TW201721129A - Method and system of using a mobile device for analyte detection - Google Patents

Abstract

A method and system for determining an analyte concentration in a fluid sample. A mobile device such as a smart phone includes a processor, a camera, and a memory. A carrying case is provided to hold the mobile device. The carrying case has a sensor housing to hold a test sensor having a reaction area for holding the fluid sample. When the carrying case is mated with the mobile device, the reaction area of the test sensor is aligned with the camera. A metering application is loaded on the mobile device. The application is executed by the processor to capture image data of the fluid sample from the camera and analyze the content of the fluid sample based on the image data.

Description

Method and system for using analytes for analyte detection

The present invention relates generally to a system for fluid analyte analysis (blood glucose) and, more particularly, to a system for using a mobile device in conjunction with a carrying case to provide a fluid analyte assay.

Quantitative determination of analytes in body fluids is very important in the diagnosis and maintenance of certain physiological conditions. For example, diabetic patients (PWD) frequently check the level of glucose in their body fluids. The results of these tests can be used to modulate glucose intake in the diet of a diabetic patient and/or to determine whether insulin or other drugs need to be administered. A PWD typically uses a measurement device (e.g., a blood glucose meter) that calculates a concentration of glucose from a fluid sample in one of the PWDs, wherein the fluid sample is collected on one of the test sensors received by the measurement device. Failure to perform a corrective action may have a serious medical impact on the patient. One method of monitoring one's blood glucose levels is to use a portable test device. The portable nature of these devices allows the user to conveniently test their blood glucose levels at different locations. One type of device utilizes an electrochemical test sensor to collect and analyze blood samples. A user uses a lancet to obtain a blood sample for testing one of the sensors. Electrochemical test sensors typically include an electrode that electrically measures the reaction of a blood sample to determine an analyte concentration when mated with the instrument. Therefore, the user must carry a special instrument device to determine blood sample analysis. Manufacturing machine inductive strips are relatively expensive because they must use noble metals to make the electrodes. An alternative relies on the application of light to one of the fluid test samples based on the optical test sensor strip. The color of the sample is detected by a dedicated instrument and used to analyze the contents of the fluid sample. Although the manufacture of such sensors is relatively inexpensive, the sensors still require a dedicated instrument to optically sense the fluid sample and analyze the data to determine the contents of the sample. Therefore, there is a need for a test sensor system that can use a mobile device that is already in use as an instrumentation device, thereby eliminating the need for a separate instrument. There is a further need for a system that uses an optical based test sensor to eliminate the need for an electrochemical test sensor. There is also a need for a metering application that can be operated on a mobile device to provide an analysis of the contents of a fluid.

According to an example, a measurement system for determining an analyte concentration in a fluid sample is disclosed. The system includes a mobile device having a processor, a camera, and a memory. The system includes a carrying case having a sensing housing for holding a test sensor. The test sensor has a reaction zone for holding the fluid sample. The carrying case can cooperate with the mobile device to align the reaction area with the camera when the carrying case is mated with the mobile device. The processor is operative to capture image data of the fluid sample from the camera and analyze the contents of the fluid sample based on the image data. Another example is a carrying case for allowing a mobile device to determine an analyte concentration in a fluid sample on a test sensor. The carrying case has a backing plate including a pair of guiding members for holding the mobile device, and a passage in the backing plate for holding a reaction area for holding a fluid sample Test the sensor. The carrying case includes an aperture in the backing plate that is aligned with a camera on the mobile device. When the test sensor is inserted into the channel, the reaction zone is aligned with the aperture. Another example is a method of determining the concentration of an analyte in a fluid sample by a mobile device in conjunction with a carrying case. The mobile device includes a processor, a memory, and a camera. An analyte concentration metering application is loaded into the memory of the mobile device. A test sensor having a reaction zone in a slot is received in the carrying case. The test sensor is positioned to align the reaction zone proximate to the camera. A fluid sample is collected in the reaction zone of the test sensor. The camera is operated to take an image of the fluid sample. Image analysis of the fluid sample determines the analyte concentration of the fluid sample from a color change caused by mixing the reagent with the fluid sample. Another example is a method of determining the concentration of an analyte in a fluid sample using a mobile device having a processor, a memory, and a camera. An analyte concentration metering application is loaded into the memory of the mobile device. A carrying case cooperates with the mobile device. The carrying case has a slot for receiving a test sensor having a reaction zone. The test sensor is positioned by the carrying case to align the reaction zone to the camera. A fluid sample is collected in the reaction zone of the test sensor. The camera is operated to take an image of the fluid sample. Image analysis of the fluid sample determines the analyte concentration of the fluid sample from a color change caused by mixing the reagent with the fluid sample. Other aspects of the invention will be apparent to those skilled in the <RTIgt;

(S) CROSS REFERENCE TO RELATED APPLICATIONS The application claims priority September 29, 2015 of U.S. Provisional Patent Application No. 62 Priority / Number of 234,382, the entire contents of which are incorporated by reference herein. Copyright One of the disclosures of this patent document contains copyrighted material. The copyright owner has no objection to the complete reproduction of the contents of the patent disclosure by anyone, as in the Patent or Trademark Office, but retains all other rights. 1A shows a fluid analyte system 100 for collecting and analyzing a fluid sample, such as for determining an analyte concentration of a fluid sample. System 100 includes a mobile device 102 that can be a mobile phone, a smart phone, or other suitable device. System 100 includes a carrying case 104 for protecting one of mobile devices 102. As explained above, the carrying case 104 has a dedicated component that allows an optical based test sensor 110 to be positioned relative to the mobile device 102. As shown in FIG. 1B, a two-piece carrying case 105 for holding the mobile device 102 includes a standard upper protective case 106 and a lower protective case 108. The standard upper protective case 106 slides over the upper portion of the mobile device 102 and the lower protective case 108 slides over the lower portion of the mobile device 102 for a user to carry the mobile device 102 and protect the mobile device 102 from blunt force impact or contaminants exposure. In FIG. 1A, instead of the upper upper protective case 106 in FIG. 1B, one of the holding test sensors 110 may be used instead of the upper protective case 112 to form the carrying case 104. The lower protective case 108 remains the same between the carrying case 104 in FIG. 1A and the carrying case 105 in FIG. 1B. Test sensor 110 maintains the collected fluid from the user for testing and analysis by mobile device 102. The protective boxes 106, 112 and the lower protective case 108 can be constructed from a plastic material such as polycarbonate. It is contemplated that the protective cartridges can be made from other polymeric or non-polymeric materials. A lining made of rubber may be provided for the side of the carrying case 104 for additional shock protection of the mobile device 102. The carrying case 104 holds the mobile device 102, thereby mating the upper protective case 112 with the lower protective case 108, as shown in Figures 2A-2D. The upper protective case 106 can be used in place of the upper protective case 106 to hold the test sensor 110 and allow the mobile device 102 to analyze one of the fluid samples on the test sensor 110. Therefore, in the normal case, the standard upper protective case 106 is used together with the lower protective case 108. As will be explained hereinafter, when a user wishes to test a fluid sample, the user replaces the standard upper protective case 106 with the upper protective case 112. The upper protective case includes a test sensor housing 114 as shown in Figures 2B-2D and thus allows a user to insert the test sensor 110 for receiving one of the fluid samples for testing. Of course, the upper protective case 112 can be used during normal conditions. In this example, the mobile device 102 can be a smart phone such as the iPhone 6® manufactured by Apple Corp., which has a processor for executing different applications, a camera, and a light source. However, other smart phones or mobile devices having similar capabilities, such as an Android phone, a Galaxy phone, etc., can be used. The mobile device 102 has a front surface 120 that includes a display screen 122 and a function button 124 that can be a home button, as shown in FIG. 1A. As shown in FIG. 2A, the front of the carrying case 104 is open to allow a user to view the display screen 122 and operate the mobile device 102 via the function button 124 and the touch display screen 122. 2D shows a rear view of one of the mobile devices 102 with the protective case 112 installed. As shown in FIG. 2B, the carrying case covers the back of the mobile device 102 extensively. As shown in FIG. 2D, the mobile device 102 has a rear surface 130 that includes a lens for a camera 132 and a light source 134. An optional infrared (IR) sensor 136 can be provided in this embodiment. As shown in FIG. 1A, test sensor 110 includes an elongated rectangular body 150 having a fluid receiving end 152 and a reaction region 154 opposite fluid receiving end 152. In this example, the test sensor 110 includes: a capillary channel on the elongated rectangular body 150; and a reagent layer for maintaining a reaction with a fluid sample introduced into the reaction zone 154 through the capillary channel One of the reagents. As shown in FIG. 3A, the upper protective case 112 has a generally planar backing plate 310 that includes two side guides 312 and 314 each including an inner track that mates with a side of the mobile device 102. Side guides 312 and 314 include respective outer rubber bumpers 316 and 318 that cushion the upper protective casing 112 from vibration. The backplane 310 includes a camera aperture 320 that is aligned with the lens of the camera 132 (FIG. 2D) and the light source 134 (FIG. 2D) when the upper protective case 112 is mated with the mobile device 102. The test sensor housing 114 can include a sensor holder 330 that includes a slot 332 that is sized to receive one of the test sensors 110. The slot 332 causes one of the rectangular channels 334 formed in the sensor holder 330 to hold the test sensor 110. The channel 334 is of sufficient length that the fluid receiving end 152 extends from the slot 332 when the test sensor 110 is fully inserted into the channel 334 while the reaction zone 154 is aligned with the camera aperture 320. The sensor housing 330 includes a light guide 336 that extends between the flash and the camera when the cassette 104 is inserted into the mobile device 102. As shown in FIG. 2D, light guide 336 transmits light from light source 134 to illuminate camera 132. The standard upper protective case 106 of FIG. 1B is similar in construction to the upper protective case 112, but the standard upper protective case 106 cannot hold the test sensor 110. As shown in FIG. 1B, the standard upper protective case 106 includes a backing plate 160 having side guides 162 and 164 that hold the sides of the mobile device 102. The backplane 160 includes a camera aperture 170 that aligns with the lens of the camera 132 when the protective cover 106 is mated with the mobile device 102. The camera aperture 170 allows a user of the mobile device 102 to take an image through the camera 132 as the mobile device 102 is inserted into the carrying case 104. Camera aperture 170 is also aligned with light source 134 to allow flash from light source 134 to function. As shown in FIG. 3B, the lower protective case 108 includes a backing plate 350 that holds one of the two side guides 352 and 354. The side guides 352 and 354 each have an internal rail that mates with the side of the mobile device 102. The side guides 352 and 354 each include respective outer rubber bumpers 356 and 358 for further cushioning the carrying case 104 from vibration. A dedicated fluid metering application can be loaded into the mobile device 102 as will be explained below. When the test sensor 110 is inserted into the upper carrying case 112, the test sensor 110 can be used to collect fluid samples from one of the users in the reaction zone 154. For example, a user may use a lancing device to pierce a finger or other area of the body to produce a blood sample at the surface of the skin. The user can then collect the blood sample by placing the fluid in the receiving end 152 of the test sensor 110 extending from the upper carrying case 112. The fluid is wicked into the reaction zone 154 of the test sensor 110 via a capillary channel. Test sensor 110 contains reagents that react with the sample to indicate the concentration of one of the analytes in the sample. As will be explained below, the reagent reaction changes the color of the sample. After filling the reaction zone 154 with the blood sample, the sensor 110 is inserted into the carrying case 104, as shown in Figures 2A-2D. The user then executes the dedicated fluid metering application on the mobile device 102. The dedicated fluid metering application operates the light source 134 on the mobile device 102. Light from source 134 is directed by light guide 336 on upper protective case 112 to illuminate camera 132. Camera 132 in mobile device 102 is activated to capture an image of the illuminated fluid sample. The image is stored by the mobile device 102 and the dedicated fluid metering application performs analysis of the fluid sample via the image data. Of course, the mobile device 102 can transmit the data or analysis to another storage device, such as cloud storage or a server, via wireless communication, as will be described below. Examples of types of analytes that can be collected include glucose, lipid profiles (eg, cholesterol, triglycerides, LDL, and HDL), microproteins, hemoglobin A1 _C , fructose, lactic acid, or bilirubin. It is expected that other analyte concentrations can also be determined. It is also contemplated that more than one analyte can be assayed. For example, the analyte can be located in a whole blood sample, a serum sample, a plasma sample, or other body fluids and non-body fluids such as ISF (interstitial fluid) and urine. As used in this application, the term "concentration" refers to analyte concentration, activity (eg, enzyme and electrolyte), potency (eg, antibody), or any other measured concentration used to measure an analyte. Under the direction of a dedicated fluid metering application, the mobile device 102 acts as a beam splitter that uses the camera 132 as one of the input devices for measuring the analyte concentration in the fluid sample on the test sensor 110. For example, an analyte system and one of the samples of one of the body fluids can be reacted to produce a color reaction that causes the fluid sample to change color due to the reaction between the reagent and the analyte. The degree of color change is indicative of one of the analyte concentrations in the body fluid. The color change of the sample can be evaluated to measure the absorption level, such as from one of the light sources 134. Thus, camera 132 captures an original optical signal based on light absorbed by the fluid sample on test sensor 110 and reflected from the fluid sample on test sensor 110. In this example, camera 132 captures a charge coupled device (CCD) array of red, green, and blue (RGB) sub-pixels of the image of the fluid sample. The dedicated fluid metering application can individually interrogate red, green or blue pixel data from the CCD array to improve signal selectivity by resolving the specific gravity of the different wavelengths of the visible spectrum from the fluid sample. Alternatively, a filter can be included in the test sensor 110 to filter light from the source 134 or cover the reaction area 154. The change in optical properties can be compared to the previously stored calibration data obtained by similarly testing one of the known analyte concentrations to calibrate the sample. Alternatively, the sensing capillary may be uncoated with a reagent and the analyte concentration determined by reading the amount of analyte directly at a particular wavelength. Additionally, the application can use the IR sensor 136 to perform additional measurements on the fluid sample. The IR sensor 136 includes an IR light source and an IR light detector. The hematocrit level of the entire blood affects the spectral response across the visible region and near IR ("infrared") light regions (eg, 400 nm to 1100 nm). Light transmittance varies with different hematocrit levels and is proportional to different hematocrit levels due to differences in scattered light due to the number of red blood cells. The hematocrit transmission shift at near IR wavelength is proportional to the hematocrit level of the blood. Thus, the IR source can be activated and the reflected/transmitted IR light from the sample associated with the number of red blood cells can be measured to determine the hematocrit level. The metering application can display the results of the reading on the display 122 of the mobile device 102. Other analytics functions such as providing instructions, providing reminders, and presenting detailed analysis of results can be performed by the metering application. The data can be stored in the mobile device 102 and can be transmitted to a caregiver, remote storage device, or other computing device. 4A is a block diagram showing the transmission of optical signals from test sensor 110 to mobile device 102. As shown in FIG. 4A, the test sensor 110 is inserted into the upper protective case 112 such that the reaction area 154 is approximately aligned with the camera 132 and a corresponding lens 402 on the mobile device 102. A fluid sample 400 flows into the reaction zone 154 of the test sensor 110. Upper protective case 112 includes a collection lens 406 that is aligned with one of the windows 408 at the bottom of reaction zone 154. The light guide 336 of the upper protective case 112 includes a collimating lens 410 aligned with the light source 134 of the mobile device 102. Light guide 336 transmits light from collimating lens 410 to an output 412 positioned adjacent one of sample 400. Light from output 412 is transmitted through window 408 and through sample 400. Sample 400 scatters light to collecting lens 406. Light collecting lens 406 collects light scattered by fluid sample 400 in reaction zone 154 to direct light to lens 402. In this manner, light from source 134 is transmitted to illuminate sample 400 for camera 132 and optical data from sample 400 is taken for analyte analysis. IR sensor 136 is also shown in Figure 4A. IR sensor 136 is proximate to camera 132 and can be directed to detect infrared light transmitted through sample 400. The infrared light reflected/transmitted through the sample 400 can be sensed by the infrared sensor 136 and the metrology application can determine the hematocrit content of the sample 400 based on the wavelength of the infrared light transmitted through the sample 400. 4B is a block diagram of one of the alternative systems 450 for analyte analysis based on light reflection and thus without the need for a light guide. As can be seen in FIG. 4B, if the light source 134 is sufficiently close to the camera lens 402, the light from the light source 134 is at an angle toward the sample 400 and is reflected from the rear surface of the upper protective case 112 and returned to the camera 132, as in FIG. 4B. The arrow shows. In this manner, the sample 400 can be illuminated and captured by the camera 132 through the window 408. 5 is a block diagram of one component of a mobile user device such as one of the mobile user devices 102 of FIG. The mobile user device 102 includes an application processor 510, a power source 512, a baseband processor 516, and a codec (CODEC) 518. The display 122 is an LCD touch screen that allows the user to control the application executed by the application processor 510 via the touch input and view the graphics generated by the application processor 510. Display 122 is controlled by a touch screen controller 520. Application processor 510 can be coupled to various devices such as camera 132, flash 134, IR sensor 136, and other interfaces such as a communication device. The baseband processor 516 receives signals from a network transmission receiver 530 to allow communication with a network, such as the Internet, and receives a geo-referenced receiver 532 from one of the locations that is permitted to receive location data to determine the mobile device 102. signal. The baseband processor 516 processes the signals and is coupled to the CODEC 518, which converts the signals for use by the application processor 510. The CODEC 518 also decodes the audio signals received by a microphone 540 and encodes the data signals output by a speaker 542 for use in functions such as one of the application applications executed by the application processor 510. Of course, other audio devices such as a headset can be coupled through the CODEC 518. Processors 510 and 516 can use one or more general purpose computer systems, microprocessors, digital signal processors, microcontrollers, application specific integrated circuits (ASICs), programmable logic devices (PLDs), field programmable Logic devices (FPLDs), field programmable gate arrays (FPGAs), and the like are conveniently implemented, and are programmed according to teachings as described and illustrated herein, such as those in the computer, software, and networking fields. Will understand. The operating system software and other applications are stored on a read only memory (ROM) 550, a random access memory (RAM) 552, and a memory storage device 554 for access by the application processor 510. In this example, memory storage device 554 is a flash memory, but other memory devices can be used. The application stored on the memory storage device 554 can include a fluid metering application. In this example, the fluid metering application can be preloaded on the mobile device 102 or can be provided as an application that can be downloaded from a web server to the mobile device 102. The memory storage device 554 includes a machine readable medium having stored thereon one or more of any one or more of the methodologies or functions described herein (eg, software). The instructions may also reside wholly or at least partially within memory storage device 554, ROM 550, RAM 552, and/or processor 510 or 516 during execution by mobile device 102. The instructions can be transmitted or received over a network via the network transmission receiver 530. Although the machine-readable medium is shown as a single medium in an example, the term "machine-readable medium" should be taken to include a single medium or multiple media that store one or more sets of instructions (eg, a centralized Or distributed database and / or associated cache area and server). The term "machine-readable medium" can also be taken to include any or more of the methodologies that can store, encode, or carry a set of instructions for execution by a machine and cause the machine to perform various embodiments, or can be stored, encoded, or carried. This instruction set utilizes any media of the data structure associated with or associated with this instruction set. Accordingly, the term "machine-readable medium" can be considered to include, but is not limited to, solid state memory, optical media, and magnetic media. Such as one of the system's random access memory (RAM) or a read-only memory (ROM) or a floppy disk, hard disk, CD ROM, DVD ROM, flash or magnetic, optical or by coupling to one of the processors Various different types of memory storage devices for other computer readable media that read and/or write to the system can be used for the memory in the mobile device 102. The operation of the metering application on the example mobile device 102 shown in FIGS. 1 and 5 will now be described with reference to the flow charts shown in FIG. 6 with reference to FIGS. 1 through 5. The flowchart of Figure 6 is representative of one of the example machine readable instructions for implementing the application to collect an image of a fluid sample and perform an inclusion analysis based on the image. In this example, the machine readable instructions comprise an algorithm executed by (a) a processor, (b) a controller, and/or (c) one or more other suitable processing devices. The algorithm can be embodied in tangible media stored in, for example, a flash memory, a CD-ROM, a floppy disk, a hard disk drive, a digital video (multi-function) compact disk (DVD), or other memory device. In the software above, but the average person will readily understand that the entire algorithm and/or portions thereof may alternatively be performed by one device other than a processor or/or may be embodied in a firmware or dedicated hardware in a well-known manner. Medium (for example, it can be an application specific integrated circuit (ASIC), a programmable logic device (PLD), a programmable logic device (FPLD), a programmable gate array (FPGA), discrete logic, etc. carried out). For example, any or all of the components of the interfaces may be performed by software, hardware, and/or firmware. Moreover, some or all of the machine readable instructions represented by the flowchart of FIG. 6 may be manually implemented. Moreover, although the example algorithm is described with reference to the flowchart depicted in FIG. 6, one of ordinary skill in the art will readily appreciate that many other methods of implementing such example machine readable instructions may alternatively be used. For example, the order of execution of the blocks may be changed, and/or some of the blocks described may be modified, eliminated or combined. The metering application receives an indication from the user that the test sensor 110 has been inserted into the upper protective case 112 (as shown in Figures 2A-2D) and has collected a fluid sample (600). Next, the metrology application operates the light source 134 to cause a flash to illuminate the fluid sample (602) through transmission through a light guide as shown in FIG. 4A or via reflection as shown in FIG. 4B. Next, the metrology application operates camera 132 to capture an image of the illuminated sample (604). Next, the metrology application determines color data from the sample via different color sub-pixels (606). The color data is correlated with the concentration of the analyte via a lookup table, algorithm or other method (608). The results of the analysis are stored in memory (610). The result is then displayed on display 122 (612). One advantage of system 100 is that the "instrument" in this context is one of the non-electronic, low cost adapters in the form of one of the applications executing on mobile device 102. Although system 100 requires a fluid metering application stored on mobile device 102 that includes signal processing and analysis functions, there is no separate hardware other than mobile device 102. Therefore, the application is easy to update and can be inexpensively distributed to users who already have an existing mobile device such as a smart phone and the like. The use of an optical based test strip such as test sensor 110 eliminates the need to utilize precious metals, thereby reducing the cost of the test sensor. It is intended that the scope of the invention, and the scope of the invention as set forth in the appended claims.

100‧‧‧Fluid Analyte System
102‧‧‧Mobile devices
104‧‧‧ Carrying case
105‧‧‧ Carrying case
106‧‧‧Standard protection box
108‧‧‧Under the protection box
110‧‧‧Test Sensor
112‧‧‧Up protection box
114‧‧‧Test sensor housing
120‧‧‧ front surface
122‧‧‧Display screen/display
124‧‧‧ function button
130‧‧‧Back surface
132‧‧‧ camera
134‧‧‧Light source/flash
136‧‧‧Infrared (IR) sensor
150‧‧‧Slim rectangular body
152‧‧‧ Fluid receiving end
154‧‧‧Reaction area
160‧‧‧ Backplane
162‧‧‧ side guides
164‧‧‧ side guides
170‧‧‧ camera aperture
310‧‧‧ Backplane
312‧‧‧ side guides
314‧‧‧ side guides
316‧‧‧ rubber bumper
318‧‧‧ rubber bumper
320‧‧‧ camera aperture
330‧‧‧Sensor Holder/Sensor Housing
332‧‧‧ slot
334‧‧‧Rectangular channel
336‧‧‧Light guides
350‧‧‧ Backplane
352‧‧‧ side guides
354‧‧‧ side guides
356‧‧‧ rubber bumper
358‧‧‧ rubber bumper
400‧‧‧ fluid sample
402‧‧‧ camera lens
406‧‧‧Collection lens
408‧‧‧ window
410‧‧‧ collimating lens
412‧‧‧output
450‧‧‧Alternative system
510‧‧‧Application Processor
512‧‧‧Power supply
516‧‧‧Baseband processor
518‧‧‧CODEC
520‧‧‧Touch Screen Controller
530‧‧‧Network transmission receiver
532‧‧‧ Georeferenced Receiver
540‧‧‧ microphone
542‧‧‧Speaker
550‧‧‧Read-only memory (ROM)
552‧‧‧ Random Access Memory (RAM)
554‧‧‧Memory storage device
600‧‧‧ operation
602‧‧‧ operation
604‧‧‧ operation
606‧‧‧ operation
608‧‧‧ operation
610‧‧‧ operation
612‧‧‧ operation

1A is an exploded perspective view of one of the fluid analyte systems using an existing mobile device and a dedicated upper carrying case assembly in accordance with an embodiment; FIG. 1B is one of the mobile devices of FIG. 1A having a standard carrying case 2A is a front perspective view of one of the mobile devices of FIG. 1 having an assembled carrying case according to an embodiment; FIG. 2B is a rear perspective view of one of the mobile devices of FIG. 1 having an assembled carrying case; Figure 2C is a side elevational view of the mobile device of Figure 1 with the assembled carrying case; Figure 2D shows a rear view of one of the mobile devices of Figure 1 with the assembled carrying case; Figure 3A is a top portion of the carrying case of Figure 1 Figure 3B is a close-up perspective view of one of the lower portions of the carrying case of Figure 1; Figure 4A is a mobile device, test sensor and carrying device of Figure 1 for measuring a fluid sample. Figure 4B is a diagram of one of the alternative interfaces between the mobile device, the test sensor and the carrying case of Figure 1 for measuring a fluid sample; Figure 5 Can be incorporated into the fluid analyte system of Figure 1. A block diagram of one mobile device; and Figure 6 is a flowchart of one application one fluid sample measurement can be performed on the mobile apparatus of FIG. The present invention is susceptible to various modifications and alternative forms, and the specific embodiments thereof are shown by way of illustration only and are described in detail herein. However, it is understood that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, equivalents and alternatives of the invention and the scope of the invention as defined by the appended claims.

102‧‧‧Mobile devices

122‧‧‧Display screen/display

132‧‧‧ camera

134‧‧‧Light source

136‧‧‧Infrared (IR) sensor

510‧‧‧Application Processor

512‧‧‧Power supply

516‧‧‧Baseband processor

518‧‧‧CODEC

520‧‧‧Touch Screen Controller

530‧‧‧Network transmission receiver

532‧‧‧ Georeferenced Receiver

540‧‧‧ microphone

542‧‧‧Speaker

550‧‧‧Read-only memory (ROM)

552‧‧‧ Random Access Memory (RAM)

554‧‧‧Memory storage device

Claims (18)

A measuring system for determining an analyte concentration in a fluid sample, comprising: a mobile device comprising a processor, a camera and a memory; a carrying case having a test feeling for holding a sensor housing having a reaction area for holding the fluid sample, the carrying case being engageable with the mobile device to enable the reaction area when the carrying case cooperates with the mobile device The camera is aligned, and wherein the processor is operative to retrieve image data of the fluid sample from the camera and analyze the contents of the fluid sample based on the image data. The measurement system of claim 1, wherein the carrying case comprises an upper protection box and a lower protection box. The measurement system of claim 1, wherein the mobile device comprises a light source proximate to the camera. The measurement system of claim 3, wherein the test sensor comprises a window that allows light to be transmitted to the reaction area and wherein the carrying case comprises a light guide having an input end and an output end, with test sensing When the carrying case is mated with the mobile device, the input is aligned with the light source and the output is adjacent to the window, the light guide directs light from the light source to the fluid sample in the reaction zone. The measuring system of claim 3, wherein the carrying case comprises a collimating lens substantially aligned with the reaction zone, the reaction zone being opposite the output end of the light pipe. The measurement system of claim 3, wherein the test sensor comprises a collection lens opposite the window. The measurement system of claim 1, wherein the mobile device comprises an infrared light emitter, and wherein the processor is operative to determine the fluid sample by emitting an IR light and measuring the IR light reflected from the sample Hematocrit inclusions. The measuring system of claim 2, wherein the upper protective case comprises a backing plate for holding the mobile device and two side guides, the upper protective case comprising the sensor housing. The measurement system of claim 8, wherein the sensor housing includes a slot for inserting the test sensor. The measurement system of claim 1, wherein the test sensor comprises a body having a fluid receiving end, a capillary from the fluid receiving end leading to the reaction zone, and a reagent layer. A carrying case for allowing a mobile device to determine an analyte concentration in a fluid sample on a test sensor, the carrying case comprising: a backing plate including a pair of guides for holding the mobile device a passage in the backing plate for holding the test sensor having a reaction area for holding a fluid sample; and an aperture in the backing plate, which is associated with a camera on the mobile device Precisely, when the test sensor is inserted into the channel, the reaction zone is aligned with the aperture. The carrying case of claim 11, further comprising a lower protective case, wherein the back plate forms an upper protective case. The carrying case of claim 11, wherein the test sensor comprises a window that allows light to be transmitted to the reaction area, and wherein the carrying case comprises a light guide having an input end and an output end, and having the test feeling When the carrying case of the measuring device cooperates with the mobile device, the input end is aligned with a light source on the mobile device and the output end is adjacent to the window, and the light guiding member guides light from the light source into the reaction area The fluid sample. A carrying case according to claim 13 wherein the carrying case comprises a collimating lens substantially aligned with the reaction zone, the reaction zone being opposite the output end of the light pipe. The carrying case of claim 11, wherein the upper protective case comprises a back plate for holding the mobile device and two side guides, the upper protective case comprising the sensor housing. A carrying case according to claim 15 wherein the sensor housing includes a slot for insertion into the test sensor. A method for determining an analyte concentration in a fluid sample by a mobile device in cooperation with a carrying case, the mobile device comprising a processor, a memory and a camera, the method comprising: concentrating an analyte a metering application loaded in the memory of the mobile device; a test sensor having a reaction zone received in a slot of the carrying case, the test sensor being received to bring the reaction zone close to the Aligning with a camera; collecting a fluid sample in the reaction zone of the test sensor; operating the camera to capture an image of the fluid sample; and analyzing the image from the fluid sample by mixing with the fluid sample The color change caused by a reagent determines the analyte concentration of the fluid sample. A method for determining an analyte concentration in a fluid sample using a processor, a memory, and a camera, the method comprising: loading an analyte concentration metering application to the memory of the mobile device Cooperating with the mobile device, the carrying case has a slot for receiving a test sensor having a reaction area, wherein the test sensor is positioned by the carrying case to enable the The reaction zone is aligned near the camera; a fluid sample is collected in the reaction zone of the test sensor; the camera is operated to capture an image of the fluid sample; and the image analysis from the fluid sample is performed The fluid sample is mixed with a color change caused by the reagent to determine the analyte concentration of the fluid sample.