DESC:FIELD OF THE INVENTION
The present invention relates to image processing techniques. More particularly, the present invention relates to systems, methods and devices used to perform image analysis of medical self-test results for evaluating medical conditions at the patient’s location.
BACKGROUND OF THE INVENTION
The diagnostic tests kits are often used for testing for the presence of an analyte in the biological samples. The analyte may be, without limitation, a compound, virus, bacteria, protein etc. The biological sample to be tested is inserted or applied to the test kit. The test kit comprises one or more measurement regions and the antigen corresponding to the sample to be tested. The response of the test kit to the sample is visibly observed in observation window on the kit. The term "test kit" may be used interchangeably to describe a device which contains at least one color change region in response to an analyte.
The response of the test kit to the sample shows a color change that may be analyzed by eye, however, such an approach only provides for a subjective determination. Additionally many users are not clearly deduce or analyze the results appearing on the test kits. Therefore, there is need of a quantifiable output for the correct determination of the result of the biological sample analyses.
There are several existing technologies wherein the test kit may be inserted into dedicated reading devices where it is subjected to predetermined illumination conditions so that the response of the measurement region on the observation window can be measured. However such dedicated test kit reading devices are expensive and require the user to have access to such equipment. Some of the existing systems and methods rely on a healthcare worker to be physically present to interpret result and may or may not result in the operator or human interpretation error.
Furthermore, the known imaging-based readers suffer from certain drawbacks. Specifically, the cost associated with these optical readers and the supporting electronics required to analyze the image scanned by the optical reader, such as a micro controller with good image processing capability, can be relatively high and can prevent broad implementations of a consumer-based product utilizing such optic-electronic readers.
Therefore, there is a need of a cost effective device desirable to create a portable, low-cost, stand-alone assay test kit reader which utilizes at least one detector (or array of detectors) to detect the presence of a plurality of different analyte regions on the diagnostic test kit without regard for the pattern of the analyte regions on the assay test kit. The test kit image reader of the present invention can be used for scanning different types of the test for the purpose of interpretation of the accurate results of the presence of the analyte in the biological sample.

OBJECT OF THE INVENTION
It is an object of the present invention to provide a portable diagnosis test kit image analyzer that facilitates the parallel processing of multiple colorimetric-based or fluorescent-based lateral flow immunoassay test kits or chemistry-based test kits for automated testing at the point-of-care.

It is another object of the present invention to provide a diagnosis test kit image analyzer that automates the testing using indicators that can be detected through optical methods.

It is still another object of the present invention to provide a diagnosis test kit image analyzer to communicate detected biomarkers indicative of a condition to a network-connected computing device and/or network-connected database and/or a linked personal device.

It is yet another object of the present invention to provide a diagnosis test kit image analyzer for automating the processing of tests, optically analyzing indicators to predict a medical condition and automating the disposal of analyzed test results.
It is still another object of the present invention to provide a diagnosis test kit image analyzer which is compact, portable and economical.
Furthermore, objectives, advantages, and features of the present invention will become apparent from the detailed description provided herein below, in which various features and functionalities of the disclosed invention are illustrated by way of the following examples.

SUMMARY OF THE INVENTION
The present invention relates to portable device for image-based analyses of the diagnosis kit comprising a non-transitory computer implemented portable analyzer unit, a visual display screen integrated with a touch screen interface to operate the analyzer unit, an optical sensor integrated camera configured to capture and scan images of the reaction zone on a test kit following the application of a biological sample to the test kit, a lighting component to illuminate the reaction zone on the test strip, a plurality modules interface to receive and send signals, a processor to process the scanned image and determine a test result, a connection module for automatic transfer of the test results to a remote storage device and/or on personal device when such remote storage device or personal device is physically separate from the analyzer unit device, a memory module having instructions stored thereon to identify signal generated by the optical sensor, an identification information and to automatically send the test result associated with the said identification information on display screen and a housing component with a tray to hold the test kit, wherein the said tray is fixed in a position relative to the optical sensor camera and the lighting component.
The optical sensor integrated camera captures and scans the images of the reaction zone on a test kit following the application of a biological sample to the test to generate an indicative signal for processing and determination of result.
The plurality modules interface to receive and send signals collected from image data for further processing by the processor module for analysis for determining the results.
The processor may be a microcontroller, microprocessor, ASIC (application-specific integrated circuit) or combination of multiple processors. The connection module employs a stable signal of network for automatic transfer of data of the test results to the remote storage unit or linked personal device of the users.
The memory module has instructions stored thereon to identify indicative signals generated by the optical sensor, identify the barcode on the test kit related to the type test kit and the details of the user of the said test kit for enabling automatic sending of the test results associated with the said identification information on display screen of analyzer and optionally to the remote storage devices or linked personal devices.
The housing component with a tray can hold at least one quick diagnostic test with shape and size and the said test kit reader can accommodate more than one different quick diagnostic tests.
The camera possesses sensors that may either CCD (charged coupled device) or CMOS (complementary metal–oxide–semiconductor) detection technology or alike.
The exterior of the reader is exquisite and compact with strong and durable structure made from material selected from a synthetic plastic materials, for example polycarbonate, ABS, polystyrene, or polypropylene or alike.
The test result is stored optionally on the in-built storage unit of the analyzer or transmitted to remote storage device and the linked personal devices of the user by the connection modules. Additionally the data may be also printed or transferred to USB device by using provided USB ports.

BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 of the present invention illustrates the flow chart of the sequence of events to read the test strip.

DESCRIPTION OF THE INVENTION
The following detailed description sets forth to provide a more thorough understanding of the present invention. The description of the drawings provided hereafter is to be considered as an illustration and not as a limitation.
The present invention relates to a portable test kit image analyzer that are capable of interpreting the result of the diagnostic test kit by processing images scanned by an image sensor of the said diagnostic test kit. The terms “test kit image analyzer” or “test kit reader” are used interchangeably throughout the description and the claims of the specification. The words “test kit” or “test strip” are used interchangeably throughout the description and the claims of the specification
The test kit image analyzer of the present invention comprises a non-transitory portable analyzer unit comprising a visual display screen integrated with a touch screen interface, an optical sensor integrated camera positioned to capture and scan the image of a change on a test kit following the application of a biological sample to the test kit, the optical sensor is configured to generate a signal indicative of the captured and scanned image of a change on a test kit, a lighting component, a plurality modules interface to receive and send signals, a connection module, at least one processor to determine a test result, a memory having instructions stored thereon to identify signal generated by the optical sensor, to identify the barcode as an identification information and automatically send the test result associated with the identification information on display screen of analyzer and optionally to the remote storage device or linked personal device in response to determining that the connection module has the connection capability with the said storage device or said personal device and optionally a in-built storage unit configured to automatically store the test result associated with the identification information.
In an embodiment the reader is an a non-transitory readable unit receiving the image data from an optical sensor camera, the said optical sensor captures and scans the image of the change in an characteristic of an test kit inserted into or positioned proximate to the analyzer unit. The determination of the test result is based at least in part on analyzing the test kit image data and change on a test kit following the application of a biological sample to the test kit. The determination of a connection capability of the connection module is based on the automatic transfer of the test results to a remote storage device and/or on personal device when such remote storage device or personal device is physically separate from the analyzer unit device.
In an embodiment, a non-transitory readable may further have a housing component with a tray to hold the test kit wherein the said tray is fixed in a position relative to the optical sensor camera and the lighting component. The housing component can hold at least one quick diagnostic test with varied shape and size and the said test kit reader can accommodate more than one different quick diagnostic tests.
In an embodiment, the test kit is applied with biological sample; the said test kit may have a development time of few minutes for enabling the reaction. After few minutes, the user may insert the test kit into an analyzer for the analysis of the test results. Upon insertion of the test kit into the basic assay analyzer, the optical sensor camera positioned to capture and scan the image of a change in biomarkers on a test kit. The optical sensor is configured to generate a signal indicative of the captured and scanned image of the test kit and the interface of the plurality modules receive and send signals collected from image data for further processing by the processor module for analysis for determining the results. Upon processing analyzer provide the interpretation of the results in detail, depending on the change shown by indicative biomarkers on the test kit through a visual display screen.
In an embodiment, the analyzer further comprises of a memory module having instructions stored thereon to identify signal generated by the optical sensor, to identify the barcode on the test kit as an identification information of type test kit and optionally details of the user of test and then automatically send the test result associated with the identification information on display screen of analyzer and in some embodiments optionally to the remote storage device or linked personal device in response to determining that the connection module has the connection capability with the said storage device or said personal device and optionally an in-built storage unit configured to automatically store the test result associated with the identification information.
In an embodiment the analyzer of the present invention has an advanced scanning technology with an excellent SNR (signal to noise ratio) to characterize image quality, as the higher the signal level the more useful information there is within the image. The imaging system, as disclosed herein, may include a camera with one or more lighting elements including but not limited to LEDs arranged around the camera to illuminate the test strips. The camera possesses sensors that may either CCD (charged coupled device) and/or CMOS (complementary metal–oxide–semiconductor) detection technology. To achieve a high-quality imaging system, the components may be selected to have a high resolution and large image area for the sensor, which improves the signal quality and reduces the noise of the raw image. The optical sensor integrated camera scans the test kit reaction zone and generates an indicative signal. The instructions stored on the memory module of the said analyzer then identify the signal and the barcode associated with the test kit. The processing module then processes the image and determines the results based on immuno-chromatography technology. The result analysis and the identification information associated with it is then displayed on the screen and is sent automatically to the remote storage and/or linked personal device of the user and optionally to the in-built storage unit of reader.
The processor used the test kit analyzer of the present invention may be a microcontroller, microprocessor, ASIC (application-specific integrated circuit) or the like, and in some embodiments may include multiple processors.
The exterior of the reader is exquisite and compact with strong and durable structure made from material selected from a synthetic plastic materials, for example polycarbonate, ABS, polystyrene, or polypropylene or alike.
The connection modules employ stable signal of network for transfer of data of the test results to the remote storage or linked personal device of the users. In an embodiment, the optional in-built storage unit may be integrated with the analyzer unit to store test data.
In an embodiment the test kit analyzer is powered by the electrical source or replaceable batteries. Additionally there can be printer module in-built/attached to analyzer unit for instant test result printing. In an embodiment the analyzer is provided with at least one USB (universal serial bus) ports to enable the users to transfer the data stored on the analyzer.
Working:
In an embodiment as illustrated in the figure 1, the rapid diagnostic test kit is used by the user to detect the presence of the analyte. The user applies the biological sample on to the test strip and then inserts the test strip in the analyzer for the determination of the test result. The test strip has specific binding zone with specific reagent for binding with the analyte (if present) forming a reagent-analyte complex. The test kit analyzer and the test strip of diagnostic test kit are carefully aligned to the fact that the visible change formed at the reaction zone or the observation zone of strip is captured by the camera. The reaction zones are usually quite narrow in size in the width and small displacement of the said zone relative to the position of alignment of the camera may have significant effect on the capturing of image by the analyzer. The housing component with a tray to hold the test kit therefore aids in proper alignment of the test strip relative to position of the camera to enable capturing of image of reaction zone.
The processor in an embodiment compare the image data to a plurality of templates or pre-identified patterns stored in the memory of the analyzer to determine a test result. In some embodiments, the test result determination is performed based on the adaptive read process of the image data to improve specificity of the test results and reduce any false positive results by compensating for background and non-specific binding of sample and reagent.
The test result is displayed on visual display screen in detail along with captured image. The test result is stored optionally on the in-built storage unit of the analyzer or transmitted to remote storage device and the linked personal devices of the user by the connection modules. Additionally the data may be also printed or transferred to USB device by using provided USB ports.
Example:
In an embodiment, the analyzer may be used in home or in point of care testing to detect the pregnancy hormone hCG. The pregnancy kit can be used by the user and the test strip can is inserted in to analyzer unit to determine the results. The result can be viewed on the screen and can also be saved in USB device or transmitted to personal device and can also be deleted from the analyzer to maintain the privacy of the user.
The test kit analyzer of the present invention has non-limiting shapes, sizes, colors and orientation. The analyzer is user-friendly allowing the user to modify the language of display as per their choice.
The afore-said invention is described with reference to preferred and alternate embodiments. Any modifications and alterations will become apparent to those skilled in the art upon reading and understanding the detailed discussion of the invention provided herein. This invention is intended to include all such possible modifications and alterations insofar as they do not depart from the scope of the present invention. ,CLAIMS:1. A portable device for image-based analyses of diagnostic test kit, the device comprises:
a) a housing with a tray configured to securely hold a diagnostic test kit containing a biological sample to be tested, wherein, the said tray is fixed in a position relative to the optical sensor camera and the lighting component;
b) a camera configured to capture and scan images of reaction zone of the diagnostic test kit following application of a biological sample;
c) a lighting component to illuminate the reaction zone on the test strip;
a) an optical sensor configured to detect changes in optical characteristics in the reaction zone of the diagnostic test kit, wherein, the optical sensor generate a signal indicating the detected changes in optical characteristics of the assay;
d) a plurality of module interface to receive and send signals;
e) a processor to process the scanned image and determine a test result;
f) a visual display screen integrated with a touch screen interface to operate the image based analyzer unit and display test result;
g) a communication module for automatic transfer of the test results to a remote storage device and/or on personal device when such remote storage device or personal device is physically separate from the analyzer unit device; and
h) a memory module having instructions stored thereon to identify signal generated by the optical sensor, an identification information and to automatically send the test result associated with the said identification information on display screen.

2. The portable device for image-based analyses of the diagnosis kit as claimed in claim 1, wherein the optical sensor integrated camera captures and scans the images of the reaction zone on a test kit following the applications of a biological sample to the test to generate an indicative signal for processing and determination of result.

3. The portable device for image-based analyses of the diagnosis kit as claimed in claim 1, wherein the plurality modules interface to receive and send signals collected from image data for further processing by the processor module for analysis for determining the results.

4. The portable device for image-based analyses of the diagnosis kit as claimed in claim 1, wherein the processor may be a microcontroller, microprocessor, ASIC (application-specific integrated circuit) or combination of multiple processors.

5. The portable device for image-based analyses of the diagnosis kit as claimed in claim 1, wherein the connection module employ a stable signal of network for automatic transfer of data of the test results to the remote storage unit or linked personal device of the users.

6. The portable device for image-based analyses of the diagnosis kit as claimed in claim 1, wherein the memory module has instructions stored thereon to identify indicative signals generated by the optical sensor, identify the barcode on the test kit related to the type test kit and the details of the user of the said test kit for enabling automatic sending of the test results associated with the said identification information on display screen of analyzer and optionally to the remote storage devices or linked personal devices.

7. The portable device for image-based analyses of the diagnosis kit as claimed in claim 1, wherein the housing component with a tray can hold at least one quick diagnostic test with shape and size and the said test kit reader can accommodate more than one different quick diagnostic tests.

8. The portable device for image-based analyses of the diagnosis kit as claimed in claim 1, wherein the camera possesses sensors that may either CCD (charged coupled device) or CMOS (complementary metal–oxide–semiconductor) detection technology or alike.

9. The portable device for image-based analyses of the diagnosis kit as claimed in claim 1, wherein the exterior of the reader is exquisite and compact with strong and durable structure made from material selected from a synthetic plastic materials, for example polycarbonate, ABS, polystyrene, or polypropylene or alike.