WO2023216638A1 - 一种用于检测凝血项目的检测装置及试剂卡 - Google Patents

一种用于检测凝血项目的检测装置及试剂卡 Download PDF

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Publication number
WO2023216638A1
WO2023216638A1 PCT/CN2022/144438 CN2022144438W WO2023216638A1 WO 2023216638 A1 WO2023216638 A1 WO 2023216638A1 CN 2022144438 W CN2022144438 W CN 2022144438W WO 2023216638 A1 WO2023216638 A1 WO 2023216638A1
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WO
WIPO (PCT)
Prior art keywords
detection
reagent
module
reagent card
card
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Application number
PCT/CN2022/144438
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English (en)
French (fr)
Inventor
肖华
梁国绿
张志国
胡彦勇
Original Assignee
深圳市帝迈生物技术有限公司
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Application filed by 深圳市帝迈生物技术有限公司 filed Critical 深圳市帝迈生物技术有限公司
Publication of WO2023216638A1 publication Critical patent/WO2023216638A1/zh

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Classifications

    • 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
    • G01N33/52Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements

Definitions

  • the present application relates to the technical field of medical devices, and in particular to a detection device and reagent card for detecting coagulation items.
  • the existing detection device for detecting coagulation items is used to detect the coagulation ability of samples, including a sample storage module and a reagent storage module.
  • the sample storage module is used to store multiple test tubes, and the reagent storage module stores multiple reagent bottles.
  • the bottle is used to load a large amount of reagents, which can meet the use of dozens of detection samples and is suitable for scenarios with large sample volumes. In scenarios where the sample volume is small (for example, there are only a few test samples), reagent bottles with a shelf life will be wasted because they cannot be used up after being opened. Therefore, the existing detection device has the problem that it cannot be used well for single-person sample detection.
  • the present application provides a detection device for detecting coagulation items, including: a reagent storage module, including a single-person reagent storage module, and the single-person reagent storage module includes at least one reagent card storage channel, To store a reagent card, wherein the reagent card includes at least one reagent storage position to store a single-person test reagent to perform a single-person coagulation test; a distribution module for injecting the collected sample into the test cup, and The single-portion detection reagent in the reagent card is injected into the detection cup; an incubation detection module is used to incubate the sample in the detection cup and detect the sample in the detection cup to obtain Coagulation test results.
  • a reagent storage module including a single-person reagent storage module, and the single-person reagent storage module includes at least one reagent card storage channel, To store a reagent card, wherein the reagent card includes at least one reagent storage position to store a single-
  • the sample storage module is used to store the test tubes.
  • the distribution module is used to inject the samples from the test tubes into the detection cup.
  • the scanning module is used to scan the identification information of the test tubes so that the detection device will The identification information is bound to the coagulation test results.
  • it further includes a detection cup storage module for storing the detection cup, a distribution module for injecting the collected sample into the detection cup in the detection cup storage module, and injecting the single-person detection reagent in the reagent card into the detection cup. Test cup in the cup storage module.
  • a grabbing module is further included, and the grabbing module is used to move the detection cup from the detection cup storage module to the incubation detection module.
  • the reagent storage module includes a multi-part reagent storage module, the multi-part reagent storage module is used to store reagent bottles to perform multi-part coagulation testing, and the distribution module converts the reagent bottles into The detection reagent or the single-portion detection reagent in the reagent card is injected into the detection cup.
  • the reagent card includes a first reagent card, and the first reagent card only includes at least one reagent storage position for storing single-use detection reagents; at least one reagent card storage channel includes a first reagent card storage channel for storing First reagent card.
  • the reagent card includes a second reagent card.
  • the second reagent card only includes at least one reagent storage position and at least one detection position.
  • the reagent storage position is used to store single-use detection reagents, and the detection position is used as a detection cup; distribution The module is used to inject the sample into the detection position, and inject the detection reagent in the reagent bottle or the single-use detection reagent in the reagent card into the detection position; at least one reagent card storage channel includes a second reagent card storage channel for storage Second reagent card.
  • the reagent card includes a third reagent card.
  • the third reagent card includes at least one reagent storage position and a sample storage position.
  • the reagent storage position is used to store single-use detection reagents, and the sample storage position is used to store samples; at least one reagent
  • the card storage channel includes a third reagent card storage channel, which is used to store the third reagent card.
  • the reagent card includes a fourth reagent card.
  • the fourth reagent card only includes at least one reagent storage position, at least one detection position and a sample storage position.
  • the reagent storage position is used to store single-person detection reagents, and the sample storage position is used to Store samples, and the detection position is used as a detection cup;
  • the distribution module is used to inject samples into the detection position, and inject detection reagents in reagent bottles or single-use detection reagents in reagent cards into the detection position; at least one reagent card is stored
  • the channel includes a fourth reagent card storage channel for storing the fourth reagent card.
  • the incubation detection module includes a first incubation detection channel, when the first reagent card storage channel stores the first reagent card or the third reagent card storage channel stores the third reagent card to perform a single-person coagulation test, or detect
  • the distribution module injects the sample and the single-person detection reagent into the detection cup respectively; or, the distribution module injects the sample and the detection reagent in the reagent bottle into the detection cup respectively, and the detection cup is transferred to The first incubation detection channel.
  • the incubation detection module includes a second incubation detection channel, and the second incubation detection channel is set correspondingly to the second reagent card storage channel and/or the fourth reagent card storage channel.
  • the second reagent card is inserted into the second reagent card
  • the storage channel or the fourth reagent card is placed in the fourth reagent card storage channel
  • at least one detection position in the second reagent card or the fourth reagent card is placed in the second incubation detection channel, so that the at least one detection position is used respectively.
  • the distribution module injects the sample and the single-use detection reagent into the detection position respectively; or the distribution module injects the sample and the detection reagent in the reagent bottle into the detection position respectively.
  • the first incubation detection channel is an optical detection channel.
  • the optical detection channel includes an optical detection module
  • the optical detection module includes a light source generator and a light detector
  • the light source generator is used to emit a light beam
  • the light beam irradiates the sample to be tested in the detection cup.
  • Scattered light or transmitted light is generated
  • the photodetector is used to detect the scattered light or transmitted light, and convert the scattered light or transmitted light into an electrical signal to obtain the detection result.
  • the first incubation detection channel is a magnetic bead detection channel.
  • the magnetic bead detection channel includes a magnetic bead detection module, the magnetic bead detection module includes an alternating coil and a detection coil, and a groove is provided in the detection cup, so that the magnetic beads can be placed in the groove.
  • the alternating coil is used to drive the magnetic bead to roll
  • the detection coil is arranged in a plane perpendicular to the alternating coil to detect the magnetic field produced by cutting the alternating coil during the rolling process of the magnetic bead. Inducing current to obtain the detection result.
  • the first incubation detection channel is an optical and magnetic bead hybrid detection channel.
  • the optical and magnetic bead hybrid detection channel includes a light source generator, a light detector, an alternating coil and a detection coil.
  • the light source generator and the light detector are arranged oppositely and located between the alternating coil and the Above the detection coil; the detection coil is arranged in a plane perpendicular to the alternating coil.
  • the present application provides a reagent card, which is applied to the above-mentioned detection device.
  • the reagent card includes a main body and at least one reagent storage position.
  • the reagent storage position is provided on the main body.
  • the reagent storage position It is used to store single-person test reagents so that the detection device can perform single-person coagulation tests.
  • the reagent card further includes a handle, and the handle is provided at one end of the main body.
  • the reagent card includes a sample storage position, and the sample storage position is used to store samples.
  • the reagent card includes at least one detection position, and the detection position is used as a detection cup as a detection device.
  • this application proposes a detection device for detecting coagulation items, including a reagent storage module, a distribution module and an incubation detection module; the reagent storage module includes a multi-person reagent storage module and a single-person reagent storage module.
  • the multi-person reagent storage module is used to store reagent bottles to perform multi-person coagulation testing;
  • the single-person reagent storage module includes at least one reagent card storage channel to store the reagent card, and the reagent card includes at least one reagent storage location to store
  • a single-person test reagent is used to perform a single-person coagulation test;
  • the distribution module is used to inject the collected sample into the test cup, and transfer the detection reagent in the reagent bottle or the single-person test in the reagent card.
  • the detection reagent is injected into the detection cup;
  • the incubation detection module is used to incubate the sample in the detection cup and detect the sample in the detection cup to obtain the coagulation detection result.
  • the detection device stores the reagent card through the single-portion reagent storage module, and the reagent storage position of the reagent card is used to store the single-portion detection reagent, so as to provide the single-portion detection reagent to the detection device without using the multi-portion reagent storage module.
  • the reagent bottle can meet the requirements of the detection device for single-person sample detection, and also avoids the waste of large bottles of reagents.
  • the detection method of the detection device is diverse, which can meet the detection needs of users in different situations, and improves the user experience and the convenience of detection.
  • Figure 1 is a schematic framework diagram of the first embodiment of the detection device of the present application.
  • Figure 2 is a schematic structural diagram of the first embodiment of the reagent card of the present application.
  • Figure 3 is a schematic structural diagram of the first embodiment of the optical detection module of the present application.
  • Figure 4 is a schematic structural diagram of the first embodiment of the magnetic bead detection module of the present application.
  • Figure 5 is a schematic structural diagram of the first embodiment of the optical detection module and magnetic bead detection module of the present application
  • Figure 6 is a schematic structural diagram of the second embodiment of the reagent card of the present application.
  • Figure 7 is a schematic structural diagram of the third embodiment of the reagent card of the present application.
  • Figure 8 is a schematic structural diagram of the fourth embodiment of the reagent card of the present application.
  • reagent storage module 11 multi-person reagent storage module 111, single-person reagent storage module 112, reagent bottle 113, commonly used reagent bottle 114, reagent card storage channel 115, reagent card 116, reagent storage position 117, handle 118.
  • an embodiment means that a particular feature, structure or characteristic described in connection with the embodiment can be included in at least one embodiment of the present application.
  • the appearances of this phrase in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Those skilled in the art understand, both explicitly and implicitly, that the embodiments described herein may be combined with other embodiments.
  • Figure 1 is a schematic framework diagram of the first embodiment of the detection device of the present application
  • Figure 2 is a schematic structural diagram of the first embodiment of the reagent card of the present application.
  • the detection device in this embodiment is used to detect coagulation items.
  • the detection device includes a reagent storage module 11, a distribution module 12, an incubation detection module 13 and a detection cup 14.
  • the reagent storage module 11 includes a multi-person reagent storage module 111 and a single-person reagent storage module 112 .
  • the multi-person reagent storage module 111 is used to store reagent bottles 113 to perform multi-person coagulation testing; the reagent bottles 113 stored in the multi-person reagent storage module 111 include PT (Prothrombin time, prothrombin time) reagent, APTT (Activated At least one reagent among Partial Thromboplastin Time, activated partial thromboplastin time) reagent, TT (Thrombin Time, thrombin time) reagent and FIB (Fibrinogen, fibrinogen) reagent.
  • PT Prothrombin time, prothrombin time
  • APTT Activated At least one reagent among Partial Thromboplastin Time, activated partial thromboplastin time
  • TT Thrombin Time, thrombin time
  • FIB Fibrinogen,
  • the multi-portion reagent storage module 111 is also used to store commonly used reagent bottles 114, which are used to store buffers, cleaning solutions and/or diluents; wherein, the commonly used reagent bottles 114 and reagent bottles 113 can be in the form of Array layout settings.
  • the single-serve reagent storage module 112 includes at least one reagent card storage channel 115 , and the reagent card storage channel 115 is used to store reagent cards 116 .
  • the reagent card 116 includes at least one reagent storage position 117.
  • the reagent storage position 117 is used to store a single-person test reagent to perform a single-person coagulation test.
  • the reagent card 116 includes four reagent storage locations 117, and the four reagents can be used to store PT reagents, APTT reagents, TT reagents, and FIB reagents in the storage locations 117 respectively.
  • the distribution module 12 is used to inject the collected samples into the detection cup 14 , and inject the detection reagents in the reagent bottle 113 or the single-use detection reagent in the reagent card 116 into the detection cup 14 .
  • the distribution module 12 injects the sample into the detection cup 14, and then injects the detection reagent in the reagent bottle 113 or the single-serve detection reagent in the reagent card 116 into the corresponding detection cup 14.
  • the incubation detection module 13 is used to incubate the sample in the detection cup 14 and detect the sample in the detection cup 14 to obtain coagulation detection results.
  • the distribution module 12 is used to inject the sample and the single-person detection reagent into the detection cup 14 respectively, and then the detection cup 14 moves to the incubation detection module 13 so that the detection cup 14
  • the sample in the sample is incubated with a single-person detection reagent; the incubation detection module 13 detects the incubated sample to obtain a coagulation detection result.
  • the distribution module 12 is used to inject the samples and the detection reagents in the reagent bottle 113 into the detection cup 14 respectively, and then the detection cup 14 moves to the incubation detection module 13 so that the detection The sample in the cup 14 is incubated with the detection reagent; the incubation detection module 13 detects the incubated sample to obtain a coagulation detection result.
  • the detection device is used to perform four coagulation tests on the sample.
  • the detection device performs PT detection items, APTT detection items, TT detection items and FIB detection items on the sample.
  • the reagent storage module 11 of this embodiment includes a multi-person reagent storage module 111 and a single-person reagent storage module 112; the multi-person reagent storage module 111 is used to store reagent bottles 113 to perform multi-person coagulation testing; the single-person reagent storage module 111 is used to store reagent bottles 113 for multiple people.
  • the reagent storage module 112 includes at least one reagent card storage channel 115, and the reagent card storage channel 115 is used to store the reagent card 116; the reagent card 116 includes at least one reagent storage position 117, and the reagent storage position 117 is used to store single-person detection reagents.
  • a single-person coagulation test is performed; therefore, the detection device stores the reagent card 116 through the single-person reagent storage module 112, and the reagent storage position 117 of the reagent card 116 is used to store the single-person detection reagent, so as to provide a single-person test to the detection device.
  • Reagents do not need to use the reagent bottles 113 of the multi-person reagent storage module 111 to meet the requirements of the detection device for single-person sample detection, and also avoid the waste of large bottles of reagents (reagents in the reagent bottle 113).
  • the detection method of the detection device is diverse, which can meet the detection needs of users in different situations, and improves the user experience and the convenience of detection.
  • the detection device includes a sample storage module 15, a scanning module 16, a detection cup storage module 17 and a grabbing module 18.
  • the sample storage module 15 is used to store test tubes 151 , and the test tubes 151 can be used to store samples, which can be whole blood samples; the distribution module 12 can be used to inject samples from the test tubes 151 into the detection cup 14 .
  • the scanning module 16 is used to scan the identification information of the test tube 151. For example, the scanning module 16 scans the label or barcode of the test tube 151 to obtain the identification information.
  • the detection device binds the identification information and the coagulation test results to bind the test tube 151 to the coagulation test results.
  • the detection cup storage module 17 is used to store the detection cup 14, where the detection cup storage module 17 is spaced apart from the incubation detection module 13.
  • the distribution module 12 is used to inject the collected samples into the detection cup 14 in the detection cup storage module 17, and
  • the detection reagent in the reagent bottle 113 or the single-use detection reagent in the reagent card 116 is injected into the detection cup 14 in the detection cup storage module 17 .
  • the grabbing module 18 is used to move the test cup 14 from the test cup storage module 17 to the incubation detection module 13 .
  • the grabbing module 18 includes a grabbing arm and a grabbing hand. The grabbing arm grabs the detection cup 14 through the grabbing hand to move the detection cup 14 from the detection cup storage module 17 to the incubation detection module 13 .
  • the reagent card 116 includes a first reagent card, and the first reagent card only includes at least one reagent storage position 117. As shown in FIG. 2, the at least one reagent storage position 117 is used to store single-use detection reagents. At least one reagent card storage channel 115 of the single-serve reagent storage module 112 includes a first reagent card storage channel, and the first reagent card storage channel is used to place the first reagent card.
  • the reagent card 116 includes a handle 118 , which is provided at one end of the reagent card 116 , and the user can easily hold the reagent card 116 through the handle 118 .
  • the reagent card 116 includes a reagent card label. The reagent card label is provided on the reagent card 116 and is used to represent the production information of the reagent card 116 .
  • the single-serve detection reagent is a dry powder reagent; before the distribution module 12 absorbs the single-server detection reagent from the reagent storage position 117 , the distribution module 12 adds the reconstituted solution to the dry powder reagent in the reagent card 116 .
  • the surface of the reagent card 116 is sealed to facilitate storage and transportation.
  • the incubation detection module 13 includes a first incubation detection channel 131.
  • the distribution The module 12 injects the sample and the single-serve detection reagent into the detection cup 14 respectively; or the distribution module 12 injects the sample and the detection reagent in the reagent bottle 113 into the detection cup 14 respectively.
  • the detection cup 14 is transferred to the first incubation detection channel 131 , for example, the grabbing module 18 transfers the detection cup 14 to the first incubation detection channel 131 .
  • the grabbing module 18 moves the detection cup 14 from the detection cup storage module 17 to the liquid dispensing level, and the liquid dispensing level can be located in the testing cup storage module 17 Or incubate in the detection module 13.
  • the distribution module 12 injects the sample in the test tube 151 of the sample storage module 15 into the detection cup 14 and cleans the distribution module 12 .
  • the distribution module 12 absorbs the single-serve detection reagent from the reagent storage position 117 of the first reagent card, and injects the single-server detection reagent into the detection cup 14 .
  • the grabbing module 18 moves the detection cup 14 from the liquid dispensing level to the first incubation detection channel 131 of the incubation detection module 13 . After the sample in the detection cup 14 and the single-use detection reagent are incubated, the sample in the detection cup 14 is detected through the first incubation detection channel 131 to calculate the coagulation time of the sample, the concentration of the sample, or the activity index of the sample, etc. Coagulation test results.
  • the grabbing module 18 moves the detection cup 14 from the detection cup storage module 17 to the liquid dispensing level.
  • the distribution module 12 injects the sample in the test tube 151 of the sample storage module 15 into the detection cup 14, and cleans the distribution module 12; optionally, the distribution module 12 injects the quantitative diluent or quantitative buffer of the commonly used reagent bottle 114 into the detection cup. 14, to dilute the sample in the test cup 14.
  • the distribution module 12 draws the detection reagent from the reagent bottle 113 and injects the detection reagent into the detection cup 14 .
  • the grabbing module 18 moves the detection cup 14 from the liquid dispensing level to the first incubation detection channel 131 of the incubation detection module 13 .
  • the sample in the detection cup 14 is detected through the first incubation detection channel 131 to calculate the coagulation test results such as the coagulation time of the sample, the concentration of the sample, or the activity index of the sample. .
  • the detection device can not only meet the needs of large-volume coagulation tests for multiple people, but also can meet the needs of coagulation tests for a single person, realizing multiple uses in one machine, meeting the different needs of users, improving the user experience, and being easy to maintain.
  • the distribution module 12 is used to perform a mixing operation after injecting the collected sample into the detection cup 14 and injecting the detection reagent in the reagent bottle 113 or the single-portion detection reagent in the reagent card 116 into the detection cup 14,
  • the dispensing needle of the dispensing module 12 can achieve mixing through suction and spitting, vibration, etc.
  • the distribution module 12 includes multiple dispensing needles.
  • the multiple dispensing needles of the distribution module 12 draw multiple samples from different test tubes 151 in the sample storage module 15 at the same time, and inject the multiple samples into the corresponding detection cups 14
  • the multiple dispensing needles of the distribution module 12 draw corresponding single-person detection reagents from multiple reagent cards 116 at the same time, and inject the single-person detection reagents into multiple detection cups at the same time, and the distribution module 12 realizes simultaneous collection. Or inject multiple samples and multiple single-person detection reagents to increase the detection throughput of the detection device and improve detection efficiency.
  • the detection device includes a reagent card strip scheduling module, which is used to move the reagent card 116 to the reagent card storage channel 115 when the detection device detects the sample, and remove the reagent card 116 from the reagent card when the detection device completes the detection of the sample. Card storage channel 115 is removed. Therefore, the reagent card strip scheduling module can realize the loading and unloading of the reagent card 116, improve the automation level of the detection device, and improve the detection efficiency.
  • the detection device includes a test tube scheduling module, which is used to move the test tube rack to a preset position when the detection device detects the sample, and to move the test tube rack out when the detection device completes the detection of the sample, which can improve the automation of the detection device. level, simplifying operations.
  • a test tube scheduling module which is used to move the test tube rack to a preset position when the detection device detects the sample, and to move the test tube rack out when the detection device completes the detection of the sample, which can improve the automation of the detection device. level, simplifying operations.
  • the detection device includes a telescopic mechanism, and the detection cup storage module 17 is installed on the telescopic mechanism.
  • the telescopic mechanism is used to move the detection cup storage module 17 out of the detection device to facilitate the user to replace the detection cup 14, which can ensure that the detection device can replace the detection cup 14 without stopping and maintain the accuracy of the test. Continuity.
  • the testing cup storage module 17 includes an automatic screening mechanism for testing cups, which is used to automatically screen the testing cups and move the screened testing cups 14 to the grabbing module 18 to sort the scattered testing cups 14 .
  • the detection cup storage module 17 when the detection cups 14 in the detection cup storage module 17 are insufficient, the detection cup storage module 17 generates an alarm signal to remind the user to add new detection cups 14 to the detection cup storage module 17 .
  • the first incubation detection channel 131 is an optical detection channel.
  • the detection cup 14 is disposed in the first incubation detection channel 131 so that the optical detection module 30 can detect the sample in the detection cup 14 and the single-person portion. reagents for testing.
  • the optical detection module 30 includes a light source generator 31 and a light detector 32.
  • the light source generator 31 is used to emit a light beam, and the light beam is irradiated to the sample to be tested in the detection cup 14 to generate scattered light or transmitted light;
  • the light detector 32 is used to detect the scattered light. or transmitted light, convert scattered light or transmitted light into electrical signals, and then obtain detection results. Therefore, the detection cup 14 used in the optical detection module 30 needs to be made of a material with good light transmittance; the cross-sectional shape of the detection cup 14 can be circular or rectangular so as to be disposed in the first incubation detection channel 131 .
  • the first incubation detection channel 131 is a magnetic bead detection channel.
  • the detection cup 14 is disposed in the first incubation detection channel 131, so that the magnetic bead detection module 40 can detect the samples in the detection cup 14 and the single person. A portion of the detection reagent is used for testing.
  • the magnetic bead detection module 40 includes an alternating coil 41 and a detection coil 42, in which the inner wall of the detection cup 14 is provided with grooves to facilitate the rolling of magnetic beads in the grooves.
  • the alternating coil 41 is used to drive the magnetic beads to roll.
  • the rolling amplitude of the magnetic beads becomes smaller and smaller; the detection coil 42 is arranged in a plane perpendicular to the alternating coil 41 and is used to detect the rolling of the magnetic beads. During the process, the induced current generated by the alternating coil 41 is cut, and the detection result is obtained; the cross-sectional shape of the detection cup 14 can be circular or rectangular so as to be disposed in the first incubation detection channel 131 .
  • the optical detection module 30 is easily affected by substances such as chyle, jaundice, and hemolysis in the sample to be tested, which in turn leads to deviations in the detection results; while the magnetic bead detection module 40 is not affected by substances such as chyle, jaundice, and hemolysis in the sample to be tested. Influence.
  • the first incubation detection channel 131 is an optical and magnetic bead hybrid detection channel.
  • the detection cup 14 is disposed in the first incubation detection channel 131 so that the optical and magnetic bead hybrid detection module 50 can detect the detection cup. 14 samples and a single test reagent for testing. It includes a light source generator 51, a light detector 52, an alternating coil 53 and a detection coil 54.
  • the light source generator 51 and the light detector 52 are arranged oppositely and are located above the alternating coil 53 and the detection coil 54; the detection coil 54 is arranged between The alternating coils 53 are in a vertical plane. Therefore, the optical and magnetic bead hybrid detection module 50 of this embodiment reduces the number of channels of the first incubation detection channel 131 by merging the optical detection method and the magnetic bead detection method in the same channel.
  • the detection device includes a display screen 19 for displaying an operation interface.
  • the operation interface displays detection items that the detection device can detect, so that the user can select detection items on the operation interface; or the operation interface is used to display detection results. .
  • the detection device includes a scanner gun 20 for scanning the identification information of the reagent card 116 .
  • the detection device includes a cleaning liquid module 21, a waste liquid module 22, a power supply 23, a cleaning tank 24, a printer 25 and a waste cup bucket 26.
  • the power supply 23 is used to power the detection device;
  • the cleaning fluid module 21 is used to provide cleaning fluid to the detection device, including a cleaning fluid barrel 211 and a first pump body 212.
  • the first pump body 212 is used to draw cleaning fluid from the cleaning fluid barrel 211.
  • the waste liquid module 22 is used to collect waste liquid from the detection device, and includes a waste liquid barrel 221 and a second pump body 222 .
  • the second pump body 222 is used to pump the waste liquid from the detection device to the waste liquid barrel 221 .
  • the cleaning tank 24 is used to clean the dispensing needle of the dispensing module 12;
  • the scanning module 16, the sample storage module 15, the reagent storage module 11 and the display screen 19 are arranged in sequence along the first direction of the detection device, and the reagent storage module 11 and the incubation detection module 13 are arranged in sequence along the second direction of the detection device.
  • the first direction and the second direction are vertically arranged, so as to make the layout of the detection device compact and reduce the volume of the detection device.
  • the detection device includes a needle storage area.
  • the needle of the distribution module 12 is a disposable tip.
  • the dispensing arm of the distribution module 12 picks up the needle from the needle storage area.
  • the dispensing arm of the distribution module 12 can be a pneumatic device. No liquid circuit design is required, reducing costs.
  • the reagent card 116 includes a third reagent card, wherein the third reagent card includes at least one reagent storage position 117 and a sample storage position 119, wherein the at least one reagent storage position 117 is respectively It is used to store single-person test reagents, and the sample storage position 119 is used to store samples, such as single-person samples.
  • At least one reagent card storage channel 115 of the reagent storage module 11 includes a third reagent card storage channel, and the third reagent card storage channel is used to store the third reagent card.
  • the first incubation detection channel 131 further corresponds to the third reagent card storage channel.
  • the third reagent card storage channel stores the third reagent card, to perform a single-person coagulation test, or the detection device performs a multi-person coagulation test.
  • the distribution module 12 injects the sample and the detection reagent for a single dose into the detection cup 14 respectively; or, the distribution module 12 injects the sample and the detection reagent in the reagent bottle 113 into the detection cup 14 respectively.
  • the detection cup 14 is transferred to the first incubation detection channel 131 , for example, the grabbing module 18 transfers the detection cup 14 to the first incubation detection channel 131 .
  • the grabbing module 18 moves the detection cup 14 from the detection cup storage module 17 to the liquid dispensing level, and the liquid dispensing level can be located in the testing cup storage module 17 Or incubate in the detection module 13.
  • the distribution module 12 injects the sample in the sample storage position 119 of the third reagent card into the detection cup 14 and cleans the distribution module 12 .
  • the distribution module 12 absorbs the single-serve detection reagent from the reagent storage position 117 of the third reagent card, and injects the single-server detection reagent into the detection cup 14 .
  • the grabbing module 18 moves the detection cup 14 from the liquid dispensing level to the first incubation detection channel 131 of the incubation detection module 13 . After the sample in the detection cup 14 and the single-use detection reagent are incubated, the sample in the detection cup 14 is detected through the first incubation detection channel 131 to calculate the coagulation time of the sample, the concentration of the sample, or the activity index of the sample, etc. Coagulation test results.
  • other components of the detection device may be the same as the detection device of the above embodiment, and will not be described again here.
  • the reagent card 116 includes a second reagent card, wherein the second reagent card includes at least one reagent storage position 117 and at least one detection position 120 , wherein the at least one reagent storage position 117 They are respectively used to store single-use detection reagents, and the detection position 120 is used as the detection cup 14 .
  • the distribution module 12 injects the sample into the detection position 120 and injects the detection reagent from the reagent bottle 113 or the single-use detection reagent from the second reagent card into the detection position 120 .
  • At least one reagent card storage channel 115 of the reagent storage module 11 includes a second reagent card storage channel, and the second reagent card storage channel is used to store the second reagent card.
  • the incubation detection module 13 includes a second incubation detection channel 132 , and the second incubation detection channel 132 is provided corresponding to the second reagent card storage channel.
  • the distribution module 12 injects the sample and the single-serve detection reagent into the detection position 120 respectively; or, the distribution module 12 injects the sample and the detection reagent in the reagent bottle 113 into the detection position 120 respectively.
  • the distribution module 12 injects the sample in the test tube 151 of the sample storage module 15 into the corresponding detection position 120, and Distribution module 12 performs cleaning.
  • the distribution module 12 absorbs the single-serve detection reagent from the reagent storage position 117 of the second reagent card, and injects the single-server detection reagent into the corresponding detection position 120 .
  • the sample at the detection position 120 and the single-use detection reagent are incubated, the sample at the detection position 120 is detected through the second incubation detection channel 132 to calculate the coagulation time of the sample, the concentration of the sample, or the activity index of the sample, etc. Coagulation test results.
  • the second incubation detection channel 132 is an optical detection channel, a magnetic bead detection channel, or a hybrid optical and magnetic bead detection channel, which is the same as the first incubation detection channel 131 and will not be described again here.
  • the reagent card 116 includes a fourth reagent card, wherein the fourth reagent card includes at least one reagent storage position 117, a sample storage position 119 and at least one detection position 120, wherein at least A reagent storage position 117 is used to store single-use detection reagents, a sample storage position 119 is used to store samples, and a detection position 120 is used as a detection cup 14 .
  • the distribution module 12 injects the sample into the detection position 120 and injects the detection reagent from the reagent bottle 113 or the single-use detection reagent from the fourth reagent card into the detection position 120 .
  • At least one reagent card storage channel 115 of the reagent storage module 11 includes a fourth reagent card storage channel, and the fourth reagent card storage channel is used to store the fourth reagent card.
  • the second incubation detection channel 132 is provided correspondingly to the fourth reagent card storage channel.
  • the fourth reagent card is placed into the fourth reagent card storage channel
  • the at least one detection position 120 in the fourth reagent card is placed into the second incubation detection channel 132, so that the at least one detection position 120 is used as a detection channel respectively.
  • the distribution module 12 injects the sample and the single-serve detection reagent into the detection position 120 respectively; or, the distribution module 12 injects the sample and the detection reagent in the reagent bottle 113 into the detection position 120 respectively.
  • the distribution module 12 injects the sample in the sample storage position 119 of the fourth reagent card into the corresponding detection position 120, And clean the distribution module 12.
  • the distribution module 12 absorbs the single-serve detection reagent from the reagent storage position 117 of the fourth reagent card, and injects the single-server detection reagent into the corresponding detection position 120 .
  • the sample at the detection position 120 and the single-use detection reagent are incubated, the sample at the detection position 120 is detected through the second incubation detection channel 132 to calculate the coagulation time of the sample, the concentration of the sample, or the activity index of the sample, etc. Coagulation test results.
  • the reagent card 116 includes a main body and at least one reagent storage position 117 and a handle 118. At least one reagent storage position 117 is provided on the main body, and the handle 118 is provided on one end of the main body. At least one reagent storage position 117 is used to store a single-person test reagent, so that the detection device can perform a single-person coagulation test, which is the same as the above embodiment and will not be described again. At this time, the reagent card 116 serves as the first reagent card in the above embodiment.
  • the reagent card 116 includes at least one reagent storage position 117 and a sample storage position 119, wherein at least one reagent storage position 117 is used to store single-use detection reagents, and the sample storage position 119 is used to store Samples, such as single-serve samples.
  • the reagent card 116 serves as the third reagent card in the above embodiment.
  • the reagent card 116 includes at least one reagent storage position 117 and at least one detection position 120 , wherein the at least one reagent storage position 117 is used to store single-use detection reagents, and the detection position 120 is used as a Detection cup 14, at this time the reagent card 116 serves as the second reagent card in the above embodiment.
  • the reagent card 116 includes at least one reagent storage position 117, a sample storage position 119 and at least one detection position 120, wherein the at least one reagent storage position 117 is used to store a single test reagent, sample respectively.
  • the storage position 119 is used to store samples, and the detection position 120 is used as the detection cup 14.
  • the reagent card 116 serves as the fourth reagent card in the above embodiment.
  • the reagent storage module 11 of the present application includes a multi-part reagent storage module 111 and a single-part reagent storage module 112; the multi-part reagent storage module 111 is used to store reagent bottles 113 to perform multi-part coagulation testing. ;
  • the single-person reagent storage module 112 includes at least one reagent card storage channel 115, which is used to store the reagent card 116; the reagent card 116 includes at least one reagent storage position 117, and the reagent storage position 117 is used to store the single-person portion.
  • the detection reagent is used to perform a single-person coagulation test; therefore, the detection device stores the reagent card 116 through the single-person reagent storage module 112, and the reagent storage position 117 of the reagent card 116 is used to store the single-person detection reagent, so as to provide the detection device with
  • the detection device stores the reagent card 116 through the single-person reagent storage module 112
  • the reagent storage position 117 of the reagent card 116 is used to store the single-person detection reagent, so as to provide the detection device with
  • For single-person detection reagents there is no need to use the reagent bottles 113 of the multi-person reagent storage module 111 to meet the requirements of the detection device for single-person sample detection and to avoid the waste of large bottles of reagents.
  • the detection method of the detection device is diverse, which can meet the detection needs of users in different situations, and improves the user experience and the convenience of detection.

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Abstract

本申请公开了一种用于检测凝血项目的检测装置及试剂卡,该检测装置包括:试剂存储模块,包括多人份试剂存储模块和单人份试剂存储模块,多人份试剂存储模块用于存放试剂瓶;单人份试剂存储模块包括至少一试剂卡存储通道,以存储试剂卡,试剂卡包括至少一试剂存放位以存放单人份检测试剂;分配模块,用于将采集的样本注入至检测杯中,并将试剂瓶中的检测试剂或试剂卡中的单人份检测试剂注入至检测杯中;孵育检测模块,用于孵育检测杯中的样本并对检测杯中的样本进行检测,以得到凝血检测结果。通过上述方式,能够满足检测装置对单人份样本检测,也避免了大瓶试剂的浪费。

Description

一种用于检测凝血项目的检测装置及试剂卡
相关申请的交叉引用
本申请要求享有于2022年05月12日提交的名称为“一种用于检测凝血项目的检测装置及试剂卡”的中国专利申请2022105208867的优先权,该申请的全部内容通过引用并入本文中。
技术领域
本申请涉及医疗器械技术领域,特别是涉及一种用于检测凝血项目的检测装置及试剂卡。
背景技术
现有的用于检测凝血项目的检测装置用于检测样本的凝血能力,包括样本存放模块和试剂存放模块,其中样本存放模块用于存放多个试管,试剂存放模块存放有多个试剂瓶,试剂瓶用于装载大量试剂,可以满足数十个检测样本的使用,可适用于样本量大的场景。而在样本量较少(如只有几个检测样本)的场景下,具有使用期限的试剂瓶在被开启后,由于不能用完,便会被浪费。因此,现有的检测装置存在不能较好地用于单人份样本检测使用的问题。
技术问题
现有的检测装置存在不能较好地用于单人份样本检测使用的问题。
技术解决方案
为解决上述问题,本申请提供了一种用于检测凝血项目的检测装置,包括:试剂存储模块,包括单人份试剂存储模块,所述单人份试剂存储模块包括至少一试剂卡存储通道,以存储试剂卡,其中,所述试剂卡包括至少一试剂存放位以存放单人份检测试剂,以执行单人份凝血检测;分配模块,用于将采集的样本注入至检测杯中,并将所述试剂卡中的所述单人份检测试剂注入至所述检测杯中;孵育检测模块,用于孵育所述检测杯中的样本,并对所述检测杯中的样本进行检测,以得到凝血检测结果。
可选地,进一步包括样本存储模块和扫描模块,样本存储模块用于存放试管,分配模块用于将试管的样本注入至检测杯中;扫描模块用于扫描试管的标识信息,以使检测装置将标识信息与凝血检测结果进行绑定。
可选地,进一步包括检测杯存储模块,用于存放检测杯,分配模块用于将采集的样本注入至检测杯存储模块中的检测杯,并将试剂卡中的单人份检测试剂注入至检测杯存储模块中的检测杯。
可选地,进一步包括抓取模块,抓取模块用于将检测杯从检测杯存储模块移动至孵育检测模块。
可选地,所述试剂存储模块包括多人份试剂存储模块,所述多人份试剂存储模块用于存放试剂瓶,以执行多人份凝血检测,所述分配模块将所述试剂瓶中的检测试剂或所述试剂卡中的所述单人份检测试剂注入至所述检测杯中。
可选地,试剂卡包括第一试剂卡,第一试剂卡仅包括至少一个试剂存放位,用以存放单人份检测试剂;至少一试剂卡存储通道包括第一试剂卡存储通道,用于存储第一试剂卡。
可选地,试剂卡包括第二试剂卡,第二试剂卡仅包括至少一个试剂存放位和至少一个检测位,试剂存放位用于存放单人份检测试剂,检测位用于作为检测杯;分配模块用于将样本注入至检测位,并将试剂瓶中的检测试剂或试剂卡中的单人份检测试剂注入至检测位;至少一试剂卡存储通道包括第二试剂卡存储通道,用于存储第二试剂卡。
可选地,试剂卡包括第三试剂卡,第三试剂卡包括至少一个试剂存放位和样本存放位,试剂存放位用于存放单人份检测试剂,样本存放位用于存放样本;至少一试剂卡存储通道包括第三试剂卡存储通道,用于存储第三试剂卡。
可选地,试剂卡包括第四试剂卡,第四试剂卡仅包括至少一个试剂存放位、至少一个检测位和样本存放位,试剂存放位用于存放单人份检测试剂,样本存放位用于存放样本,检测位用于作为检测杯;分配模块用于将样本注入至检测位,并将试剂瓶中的检测试剂或试剂卡中的单人份检测试剂注入至检测位;至少一试剂卡存储通道包括第四试剂卡存储通道,用于存储第四试剂卡。
可选地,孵育检测模块包括第一孵育检测通道,当第一试剂卡存储通道存放有第一试剂卡或者第三试剂卡存储通道存放有第三试剂卡以执行单人份凝血检测,或检测装置执行多人份凝血检测时,分配模块将样本和单人份检测试剂分别注入检测杯中;或,分配模块将样本和试剂瓶中的检测试剂分别注入检测杯中,且检测杯被转移至第一孵育检测通道。
可选地,孵育检测模块包括第二孵育检测通道,且第二孵育检测通道与第二试剂卡存储通道和/或第四试剂卡存储通道对应设置,当第二试剂卡置入第二试剂卡存储通道或第四试剂卡置入第四试剂卡存储通道时,第二试剂卡或第四试剂卡中的至少一个检测位被置入至第二孵育检测通道,以使至少一个检测位分别用作为检测杯,分配模块将样本和单人份检测试剂分别注入检测位中;或,分配模块将样本和试剂瓶中的检测试剂分别注入检测位中。
可选地,所述第一孵育检测通道为光学检测通道。
可选地,所述光学检测通道包括光学检测模块,所述光学检测模块包括光源发生器和光探测器,所述光源发生器用于发出光束,所述光束照射至所述检测杯中的待测样本产生散射光或透射光,所述光探测器用于探测所述散射光或所述透射光,将所述散射光或所述透射光转换为电信号,以得到所述检测结果。
可选地,所述第一孵育检测通道为磁珠检测通道。
可选地,所述磁珠检测通道包括磁珠检测模块,所述磁珠检测模块包括交替线圈和检测线圈,所述检测杯内设置有沟槽,以使所述磁珠在所述沟槽内滚动;所述交替线圈用于驱动所述磁珠滚动,所述检测线圈设置于与所述交替线圈垂直的平面内,用于检测所述磁珠滚动过程中切割所述交替线圈所产生的感应电流,以得到所述检测结果。
可选地,所述第一孵育检测通道为光学和磁珠混合检测通道。
可选地,所述光学和磁珠混合检测通道包括光源发生器、光探测器、交替线圈和检测线圈,所述光源发生器和所述光探测器相对设置,且位于所述交替线圈和所述检测线圈的上方;所述检测线圈设置于与所述交替线圈垂直的平面内。
为解决上述问题,本申请提供了一种试剂卡,应用于上述检测装置,所述试剂卡包括主体和至少一试剂存放位,所述试剂存放位设置在所述主体上,所述试剂存放位用于存放单人份检测试剂,以使所述检测装置执行单人份凝血检测。
可选地,所述试剂卡还包括把手,所述把手设置于所述主体的一端。
可选地,试剂卡包括样本存放位,样本存放位用于存放样本。
可选地,试剂卡包括至少一个检测位,检测位用于作为检测装置的检测杯。
有益效果
区别于现有技术,本申请提出了一种用于检测凝血项目的检测装置,包括试剂存储模块、分配模块和孵育检测模块;试剂存储模块包括多人份试剂存储模块和单人份试剂存储模块,多人份试剂存储模块用于存放试剂瓶,以执行多人份凝血检测;单人份试剂存储模块包括至少一试剂卡存储通道,以存储试剂卡,试剂卡包括至少一试剂存放位以存放单人份检测试剂,以执行单人份凝血检测;分配模块用于将采集的样本注入至检测杯中,并将所述试剂瓶中的检测试剂或所述试剂卡中的所述单人份检测试剂注入至所述检测杯中;孵育检测模块用于孵育所述检测杯中的样本,并对所述检测杯中的样本进行检测,以得到凝血检测结果。因此,检测装置通过单人份试剂存储模块存储试剂卡,试剂卡的试剂存放位用于存放单人份检测试剂,以实现向检测装置提供单人份检测试剂,无需使用多人份试剂存储模块的试剂瓶,以满足检测装置对单人份样本检测,也避免了大瓶试剂的浪费。该检测装置的检测方式具有多样性,可满足用户不同情况下的检测需求,提高了用户的使用体验和检测的方便性。
附图说明
为了更清楚地说明本申请实施例中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本申请的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动性的前提下,还可以根据这些附图获得其它的附图。其中:
图1是本申请检测装置的第一实施例的框架示意图;
图2是本申请试剂卡的第一实施例的结构示意图;
图3是本申请光学检测模块的第一实施例的结构示意图;
图4是本申请磁珠检测模块的第一实施例的结构示意图;
图5是本申请光学检测模块和磁珠检测模块的第一实施例的结构示意图;
图6是本申请试剂卡的第二实施例的结构示意图;
图7是本申请试剂卡的第三实施例的结构示意图;
图8是本申请试剂卡的第四实施例的结构示意图;
附图标号:试剂存储模块11、多人份试剂存储模块111、单人份试剂存储模块112、试剂瓶113、常用试剂瓶114、试剂卡存储通道115、试剂卡116、试剂存放位117、把手118、样本存放位119、检测位120;分配模块12;孵育检测模块13、第一孵育检测通道131、第二孵育检测通道132;检测杯14;样本存储模块15、试管151;扫描模块16;检测杯存储模块17;抓取模块18;显示屏19;扫描枪20;清洗液模块21、清洗液桶211、第一泵体212;废液模块22、废液桶221、第二泵体222;电源23;清洗池24;打印机25;废杯桶26;光学检测模块30、光源发生器31、光探测器32;磁珠检测模块40、交替线圈41、检测线圈42;光学和磁珠混合检测模块50、光源发生器51、光探测器52、交替线圈53以及检测线圈54。
具体实施方式
为使本申请的上述目的、特征和优点能够更为明显易懂,下面结合附图,对本申请的具体实施方式做详细的说明。可以理解的是,此处所描述的具体实施例仅用于解释本申请,而非对本申请的限定。另外还需要说明的是,为了便于描述,附图中仅示出了与本申请相关的部分而非全部结构。基于本申请中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其它实施例,都属于本申请保护的范围。
本申请中的术语“第一”、“第二”等是用于区别不同对象,而不是用于描述特定顺序。此外,术语“包括”和“设置有”以及它们任何变形,意图在于覆盖不排他的包含。例如包含了一系列步骤或单元的过程、方法、系统、产品或设备没有限定于已列出的步骤或单元,而是可选地还包括没有列出的步骤或单元,或可选地还包括对于这些过程、方法、产品或设备固有的其它步骤或单元。
在本文中提及“实施例”意味着,结合实施例描述的特定特征、结构或特性可以包含在本申请的至少一个实施例中。在说明书中的各个位置出现该短语并不一定均是指相同的实施例,也不是与其它实施例互斥的独立的或备选的实施例。本领域技术人员显式地和隐式地理解的是,本文所描述的实施例可以与其它实施例相结合。
请参见图1-2所示,图1是本申请检测装置的第一实施例的框架示意图;图2是本申请试剂卡的第一实施例的结构示意图。本实施例的检测装置用于检测凝血项目,检测装置包括试剂存储模块11、分配模块12、孵育检测模块13和检测杯14。
其中,试剂存储模块11包括多人份试剂存储模块111和单人份试剂存储模块112。多人份试剂存储模块111用于存放试剂瓶113,以执行多人份凝血检测;多人份试剂存储模块111所存放的试剂瓶113包括PT(Prothrombin time,凝血酶原时间)试剂、APTT(Activated Partial Thromboplastin Time, 活化部分凝血活酶时间)试剂、TT(Thrombin Time,凝血酶时间)试剂和FIB(Fibrinogen,纤维蛋白原)试剂中的至少一种试剂。
可选地,多人份试剂存储模块111还用于存放常用试剂瓶114,常用试剂瓶114用于存放缓冲液、清洗液和/或稀释液;其中,常用试剂瓶114与试剂瓶113可以呈阵列排布设置。
单人份试剂存储模块112包括至少一试剂卡存储通道115 ,试剂卡存储通道115 用于存储试剂卡116。试剂卡116包括至少一个试剂存放位117,试剂存放位117用于存放单人份检测试剂,以执行单人份凝血检测。例如,试剂卡116包括四个试剂存放位117,四个试剂可分别用于存放位117分别存放PT试剂、APTT试剂、TT试剂和FIB试剂。
分配模块12用于将采集的样本注入至检测杯14中,并将试剂瓶113中的检测试剂或试剂卡116中的单人份检测试剂注入至检测杯14中。例如分配模块12样本注入检测杯14中,再将试剂瓶113中的检测试剂或试剂卡116中的单人份检测试剂注入至对应的检测杯14中。
孵育检测模块13用于孵育检测杯14中的样本,并对检测杯14中的样本进行检测,以得到凝血检测结果。
在检测装置对样本执行单人份凝血检测时,分配模块12用于将样本和单人份检测试剂分别注入至检测杯14中之后,检测杯14移动至孵育检测模块13,以使检测杯14中的样本和单人份检测试剂进行孵育;孵育检测模块13对孵育后的样本进行检测,得到凝血检测结果。在检测装置对样本执行多人份凝血检测时,分配模块12用于将样本和试剂瓶113中的检测试剂分别注入至检测杯14中之后,检测杯14移动至孵育检测模块13,以使检测杯14中的样本和检测试剂进行孵育;孵育检测模块13对孵育后的样本进行检测,得到凝血检测结果。
可选地,检测装置用于对样本进行凝血四项检测,例如检测装置对样本进行PT检测项目、APTT检测项目、TT检测项目和FIB检测项目。
本实施例的试剂存储模块11包括多人份试剂存储模块111和单人份试剂存储模块112;多人份试剂存储模块111用于存放试剂瓶113,以执行多人份凝血检测;单人份试剂存储模块112包括至少一试剂卡存储通道115 ,试剂卡存储通道115 用于存储试剂卡116;试剂卡116包括至少一个试剂存放位117,试剂存放位117用于存放单人份检测试剂,以执行单人份凝血检测;因此检测装置通过单人份试剂存储模块112存储试剂卡116,试剂卡116的试剂存放位117用于存放单人份检测试剂,以实现向检测装置提供单人份检测试剂,无需使用多人份试剂存储模块111的试剂瓶113,以满足检测装置对单人份样本检测,也避免了大瓶试剂(试剂瓶113的试剂)的浪费。该检测装置的检测方式具有多样性,可满足用户不同情况下的检测需求,提高了用户的使用体验和检测的方便性。
可选地,检测装置包括样本存储模块15、扫描模块16、检测杯存储模块17和抓取模块18。
其中,样本存储模块15用于存放试管151,试管151可以用于存储样本,样本可以为全血样本;分配模块12可以用于将试管151的样本注入至检测杯14中。
扫描模块16用于扫描试管151的标识信息,例如扫描模块16扫描试管151的标签或条码,以得到标识信息。检测装置将标识信息与凝血检测结果进行绑定,以实现试管151与凝血检测结果绑定。
检测杯存储模块17用于存放检测杯14,其中检测杯存储模块17与孵育检测模块13间隔设置,分配模块12用于将采集的样本注入至检测杯存储模块17中的检测杯14,并将试剂瓶113中的检测试剂或试剂卡116中的单人份检测试剂注入至检测杯存储模块17中的检测杯14。
抓取模块18用于将检测杯14从检测杯存储模块17移动至孵育检测模块13。例如,抓取模块18包括抓取臂和抓取手,抓取臂通过抓取手抓取检测杯14,以将检测杯14从检测杯存储模块17移动至孵育检测模块13。
可选地,试剂卡116包括第一试剂卡,第一试剂卡仅包括至少一个试剂存放位117,如图2所示,至少一个试剂存放位117用于存放单人份检测试剂。单人份试剂存储模块112的至少一试剂卡存储通道115包括第一试剂卡存储通道,第一试剂卡存储通道用于放置第一试剂卡。
可选地,试剂卡116包括把手118,设置于试剂卡116的一端,用户通过把手118便于手持试剂卡116。此外,试剂卡116包括试剂卡标签,试剂卡标签设置于试剂卡116上,用于表示试剂卡116的生产信息。
可选地,单人份检测试剂为干粉试剂;在分配模块12从试剂存放位117吸取单人份检测试剂之前,分配模块12将复溶液加入试剂卡116的干粉试剂。此外,试剂卡116的表面封膜,以便于存储和运输。
可选地,孵育检测模块13包括第一孵育检测通道131,当第一试剂卡存储通道存放有第一试剂卡,以执行单人份凝血检测,或者检测装置执行多人份凝血检测时,分配模块12将样本和单人份检测试剂分别注入检测杯14中;或者,分配模块12将样本和试剂瓶113中的检测试剂分别注入检测杯14中。检测杯14被转移至第一孵育检测通道131,例如抓取模块18将检测杯14转移至第一孵育检测通道131。
以下描述检测装置基于第一试剂卡执行单人份凝血检测的检测流程:抓取模块18将检测杯14从检测杯存储模块17移动至分液位,分液位可以位于检测杯存储模块17内或孵育检测模块13内。分配模块12将样本存储模块15的试管151中的样本注入检测杯14,并对分配模块12进行清洗。分配模块12从第一试剂卡的试剂存放位117吸取单人份检测试剂,并将单人份检测试剂注入检测杯14。抓取模块18将检测杯14从分液位移动至孵育检测模块13的第一孵育检测通道131。在检测杯14的样本和单人份检测试剂完成孵育之后,通过第一孵育检测通道131对检测杯14的样本进行检测,以计算得出样本的凝固时间、样本的浓度或者样本的活性指标等凝血检测结果。
以下描述检测装置执行多人份凝血检测的检测流程:抓取模块18将检测杯14从检测杯存储模块17移动至分液位。分配模块12将样本存储模块15的试管151中的样本注入检测杯14,并对分配模块12进行清洗;可选地,分配模块12将常用试剂瓶114的定量稀释液或定量缓冲液注入检测杯14,以稀释检测杯14的样本。分配模块12从试剂瓶113吸取检测试剂,并将检测试剂注入检测杯14。抓取模块18将检测杯14从分液位移动至孵育检测模块13的第一孵育检测通道131。在检测杯14的样本和检测试剂完成孵育之后,通过第一孵育检测通道131对检测杯14的样本进行检测,以计算得出样本的凝固时间、样本的浓度或者样本的活性指标等凝血检测结果。
可选地,在检测装置对样本完成检测之后,检测装置进行清洗和维护。因此检测装置既能满足多人份的大批量凝血检测,又能满足单人份的凝血检测,实现一机多用,满足用户不同需求,提高用户的使用体验,易于维护。
此外,分配模块12用于在将采集的样本注入至检测杯14中,并将试剂瓶113中的检测试剂或试剂卡116中的单人份检测试剂注入至检测杯14之后进行混匀操作,例如分配模块12的分注针可以通过吸吐、振动等方式实现混匀。
可选地,分配模块12包括多个分注针,分配模块12的多个分注针同时从样本存储模块15中的不同试管151吸取多个样本,并将多个样本注入对应的检测杯14中;此外,分配模块12的多个分注针同时从多个试剂卡116吸取对应的单人份检测试剂,并将单人份检测试剂同时注入多个检测杯中,分配模块12实现同时采集或注入多个样本和多个单人份检测试剂,以提高检测装置的检测通量,提高检测效率。
可选地,检测装置包括试剂卡条调度模块,用于在检测装置对样本进行检测时将试剂卡116移至试剂卡存储通道115,并在检测装置对样本完成检测时将试剂卡116从试剂卡存储通道115移出。因此,试剂卡条调度模块能够实现对试剂卡116的装载和卸载,提高检测装置的自动化程度,提高检测效率。
可选地,检测装置包括试管调度模块,用于在检测装置对样本进行检测时将试管架移动至预设位置,并在检测装置对样本完成检测时将试管架移出,能够提高检测装置的自动化程度,简化操作。
可选地,检测装置包括伸缩机构,检测杯存储模块17安装于伸缩机构上。在检测杯存储模块17需要更换检测杯14时,伸缩机构用于将检测杯存储模块17移出检测装置,以方便用户更换检测杯14,能够保证检测装置实现不停机更换检测杯14,保持测试的连续性。
可选地,检测杯存储模块17包括检测杯自动筛选机构,用于检测杯自动筛选机构,并将筛选出来的检测杯14移动至抓取模块18,以将散乱的检测杯14进行排序。此外,在检测杯存储模块17的检测杯14不足时,检测杯存储模块17产生报警信号,以提醒用户向检测杯存储模块17添加新的检测杯14。
可选地,第一孵育检测通道131为光学检测通道,如图3所示,检测杯14设置于第一孵育检测通道131,以使光学检测模块30对检测杯14的样本和单人份检测试剂进行检测。光学检测模块30包括光源发生器31和光探测器32,光源发生器31用于发出光束,光束照射至检测杯14中的待测样本产生散射光或透射光;光探测器32用于探测散射光或透射光,将散射光或透射光转换为电信号,进而得到检测结果。因此,应用于光学检测模块30的检测杯14需要采用透光性良好的材质;检测杯14的截面形状可以为圆形或长方形,以便设于第一孵育检测通道131。
可选地,第一孵育检测通道131为磁珠检测通道,如图4所示,检测杯14设置于第一孵育检测通道131,以使磁珠检测模块40对检测杯14的样本和单人份检测试剂进行检测。磁珠检测模块40包括交替线圈41和检测线圈42,其中检测杯14的内壁设置有沟槽,以便于磁珠在沟槽内滚动。交替线圈41用于驱动磁珠滚动,随着待测样本的凝固过程中,磁珠滚动的幅度越来越小;检测线圈42设置于与交替线圈41垂直的平面内,用于检测磁珠滚动过程中切割交替线圈41所产生的感应电流,进而得到检测结果;检测杯14的截面形状可以为圆形或长方形,以便设于第一孵育检测通道131。
其中,光学检测模块30容易受到待测样本中的乳糜、黄疸、溶血等物质影响,进而导致检测结果出现偏差;而磁珠检测模块40不会受到待测样本中的乳糜、黄疸、溶血等物质影响。
可选地,第一孵育检测通道131为光学和磁珠混合检测通道,如图5所示,检测杯14设置于第一孵育检测通道131,以使光学和磁珠混合检测模块50对检测杯14的样本和单人份检测试剂进行检测。其包括光源发生器51、光探测器52、交替线圈53和检测线圈54,其中光源发生器51和光探测器52相对设置,且位于交替线圈53和检测线圈54的上方;检测线圈54设置于与交替线圈53垂直的平面内。因此本实施例的光学和磁珠混合检测模块50通过将光学检测方法和磁珠检测方法合并在同一通道中,降低了第一孵育检测通道131的通道数量。
可选地,检测装置包括显示屏19,用于显示操作界面,例如操作界面上显示检测装置可以检测的检测项目,以使用户在操作界面上选择检测项目;或者,操作界面用于显示检测结果。
可选地,检测装置包括扫描枪20,用于扫描试剂卡116的标识信息。
可选地,检测装置仪包括清洗液模块21、废液模块22、电源23、清洗池24、打印机25和废杯桶26。电源23用于为检测装置供电;清洗液模块21用于向检测装置提供清洗液,包括清洗液桶211和第一泵体212,第一泵体212用于从清洗液桶211抽取清洗液。废液模块22用于收集检测装置的废液,包括废液桶221和第二泵体222,第二泵体222用于将检测装置的废液抽取至废液桶221。清洗池24用于对分配模块12的分注针进行清洗;打印机25用于打印凝血检测结果;废杯桶26用于放置完成检测的检测杯14。
其中,扫描模块16、样本存储模块15、试剂存储模块11和显示屏19沿着检测装置的第一方向依次排布设置,试剂存储模块11和孵育检测模块13沿着检测装置的第二方向依次排布设置,第一方向与第二方向垂直设置,以使检测装置的布局紧凑,缩小检测装置的体积。
可选地,检测装置包括针头存放区,分配模块12的针头为一次性的tip头,分配模块12的分注臂从针头存放区扎取针头,分配模块12的分注臂可以为气动装置,无需液路设计,降低成本。
在本申请的一实施例中,如图6所示,试剂卡116包括第三试剂卡,其中第三试剂卡包括至少一试剂存放位117和样本存放位119,其中至少一试剂存放位117分别用于存放单人份检测试剂,样本存放位119用于存放样本,例如单人份样本。
试剂存储模块11的至少一试剂卡存储通道115包括第三试剂卡存储通道,第三试剂卡存储通道用于存放第三试剂卡。
如图1所示,第一孵育检测通道131进一步对应于第三试剂卡存储通道,当第三试剂卡存储通道存放有第三试剂卡,以执行单人份凝血检测,或者检测装置执行多人份凝血检测时,分配模块12将样本和单人份检测试剂分别注入检测杯14中;或者,分配模块12将样本和试剂瓶113中的检测试剂分别注入检测杯14中。检测杯14被转移至第一孵育检测通道131,例如抓取模块18将检测杯14转移至第一孵育检测通道131。
以下描述检测装置基于第三试剂卡执行单人份凝血检测的检测流程:抓取模块18将检测杯14从检测杯存储模块17移动至分液位,分液位可以位于检测杯存储模块17内或孵育检测模块13内。分配模块12将第三试剂卡的样本存放位119中的样本注入检测杯14,并对分配模块12进行清洗。分配模块12从第三试剂卡的试剂存放位117吸取单人份检测试剂,并将单人份检测试剂注入检测杯14。抓取模块18将检测杯14从分液位移动至孵育检测模块13的第一孵育检测通道131。在检测杯14的样本和单人份检测试剂完成孵育之后,通过第一孵育检测通道131对检测杯14的样本进行检测,以计算得出样本的凝固时间、样本的浓度或者样本的活性指标等凝血检测结果。此外,检测装置的其他部件可以与上述实施例的检测装置相同,在此不再赘述。
在本申请的一实施例中,如图7所示,试剂卡116包括第二试剂卡,其中第二试剂卡包括至少一个试剂存放位117和至少一个检测位120,其中至少一试剂存放位117分别用于存放单人份检测试剂,检测位120用于作为检测杯14。分配模块12将样本注入检测位120,并将试剂瓶113的检测试剂或第二试剂卡的单人份检测试剂注入至检测位120。
试剂存储模块11的至少一试剂卡存储通道115包括第二试剂卡存储通道,第二试剂卡存储通道用于存放第二试剂卡。
如图1所示,孵育检测模块13包括第二孵育检测通道132,第二孵育检测通道132与第二试剂卡存储通道对应设置。当第二试剂卡置入第二试剂卡存储通道时,第二试剂卡中的所述至少一个检测位120被置入至第二孵育检测通道132,以使至少一个检测位120分别用作为检测杯14,分配模块12将样本和单人份检测试剂分别注入检测位120中;或者,分配模块12将样本和试剂瓶113中的检测试剂分别注入检测位120中。
以下描述检测装置基于第二试剂卡执行单人份凝血检测的检测流程:如图1和7所示,分配模块12将样本存储模块15的试管151中的样本注入对应的检测位120,并对分配模块12进行清洗。分配模块12从第二试剂卡的试剂存放位117吸取单人份检测试剂,并将单人份检测试剂注入对应的检测位120。在检测位120的样本和单人份检测试剂完成孵育之后,通过第二孵育检测通道132对检测位120的样本进行检测,以计算得出样本的凝固时间、样本的浓度或者样本的活性指标等凝血检测结果。
可选地,第二孵育检测通道132为光学检测通道或磁珠检测通道或光学和磁珠混合检测通道,与第一孵育检测通道131相同,在此不再赘述。
在本申请的一实施例中,如图8所示,试剂卡116包括第四试剂卡,其中第四试剂卡包括至少一个试剂存放位117、样本存放位119和至少一个检测位120,其中至少一试剂存放位117分别用于存放单人份检测试剂,样本存放位119用于存放样本,检测位120用于作为检测杯14。分配模块12将样本注入检测位120,并将试剂瓶113的检测试剂或第四试剂卡的单人份检测试剂注入至检测位120。
试剂存储模块11的至少一试剂卡存储通道115包括第四试剂卡存储通道,第四试剂卡存储通道用于存放第四试剂卡。
如图1所示,第二孵育检测通道132与第四试剂卡存储通道对应设置。当第四试剂卡置入第四试剂卡存储通道时,第四试剂卡中的所述至少一个检测位120被置入至第二孵育检测通道132,以使至少一个检测位120分别用作为检测杯14,分配模块12将样本和单人份检测试剂分别注入检测位120中;或者,分配模块12将样本和试剂瓶113中的检测试剂分别注入检测位120中。
以下描述检测装置基于第四试剂卡执行单人份凝血检测的检测流程:如图1和8所示,分配模块12将第四试剂卡的样本存放位119中的样本注入对应的检测位120,并对分配模块12进行清洗。分配模块12从第四试剂卡的试剂存放位117吸取单人份检测试剂,并将单人份检测试剂注入对应的检测位120。在检测位120的样本和单人份检测试剂完成孵育之后,通过第二孵育检测通道132对检测位120的样本进行检测,以计算得出样本的凝固时间、样本的浓度或者样本的活性指标等凝血检测结果。
本申请还提供一种试剂卡,如图2所示,试剂卡116包括主体和至少一个试剂存放位117和把手118,至少一个试剂存放位117设置在主体上,把手118设置于主体的一端,至少一个试剂存放位117用于存放单人份检测试剂,以使检测装置执行单人份凝血检测,与上述实施例相同,在此不再赘述。此时试剂卡116作为上述实施例的第一试剂卡。
可选地,如图6所示,试剂卡116包括至少一试剂存放位117和样本存放位119,其中至少一试剂存放位117分别用于存放单人份检测试剂,样本存放位119用于存放样本,例如单人份样本。此时试剂卡116作为上述实施例的第三试剂卡。
可选地,如图7所示,试剂卡116包括至少一个试剂存放位117和至少一个检测位120,其中至少一试剂存放位117分别用于存放单人份检测试剂,检测位120用于作为检测杯14,此时试剂卡116作为上述实施例的第二试剂卡。
可选地,如图8所示,试剂卡116包括至少一个试剂存放位117、样本存放位119和至少一个检测位120,其中至少一试剂存放位117分别用于存放单人份检测试剂,样本存放位119用于存放样本,检测位120用于作为检测杯14,此时试剂卡116作为上述实施例的第四试剂卡。
综上所述,本申请的试剂存储模块11包括多人份试剂存储模块111和单人份试剂存储模块112;多人份试剂存储模块111用于存放试剂瓶113,以执行多人份凝血检测;单人份试剂存储模块112包括至少一试剂卡存储通道115 ,试剂卡存储通道115 用于存储试剂卡116;试剂卡116包括至少一个试剂存放位117,试剂存放位117用于存放单人份检测试剂,以执行单人份凝血检测;因此检测装置通过单人份试剂存储模块112存储试剂卡116,试剂卡116的试剂存放位117用于存放单人份检测试剂,以实现向检测装置提供单人份检测试剂,无需使用多人份试剂存储模块111的试剂瓶113,以满足检测装置对单人份样本检测,也避免了大瓶试剂的浪费。该检测装置的检测方式具有多样性,可满足用户不同情况下的检测需求,提高了用户的使用体验和检测的方便性。
以上所述仅为本申请的实施方式,并非因此限制本申请的专利范围,凡是利用本申请说明书及附图内容所作的等效结构或等效流程变换,或直接或间接运用在其他相关的技术领域,均同理包括在本申请的专利保护范围内。

Claims (21)

  1. 一种用于检测凝血项目的检测装置,其中,包括:
    试剂存储模块,包括单人份试剂存储模块,所述单人份试剂存储模块包括至少一试剂卡存储通道,以存储试剂卡,其中,所述试剂卡包括至少一试剂存放位以存放单人份检测试剂,以执行单人份凝血检测;
    分配模块,用于将采集的样本注入至检测杯中,并将所述试剂卡中的所述单人份检测试剂注入至所述检测杯中;
    孵育检测模块,用于孵育所述检测杯中的样本,并对所述检测杯中的样本进行检测,以得到凝血检测结果。
  2. 根据权利要求1所述的检测装置,其中,进一步包括样本存储模块和扫描模块,所述样本存储模块用于存放试管,所述分配模块用于将所述试管的样本注入至所述检测杯中;所述扫描模块用于扫描所述试管的标识信息,以使所述检测装置将所述标识信息与所述凝血检测结果进行绑定。
  3. 根据权利要求1或2所述的检测装置,其中,进一步包括检测杯存储模块,用于存放所述检测杯,所述分配模块用于将采集的样本注入至所述检测杯存储模块中的检测杯,并将所述试剂卡中的所述单人份检测试剂注入至所述检测杯存储模块中的检测杯。
  4. 根据权利要求3所述的检测装置,其中,进一步包括抓取模块,所述抓取模块用于将所述检测杯从所述检测杯存储模块移动至所述孵育检测模块。
  5. 根据权利要求1-4任一项所述的检测装置,其中,所述试剂存储模块包括多人份试剂存储模块,所述多人份试剂存储模块用于存放试剂瓶,以执行多人份凝血检测,所述分配模块将所述试剂瓶中的检测试剂或所述试剂卡中的所述单人份检测试剂注入至所述检测杯中。
  6. 根据权利要求1-5任一项所述的检测装置,其中,所述试剂卡包括第一试剂卡,所述第一试剂卡仅包括至少一个试剂存放位,用以存放所述单人份检测试剂;所述至少一试剂卡存储通道包括第一试剂卡存储通道,用于放置所述第一试剂卡。
  7. 根据权利要求1-6任一项所述的检测装置,其中,所述试剂卡包括第二试剂卡,所述第二试剂卡仅包括至少一个试剂存放位和至少一个检测位,所述试剂存放位用于存放所述单人份检测试剂,所述检测位用于作为所述检测杯;所述分配模块用于将所述样本注入至所述检测位,并将试剂瓶中的检测试剂或所述试剂卡中的所述单人份检测试剂注入至所述检测位;所述至少一试剂卡存储通道包括第二试剂卡存储通道,用于放置所述第二试剂卡。
  8. 根据权利要求1-7任一项所述的检测装置,其中,所述试剂卡包括第三试剂卡,所述第三试剂卡包括至少一个试剂存放位和样本存放位,所述试剂存放位用于存放所述单人份检测试剂,所述样本存放位用于存放所述样本;所述至少一试剂卡存储通道包括第三试剂卡存储通道,用于放置所述第三试剂卡。
  9. 根据权利要求1-8任一项所述的检测装置,其中,所述试剂卡包括第四试剂卡,所述第四试剂卡仅包括至少一个试剂存放位、至少一个检测位和样本存放位,所述试剂存放位用于存放所述单人份检测试剂,所述样本存放位用于存放所述样本,所述检测位用于作为所述检测杯;所述分配模块用于将所述样本注入至所述检测位,并将所述试剂瓶中的检测试剂或所述试剂卡中的所述单人份检测试剂注入至所述检测位;所述至少一试剂卡存储通道包括第四试剂卡存储通道,用于放置所述第四试剂卡。
  10. 根据权利要求6-9任一项所述的检测装置,其中,所述孵育检测模块包括第一孵育检测通道,当第一试剂卡存储通道存放有第一试剂卡或者第三试剂卡存储通道存放有第三试剂卡以执行单人份凝血检测,或所述检测装置执行多人份凝血检测时,所述分配模块将所述样本和所述单人份检测试剂分别注入所述检测杯中;或,所述分配模块将所述样本和所述试剂瓶中的检测试剂分别注入所述检测杯中,且所述检测杯被转移至所述第一孵育检测通道。
  11. 根据权利要求6-9任一项所述的检测装置,其中,所述孵育检测模块包括第二孵育检测通道,且所述第二孵育检测通道与第二试剂卡存储通道和/或第四试剂卡存储通道对应设置,当第二试剂卡置入所述第二试剂卡存储通道或第四试剂卡置入所述第四试剂卡存储通道时,所述第二试剂卡或所述第四试剂卡中的所述至少一个检测位被置入至所述第二孵育检测通道,以使所述至少一个检测位分别用作为所述检测杯,所述分配模块将所述样本和所述单人份检测试剂分别注入所述检测位中;或,所述分配模块将所述样本和所述试剂瓶中的检测试剂分别注入所述检测位中。
  12. 根据权利要求10所述的检测装置,其中,所述第一孵育检测通道为光学检测通道。
  13. 根据权利要求12所述的检测装置,其中,所述光学检测通道包括光学检测模块,所述光学检测模块包括光源发生器和光探测器,所述光源发生器用于发出光束,所述光束照射至所述检测杯中的待测样本产生散射光或透射光,所述光探测器用于探测所述散射光或所述透射光,将所述散射光或所述透射光转换为电信号,以得到所述检测结果。
  14. 根据权利要求10所述的检测装置,其中,所述第一孵育检测通道为磁珠检测通道。
  15. 根据权利要求14所述的检测装置,其中,所述磁珠检测通道包括磁珠检测模块,所述磁珠检测模块包括交替线圈和检测线圈,所述检测杯内设置有沟槽,以使所述磁珠在所述沟槽内滚动;所述交替线圈用于驱动所述磁珠滚动,所述检测线圈设置于与所述交替线圈垂直的平面内,用于检测所述磁珠滚动过程中切割所述交替线圈所产生的感应电流,以得到所述检测结果。
  16. 根据权利要求10所述的检测装置,其中,所述第一孵育检测通道为光学和磁珠混合检测通道。
  17. 根据权利要求16所述的检测装置,其中,所述光学和磁珠混合检测通道包括光源发生器、光探测器、交替线圈和检测线圈,所述光源发生器和所述光探测器相对设置,且位于所述交替线圈和所述检测线圈的上方;所述检测线圈设置于与所述交替线圈垂直的平面内。
  18. 一种试剂卡,其中,应用于如权利要求1-17任一项所述检测装置,所述试剂卡包括主体和至少一试剂存放位,所述试剂存放位设置在所述主体上,所述试剂存放位用于存放单人份检测试剂,以使所述检测装置执行单人份凝血检测。
  19. 根据权利要求18所述的试剂卡,其中,所述试剂卡还包括把手,所述把手设置于所述主体的一端。
  20. 根据权利要求18所述的试剂卡,其中,所述试剂卡包括样本存放位,所述样本存放位用于存放样本。
  21. 根据权利要求18-20任一项所述的试剂卡,其中,所述试剂卡包括至少一个检测位,所述检测位用于作为所述检测装置的检测杯。
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CN113970645A (zh) * 2020-06-30 2022-01-25 深圳市液芯科技有限公司 多逻辑运行的生物检测设备和试剂卡及其检测方法
CN113376367A (zh) * 2021-06-02 2021-09-10 广州蓝勃生物科技有限公司 免疫分析仪
CN214953581U (zh) * 2021-06-30 2021-11-30 深圳市帝迈生物技术有限公司 生物样本联检设备

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CN117741171A (zh) * 2024-02-19 2024-03-22 深圳市帝迈生物技术有限公司 样本分析仪的检测控制方法和样本分析仪控制器
CN117741170B (zh) * 2024-02-19 2024-05-24 深圳市帝迈生物技术有限公司 质控品实验项目登记方法及检测控制方法
CN117741171B (zh) * 2024-02-19 2024-05-28 深圳市帝迈生物技术有限公司 样本分析仪的检测控制方法和样本分析仪控制器

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