WO2013120191A1 - Informative diagnostic kit and device for immunochromatographic detection - Google Patents

Informative diagnostic kit and device for immunochromatographic detection Download PDF

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Publication number
WO2013120191A1
WO2013120191A1 PCT/CA2013/000142 CA2013000142W WO2013120191A1 WO 2013120191 A1 WO2013120191 A1 WO 2013120191A1 CA 2013000142 W CA2013000142 W CA 2013000142W WO 2013120191 A1 WO2013120191 A1 WO 2013120191A1
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WO
WIPO (PCT)
Prior art keywords
information
test
test strip
storage means
strip
Prior art date
Application number
PCT/CA2013/000142
Other languages
French (fr)
Inventor
Hsiang Yung TENG
Chung Chin SUN
Original Assignee
Vitrum Diagnostics Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Vitrum Diagnostics Inc. filed Critical Vitrum Diagnostics Inc.
Publication of WO2013120191A1 publication Critical patent/WO2013120191A1/en

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84Systems specially adapted for particular applications
    • G01N21/8483Investigating reagent band
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/4875Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
    • G01N33/48778Containers specially adapted therefor, e.g. for dry storage

Definitions

  • the present invention relates to a test strip for use with an apparatus for acquiring test results.
  • the present invention also relates to a diagnostic kit or a system comprising the test strip and a method for quantifying one or more analytes in a fluid sample using the test strip.
  • a microprocessor/read only memory (ROM) combination controls the operation of the biosensing apparatus and enables it to execute various procedures to obtain a desired analyte reading.
  • test strip lots In order to account for lot-to-lot variation in the test strips, it is commonplace for test strip lots to be calibrated during their manufacture. Such calibration typically includes the determination of calibration parameters and the assignment of a test strip calibration code, associated with those calibration parameters, to each of the test strip lots, and the calibration information is stored in a memory of the biosensing apparatus (US 5,837,546 and US
  • test strips of different model types may have different test area layouts and different quantification formulae.
  • input of the model type or access to the calibration information is necessary in a prior art diagnostic kit, which requires additional manual control or configuration and is time-consuming. Therefore, a diagnostic kit or system for simple and rapid detection of analyte levels in a fluid sample is desired.
  • test strip for use with an apparatus for acquiring test results, the test strip comprising:
  • an information storage means adapted to provide the apparatus with information at substantially the same time as the apparatus is acquiring the test results.
  • the biochemical test is an immunochromatographic test.
  • the information comprises information selected from the group consisting of information on the control of the apparatus, manufacturing information of the test strip, information of the model or batch number of the test strip, information of quantity and location(s) of the test area(s), information on quantification parameter(s) or formula, calibration information, and combination thereof.
  • the information storage means may be in the form of a content-resolved image, a passively information providing component, or a solid state memory.
  • the information storage means is in the form of a bar code or a quick response (QR) code or a radio-frequency identification (RFID) tag.
  • test strip(s) (a) one or more test strip(s) according to the present invention.
  • an apparatus comprising: an information acquiring unit, and a communication unit for communicating with a PC or a mobile device.
  • the information acquiring unit is an image acquiring unit including optical image acquiring devices for acquiring a digital image of the strip.
  • the communication unit communicates with the PC or the mobile device via a wire link or via a wireless link, preferably via a wireless link, more preferably via a Bluetooth or Wi-Fi interface.
  • test strip(s) of the present invention (a) one or more test strip(s) of the present invention
  • an apparatus comprising: an information acquiring unit; and a communication unit for communicating with a mobile device;
  • a mobile device comprising: one or more processors; and one or more memories adapted to store a plurality of machine-readable instructions which when executed by the one or more processors are adapted to cause the mobile device to perform a method comprising: receiving digital information of the one or more test strip(s) acquired by the information acquiring unit of the apparatus; processing the digital information to acquire at least one characteristic of the one or more biochemical tests and information encoded/stored in the information storage means of the test strip(s); quantifying the characteristic based on the information encoded/stored in the information storage means and information acquired from the sever; and displaying a quantification result.
  • the digital information comprising a digital image of the one or more test strips.
  • the mobile device quantifying the characteristic based on the information encoded in the information storage means and information acquired from the sever to obtain analytical results.
  • the method further comprises a step: (f) displaying the analytical results on a window based framework with touch-triggered graphic interface.
  • Fig. 1 is a diagram illustrating the layout of one embodiment of the present invention, a test strip 101, comprising a substrate 10, an information storage means 12, and one or more test area(s) 14, and one or more sample area(s) 16.
  • FIG. 2 shows an apparatus 201 which may be used in the diagnostic kit of the present invention.
  • the apparatus 201 comprises a user interface 22 and a strip casket 24.
  • the strip casket 24 has one or more strip slot(s) 26 set up thereon.
  • FIG. 3 is a diagram illustrating one embodiment of the present invention, a system 301 comprising one or more test strip(s) 102, an apparatus 201 comprising an information acquiring unit and a communication unit for communicating with a mobile device, a sever 32 for storing updated information of different models and batches of test strips, and a mobile device 34 for processing information acquired by and from the apparatus, quantification of the test results and display of the same.
  • Fig. 4 shows how a cloud database 42 may communicate with the App on the mobile device and make the test results available in a police database 44 or a doctor's end 46.
  • the present invention provides a test strip, for use with an apparatus for acquiring test results, the test strip comprising:
  • an information storage means adapted to provide the apparatus with information at substantially the same time as the apparatus is acquiring the test results.
  • Immunochromatographic strip formats are increasingly popular for qualitative and semi-quantitative assays which use visual detection schemes. Quantification of immunochromatographic test results via a method comprising acquiring a digital image of an immunochromatographic test with an image acquiring unit is described, e.g. in US
  • the biochemical test is preferably an immunoassay, and more preferably an immunochromatographic assay.
  • the quantification of the test results is through an optical image detection method.
  • the results of an immunochromatographic assay may be detected via an optical image detection method, i.e., different colors represent different range of analyte levels.
  • an information storage means into a test strip
  • model-specific or batch specific information required manual configuration may be acquired by a detection apparatus along with the test results at one time, saving time and reducing human errors.
  • the information storage means on the test strip may store information necessary for the later quantification of the biochemical reactions, information useful in enhancing the accuracy of the quantification and other desired information.
  • the information is encoded or stored in the information storage means and can be obtained by acquiring digital information from the information storage means and processing the digital information.
  • the information storage means may be in the form of a content-resolved image, a solid state memory, a passively information providing component, an active information providing component, or a semi-active information providing component.
  • the information storage means is in the form of a radio-frequency identification (RFID) tag which is a semi- active information providing component.
  • RFID radio-frequency identification
  • the information storage means is in the form of a bar code or a quick response (QR) code.
  • the information encoded/stored in the information storage means may comprise information selected from the group consisting of information on the control of the apparatus, manufacturing information of the test strip, information of the model or batch number of the test strip, information of quantity and location(s) of the test area(s), information on quantification parameter(s) or formula, calibration information, and combination thereof.
  • the information encoded/stored in the information storage means comprises information on the control of an acquiring device, such as an image acquiring device.
  • information on the control of an acquiring device includes but is not limited to information on the layout of the test area(s) and testing information on the biochemical reactions for the state of art on single qualitative analysis, single semi-quantitative analysis, single quantitative, multiple semi- qualitative analyses, or multiple qualitative analyses.
  • manufacturing information of the test strip may be encoded/stored in the information storage means.
  • information of the test strip includes but is not limited to lot/batch number of the test strip, manufacturing date of the test strip, and model type of the test strip.
  • information encoded/stored in the information storage means comprises calculation information of the test strip, which can be acquired and used in the later calculation of a characteristic of the biochemical reaction.
  • Calculation information of the test strip includes but is not limited to model-specific numerical constants or weights and items.
  • information encoded/stored in the information storage means comprises calibration information of the test strip.
  • calibration information of the test strip includes but is not limited to a set of lot-specific calibration parameters of the test strip, model specific calibration information, detection range, cutoff values, calibration parameters, and aging coefficient.
  • information encoded/stored in the information storage means comprises information on the control of an acquiring device, manufacturing information of the test strip, calculation information of the test strip and calibration information of the test strip, and said information can be obtained by acquiring digital image of the information storage means in the optical image detection method along with the biochemical reaction results.
  • Fig. 1 is a diagram illustrating the layout of one embodiment of the present invention, a test strip 101 for use with an apparatus for acquiring test results, where a plurality of test areas 14 arranged in separated lanes and an information storage means 12, adapted to provide the apparatus with information at substantially the same time as the apparatus is acquiring the test results, are set up on a substrate 10.
  • the information storage means 12 may be in the form of a content-resolved image, a solid state memory, a passively information providing component, an active information providing component, or a semi- active information providing component.
  • the test strip 101 further comprises a plurality of sample areas 16 for sample application.
  • incorporating an information storage means adapted to provide the apparatus with information at substantially the same time as the apparatus is acquiring the test results into a test strip has several advantages over the prior art, for example, faster and more accurate quantification, easier handling, and feasible
  • test strip of the present invention can be used in tandem with an apparatus for detecting/quantifying the biochemical reactions on the test strip.
  • the apparatus may be in any form of devices or meters known in the art, such as in the form of a hand-held meter or scanner.
  • Another aspect of the present invention is to provide a diagnostic kit comprising:
  • test strip(s) (a) one or more test strip(s) according to the present invention.
  • an apparatus comprising an information acquiring unit, and a communication unit for communicating with a sever, a PC or a mobile device.
  • the biochemical test is preferably an immunoassay, and more preferably an immunochromatographic assay. Quantification of an immunochromatographic assay may be achieved via an optical image detection method, such as disclosed in US 2005/0059160.
  • the information storage means may be in the form of a content-resolved image, a solid state memory, a passively information providing component.
  • the information storage means is in the form of a radio-frequency identification (RFID) tag.
  • RFID radio-frequency identification
  • the information storage means is in the form of a bar code or a quick response (QR) code.
  • the information encoded in the information storage means can be acquired through the information acquiring unit of the apparatus at substantially the same time as acquiring a digital image of the strip, either by the optical image acquiring devices or by additional information acquiring device for obtaining the information encoded/stored in, e.g., a RFID tag or a solid state memory.
  • the apparatus comprises an information acquiring unit for acquiring digital information, e.g. a digital image, of the strip and for acquiring the information
  • the information acquiring unit may comprise an image acquiring unit including optical image acquiring devices for acquiring a digital image of the strip.
  • Fig. 2 shows an apparatus 201 having information acquiring capability, e.g. image scanning capability which may be used in the diagnostic kit of the present invention.
  • the apparatus 201 comprises a user interface 22 and a strip casket 24.
  • the strip casket 24 has one or more strip slot(s) 26 set up thereon. After applying sample(s) to the test strip(s) of the present invention and allowing reaction for a period of time, a user may put the strip(s) into the one or more strip slot(s) 26 of the strip casket 24 for the subsequent information acquiring and/or quantification.
  • the apparatus 201 may scan and acquire a digital image of the test strip(s) and transfer the digital image to a PC for subsequent processing and quantification, based on the information encoded/stored in the information storage means of the strip(s) which is acquired at substantially the same time as the apparatus is scanning the digital image.
  • the communication unit of the apparatus is capable of communicating with a server, a PC and/or a mobile device.
  • the communication unit may communicate with the other device via a wire link or via a wireless link, preferably via a wireless link.
  • the communication unit may communicate with the other device via a Bluetooth or Wi-Fi interface.
  • the information on the test results and the information encoded/stored in the information storage means of the test strip may be processed and used in the subsequent quantification by the apparatus itself, or transferred to another device, e.g. a mobile device, for processing and quantification.
  • the information on the test results and the information encoded/stored in the information storage means is transferred to another device for further processing and quantification.
  • the apparatus may further comprise a characteristic acquiring unit comprising a processor for acquiring at least one characteristic of the one or more biochemical tests based on a digital content of the strip acquired by the information acquiring unit.
  • the processor of the characteristic acquiring unit may comprise a content capturing component and digital processing module for processing the digital content of the strip.
  • the apparatus may further comprise a quantifying unit comprising a processor for quantifying the characteristic based on the information encoded/stored in the information storage means. Specific formulas for calculating and quantifying the characteristic are implemented in the processor of the quantifying unit.
  • the characteristic of the one or more biochemical reactions obtained by the characteristic acquiring unit and the information encoded in the information storage means obtained by the information acquiring unit are conveyed to the quantifying unit and are used for further calculation to quantify the characteristic.
  • the another device may connect to a sever for acquiring updated information of different models and batches of test strips, including but not limited to manufacturing information of the test strip, information of quantity and location(s) of the test area(s), information on quantification parameter(s) or formula, calibration information, and combination thereof.
  • a digital image of the one or more test strip(s) acquired by the information acquiring unit of the apparatus may be transferred to a mobile device by the communication unit of the apparatus, the mobile device may then process the digital image to obtain model and batch numbers of the one or more test strip(s), information of quantity and location(s) of the test area(s), and the mobile device may subsequently acquire information on quantification parameter(s) or formula, calibration information and incorporated all the information to calculate a quantification/analytic result.
  • the present invention provides a system, which may be used for quantifying one or more analytes in a fluid sample via an optical image detection method, the system comprising:
  • test strip(s) of the present invention (a) one or more test strip(s) of the present invention
  • an apparatus comprising: an information acquiring unit; and a communication unit for communicating with a mobile device;
  • a mobile device comprising: one or more processors; and one or more memories adapted to store a plurality of machine-readable instructions which when executed by the one or more processors are adapted to cause the mobile device to perform a method comprising:
  • Fig. 3 shows one embodiment of the present invention, a system 301 comprising one or more test strip(s) 102, an apparatus 201 comprising an information acquiring unit and a communication unit for communicating with a mobile device, a sever 32 for storing updated information of different models and batches of test strips, and a mobile device 34 for processing information acquired by and from the apparatus, quantification of the test results and display of the same.
  • the information storage means of the test strip is in the form of a QR code.
  • An App installed on the mobile device 34 may perform the following process. After receiving a scanned image of the one or more test strip(s) 102 acquired by the information acquiring unit of the apparatus 201, acquire information from QR Code (e.g.
  • a cloud database in the system of the present invention.
  • Fig. 4 shows how a cloud database 42 may communicate with the App on the mobile device and make the test results available in a police database 44 or a doctor's end 46.
  • the present invention provides a method for quantifying one or more analytes in a fluid sample comprising:
  • the mobile device quantifying the characteristic based on the information encoded in the information storage means and information acquired from the sever to obtain analytical results.
  • the method further comprises a step (f) for displaying the analytical results on a window based framework with touch-triggered graphic interface.
  • the method is carried out using the diagnostic kit according to the invention.

Abstract

The present invention provides a test strip for use with an apparatus for acquiring test results, the test strip comprising (a) one or more test area(s) for performing one or more biochemical tests; and (b) an information storage means adapted to provide the apparatus with information at substantially the same time as the apparatus is performing the optical image detection method. In another aspect, the present invention provides a diagnostic kit comprising a test strip of the present invention and an apparatus comprising an information acquiring unit; and a communication unit for communicating with a PC or a mobile device. Also provide is a method for quantifying one or more analytes in a fluid sample.

Description

TITLE OF THE INVENTION
INFORMATIVE DIAGNOSTIC KIT AND DEVICE FOR I MUNOCHROM ATOGRAPHIC DETECTION
FIELD OF THE INVENTION
[0001] The present invention relates to a test strip for use with an apparatus for acquiring test results. The present invention also relates to a diagnostic kit or a system comprising the test strip and a method for quantifying one or more analytes in a fluid sample using the test strip.
BACKGROUND OF THE INVENTION
[0002] Biosensing instruments used for the detection of analyte levels in a fluid sample
(such as blood) often employ disposable sample strips that include one or more reaction areas. A microprocessor/read only memory (ROM) combination controls the operation of the biosensing apparatus and enables it to execute various procedures to obtain a desired analyte reading.
In order to account for lot-to-lot variation in the test strips, it is commonplace for test strip lots to be calibrated during their manufacture. Such calibration typically includes the determination of calibration parameters and the assignment of a test strip calibration code, associated with those calibration parameters, to each of the test strip lots, and the calibration information is stored in a memory of the biosensing apparatus (US 5,837,546 and US
6,780,645). Further, test strips of different model types may have different test area layouts and different quantification formulae. However, before detecting the analytes, input of the model type or access to the calibration information is necessary in a prior art diagnostic kit, which requires additional manual control or configuration and is time-consuming. Therefore, a diagnostic kit or system for simple and rapid detection of analyte levels in a fluid sample is desired.
BRIEF SUMMARY OF THE INVENTION
[0003] Accordingly, it is an object of this invention to provide a test strip, for use with an apparatus for acquiring test results, the test strip comprising:
(a) one or more test area(s) for performing one or more biochemical tests; and
(b) an information storage means adapted to provide the apparatus with information at substantially the same time as the apparatus is acquiring the test results.
[0004] In one preferred embodiment of the present invention, the biochemical test is an immunochromatographic test.
[0005] According to the present invention, the information comprises information selected from the group consisting of information on the control of the apparatus, manufacturing information of the test strip, information of the model or batch number of the test strip, information of quantity and location(s) of the test area(s), information on quantification parameter(s) or formula, calibration information, and combination thereof.
[0006] The information storage means may be in the form of a content-resolved image, a passively information providing component, or a solid state memory. Preferably, the information storage means is in the form of a bar code or a quick response (QR) code or a radio-frequency identification (RFID) tag.
[0007] It is another object of this invention to provide a diagnostic kit for quantifying one or more analytes, comprising:
(a) one or more test strip(s) according to the present invention; and
(b) an apparatus comprising: an information acquiring unit, and a communication unit for communicating with a PC or a mobile device.
[0008] In one preferred embodiment of the present invention, the information acquiring unit is an image acquiring unit including optical image acquiring devices for acquiring a digital image of the strip.
[0009] According to the present invention, the communication unit communicates with the PC or the mobile device via a wire link or via a wireless link, preferably via a wireless link, more preferably via a Bluetooth or Wi-Fi interface.
[0010] It is yet another object of this invention to provide a system comprising:
(a) one or more test strip(s) of the present invention;
(b) an apparatus comprising: an information acquiring unit; and a communication unit for communicating with a mobile device;
(c) a sever for storing updated information of different models and batches of test strips; and
(d) a mobile device comprising: one or more processors; and one or more memories adapted to store a plurality of machine-readable instructions which when executed by the one or more processors are adapted to cause the mobile device to perform a method comprising: receiving digital information of the one or more test strip(s) acquired by the information acquiring unit of the apparatus; processing the digital information to acquire at least one characteristic of the one or more biochemical tests and information encoded/stored in the information storage means of the test strip(s); quantifying the characteristic based on the information encoded/stored in the information storage means and information acquired from the sever; and displaying a quantification result.
[0011] In one preferred embodiment of the present invention, the digital information comprising a digital image of the one or more test strips. [0012] It is still another object of this invention to provide a method for quantifying one or more analytes in a fluid sample, comprising:
(a) providing an apparatus for quantifying one or more analytes in a fluid sample via an optical image detection method, and a test strip comprising one or more test area(s) for performing one or more biochemical tests and an information storage means adapted to provide the apparatus with information at substantially the same time as the apparatus is performing the optical image detection method;
(b) applying the fluid sample to the strip to perform the one or more biochemical tests;
(c) positioning the strip in an information acquiring unit of the apparatus and acquiring digital information of the strip;
(d) a mobile device acquiring at least one characteristic of the one or more biochemical tests and information encoded in the information storage means of the test strip; and
(e) the mobile device quantifying the characteristic based on the information encoded in the information storage means and information acquired from the sever to obtain analytical results.
[0013] In one preferred embodiment of the present invention, the method further comprises a step: (f) displaying the analytical results on a window based framework with touch-triggered graphic interface.
It is believed that a person of ordinary knowledge in the art to which the present invention belongs can utilize the present invention to its broadest scope based on the descriptions herein with no need of further illustration. Therefore, the following descriptions should be understood as of demonstrative purpose instead of limitative in any way to the scope of the present invention.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0014] For the purpose of illustrating the invention, there are shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the preferred embodiments shown.
[0015] Fig. 1 is a diagram illustrating the layout of one embodiment of the present invention, a test strip 101, comprising a substrate 10, an information storage means 12, and one or more test area(s) 14, and one or more sample area(s) 16.
[0016] Fig. 2 shows an apparatus 201 which may be used in the diagnostic kit of the present invention. The apparatus 201 comprises a user interface 22 and a strip casket 24. The strip casket 24 has one or more strip slot(s) 26 set up thereon.
[0017] Fig. 3 is a diagram illustrating one embodiment of the present invention, a system 301 comprising one or more test strip(s) 102, an apparatus 201 comprising an information acquiring unit and a communication unit for communicating with a mobile device, a sever 32 for storing updated information of different models and batches of test strips, and a mobile device 34 for processing information acquired by and from the apparatus, quantification of the test results and display of the same.
[0018] Fig. 4 shows how a cloud database 42 may communicate with the App on the mobile device and make the test results available in a police database 44 or a doctor's end 46.
DETAILED DESCRIPTION OF THE INVENTION
[0019] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by a person skilled in the art to which this invention belongs. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.
[0020] As used herein, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a sample" includes a plurality of such samples and equivalents thereof known to those skilled in the art.
[0021] In one aspect, the present invention provides a test strip, for use with an apparatus for acquiring test results, the test strip comprising:
(a) one or more test area(s) for performing one or more biochemical tests; and
(b) an information storage means adapted to provide the apparatus with information at substantially the same time as the apparatus is acquiring the test results.
[0022] Immunochromatographic strip formats are increasingly popular for qualitative and semi-quantitative assays which use visual detection schemes. Quantification of immunochromatographic test results via a method comprising acquiring a digital image of an immunochromatographic test with an image acquiring unit is described, e.g. in US
2005/0059160.
[0023] According to the present invention, the biochemical test is preferably an immunoassay, and more preferably an immunochromatographic assay. Preferably, the quantification of the test results is through an optical image detection method.
[0024] The results of an immunochromatographic assay may be detected via an optical image detection method, i.e., different colors represent different range of analyte levels. By incorporating an information storage means into a test strip, model-specific or batch specific information required manual configuration may be acquired by a detection apparatus along with the test results at one time, saving time and reducing human errors.
[0025] The information storage means on the test strip may store information necessary for the later quantification of the biochemical reactions, information useful in enhancing the accuracy of the quantification and other desired information. The information is encoded or stored in the information storage means and can be obtained by acquiring digital information from the information storage means and processing the digital information.
[0026] According to the present invention, the information storage means may be in the form of a content-resolved image, a solid state memory, a passively information providing component, an active information providing component, or a semi-active information providing component. In some embodiments of the present invention, the information storage means is in the form of a radio-frequency identification (RFID) tag which is a semi- active information providing component. In preferred embodiments of the present invention, the information storage means is in the form of a bar code or a quick response (QR) code.
[0027] The information encoded/stored in the information storage means may comprise information selected from the group consisting of information on the control of the apparatus, manufacturing information of the test strip, information of the model or batch number of the test strip, information of quantity and location(s) of the test area(s), information on quantification parameter(s) or formula, calibration information, and combination thereof.
[0028] In some embodiments of the present invention, the information encoded/stored in the information storage means comprises information on the control of an acquiring device, such as an image acquiring device. According to the present invention, information on the control of an acquiring device includes but is not limited to information on the layout of the test area(s) and testing information on the biochemical reactions for the state of art on single qualitative analysis, single semi-quantitative analysis, single quantitative, multiple semi- qualitative analyses, or multiple qualitative analyses.
[0029] In other embodiments of the present invention, manufacturing information of the test strip may be encoded/stored in the information storage means. Manufacturing
information of the test strip includes but is not limited to lot/batch number of the test strip, manufacturing date of the test strip, and model type of the test strip.
[0030] In certain embodiments of the present invention, information encoded/stored in the information storage means comprises calculation information of the test strip, which can be acquired and used in the later calculation of a characteristic of the biochemical reaction. Calculation information of the test strip includes but is not limited to model-specific numerical constants or weights and items.
[0031] In some embodiments of the present invention, information encoded/stored in the information storage means comprises calibration information of the test strip. According to the present invention, calibration information of the test strip includes but is not limited to a set of lot-specific calibration parameters of the test strip, model specific calibration information, detection range, cutoff values, calibration parameters, and aging coefficient.
[0032] In one particular embodiment of the invention, information encoded/stored in the information storage means comprises information on the control of an acquiring device, manufacturing information of the test strip, calculation information of the test strip and calibration information of the test strip, and said information can be obtained by acquiring digital image of the information storage means in the optical image detection method along with the biochemical reaction results.
[0033] Fig. 1 is a diagram illustrating the layout of one embodiment of the present invention, a test strip 101 for use with an apparatus for acquiring test results, where a plurality of test areas 14 arranged in separated lanes and an information storage means 12, adapted to provide the apparatus with information at substantially the same time as the apparatus is acquiring the test results, are set up on a substrate 10. The information storage means 12 may be in the form of a content-resolved image, a solid state memory, a passively information providing component, an active information providing component, or a semi- active information providing component. In this embodiment, the test strip 101 further comprises a plurality of sample areas 16 for sample application.
[0034] According to the present invention, incorporating an information storage means adapted to provide the apparatus with information at substantially the same time as the apparatus is acquiring the test results into a test strip has several advantages over the prior art, for example, faster and more accurate quantification, easier handling, and feasible
implementation on point-of-care testing.
[0035] The test strip of the present invention can be used in tandem with an apparatus for detecting/quantifying the biochemical reactions on the test strip. The apparatus may be in any form of devices or meters known in the art, such as in the form of a hand-held meter or scanner.
[0036] Accordingly, another aspect of the present invention is to provide a diagnostic kit comprising:
(a) one or more test strip(s) according to the present invention; and
(b) an apparatus comprising an information acquiring unit, and a communication unit for communicating with a sever, a PC or a mobile device.
[0037] The biochemical test is preferably an immunoassay, and more preferably an immunochromatographic assay. Quantification of an immunochromatographic assay may be achieved via an optical image detection method, such as disclosed in US 2005/0059160. [0038] According to the present invention, the information storage means may be in the form of a content-resolved image, a solid state memory, a passively information providing component. In some embodiments of the invention, the information storage means is in the form of a radio-frequency identification (RFID) tag. In preferred embodiments of the invention, the information storage means is in the form of a bar code or a quick response (QR) code.
[0039] The information encoded in the information storage means can be acquired through the information acquiring unit of the apparatus at substantially the same time as acquiring a digital image of the strip, either by the optical image acquiring devices or by additional information acquiring device for obtaining the information encoded/stored in, e.g., a RFID tag or a solid state memory.
[0040] The apparatus comprises an information acquiring unit for acquiring digital information, e.g. a digital image, of the strip and for acquiring the information
encoded/stored in the information storage means of the test strip. According to the present invention, the information acquiring unit may comprise an image acquiring unit including optical image acquiring devices for acquiring a digital image of the strip.
[0041] Fig. 2 shows an apparatus 201 having information acquiring capability, e.g. image scanning capability which may be used in the diagnostic kit of the present invention. The apparatus 201 comprises a user interface 22 and a strip casket 24. The strip casket 24 has one or more strip slot(s) 26 set up thereon. After applying sample(s) to the test strip(s) of the present invention and allowing reaction for a period of time, a user may put the strip(s) into the one or more strip slot(s) 26 of the strip casket 24 for the subsequent information acquiring and/or quantification. For example, the apparatus 201 may scan and acquire a digital image of the test strip(s) and transfer the digital image to a PC for subsequent processing and quantification, based on the information encoded/stored in the information storage means of the strip(s) which is acquired at substantially the same time as the apparatus is scanning the digital image.
[0042] The communication unit of the apparatus is capable of communicating with a server, a PC and/or a mobile device. The communication unit may communicate with the other device via a wire link or via a wireless link, preferably via a wireless link. In certain embodiments of the present invention, the communication unit may communicate with the other device via a Bluetooth or Wi-Fi interface.
[0043] According to the present invention, the information on the test results and the information encoded/stored in the information storage means of the test strip may be processed and used in the subsequent quantification by the apparatus itself, or transferred to another device, e.g. a mobile device, for processing and quantification. In preferred embodiments of the present invention, the information on the test results and the information encoded/stored in the information storage means is transferred to another device for further processing and quantification.
[0044] In the case that the information on the test results and the information
encoded/stored in the information storage means of the test strip is processed and used in the subsequent quantification by the apparatus itself, the apparatus may further comprise a characteristic acquiring unit comprising a processor for acquiring at least one characteristic of the one or more biochemical tests based on a digital content of the strip acquired by the information acquiring unit. The processor of the characteristic acquiring unit may comprise a content capturing component and digital processing module for processing the digital content of the strip. In addition, the apparatus may further comprise a quantifying unit comprising a processor for quantifying the characteristic based on the information encoded/stored in the information storage means. Specific formulas for calculating and quantifying the characteristic are implemented in the processor of the quantifying unit. The characteristic of the one or more biochemical reactions obtained by the characteristic acquiring unit and the information encoded in the information storage means obtained by the information acquiring unit are conveyed to the quantifying unit and are used for further calculation to quantify the characteristic.
[0045] In the case that the test results and the information encoded/stored in the information storage means is transferred to another device for further processing and quantification, the another device may connect to a sever for acquiring updated information of different models and batches of test strips, including but not limited to manufacturing information of the test strip, information of quantity and location(s) of the test area(s), information on quantification parameter(s) or formula, calibration information, and combination thereof. For example, a digital image of the one or more test strip(s) acquired by the information acquiring unit of the apparatus may be transferred to a mobile device by the communication unit of the apparatus, the mobile device may then process the digital image to obtain model and batch numbers of the one or more test strip(s), information of quantity and location(s) of the test area(s), and the mobile device may subsequently acquire information on quantification parameter(s) or formula, calibration information and incorporated all the information to calculate a quantification/analytic result.
[0046] In view of the foregoing, a person having ordinary skill in the art would recognize that the present invention provides a diagnostic kit with faster and more accurate
quantification, easier handling, and feasible implementation on point-of-care testing. [0047] In one further aspect, the present invention provides a system, which may be used for quantifying one or more analytes in a fluid sample via an optical image detection method, the system comprising:
(a) one or more test strip(s) of the present invention;
(b) an apparatus comprising: an information acquiring unit; and a communication unit for communicating with a mobile device;
(c) a sever for storing updated information of different models and batches of test strips; and
(d) a mobile device comprising: one or more processors; and one or more memories adapted to store a plurality of machine-readable instructions which when executed by the one or more processors are adapted to cause the mobile device to perform a method comprising:
(i) receiving digital information of the one or more test strip(s) acquired by the information acquiring unit of the apparatus;
(ii) processing the digital information to acquire at least one characteristic of the one or more biochemical tests and information encoded/stored in the information storage means of the test strip(s);
(iii) quantifying the characteristic based on the information encoded/stored in the information storage means and information acquired from the sever; and
(iv) displaying a quantification result.
[0048] Fig. 3 shows one embodiment of the present invention, a system 301 comprising one or more test strip(s) 102, an apparatus 201 comprising an information acquiring unit and a communication unit for communicating with a mobile device, a sever 32 for storing updated information of different models and batches of test strips, and a mobile device 34 for processing information acquired by and from the apparatus, quantification of the test results and display of the same. In the present embodiment, the information storage means of the test strip is in the form of a QR code. An App installed on the mobile device 34 may perform the following process. After receiving a scanned image of the one or more test strip(s) 102 acquired by the information acquiring unit of the apparatus 201, acquire information from QR Code (e.g. Batch Information, Test Strip Model Type) and communicates with the sever 32 to acquire test strip information according to the batch/model numbers. Subsequently, quantify the characteristic based on the information encoded/stored in the information storage means of the one or more test strip(s) 102 and information acquired from the sever 32, for example, by finding test area(s) and extract color, constructing formula between color information and test values, and calculating test values by applying current color information into formula information. Lastly, displaying a quantification result on the mobile device 34. [0049] Furthermore, the present invention also contemplates the incorporation of a cloud database in the system of the present invention. Fig. 4 shows how a cloud database 42 may communicate with the App on the mobile device and make the test results available in a police database 44 or a doctor's end 46.
[0050] The quantification will now be described more specifically with reference to the following example, which is provided for the purpose of demonstration rather than limitation.
[0051] Example 1 :
[0052] Following steps are taken to establish a formula between color information and concentrations, which is stored in QR code/Cloud database:
[0053] 1. Take a picture of test strip knowing the concentration.
2. Apply noise filtering to the whole picture (e.g. Averaging-based adaptive filter).
3. Apply edge detection or binarization/histogram to extract test line and control lines from the picture.
4. Get the average gray value of background of test strip, noted as G0.
5. Iterate all the pixels in test line by calculating∑i= i log-^, G as the gray
Gx
value of each pixeL
6. Iterate all the pixels in control line by calculating∑tLi log-^, G^ as the gray value of each pixeL
7. Calculate V= (∑*Li log-¾)/(∑" i Iog-¾) , which is considered as the test
Gx Gx
value of the test strip.
8. Mark the point in a V-Concentration graph, change the concentration of test trip and repeat 1 -7, each concentration is repeated 3-4 times.
[0054] Following steps are taken to estimate the concentration given the picture of test strip:
1. Take a picture of the test strip(s).
2. Detect QR code, get batch number and retrieve the slope and intercept from Cloud Database/QRCode and reproduce the reverse function of V-Concentration function, f(V)=f '(Concentration).
3. Repeat above steps 2-7 for establishing a formula and get V from test strip, and get concentration value from f(V).
[0055] In one still further aspect, the present invention provides a method for quantifying one or more analytes in a fluid sample comprising:
(a) providing an apparatus for quantifying one or more analytes in a fluid sample via an optical image detection method, and a test strip comprising one or more test area(s) for performing one or more biochemical tests and an information storage means adapted to provide the apparatus with information at substantially the same time as the apparatus is performing the optical image detection method;
(b) applying the fluid sample to the strip to perform the one or more biochemical tests;
(c) positioning the strip in an information acquiring unit of the apparatus and acquiring digital information of the strip;
(d) a mobile device acquiring at least one characteristic of the one or more biochemical tests and information encoded in the information storage means of the test strip; and
(e) the mobile device quantifying the characteristic based on the information encoded in the information storage means and information acquired from the sever to obtain analytical results.
[0056] In certain embodiments of the invention, the method further comprises a step (f) for displaying the analytical results on a window based framework with touch-triggered graphic interface. In preferred embodiments of the invention, the method is carried out using the diagnostic kit according to the invention.
[0057] It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.

Claims

CLAIMS What is claimed is:
1. A test strip, for use with an apparatus for acquiring test results, the test strip comprising: (a) one or more test area(s) for performing one or more biochemical tests; and
(b) an information storage means adapted to provide the apparatus with information at substantially the same time as the apparatus is acquiring the test results.
2. The test strip of claim 1, wherein the biochemical test is an immunochromatographic test.
3. The test strip of claim 1 , wherein the information comprises information selected from the group consisting of information on the control of the apparatus, manufacturing information of the test strip, information of the model or batch number of the test strip, information of quantity and location(s) of the test area(s), information on quantification parameter(s) or formula, calibration information, and combination thereof.
4. The test strip of claim 1 , wherein the information storage means is in the form of a content-resolved image, a passively information providing component, an active information providing component, a semi-active information providing component, or a solid state memory.
5. The test strip of claim 4, wherein the information storage means is in the form of a bar code or a quick response (QR) code.
6. The test strip of claim 4, wherein the information storage means is in the form of a radio-frequency identification (RFID) tag.
7. A diagnostic kit comprising:
(a) one or more test strip according to claim 1 ; and (b) an apparatus comprising: an information acquiring unit; and
a communication unit for communicating with a server, a PC or a mobile device.
8. The diagnostic kit of claim 7, wherein the biochemical test is an immunochromatographic test.
9. The diagnostic kit of claim 7, wherein the information acquiring unit is an image acquiring unit including optical image acquiring devices for acquiring a digital image of the strip.
10. The diagnostic kit of claim 7, wherein the information storage means is in the form of a content-resolved image, a passively information providing component, an active information providing component, a semi-active information providing component, or a solid state memory.
11. The diagnostic kit of claim 10, wherein the information storage means is in the form of a bar code or a QR code.
12. The diagnostic kit of claim 10, wherein the information storage means is in the form of a RFID tag.
13. The diagnostic kit of claim 7, wherein the communication unit communicates with the sever, the PC or the mobile device via a wire link or via a wireless link.
14. The diagnostic kit of claim 13, wherein the communication unit communicates with the sever, the PC or the mobile device via a wireless link.
15. The diagnostic kit of claim 13, wherein the communication unit communicates with the sever, the PC or the mobile device via a Bluetooth or Wi-Fi interface.
16. A system comprising:
(a) one or more test strip according to claim 1 ;
(b) an apparatus comprising: an information acquiring unit; and
a communication unit for communicating with a mobile device;
(c) a sever for storing updated information of different models and batches of test strips; and
(d) a mobile device comprising: one or more processors; and one or more memories adapted to store a plurality of machine-readable instructions which when executed by the one or more processors are adapted to cause the mobile device to perform a method comprising: receiving digital information of the one or more test strip(s) acquired by the information acquiring unit of the apparatus; processing the digital information to acquire at least one characteristic of the one or more biochemical tests and information encoded/stored in the information storage means of the test strip(s); quantifying the characteristic based on the information encoded/stored in the information storage means and information acquired from the sever; and displaying a quantification result.
17. The system of claim 16, wherein the biochemical test is an immunochromatographic test.
18. The system of claim 16, the digital information comprising a digital image of the one or more test strips.
19. A method for quantifying one or more analytes in a fluid sample, comprising:
(a) providing an apparatus for quantifying one or more analytes in a fluid sample via an optical image detection method, and a test strip comprising one or more test area(s) for performing one or more biochemical tests and an information storage means adapted to provide the apparatus with information at substantially the same time as the apparatus is performing the optical image detection method;
(b) applying the fluid sample to the strip to perform the one or more biochemical tests;
(c) positioning the strip in an information acquiring unit of the apparatus and acquiring digital information of the strip;
(d) a mobile device acquiring at least one characteristic of the one or more biochemical tests and information encoded in the information storage means of the test strip; and
(e) the mobile device quantifying the characteristic based on the information encoded in the information storage means and information acquired from the sever to obtain analytical results.
20. The method of claim 19 further comprising (f) displaying the analytical results on a window based framework with touch-triggered graphic interface.
PCT/CA2013/000142 2012-02-17 2013-02-18 Informative diagnostic kit and device for immunochromatographic detection WO2013120191A1 (en)

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Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015070704A1 (en) * 2013-11-13 2015-05-21 成都领御生物技术有限公司 Test bar card
WO2015070700A1 (en) * 2013-11-12 2015-05-21 成都领御生物技术有限公司 Quantum dot-labeled test strip card
WO2015070702A1 (en) * 2013-11-13 2015-05-21 成都领御生物技术有限公司 Test strip card
CN105510609A (en) * 2015-11-26 2016-04-20 宁波美康保生生物医学工程有限公司 In vitro test piece and application method thereof
WO2016150134A1 (en) * 2015-03-21 2016-09-29 杨轶轩 Test paper reading method, and pregnancy test and ovulation test method therefor
WO2018082257A1 (en) * 2016-11-05 2018-05-11 深圳市前海安测信息技术有限公司 Biomarker detecting system and method based on colloidal gold test strip
WO2019082467A1 (en) * 2017-10-25 2019-05-02 オルガノ株式会社 Sample analysis device, sample analysis method, sample analysis system, and program
JP2020168602A (en) * 2019-04-02 2020-10-15 オルガノ株式会社 Sample analysis system, sample analysis method and terminal device
US11423637B2 (en) * 2015-02-09 2022-08-23 Digital Concepts Of Missouri, Inc. Test strip mobile app system and method
US11772986B2 (en) 2015-02-09 2023-10-03 Digital Concepts Of Missouri, Inc. Spa/pool water treatment system and method

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI585407B (en) * 2015-09-21 2017-06-01 群燿科技股份有限公司 Optical detecting device, an optical detecting method and an optical detecting system
CN106501510A (en) * 2016-11-28 2017-03-15 贝知(上海)信息科技有限公司 Quick diagnosis test batch calibration system and method
US20220020481A1 (en) 2020-07-20 2022-01-20 Abbott Laboratories Digital pass verification systems and methods

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6818180B2 (en) * 1996-04-05 2004-11-16 Roche Diagnostics Operations, Inc. Devices for testing for the presence and/or concentration of an analyte in a body fluid
US8106780B2 (en) * 2005-02-08 2012-01-31 Abbott Diabetes Care Inc. Analyte meter including an RFID reader

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6818180B2 (en) * 1996-04-05 2004-11-16 Roche Diagnostics Operations, Inc. Devices for testing for the presence and/or concentration of an analyte in a body fluid
US8106780B2 (en) * 2005-02-08 2012-01-31 Abbott Diabetes Care Inc. Analyte meter including an RFID reader

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015070700A1 (en) * 2013-11-12 2015-05-21 成都领御生物技术有限公司 Quantum dot-labeled test strip card
WO2015070702A1 (en) * 2013-11-13 2015-05-21 成都领御生物技术有限公司 Test strip card
WO2015070704A1 (en) * 2013-11-13 2015-05-21 成都领御生物技术有限公司 Test bar card
US11423637B2 (en) * 2015-02-09 2022-08-23 Digital Concepts Of Missouri, Inc. Test strip mobile app system and method
US11772986B2 (en) 2015-02-09 2023-10-03 Digital Concepts Of Missouri, Inc. Spa/pool water treatment system and method
WO2016150134A1 (en) * 2015-03-21 2016-09-29 杨轶轩 Test paper reading method, and pregnancy test and ovulation test method therefor
CN105510609A (en) * 2015-11-26 2016-04-20 宁波美康保生生物医学工程有限公司 In vitro test piece and application method thereof
WO2018082257A1 (en) * 2016-11-05 2018-05-11 深圳市前海安测信息技术有限公司 Biomarker detecting system and method based on colloidal gold test strip
WO2019082467A1 (en) * 2017-10-25 2019-05-02 オルガノ株式会社 Sample analysis device, sample analysis method, sample analysis system, and program
JP7008468B2 (en) 2017-10-25 2022-01-25 オルガノ株式会社 Sample analyzer, sample analysis method, sample analysis system, and program
JP2019078661A (en) * 2017-10-25 2019-05-23 オルガノ株式会社 Sample analyzer, sample analysis method, sample analysis system, and program
JP2020168602A (en) * 2019-04-02 2020-10-15 オルガノ株式会社 Sample analysis system, sample analysis method and terminal device
JP7263084B2 (en) 2019-04-02 2023-04-24 オルガノ株式会社 SAMPLE ANALYSIS SYSTEM, SAMPLE ANALYSIS METHOD AND TERMINAL DEVICE

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