TWI534430B - Test strips and method for reading test strips - Google Patents

Description

Test piece and method of reading test piece

The present invention is generally directed to photometric analysis of one or more analytes applied to a test strip.

The first figure shows a prior art test strip 100 having a reaction zone 102. The reaction zone 102 contains reagents that react with analytes in the sample, such as glucose in a blood sample. When the sample sample reaches the reaction zone 102, the reaction zone 102 changes color depending on the characteristics of the analyte, such as the level of glucose in the blood. The user visually compares the color of reaction zone 102 to chart 104, correlating the color of reaction zone 102 to the identity of the analyte. Further, the user inserts the specimen test piece 100 into the scale to optically determine the characteristics of the analyte.

According to an aspect of the present invention, a sample test piece for detecting an analyte property in a sample sample provides a reaction zone, the reaction zone is configured to receive the sample sample, and a color correction zone, the color correction zone It is arranged to determine the color of the reaction zone after receiving the sample of the sample. In some embodiments, a plurality of reaction zones are provided, each zone being configured to detect a different range of analyte property values.

In accordance with other aspects of the present invention, a method is provided for a computing device to read a sample test piece using an imaging device to detect an analyte characteristic in a sample sample. In some embodiments, the method includes extracting one or more images of the test strip, wherein each image includes a reaction zone and a color correction zone on the test strip. In these embodiments, the method further comprises determining the color of the reaction zone based on the color correction zone from the one or more images and correlating the color of the reaction zone to a property value of the analyte.

In some embodiments, a method is provided for capturing at least two images of the test strip, wherein each image comprises a reaction zone. The method further includes determining the image from the images A color concentration of the reaction zone changes, and a time difference when the images are captured. The method also includes correlating the color density change to the time difference to a characteristic value of the analyte.

In some embodiments, a method of capturing a first image of the test strip is provided. The image contains reaction zones, each zone being arranged to detect a different range of analyte property values. The method further comprises selecting one of the reaction zones and correlating the selected reaction zone to a property value of the analyte.

100‧‧‧sample test piece

102‧‧‧Reaction zone

104‧‧‧Chart

200‧‧‧sample test piece

202‧‧‧Reaction zone

204‧‧‧ School color area

206‧‧‧School area

208‧‧‧ imaging device

210‧‧‧ Computing device

212‧‧‧ images

502‧‧‧Reaction zone

506‧‧ ‧ pixels

508‧‧ ‧ pixels

510‧‧‧Central pixel

300‧‧‧Check sample

302‧‧‧Reaction zone

304‧‧‧ School color area

306‧‧‧School area

Section 306A‧‧‧

Section 306B‧‧‧

400‧‧‧Configuration

402‧‧‧Reaction zone

404‧‧‧ School color area

500‧‧‧Configuration

504‧‧‧ School color area

600‧‧‧sample test piece

602‧‧‧Timed Capillary

604‧‧‧Capillary inlet

606‧‧‧Reactive capillary

608‧‧‧Reaction zone

700‧‧‧sample test piece

702‧‧‧Reaction zone

704‧‧‧Time zone

706‧‧‧ School color area

900‧‧‧Chart

902‧‧‧ Curve

904‧‧‧ Curve

906‧‧‧ Curve

908‧‧‧Time window

1300‧‧‧ test sample

1302A‧‧‧Reaction zone

1302B‧‧‧Reaction zone

1302C‧‧‧Reaction zone

1302D‧‧‧Reaction zone

1302‧‧‧Reaction zone

1304‧‧‧ School color area

1306‧‧‧ School District

1400‧‧‧ test sample

1402A‧‧‧Reaction zone

1402B‧‧‧Reaction zone

1402C‧‧‧Reaction zone

1402D‧‧‧Reaction zone

1402‧‧‧Reaction zone

1500‧‧‧ test sample

1502A‧‧‧Reaction zone

1502B‧‧‧Reaction zone

1502C‧‧‧Reaction zone

1502D‧‧‧Reaction zone

1502‧‧‧Reaction zone

1600‧‧‧sample test piece

1602A‧‧‧Reaction zone

1602B‧‧‧Reaction zone

1602C‧‧‧Reaction zone

1602D‧‧‧Reaction zone

1602‧‧‧Reaction zone

1604‧‧‧Capillary inlet

1606‧‧‧Capillary

1802‧‧ images

1804‧‧ images

1806‧‧‧Image

1902‧‧ images

1904‧‧ images

1906‧‧ images

2000‧‧‧ test sample

2002‧‧‧Reaction zone

2004‧‧‧Reaction zone

2006‧‧‧Reaction zone

2100‧‧‧sample test piece

2102‧‧‧Capillary inlet

2104‧‧‧Capillary

2106‧‧‧Reaction zone

2108‧‧‧ hole

2110‧‧‧Top opening

2112‧‧‧Transparent film

2114‧‧‧ bottom opening

2116‧‧‧Transparent film

2200‧‧‧ Chart

2300‧‧‧ Chart

The above and other features of the present invention will be more fully understood from the following description and appended claims. It is understood that the drawings illustrate only certain embodiments of the invention, and are in no way

In the drawings: the first figure shows a prior art sample test piece; the second figure shows a sample test piece having a reaction zone, a color correction zone and a calibration temperature zone in one or more examples of the present invention; The third figure shows a sample test piece having a reaction zone, a color correction zone and a calibration zone in one or more examples of the present invention; and the fourth figure shows a reaction zone in one or more examples of the present invention. And a configuration of a color correction zone; the fifth diagram shows the configuration of a reaction zone and a color correction zone in one or more examples of the present invention; and the sixth figure shows a section having a timing capillary in one or more examples of the present invention. The test piece of the sample; the seventh figure shows a sample test piece having a reaction zone and a time zone in one or more examples of the present invention; and the eighth figure is for a computing device to perform a diagnostic application to calculate A method flow for reading a sample test piece in one or more of the examples of the present invention; and a ninth figure for illustrating an analyte characteristic value for one or more examples of the present invention, and plotting a color parameter as a function of time ; Figure 11 is a flow diagram of a method for causing a computing device to perform a diagnostic application to quickly read a sample test piece in one or more of the examples of the present invention using a difference calculation; An application method for tracking a user's diet in conjunction with an analyte property value in one or more of the examples of the present invention; and a twelfth graph graphically illustrating meals, meal times, and analytes in one or more of the examples of the present invention Correlation of characteristic values within one day; Figure 13A shows a sample test piece comprising a set of reaction zones within one or more of the examples of the present invention to detect different ranges of analyte property values; Thirteen B, Thirteenth, and Thirteenth D diagrams show a sample test piece of the thirteenth A chart after receiving a sample of a sample having different analyte property values in one or more of the examples of the present invention; Figure 4 shows a sample test piece comprising a set of reaction zones in one or more of the examples of the invention to detect different ranges of analyte property values; the fifteenth image shows a sample test piece comprising the present Inventing a set of reaction zones within one or more of the examples to Measuring different ranges of analyte property values; Figure 16 shows a sample test strip comprising a set of reaction zones within one or more of the examples of the invention to detect different ranges of analyte property values; The method for causing a computing device to perform a diagnostic application to read a sample test piece having a plurality of reaction zones to detect different ranges of analyte property values in one or more of the examples of the present invention; Figure 18 shows a sample test piece at different exposure levels to enhance details of a particular reaction zone within one or more of the examples of the present invention; Figure 19 shows a sample test piece at different flash intensities, Enhancing details of a particular reaction zone within one or more of the examples of the invention; FIG. 20 shows a sample test piece comprising a plurality of reaction zones for detecting different analytes in one or more of the examples of the invention The characteristic value; the twenty-first figure shows a cross-sectional view of a sample test piece in one or more examples of the present invention; and the twenty-second figure is a first analysis for one or more examples of the present invention. a property value, plotting a first color as a function of time; and a twenty-third diagram illustrating a second analyte property value for one or more of the examples of the invention, drawing a second as a function of time The curve of color.

The second figure shows an exemplary embodiment of a sample strip 200 in one or more examples of the present invention. The sample test strip 200 includes a reaction zone 202 for accepting a sample of the sample. Reaction zone 202 contains a plurality of reagents for chemically reacting with analytes within the sample of the sample and producing one or more color parameters that are proportional to the analyte property values within the sample of the sample. In some embodiments, the one or more color parameters comprise the color or color and color density of the reaction zone 202. In one example, the color is the hue of reaction zone 202 and the color density is the brightness of reaction zone 202. The hue and brightness are the hue, saturation, and brightness (HSL) color space color components determined by the red, green, and blue (RGB) values of the pixels captured by a camera. For convenience, color and color density can be collectively referred to as color. Such agents may be proprietary to the analyte and may comprise one or more enzymes, one or more antibodies, and/or one or more dyes. For example, the reagent for testing blood glucose may include glucose oxidase, heteropoly acid, and tetradecyl ammonium nitrate.

In one example, the specimen test strip 200 includes a color correction zone 204 that is part of the specimen test strip 200. In one example, the color correction zone 204 is used to determine the color of the reaction zone 202 under different illumination conditions. In this example, the color correction area 204 can be a color map having an arrangement of known color samples. In another example, the color correction zone 204 is used to correct the detected color of the reaction zone 202 to remove the effects of the illumination. In this example, the color correction zone 204 can be a gray card of known reflectance (e.g., 18%) used as a color corrected white balance reference. When a computing device 210 captures an image 212 of the specimen strip 200, the gray card 204 can also serve as an exposure reference. In one example, a color map or gray card 204 is printed on the specimen test strip 200.

In one example, color correction zone 204 is a virtual reaction zone having one or more known colors. The virtual reaction zone 204 maintains the same color in use because it lacks one or more enzymes, one or more antibodies, or one or more dyes. In another example, the virtual reaction zone 204 maintains the same color because it does not accept any sample samples.

In one example, the specimen test strip 200 includes a temperature zone 206 that is part of the specimen strip 200 along with the reaction zone 202 and the color correction zone 204. The temperature zone 206 is changed according to its temperature The color is changed and used to correct the color of the reaction zone 202 in accordance with the chemical reaction between the reagents and the temperature of the analyte to the analyte strip 200. In one example, the temperature zone 206 comprises, for example, a thermochromic dye (eg, a leuco dye such as a spironolactone, a fluorescent yellow parent, a spiropyran, or a bismuth hydride) such as titanium dioxide or zinc oxide. Or an inorganic material such as indium oxide or a thermochromic liquid crystal. In another example, the temperature zone 206 is a wafer, a mechanical device, or a motor device that indicates temperature. Instead of or in addition to using the temperature zone 206, the computing device 210 can use the built-in temperature sensor to approximately determine the temperature of the reaction zone 202.

The user uses an imaging device 208 on the computing device 210 to capture the image 212 of the reaction zone 202 and at least one of the color correction zone 204 and the calibration zone 206. The imaging device 208 can be a camera, a scanner or another similar device, and the computing device 210 can be a smart phone, a tablet computer, a laptop computer, a desktop computer or another similar device. . Computing device 210 runs a diagnostic application that analyzes image 212 to determine the analyte characteristics from the color of reaction zone 202.

In one example, the diagnostic application uses color correction zone 204 within image 212 to determine the color of reaction zone 202. When the color correction zone 204 is a color map, the diagnostic application compares the full or partial color of the reaction zone 202 with a known color sample of the color correction zone 204 to determine the color of the reaction zone 202. Additionally, the diagnostic application can manipulate the image 212 until the color map 204 matches its known color and then read the color of all or a portion of the reaction zone 202. When the color correction area 204 is a gray card, the diagnostic application manipulates the image 212 until the gray card 204 in the image 212 has the correct white balance and then reads the color of the reaction zone 202.

In another example, the diagnostic application uses the color correction zone 204 in the image 212 to determine the color of the reaction zone 202 and correct the color using the calibration zone 206 within the image 212. The diagnostic application determines the temperature of the test strip 200 from the temperature sensing zone 206 or the built-in temperature sensor of the computing device 210, and then uses the known relationship between the temperature and the color of the reaction zone 202 to correct the color of the reaction zone 202 for temperature. . This relationship can be determined by experiment, arithmetic, or both. The diagnostic application can perform the temperature correction using the calibration zone 206 either before or after any other modifications described in the present invention.

In one example, the diagnostic application calibrates the brightness of image 212 prior to using color correction zone 204 and calibration zone 206. The diagnostic application evaluates the brightness of the reaction zone 202 Curve to determine if the brightness is consistent. The diagnostic application determines the brightness profile from RGB values across at least two locations of reaction zone 202 or color correction zone 204 (e.g., diagonal pixels 506 and 508 in the fifth plot). When the brightness curve between the two positions is higher than the noise level by a threshold amount (for example, the brightness curve is twice the noise level), the brightness on the reaction area 202 is inconsistent, and the diagnostic application corrects the image 212. Brightness. In one example, the diagnostic application uses the following equation to correct the brightness of image 212: RGBnew=i*(R(x,y), G(x,y),B(x,y))/(Rest(x) , y), Gest(x, y), Best(x, y))

Where R(x, y), G(x, y), B(x, y) are the original RGB values of one pixel, Rest(x, y), Gest(x, y), Best(x, y) are The RGB values are evaluated for the brightness curve on the same pixel, and i is the maximum RGB value of the color of the reaction zone. For example, the color correction zone 204 can include a white ring that surrounds the reaction zone 202. Assume that within image 212, the RGB value of corner 506 is (200, 200, 200) and the value of corner 508 is (100, 100, 100). Further assume that the illumination curve is a straight line. Based on these assumptions, a white point on the central pixel 510 of the reaction zone 502 in the fifth diagram should have an RGB value of (150, 150, 150). When the color on pixel 510 is not white, the RGB value is replaced by (125, 75, 75), and the new RGB value of the center point is i*(125, 75, 75) / (150, 150, 150), where i is (255, 255, 255).

After one or more of the corrections described within the present invention, the diagnostic application extracts pixels (e.g., 50 to 100 pixels) from the reaction zone 202 and determines its value (e.g., color or color and color) for one or more color parameters. concentration). The diagnostic application averages the one or more color parameter values and associates the one or more average color parameters to the analyte property values (eg, the concentration level of glucose in the blood).

In one example, reaction zone 202, color correction zone 204, and tempering zone 206 are rectangular, and regions 204 and 206 are adjacent to the top and bottom sides of region 202, respectively. The reaction zone 202, the color correction zone 204, and the calibration zone 206 can take other shapes and configurations.

The third figure shows a sample test strip 300 having a different configuration than a reaction zone 302, a color correction zone 304, and a calibration zone 306 in one or more examples of the present invention. The color correction zone 306 is divided into portions 306A and 306B, and the left and right sides of the reaction zone 302 are sandwiched by portions 306A and 306B, respectively. The color correction zone 304 is adjacent to the bottom side of the combination of the reaction zone 302 and the calibration zone 306.

The fourth figure shows a reaction zone 402 and a school in one or more examples of the present invention. Configuration 400 of color zone 404. The color correction zone 404 surrounds the reaction zone 402. In one example, reaction zone 402 has a circular shape and color correction zone 404 has a toroidal shape.

The fifth figure shows a configuration 500 of a reaction zone 502 and a color correction zone 504 in one or more of the examples of the present invention. Similar to configuration 400 (fourth map), color correction zone 504 surrounds reaction zone 502. However, the reaction zone 502 has a rectangular shape and the color correction zone 504 has a toroidal shape.

The sixth figure shows a partial sample test strip 600 having a timing capillary 602 in one or more examples of the present invention. The sample test piece 600 represents a sample test piece having any of the reaction zone, the color correction zone, and the calibration zone configuration described in the present invention. The sample test strip 600 includes a capillary inlet 604, a reaction capillary 606, and a reaction zone 608. Reaction capillary 606 connects capillary inlet 604 to reaction zone 608. Timing capillary 602 is coupled to capillary inlet 604. The cross section of the timing capillary 602 is smaller than the reaction capillary 606. When the capillary inlet 604 receives a sample of the sample, the reaction capillary 606 transports a majority of the sample sample to the reaction zone 608 to detect the characteristics of the analyte. A small portion of the sample sample moves along the timing capillary 602, which is marked as duration, so the progress of the sample sample within the timing capillary 602 is used as a timer to indicate when the sample test strip 600 should be read.

The seventh diagram shows a sample test strip 700 having a reaction zone 702 and a time zone 704 in one or more examples of the present invention. The sample test piece 700 represents a sample test piece having any of the reaction zone, the color correction zone, and the temperature zone configuration described in the present invention. The timing zone 704 is another reaction zone for receiving the sample of the specimen. For example, a similar test strip 600, the test strip 700 can include a reaction capillary coupled to the capillary inlet and reaction zone 702, and a timing capillary that connects the capillary inlet to the timing zone 704. In view of the fact that reaction zone 702 has reagents that produce a non-linear response to the sample sample, timing zone 704 has reagents that produce a substantially linear response to the sample sample, such that the color change of timing zone 704 is used as a timer to indicate when should The sample test piece 700 is read. In one example, the timing zone 704 is already sealed and contains cobalt chloride (CoCl2), which changes from blue to pink to return to the water molecules within the sample. The specimen test strip 700 may also include a calibration color zone 706 and a calibration temperature zone 708.

In one example, the time zone 704 will change color due to light once the sample test strip 700 is removed from the opaque sealed package. The timing zone 704 linearly changes color to respond to the light, indicating how much time the sample test strip 700 is taken out of the package, indicating that the sample test piece should be read. The reaction time of the reaction zone 702 of 700 with a sample of the sample. A clean protective film can cover the timing zone 704. In one example, timing zone 704 comprises photochromic dyes such as azobenzenes, o-hydroxybenzylidene anilines, physicochemicals, spiropyrans or spirooxazines.

In one example, the time zone 704 may change color due to humidity once the sample test strip 700 is removed from the sealed package. The timing zone 704 linearly changes color to respond to humidity, indicating how long the sample strip 700 is removed from the package, approximately indicating the reaction time of the reaction zone 702 and a sample sample from which the sample strip 700 should be read. A perforated clean protective film that controls exposure to humidity can cover the timing zone 704. In one example, timing zone 704 includes CoCl2 that changes from blue to pink.

Instead of using timing zone 704, computing device 210 can use the built-in timer to approximate the reaction time of reaction zone 702 with the sample of the sample.

Figure 8 is a diagram of a computing device (e.g., computing device 210 in the second diagram) executing a diagnostic application to read a sample test piece in one or more of the examples of the present invention (e.g., a test sample in the second image) The flow of method 800 of slice 200). In any of the methods described herein, although the blocks are sequentially illustrated, the blocks may be executed simultaneously and/or in a different order than described. In addition, many of the blocks may be combined into fewer blocks, divided into additional blocks, and/or eliminated, depending on the desired implementation. Method 800 begins at block 802.

Within block 802, computing device 210 captures one or more images 212 of sample test strip 200. A plurality of images 212 can be captured so that a stable image without any blur can be selected from the image 212. The image 212 can be taken in a quick mode (eg, in continuous or fast shooting mode), or from a video. In one example, each image 212 includes a reaction zone 202 and a color correction zone 204. In another example, each image 212 also includes a temperature zone 206. In yet another example, each image 212 further includes a timing zone 602 or 704.

When the color correction area 204 is a gray card, the computing device 210 can use the color correction area 204 as an exposure reference for capturing the image 212. Additionally, computing device 210 may use an object (eg, grass or human skin) having a reflection coefficient of approximately 18% close to the specimen coupon as an exposure reference. The computing device 210 can automatically identify the exposure reference, or the user can direct the imaging device 208 with the exposure reference to set the correct exposure.

In one example, the computing device 210 places the sample in the specimen on the specimen. After 200, the image 212 is captured at an appropriate time. As previously described, the timing zone 602 or 704 can indicate when the image 212 should be captured. The computing device 210 can monitor the time zone 602 or 704 and automatically capture the image 212, or the user can direct the imaging device 208 to capture the image 212 from the visual inspection time zone 602 or 704. Block 802 is followed by selective block 803.

Within selective block 803, computing device 210 selects stable image 212 without any blurring. The diagnostic application can use the built-in accelerometer of the computing device 210 to determine whether an image 212 is stable to determine whether the computing device 210 is stable when capturing the image 212. The diagnostic application can also use the built-in accelerometer to alert when the image 212 is to be captured and the user has not stabilized the computing device 210. Selective block 803 is followed by block 804.

Within block 804, computing device 210 corrects the brightness of reaction zone 202 within image 212. As previously described, computing device 210 evaluates the brightness profile of reaction zone 202 within image 212 and then corrects the brightness of reaction zone 202 within image 212 when the brightness is inconsistent. Block 804 is followed by block 806.

Within block 806, computing device 210 determines the color of reaction zone 202 within image 212. As previously described, the computing device 210 determines the color of the reaction zone 202 based on the color correction zone 204 within the image 212 when the color correction zone 204 is a color map. Otherwise computing device 210 simply reads the color of reaction zone 202 from image 212. Block 806 is followed by block 807.

Within block 807, computing device 210 modifies the color of reaction zone 202 based on one or more correction zones. In one example, computing device 210 corrects the color of reaction zone 202 for white balance based on color correction zone 204 within image 212 when color correction zone 202 is a color map. In one example, computing device 210 corrects the color of reaction zone 202 for temperature based on temperature zone 206 within image 212. Note that the order of blocks 806 and 807 can be reversed. Block 807 is followed by block 808.

Within block 808, computing device 210 associates the color or color of the sample pixels from reaction zone 202 within image 212 with the color density to an analyte property value (eg, a glucose level).

The rate of change of the color parameters in reaction zone 202 can be based on the analyte property value. The rate of change of the color parameter can be plotted as a curve time plot for each analyte property value. The ninth diagram is a chart 900 illustrating the drawing of a color for three analyte property values (eg, three glucose levels) The parameters (eg, color density) elapse through three curves 902, 904, and 906 of time. Each curve has a different slope in the time window (e.g., time window 908) and is unique to the corresponding analyte property value. Thus the difference between the at least two color parameter values and the difference between the two values can be used to identify the corresponding analyte property value. The time window is placed for a period of time longer than waiting for a conventional sample test piece, for example, 10 seconds or more, for example, 2 and 3 seconds after the sample sample is placed on the sample test piece 200. .

Figure 11 is a diagram of a computing device (e.g., computing device 210 in the second diagram) executing a diagnostic application to quickly read a sample of one or more of the samples of the present invention using a difference calculation (e.g., a second image) The flow of the method 1000 of the sample test piece 200). Method 1000 begins at block 902.

Within block 1002, computing device 210 captures at least two images 212 of sample test strip 200 in time window 908. The image 212 can be taken in a quick mode (eg, in continuous or fast shooting mode), or from a video. For example, the first image 212 is captured at a first time and the second image 212 is captured at a second time. The time difference between the first and second times is calculated as a time window (e.g., time window 908 shown in the ninth figure). Each image 212 is contained in a reaction zone 202 on the sample strip 200. In one example, each image 212 is also included in the color correction area 204 on the sample test strip 200. In another example, each image further includes one or more additional correction zones on the specimen strip 200, such as the temperature zone 206. In one example, computing device 210 selects image 212 captured on time window 908 based on time zone 602 or 704. Block 1002 is followed by block 1004.

Within block 1004, computing device 210 determines the color of reaction zone 202 within each image 212 using any of the methods described herein, including illumination correction, color correction, and temperature correction. Block 1004 is followed by block 1006.

Within block 1006, computing device 210 determines a change in color density of reaction zone 202 from image 212. Block 1006 is followed by block 1008.

Within block 1008, computing device 210 correlates the color density change to an analyte property value. Computing device 210 uses the arithmetic representation of chart 900 or chart 900 to determine the analyte property value. In particular, computing device 210 moves time window 908 along curves 902, 904, and 906. The concentration change of a curve in the time window matches the concentration change of the reaction zone 202. Reaction zone 202 has an analyte property value for the curve.

11 is a flow diagram of a method 1100 for a computing device (eg, computing device 210 in the second diagram) to perform a diagnostic application to track a user's diet with an analyte property value in one or more of the examples of the present invention. . Method 1100 begins at block 1102.

Within block 1102, computing device 210 captures an image of a meal. Block 1102 is followed by block 1104.

Within block 1104, computing device 210 records the time of a meal. Block 1104 is followed by block 1106.

Within block 1106, computing device 210 associates the meal with time for an analyte property value determined at the same time and records the association. The analytical property values can be determined using any of the methods described within the present invention. Blocks 1102, 1104, and 1106 can be repeated to track the diet of a user over a period of time. Block 1106 is followed by block 1108.

Within block 1108, computing device 210 displays the relevance of the record. The computing device 210 can also transmit the relevance of the record to another computing device via a computer network, for example, to a doctor's computer for medical treatment. The twelfth graph graphically illustrates the association of meal points, meal times, and analyte property values within one day in one or more of the examples of the present invention.

Fig. 13A shows a sample test piece 1300 in one or more examples of the present invention. The sample test piece 1300 includes a set of reaction zones 1302A, 1302B, 1302C, and 1302D (collectively referred to as "reaction zone 1302" or separately referred to as a general "reaction zone 1302"). Each reaction zone 1302 is for detecting a different range of analyte property values within the sample of the sample. In the example of detecting glucose levels, reaction zone 1302A detects 0 to 100 milligrams per milliliter (mg/dL), reaction zone 1302B detects 0 to 200 mg/dL, and reaction zone 1302C detects 0 to 400 mg/dL. Reaction zone 1302D detects 0 to 800 mg/dL. To detect different ranges of analyte property values, reaction zone 1302 has different concentrations of one or more reagents. Additionally, reaction zone 1302 has different reagents.

The specimen strip 1300 can include a capillary inlet and a capillary through the contact reaction zone 1302 for delivering a sample of the sample. Additionally, the test strip 1300 can include a coating zone that overlaps and contacts the reaction zone 1302 to disperse the sample into the reaction zone 1302. In an example where the sample is delivered to reaction zone 1302 without any structure, the user can also manually apply the sample to reaction zone 1302. The sample test strip 1300 may further include a calibration color area 1304 and a calibration temperature area 1306.

Fig. 13A shows a sample test piece 1300 in the case of a pre-test. Fig. 13B shows a sample test piece 1300 that receives a 150 mg/dL glucose sample sample in one or more examples of the present invention. When the concentration of glucose is higher than the range of the reaction zone 1302A, an oversaturated color occurs, which cannot be used to determine the level of glucose. However, reaction zones 1302B, 1302C, and 1302D can be used. The color of reaction zone 1302B has good saturation, thus providing better readings than reaction zones 1302C and 1302D.

A thirteenth C-C shows a sample test piece 1300 that receives a 300 mg/dL glucose sample sample in one or more examples of the present invention. When the concentration of glucose is higher than the range of the reaction zones 1302A and 1302B, an oversaturated color occurs, which cannot be used to determine the level of glucose. However, reaction zones 1302C and 1302D can be used. The color of reaction zone 1302C has good saturation, thus providing a better reading than reaction zone 1302D.

A thirteenth D-ray shows a sample test piece 1300 that receives a 600 mg/dL glucose sample sample in one or more examples of the present invention. When the concentration of glucose is higher than the range of the reaction zones 1302A, 1302B, and 1302C, an oversaturated color occurs, which cannot be used to determine the level of glucose. The color of reaction zone 1302D has good saturation and is therefore used to determine the glucose level.

In one example, reaction zone 1302 is rectangular and arranged in a column with a generally rectangular boundary. Reaction zone 1302 can take on other shapes and configurations.

The fourteenth image shows a sample test piece 1400 having different configurations of reaction zones 1402A, 1402B, 1402C, and 1402D (collectively referred to as "reaction zones 1402") in one or more examples of the present invention. Within the test strip 1400, the reaction zone 1402 is square and configured to have a square outer boundary. Similar to the specimen test strip 1300, the specimen test strip 1400 can include a structure for transferring the sample to the reaction zone 1402, or the user can manually apply the sample to the reaction zone 1402.

The fifteenth diagram shows a sample test strip 1500 having different configurations of reaction zones 1502A, 1502B, 1502C, and 1502D (collectively referred to as "reaction zones 1502") in one or more examples of the present invention. Within the specimen test strip 1500, the reaction zone 1502 is triangular and configured to have a square outer boundary. Similar to the specimen test strip 1300, the specimen test strip 1500 can include a structure for transferring the sample to the reaction zone 1502, or the user can manually apply the sample to the reaction zone 1502.

Figure 16 shows a sample test strip 1600 having different reaction zones 1602A, 1602B, 1602C, and 1602D (collectively referred to as "reaction zone 1602") in one or more examples of the present invention. Configuration. Within the specimen strip 1600, a capillary inlet 1604 is coupled to the reaction zone 1602 by a capillary 1606. Reaction zone 1602 surrounds capillary inlet 1604 equidistantly at the same distance from capillary inlet 1604.

Figure 17 is a diagram of a computing device (e.g., computing device 210 in the second diagram) executing a diagnostic application to read that there are multiple reaction zones in one or more of the examples of the present invention to detect an analyte characteristic value that is different. A method 1700 procedure for a range of test strips (e.g., sample strip 1300 in Fig. 13). Method 1700 begins at block 1702.

In block 1702, computing device 210 captures an image of sample test strip 1300. The image contains a reaction zone 1302. As previously described, each reaction zone 1302 is used to detect a different range of analyte property values. Computing device 210 determines the color of each reaction zone 1302 using any of the methods described within this invention. Block 1702 is followed by block 1704.

Within block 1704, computing device 210 selects reaction zone 1302 of appropriate saturation. The computing device 210 begins the test from the smallest range to the reaction zone 1302 having the largest range. When the average RGB value of reaction zone 1302 is near its noise level (e.g., ~10), indicating that the analyte concentration has exceeded the detection limit, computing device 210 proceeds to test the next reaction zone 1302. This process continues until computing device 210 selects a reaction zone 1302 whose average RGB value is greater than its noise level. Block 1704 is followed by block 1706.

Within block 1706, computing device 210 associates the color or color of selected reaction zone 1302 with the color density for an analyte property value.

Method 1700 is augmented by taking multiple images of sample test strip 1300 on multiple exposures in one or more examples of the present invention. The eighteenth image shows images 1802, 1804, and 1806 of the specimen strip 1300 at 1/60, 1/30, and 1/15 second shutters, respectively, in one or more examples of the present invention. In one extreme, image 1802 is underexposed to enhance detail for detecting higher concentrations of one or more reaction zones (e.g., reaction zone 1302D), thereby increasing the sensitivity of these reaction zones. At the other extreme, image 1806 is overexposed to enhance detail for detecting lower concentrations of one or more reaction zones (e.g., reaction zone 1302B), thereby increasing the sensitivity of these reaction zones. Using the exposure between extremes, image 1804 enhances the details of one or more reaction zones (e.g., reaction zone 1302C) used to detect intermediate concentrations, thereby increasing the sensitivity of these reaction zones.

Computing device 210 can be based on the average of all reaction zones 1302 within each image The RGB value is used to select one of the images 1802, 1804, and 1806. When the average RGB value of all of the reaction zones 1302 in an image is too low (e.g., <30) or too high (e.g., >240), indicating that the exposure time of the image is not appropriate, the computing device 210 selects another image.

Instead of adjusting the exposure, method 1700 is augmented by taking multiple images of sample test strip 1300 under multiple brightness (eg, flash or intense light) within one or more examples of the present invention. The nineteenth image shows images 1902, 1904, and 1906 of the sample strip 1300 under low, medium, and high flash intensities, respectively, in one or more examples of the present invention. In one extreme, image 1902 is under low brightness to enhance detail for detecting lower concentrations of one or more reaction zones (e.g., reaction zone 1302A), thereby increasing the sensitivity of these reaction zones. In other extremes, image 1906 enhances the sensitivity of detecting the higher concentration of one or more reaction zones (e.g., reaction zone 1302D) under high brightness, thereby increasing the sensitivity of these reaction zones. Using medium brightness, image 1904 enhances the detail of one or more reaction zones (e.g., reaction zone 1302C) used to detect intermediate concentrations, thereby increasing the sensitivity of these reaction zones.

In this mode, computing device 210 can test a light source (eg, a flash) before capturing images 1902, 1904, and 1906 to determine that operation is normal. For example, computing device 210 turns on the flash at least once and uses the detected change in brightness to determine if the flash is functioning.

Computing device 210 can select one of images 1902, 1904, and 1906 based on the average RGB value of all or a portion of reaction zone 1302 within each image. When the average RGB value of an intra-image reaction zone 1302 is too low (e.g., <30) or too high (e.g., >240), it indicates that the illumination brightness of the image is not appropriate, and the computing device 210 selects another image.

Fig. 20 shows a sample test piece 2000 in one or more examples of the present invention. The sample test strip 2000 contains a plurality of reaction zones to detect characteristic values of different analytes. In one example, the sample test strip 2000 includes a reaction zone 2002 for detecting a characteristic of a first analyte in a sample of the sample, a reaction zone for detecting characteristics of the second analyte in the sample of the sample, or A plurality of reaction zones 2004 (e.g., two reaction zones 2004), and a reaction zone or plurality of reaction zones 2006 (e.g., three reaction zones 2006) that detect the characteristics of the third analyte in the sample of the sample. Similar to the reaction zone 1302 described in FIG. 13A, the plurality of reaction zones 2004 each detect a different range of the second analyte property values, and each of the plurality of reaction zones 2006 detects the third analysis. Different ranges of property values.

In one example, an analyte within the sample of the sample is known to affect the detection of another analyte. For example, reaction zone 2006 detects glucose in a blood sample, and reaction zone 2004 detects hematocrit (HCT) levels within the blood sample. The HCT level can be detected directly or indirectly (ie by determining the level of another substance in the blood sample). The diagnostic application determines the HCT level and then uses the known relationship between the HCT and the glucose level to correct the glucose level. This relationship can be determined by experiment, arithmetic, or both. The diagnostic application can perform the HCT correction either before or after any other modifications described in the present invention.

The computing device 210 can also determine the HCT level from the sample test strips in other manners. The twenty-first figure shows a cross-sectional view of a sample test piece 2100 in one or more examples of the present invention. Within the specimen test strip 2100, a hole is provided in the path of the blood sample, a light illuminates through the blood sample, and the resulting light color is correlated to the HCT level. In one example, the test strip 2100 includes a capillary inlet 2102, a capillary 2104 coupled to the capillary inlet 2102, and a reaction zone 2106 coupled to the capillary 2104. A hole 2108 is defined through the capillary 2104. A transparent film 2112 covers the top opening 2110 of the aperture 2108 and a transparent film 2116 covers the bottom opening 2114. The computing device 210 illuminates the light through the aperture 2108 and extracts the color of the light exiting the aperture 2108 and then correlates to the HCT level based on the percentage of red blood cells within the blood. In another example, the film 2116 has a coefficient of reflection that exceeds the film 2112. Part of the light is reflected or scattered back to the top opening 2110 and is retrieved by computing device 210 to determine the HCT level.

In another example, a piece of rectangular material that filters red blood cells and absorbs plasma is provided on the test strip. The HCT level is then correlated to the amount of plasma that has been absorbed, as determined by the distance the blood sample is moved upward in the test strip.

The method 800 does not use a timing zone (eg, timing zone 602 or 704) that is separate from a reaction zone, and the second color component of a reaction zone can be utilized to detect time, and the first color component of the reaction zone is used to detect the present Inventing one or more of the examples within an analyte property.

Figure 22 is a diagram illustrating the change in the first color component (e.g., red) of the reaction zone as a function of time for an analyte characteristic value (e.g., glucose level in blood) for one or more of the examples of the present invention. Graph 2200. As can be seen, the curve of the first color component is rapidly converted to a constant value and thus can be used to indicate individual values of the analyte characteristics.

A twenty-third figure is an illustration of the analyte in one or more examples of the invention. A property value plotting a graph 2300 of the change in the second color component (e.g., blue component) of the reaction zone as a function of time. As can be seen, the curve of the second color component changes over time and can therefore be used as a timer to indicate when to read the first color component and to determine the analyte property value (ie, after the first color component is settled) . In one example, within block 802 of method 800, computing device 210 can retrieve a plurality of images 212, determine when the second color component indicates an appropriate time to read the first color component, and read at that time. The first color component is taken to determine the analyte property value.

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

Many of the specific embodiments of the present invention disclosed in the present specification are understood, and many modifications may be made without departing from the spirit and scope of the invention. Therefore, the specific embodiments disclosed in the specification are not to be construed as limiting

200‧‧‧sample test piece

202‧‧‧Reaction zone

204‧‧‧ School color area

206‧‧‧School area

208‧‧‧ imaging device

210‧‧‧ Computing device

212‧‧‧ images

Claims (42)

A sample test piece for detecting an analyte characteristic in a sample of a sample, the test piece comprising: a reaction zone for accepting the sample of the sample, and changing a color based on the characteristic of the analyte in the sample of the sample; a color correction zone comprising one or more samples having known color characteristics that are used to determine a color of the reaction zone under different lighting conditions, including exposure or illumination brightness; and a temperature zone, Based on the temperature of the temperature zone, the color is changed, which is used to adjust a measure of the analyte's characteristics. The sample test piece of claim 1, wherein the color correction zone is used to determine a color density of the reaction zone and the color of the reaction zone after receiving the sample of the sample. For example, the sample test piece of the first application of the patent scope, wherein the school temperature zone includes a plurality of temperature departments. For example, in the sample test piece of claim 1, wherein the color correction zone surrounds the reaction zone. The sample test piece of claim 4, wherein the color correction zone comprises an annular area. The sample test piece of claim 1, wherein the color correction zone comprises a virtual reaction zone comprising an enzyme in the reaction zone but lacking a dye in the reaction zone. The sample test piece of claim 1, wherein the color correction zone comprises a virtual reaction zone comprising a dye in the reaction zone but lacking an enzyme in the reaction zone. The sample test piece of claim 1, wherein the color correction zone comprises a color map having a known color sample or a gray card having a known reflectance. The sample test piece of claim 1 of the patent application further includes a timing capillary for receiving the sample of the sample, the timing capillary marking duration. For example, the sample test piece of the patent application scope 1 further includes a time zone for receiving the sample sample, and linearly changing the color to and from the sample sample. For example, the sample test piece of the scope of claim 1 includes a time zone to change the color in response to brightness or humidity. For example, the sample test piece of claim 1 of the patent scope includes a further reaction zone to receive the sample. Sample sample. For example, in the sample test piece of claim 12, wherein the reaction zone detects the glucose level and the other reaction zone detects a hematocrit level. The sample test piece of claim 1 further includes: a hole in a path of the sample of the sample; a top end of the hole covered by a first film, the first film being transparent; One of the holes covered by a second film is open at the bottom. The sample test piece of claim 14, wherein the second film is more reflective than the first film. A method for a computing device to read a sample test piece using an imaging device to detect an analyte characteristic in a sample sample, the method comprising: capturing an image of the sample test piece, wherein: The image includes a reaction zone, a color correction zone and a calibration zone on the sample test strip; the reaction zone has a color according to the characteristics of the analyte; the color correction zone has one or more colors; The calibration zone has a color according to its temperature; determining the color of the reaction zone based on the one or more colors of the calibration zone; and determining a characteristic value of the analyte, and including: the reaction zone The color is associated with the characteristic value of the analyte, and then the characteristic value of the analyte is adjusted according to the color of the calibration zone; or the color of the reaction zone is adjusted according to the color of the calibration zone, This color of the reaction zone is then correlated to the characteristic value of the analyte. The method of claim 16, wherein the determining the color of the reaction zone comprises determining a color concentration of the reaction zone and the color of the reaction zone based on the one or more colors of the color correction zone, And wherein the color associated with the reaction zone comprises correlating the color density and the color of the reaction zone to a characteristic value of the analyte. The method of claim 17, further comprising selecting a stable image from the images, as a color for determining the reaction zone, or the color of the reaction zone and the color The image of the concentration. The method of claim 16, wherein the image comprises a video frame. The method of claim 16, further comprising: determining whether the brightness of the image is consistent from at least two positions on the color correction area; and correcting the brightness of the image when the brightness of the image is inconsistent. The method of claim 20, wherein the effect of correcting the brightness on the image comprises: determining a brightness curve from the at least two positions on the color correction area; and evaluating the RGB of the brightness curve on a pixel in the reaction area. The value; and the corrected RGB value of the pixel is determined as follows: RGB _new = i *(R(x,y), G(x,y),B(x,y))/(R _est (x,y), G _est (x, y), B _est (x, y)) where R(x, y), G(x, y), B(x, y) are the original RGB values of the pixel, R _est (x , y), G _est (x, y), B _est (x, y) are the evaluated RGB values of the luminance curve on the pixel, and i is the maximum RGB value of a color in the reaction zone. The method of claim 17, wherein the image further comprises a further reaction zone on the sample test strip, and the method further comprises modifying the color of the reaction zone according to the other reaction zone, or the reaction zone Color and the color density. The method of claim 22, wherein the reaction zone detects a glucose level and the other reaction zone detects a hematocrit level. The method of claim 16, further comprising: guiding a light through a top opening of a hole in a path of the sample sample in the sample test piece; determining to leave from the bottom opening of the hole or open from the top end One of the colors of the reflected light; the color of the light is associated with an other value of a characteristic of the other analyte; and the other value of the other analyte characteristic corrects the color of the reaction zone. The method of claim 24, wherein the analyte characteristic is a glucose level and the other analyte characteristic is a hematocrit level. The method of claim 16, wherein the image is further included in the sample test piece The last timer, and the method further includes determining, based on the timer, when to capture the image. The method of claim 26, wherein the timer comprises a timing capillary. The method of claim 26, wherein the timer comprises a time zone that receives the sample of the sample and linearly changes the color to and from the sample. The method of claim 26, wherein the timer includes a timing zone that changes color in response to brightness or humidity as the specimen is removed from a package. The method of claim 17, wherein: determining the color of the reaction zone or the color of the reaction zone and the color concentration according to one or more colors of the color correction zone comprises: determining one of the reaction zones The second color component indicates an appropriate time to read a first color component of the reaction zone, determining the first color component of the reaction zone; and the color of the reaction zone, or the color of the reaction zone The color concentration associated with the characteristic value of the analyte comprises correlating the first color component to the characteristic value of the analyte. The method of claim 16, further comprising: capturing an image of the meal at a time; associating the image of the meal, the time, and the characteristic value of the analyte; and displaying or transmitting the image of the meal The time and the correlation of the characteristic value of the analyte. A computing device using an imaging device to detect an analyte characteristic in a sample sample from a sample test piece having a plurality of reaction zones, and the reaction zones have different ranges depending on an analyte property value a color method, the method comprising: capturing a plurality of images of the sample test piece under different exposure levels or illumination brightness; selecting one of the images including the images of the plurality of reaction zones, the images being captured The reaction zone has a suitable degree of exposure or a suitable illumination brightness; selecting a captured reaction zone from the image; and correlating the color of the captured reaction zone to the characteristic value of the analyte comprises: Determining the color of the captured reaction zone according to a captured color correction area in the image And correlating the color of the extracted reaction zone to the characteristic value of the analyte, and then adjusting the characteristic value of the analyte according to a captured temperature zone in the selected image; or according to the A captured temperature zone in the image is selected to adjust the color of the captured reaction zone, and then the color of the captured reaction zone is correlated to the characteristic value of the analyte. The method of claim 32, wherein selecting the captured reaction zone from the image comprises selecting a captured reaction zone having a suitable saturation for the plurality of captured reaction zones within the image. The method of claim 33, wherein the captured reaction zone is selected from the image because the captured reaction zone has an average RGB value greater than a noise level of the captured reaction zone. The method of claim 34, wherein the image is selected from the plurality of images because the plurality of captured reaction regions within the image have an average RGB value between corresponding thresholds. The method of claim 32, wherein the image is selected from the plurality of images because the plurality of captured reaction regions within the image have an average RGB value between corresponding thresholds. The method of claim 32, wherein the sample test piece further comprises a plurality of other reaction zones, the other plurality of reaction zones having other plural colors, which are based on values of the other analytes in other different ranges. And the method further comprises: selecting, from the other plurality of images, other images including the other captured reaction regions, the captured reaction regions having another suitable exposure level or another suitable illumination brightness; In the other images, one other selected reaction zone is selected; and the other color of the other captured reaction zone is associated with another value of the other analyte characteristic. The method of claim 37, wherein selecting the other captured reaction zone from the other images comprises selecting a plurality of captured reaction zones of the other plurality of captured reaction zones in the other image, A suitable saturation. The method of claim 38, wherein the other image is selected from the plurality of other images because the other captured reaction regions in the other image have an average between corresponding thresholds RGB value. The method of claim 39, wherein the other extracted reaction zone is selected from the other images because the other captured reaction zone has a noise level greater than the other captured reaction zone The average RGB value. The method of claim 37, wherein the other extracted reaction zone is selected from the other images because the other captured reaction zone has a noise level greater than the other captured reaction zone The average RGB value. The method of claim 32, wherein the sample test piece further comprises a color correction zone and a calibration temperature zone; the color correction zone has one or more known colors; the temperature zone has a temperature according to the temperature One color.