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WO2022233430A1 - Cartouche de test - Google Patents

Cartouche de test Download PDF

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Publication number
WO2022233430A1
WO2022233430A1 PCT/EP2021/062154 EP2021062154W WO2022233430A1 WO 2022233430 A1 WO2022233430 A1 WO 2022233430A1 EP 2021062154 W EP2021062154 W EP 2021062154W WO 2022233430 A1 WO2022233430 A1 WO 2022233430A1
Authority
WO
WIPO (PCT)
Prior art keywords
test
test cassette
electronic circuit
protective film
cassette
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2021/062154
Other languages
German (de)
English (en)
Inventor
Achim Heyne
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to PCT/EP2021/062154 priority Critical patent/WO2022233430A1/fr
Priority to EP21725093.5A priority patent/EP4178719A1/fr
Publication of WO2022233430A1 publication Critical patent/WO2022233430A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502715Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84Systems specially adapted for particular applications
    • G01N21/8483Investigating reagent band
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366Apparatus specially adapted for solid-phase testing
    • G01N33/54386Analytical elements
    • G01N33/54387Immunochromatographic test strips
    • G01N33/54388Immunochromatographic test strips based on lateral flow
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14Process control and prevention of errors
    • B01L2200/141Preventing contamination, tampering
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/02Identification, exchange or storage of information
    • B01L2300/025Displaying results or values with integrated means
    • B01L2300/027Digital display, e.g. LCD, LED
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/041Connecting closures to device or container
    • B01L2300/044Connecting closures to device or container pierceable, e.g. films, membranes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/046Function or devices integrated in the closure
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/06Auxiliary integrated devices, integrated components
    • B01L2300/0627Sensor or part of a sensor is integrated
    • B01L2300/0645Electrodes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0809Geometry, shape and general structure rectangular shaped
    • B01L2300/0825Test strips
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00Moving or stopping fluids
    • B01L2400/04Moving fluids with specific forces or mechanical means
    • B01L2400/0403Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406Moving fluids with specific forces or mechanical means specific forces capillary forces
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/005Assays involving biological materials from specific organisms or of a specific nature from viruses
    • G01N2333/08RNA viruses
    • G01N2333/165Coronaviridae, e.g. avian infectious bronchitis virus
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2469/00Immunoassays for the detection of microorganisms
    • G01N2469/10Detection of antigens from microorganism in sample from host

Definitions

  • the invention relates to a test cassette for carrying out a lateral flow test for the qualitative detection of substances with antibodies, comprising a test strip arranged in the test cassette, a sample area arranged on the test strip to which a sample to be tested is applied, a test area arranged on the test strip, arranged to display the test result, an opening in the test cassette, which is arranged above the sample area of the test strip.
  • the virus SARS-CoV-2 colloquially known as coronavirus, is a betacoronavirus similar to the SARS pathogen and is probably of zoonotic origin.
  • the virus was identified as the causative agent of the disease COVID-19 in early 2020.
  • the virus is between 60 and 140 nanometers in size and is usually transmitted in close human contact by droplets and aerosols.
  • COVID-19 a "public health emergency of international concern" on January 30, 2020.
  • COVID-19 was declared a pandemic on March 11, 2020.
  • Rapid antigen tests are being carried out to contain the pandemic. Rapid antigen tests (also referred to as point-of-care tests) can be carried out outside of a laboratory near the patient and faster than the PCR tests (polymerase chain reaction) in 15-30 minutes.
  • PCR tests polymerase chain reaction
  • SARS-CoV-2 rapid antigen tests can play a role in situations where a quick result is important and where people's contagiousness needs to be assessed promptly and on-site.
  • the lateral flow test is a combination of thin-layer chromatography and immunostaining. Because they require less equipment than other immunoassays, lateral flow tests are often used in the form of test strips.
  • the sample to be tested is applied to the sample area on the porous paper or sintered polymer test strip. After the addition of the eluent, the sample begins to spread across the test strip due to capillary forces (thin-layer chromatography). The sample migrates with the liquid to an area where dried salt and carbohydrate immunoconjugates are located. The liquid will dissolve the immunoconjugate, allowing it to bind to the molecule to be detected (the antigen) in the sample, if present.
  • the liquid continues to migrate into the capillary area, where an antibody has been immobilized in a small area, which binds to another site on the surface of the molecule to be detected, thereby binding and enriching it in this area while the liquid continues to migrate. Due to the enrichment of the molecule to be detected, the bound Depending on the immunoconjugate, e.g. B. a stain, a fluorescent stain or a magnetic label. Usually there is a second test strip that is used as a negative control with control liquid and excludes false positive results.
  • Rapid antigen tests can be made dependent on this in order to detect corona infections better and faster and thus interrupt chains of infection.
  • BfArM Federal Institute for Drugs and Medical Devices granted the first self-tests for the detection of the coronavirus special approval (cf. https://www .bfarm.de/DE/Medizin employment/Antigentests/_node.ht ml - retrieved on April 30, 2021).
  • the negative test result of a quick test is currently valid for a maximum of 24 hours.
  • a disadvantage of the known self-tests for the detection of the corona virus is that the up-to-dateness of the test result cannot be checked. Only if the rapid test is issued by a third party with a certificate can the test be checked for being up-to-date.
  • the invention is based on the object of creating a test cassette for carrying out a lateral flow test for the qualitative detection of substances with antibodies, in particular for the detection of the corona virus, in which the up-to-dateness of the test result of the self-test can be checked without any problems is.
  • test cassette for carrying out a lateral flow test having the features of claim 1.
  • the solution is based on the idea that the sample area, which is accessible via an opening in the test cassette and to which the sample to be tested is applied, is covered by a protective film that must be removed to use the test cassette as part of the self-test, and at the same time a electronic circuit activated, which helps to determine the age of the test performed.
  • the task is solved with a test cassette for carrying out a lateral flow test for the qualitative detection of substances with antibodies of the type mentioned at the outset by an electronic circuit comprising a timer arranged inside the test cassette and at least one display arranged on the test cassette, a power supply for the electronic circuit comprising a battery arranged within the test cassette and a spring contact which is set up to establish an electrically conductive connection between one of the two poles of the battery and the electronic circuit, the electronic circuit being set up in such a way that each display according to Establishing the electrically conductive connection is activated for a defined period of time and a detachable protective film arranged on the test cassette, which covers the sample area of the test strip and at the same time separates the electrically conductive connection between the spring contact and the pole of the battery, whereby the protective film detaches the sample area released and at the same time the electrically conductive connection between the pole of the battery and the spring contact is made.
  • the protective film is preferably designed as a strip and can additionally be provided with an adhesive layer on one side.
  • the sample area is released and the electrical connection between the battery terminal and the electronic circuit is immediately established.
  • Establishing the electrically conductive connection activates at least one display, in particular a light-emitting diode, for a defined period of time.
  • the defined period corresponds, for example, to the intended period of validity of a negative test result.
  • the strip-shaped protective film can preferably only be detached by a pulling movement.
  • the protective film extends outwards for this purpose, starting from the spring contact between the opening and the sample area, through an outlet opening in the test cassette, with the protective film having a section located outside of the test cassette as a pulling aid for detaching the protective film .
  • the opening above the sample area is preferably arranged in a trough-shaped depression in the test cassette.
  • test cassette is placed horizontally on a surface.
  • the sample is added from a sample tube with a dropper tip attached, about 3 drops of the sample for current antigen rapid tests.
  • a waiting period then begins until the test result can be read in the test area.
  • the waiting time for current quick tests is about 15 minutes.
  • the end of the waiting time can be indicated by a display on the electronic circuit or an operating mode of one of the electrical Ads are signaled, for example by a flashing or a continuous mode of one of the displays.
  • the same display in a different operating mode or another display signals that the protective film has been removed from the test cassette and a test has been carried out.
  • the display signaling the activation and use of the test cassette is only activated by the electronic circuit for a defined period of time, for example 24 hours. This is the duration that, according to the current legal situation, coincides with the expiry of the validity period of a negative test result of a rapid antigen test for the detection of the coronavirus.
  • the electronic circuit is preferably set up in such a way that each light-emitting diode is operated in a flashing mode during the defined period of time. Operation in continuous mode is preferably only provided for a short time of, for example, one minute immediately after the protective film has been pulled off, in order to signal to the user that the sample to be tested must be placed on the sample area.
  • the electronic circuit of the test cassette is set up in such a way that a plurality of light-emitting diodes, for example three light-emitting diodes, are activated in a cascaded manner for a defined period of time after the power supply is switched on for the first time.
  • the cascaded operation of the light-emitting diodes makes it possible to signal different periods of validity of a negative test result with one and the same test cassette.
  • a first green light-emitting diode goes out after 24 hours, for example, a second yellow light-emitting diode goes out after 48 hours, for example, and a third red light-emitting diode finally goes out after 72 hours.
  • the test cassette is able to signal different periods of validity of the test result with simple display means.
  • the test strip arranged in the test cassette is set up in particular for carrying out a SARS-CoV-2 antigen rapid test.
  • Such test strips usually have a control area (C) in addition to the test area (T). If the test is negative, only a single colored line will appear in the control area (C) while no visible colored line will appear in the test area (T). If no control lines appear at the time of reading, the test is invalid.
  • test cassette according to the invention for carrying out a lateral flow test is explained in more detail below with reference to the drawings.
  • Figure 1 is a schematic representation of a test cassette according to the invention in plan and
  • FIG. 2 shows a schematic representation of an electronic circuit of the test cassette according to the invention.
  • FIG. 1 shows a test cassette (1) for carrying out a lateral flow test, here a SARS-CoV-2 antigen rapid test.
  • the test cassette (1) usually consists of a bottom part and a cover.
  • a test strip (2) is attached inside the test cassette (1).
  • the test strip (2) consists of porous paper and has a sample area (3) onto which a sample to be tested is applied through an opening (4) in the cover of the test cassette (1).
  • the sample containing an eluent spreads across the test strip (2) due to capillary forces.
  • the sample migrates along the test strip (2) with the liquid and signals a positive test result in a test area (5) and the validity of the test, i.e. the functionality of the test cassette (1), in a control area (6) that may also be present.
  • a battery (7) in particular in the form of a so-called button cell, is arranged inside the test cassette (1).
  • a button cell is a small, round cross-section electrochemical cell with an overall height less than the overall diameter and a supply voltage im Provides low-voltage range.
  • the battery (7) is part of a voltage supply (13) arranged inside the test cassette (1) for an electronic circuit (9) arranged on a circuit board (8); the circuit (9) comprises an electronic chip with a timer (10) and three displays (11) designed as light-emitting diodes (11.1,11.2,11.3), each of which has a series resistor (12) on the timer (10) and the voltage supply ( 13) are connected.
  • the power supply (13) of the electronic circuit (9) includes a holder for the battery (7), a back-up capacitor (14) to stabilize the supply voltage and a spring contact (15) used to create an electrically conductive connection between the positive pole (16) the battery (7) and the electronic circuit (9) is set up.
  • the negative pole (17) of the battery (7) is connected to ground (18); in addition, pin 2 of the chip with the timer (10) is connected to ground (18).
  • the spring contact (15) is designed, for example, as a spring clip that rests on the face of the button cell that forms the positive pole (16), while the opposite face that forms the negative pole rests on a corresponding ground contact of the circuit board (8) with the electronic circuit (9). rests.
  • a protective film (19) is detachably attached to the test cassette (1).
  • the protective film (19) consists of an electrically insulating material, for example a plastic film, and is in the form of a strip, as can be seen in particular from the plan view in FIG.
  • the protective film (19) is arranged inside the test cassette in such a way that it covers the sample area (3) of the test strip
  • test strip (2) i.e. the sample area (3) of the test strip (2) is only accessible after removing the protective film (19) through the opening (4) in the cover of the test cassette (1).
  • the protective film (19) separates the electrical connection between the spring contact (15) and the positive pole (16) of the battery (7).
  • the protective film (19) lies on the surface of the battery (7) forming the positive pole (16) and is fixed by the spring contact (15).
  • the protective film (19) is placed between the opening (4) and the sample area, starting from the spring contact (15) and the positive pole (16) of the battery (7).
  • the protective film has a section that serves as a pulling aid (21) for detaching the protective film (19).
  • the above-described guidance of the protective film (19) inside the test cassette (1) means that the protective film (19) can only be detached by a pulling movement using the pulling aid (21).
  • the pulling movement ensures that when the sample area (3) on the test strip (2) is released, the voltage supply (13) of the electronic circuit (9) is also activated.
  • the activated power supply (13) starts the timer (10) and activates the LEDs (11.1, 11.2, 11.3) in a cascaded manner:
  • the green light-emitting diode (11.1) After removing the protective film (19), the green light-emitting diode (11.1) first flashes for 24 hours activated. After 24 hours, the green LED (11.1) goes out and the yellow LED (11.2) is activated in a flashing mode for another 24 hours. After a total of 48 hours, the second LED (11.2) also goes out and the third, red LED is activated in a flashing mode for a further period of 24 hours.
  • the timer (10) can also be configured in such a way that after the power supply (13) has been activated for the first time, one of the light-emitting diodes, for example the red light-emitting diode (11.3) lights up for one minute to indicate to the user that the sample has reached the sample area (3 ) is to be abandoned. After the minute has elapsed, another light-emitting diode, e.g.
  • test cassette (1) is suitable for carrying out any lateral flow test and not just for carrying out a SARS-CoV-2 antigen rapid test

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Engineering & Computer Science (AREA)
  • Clinical Laboratory Science (AREA)
  • Urology & Nephrology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Dispersion Chemistry (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)

Abstract

L'invention concerne une cartouche de test pour effectuer un test par écoulement latéral afin de détecter qualitativement des substances au moyen d'anticorps, plus particulièrement pour la détection du coronavirus; la valeur d'actualité du résultat du test de l'auto-test peut être vérifiée sans problème. La région d'échantillon, qui est accessible par une ouverture dans la cartouche de test et sur laquelle l'échantillon à analyser est placé, est recouverte d'un film protecteur, qui doit nécessairement être retiré afin de mettre la cartouche de test en utilisation dans l'auto-test et qui, en même temps, active un circuit électronique, au moyen duquel l'ancienneté du test réalisé peut être déterminée.
PCT/EP2021/062154 2021-05-07 2021-05-07 Cartouche de test Ceased WO2022233430A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
PCT/EP2021/062154 WO2022233430A1 (fr) 2021-05-07 2021-05-07 Cartouche de test
EP21725093.5A EP4178719A1 (fr) 2021-05-07 2021-05-07 Cartouche de test

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2021/062154 WO2022233430A1 (fr) 2021-05-07 2021-05-07 Cartouche de test

Publications (1)

Publication Number Publication Date
WO2022233430A1 true WO2022233430A1 (fr) 2022-11-10

Family

ID=75904916

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2021/062154 Ceased WO2022233430A1 (fr) 2021-05-07 2021-05-07 Cartouche de test

Country Status (2)

Country Link
EP (1) EP4178719A1 (fr)
WO (1) WO2022233430A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117533581A (zh) * 2023-11-24 2024-02-09 晶科能源股份有限公司 自动上料系统及自动上料系统的上料方法

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0937249A1 (fr) * 1996-10-30 1999-08-25 Mercury Diagnostics, Inc. Systeme d'essai synchronise de l'analysat
US20120282636A1 (en) * 2011-05-04 2012-11-08 Pop Test, Llc Diagnostic Device
GB2569539A (en) * 2017-12-19 2019-06-26 Sumitomo Chemical Co Assay device
EP3569716A1 (fr) * 2018-05-14 2019-11-20 Consejo Superior De Investigaciones Científicas (CSIC) Procédé de contrôle de synchronisation d'événements dans un dispositif microfluidique et dispositif microfluidique de temporisateur

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0937249A1 (fr) * 1996-10-30 1999-08-25 Mercury Diagnostics, Inc. Systeme d'essai synchronise de l'analysat
US20120282636A1 (en) * 2011-05-04 2012-11-08 Pop Test, Llc Diagnostic Device
GB2569539A (en) * 2017-12-19 2019-06-26 Sumitomo Chemical Co Assay device
EP3569716A1 (fr) * 2018-05-14 2019-11-20 Consejo Superior De Investigaciones Científicas (CSIC) Procédé de contrôle de synchronisation d'événements dans un dispositif microfluidique et dispositif microfluidique de temporisateur

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117533581A (zh) * 2023-11-24 2024-02-09 晶科能源股份有限公司 自动上料系统及自动上料系统的上料方法

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