Portable analyzer

Abstract

The portable analyzer, especially for conducting amplification reactions of biological samples (107) with the measurement of fluorescence, comprising a casing (134) and an top lid (112) and at least one reaction socket (108) covered from the inside with a silicone layer (117), made of heat conducting material (119), with a bifilar (118) winding made of wire made of electricity conductive material, covered with a layer of enamel (120), the said analyzer is of layered construction, comprising the layered PCB boards constituting the controlling unit (103), the LED unit with the spectral analyzer (102) and the heating unit (101) for the reaction sockets (108 ), the units connected by pin connectors (104, 105), and reaction sockets (108) are arranged in the space between the heating unit (101) and LED unit with the spectral analyzer (102), and a space between heating unit (101) and LED unit (102) constitutes ventilation duct (109) terminated with fan (100), and a device comprises at least one socket (106) dedicated for conducting nucleic acids isolation process or incubation arranged in a space between heating unit (101) and LED unit with the spectral analyzer (102) and device comprises optic fiber heads (121) between the LED unit (102) and the reaction socket (108).

Description

[0001] Portable analyzer

[0002] Field of invention

[0003] The invention relates to a field of portable analyzers of biological samples. In particular, the invention provides technical parameters over shorter measurement times and at much lower production costs in comparison to competitive devices.

[0004] State of the art.

[0005] Due to dynamic development of biotechnology and increasing demands in the research area of molecular diagnostics and genetic testing, there is an urgent need for innovative constructions of devices suitable for performing amplification reactions. New technologies should be characterized by greater efficiency, enabling faster and more effective replication of genetic material, which is crucial in circumstances when quick reaction is needed, such as epidemies. In addition, accuracy is of comparable importance, especially when detecting pathogens at low concentrations or genetic mutations, such situations require apparatuses of increased accuracy and minimized risk of measurement errors.

[0006] Broadening a scope of possible applications of said technology to areas such as food safety tests (including water) or procedures applied in providing biosecurity of livestock, is a key factor as well. In particular, such devices may be useful in veterinary clinics, as aiding tools in treatment of companion animals, which is of special value when facing growing economic costs of phenomenon of antimicrobial resistance (AMR). Availability of simple and fast devices plays a key role in the abovementioned areas, enabling rapid and precise diagnoses or therapeutic activities, even in field or environmental conditions with limited access to advanced laboratory infrastructure.

[0007] Examples of portable devices dedicated for analyzing biological samples have already been known from the state of the art.

[0008] The Polish patent document PL240709 discloses the cooling and heating unit capable of performing simultaneous fluorescence measurements, to be used in devices for chain amplification reactions of biological samples with DNA. The invention is applicable for rapid amplification reactions.

[0009] CN204356338U discloses a unit comprising a mounting plate, excitation system, reaction tube and a camera. The mounting plate is arranged horizontally and the excitation system comprises the optical mounting socket, the light source and light guiding column. The light source and the optical mounting socket are connected with the plate and the light guiding column. The disclosed device is characterized by high degree of sophistication in terms of the number of elements which directly affects its cost and may elevate the effective costs of performed PCR analyses.

[0010] The document EP2149610B1 discloses portable device or microdevice designed for detecting genetic material in the biological sample by PCR technique. The aim of the invention was to improve portability, precision and effectivity of the device for PCR in comparison to laboratory analysis. The presented solution has no layered construction and comprises only one PCB board, arranged above the reaction chamber.

[0011] The portable analyzer, according to the invention has a layered construction, comprising layered PCB boards, which taken together constitute control unit, the LED unit, comprising spectral analyzer, the heating unit for reaction sockets and the socket for separation process, and all layers are joined by pin connectors. Due to such a construction the device is small and is convenient as a portable tool to carry out all preparatory processes and amplification itself. Both compact design and the comprehensiveness of application is an advantage over other analyzers previously disclosed in the prior art.

[0012] Disclosure of the invention

[0013] The subject of the invention is a portable analyzer, especially for carrying out amplification reactions of biological samples with fluorescence measurements, comprising casing and a top lid, and at least one reaction socket covered from the inside with silicone layer, made of heat conducting material, with a bifilar winding made of wire made of electricity conductive material, covered with a layer of enamel. The analyzer has a layered construction, comprising layered PCB boards which taken together constitute control unit, the LED unit comprising spectral analyzer, the heating unit for reaction sockets and all units are joined by pin connectors, and with the reaction sockets placed in the space between the heating unit and the LED unit comprising spectral analyzer, and the space between the heating unit and the LED unit constitutes the ventilation duct terminated with a fan, and the device comprises at least one socket dedicated for conducting nucleic acids isolation process or incubation, located in the space between the heating unit and the LED unit comprising spectral analyzer, and comprises optic fiber heads between the LED unit and the reaction socket.

[0014] Preferably, the top lid comprises the heating elements in the form of sleeves made of heat conducting material and the movable heating element, placed in the casing of the heating elements, and the spring between the top lid and the casing of the heating elements.

[0015] Preferably, the electricity conducting material and the heat conducting material is copper.

[0016] Preferably, the analyzer is powered by 230 V AC or by 12 V DC. Preferably, the upper part of the optic fiber head comprises a flange surrounding the lower part of the reaction tube protruding from the reaction socket.

[0017] Preferably, the heating unit comprises the endmill which limits the heat flow from the reaction socket to the heating unit.

[0018] Preferably, the top lid comprises the permanent magnet which interacts with the Hall sensor mounted on the heating unit.

[0019] Preferably, the top lid comprises the permanent magnet which interacts with the second permanent magnet fixed in the casing of the analyzer.

[0020] Preferably, the permanent magnets are neodymium magnets.

[0021] Preferably, the reaction sockets are connected to the heating unit by soldering the socket's heat conducting material to the edge of the hole in the heating unit.

[0022] Preferably, there is a sealing between the top lid and the reaction socket, the said sealing may be in form of microrubber or polyethylene tape.

[0023] Preferably, the parameters of analysis may be defined via the user interface in the external device such as computer, laptop, smartphone trough connection with the analyzer by cable connection or by wireless connection.

[0024] In another aspect, the invention relates to a use of portable analyzer in amplification reactions comprising reactions conducted using PCR, qPCR, RT-PCR, RT-qPCR and LAMP techniques.

[0025] The device according to the invention enables performing screening tests directly at the place of occurrence of the tested pathogen or to conduct other type of genetic diagnostic testing using the nucleic acids amplification methods, both in non-laboratory and laboratory environments. In addition, the device according to the invention ensures implementation of all preparatory processes such as: incubation, isolation of nucleic acids and amplification process itself. The layered construction of the device is a unique solution, which is not known from other analyzers. Moreover, the device achieves the technical parameters in shorter processing times and at much lower costs of production in comparison to competitive solutions.

[0026] Index of Figures:

[0027] The subject of the invention in embodiments is illustrated in the drawing in which:

[0028] Fig. 1 illustrates the internal construction of the analyzer;

[0029] Fig. 2 shows the cross-section through the top lid of the analyzer; Fig. 3 shows the cross-section through the reaction socket;

[0030] Fig. 4 shows the cross-section through the optic fiber head;

[0031] Fig. 5 shows the cross-section through the casing of the analyzer, with the depiction of the heating unit;

[0032] Fig. 6 shows the cross-section through the top lid mounted in the casing of the analyzer;

[0033] Examples:

[0034] According to the example, the portable analyzer, especially for conducting the amplification reactions of biological samples 107 with the measurement of the fluorescence comprises at least one reaction socket 108 covered from the inside with the silicone layer 1 17, made of heat conducting material 119, with bifilar winding 1 18 made of wire made of electricity conducting material in enamel 120. The device according to the invention is depicted on Fig. 1 , the said device is of layered construction, comprising the layered PCB boards constituting the controlling unit 103, the LED unit with the spectral analyzer 102 and the heating unit 101 for the reaction sockets 108 and the isolation process socket 106, connected by the pin connectors 104, 105. The reaction sockets 108 are located in the space between the heating unit 101 and the LED unit with the spectral analyzer 102, formed as a ventilation duct 109 terminated with the fan 100. In addition, the device comprises at least one socket dedicated for conducting nucleic acids isolation process or incubation 106 and the optic fiber heads 121 between the LED unit 102 and the reaction socket 108.

[0035] The portability of the device is provided by the small size of the analyzer, i.e. 8 cm x 1 1 cm x 13 cm thanks to use of innovative heating and cooling system for the reaction tubes in the heating sockets, elimination of connection by tapes and cables due to layered construction of the analyzer. The weight of the analyzer (without the accumulator cells) does not exceed 0,5 kg, and the demand for the energy (electric power) remains within 15-36 W. The special feature of the said analyzer is its layered construction (Fig. 1). Moreover, the device is equipped with the top lid 1 12 connected with the heating unit 101 by an electric tape (Fig. 2).

[0036] Fig. 2 depicts the top lid 1 12 comprising the heating elements in form of sleeves 1 13 made of heat conducting material and the heating element - plate 114. Plate 1 14 transfers the heat through heat conducting glue on the sleeve 1 13. The element 1 1 1 is a casing for elements 1 13 and 1 14, and such assembly is located in the top lid 1 12. What is more, there is a spring 1 10 in the space between the top lid 1 12 and the element 1 1 1 , which tightens the sleeves to the tested samples. The top lid 1 12 comprises the heating element 1 14 arranged movably which ensures that it is tightened with constant force to the samples containing the tested biological material, what is accomplished by mounting the spring 1 10 between the top lid 1 12 and a casing 1 11 oF the heating elements with the PCB board comprising the heating elements in form of sleeves 1 13 made of heat conducting material, and the heating plate 1 1 . The process of heating by the top lid, which means maintaining the set temperature value, is controlled by the controlling unit 103. The connection between the controlling unit 103 and the heating unit 101 is realized by tape connection. The sleeves 1 13 made of material of good heat conducting properties were mounted in order to ensure maintaining constant temperature at the upper area of the samples containing biological material 107 in such a way that they surround the upper parts of the samples, that protrude from the reaction sockets 108 are located. The attachment of the heating plate 1 14 to the top lid 1 12 is insulated by use of technical cork 1 15. The assembly was mounted into the element 1 1 1 in the lid 1 12, and fixed from the bottom by the mounting frame 1 16 (Fig. 2).

[0037] Fig. 3 shows the arrangement of the reaction sockets 108, ensuring minimization the temperature losses and provide good heat transfer coupling from the socket to the tested sample.

[0038] The heat conducting material and the electricity conducting material is copper, yet any other material capable of conducting heat or electricity may also be applied. Other metals, alloys or materials of good heat and electricity conducting properties may be used depending on specific needs. To satisfy the requirements, the suitable material shall be chosen taking into account its properties such as conductivity, endurance, price and availability.

[0039] The analyzer is a portable device that enables performing stationary diagnostic tests in the places where 230 V AC power supply is available or mobile diagnostic tests where the device is powered by 12 V DC. The reaction parameters are defined by the dedicated software with the user interface on an external device such as computer, laptop or smartphone connected via USB port or by wireless WiFi or Bluetooth connection.

[0040] The device may be used to examine biological material using techniques based on nucleic acids amplification methods, comprising methods of reversed RNA transcription such as PCR, qPCR, RT-PCR, LAMP and other molecular techniques involving modification or reproduction of part of RNA, DNA or cDNA. The said analyzer is also suitable for performing any other process from the area of molecular biology, for which incubation or complex temperature protocols are required, also for conducting independent isolation reaction of genetic material. The reaction sockets enable detection up to four different loci in one socket. The use of defined testing panels for identification specified parts of genome or transcriptome loci) allows up to four findings (detections) of different loci to be performed with a single test.

[0041] Optic fiber heads 121 (Fig. 4) ensure light transmission via optic fiber waveguides 122, 127 between the wavelength-specific excitation elements LEDs 125 and the reaction tube containing biological material 107. Moreover, the optic fiber heads ensure transmission of excitation fluorescence light from the reaction tube to the sensor 123 (spectrometer sensor) which enables readout of the fluorescence spectral answer to the sample excitation. The upper part of the optic fiber head comprises the flange 126 which surrounds the lower part of the reaction tube 107 protruding from the reaction socket 108. The use of the flange 126 minimizes cooling of the uncovered part of the reaction tube by the air passing through the ventilation duct 109. The element 124, that is the bandpass filter, lets through the light of specified wavelength values from the LED diode 125 to the tested sample. Such type of filters are in common use.

[0042] In the heating unit 101 , around the mounting hole of the reaction socket 108, there is the endmill 130, leaving only minimal connection between the mounting hole and the rest of the heating unit 101 to ensure minimization of the heat flow from the reaction socket to the unit (thermal separation).

[0043] In order to ensure control of the processes performed in the described analyzer, the mechanism controlling the closing of the top lid 112 with the heating elements tightening the reaction tubes with the biological material 107 was introduced. Opening the top lid 1 12 while the examining process is ongoing will result in the change of the temperature of the tested sample and disruption of detection of the analyzed locus. To prevent such a situation there is a permanent magnet 129, depicted on Fig. 5, mounted on a top lid with a heating elements, which interacts with the Hall sensor 128, mounted on the heating unit 101 , while the top lid is in closed position. Opening the top lid interrupts the interaction between the magnet and the sensor, what is detected by the analyzer controlling unit 103 and results in cease of operation of the analyzer.

[0044] In the lower part of the top lid 1 12 there is the heating element 1 14. The main purpose of the top lid is to tighten and to provide heat from the upper side to the examined samples containing the biological material 107 in the reaction socket. The top lid is equipped with strong permanent magnet 132, which interacts with the second magnet 133 arranged in the casing 134 of the analyzer (Fig. 6). Both magnets face each other with the opposite poles, what guarantees the firm closing of the top lid 1 12. The top lid is thus prevented from accidental opening during the ongoing experiments since the opening requires use of quite amount of force. Advantageously, the permanent magnets 132 and 133 are the neodymium magnets.

[0045] Some part of the junction between the reaction sockets 108 and the holes in the casing 134 is filled with polyethylene tape or microrubber tape to provide sealing 131 between the ventilation duct 109 and the samples with the biological material 107 (Fig. 6). The airflow may cause local cooling of the examined samples, resulting in precipitation of condensate on the reaction tubes and disruption of the amplification process due to false fluorescence measurement readouts.

[0046] All details of the specified reaction parameters such as: temperature, duration times of the processes, the way of excitation by LED diodes, the number of cycles, etc. are determined via the user interface - software implemented on the external device such as computer, laptop, smartphone linked to the analyzer through the cable with USB port connection or by wireless WiFi or Bluetooth connection. The specified parameters are saved by the analyzer and the further process is performed automatically and the results collected after each reaction cycle are transmitted to the computer or to the device like smartphone, to be processed by algorithm which decides if the locus sought in the undergoing reaction was detected or not.

[0047] 100 fan

[0048] 101 heating unit

[0049] 102 LED unit with spectral analyzer

[0050] 103 controlling unit

[0051] 104 pin connector

[0052] 105 pin connector

[0053] 106 isolation process socket

[0054] 107 sample with the examined material

[0055] 108 reaction socket

[0056] 109 ventilation duct

[0057] 1 10 spring

[0058] 1 1 1 casing for heating elements 1 13 and 1 14

[0059] 1 12 top lid 113 heating element in form of sleeve

[0060] 114 mobile heating element - plate

[0061] 115 technical cork

[0062] 116 mounting frame

[0063] 117 silicone layer

[0064] 118 bifilar winding

[0065] 119 the layer of heat conducting material

[0066] 120 enamel layer

[0067] 121 optic fiber heads

[0068] 122 optic fiber waveguide

[0069] 123 sensor

[0070] 124 bandpass filter

[0071] 125 LED diode

[0072] 126 flange

[0073] 127 optic fiber waveguide

[0074] 128 Hall sensor

[0075] 129 permanent magnet interacting with the Hall sensor

[0076] 130 endmill

[0077] 131 sealing

[0078] 132 permanent magnet on the top lid

[0079] 133 permanent magnet on the casing

[0080] 134 casing

Claims

AMENDED CLAIMS received by the International Bureau on 1 October 2025 (01.10.2025)1 . A portable analyzer, especially for conducting amplification reactions of biological samples (107) with measurement of fluorescence, comprising a casing (134) a top lid (1 12) and at least one reaction socket (108) covered from the inside with a silicone layer (1 17), made of heat conducting material (1 19), with a bifilar winding (1 18) made of wire made of electricity conductive material, covered with a layer of enamel (120), characterized in that the portable analyzer is of a layered construction, comprising a layered PCB boards, wherein the PCB boards are: a controlling unit (103), an LED unit with a spectral analyzer (102), and a heating unit (101) for reaction sockets (108), which are connected by pin connectors (104, 105), and the reaction sockets (108) are arranged in a space between the heating unit (101) and LED unit with a spectral analyzer (102), and a space between heating unit (101) and LED unit constitutes ventilation duct (109) terminated with fan (100), and the portable analyzer comprises at least one socket (106) for conducting nucleic acids isolation process or incubation arranged in a space between heating unit (101) and LED unit with a spectral analyzer (102), and comprises an optic fiber heads (121) between the LED unit with a spectral analyzer (102) and the reaction socket (108).

2. The portable analyzer according to claim 1 , characterized in that the top lid (112) comprises a heating elements in a form of sleeves (1 13) made of heat conducting material and a mobile heating element (1 14) arranged in the casing of the heating elements, and a spring (110) between the top lid (1 12) and a casing (11 1) of the heating elements.

3. The portable analyzer according to claim 1 or 2 characterized in that the heat conducting material and the electricity conducting material is copper.

4. The portable analyzer according to any of claims 1 -3 characterized in that it is powered by 230 V AC or by 12 V DC.

5. The portable analyzer according to any of claims 1 -4 characterized in that the upper part of the optic fiber head (121) comprises a flange (126) surrounding a lower part of the reaction tube protruding from the reaction socket (108).

6. The portable analyzer according to any of claims 1 -5, characterized in that the heating unit (101) comprises an endmill (130) which limits the heat flow from the reaction socket (108) to the heating unit (101).

7. The portable analyzer according to any of claims 1 -6, characterized in that the top lid (112) comprises a permanent magnet (129) which interacts with a Hall sensor (128) mounted on the heating unit (101).

8. The portable analyzer according to any of claims 1 -7, characterized in that the top lid (112) comprises a permanent magnet (132) which interacts with a second permanent magnet (133) fixed in the analyzer casing (134).

9. The portable analyzer according to claim 8, characterized in that the permanent magnets (132, 133) are the neodymium magnets.

10. The portable analyzer according to any of claims 1 -9, characterized in that the reaction sockets (108) are connected to the heating unit (101) by soldering the heat conducting material (119) of the reaction socket (108) to the edge of the hole in the heating unit (101).1 1. The portable analyzer according to any of claims 1 -10, characterized in that there is a sealing (131) between top lid (1 12) and the reaction socket (108), the said sealing can be made of microrubber or polyethylene tape.

12. The portable analyzer according to any of claims 1 -1 1 , characterized in that the parameters of analysis are defined via the user interface in the external device such as computer, laptop, smartphone with established connection with the analyzer by cable connection or by wireless connection.

13. Use of the portable analyzer according to any of claims 1 -12 in amplification reactions comprising reactions conducted using PCR, qPCR, RT-PCR, RT-qPCR and LAMP techniques.

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