RU120556U1 - DEVICE FOR READING ANALYSIS RESULTS PERFORMED BY TEST STRIP - Google Patents

Abstract

1. A device for reading the results of analyzes carried out using test strips, containing a housing, a holder for test strips, an illuminator with a system for lighting the test strip in incident light and an image detector, characterized in that the device contains an optical system for projection onto an image detector illuminated test strips and a software and hardware complex for automatic identification of test strips from their fixed image and recognition of analytical information from the images of test strips, made with the ability to localize on the image of the test strips the zones necessary for measurements, the image in each of which can be analyzed independently, as well as a block of information transfer from the device to the operator's computer or to the Internet. ! 2. The device according to claim 1, characterized in that the test strip illuminator is configured to excite luminescence of the measured zones of the test strip. ! 3. The device of claim 1, wherein the test strip illuminator comprises optical fibers for transmitting light from the source to the test strip. ! 4. A device according to claim 1, wherein the test strip illuminator comprises light filters for illuminating the test strip with light of a certain wavelength. !five. The device according to claim 1, characterized in that the test strip illuminator is configured to set a specific illumination wavelength using a hardware-software complex. ! 6. The device according to claim 1, characterized in that the hardware-software complex of the device contains a database of test strips indicating the norm and pathology. ! 7. The device according to claim 1, characterized by those

Description

The utility model relates to the field of laboratory diagnostics, in particular, to devices for laboratory studies performed using test strips and recording their results.

Currently, a significant number of laboratory studies are performed using specially developed methods based on dry chemistry test strips, where chemical reactions with the formation of stained products and immunochromatographic test strips, which are based on the use of specific antibodies with different labels, are used to determine the concentrations of the corresponding analytes. .

Different test strips, which differ in geometric dimensions, number and location on the surface of the analyzed zones, contain different reagents, in this regard, the variety of dry chemistry strips and immunochromatographic strips can be very large. There are strips only for the detection of a particular substance, strips for the semi-quantitative determination of the content of one or more substances, strips for determining the activity of the determined substances in the analyzed object, etc. In addition to the zone in which the sample interacts with the reagent, test strips, depending on the purpose or manufacturer, may contain additional zones, the color of which allows you to clarify or facilitate the analysis. So, test strips of some manufacturers contain a bar code that allows you to automatically determine the purpose of the strip, release date, batch number, etc. Test strips may contain one or more calibration zones or comparison zones to more accurately determine the amount of analyte to be determined. In many test strips there is a reference zone by which they judge the correctness of the analysis.

Typically, test strip reading devices are produced by the same companies that produce the test strips themselves, for example, Jonson & Jonson manufactures a series of Vitros recording systems for recording analyzes performed using dry chemistry test strips manufactured by this company. company (www.vitros.com). The company "77 Elektronika" produces a series of devices for recording the results of urine tests performed using dry chemistry test strips (www.electronika.hu) ;. Vedalab (France) manufactures the Easy Reader device for obtaining quantitative data using the test strips of this company (www.vedalab.com).

The closest analogue (prototype) is an INTEGRAL METER FOR STUDYING SAMPLES (Patent RU 2343833, published January 20, 2009), which contains a housing, a holder for test strips, and a photometric detector.

The disadvantage of the prototype and other specified devices is the low functionality, expressed in the absence of the ability to save the image of the test strip - the primary document of the test, the inability to transfer this image using communication tools to other persons, and the inability to use the device for any other type of test strips .

The technical result to which the utility model is directed is to increase the functionality of the device for reading the results of the analysis, which is manifested in the fact that the device, in contrast to the prototype, is configured to register, receive and transmit to other persons (for example, to the Data Processing Center or to the attending doctor) the results of analyzes carried out using various test strips manufactured by different companies, both in the laboratory and directly at the scene, for example, by doctors with help ”, or tests conducted by the patients themselves, which, in turn, will accelerate the possibility of making decisions on the necessary preventive or therapeutic measures, i.e. treatment effectiveness.

The technical result is achieved by the fact that the device for reading the results of analyzes carried out using test strips contains a housing, a holder of test strips, which, unlike the prototype, is adapted to fix all known types of test strips that differ in geometric dimensions, a illuminator with a system illumination of the test strip in incident light, an image detector, an optical system for projecting an image of an illuminated test strip on, an image detector, and, unlike the prototype, contains software a hardware complex for automatic identification of test strips by their captured image and recognition of analytical information from images of test strips, adapted to adapt to new types of test strips, as well as a unit for transmitting information from the device to the operator’s computer or to the Internet.

The lighting system can be configured to set a specific wavelength of illumination using a hardware-software complex, as well as to establish a wavelength that causes luminescence of the measurement zone of the test strip.

The image detector may be configured to capture a luminescent image.

The lighting system can be made containing optical fibers to transmit light from the source to the test strip.

The lighting system can be made containing light filters to illuminate the test strip with light of a specific wavelength.

The hardware-software complex of the device may contain a database of all known types of test strips indicating the norm and pathology.

The hardware-software complex can be configured to provide the operator with the results of the analysis in the form of an audio and / or light signal, indicating the presence of pathology in the measurement results

Figure 1 shows a block diagram of a device.

Figure 2 shows the location of the zones on the test strip and the resulting value of the concentration of glucose in the blood in the program window. 1 - measurement zone, the color intensity in which corresponds to the amount of glucose in the sample; 2 - zone of the primary document (image) of the test stored in the computer memory; 3 - compensation zone for normalization, if necessary, to correct the lighting intensity; 4 is a possible test identification area with a color code.

Figure 3 shows the location of the zones on the test strip values of the markers of myocardial infarction and the resulting values in the program window. A. Test strip with the location on it of various zones indicated by blue rectangles: 1 - zone of the primary document (image) of the test stored in the computer's memory; 2 - compensation zone for normalization, if necessary, correction of the light intensity; 3, 4, 5, 6 - intensity measurement zones. The color intensity of the band within each zone corresponds to the amount of the corresponding cardiomarker analyte in the sample. C, Myo, CK-MB, TnI - designations of cardiomarkers. 7 - identification area with a color code. B. An enlarged schematic representation of the measurement zones and histograms of the color intensity of the bands. V. - the results of the quantitative determination of cardiomarkers in the program window, the hardware-software complex of the device.

The device is a single unit 1, including a holder 2 of test strips 3, which provides rigid geometric fixation of any type of test strip, an illumination system 4 for illuminating the test strip, an optical system 5 for imaging the test strip, an image detector 6 made, for example , in the form of a CCD or CMOS matrix, on the surface of which an optical system 5 forms an image of a test strip 3, as well as a hardware-software complex 7 (for example, in the form of a microprocessor with downloadable software eat or a computer) that provides recognition of the image of the test strip being analyzed, including the automatic identification of the type of test strip and the decoding of analytical information from the image of the test strip. In addition, the device includes an information transfer unit 8 to an operator’s computer 9 or to the Internet. The lighting system can be configured to set a specific wavelength of illumination using a hardware-software complex, as well as to establish a wavelength that causes luminescence of the measurement zone of the test strip. The image detector may be configured to capture a luminescent image. The lighting system can be made containing optical fibers to transmit light from the source to the test strip. The lighting system can be made containing light filters to illuminate the test strip with light of a specific wavelength. The hardware-software complex of the device may contain a database of all known types of test strips indicating the norm and pathology. The hardware-software complex can be configured to provide the operator with the results of the analysis in the form of an audio and / or light signal, indicating the presence of pathology in the measurement results.

An image of a test strip is obtained on the image detector matrix, on which zones necessary for measurements can be fixed and marked in a certain way, the image in each of which can be analyzed independently. For most types of strips, zones are significant: the area of the saved image of the test strip; an identification zone containing a barcode, color, or some other code that defines information about the purpose, calculation scheme of the analysis results, serial number, release date, and any other strip characteristics; reference zone or comparison zone, allowing to normalize the received data on the value of the light intensity; one or more analytical zones, the color intensity of which allows you to determine the content of the analyte; control zone for immunochromatographic tests, indicating that the analysis was correct.

The program in the hardware-software complex 7 allows you to arbitrarily localize all these zones on the test strip of any type and geometry, according to the code, determines the type of test strip and, based on the image analysis, calculates the color intensity values of the analytical zone of the test strip and gives the analysis result in graphical or tabular form to the operator or the Internet.

The operation of the device is illustrated by the following examples.

Example 1. Determination of blood glucose concentration using a Betachek test strip (Betachek. Indicator Strips for Blood Glucose Testing. Instruction for Visual or Meter Reading. Analytical Features Description. / National Diagnostic Products PTY. Ltd. - Sydney, Australia, 2004). 30 μl of capillary blood was applied to the test strip, incubation was carried out for 30 seconds, and blood was removed from the test strip. The test strip is placed in the device holder. The location of the zones on the test strip and the obtained value of the concentration of glucose in the blood in the program window is shown in the lower part of figure 2. In the upper part is an image of a test strip indicating the location of various zones on it, indicated by rectangular frames.

Example 2. Determining the value of markers of myocardial infarction using a test strip firm "YD Diagnostics" (South Korea). 30 μl of capillary blood was applied to the test strip, incubation was carried out for 10 minutes. The test strip is placed in the device holder. The location of the zones on the test strip and the obtained values of the concentration of cardiomarkers in the program window are shown in Fig.3.

Claims (7)

1. A device for reading the results of analyzes carried out using test strips, comprising a housing, a holder of test strips, an illuminator with a test strip lighting system in incident light, and an image detector, characterized in that the device comprises an optical system for projecting onto an image detector illuminated test strips and a hardware-software complex for automatic identification of test strips by their captured image and recognition of analytical information from images of test strips with the ability to locate the image of the test strip zone necessary for performing the measurement, the image in each of which can be analyzed independently, as well as the information transmission unit from the device to a computer operator or Internet network. 2. The device according to claim 1, characterized in that the illuminator of the test strip is configured to excite luminescence of the measured zones of the test strip. 3. The device according to claim 1, characterized in that the illuminator of the test strip contains optical fibers for transmitting light from the source to the test strip. 4. The device according to claim 1, characterized in that the illuminator of the test strip contains filters for illuminating the test strip with light of a specific wavelength. 5. The device according to claim 1, characterized in that the illuminator of the test strip is configured to set a specific wavelength of illumination using a hardware-software complex. 6. The device according to claim 1, characterized in that as part of the hardware-software complex of the device contains a database of test strips indicating the norm and pathology. 7. The device according to claim 1, characterized in that the software and hardware complex is configured to provide the operator with the results of the analysis in graphical, tabular form, as well as in the form of an audio and / or light signal indicating the presence of pathology in the measurement results.