RU72340U1 - MOBILE MEDICAL DIAGNOSTIC LABORATORY METHOD BY POLYMERASE CHAIN REACTION - Google Patents

Abstract

1. Mobile medical laboratory for the diagnosis of polymerase chain reaction, characterized in that it is made in the form of at least one movable building containing an entrance sanitary lock compartment, a diagnostic compartment formed by a DNA / RNA extraction zone, a digging area of the reagents for amplification as well as an amplification and detection zone, a medical and medical compartment equipped with a workstation with a monitor, server, router, switch and telemedicine terminal, a patient and reception compartment b and a transport compartment, and equipped with means for ensuring its autonomous functioning, including at least a power supply system, a crew life support system, a communication system with the possibility of providing a video conferencing mode, preferably a satellite communication system based on a VSAT terminal, an on-board local area network, preferably LAN Ethernet, and a unit for determining the position on the ground, preferably the GLONASS system, which is coupled with a means of moving through land, and / or water, and / or through air. 2 . The mobile polymerase chain reaction diagnostic medical laboratory according to claim 1, characterized in that the DNA / RNA extraction zone is equipped with at least one microcentrifuge, an automatic dispenser with a stand, a laminar cabinet with bioprotection, a thermostat, a microtube rack and a vacuum aspirator. 3. The mobile medical laboratory for the diagnosis of polymerase chain reaction according to claim 1, characterized in that the digging area of the reagents for amprification is equipped with at least one microcentrifuge

Description

Technical field

This useful model relates to medicine and can be used to quickly diagnose infectious agents in zoonotic natural focal areas (bird flu, leptospirosis, tularemia, tick-borne encephalitis, tick-borne borreliosis, etc.) and anthroponous infections: (poliomyelitis, viral hepatitis, typhoid fever, etc.).

The prior art.

In conditions when the issue of overpopulation of the planet has become urgent, crowding in large cities has reached a critical level, and the pressure of technogenic factors on nature becomes almost irreversible and leads to a sharp weakening of immunity, it is impossible to overestimate the importance of epidemiology, i.e. section of medicine that studies the causes and patterns of the spread of epidemics. Operational diagnosis of infectious agents in real time significantly reduces the number of false-positive results, especially at the stage of the latent (latent) period of the development of an infectious disease (sometimes reaching several dozens of days). In such a situation, the possibility of real-time identification of an infectious disease at the stage of its latent development in terms of the quantitative determination of DNA / RNA of infectious agents has no alternative at all.

Known mobile medical institution [1] which is designed to provide emergency medical care, mainly affected by industrial accidents, industrial disasters, natural and environmental disasters. It is a body equipped with medical equipment and an electric network, mounted on the frames of at least two vehicles. Medical equipment is located in the form of medical departments. A disadvantage of the known device is the absence in its composition of the department for the operational diagnosis of infectious agents.

Also known from the prior art is a mobile medical complex [2], which is equipped with medical devices, devices and technical

means of providing habitability and interconnected when deploying on the ground a number of modules equipped with medical departments. The disadvantage of this device is the absence in its composition of the department for the operational diagnosis of infectious agents.

Also known is a mobile medical laboratory [3], mounted in a van containing tables, necessary to conduct research kits of components that provide the work of chemical-analytical equipment. This device provides means that amortize the aforementioned equipment when the car is moving, and means that ensure the laboratory operates in all weather conditions. The van has a compact laboratory wash. This allows this laboratory to perform analysis and research work in unequipped areas. A disadvantage of the known device is the absence in its composition of a module for the diagnosis of infectious agents.

The closest in technical essence and the achieved result to the claimed utility model is a mobile medical complex [4], formed on the basis of an airmobile ambulance vehicle. The prototype device contains container bodies mounted on the chassis of a car with forensic and pathological anatomical laboratories. The device is also equipped with devices of the laboratory department with the computer subsystem "Laboratory", for examination of human health, research on biopsy and surgical materials, production of computer and typewriting works. The automated computer subsystem “Laboratory” is a server-based local area network (client-server LAN construction scheme) connected via a switch to on-board communications equipment (VHF radio stations of the R-173 type) and equipped with medical terminals (based on laptops) with workstations (AWS) of the laboratory head, expert doctor and laboratory assistant. In addition to the server and laptops, the on-board local area network contains peripheral devices, in particular, a printer. The prototype also has a darkroom and bactericidal safety equipment, which has an ultraviolet irradiator and contains filter and ventilation units. In the device under consideration, three microscopes, portable gas analyzers, a particle concentration meter, and a refrigerator are used as laboratory equipment instruments in this device. There are places for the crew to rest and sleep, as well as means for ensuring the crew’s livelihoods, in particular, a device for heating food, a bathroom and “initial” supplies

(in the terminology of the inventors) water. In addition to the aforementioned, the prototype device contains a universal table equipped with a waste collection and disinfection unit, coupled with an ultraviolet ozonized-electrolysis water production unit (drinking, ionized, distilled, pyrogen-free and ozonized).

The disadvantage of the prototype is the high level of false positive results during the rapid detection of infectious agents.

The task of creating and applying this utility model is to reliably diagnose the presence of infectious agent (s) and establish the boundaries of its distribution area to prevent a pandemic.

The technical result expected from the use of the claimed utility model consists in reducing the number of false-positive results during the prompt detection of infectious agent (s).

The claimed technical result is achieved by the fact that the mobile medical laboratory for diagnostics by the polymerase chain reaction method is made in the form of at least one movable building containing an entrance sanitary-lock compartment, a diagnostic compartment formed by a DNA / RNA isolation zone, a reagent digging area for amplification, as well as an amplification and detection zone, a medical and medical compartment equipped with a workstation with a monitor, server, router, switch and telemedicine terminal, a compartment for patient and sampling and transport compartment, and equipped with means for ensuring its autonomous functioning, including at least a power supply system, crew life support system, a communication system with the possibility of providing a video conferencing mode, preferably a satellite communication system based on a VSAT terminal, on-board local computing a network, preferably LAN Ethernet, and a terrain positioning unit, preferably a GLONASS system, which is coupled to a means of movement by land, and / or ode, and / or air.

It is desirable that in the mobile medical laboratory for polymerase chain reaction diagnostics, the DNA / RNA extraction zone should be equipped with at least one microcentrifuge, an automatic dispenser with a stand, a laminar cabinet with bioprotection, a thermostat, a microtube rack and a vacuum aspirator.

Preferably, in the polymerase chain reaction diagnostic laboratory of a mobile medical diagnostic laboratory, the amplification reagent digging area should be equipped with at least one microcentrifuge, an automatic dispenser, with a stand, a laminar cabinet with bioprotection and a microtube rack.

It is advisable that in the mobile medical laboratory for polymerase chain reaction diagnostics, the amplification and detection zone should be equipped with at least two thermal cyclers, an amplifier and a luminescent analyzer.

It matters that in the mobile medical laboratory for polymerase chain reaction diagnostics, the telemedicine terminal would be made as a polymerase chain reaction diagnostic workstation.

It is important that in the mobile medical laboratory for diagnosis by polymerase chain reaction, the compartment for patients and taking samples would be in the form of a vestibule.

It is desirable that in a mobile medical laboratory for polymerase chain reaction diagnostics, the energy supply system would be formed by at least one electric generator based on the drive of an internal combustion engine, and / or an electric wind generator, and / or a solar battery and / or an electrohydrogen generator.

It is convenient that in the mobile medical laboratory for diagnostics by the method of polymerase chain reaction, the internal combustion engine of the electric generator would be equipped with a hopper for storing the supply of fuel and lubricants.

It is advisable that in the mobile medical laboratory for diagnosis by polymerase chain reaction, the electric wind generator would be equipped with a battery.

It is desirable that in a mobile medical laboratory for polymerase chain reaction diagnostics, the crew’s life support system should include at least a sanitary unit formed by a shower and

a dry closet, a ventilation unit, an air conditioning and disinfection unit, a heating unit, a water supply unit with reserves of drinking and industrial water, a fire safety unit and a unit for preventing unauthorized entry into a moving building.

It is advantageous that a mobile medical laboratory for polymerase chain reaction diagnostics would contain a set of medical supplies related to medical care when working with patients, in particular cotton wool and / or bandages, disinfectants, in particular medical alcohol and / or chlorhexidine, and a set of medicinal products drugs at least that meet the level of emergency care requirements.

It is advisable that in a mobile medical laboratory for polymerase chain reaction diagnostics, the moving building would contain places for the crew to rest and sleep.

It matters that in a mobile medical laboratory for polymerase chain reaction diagnostics, a Ku- or Ka-band antenna would be used as a satellite communication antenna.

Advantageously, in the mobile medical laboratory for polymerase chain reaction diagnostics, the chassis of a KAMA3-6530 car with a wheel formula of 8 × 8, or the chassis of a KAMA3-43118 car with a wheel formula of 6 × 6, would be used as a means of moving by land.

Brief Description of the Drawings

The claimed utility model is illustrated by graphic materials. Figure 1 schematically shows one of the layout options in the van of a moving building (top view); figure 2 shows the appearance of a mobile medical laboratory in accordance with the application for a utility model in an automotive embodiment of a travel inducer; figure 3. the main blocks of the on-board local area network of the claimed device and the associated telecommunication and communication systems are conventionally shown, and FIG. 4 shows external views of the best version of equipping the amplification and detection zone (FIG. 4 a) and the DNA / RNA extraction zone (FIG. 4 b) .

The list of positions:

1. The van of the moving building.

100. Entrance sanitary lock compartment.

101. Service entrance door.

102. Sliding curtain.

103. Rack-table for domestic needs.

104. A wardrobe for the crew.

105. Sanitary compartment.

1051. Shower.

1052. Dry closet.

1053. Sink of the washbasin.

110. The compartment diagnostic.

111. The area of DNA / RNA.

112. The area of excavation of reagents for amplification.

113. The zone of amplification and detection.

114. The workplace.

115. The door.

116. Medical cabinet.

117. The refrigerator.

120. The medical office compartment.

121. Workstation with monitor.

122. Server.

1221. Local area network.

1222. Network printer.

1223. Network scanner.

123. The router.

124. The switch.

125. Telemedicine terminal.

126. Video conferencing equipment.

1261. Webcam.

1262. The microphone.

1263. Audio speakers.

127. Telephone set.

128. VSAT terminal.

1281. Antenna for satellite communications.

129. Automatic antenna orientation system.

1291. Block determining the position on the ground.

130. Compartment for patients and taking samples.

131. The first door for patients and taking samples.

132. Second door for patients and taking samples.

140. Transport compartment.

2. The vehicle.

210. Outrigger.

220. Diesel generator based on ICE.

2201. Boxing for the diesel generator.

2202. Bunker for the supply of fuels and lubricants.

230. Power distribution board.

240. Gangway.

250. Boxing for placement of a satellite dish.

260. Blinds of boxing for placement of a satellite dish.

The best embodiment of the utility model

A mobile medical laboratory for polymerase chain reaction diagnostics, made according to the present utility model, comprises a van of a moving building 1 (FIG. 1, FIG. 2 and FIG. 3). The van is isothermal and moisture-dustproof, for example, similar to the structures of vans (kungs) of moving buildings known from the prior art [5, 6 and 7]. For the crew of the laboratory provides an entrance sanitary lock compartment 100 (Figure 1). The door of the service entrance 101 leads to it (Figure 1). Given the height difference from ground level to the doorway, this door is equipped with a removable alloy (for example, based on an aluminum-titanium alloy) ladder with a handrail (not shown). The space of the entrance sanitary-airlock compartment 100 (Fig. 1) is divided by several sliding shutters 102 (Fig. 1). The designs of such curtains are characterized by diversity, for example, you can use a sliding curtain in accordance with the technical solution [8]. Behind one of these sliding curtains 102 (FIG. 1), there is a table-rack for domestic needs 103 (FIG. 1) and a wardrobe for crew clothes 104 (FIG. 1). From the side of the opposite wall of the van behind the second sliding curtain 102 (Figure 1) mounted sanitary-hygienic compartment 105 (Figure 1). The aforementioned compartment is equipped with a shower cabin 1051 (Figure 1), a dry closet 1052 (Figure 1) and a washbasin sink 1053 (Figure 1), to which the corresponding sanitary pipelines equipped with shutoff valves are connected. Water is taken from a tank with a supply of technical water (containing at least 100 liters of the latter), and the used technical water is discharged into another tank that is designed to store waste. The main compartment in the declared

the device is a diagnostic compartment 110 (Figure 1), in which there is a zone for the allocation of deoxyribonucleic and ribonucleic acids (DNA / RNA) 111 (Figure 1). In the same compartment there is a zone for digging reagents for amplification (112) of Figure 1), as well as a zone of amplification and detection 113 (Figure 1). Mentioned areas contain jobs 114 (Figure 1). The diagnostic compartment 110 (FIG. 1) is equipped with two doors 115 (FIG. 1). In the immediate vicinity of the DNA / RNA extraction zone 111 (Figure 1), a medical cabinet 116 (Figure 1) with bioprotection and a refrigerator 117 (Figure 1) connected to the on-board electrical network, for example, using Peltier thermoelectric modules, are placed. The medical compartment 120 (Figure 1) supports the information and communication component of the claimed medical laboratory. In this compartment, a workstation with a monitor 121 (Fig. 1 and Fig. 3), a server 122 (Fig. 1 and Fig. 3)) of a local area network 1221 (Fig. 3), to which a network printer 1222 are connected via connectors, is located ( Figure 3), a network scanner 1223 (Figure 3). Since the claimed device, as well as in the prototype, there is a need for equipping several automated workstations (AWS) of medical specialists, it is preferable to use router 123 (Fig. 3) to build an on-board local area network 1221 (Figure 3) [9 and 10 ], and not just use the client-server LAN Ethernet construction scheme. The switch 124 (Figure 3) allows you to connect a network printer 1222 (Figure 3) and a network scanner 1223 (Figure 3) via a standard RJ45 connector. Instead of separately manufactured blocks of the router 123 (FIG. 3) and the switch 124 (FIG. 3), the use of a multiservice communication gateway is permissible. Telemedicine terminals 125 (Figure 3) can be performed as "AWP of laboratory technician for PCR diagnostics", "AWP of a doctor-epidemiologist", "AWP of an infectious disease specialist", "AWP of a nurse for receiving biomaterials", etc., see [eleven]. In the same compartment, there is a telemedicine terminal 125 (Figure 3) and video conferencing equipment 126 (Figure 3). In a minimum configuration, this equipment consists of a Web camera 1261 (Figure 3), a microphone 1262 (Figure 3), and audio speakers 1263 (Figure 3). The principles of an interactive multimedia information transmission system are known and their hardware-software implementation is disclosed in the sources [12-16]. A workstation with a monitor 127 (Fig. 3) is equipped with a VoIP telephone, and, for example, a Russified Skype software product can be used as a software product for its (telephone apparatus 127 (Fig. 3)).

To ensure the operation of the satellite communication channel, a VSAT terminal 128 (FIG. 3) was used, equipped with a Ku- or Ka-band satellite antenna (diameter from 1.2 to 1.6 m). Aiming the antenna to the satellite-repeater is done automatically by a mechanized antenna orientation system

129 (Figure 3), using signals (data) from the block determining the position on the ground 1291 (Figure 3), for example, the GLONASS system.

Between the diagnostic compartment 110 (FIG. 1) and the entrance sanitary lock compartment 100 (FIG. 1), a compartment for patients and receiving samples 130 (FIG. 1) is placed. It is equipped with a first 131 (Fig. 1) and a second 132 (Fig. 1) doors for patients to enter and exit and receive samples. In turn, in the contact zone of the driving agent with the van of the moving building 1 (FIG. 1), a transport compartment 140 (FIG. 1) is located.

The moving means 2 (FIG. 1), for example, on the basis of the chassis of the KAMA3-6530 car with a wheel formula of 8 × 8 or on the basis of the chassis of a KAMA3-43118 car with a wheel formula of 6 × 6, is equipped with triggers 210 (FIG. 2) designed for leveling the floor of the van of the moving building 1 (Fig. 1), a diesel generator based on the engine ICE 220 drive (Fig. 1), placed during march (movement) in the box of the diesel generator 2202 (Fig. 1) and containers for storing fuel and lubricants materials 2202 (Figure 1). To the electrical switchboard 230 (FIG. 2), in addition to the diesel generator on the bases of the ICE 220 (FIG. 1), other sources of electric energy generation can also be connected. These include an electric wind generator, a solar battery and an electrohydrogen generator. The electric wind generator is equipped with a battery, to which the mentioned sources can be connected independently from each other using an electric distribution panel 230 (Figure 2). An external single-phase alternating current electrical network with a voltage of 220 V can also be connected to the switchboard. The electrical switchboard 230 (Figure 2) is equipped with an electricity meter, fuses, a residual current device (RCD) and AC converters of 220 V to DC voltage 12 V. For the convenience of receiving patients, the claimed device is equipped with ramps 240 (Figure 2), equipped with handrails. In the body of the van of the moving building 1 (FIG. 2), a recess is made forming a box for placement of the satellite dish 250 (FIG. 2). On the march, it is covered with box blinds for placing a satellite antenna 260 (Figure 2), which protects the antenna from damage as a result of accidental contact with tree branches and / or protruding parts of artificial structures.

The use of a mobile medical laboratory for the diagnosis of polymerase chain reaction occurs in the following order. After the crew chief receives the exit order, replenishment of fuels and lubricants in the bunker 2202 (Figure 2), medical supplies, placing them in storage in a medical cabinet 116 (Figure 3), and food, loading it into the refrigerator 117 (Figure 3). Also produce replenishment of drinking

water and industrial water (the latter serves to ensure the functioning of the sanitary-hygienic compartment 105 (Figure 3)). Upon arrival at the parking lot, the electrical power network of the claimed device is earthed, then four outriggers 210 are pulled out (FIG. 2) and the van of the moving building 1 is horizontal (FIG. 2). From the box for the diesel generator 2201 (Figure 2), a diesel generator based on the internal combustion engine 220 is removed (Figure 1), refuel it from the hopper 2202 (Figure 2) with fuels and lubricants, and the power cable from the diesel generator based on ICE 220 (Figure 2) to the electrical switchboard 230 (Figure 2). A diesel generator is put into operation. Then, the blinds of the box are dissolved to accommodate the satellite antenna 260 (FIG. 2), and the satellite antenna 1281 (FIG. 2) is removed from the box to accommodate the satellite antenna 250 (FIG. 2). Open the door of the service entrance 101 (Fig. 3), open the first 131 (Fig. 3) and the second 132 (Fig. 3) of the door. All these doors are equipped with vents that open from the inside of the van, acting as a gateway. In each doorway, ladders 240 are fixed (FIG. 2). Next, emergency lighting (from batteries) is turned on and the sanitary-hygienic block 105 (Fig. 1) is transferred from the transport state to the working state, i.e. by manipulating the shutoff valves on the water supply, organize the supply of industrial water in the shower (equipped with a heating system up to 90 ° C) 1051 (Figure 1), as well as to the sink of the washbasin 1053 (Figure 1). The crew members put themselves in order and dress in medical gowns behind the sliding curtain 102 (Fig. 1), leaving traveling clothes in the crew's closet 104 (Fig. 1), and take turns eating food at the counter table in turn (due to space limitations) household needs 103 (Figure 1). The crew takes jobs 114 (FIG. 1), after which the crew chief who takes up work 114 (FIG. 1) behind the telemedicine terminal 125 (FIG. 1 and FIG. 3) at a workstation with a monitor 121 (FIG. 1 and FIG. .3), starts the server 122 (Fig. 3), a local area network 1221 (Fig. 3), in particular, LAN Ethernet, and video conferencing equipment 126 (Fig. 1). The information and communication equipment is activated (router 123 (FIG. 1) and switch 124 (FIG. 1) or a multi-service telecommunication gateway replacing the last two devices)). The launch of the terrain positioning unit 1291 (FIG. 1) has the consequence of obtaining data on the position of the van on the terrain, which are then sent to the actuators of the automatic antenna orientation system 129 (FIG. 1). The satellite communication antenna 1281 (FIG. 1), for example, the Ku or Ka band, mechanically targets the nearest satellite repeater. By supplying power, the VSAT terminal is activated and, as a result, a satellite communication channel is connected to the local area network 1221 (FIG. 1). Accordingly, the possibility of functioning is realized.

Webcam 1261 (FIG. 1), microphone 1262 (FIG. 1), U audio speakers 1263 (FIG. 1), and telephone set 127 (FIG. 1). At the same time, air conditioning, ventilation and bactericidal air purification systems (mainly equipped with UV irradiators) are launched in the passenger compartment of the van. If necessary (according to temperature readings overboard) include panel heaters (not shown). Check the operation of the unit to prevent unauthorized entry into a movable building, equipped with a counter. The penetration counter (used in this case and as a counter for the number of visits by patients to the van) is set to “0”. Begin the reception. Patients (or their authorized representatives) submit samples of biomaterials (or clinical materials, for example, blood) to the diagnostic compartment 110 (Figure 1). Samples are tested by polymerase chain reaction (PCR). PCR is a well-known method of molecular diagnostics, for the development of which in 1983 K. Mullis (USA) received the Nobel Prize / cm. http://www.pcr.su/. PCR is based on multiple doubling of a specific DNA region. Due to this, in a fairly short period of time, such an amount of DNA is generated that allows you to visually detect an infectious agent. The PCR method allows with 100% certainty to diagnose the presence of long-growing pathogens (excluding very laborious microbiological studies), which is especially important in gynecology and urology in the diagnosis of urogenital infections and sexually transmitted diseases. The method under consideration is also used to diagnose HIV and hepatitis. The specificity of PCR is such that even single cells of viruses and bacteria are detected, for example, such as chlamydial, mycoplasma and ureaplasma pathogens of infections. For successful analysis, sample preparation (including the transportation step) of clinical material received from a sick patient is extremely important.

It is known that in laboratory diagnostics up to 70% of false-positive results (errors) are caused by errors at the stage of sample preparation (including due to contamination of clinical materials). The PCR method is especially effective in diagnosing difficultly cultivated and secretly existing forms of microorganisms in latent and chronic infections.

After the patient receives clinical material in the diagnostic compartment 110 (Figure 1), this material is sent to the DNA / RNA extraction zone 111 (Figure 1). In this zone, clinical material is placed in a bioprotection class 2 A class A laminar cabinet and DNA / RNA (hereinafter NK) is isolated using a microcentrifuge, for example, the Eppendorf model of the MiniSpin model (speed up to 14000

rpm), a vortex microcentrifuge, for example, a Theta-2 model, an automatic dispenser, for example, a Biohit Proline model with a PP-5 stand, a tripod for 1.5 ml microtubes, and a thermostat, for example, such as a Dry-block »With a block of model A-53.

A vacuum aspirator is used to directly receive the patient’s blood (clinical material), the rest of the time it is stored under a medical cabinet 116 (Figure 1). The PCR method is based on a natural process - the complementary completion of the matrix DNA, carried out using the DNA polymerase enzyme. This reaction is called DNA replication. Natural DNA replication involves several stages, namely:

1) NK denaturation (double helix weaving, DNA strand divergence);

2) The formation of short double-stranded sections of NK (seeds needed to initiate DNA synthesis);

3) Synthesis of a new NK chain (complementary completion of both strands)

The described process can be used to obtain copies of short sections of NK specific for specific microorganisms, i.e. to carry out a targeted search for such specific sites, which is the purpose of gene diagnostics to identify pathogens of infectious diseases. The discovery of thermostable DNA polymerase (Taq polymerase) from thermophilic bacteria Thermis aquaticus, the optimum of which is in the range of 70-72 ° C, made it possible to make the process of NK replication cyclic and use it for in vitro work. The creation of programmable thermostats (amplifiers), which according to a given program carry out a cyclic change of temperatures, created the prerequisites for the widespread introduction of the PCR method in the practice of laboratory clinical diagnostics. With repeated repetition of synthesis cycles, an exponential increase in the number of copies of a specific DNA fragment occurs, which allows a small amount of the analyzed material, which may contain single cells of microorganisms, to obtain a sufficient number of NK copies for identification by electrophoresis. Complementary chain building does not begin at any point in the NK sequence, but only in certain starting blocks — short double-stranded sections. When such blocks are attached to specific sections of NK, it is possible to direct the synthesis of a new chain only in this section, and not along the entire length of the DNA chain. Two oligonucleotide seeds (20 nucleotide pairs each), called “primers”, are used to create starting blocks in the given sections of the NC. Primers are complementary to NK sequences on the left and right boundaries of a specific fragment and

are oriented in such a way that the completion of a new DNA chain proceeds only between them.

The task of the reagent digging zone for amplification 112 (FIG. 1) is dosed filling with the reagent obtained from the previous treatment in the DNA / RNA extraction zone using automatic dispensers, for example, the Biohit Proline model, 0.2 ml tubes. Dispensers are placed on PP-5 supports, and the test tubes after filling are fixed in a support for microtest tubes. In order to increase the homogeneity of the structure of the reagents, a microcentrifuge-vortex, for example, the Theta-2 model, can be used before digging. All work in this area is carried out in a laminar cabinet of the design described above. Accordingly, it is in this cabinet that all the fixtures and equipment for excavation work are located. The result of the digging procedure is a 0.2 ml tube containing a homogenized reagent composition. Thus, the following components are required for classical amplification: a) a DNA matrix (DNA or part of it containing the desired specific fragment); b) Primers (synthetic oligonucleotides (20-30 nucleotide pairs), complementary to DNA sequences at the boundaries of the specific fragment being determined). Note that the selection of a specific fragment and the selection of primers plays a crucial role in the specificity of the amplification, and this affects the quality of the analysis, c) A mixture of deoxynucleotide triphosphates (dNTPs) (a mixture of four dNTPs, which are the material for the synthesis of new complementary DNA chains); d) Taq polymerase enzyme (thermostable DNA polymerase that catalyzes the extension of primer chains by sequential addition of nucleotide bases to the growing chain of the synthesized DNA); e) Buffer solution (reaction medium containing Mg2 + ions necessary to maintain enzyme activity) To determine specific regions of the genome of RNA-containing viruses, a DNA copy is first obtained from the RNA matrix using the reverse transcription (RT) reaction catalyzed by the enzyme revertase ( reverse transcriptase). To obtain a sufficient number of copies of the desired characteristic DNA fragment, amplification involves several (20-40) cycles. Each amplification cycle includes 3 stages proceeding in different temperature conditions. In stage 1, DNA is denatured (i.e., double helix). It proceeds at 93-95 ° C for 30-40 seconds.

At stage 2, annealing takes place, leading to the addition of primers. The primers attach complementary to the corresponding sequences on opposite DNA strands at the boundaries of a specific site. For each pair

primers have their own annealing temperature, the values of which vary in the range of 50-65 ° C. The duration of annealing ranges from 20 to 60 seconds. At stage 3, the completion of DNA chains occurs. Complementary completion of DNA chains occurs in opposite directions, starting from the primer attachment sites. The material for the synthesis of new DNA strands are deoxyribonucleotide triphosphates (dNTPs) added to the solution. The synthesis process is catalyzed by the enzyme with thermostable DNA polymerase (Taq polymerase) and takes place at a temperature of 70-72 ° C. The synthesis lasts 20-40 seconds.

New DNA strands formed in the first amplification cycle serve as matrices for the second amplification cycle, in which the desired specific DNA fragment (the so-called “amplicon”) is formed. In subsequent amplification cycles, the amplicons serve as a matrix for the synthesis of new chains. Thus, the accumulation of amplicons in solution occurs according to the formula 2 ⁿ , where n is the number of amplification cycles. Therefore, even if only one double-stranded DNA molecule was initially present in the initial solution, about 10 ⁸ amplicon molecules accumulate in the solution over 30–40 cycles. This amount of amplicon is sufficient for reliable (and not false positive) visual detection by luminescent analysis (for example, on the analyzer of the ALA-1/3 BioSan model). The amplification process is carried out in a special programmable thermostat (an amplifier, for example, a Palm Cycler model from CORBETT RESEARCH), which, according to a given program, automatically changes temperatures according to a given number of amplification cycles. Note that, for example, a rotor Gene 3000 thermal cycler can be used as a thermal cycler. The equipment mentioned is placed in a laminar cabinet with bioprotection. The luminescent analyzer is equipped with a color digital video camera, which allows you to use it as a complementary Web-camera when integrated via the RJ45 connector into the on-board local area network 1221 (Figure 3). Subsequent transmission via satellite channel of the image obtained from the above color digital video camera, in fact, to an unlimited number of medical institutions specializing in PCR methods within the framework of one country, eliminates the error in making the patient an infectious diagnosis. After completing the diagnosis by PCR for the first patient, they begin work on the next potential patient. After receiving the planned number of patients (more precisely, receiving and processing clinical materials received from them, with the exception of those who donate blood directly as clinical material and therefore visit the van on their own), crew members conduct sanitary

epidemiological treatment of compartments 110, 120 and 130 (Figure 1) using chlorhexidine, illuminate the space of the latter with intense ultraviolet lamps (not shown) and close the service entrance door 101 (Figure 1) and both doors 131 and 132 (Figure 1) compartment for patients and taking samples 130 (Figure 1) for locks. After the implementation of personal hygiene measures in the sanitary-hygienic compartment 105 (Fig. 1) and eating on the counter-table 103 (Fig. 1), the crew members go to bed on folding beds (folding beds), folding up during the daytime (transforming into camping position) and removed from the compartments into the box under the bottom of the chassis of the KAMA3-6530 car with a wheel formula of 8 × 8, or the chassis of a KAMAZ 43118 car with a wheel formula of 6 × 6, used as a means of moving 2 (Figure 2).

Thus, the use of the claimed device can significantly (at times) increase the reliability of the identification, in comparison with the prototype, of an infectious agent. This is due to the fact that the analysis for the presence of infection in a person is performed at the patient’s place of residence, which eliminates errors due to contamination of clinical materials as a result of their transportation from the epidemiological focus to the research center-hospital. Delivery of all patients from the epidemiological focus to the hospital as part of the screening is not practical due to the time factor (which is important for blocking the spread of the epidemic, taking into account the latent period of the disease).

The prototype device does not have a complex of medical equipment that provides for the diagnosis of an infectious agent in the aircraft landing area based on the PCR methodology, which has a minimum error in detecting infection.

And finally, during the determination of the presence of an infectious agent in the body of a particular patient, even with the use of the most advanced diagnostics to date (the polymerase chain reaction method), the result can be easily refined or refuted by one specialist or a number of epidemiologists who are in stationary specialized medical institutions anywhere in the world. These arguments give reason to the Applicant to conclude that the technical result stated in the framework of this utility model has been achieved, i.e. result in the form of a decrease in the number of false positive results during the prompt detection of infectious agent (s).

INFORMATION SOURCES

1. Patent for the invention of the Russian Federation No. 2097499, publ. 11/27/1997

2. Patent for the invention of the Russian Federation No. 2220059, publ. 12/27/2003

3. Patent for the invention of the Russian Federation No. 2251498, publ. 05/10/2005

4. Patent for the invention of the Russian Federation No. 2291070, publ. 08/20/2006 (prototype)

5. Patent for utility model of the Russian Federation No. 37934, publ. May 20, 2004

6. Patent for utility model of the Russian Federation No. 70586, publ. January 27, 2008

7. Patent for utility model of the Russian Federation No. 62265, publ. 03/27/2007

8. Patent for the invention of the Russian Federation No. 2199936. publ. 03/10/2003

9. A. Neybauer, “Sociable house. Local area networks and the Internet for business and home. " Publishing house "ECOM", M., 2002

10. “Computer networks. First Step, ”by Wendell Odom. Williams Publishing House, Translated from English and edited by B.C. Gusev, Moscow * St. Petersburg * Kiev, 2006

11. Patent for the invention of the Russian Federation No. 2226320, publ. 03/27/2004

12. Application for invention of the Russian Federation No. 91715497, publ. 10/07/1999

13. Patent for the invention of the Russian Federation No. 2110162, publ. 04/27/1993

14. Application for the invention of the Russian Federation No. 95113095, publ. 05/12/1995 g.

15. Patent for the invention of the Russian Federation No. 2266624, publ. December 20, 2005

16. Workstation of a laboratory technician for PCR diagnostics, website http://www.infosib.com.ru.

Claims (14)

1. Mobile medical laboratory for the diagnosis of polymerase chain reaction, characterized in that it is made in the form of at least one movable building containing an entrance sanitary lock compartment, a diagnostic compartment formed by a DNA / RNA extraction zone, a digging area of the reagents for amplification as well as an amplification and detection zone, a medical and medical compartment equipped with a workstation with a monitor, server, router, switch and telemedicine terminal, a patient and reception compartment b and a transport compartment, and equipped with means for ensuring its autonomous functioning, including at least a power supply system, a crew life support system, a communication system with the possibility of providing a video conferencing mode, preferably a satellite communication system based on a VSAT terminal, an on-board local area network, preferably LAN Ethernet, and a unit for determining the position on the ground, preferably the GLONASS system, which is associated with a means of moving through land, and / or water, and / or through air. 2. The mobile medical diagnostic laboratory for polymerase chain reaction according to claim 1, characterized in that the DNA / RNA extraction zone is equipped with at least one microcentrifuge, an automatic dispenser with a stand, a laminar cabinet with bioprotection, a thermostat, a microtube rack and a vacuum aspirator. 3. The mobile medical laboratory for the diagnosis of polymerase chain reaction according to claim 1, characterized in that the digging area of the reagents for amprification is equipped with at least one microcentrifuge, an automatic dispenser with a stand, a laminar cabinet with bioprotection and a support for microtubes. 4. The mobile medical diagnostic laboratory for polymerase chain reaction according to claim 1, characterized in that the amplification and detection zone is equipped with at least two thermal cyclers, an amplifier and a luminescent analyzer. 5. Mobile medical laboratory for the diagnosis of polymerase chain reaction according to claim 1, characterized in that the telemedicine terminal is made in the form of automated workstation diagnostics by the method of polymerase chain reaction. 6. Mobile medical laboratory for the diagnosis of polymerase chain reaction according to claim 1, characterized in that the compartment for patients and taking samples is made in the form of a vestibule. 7. Mobile medical laboratory for the diagnosis of polymerase chain reaction according to claim 1, characterized in that its power supply system is formed by at least one electric generator based on the drive of an internal combustion engine and / or electric generator, and / or solar battery, and / or electrohydrogen generator. 8. The mobile medical laboratory for the diagnosis of polymerase chain reaction according to claim 1, characterized in that the internal combustion engine of the electric generator is equipped with a hopper for storing a stock of fuels and lubricants. 9. Mobile medical diagnostic laboratory by the method of polymerase chain reaction according to claim 1, characterized in that the electric generator is equipped with a rechargeable battery. 10. The mobile medical diagnostic laboratory for polymerase chain reaction according to claim 1, characterized in that the crew’s life support system includes at least a sanitary unit formed by a shower and a dry closet, a ventilation unit, an air conditioning and disinfection unit, a unit heating, a water supply unit with reserves of drinking and industrial water, a fire safety unit and a unit for preventing unauthorized entry into a moving building. 11. The mobile medical laboratory for the diagnosis of polymerase chain reaction according to claim 1, characterized in that it contains a set of medical supplies related to medical care when working with patients, in particular cotton wool and / or bandages, disinfectants, in particular medical alcohol and / or chlorhexidine, and a set of medications that are at least consistent with the level of emergency care requirements. 12. Mobile medical diagnostic laboratory by the method of polymerase chain reaction according to claim 1, characterized in that the moved building contains places for rest and sleep of the crew. 13. The mobile medical laboratory for the diagnosis of polymerase chain reaction according to claim 1, characterized in that a Ku- or Ka-band antenna is used as a satellite communication antenna. 14. The mobile medical laboratory for the diagnosis of polymerase chain reaction according to claim 1, characterized in that as a means of moving by land, use the chassis of a KAMA3-6530 car with a wheel formula of 8 × 8, or the chassis of a KAMA3-43118 car with a wheel formula of 6 × 6 .