WO2012115601A1 - System for monitoring and analysing epizootic and/or epidemic risks with identification of biological subjects - Google Patents

Abstract

The invention relates to medicine and veterinary medicine and can be used for conducting monitoring investigations in order to discover information relating to the infection of a specific subject and to provide safety from infection. Specifically, the invention relates to systems for evaluating and analysing epizootic and/or epidemic situations and for subsequently taking decisions in the field of risk analysis in epizoology and epidemiology. What is proposed is: an autonomous information research system for monitoring and analysing epizootic and/or epidemic risks with elements for the identification of biological subjects, said system comprising computer-hardware and biodiagnostic units which are adapted to one another and interact with one another by means of software.

Description

 SYSTEM OF MONITORING AND ANALYSIS OF EPISOOTIC AND / OR EPIDEMIC RISKS WITH IDENTIFICATION OF BIOLOGICAL OBJECTS

The invention relates to medicine and veterinary medicine, and can be used for monitoring studies in order to identify information about the infection of a particular object and ensuring infectious safety. Namely, the invention relates to systems for assessing and analyzing epizootic and / or epidemic situations and for subsequent decision-making in the field of risk analysis in epizootology and epidemiology.

 Objectification of systems for assessing and analyzing epizootic and / or epidemic risks is a key component in the formation of state policy in the field of infectious safety.

 Known methods for monitoring and diagnosing diseases without the use of digital technology and a computer, for example, information is collected about a particular infectious threat through monitoring studies on a representative sample of susceptible objects. To do this, use expensive modern diagnostic drugs, characterized by a sufficient degree of sensitivity and specificity. Such approaches are generally accepted and reflected in all guidelines for infectious diseases of the World Organization of Animal Health (WHO) and the International Epizootic Bureau (MEB)

 The drawback of such studies, despite the use of high-quality diagnostic kits, is the rather high risk of obtaining false information about the infection of a particular object.

This is due, first of all, to the fact that the existing operations on object identification, selection of material for research, sample preparation and analysis are performed with a significant time gap, by different researchers who record the operating procedures performed in different protocols. Respectively any error in performing the above operations will lead to a mismatch between the result and the object of research. The method is not applicable for mass coverage.

 Hamunatsu Photonics Immunochromato-Reader S 10066 is available to record the results. Thanks to this, a quick, highly sensitive, quantitative assessment of the color intensity of immunochromatographic tests can be carried out. The evaluation result is stored in a CSV file; it can be analyzed by software, in which it is easy to construct a calibration of values.

 Known barcode scanner "Argox AS 8000", it is able to provide maximum convenience when scanning barcodes of any quality.

 Gold colloid-based serological tests are available for field use by Orgenix (Israel) and Synbiotic (USA). They are simple tests based on fast immunomigration (fast immunomigration, RIM). Sensitive colloidal gold particles bind to antibodies present in the sample (whole blood, serum or plasma) and migrate along the strip. The complex is assembled on a sensitized line, where its accumulation leads to the formation of a clearly visible pink band. The control bar at the end of the window reading ensures that the test was performed correctly.

 The above analogs are, in fact, components of the invention and are not interconnected by a single control software algorithm.

 The disadvantage of all of the above analogs is the impossibility of a comprehensive approach to carrying out all operational procedures (object identification, coding of an analytical sample, conducting analysis in the field, processing and saving data in a digital format, creating and managing a database) that guarantee reliable information for epizootic and / or an epidemic situation, as well as the inability to use in veterinary medicine. With the separate use of analogues, there is a rather high risk of obtaining false information about the infection of a particular object.

To minimize the risks of such errors, an “Information Research Autonomous System for Monitoring and Analysis of Epizootic and / or Epidemic Risks with Biological Object Identification Elements” was developed, which allows one researcher, in real time, with automatic digital recording of each operation, in a short period of time identify the object, carry out the selection and preparation of the analytical sample and conduct the analysis with the subsequent automatic formation (updating) of the database.

 The well-known "System of computer monitoring of public health and diagnosing diseases" (RU, JV ° 25614, G06F15 / 00, publ.: 10.10.2002), containing equipment for measuring parameters characterizing the state of the human body, a conversion device, an interactive device, at least at least one personal computer for collecting, storing and processing information, characterized in that personal computers are connected to the Internet through a converting device and communication lines using hardware and / or software modules th protection against unauthorized access and information leakage process monitoring and diagnostics, which are also connected to the servers of specialized medical institutions.

 The disadvantages include the fact that this system cannot be applied to veterinary medicine.

 The basis of the invention, the task is to improve the system for monitoring and analysis of epizootic and / or epidemic risks with elements of identification of biological objects by creating an integrated system of interacting scanners, computer and software to obtain reliable information for the analysis of epizootic and / or epidemic situations and for the most effective methods of combating (preventing) infectious diseases of animals and humans.

 The task is achieved by creating a system of hardware-computer and bio-diagnostic blocks adapted to each other, which interact with each other through software.

 According to the invention, the hardware-computer unit comprises a computer, an image scanner, a barcode scanner.

Hardware - computer unit - computer is used for general process control, conducting a research protocol, forming a database, transferring data to a central server, etc .; a digital camera or fingerprint scanner is used to identify the object by biometric indicators; an image scanner is used for digital recording and processing of results, a barcode scanner is used for barcode identification of an object and selected analytical samples. In turn, the bio-diagnostic unit contains the object of research, research material, modern immuno-and molecular-biological diagnostic tests (enzyme-linked immunosorbent assays, rapid (rapid) tests based on gold or coal colloids, PNR tests.

 The personal computer software contains a local database, a program for interacting with printers and other printing devices, a program for interacting with image scanners, barcode scanners, a program for recognizing and analyzing images of test samples, a program for creating reports on the results of recognition and analysis of images of test samples, a program for searching and creating reports based on information from a local database, a program for entering, editing, storing and searching a passport data of research objects, a program for recording events for research objects based on the results of their testing, a program for exporting reports, test results and other information to files, a program for printing reports, test results and other information, a program for exchanging data with a central server and other system servers , a program for recognizing and analyzing biometric indicators of an object. The local database is designed to store the results of scanning, recognition, analysis, intermediate results of calculations, reference information, passport data of research objects and various service information.

 The principle of operation of the system for monitoring and analysis of epizootic and / or epidemic risks with elements of identification of biological objects is based on the sequential performance of standard operations.

 Initially, primary labeling or scanning (bar-code identification) of the object is carried out using the bar-code marking of the object (if any) and is confirmed by biometric indicators obtained using a digital camera or fingerprint scanner, followed by assignment of bar-code marking by biometric indicators. Thus, they enter data on the territorial localization of the animal, its age, breed, owner’s data, etc.

The proposed original animal identification program is based on the universal technology of bar codes, which allows each animal to be assigned an individual number containing the necessary information in accordance with international requirements. Barcode marking of the analytical sample is carried out using a pre-prepared stick immobilized on a container for sampling. Sequential bar code marking eliminates the risk of possible errors in sampling and research.

 Sampling is carried out according to existing medical and veterinary techniques in a pre-labeled container for sampling. Then they test and analyze, record the results and complete the process of automatically forming a database and sending data to a central server. Now, if necessary, you can search for data about the object on the generated database

 The system is adapted to all modern immuno-and molecular-biological diagnostic tests (enzyme-linked immunosorbent assays, rapid (rapid) tests based on gold or coal colloids, PCR tests). Conducting analysis and recording the results, using one or another test, is performed according to the instructions for the test.

 The software allows using the image scanner to scan the intensity of the staining of the reaction and control bands. Then, using a discrete algorithm, divide the results into positive, negative and uncertain.

 In the case of analyzes using tests of polymerase chain reaction and / or enzyme-linked immunosorbent assay, when specific equipment is used to evaluate the results, the system software allows using the discrete algorithm to also divide the results into positive, negative and uncertain.

 The results obtained are automatically entered into the research protocol opposite the code of the research object. At the same time, automatically, positive, negative and uncertain results are highlighted in different colors, for example, red, blue, yellow.

The software allows scanning (identification) of objects to view all the data entered in the database about the object, which allows, for example, to quickly isolate infectious dangerous animals. The principle of the system is its complete autonomy. Research can take place directly at the farms during the working day (power supply from the vehicle’s on-board network 12 V). Basic research operations are simple and affordable, which allows the use of specialists with secondary specialized education. With the correct organization of work, one specialist can carry out from 300 to 1000 studies per working day.

 As an example, we present the protocol for the analysis of immunoassays using colloidal conjugates of gold or coal. Objects of research - mammals. Depending on the configuration, tests can be produced in two versions.

 Example. one.

 Option JVs 1

 Immunosorbent - plastic comb -10 pcs. 12 teeth;

 Solution for breeding samples - 25 ml;

 Colloid conjugate - 10 vials of 2.5 ml;

 A tablet for setting the reaction - at the request of the user;

 Solution for breeding samples - vials from 0.5 ml to 10 ml;

 Disposable pipette - on request. Pharmaceutical group - In vitro diagnostic test. Detects class G antibodies specific to

adsorbed onto the solid phase antigens.

 Preparing for the test. Before starting work, you must turn on the computer and, guided by the prompts of the corresponding program, scan (identify) the object of study (or enter the relevant information about the object into the research protocol); carry out marking and scanning (identification) of the prototype. At the same time, all components of the kit must be maintained at room temperature (from + 18 ° C to + 22 ° C) for 30 minutes.

 Preparation of prototypes.

Whole blood, pieces of meat with fresh whole blood, blood or milk serum, blood plasma obtained in accordance with the protocol for serological reactions can be used as test samples. Samples, serum or whole blood with anticoagulant stored from 2 to 8 ⁰ C for three days. If it is not possible to conduct an analysis within this period, serum samples must be frozen. The process of thawing serum samples should be no more than 2 times. Samples with bacterial germination are not suitable for analysis.

 Test

Option N ° 1 Plastic comb. To prepare a working dilution of the conjugate, 2.5 ml of distilled water is added to the ampoule with the conjugate. Pipette to prevent foaming until the contents of the vial are completely dissolved.

 To formulate the reaction, 180 μl of sample dilution solution and 20 μl of test samples (serum or whole blood) are added to the wells of row A, a tablet. Well A1 is left free for positive control. The first tooth of the plastic comb serves as a positive control.

 The comb is removed from the package, holding the upper part, unfold with the marked side (barcode) to itself and inserted into the wells of row A.

 The comb is incubated in the wells of row A, at a temperature of + 18 ° C to + 22 ° C) for 20 minutes. 250 μl of distilled water are added to the wells of row B of the reaction plate. At the end of the incubation, excess moisture is removed from the teeth, holding the comb perpendicularly and wetting the tips of the teeth with filter paper. The comb is transferred to row B with distilled water and rinsed, removing and inserting the comb into the wells for 10-15 seconds.

 The diluted conjugate of colloidal gold is added 200 μl to the wells of row C and incubated at a temperature of + 18 ° C to + 22 ° C) for 20 minutes. 250 μl of distilled water are added to the wells of row D of the reaction plate.

 The reaction is stopped by transferring the comb into the distilled water of row D and carefully washed for 10 seconds. The comb is removed from row D and air dried for 2 minutes, after which the results are recorded. The results are taken into account using equipment (scanner, computer and the corresponding program).

 Example. 2.

 Option N ° 2 Immunostrip.

 Immunosorbent test strips in individual blister packs from 1 to 20 pcs;

 Immunosorbent test strips in a plastic tube-20 pcs.

 Solution for breeding samples - vials from 0.5 ml to 10 ml;

 Disposable pipette - on request. Pharmaceutical group - In vitro diagnostic test. Detects class G antibodies specific for antigens adsorbed onto the solid phase.

Preparing for the test. Before you begin, you must turn on the computer and, guided by the prompts of the corresponding program, scan (identification) of the object of study (or enter the relevant information about the object in the protocol of the study); carry out marking and scanning (identification) of the prototype. At the same time, all components of the kit must be kept at room temperature (from + 18 ° C to + 22 ° C) for 30 minutes.

 500 μl of sample dilution solution was added to the tube. Pipette 1 drop (SOMcl) of a sample or a piece of meat, which has fresh whole blood, is pipetted carefully. Immerse the test strip with the index arrows down in a test tube with the diluted sample.

 Observe the development of the color of the control strip for 10-5 seconds. The results are taken into account using equipment (scanner, computer and the corresponding program).

 Thus, the use of the invention will allow for re-barcode identification to identify sick animals. All operations with this system allow you to quickly and conveniently exchange data in real time with a central server.

Claims

CLAIM 1 Information research autonomous system for monitoring and analysis of epizootic and / or epidemic risks with elements of identification of biological objects, characterized in that it consists of hardware-computer and bio-diagnostic units adapted to each other, which interact with each other through software.  2. The system according to claim 1, characterized in that the hardware-computer unit comprises a computer, an image scanner for digital recording and processing of results, a barcode scanner for barcode identification of the animal and selected analytical samples.  3. The system according to claim 1, characterized in that the bio-diagnostic unit contains an object of research, research material, modern immuno-and molecular-biological diagnostic tests (enzyme-linked immunosorbent assays, rapid (rapid) tests based on gold or coal colloids, PCR tests).  4. The system according to claim 1, characterized in that the personal computer software contains a local database, a program for interacting with printers and other printing devices, a program for interacting with image scanners and barcode scanners, a program for recognizing and analyzing images of test samples, a program for creating reports on the results of recognition and analysis of images of test samples, a program for searching and creating reports based on information from a local database, an input program, p editing, storing and searching passport data of research objects, a program for recording events for research objects based on the results of their testing, a program for exporting reports, test results and other information to files, a program for printing reports, test results and other information, a program for exchanging data with the central server and other servers of the system, a program for recognizing and analyzing biometric indicators of an object.