204 on the test strip or peripheral device 1202 in the examples of the present disclosure. When the smart point 1204 contacts the touch screen on the portable computing device, such as the touch screen 206A (second A or B) on the device 204, the portable computing device can detect the smart points. These different configurations of the smart point 1204 may encode the analyte type, the product lot number of the test strip or peripheral device 1202, or both. The orientation of the smart point 1204 can also convey the position and orientation of the reaction zone on the test strip or peripheral device 1202.

Or the smart point 1204 is non-conductive and forms a visible code on the test strip or peripheral device 1202. Such code 1204 is captured in the image along with the reaction zone and decoded by processor 214 (second A or B map) to reveal the analyte type, test lot or product lot number of peripheral device 1202, or both. The face of code 1204 can also convey the position and orientation of the reaction zone on the test strip or peripheral device 1202.

Figure 14A shows a test strip 1400A having a reaction zone 1402 and a temperature sensor 1404A in an example of the disclosed invention. A portable computing device, such as device 204 (second A or B diagram), can electronically read temperature sensor 1404A and compensate for analyte measurements based on the temperature. Temperature sensor 1404A may be a thermistor or resistance temperature detector with a transmitter. Device 204 includes a receiver to read temperature sensor 1404A using near field communication (NFC).

Figure 14B shows a test strip 1400B having a reaction zone 1402 and a temperature indicating zone 1404B in an example of the disclosed invention. A portable computing device, such as device 204 (second A or B diagram), can optically read temperature indicating zone 1404B and based on the temperature Compensate for analyte measurements.

The fifteenth diagram shows a test strip or test strip peripheral 1500 for device 204 (second A or B diagram) in an example of the present disclosure. The test strip or peripheral device 1500 includes a test strip 1502; a light guide 1504 for directing light to the reaction zone on the test strip; and an integral structure lancet 1506.

Figure 16 shows a test strip or test strip peripheral 1600 for device 204 (second A or B diagram) in an example of the present disclosure. The test strip or peripheral device 1600 includes a lancet 1602 which is an array of microneedle needles.

The seventeenth A, seventeenth B, seventeenth C and seventeenth D diagrams show perspective, top, bottom and side views of the test strip peripheral 1700 in an example of the present disclosure. Peripheral device 1700 includes a hollow housing 1701 having a slot 1702 that receives a test strip; a reflective interior 1704 (17th C and 17D) that forms a reaction that directs light onto the test strip a light guide of the zone; and an alignment component 1706 (such as the lip of the housing shown in Figures 17C and 17D) to aid in device 204 (second A or B diagram) Placement of the peripheral device. The housing 1701 has an open bottom that is exposed to a portion of the screen 206A or flash 206B (second A or B diagram) and image sensor 208 (second A or B diagram). The housing 1701 can have a top opening 1708 that allows a user to deposit a sample of the sample onto the reaction zone of the test strip. In other examples, the housing 1701 does not have a top opening 1708 and the user stores the sample sample through one end of the test strip exposed from the peripheral device 1700. The test strip has a capillary path for transporting the sample sample from the exposed end to the reaction zone. In still other examples, peripheral device 700 includes a capillary 1709 (eg, shown in phantom in housing 1701 of FIG. 17C) that carries the sample sample to a reaction zone within housing 1701. The capillary 1709 can have a first opening at one end of the housing 1701, a conduit conveyed along the thickness of the housing, and a second opening above the reaction zone to the interior of the housing. In these examples, the reaction zone on the test strip is substantially illuminated by screen 206A or flash 206B when the reaction zone is enclosed within housing 1701 and is not exposed to ambient light. Within the housing 1701, the test strip is supported by a U-shaped guide 1710.

An eighteenth diagram shows a screen 206A of the device 204 in an example of the present disclosure. Screen 206A displays an instant preview of the captured image sensor 208 (shown in dashed lines). A boundary 1802 is displayed on the screen 206A to adjust the peripheral device 216A on the device 204. The placement indicates where the reaction zone 1804 of the test strip 202 can be located. In the example where screen 206A is used as a light source, portion 1806 of screen 206A emits light to illuminate the reaction zone on test strip 202. In these examples, portion 1806 can also be used as alignment mark 902 (ninth view) to facilitate placement of peripheral device 216A on device 204. In other examples, separate alignment marks 902 are provided on screen 206A. Screen 206A displays a capture button 1808 that accepts an input command for image sensor 208 to retrieve reaction zone 1804.

The nineteenth figure is used in the example of the disclosure of the present invention for the device 204 (second A or B picture) reading to be placed in the image sensor 208 (second A or B picture) and a portion of the screen 206A Or a flow chart of a method 1900 of the reaction zone on the test strip 202 in the test strip peripheral device 216A or 216B (second A or B diagram) above the flash 206B. Method 1900 can be performed by processor 214 (second A or B diagram) executing application 212 (second A or B diagram). Although the blocks for method 1900 are illustrated in a sequential order, the blocks may also be executed in parallel and/or in a different order than those illustrated herein. Moreover, the various blocks can be combined into fewer blocks, divided into more blocks, and/or excluded based on the desired implementation. Method 1900 can begin at block 1902.

In block 1902, processor 214 provides light with screen 206A or flash 206B to illuminate the reaction zone on test strip 202. Peripheral device 216A or 216B directs light from screen 206A or flash 206B to the reaction zone, respectively. In an example where screen 206A is used as a light source, processor 214 uses portion 1806 (eighteenth image) on the screen to illuminate the reaction zone. In these examples, portion 1806 can also be used as alignment mark 902. Block 1902 may then be block 1904.

In block 1904, the processor 214 displays on the screen 206A an instant preview that the image sensor 208 will capture. Processor 214 also displays boundary 1802 (eighteenth image) on screen 206A to indicate where the reaction zone of test strip 202 can be located by placement of peripheral device 216A or 216B on adjustment device 204. The processor 214 further displays a capture button 1808 (eighteenth image) that receives an input command to capture an image of the reaction zone on the test strip 202. Processor 214 can display alignment marks 902 (ninth view) on screen 206A for peripheral device 216A or 216B. Block 1904 may then be block 1906.

In block 1906, touch screen 206A senses any smart point on test strip 202 or peripheral device 216A or 216B that is touching the screen. Based on the configuration of these smart points, Processor 214 can determine the analyte type, the production lot number of the test strip, or both. Based on the position and orientation of the smart points, the processor 214 can more accurately determine the position and orientation of the reaction zone on the test strip 202. The processor 214 can also electronically read the presence of the temperature sensor 1404A (Fig. 14A). Block 1906 may then be block 1908.

In block 1908, the processor 214 captures the image with the image sensor 208 in response to an input command (eg, selection of the capture button 1808). When the test strip 202 includes a reference zone, the processor 214 can first determine imaging conditions based on the reference zone prior to capturing the image.

The image includes the reaction zone. The image may also include a color correction zone, a temperature indication zone, or both. Block 1908 may then be block 1910.

In block 1910, processor 214 determines an analyte characteristic based on the color of the captured reaction zone in the image. When the image includes a color correction zone, processor 214 can determine the color of the reaction zone based on the color correction zone. The processor 214 can correct the analyte characteristics based on the temperature detected by the temperature indicating zone or the temperature sensor. When the image includes a temperature indicating zone, the processor 214 determines the temperature based on the color of the temperature indicating zone.

When the processor 214 is capable of determining characteristics of a plurality of analyte types, the processor may first determine the analyte type based on the smart points on the test strip or peripheral device. When the processor 214 is capable of correcting the analyte characteristics based on the production lot number available via software update over the Internet, the processor may first determine the product lot number based on the test strip or the smart points on the peripheral device.

In some examples, processor 214 repeats method 1900 for different illumination intensity or color. In particular, processor 214 can change the intensity or color of portion 1806 on screen 206A and capture another image of the reaction zone at a different illumination intensity or color. The dynamic range of the measurement is extended using two illumination colors.

For example, capturing an image at an illumination intensity or color enhances the details for detecting lower concentrations, and capturing another image at different illumination intensities or colors to enhance detection Measure these details for higher concentrations. From the two images, processor 214 can select an image based on the average RGB value of the captured reaction zone having neither too low (e.g., <30) nor too high (>240). Processor 214 then associates the color of the captured reaction zone with the analyte property.

Processor 214 may, in the example of the present disclosure, divide portion 1806 into portions 2002 and 2004 of different intensities or colors, as shown in the twentieth diagram, rather than repeating method 1900. The first portion 2006 of the reaction zone is thus illuminated with light 2008 of a first intensity or color, and the second portion 2010 of the reaction zone is illuminated with light 2012 of a second intensity or color. The processor then determines analyte characteristics based on the two portions captured in the image. In some examples, processor 214 selects a captured portion of the image that is neither too low nor too high average RGB value, and associates the color of the captured portion with the analyte characteristic. In other examples, processor 214 calculates the average or median RGB values of the combined two captured portions and determines analyte characteristics based on the average or median RGB values. In still other examples, processor 214 calculates an average or median RGB value for each captured portion and determines an analyte characteristic based on the average or median RGB values of the captured portions of the two.

The twenty-first A, twenty-first B, twenty-first C, and twenty-first D diagrams show the first perspective, the second perspective, the top view, and the side view of the test strip peripheral device 2100 in an example of the present disclosure. . Peripheral device 2100 includes a housing 2101 having a compartment 2102 that receives a test strip; a reflective interior 2104 (21D D) that forms a light guide that directs light to a reaction zone on the test strip And an alignment component 2106 (21D D) to aid placement of the peripheral device on device 204 (second A or B diagram). The housing 2101 has a hollow body 2108 and a cover 2110 hinged to the body. The body 2108 has an open bottom that is exposed to a portion of the screen 206A or flash 206B (second or second B) and image sensor 208 (second or second B). The compartment 2102 is formed by a recessed area on the top of the body 2108. The recessed area 2102 defines an opening 2112 to expose the reaction zone of the test strip to the image sensor 208.

The cover 2110 has a top opening 2114 for the user to deposit a sample of the sample onto the reaction zone on the test strip. In other examples, the cover 2110 does not have a top opening 2114 and the user stores the sample through one end of the test strip exposed from the peripheral device 2100. The test strip has a capillary path for transporting the sample sample from the exposed end to the reaction zone. In still other examples, peripheral device 2100 includes a capillary tube 2116 (e.g., shown in phantom in the cover 2110 of FIG. 11C) that transports the sample sample to a reaction zone within housing 2101. The capillary tube 2116 can have a first opening at one end of the housing cover 2110, a conduit extending along the thickness of the cover, and a second opening above the reaction zone to the interior of the cover. In these examples The reaction zone on the test strip is substantially illuminated by screen 206A or flash 206B when the reaction zone is enclosed within housing 2101 and is not exposed to ambient light.

These features of the test strip peripherals and the test strips can be combined. For example, the test strip peripheral device can include any combination of a light guide, an alignment component, a lancet, and a smart point. Likewise, the test strip can include any combination of a reaction zone, a reference zone, a color correction zone, a temperature sensor, a temperature indicating zone, and a smart point.

The systems and methods disclosed herein can be used to test for the presence and/or concentration of a particular analyte, such as, but not limited to, glucose, cholesterol, uric acid, troponin I, ketones, proteins, nitrites, and white blood cells. Various fluids can be tested such as, but not limited to, blood, tissue fluids, urine, saliva, and other body fluids.

The various embodiments of the present invention have been described herein for the purposes of illustration and description of the embodiments of the invention. Accordingly, the various embodiments disclosed herein are not intended to be limiting, but the scope and spirit of the invention are indicated by the following claims.

204‧‧‧Portable computing device; device

200A, 200B‧‧‧ system

216A, 216B‧‧‧ test strip peripherals; peripherals

202‧‧‧Test strip

208‧‧‧Image sensor; imaging sensor

206B‧‧‧Flash

218A, 218B‧‧‧ Light guide

206A‧‧‧screen; light source; touch screen

210‧‧‧ Non-transitory computer readable media

212‧‧‧Application

214‧‧‧ processor

Claims (25)

A portable computing device for reading a reaction zone on a test strip, the test strip being located in a peripheral device, the peripheral device being placed on an image sensor of the portable computing device and a light source, the method Included: providing light with the light source, wherein the peripheral device directs light from the light source to the reaction zone, wherein providing light by the light source comprises emitting light by a portion of a screen or a flash of the portable computing device; The sensor captures an image, wherein the image includes the reaction zone; determining an analyte characteristic based on a color of the captured reaction zone in the image; changing the portion of the screen to a different color; Another image including the reaction zone is taken, wherein an analyte property is further determined based on another color of the captured reaction zone in the other image. The method of claim 1, wherein the screen comprises a touch screen, and the method further comprises sensing a plurality of areas on the test strip or a plurality of areas on the peripheral device contacting the screen. The method of claim 2, further comprising: determining a configuration of the regions, a face of the regions, or a combination thereof; and the configuration based on the regions, the face of the regions, or the Combining, determining an analyte type, a production lot number of the test strip, a face of the reaction zone on the test strip, or a combination thereof. The method of claim 3, wherein the regions comprise conductive dots made of a conductive rubber, a conductive fiber, a conductive cloth, or a combination thereof. The method of claim 1, wherein the test strip comprises a temperature sensor, and the method further comprises: electrically reading the temperature sensor to determine a temperature of the test strip; and based on the test strip This temperature corrects the analyte characteristics. The method of claim 1, wherein the test strip includes a temperature indicating area, the image further includes the temperature indicating area, and the method further comprises: correcting a sample based on the captured temperature indicating area in the image characteristic. The method of claim 1, wherein the light source comprises at least two portions of different colors, and determining that an analyte characteristic comprises color determination based on the at least two portions of the captured reaction region in the image The analyte properties. A peripheral device is disposed above an image sensor of a portable computing device and a light source to assist the portable computing device to read a reaction zone on a test strip of the peripheral device, the peripheral device The invention comprises: a light guide body for guiding light from the light source to the test strip; an alignment component to assist placement of the image sensor and the peripheral device of the light source on the portable computing device; And a hollow housing, wherein the light guide comprises a reflective interior of the hollow housing, and light from the light source is reflected from the reflective interior of the hollow housing, reflected from the test strip, and illuminated The image sensor. The peripheral device of claim 8, wherein the alignment member comprises a lip of the hollow housing to abut an edge of the portable computing device. The peripheral device of claim 8 wherein the hollow housing defines a slot for receiving the test strip. The peripheral device of claim 8 wherein the hollow housing has a top opening and an open bottom providing access to the reaction zone. The peripheral device of claim 8 wherein: the hollow housing has a closed top and an open bottom, such that when the peripheral device is placed on the portable computing device, the light source substantially illuminates the test strip And the peripheral device further comprises a capillary, or the capillary is part of the test strip, the capillary having a first end for receiving a sample of the sample and a second end for transferring the sample to the reaction zone. The peripheral device of claim 8, wherein the hollow housing comprises a body and a cover hinged to the body. The peripheral device of claim 13 wherein: the cover has a closed top and the body has an open bottom, such that when the peripheral device is placed on the portable computing device, the light source substantially illuminates the test strip ;as well as The cover further comprises a capillary or the capillary is part of the test strip, the capillary having a first end for receiving a sample of the sample and a second end for delivering the sample to the reaction zone. The peripheral device of claim 8 of the patent application further comprises a lancet or an array of microscopic needles. The peripheral device of claim 8 further includes the test strip integrated with the light guide and the alignment component. The peripheral device of claim 8 wherein the light guide comprises a covered transparent block, such that when the peripheral device is placed on the portable computing device, the test strip is substantially illuminated by the light source. The peripheral device of claim 8, wherein the light guide comprises a reflective surface, and light from the light source is reflected from the reflective surface, passes through the test strip, and illuminates the image sensor. The peripheral device of claim 8, wherein light from the light source is transmitted along the light guide, reflected from the test strip, and illuminated to the image sensor. The peripheral device of claim 8, wherein the light guide comprises first and second reflecting surfaces, and light from the light source is reflected from the first reflecting surface, reflected from the test strip, and reflected from the second The surface reflects and illuminates the image sensor. The peripheral device of claim 8, wherein the light guide comprises first and second reflecting surfaces, and light from the light source is reflected from the test strip, reflected from the first reflective surface, and reflected from the second reflective surface The surface reflects and illuminates the image sensor. The peripheral device of claim 8, wherein the light guide comprises a scattering material, and light from the light source is scattered in the light guide body, reflected from the test strip, and irradiated to the image sensor. The peripheral device of claim 8 of the patent application further includes a plurality of regions to be detected by a touch screen. The peripheral device of claim 23, wherein the regions are conductive dots configured to indicate an analyte type, a production lot number of the peripheral device, a face of the reaction zone on the test strip, or a combination thereof. The peripheral device of claim 24, wherein the conductive points comprise conductive rubber and a guide Electrical fiber, conductive cloth or a combination thereof.