Full-automatic fluorescence immunochromatography analyzer and sample detection method

Abstract

The invention provides a full-automatic fluorescence immunochromatography analyzer and a sample detection method. By adopting the kit with built-in test strips and detection reagents corresponding to each detection item, namely the kit with consumables, a user only needs to place a sample tube for collecting a to-be-detected sample (such as a blood sample) into the kit, and a follow-up analyzer can automatically perform all follow-up operations without any manual intervention. The N detection items of the to-be-detected sample are automatically detected, the number of detection items is large, complex operation of a user is not needed, only the sample tube containing the to-be-detected sample needs to be prepared, the operation difficulty of the user is lowered, operation is easy, and the automation degree is high.

Description

Technical Field

[0001] Embodiments of the present disclosure relate to the technical field of in vitro diagnostic biopharmaceuticals, and particularly to a fully automatic fluorescence immunoassay chromatograph analyzer and a sample detection method. Background Art

[0002] Fluorescence immunoassay chromatography analysis is an analytical technique that uses a fluorescent substance as a tracer to label an antigen or antibody and perform an immune reaction with the analyte, and measures the fluorescence intensity of the final product to obtain the concentration of the analyte.

[0003] Existing solutions for fluorescence immunoassay chromatography analysis of blood samples have the following problems:

[0004] First of all, blood sample detection can basically only be carried out in hospitals. For patients, there are often problems such as difficult queuing and difficult registration, which cannot meet the patients' needs for convenient examinations.

[0005] Secondly, although there are already related fluorescence immunoassay detection instruments that have been miniaturized and can be used in various scenarios such as small clinics and families, which can provide convenience for patients to perform relevant detections. But almost all of them are semi-automatic instruments, and the pre-sample processing needs to be done manually, with a low degree of automation and certain requirements for operators. For example, after sample collection (such as blood collection), it is necessary to manually use a pipette to aspirate the blood sample onto the reagent card, then use a pipette to aspirate the detection reagent (such as diluent) and mix it with the blood sample on the reagent card (such as dilution), and add the mixed liquid to the display area of the reagent card. Finally, the reagent card is manually placed into the instrument for detection and reading. The above operations of sampling, mixing, and adding samples are difficult and not suitable for general users. Summary of the Invention

[0006] Embodiments of the present disclosure provide a fully automatic fluorescence immunoassay chromatograph analyzer and a sample detection method.

[0007] In a first aspect, embodiments of the present disclosure provide a fully automatic fluorescence immunoassay chromatograph analyzer, which includes: a mobile platform module 01, a sample addition module 03, an information collection module 02, a temperature control module 04, an optical detection module 05, a data processing module 06, a power supply 07, and a reagent kit 08;

[0008] The reagent kit 08 is provided with N test strips corresponding one-to-one to each of the N detection items, where N is a positive integer;

[0009] The mobile platform module 01 is used to transport the reagent kit 08 carrying the sample to be tested;

[0010] The information collection module 02 is used to collect information on the N detection items corresponding to the reagent kit 08;

[0011] The sample addition module 03 is configured to sample and dilute the to-be-tested sample according to the N types of detection item information, and respectively add the sample to the sample addition areas of the N test strips;

[0012] The temperature control module 04 is configured to perform constant temperature incubation on the N test strips;

[0013] The optical detection module 05 is configured to perform photoelectric signal conversion on the color development areas of each of the test strips one by one;

[0014] The data processing module 6 is configured to control the mobile platform module 01, the sample addition module 03, the information acquisition module 02, the temperature control module 04, and the optical detection module 05 to perform fluorescence immunochromatographic analysis on the to-be-tested sample, so as to obtain the detection results of each of the N types of detection items in the to-be-tested sample;

[0015] The power supply 07 is configured to provide electrical energy for the mobile platform module 01, the sample addition module 03, the information acquisition module 02, the temperature control module 04, the optical detection module 05, and the data processing module 06.

[0016] In some alternative embodiments, the kit 08 includes: an upper cover 081 and a main body 082, and the N test strips are arranged between the upper cover 081 and the main body 082;

[0017] The upper cover 081 is provided with N test strip sample addition holes 0811 and N test strip detection holes 0812, and the N test strip sample addition holes 0811 and the N test strip detection holes 0812 penetrate through the upper and lower surfaces of the upper cover 081;

[0018] The sample addition areas of the N test strips are respectively exposed from the N test strip sample addition holes 0811, and the display areas of the N test strips are respectively exposed from the N test strip detection holes 0812;

[0019] The main body 082 is provided with an internally hollow cavity, and at least part of the temperature control module 04 is arranged in the internally hollow cavity;

[0020] The top of the main body 082 includes a sample operation area 0821 and a test strip channel area 0822. The sample operation area 0821 is provided with a TIP head grasping position 08211, a TIP head discarding position 08212, a sample aspiration position 08213, a detection reagent position 08214, and a sample mixing position 08215, and the N test strips are arranged in the test strip channel area 0822.

[0021] In some alternative embodiments, the kit 08 is provided with an RFID electronic tag 083; and

[0022] The information acquisition module 02 is used to acquire information on N test items corresponding to the kit 08, including:

[0023] The information acquisition module 02 is used to identify the RFID electronic tag 083 set on the kit 08 to obtain information on N test items corresponding to the kit 08.

[0024] In some alternative embodiments, the mobile platform module 01 includes: a first base 011, a second base 012, a third base 013, a first sliding guide rail 014, a second sliding guide rail 015, a first motor 016, and a second motor 017;

[0025] The second base 012 is installed on the first base 011. The first sliding guide rail 014 connects the first base 011 and the second base 012. The second base 012 can slide along the extension direction of the first sliding guide rail 014, and the extension direction of the first sliding guide rail 014 is the first direction;

[0026] The third base 013 is installed on the second base 012. The second sliding guide rail 015 connects the second base 012 and the third base 013. The third base 013 can slide along the extension direction of the second sliding guide rail 015, and the extension direction of the second sliding guide rail 015 is the second direction;

[0027] The second base 012 is driven by the first motor 016, and the third base 013 is driven by the second motor 017.

[0028] In some alternative embodiments, the mobile platform module 01 may further include a first in-place sensor 018 and a second in-place sensor 019. The first in-place sensor 018 is used to identify whether the second base 012 reaches the initial position in the first direction, and the second in-place sensor 019 is used to identify whether the third base 013 reaches the initial position in the second direction.

[0029] In some alternative embodiments, the temperature control module 04 includes an upper incubation module 041 and a lower incubation module 042. The upper incubation module 041 and the lower incubation module 042 are respectively used for performing constant-temperature incubation above and below the display areas of the N test strips.

[0030] In some alternative embodiments, the fully automatic fluorescence immunochromatography analyzer further includes:

[0031] A housing 09, with the mobile platform module 01, the sample addition module 03, the information acquisition module 02, the temperature control module 04, the optical detection module 05, the data processing module 06, and the power supply 07 disposed inside the housing 09.

[0032] In some alternative embodiments, the housing 09 is provided with a hatch door 10, through which the reagent kit 08 can enter the interior of the housing 09.

[0033] In some alternative embodiments, the hatch door 10 includes: a door panel 101, a shaft mounting hole 102 provided on the door panel 101, a hatch door shaft 103, a torsion spring limiting groove 104, and a torsion spring 105. The shaft mounting hole 102 is used for assembling the hatch door shaft 103. The door panel 101 can rotate along the hatch door shaft 103. The torsion spring limiting groove 104 is used for clamping the torsion spring 105. The door panel 101 can automatically reset under the action of the torsion force of the torsion spring 105.

[0034] In some alternative embodiments, the fully automatic fluorescence immunoassay analyzer further includes:

[0035] A display module 11, which is embedded in the housing 09. The display module 11 is used for displaying the information output by the data processing module 06. Optionally, the display module 11 is further used for receiving the data input by the user and sending it to the data processing module 06.

[0036] In some alternative embodiments, the sample addition module 03 includes:

[0037] A sampling head 031, a plunger pump 032, and a lifting drive mechanism 033. Among them, the sampling head 031 is used for sucking negative pressure, sucking TIP heads, sampling, and adding samples under the control of the plunger pump 032. The lifting drive mechanism 033 is used for controlling the moving distance of the sampling head 031.

[0038] In some alternative embodiments, the sampling head 031 has a hollow pipe structure inside. The sampling head 031 includes a connection section 0311, a boss 0312, and a sampling section 0313 that are sequentially in gas communication.

[0039] In some alternative embodiments, the plunger pump 032 includes a plunger chamber 0321 and a plunger rod 0322. The plunger rod 0322 is sleeved inside the plunger chamber 0321. The plunger rod 0322 has a first end 0322a. The extending directions of the plunger chamber 0321 and the plunger rod 0322 are the second direction. The connecting section 0311 includes a partial first connecting section 03111 extending along the second direction and a second connecting section 03112 extending along a third direction perpendicular to the first direction and the second direction. The second connecting section 03112, the boss 0312, and the sampling section 0313 extend along the third direction.

[0040] In some alternative embodiments, the first connecting section 03111 is fixedly and sealingly connected to the plunger chamber 0321. The plunger rod 0322 can move along the second direction within the plunger chamber 0321 and the first connecting section 03111.

[0041] In some alternative embodiments, the lifting drive mechanism is configured to drive the sampling head 031 to move along the third direction.

[0042] In some alternative embodiments, the plunger rod 0322 further has a second end 0322b opposite to the first end 0322a, and the plunger pump 032 further includes a plunger sensing piece 0323 fixedly disposed at the second end 0322b.

[0043] In some alternative embodiments, the sample addition module 03 is further provided with a third in-place sensor 034. The third in-place sensor 034 is configured to identify whether the sampling head 031 and the plunger pump 032 reach the initial position in the third direction.

[0044] In some alternative embodiments, the sample addition module 03 is further provided with a fourth in-place sensor 035. The fourth in-place sensor 035 is configured to identify whether the plunger rod 0322 reaches the initial position in the second direction.

[0045] In some alternative embodiments, the sample addition module 03 is further provided with an X-ring seal 0391, an O-ring seal 0392, and a negative pressure seal 0393;

[0046] The inner wall of the first connecting section 03111 in contact with the plunger rod 0322 is provided with a first groove. The plunger rod 0322 slides along the first groove within the first connecting section 03111 in the first direction. The X-ring seal 0391 is disposed at the first groove for achieving a moving seal between the first connecting section 03111 and the plunger rod 0322.

[0047] The O-ring seal 0392 is disposed on the end face of the plunger chamber 0321 close to the first connection section 03111 for achieving static sealing between the plunger chamber 0321 and the first connection section 03111.

[0048] The negative pressure seal ring 0393 is disposed on the sampling section 0313 of the sampling head 031 for forming a negative pressure seal between the sampling head 031 and the surface to be sampled when the sampling section contacts the surface to be sampled.

[0049] In a second aspect, an embodiment of the present disclosure provides a sample detection method, which is applied to the fully automatic fluorescence immunoassay analyzer described in any implementation manner of the first aspect. The method includes:

[0050] Prepare a reagent kit 08 with a sample tube 12 placed therein, and the sample tube 12 contains a sample to be tested.

[0051] The mobile platform module 01 transports the reagent kit 08 to a preset information collection position.

[0052] The information collection module 02 collects information on N detection items corresponding to the reagent kit 08.

[0053] The mobile platform module 01 transports the reagent kit 08 to a preset negative pressure position, and the sample addition module 03 applies negative pressure to the reagent kit 08.

[0054] The sample addition module 03 samples and dilutes the sample to be tested according to the information on the N detection items, and respectively adds the sample to the sample addition areas of each test strip.

[0055] The mobile platform module 01 transports the reagent kit 08 to a preset incubation position.

[0056] The temperature control module 04 performs constant temperature incubation on the N test strips.

[0057] For each detection item among the N detection items, the mobile platform module 01 transports the reagent kit 08 so that the display area of the test strip for this detection item is located at a preset detection position, and the optical detection module 05 performs photoelectric signal conversion to obtain the photoelectric signal conversion result for this detection item.

[0058] The data processing module 06 performs fluorescence immunoassay analysis on the photoelectric signal conversion result of each detection item to obtain the detection result of the sample to be tested for this detection item.

[0059] In some alternative implementation manners, the temperature control module 04 performing constant temperature incubation on the N test strips includes:

[0060] The temperature control module 4 performs constant temperature incubation on the display areas of the N test strips.

[0061] In some alternative embodiments, the temperature control module 4 performs constant-temperature incubation on the display areas of the N test strips, including:

[0062] The temperature control module 4 heats the display areas of the N test strips at a preset heating power for a preset incubation duration.

[0063] To solve the problems of low automation and high requirements for operators in existing miniaturized fluorescence immunoassay instruments, the full-automatic fluorescence immunoassay analyzer and sample detection method provided by the embodiments of the present disclosure adopt a kit with test strips and detection reagents corresponding to each detection item, that is, a kit with consumables. The user only needs to place the sample tube containing the sample to be tested (such as a blood sample tube) into the kit, and then the subsequent analyzer will automatically perform all subsequent operations without any manual intervention. Specifically, the analyzer will transport the kit to a preset information collection position through the mobile platform module 01, and the information collection module 02 will collect the information of N detection items corresponding to the kit; then, the mobile platform module 01 will transport the kit to a preset negative pressure suction position, and the sample addition module 03 will apply negative pressure to the kit 08; then, the sample addition module 03 will sample and dilute the sample to be tested according to the information of N detection items, and add the samples to N test strips respectively; then, the mobile platform module 01 will transport the kit 08 to a preset incubation position; then, the temperature control module 04 will perform constant-temperature incubation on the N test strips; then, the optical detection module 05 will perform photoelectric signal conversion on the display area of each test strip one by one; finally, the data processing module 6 will perform fluorescence immunoassay analysis according to the photoelectric signal conversion results of the optical detection module 5 for each detection item to obtain the detection results of the sample to be tested for each detection item. Thus, automatic detection of N detection items for the sample to be tested is realized, with a large number of detection items, and the user does not need to perform complex operations. The user only needs to prepare a sample tube containing the sample to be tested, which reduces the operation difficulty of the user, is simple to operate, and has a high degree of automation. Description of the Drawings

[0064] By reading the detailed description of the non-limiting embodiments with reference to the following drawings, other features, objects, and advantages of the present disclosure will become more apparent. The drawings are only for the purpose of showing the specific embodiments and are not considered as a limitation to the present disclosure. In the drawings:

[0065] Figure 1A is a perspective three-dimensional schematic diagram of a full-automatic fluorescence immunoassay analyzer according to one perspective of the present disclosure;

[0066] Figure 1B is a perspective three-dimensional schematic diagram of the exterior of a full-automatic fluorescence immunoassay analyzer according to one perspective of the present disclosure;

[0067] Figure 1C It is a three-dimensional schematic diagram when the kit is about to enter and the door of the fully automatic fluorescence immunoassay analyzer according to the present disclosure is opened;

[0068] Figure 2A It is a three-dimensional external schematic diagram of kit 08;

[0069] Figure 2B It is a three-dimensional schematic diagram of kit 08 after removing the upper cover 081;

[0070] Figure 2C It is a sectional view of kit 08;

[0071] Figure 3A and Figure 3B respectively show a three-dimensional schematic diagram of an embodiment of the cooperation relationship between the mobile platform module 01 and the kit 08 in two cases where the sample addition module 03 is shown and not shown during the process of the mobile platform module 01 transporting the kit 08 from the first perspective;

[0072] Figure 3C It shows a three-dimensional schematic diagram of an embodiment of the mobile platform module 01 without showing the sample addition module 03 and the kit 08 from the second perspective;

[0073] Figure 3D It shows a three-dimensional schematic diagram of an embodiment of the mobile platform module 01 without showing the sample addition module 03 and the kit 08 from the third perspective;

[0074] Figure 4A It shows a three-dimensional schematic diagram of an embodiment of the sample addition module 03 according to the present disclosure;

[0075] Figure 4B is Figure 4A a sectional view of the sample addition module 03 shown;

[0076] Figure 5A It shows a three-dimensional schematic diagram of an embodiment of the upper incubation module 041;

[0077] Figure 5B and Figure 5C respectively show a three-dimensional schematic diagram of an embodiment of the lower incubation module 042 from the fourth perspective and the fifth perspective;

[0078] Figure 5D and Figure 5E respectively show a schematic diagram of the assembly position relationship between the upper incubation module 041, the lower incubation module 042 and the kit 08 from the sixth perspective and the seventh perspective;

[0079] Figure 6A It is a three-dimensional schematic diagram of an embodiment of the door 10 according to the present disclosure;

[0080] Figure 6B It is an assembly schematic diagram of a bin door 10 according to an embodiment of the present disclosure;

[0081] Figure 7 It is a flowchart schematic diagram of a sample detection method according to an embodiment of the present disclosure.

[0082] Description of reference numerals:

[0083] 01 - Mobile platform module; 011 - First base; 012 - Second base; 013 - Third base; 014 - First sliding guide rail; 015 - Second sliding guide rail; 016 - First motor; 017 - Second motor; 018 - First in - place sensor; 019 - Second in - place sensor; 01Ia - Installation position interface of information acquisition module 02; 01Ib - Installation position interface of temperature control module 04; 02 - Information acquisition module; 03 - Sampling module; Sampling head 031; Front end 031a; Tail end 031b; Connection section 0311; First connection section 03111; Second connection section 03112; Boss 0312; Sampling section 0313; Plunger pump 032; Plunger cavity 0321; Third end 0321a; Fourth end 0321b; Plunger rod 0322; First end 0322a; Second end 0322b; Plunger induction sheet 0323; Fourth motor 0324; Second rack 0325; Second gear 0326; Lifting drive mechanism 033; Third motor 0331, First rack 0332; Third in - place sensor 034; Fourth in - place sensor 035; Support plate 036; Guide rod 037; Sensor fixing plate 0381; Connection plate 0382; Flexible cable 0383; Plug - in terminal interface 0384; Star - shaped sealing ring 0391; O - ring 0392; Negative pressure sealing ring 0393; 04 - Temperature control module; 041 - Upper incubation module; 0411 - First heating film; 0412 - First heat conducting block; 0413 - First temperature control circuit board; 0414 - First plastic adapter plate; 042 - Lower incubation module; 0421 - Second heating film; 0422 - Second heat conducting block; 0423 - Second temperature control circuit board; 0424 - Second plastic adapter plate; 0425 - Temperature control adapter plate; 0426 - Temperature control board in - place sensor; 05 - Optical detection module; 06 - Data processing module; 07 - Power supply; 08 - Reagent kit; 081 - Upper cover; 0811 - Test strip sampling hole; 0812 - Test strip detection hole; 082 - Main body; 0821 - Sample operation area; 08211 - TIP head grasping position; 08212 - TIP head discarding position; 08213 - Sample sampling position; 08214 - Detection reagent position; 08215 - Sample mixing position; 08221 - Test strip channel; 0822 - Test strip channel area; 0823 - Internally hollow cavity; 083 - RFID electronic tag; 09 - Outer shell; 10 - Chamber door; 11 - Display module; 12 - Sample tube; 13 - TIP head. Detailed implementation manners

[0084] The embodiments of the present disclosure will be described in detail below. Examples of the embodiments are shown in the accompanying drawings, where the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are intended to explain the present disclosure and should not be construed as limiting the present disclosure.

[0085] It should be noted that, without conflict, the embodiments in the present disclosure and the features in the embodiments may be combined with each other. The following will describe the present disclosure in detail with reference to the accompanying drawings and in conjunction with the embodiments.

[0086] It should be understood that in the description of the present disclosure, the orientation or positional relationships indicated by the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "clockwise", "counterclockwise", etc. are based on the orientation or positional relationships shown in the drawings. These are only for the convenience of describing the present disclosure and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation to the present disclosure.

[0087] In addition, the terms "first" and "second" are only used for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include one or more of such features. In the description of the present disclosure, unless otherwise specified, the meaning of "a plurality" is two or more, unless otherwise clearly defined.

[0088] In the present disclosure, unless otherwise clearly specified and defined, terms such as "mounted", "connected", "coupled", "fixed", etc. should be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or an integral connection; it may be a mechanical connection or an electrical connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present disclosure may be understood according to specific circumstances.

[0089] In the present disclosure, unless otherwise clearly specified and defined, the first feature being "above" or "below" the second feature may include the direct contact between the first and second features, or may include the situation where the first and second features are not in direct contact but in contact through other features therebetween. Moreover, the first feature being "above", "over" and "on" the second feature includes that the first feature is directly above and obliquely above the second feature, or merely indicates that the horizontal height of the first feature is higher than that of the second feature. The first feature being "below", "under" and "beneath" the second feature includes that the first feature is directly below and obliquely below the second feature, or merely indicates that the horizontal height of the first feature is lower than that of the second feature.

[0090] The following refers to Figure 1A , wherein Figure 1A is a three-dimensional schematic view of a perspective of a fully automatic fluorescence immunoassay chromatograph according to the present disclosure.

[0091] As Figure 1A shown, the fully automatic fluorescence immunochromatography analyzer may include a mobile platform module 01, an information collection module 02, a sampling module 03, a temperature control module 04, an optical detection module 05, a data processing module 06, a power supply 07, and a reagent kit 08.

[0092] Among them, the reagent kit 08 is provided with N test strips corresponding one-to-one to each of the N detection items. N is a positive integer. It can be understood that when N is greater than or equal to 2, there are at least two test strips in the reagent kit 08, which can support at least two detection items.

[0093] Exemplarily, please refer to Figure 2A , Figure 2B and Figure 2C , Figure 2A which is an external three-dimensional schematic diagram of the reagent kit 08, Figure 2B which is a three-dimensional schematic diagram of the reagent kit 08 after removing the upper cover 081, Figure 2C which is a sectional view of the reagent kit 08. As Figure 2A , Figure 2B and Figure 2C shown, the reagent kit 08 includes: an upper cover 081 and a main body 082, and N test strips can be placed between the upper cover 081 and the main body 082. Among them: three test strip sampling holes 0811 and three test strip detection holes 0812 are provided in the upper cover 081, and the three test strip sampling holes 0811 and the three test strip detection holes 0812 penetrate the upper and lower surfaces of the upper cover 081.

[0094] When the reagent kit 08 is provided with test strips, the sampling areas of the three test strips are respectively exposed from the three test strip sampling holes 0811, and the display areas of the three test strips are respectively exposed from the three test strip detection holes 0812. In this way, the sampling module 03 can add samples to the corresponding sampling areas of the lower test strips by adding samples to the test strip sampling holes 0811. Similarly, the optical detection module 05 can also perform optical detection on the test strip detection holes 0812 to perform optical detection on the display areas of the corresponding lower test strips.

[0095] The main body 082 is a hollow structure inside, that is, an internal hollow cavity 0823 can be provided, and at least part of the temperature control module 04 can be provided in the internal hollow cavity 0823. Thus, the internal hollow cavity 0823 can cooperate with the temperature control module 04, and at least part of the heating function module of the temperature control module 04 can enter the internal hollow cavity 0823 to heat each test strip above the internal hollow cavity 0823 to achieve constant temperature incubation.

[0096] The top of the main body 082 includes a sample operation area 0821 and a test strip channel area 0822. The sample operation area 0821 is provided with a TIP head grasping position 08211, a TIP head discarding position 08212, a sample aspiration position 08213, a detection reagent position 08214, and a sample mixing position 08215.

[0097] Among them, a TIP head cavity can be arranged below the TIP head grasping position 08211, and at least one TIP head 13 is accommodated in the TIP head cavity. The sampling head 031 can aspirate the TIP head 13 from the above-mentioned TIP head grasping position 08211 and assemble it on the sampling section 0313 of the sampling head 031.

[0098] The TIP head discarding position 08212 is used to release the unnecessary TIP head 13 to the TIP head discarding position 08212 after the sampling head 031 completes the tasks of aspirating and adding samples using the TIP head 13.

[0099] The sample aspiration position 08213 is connected to an aspiration cavity below. The aspiration cavity can accommodate the sample to be tested from the sample tube 12. The sample aspiration position 08213 is used to cooperate with the sampling section 0313 of the sampling head 031 to form negative pressure in the sampling head 031. After the sampling head 031 is assembled with the TIP head 13, it can aspirate the sample to be tested flowing from the sample tube 12 from the sample aspiration position 08213.

[0100] The detection reagent position 08214 is connected to a reagent cavity below. The reagent cavity contains a diluent. After the sampling head 031 is assembled with the TIP head 13, it can aspirate the diluent from the detection reagent position 08214.

[0101] The sample mixing position 08215 is connected to a sample addition cavity below. After the sampling head 031 is assembled with the TIP head 13, it can aspirate the sample to be tested from the sample aspiration position 08213, then add the sample to the sample mixing position 08215, and then aspirate the diluent from the detection reagent position 08214 and also add it to the sample mixing position 08215. Furthermore, the diluted sample to be tested is accommodated in the sample addition cavity below the sample mixing position 08215. The diluted sample to be tested can be aspirated from the sample addition cavity below the sample mixing position 08215 using the TIP head 13 assembled on the sampling head 031 and then added to the required test strip sample addition hole 0811.

[0102] The kit 08 can also be provided with a sample tube position 084. The sample tube position 084 is used to support the sample tube 12 and connect the sample tube 12. The sample tube 12 can accommodate the sample to be tested (for example, a blood sample).

[0103] The sample tube 12 is provided with a sealed tube cap. The middle part of the tube cap of the sample tube 12 is made of silica gel. The kit 08 is provided with a hollow puncture tip corresponding to the position of the silica gel in the middle of the tube cap of the sample tube 12. When the tube cap of the sample tube 12 is inverted downward onto the sample tube position 084, the hollow puncture tip provided by the kit 08 can pierce the silica gel in the middle of the tube cap of the sample tube 12, and the sample transfer cavity is below the inverted position of the sample tube 12 at the sample tube position 084. In this way, the sample tube 12 can communicate with the above-mentioned sample transfer cavity, and then the sample to be tested in the sample tube 12 can enter the sample transfer cavity of the kit 08 under the action of negative pressure.

[0104] In addition, a sampling cavity can also be provided below the sample sampling position 08213. The sampling cavity is also communicated with the sample transfer cavity. When the sampling head 031 of the sample adding module 03 contacts the sample sampling position 08213 to draw negative pressure, the sample to be tested in the sample tube 12 can be drawn into the sample transfer cavity of the kit 08 by drawing negative pressure, and then into the sampling cavity below the sample sampling position 08213. Subsequently, after the sampling head 031 is assembled with the TIP head 13, the sample to be tested can be aspirated from the sampling cavity below the sample sampling position 08213 of the kit 08.

[0105] The test strip channel area 0822 is provided with three test strip channels 08221. One test strip can be placed on each test strip channel 08221, and the three test strips are respectively arranged in the three test strip channels 08221 of the test strip channel area 0822. After each test strip is placed on the test strip channel 082221, the test strip adding hole 0811 on the upper cover 081 corresponds to the adding area of the test strip below, and then the sample to be tested can be added from the test strip adding hole 0811 on the upper cover 081, and then the sample to be tested can directly enter the adding area of the test strip. Similarly, the test strip detection hole 0812 on the upper cover 081 corresponds to the display area (or detection area) of the test strip below, and then the display area (or detection area) of the test strip below can be observed from the test strip detection hole 0812 on the upper cover 081.

[0106] In addition, an RFID electronic tag 083 can be provided on the side wall of the kit 08, and the specific N kinds of test item information corresponding to the kit 08 are stored through the above-mentioned RFID electronic tag. For example, the test item information can include a test item identifier for uniquely indicating a specific test item. For example, the kit 08 is designed to be able to detect three test items A, B, and C. Correspondingly, three test strips for test items A, B, and C are respectively placed in the three test strip channels 08221 of the kit 08, and the test item information of test items A, B, and C can be stored in the RFID electronic tag 083. The information collection module 02 can obtain the N kinds of test item information corresponding to the kit 08 by reading the RFID electronic tag 083.

[0107] It should be noted that Figure 2A 、 Figure 2B and Figure 2C only exemplarily show a specific example where Kit 08 corresponds to N = 3. In practice, the value of N can be designed according to actual needs, and the present disclosure does not make specific limitations thereon. For example, N can also be 1, 2, 3, 4, and larger positive integers, etc.

[0108] The mobile platform module 01 is used to transport Kit 08 carrying the sample to be tested. It can be understood that various implementation methods can be adopted here to design the mobile platform module 01 so that the mobile platform module 01 can transport Kit 08.

[0109] Exemplarily, reference can be made to Figure 3A 、 Figure 3B 、 Figure 3C and Figure 3D . Figure 3A and Figure 3B respectively show a perspective view of an embodiment of the cooperation relationship between the mobile platform module 01 and Kit 08 in two cases where the sample addition module 03 is shown and not shown during the process of the mobile platform module 01 transporting Kit 08 from the first perspective. Figure 3C shows a perspective view of an embodiment of the mobile platform module 01 without showing the sample addition module 03 and Kit 08 from the second perspective, Figure 3D shows a perspective view of an embodiment of the mobile platform module 01 without showing the sample addition module 03 and Kit 08 from the third perspective.

[0110] As Figure 3A 、 Figure 3B 、 Figure 3C and Figure 3D shown, the mobile platform module 01 includes a first base 011, a second base 012, a third base 013, and related sliding parts and driving parts. Among them, the second base 012 is installed on the first base 011, and the two are connected by a first sliding guide rail 014. The second base 012 can slide along the extension direction of the first sliding guide rail 014, and the extension direction of the first sliding guide rail 014 can be the first direction.

[0111] The third base 013 is installed on the second base 012, and the two are connected by a second sliding guide rail 015. The third base 013 can slide along the extension direction of the second sliding guide rail 015, and the extension direction of the second sliding guide rail 015 can be the second direction.

[0112] The driving force for the sliding of the first base 011, the second base 012, and the third base 013 is provided by a motor, and the driving method adopts the meshing method of a gear and a rack. Specifically, the second base 012 is provided with a driving force by the first motor 016, and the third base 013 is provided with a driving force by the second motor 017.

[0113] The kit 08 can be installed on the third base 013. Furthermore, the kit 08 can be driven by the second motor 017 to move along the extension direction of the second sliding guide 015 (i.e., the second direction). In addition, since the third base 013 is arranged on the second base 012, the kit 08 can also be driven by the first motor 016 to move along the extension direction of the first sliding guide 014 (i.e., the first direction). Finally, the kit 08 can be driven by the moving platform module 01 to move along the first direction and / or the second direction. It can be understood that the process of the kit 08 entering the analyzer from the outside of the analyzer is a movement along the second direction.

[0114] The moving platform module 01 may further include a first in-place sensor 018 and a second in-place sensor 019. Among them, the first in-place sensor 018 is used to identify whether the second base 012 reaches the initial position in the first direction, and the second in-place sensor 019 is used to identify whether the third base 013 reaches the initial position in the second direction.

[0115] Specifically, the initial position of the second base 012 in the first direction can be determined by the first in-place sensor 018, and the initial position of the third base 013 in the second direction can be determined by the second in-place sensor 019. To realize the positioning of the initial position of the second base 012 in the first direction and the initial position of the third base 013 in the second direction. After each detection is completed, the second base 012 in the moving platform module 01 needs to return to the initial position in the first direction, and the third base 013 needs to return to the initial position in the second direction. And before each detection, it is also necessary to detect whether the second base 012 and the third base 013 are respectively in their initial positions in the first direction and the second direction. And when it is confirmed that both are in the initial positions, through the control of the first motor 016 and the second motor 017, the movement distance and direction of the second base 012 and the third base 013 are precisely controlled, and further the movement distance and direction of the kit 08 are precisely controlled.

[0116] Optionally, the mobile platform module 01 also provides an installation location interface 01Ia for the information collection module 02 and an installation location interface 01Ib for the temperature control module 04. The installation location interface 01Ia of the information collection module 02 can be set on the side wall of the third base 013. Furthermore, the information collection module 02 can be fixedly installed on the third base 013 of the mobile platform module 01 through the installation location interface 01Ia. In this way, after the test kit 08 enters the third base 013, the information collection module 02 can read the RFID electronic tag 083 set on the side wall of the test kit 08 to obtain the N types of test item information corresponding to the test kit 08. The installation location interface 01Ib of the temperature control module 04 can be set on the end face of the third base 013 that is perpendicular to the extension direction of the second sliding guide 015 and parallel to the extension direction of the first sliding guide 014. In this way, the temperature control module 04 can fixedly set some or all of the heating function modules inside the third base 013 through the above installation hole position interface 01Ib. In this way, after the test kit 08 enters the third base 013, since the test kit 08 is hollow inside and has an internal hollow cavity 0823, the heating function module of the temperature control module 04 that enters the inside of the third base 013 can be inserted into the above internal hollow cavity 0823, and then heat the test strip above the internal hollow cavity 0823 of the test kit 08 to achieve constant temperature incubation.

[0117] The information collection module 02 is used to collect the N types of test item information corresponding to the test kit 08. Here, the information collection module 02 can be provided with information reading devices of corresponding types according to the types of test item information storage elements set on the test kit 08.

[0118] As an example, when the test kit 08 is provided with an RFID electronic tag 083, the information collection module 02 can be an RFID electronic tag reader, that is, a circuit board with the function of reading RFID electronic tags. Exemplarily, the information collection module 02 can be set on the side wall of the third base 013 of the mobile platform module 01. When the test kit 08 is inserted into the third base 013, the information collection module 02 will automatically read the RFID electronic tag set on the side wall of the test kit 08 to obtain the test item information of the N types of test items corresponding to the test kit 08, and send the above test item information to the data processing module 06.

[0119] The sample addition module 03 is used to sample and dilute the test sample according to the N types of test item information corresponding to the test kit 08, and add the sample to the sample addition areas of N test strips respectively. Specifically, the sample addition module 03 can be used to automatically suck negative pressure on the test kit 08, suck the TIP head, sample and add the sample.

[0120] Exemplarily, reference can be made to Figure 4A and Figure 4B . Figure 4AA three-dimensional schematic diagram of an embodiment of the sampling module 03 according to the present disclosure is shown. As Figure 4A shown, the sampling module 03 may include a sampling head 031, a plunger pump 032, and a lifting drive mechanism 033. Among them:

[0121] The sampling head 031 provides functions of sucking negative pressure, sucking the TIP head, sampling, and adding samples (or spitting samples). The sampling head 031 may include a front end 031a and a tail end 031b. The front end 031a of the sampling head 031 has a spike that can pierce the sealing structure (e.g., a sealing film) of the sample tube. The head (or sampling section) of the sampling head 031 near the front end 031a can be adaptively designed according to the shape and size of the TIP head 13 to be sucked, so as to fix the TIP head 13 on the head of the sampling head 031.

[0122] Exemplarily, the head of the sampling head 031 may be conical and cooperate with and seal the TIP head 13. As Figure 4A shown, in order to have good stability, the inner wall of the tail of the TIP head 13 to be sucked has a first taper, and the outer wall of the head (or sampling section) of the sampling head 031 has a taper adapted to the first taper of the inner wall of the tail of the TIP head 13. After the up and down movement of the TIP head 13 and the sampling head 031, the outer wall of the head of the sampling head 031 can be stuck in the inner wall of the tail of the TIP head 13.

[0123] In order to achieve the function of sucking negative pressure of the sampling head 031, from the tail end 031b to the front end 031a direction, the sampling head 031 may include a connecting section 0311, a boss 0312, and a sampling section 0313 (i.e., the sampling part of the sampling head 031 near the front end 031a). Among them, the connecting section 0311 and the boss 0312 are connected through a groove, and the sealing between the connecting section 0311 and the boss 0312 is achieved by fixing a sealing ring through the above groove. The material of the sampling head 031 can be SUS 304 selected according to wear resistance and service life. The boss 0312 and the sampling section 0313 can also be connected through a groove, and the sealing between the boss 0312 and the sampling section 0313 is achieved by fixing a sealing ring through the above groove.

[0124] The plunger pump 032 may include a plunger chamber 0321 and a plunger rod 0322. The plunger rod 0322 is sleeved inside the plunger chamber 0321, and the plunger rod 0322 has a first end 0322a. The extending direction of the plunger chamber 0321 and the plunger rod 0322 (as Figure 4A shown, the left and right direction) is the second direction.

[0125] The sampling head 031 is a 90-degree corner sampling head. Among them, the connecting section 0311 includes a partial first connecting section 03111 extending along the second direction and a third direction (as Figure 4AAs shown, a partial second connection section 03112 extending in the vertical direction (up and down direction), and the second connection section 03112, the boss 0312, and the sampling section 0313 extend in the third direction.

[0126] The first connection section 03111 of the sampling head 031 is fixedly and sealingly connected to the plunger chamber 0321.

[0127] The sampling head 031 is a hollow pipe structure inside, and the plunger rod 0322 can move in the second direction within the plunger chamber 0321 and the first connection section 03111. That is, it can be understood that there is gas communication between the sampling head 031 and the plunger chamber 0321. Furthermore, the air pressure inside the plunger chamber 0321 and the sampling head 031 can be controlled by the movement of the plunger rod 0322, and then the sampling head 031 can be controlled to suck negative pressure, suck the TIP head, sample or add samples, as well as the specific volume of sampling or adding samples.

[0128] The lifting drive mechanism 033 is used to drive the sampling head 031 and the plunger pump 032 to move in the third direction (such as Figure 3A As shown, the up and down direction), that is, the sampling head 031 can move in the third direction driven by the lifting drive mechanism 033.

[0129] Exemplarily, as Figure 4A shown, the lifting drive mechanism 033 may include a third motor 0331, a first rack 0332, and a first gear ( Figure 4A not shown in the figure). The first rack 0332 extends in the third direction (such as Figure 4A shown, the up and down direction). When the third motor 0331 is energized and rotates, its output shaft can drive the first gear to rotate. The teeth of the first gear mesh with the teeth of the first rack 0332. The rotational movement of the first gear is transmitted to the first rack 0332 through the meshing of the tooth shapes. Then, the first rack 0332 moves linearly along its length direction (such as Figure 4A shown, the up and down direction). The first rack 0332 is meshingly connected to the plunger chamber 0321. Since the sampling head 031 is fixedly connected to the plunger chamber 0321, the linear movement of the first rack 0332 drives the plunger chamber 0321 and the sampling head 031 to move in the third direction (such as Figure 4A shown, the up and down direction).

[0130] Optionally, as Figure 4A shown, the plunger rod 0322 further has a second end (or tail) 0322b opposite to the first end 0322a, and the plunger pump 032 may further include a plunger sensing piece 0323 fixedly arranged at the second end 0322b. The plunger chamber 0321 correspondingly has a third end 0321a and a fourth end 0321b respectively corresponding to the first end 0322a and the second end 0322b of the plunger rod 0322.

[0131] Optionally, the sample addition module 03 may also be provided with a third in-place sensor 034. Among them:

[0132] The third in-place sensor 034 is used to identify whether the sampling head 031 and the plunger pump 032 reach the initial position in the third direction. Optionally, the initial positions of the sampling head 031 and the plunger pump 032 in the third direction are the initial positions where the sampling head 031 and the plunger pump 032 are farthest from the front end 031a in the third direction (as Figure 4A shown, it can be understood as the uppermost position, or the topmost position). The third in-place sensor 034 can be fixedly arranged relative to the lifting drive mechanism 033 and is arranged at the position farthest from the front end 031a in the third direction. The third in-place sensor 034 can be used to detect the parts of the sampling head 031 and the plunger pump 032 in the direction farthest from the front end 031a, indicating that the sampling head 031 and the plunger pump 032 reach the initial position in the third direction, that is, reach the uppermost position. Subsequently, precise control of the moving distance and direction of the sampling head 031 and the plunger pump 032 in the third direction can be achieved by controlling the third motor 0331.

[0133] Optionally, the sample addition module 03 may also be provided with a fourth in-place sensor 035. The fourth in-place sensor 035 is used to identify whether the plunger rod 0322 reaches the initial position in the second direction.

[0134] Optionally, the initial position of the plunger rod 0322 in the second direction is the initial position where the plunger rod 0322 is closest to the first end 0322a in the second direction (as Figure 4A shown, it can be understood as the rightmost position).

[0135] The fourth in-place sensor 035 can be arranged at the position of the second end 0322b of the plunger cavity 0321 closest to the plunger rod 0322, that is, the fourth end 0321b. In this way, if the plunger rod 0322 moves towards the first end 0322a and finally the plunger induction piece 0323 arranged at the second end 0322b of the plunger rod 0322 reaches the position of the fourth in-place sensor 035 (that is, the fourth end 0321b), the fourth in-place sensor 035 detects the target, indicating that the plunger rod 0322 reaches the initial position in the second direction, and the plunger rod 0322 discharges the gas in the plunger cavity 0321, thereby forming a negative pressure in the sampling head 031. Subsequently, precise control of the moving distance and direction of the plunger rod 0322 in the second direction can be achieved by controlling the plunger pump 032, and further control the negative pressure suction of the sampling head 031, the suction of the TIP head, the sampling or sample ejection, and the precise quantitative control of the sampling or sample ejection, so as to realize the adjustable sampling volume and the adjustable sample addition (or sample ejection) volume.

[0136] Specifically, as Figure 4AAs shown, the plunger pump 032 may further include a fourth motor 0324, a second rack 0325, and a second gear 0326. Among them, the second rack 0325 extends in the second direction. When the fourth motor 0324 is energized and rotates, its output shaft can drive the second gear 0326 to rotate. The teeth of the second gear 0326 mesh with the teeth of the second rack 0325. The rotational motion of the second gear 0326 is transmitted to the second rack 0325 through the meshing of the tooth profiles. Then, the second rack 0325 moves linearly along its length direction (as Figure 4A shown, the left - right direction). The plunger rod 0322 is meshed and connected with the second rack 0325. The linear motion of the second rack 0325 drives the plunger rod 0322 to move in the second direction (as Figure 4A shown, the left - right direction). Furthermore, by controlling the fourth motor 0324, the movement distance and direction of the plunger rod 0322 in the second direction can be precisely controlled. Then, the suction head 031 can be controlled to suck negative pressure, pick up the TIP head, aspirate or dispense samples, and precisely quantitatively control the aspiration or dispensing of samples, realizing the adjustability of the aspiration volume and the adjustability of the sample addition (or sample dispensing) volume.

[0137] Optionally, the sample addition module 03 may further include a support plate 036 and a guide rod 037. The support plate 036 cooperates with the plunger cavity 0321 to provide a positioning reference and structural support for each functional part, and complete the assembly and installation of each functional part. Among them, the functional part, the guide rod 037 and the first rack 0332 of the lifting drive mechanism 033 are arranged on the support plate 036, and the functional part, the plunger rod 0322 is arranged in the plunger cavity 0321.

[0138] Here, the guide rod 037 is used to provide support and guidance for the suction head 031 and the first rack 0332.

[0139] Optionally, the sample addition module 03 may further include: a sensor fixing plate 0381 and a connecting plate 0382. Here, the sensor fixing plate 0381 is used to fix and support the fourth in - place sensor 035, and the connecting plate 0382 is used to fix and support the third motor 0331.

[0140] Optionally, as Figure 4A shown, the sample addition module 03 may further include a flexible cable 0383. The flexible cable 0383 is a flexible cable used for internal connection in the sample addition module 03. One end of the flexible cable 0383 is connected to the data processing module 06, and the other end is connected to each electronic component inside the sample addition module 03, such as the plunger pump 032, the lifting drive mechanism 033, the third in - place sensor 034, the fourth in - place sensor 035, etc. That is, the data processing module 06 can send control instructions to each electronic component inside the sample addition module 03 through the flexible cable 0383, and conversely, the electronic components inside the sample addition module 03 can also feedback messages to the data processing module 06.

[0141] Optionally, the sample loading module 03 may further include a plug-in terminal interface 0384. The plug-in terminal interface 0384 is the terminal interface corresponding to the flexible cable 0383, and the power supply lines, data lines, etc. of the various electronic components in the sample loading module 03 can be connected to the plug-in terminal interface 0384.

[0142] Optionally, please refer to Figure 4B , Figure 4B is Figure 3A the sectional view of the sample loading module 03 shown in. As Figure 4B shown, the sample loading module 03 may further include a star-shaped sealing ring 0391, an O-ring 0392, and a negative pressure sealing ring 0393.

[0143] A groove is provided on the inner wall of the plunger rod 0322 in contact with the portion of the sample pipette tip 031 extending in the second direction. The plunger rod 0322 can slide along the groove in the sample pipette tip 031 in the second direction, and the star-shaped sealing ring 0391 is provided at the groove for achieving a moving seal between the sample pipette tip 031 and the plunger rod 0322. Since the contact area of the star-shaped sealing ring is relatively large, it is equivalent to that the sealing performance between the plunger rod 0322 and the sample pipette tip 031 is also relatively good when the plunger rod 0322 is in a moving state.

[0144] The O-ring 0392 is provided at the end face of the plunger cavity 0321 close to the sample pipette tip 031 for achieving a static seal between the plunger cavity 0321 and the sample pipette tip 031.

[0145] The negative pressure sealing ring 0393 is provided at the sample suction section 0313 of the sample pipette tip 031, for example, at one end of the sample suction section 0313 away from the front end 031a, for forming a negative pressure seal between the sample pipette tip 031 and the sample suction position 08213 of the reagent kit 08 when the sample pipette tip 031 contacts the sample suction position 08213 of the reagent kit 08, ensuring the negative pressure during the negative pressure suction process, so that the sample to be tested can be sucked from the sample tube 12 to the sample transfer cavity of the reagent kit 08, and then the sample pipette tip 031 can suck the sample to be tested from the suction cavity corresponding to the sample suction position 08213 of the reagent kit 08 by using the TIP13 tip.

[0146] Optionally, various performance parameters of the fourth motor 0324 can be determined according to the moving speed of the plunger rod 0322 in the second direction.

[0147] Optionally, as Figure 3B shown, the length of the plunger rod 0322 consists of three parts: an effective functional length L1, a driving requirement length L2, and a structural requirement length L3.

[0148] Among them, the effective functional length L1 is determined according to the maximum sample suction volume requirement.

[0149] The structural requirement length L3 is determined according to the structural support requirements of the plunger pump 032.

[0150] Since the plunger pump 032 itself also has the function of structural support, it needs to support the sensor fixing plate 0381, the plunger sensing piece 0323, and the plug-in terminal interface 0384. Therefore, the structural requirement length L3 can be designed according to the structural support requirements for supporting the sensor fixing plate 0381, the plunger sensing piece 0323, and the plug-in terminal interface 0384.

[0151] The sample addition process using the sample addition module 03 can include: sucking negative pressure, sucking the TIP head, sucking the sample, and adding the sample (or spitting out the sample). Here, the object of sample sucking and sampling can be the sample to be tested or the diluent.

[0152] This sample addition process includes a lifting motion (i.e., the sample sucking head 031 and the plunger pump 032 move along the third direction driven by the third motor 0331) and a left-right motion (i.e., the plunger pump 032 moves along the second direction driven by the fourth motor 0324).

[0153] Here, the driving requirement length L2, that is, the length of the second rack 0325, is determined according to the movement stroke of the left-right motion in the above sample addition process.

[0154] The various performance parameters of the third motor 0331 can be comprehensively determined according to the movement stroke of the lifting motion and the downward pressure required to pick up the TIP head 13 in the above sample addition process. For example, the torque, holding torque, rotational speed, etc. of the third motor 0331.

[0155] The temperature control module 04 is used for incubating N test strips at a constant temperature. It can be understood that the temperature control module 04 can include a heating function module and a corresponding temperature control circuit board, and receives instructions from the data processing module 06 through the temperature control circuit board to control whether to heat.

[0156] Exemplarily, reference can be made to Figure 5A 、 Figure 5B 、 Figure 5C and Figure 5D .

[0157] Figure 5A Shows a three-dimensional schematic diagram of an embodiment of the upper incubation module 041.

[0158] Figure 5B and Figure 5C Respectively show three-dimensional schematic diagrams of an embodiment of the lower incubation module 042 from the fourth perspective and the fifth perspective.

[0159] Figure 5D and Figure 5ESchematic diagrams of the assembly position relationships between the upper incubation module 041, the lower incubation module 042 and the kit 08 from the sixth perspective and the seventh perspective are respectively shown.

[0160] As Figure 5A , Figure 5B , Figure 5C , Figure 5D and Figure 5E shown, the temperature control module 04 includes an upper incubation module 041 and a lower incubation module 042. The upper incubation module 041 and the lower incubation module 042 are respectively used for performing constant temperature incubation above and below the display areas of N test strips.

[0161] Specifically, the upper incubation module 041 can be used to heat the display areas of the test strips above the test strip detection holes 0812 of the kit 08, while the lower incubation module 042 is used to heat the internal hollow cavity 0823 of the kit 08, so as to heat the display areas of the test strips above the internal hollow cavity 0823 from below to achieve constant temperature incubation.

[0162] As Figure 5A shown, the upper incubation module 041 may include a first heating film 0411, a first heat conducting block 0412, a first temperature control circuit board 0413 and a first plastic adapter board 0414.

[0163] Among them, the first heating film 0411 can be various heating films with heating functions after being powered on, such as PI heating film (polyimide heating film), graphene heating film, carbon fiber heating film, low-temperature radiant electrothermal film, PTC ceramic heating film, etc.

[0164] The first heat conduction block 0412 is in contact with the first temperature control circuit board 0413 and the first heating film 0411 respectively. The first heat conduction block 0412 can be made of various materials with good heat conduction performance. The first heat conduction block 0412 can be in contact with and stacked with the first heating film 0411 and the first temperature control circuit board 0413, so that the first heat conduction block 0412 can obtain heat from the first heating film 0411 as quickly as possible to the greatest extent, and enable the first temperature control circuit board 0413 to detect the temperature of the first heat conduction block 0412 in real time. When the first temperature control circuit board 0413 detects that the temperature of the first heat conduction block 0412 is lower than the preset incubation temperature (for example, 37 °C), the first temperature control circuit board 0413 can automatically connect the power supply of the first heating film 0411 to heat the first heat conduction block 0412 to increase the temperature of the first heat conduction block 0412, so as to realize heating the display areas of the test strips below the test strip detection hole 0812 of the test kit 08. When the first temperature control circuit board 0413 detects that the temperature of the first heat conduction block 0412 is higher than the preset incubation temperature, the first temperature control circuit board 0413 can automatically cut off the power supply of the first heating film 0411 to stop heating the first heat conduction block 0412, avoiding the temperature of the display areas of the test strips from being too high, so as to realize constant temperature incubation of the display areas of the test strips.

[0165] Optionally, the first temperature control circuit board 0413 and the first heating film 0411 can be arranged side by side on the same surface of the first heat conduction block 0412.

[0166] The first plastic adapter plate 0414 is used to support, assemble and fix the first heating film 0411, the first heat conduction block 0412 and the first temperature control circuit board 0413.

[0167] As Figure 5D and Figure 5E shown, when the test kit 08 arrives at the preset incubation position under the transportation of the mobile platform module 01, the first heat conduction block 0412 of the upper incubation module 041 is directly above the test strip detection hole 0812 of the test kit 08, so as to perform constant temperature incubation on the display areas of the test strips below the test strip detection hole 0812. Specifically, the first heat conduction block 0412 (due to the occlusion of the three-dimensional view, Figure 5D and Figure 5E the first heat conduction block 0412 cannot be presented in) is directly above the test strip detection hole 0812 of the test kit 08, and the first heating film 0411 is above the first heat conduction block 0412.

[0168] As Figure 5B and Figure 5C shown, the lower incubation module 042 includes a second heating film 0421, a second heat conduction block 0422, a second temperature control circuit board 0423, a second plastic adapter plate 0424 and a temperature control adapter plate 0425.

[0169] Among them, the second heating film 0421 can be various heating films that have a heating function after being energized, such as PI heating films (polyimide heating films), graphene heating films, carbon fiber heating films, low-temperature radiation electrothermal films, PTC ceramic heating films, etc.

[0170] The second heat conduction block 0422 is in contact with the second temperature control circuit board 0423 and the second heating film 0421 respectively. The second heat conduction block 0422 can be made of various materials with good heat conduction performance, so that the second heat conduction block 0422 can quickly obtain heat from the second heating film 0421 and enable the second temperature control circuit board 0423 to detect the temperature of the second heat conduction block 0422 in real time. When the second temperature control circuit board 0423 detects that the temperature of the second heat conduction block 0422 is lower than the preset incubation temperature, the second temperature control circuit board 0423 can automatically connect the power supply of the second heating film 0421 to heat the second heat conduction block 0422, so as to heat the display areas of the test strips below the test strip detection holes 0812 of the test kit 08 to increase the temperature. When the second temperature control circuit board 0423 detects that the temperature of the second heat conduction block 0422 is higher than the preset incubation temperature, the second temperature control circuit board 0423 can automatically cut off the power supply of the second heating film 0421 to stop heating the second heat conduction block 0422 and prevent the temperature of the display areas of the test strips below the test strip detection holes 0812 of the test kit 08 from being too high, so as to achieve constant temperature incubation of the display areas of the test strips.

[0171] Optionally, the second heating film 0421 and the second heat conduction block 0422 can be stacked.

[0172] The second plastic adapter board 0424 cooperates with the temperature control adapter board 0425 to realize the electrical and / or communication connection between the second heating film 0421, the second temperature control circuit board 0423 and the temperature control board in-place sensor 0426 and other external electronic components. For example, it is used to realize the electrical connection between the second heating film 0421, the second temperature control circuit board 0423 and the temperature control in-place sensor 0426 and the power supply 07 to obtain electrical energy from the power supply 07.

[0173] In addition, the second plastic adapter board 0424 cooperates with the temperature control adapter board 0425 to heat below the color development areas of the test strips to reduce the incubation time and control the constancy of the reaction temperature, thereby ensuring the detection consistency. For example, as Figure 5DAs shown, the temperature control adapter board 0425 can be fixed to the mobile platform module 01 through the mounting hole position interface 01Ib of the mobile platform module 01. Other parts of the lower incubation module 042 except the temperature control adapter board 0425 and the temperature control board in-place sensor 0426 can be arranged in the internal space of the third base 013 of the mobile platform module 01. And when the test kit 08 enters the internal of the third base 013 of the mobile platform module 01, other parts of the lower incubation module 042 except the temperature control adapter board 0425 and the temperature control board in-place sensor 0426 can be gradually inserted into the internal hollow cavity 0823 of the test kit 08 until the temperature control board in-place sensor 0426 detects the target. At this time, it indicates that the test kit 08 has reached the preset incubation position, that is, the first heat conduction block 0412 (due to the occlusion of the perspective view, Figure 5D and Figure 5E the first heat conduction block 0412 cannot be presented in) is directly above the test strip detection hole 0812 of the test kit 08, and the second heat conduction block 0422 reaches directly below the display area of each test strip. Then the temperature control board in-place sensor 0426 can transmit the signal of detecting the target to the data processing module 06. Furthermore, the data processing module 06 can control the first temperature control circuit board 0413 to connect the power supply of the first heating film 0411, and control the second temperature control circuit board 0423 to connect the power supply of the second heating film 0421, so as to heat the display areas of each test strip above the internal hollow cavity 0823 of the test kit 08 to achieve constant temperature incubation.

[0174] The optical detection module 05 is used to perform photoelectric signal conversion on the color development area of the test kit. Here, the optical detection module 05 can be various modules that are currently known or developed in the future, which irradiate the display area of the test strip with laser light, detect that the fluorescent substance of the test strip will emit fluorescent signals of a certain wavelength, and detect the intensity information of the fluorescence through a photoelectric sensor and convert it into an electrical signal.

[0175] The optical detection module 05 can be electrically connected to the power supply 07 to obtain electrical energy, and can also be communicatively connected to the data processing module 06, so as to transmit the detected electrical signal to the data processing module 06.

[0176] The data processing module 06 is used to control the mobile platform module 01, the sample addition module 03, the information collection module 02, the temperature control module 04 and the optical detection module 05, so as to perform fluorescence immunoassay on the sample to be tested and obtain the test results of each test item in N test items of the sample to be tested.

[0177] Power supply 07 is used to supply electrical energy to the mobile platform module 01, the information acquisition module 02, the sample addition module 03, the temperature control module 04, the optical detection module 05, and the data processing module 06. It can be understood that the power supply 07 can be electrically connected to the mobile platform module 01, the information acquisition module 02, the sample addition module 03, the temperature control module 04, the optical detection module 05, and the data processing module 06. Here, the power supply 07 can be various types of electrical energy supply devices. For example, the power supply 07 can be used to receive an external input power supply (such as mains AC or DC) and convert it into the voltage or current required by each component in the analyzer. The power supply 07 can also be used to convert the built-in battery into the voltage or current required by each component in the analyzer.

[0178] Optionally, reference can be made to Figure 1B and Figure 1C , Figure 1B which is a three-dimensional schematic view of a perspective outside the fully automatic fluorescence immunoassay analyzer according to the present disclosure. Figure 1C which is a three-dimensional schematic view of the fully automatic fluorescence immunoassay analyzer when the kit is about to enter with the door of the analyzer opened.

[0179] Such as Figure 1B and Figure 1C shown, the fully automatic fluorescence immunoassay analyzer may further include: a housing 09. The mobile platform module 01, the information acquisition module 02, the sample addition module 03, the temperature control module 04, the optical detection module 05, the data processing module 06, and the power supply 07 are arranged inside the housing 09. The housing 09 is used to protect the above-mentioned components and prevent dust and contaminants from affecting the performance of the above-mentioned components.

[0180] Optionally, a door 10 that can be opened and closed may also be provided on the housing 09. The size of the door 10 needs to meet the requirement that the kit 08 can enter and exit the door 10, so as to enable the kit 08 to enter the analyzer from the external analyzer and reach the mobile platform module 01, and thus can reach different positions under the transportation of the mobile platform module 01.

[0181] Exemplarily, please refer to Figure 6A and Figure 6B , Figure 6A which is a three-dimensional schematic view of an embodiment of the door 10 according to the present disclosure. Figure 6B which is an assembly schematic view of an embodiment of the door 10 according to the present disclosure. As Figure 6A and Figure 6B shown, the door 10 includes: a door panel 101 and a rotating shaft mounting hole 102, a door shaft 103, a torsion spring limiting groove 104, and a torsion spring 105 provided on the door panel 101.

[0182] Among them, the rotating shaft mounting hole 102 is used to assemble the door shaft 103 of the bin door. The door panel 101 can rotate along the door shaft 103 of the bin door. The torsion spring limiting groove 104 is used to hold the torsion spring 105, and the door panel 101 can automatically reset under the action of the torsion force of the torsion spring 105. The specific assembly relationship is as Figure 6B shown.

[0183] As Figure 1C , Figure 3C and Figure 6B shown, the third base 013 may include a bearing base plate 0131 and two limiting side plates 0132 that are perpendicular to the bearing base plate 0131, extend along the second direction and are parallel. The bearing base plate 0131 is fixedly connected to the two limiting side plates 0132 and is aligned at one end away from the bin door 10 in the second direction. At one end close to the bin door 10, the bearing base plate 0131 protrudes from the two limiting side plates 0132, that is, the length of the bearing base plate 0131 extending in the second direction is greater than the length of the two limiting side plates 0132 extending in the second direction. When it is necessary to place the reagent kit 08, control the working parameters of the second motor 017 so that the third base 013 of the mobile platform module 01 moves in the second direction towards the bin door 10 under the drive of the second motor 017. When the third base 013 moves towards the bin door 10, due to the longer length of the bearing base plate 0131, it will first touch the bin door 10. The bin door panel 101 rotates along the door shaft 103 of the bin door to the Figure 6B shown position under the push of the bearing base plate 0131 of the third base 013 from the inside to the outside. At this time, the reagent kit 08 can be placed on the bearing base plate 0131. The two sides of the reagent kit 08 are limited by the limiting side plates 0132, and the reagent kit 08 can slide in the second direction away from the bin door 10 under the action of the pushing force when placed, as Figure 1C shown. As can be known from the previous description, since the lower incubation module 042 is fixedly arranged with the third base 013, as the reagent kit 08 gradually enters the inside of the third base 013 of the mobile platform module 01, other parts of the lower incubation module 042 except the temperature control adapter board 0425 and the temperature control board in-place sensor 0426 can gradually be inserted into the internal hollow cavity 0823 of the reagent kit 08 until the temperature control board in-place sensor 0426 detects the target. At this time, it indicates that the reagent kit 08 has completely entered the inside of the third base 013. Then, the temperature control board in-place sensor 0426 can transmit the signal of detecting the target to the data processing module 06. Furthermore, the data processing module 06 can control the working parameters of the second motor 017 so that the third base 013 retracts into the analyzer, that is, moves in the direction away from the bin door 10. When the bearing base plate 0131 of the third base 013 retracts into the analyzer and leaves the bin door 10, the door shaft 103 of the bin door will automatically reset under the drive of the torsion spring 105, realizing the automatic closing of the bin door 10.

[0184] Optionally, asFigure 1B and Figure 1C As shown, the fully automatic fluorescent immunochromatographic analyzer may further include: a display module 11, which is embedded in the housing 09 and used to display information output by the data processing module 06. For example, the display module 11 may be used to display the test results of each test item of the N test items corresponding to the test kit 08 for the sample to be tested. The display module 11 may also be used to display operation prompt information interfaces for various sample tests.

[0185] Optionally, the display module 11 is also used to receive data input by the user and send it to the data processing module 06. For example, the display module 11 may be a touch screen, which may receive specific operation instructions (e.g., start detection) input by the user, and the above operation instructions may be sent to the data processing module 06, and the specific operation corresponding to the above operation instructions is completed under the control of the data processing module 06.

[0186] It should be noted that the in-place sensors in the present disclosure may be various sensors used to detect whether an object or device has reached a predetermined position. The present disclosure does not make any specific limitation on this. For example, the in-place sensors may include but are not limited to the following types: photoelectric, magnetic induction, Hall, proximity, etc.

[0187] Please refer to the following Figure 7 , Figure 7 It shows the use of Figure 1A And the process of the sample detection method performed by the fully automatic fluorescent immunochromatography analyzer described in each of the above optional embodiments, the sample detection method comprises the following steps:

[0188] Step 701, prepare the reagent kit 08 containing the sample tube 12.

[0189] Specific as Figure 1A , Figure 2A , Figure 2B and Figure 2C As shown, the sample tube 12 can be turned upside down in the sample tube position 084 specially provided in the sample operation area 0821 of the reagent box 08 for placing the sample tube 12. The sample to be tested is contained in the sample tube 12. The hollow thorn tip provided in the reagent box 08 will pierce the silicone in the middle of the tube cover of the sample tube 12, but since no negative pressure is generated, the sample to be tested is still kept in the sample tube 12 at this time.

[0190] Step 702: The mobile platform module 01 transports the reagent kit 08 to a preset information collection location.

[0191] As an example, the display module 11 can display a user interface. The above user interface may include a startup detection display object for indicating startup detection (e.g., written with "Startup Detection"). The user interacts with the above startup detection display object to send an instruction for startup detection to the data processing module 06. Then, the data processing module 06 can send an instruction to the mobile platform module 01. By controlling the working parameters of the second motor 017, the third base 013 of the mobile platform module 01 moves in the second direction towards the direction of the chamber door 10 under the drive of the second motor 017. When the third base 013 moves towards the chamber door 10, due to the relatively long length of the bearing base plate 0131, it will first touch the chamber door 10. The chamber door panel 101 rotates along the chamber door rotating shaft 103 to Figure 6B the position shown. At this time, the reagent kit 08 can be placed on the bearing base plate 0131. The two sides of the reagent kit 08 are limited by the limiting side plates 0132, and the reagent kit 08 can slide in the second direction away from the chamber door 10 under the thrust force during placement, as shown in Figure 1C the figure. As described above, since the lower incubation module 042 is fixedly arranged with the third base 013, as the reagent kit 08 gradually enters the interior of the third base 013 of the mobile platform module 01, other parts of the lower incubation module 042 except the temperature control adapter plate 0425 and the temperature control plate in-place sensor 0426 can gradually be inserted into the internal hollow cavity 0823 of the reagent kit 08 until the temperature control plate in-place sensor 0426 detects the target. At this time, it indicates that the reagent kit 08 has completely entered the interior of the third base 013. Then, the temperature control plate in-place sensor 0426 can transmit the signal of detecting the target to the data processing module 06. Furthermore, the data processing module 06 can control the working parameters of the second motor 017 to make the third base 013 retract into the analyzer, that is, move in the direction away from the chamber door 10. When the bearing base plate 0131 of the third base 013 retracts into the analyzer and leaves the chamber door 10, the chamber door rotating shaft 103 will automatically reset under the drive of the torsion spring 105 to realize the automatic closing of the chamber door 10. Correspondingly, the reagent kit 08 also continues to move in the second direction under the drive of the body 0131 towards the interior of the analyzer. Then, the data processing module 06 can control the first motor 016 and / or the second motor 017 to work, and detect whether the third base 013 and the second base 012 both reach their respective initial positions through the second in-place sensor 019 and the first in-place sensor 018. Since the relative distances between the preset information collection position and the initial positions of the third base 013 and the second base 012 are fixed, the subsequent data processing module 06 can control the working parameters of the first motor 016 and / or the second motor 017 according to the above respective fixed distances, thereby driving the movement of the reagent kit 08 to make the reagent kit 08 reach the preset information collection position.

[0192] Step 703: The information acquisition module 02 acquires information on N types of test items corresponding to the test kit 08.

[0193] After receiving the message that the test kit 08 has reached the preset information acquisition position, the data processing module 06 can control the information acquisition module 02 to acquire information on N types of test items corresponding to the test kit. Specifically, when the test kit 08 is provided with an RFID electronic tag 083, the information acquisition module 02 can read the RFID electronic tag 083 through an RFID electronic tag reader to obtain information on N types of test items corresponding to the test kit 08.

[0194] Here, the test item information may include a test item identifier for uniquely indicating a specific test item.

[0195] Step 704: The mobile platform module 01 transports the test kit 08 to the preset negative pressure suction position, and the sampling module 03 applies negative pressure to the test kit 08.

[0196] Specifically, the data processing module 06 can first control the first motor 016 and / or the second motor 017 to work, detect whether the third base 013 reaches the initial position in the second direction through the second in-place sensor 019, and detect whether the second base 012 reaches the initial position in the first direction through the first in-place sensor 018. If both reach, the data processing module 06 then controls the operating parameters of the first motor 016 and the second motor 017, thereby driving the movement of the test kit 08 so that the test kit 08 reaches the preset negative pressure suction position. The preset negative pressure suction position may be the sample suction position 08213 of the test kit 08. That is, specifically, it is such that the sample suction position 08213 (i.e., the negative pressure suction position) of the test kit 08 is located below the suction section 0313 of the sampling head 031.

[0197] Then, it is possible to control the lifting drive mechanism 033 in the sampling module 03 to drive the sampling head 031 and the plunger pump 032 to move in the third direction (as Figure 4A shown, the up and down direction), so that the suction section 0313 is in sealed contact with the sample suction position 08213 (i.e., the negative pressure suction position) of the test kit 08. Then, by controlling the movement of the plunger rod 0322 in the sampling module 03, a negative pressure is formed inside the plunger chamber 0321 and the sampling head 031. Since the sample suction position 08213 (i.e., the negative pressure suction position) of the test kit 08 is connected to the sampling cavity, the sampling cavity is also connected to the sample transfer cavity of the test kit 08, and the sample transfer cavity of the test kit 08 is connected to the sample tube 10. Under the action of the above negative pressure, the test sample in the sample tube 10 will flow through the sample transfer cavity of the test kit 08 and enter the sampling cavity below the sample suction position 08213 (i.e., the negative pressure suction position).

[0198] Step 705: The sampling module 03 samples and dilutes the sample to be tested according to N kinds of test item information, and respectively adds the sample to the sample adding areas of each test strip.

[0199] Generally speaking, for each kind of test item information, the sampling module 03 can determine the sampling volume, diluent taking volume, sample adding volume, diluent adding volume, volume of the sampled and diluted sample, volume of the sample added and diluted, and to which specific sample mixing position 08215 the sample is added for the specific test item indicated by the test item information.

[0200] Then, for each test item information, perform the following sampling and dilution and sample adding operations:

[0201] First step, assemble the TIP head: Grab a TIP head 13 from the TIP head grabbing position 08211 of the reagent kit 08 and assemble it to the sampling section 0313 of the sampling head 031.

[0202] Second step, sample and then discharge the sample: Use the sampling head 031 and the TIP head 13 to aspirate the sampled volume of the sample to be tested from the sample aspiration position 08213 and then add it to the sample mixing position 08215 indicated by the test item information, and then release the TIP head 13 assembled on the sampling head 031 to the TIP head discard position 08212.

[0203] Third step, assemble the TIP head: Grab a TIP head 13 from the TIP head grabbing position 08211 of the reagent kit 08 and assemble it to the sampling section 0313 of the sampling head 031.

[0204] Fourth step, aspirate the diluent and then discharge the sample: Use the sampling head 031 and the TIP head 13 to aspirate the diluent of the diluent taking volume in the test item information from the test reagent position 08214 and then add it to the sample mixing position 08215 indicated by the test item information to complete the sample dilution, and then release the TIP head 13 assembled on the sampling head 031 to the TIP head discard position 08212.

[0205] Fifth step, assemble the TIP head: Grab a TIP head 13 from the TIP head grabbing position 08211 of the reagent kit 08 and assemble it to the sampling section 0313 of the sampling head 031.

[0206] Sixth step, use the sampling head 031 and the TIP head 13 to aspirate the diluted sample from the sample mixing position 08215 and then add it to the test strip sample adding hole 0811 indicated by the test item information.

[0207] Through the above first step to the fifth step, the sampling, dilution and sample adding operations for one test item can be completed.

[0208] Specifically, the first step to the fifth step can be executed as follows:

[0209] First step, assembling the TIP head: Grab a TIP head 13 from the TIP head grabbing position 08211 of the kit 08 and assemble it onto the sampling section 0313 of the sampling head 031.

[0210] First, the moving platform module 01 transports the kit 08 so that the TIP head grabbing position 08211 of the kit 08 is located directly below the sampling head 031.

[0211] Then, assemble the sampling head 031 with the TIP head 13 on the outermost surface below the TIP head grabbing position 08211 to form a sealed structure. Specifically, by controlling the operating parameters of the third motor 0331 in the lifting drive mechanism 033, the sampling head 031 can be lowered into the TIP head cavity below the TIP head grabbing position 08211 and suck the outermost TIP head 13, finally assembling the TIP head 13 with the sampling head 031 to form a sealed structure. For example, the sampling section 0313 can be assembled with the tail of the TIP head 13.

[0212] Second step, discharging the sample after sampling: Use the sampling head 031 and the TIP head 13 to suck the test sample with the sampling volume in the test item information from the sample sampling position 08213 and then add the sample to the sample mixing position 08215 indicated by the test item information, and then release the TIP head 13 assembled on the sampling head 031 to the TIP head discard position 08212.

[0213] First, the moving platform module 01 transports the kit 08 so that the sample sampling position 08213 of the kit 08 is located directly below the TIP head 13 assembled on the sampling section 0313.

[0214] After that, control the operating parameters of the third motor 0331 in the lifting drive mechanism 033 so that the sampling head 031 descends to make the TIP head 13 assembled below the sampling section 0313 enter the sample sampling position 08213 of the kit 08.

[0215] Next, the operating parameters of the fourth motor 0324 in the plunger pump 032 can be controlled to move the plunger rod 0322 in the second direction, thereby controlling the movement of the plunger rod 0322 to evacuate the gas in the plunger chamber 0321, so as to create a negative pressure in the sampling head 031 and the TIP head 13. Then, control the movement of the plunger rod 0322 to aspirate the sample to be tested from the sample aspiration position 08213 of the reagent kit 08 through the TIP head 13, that is, aspirate the sample to be tested from the sample transfer chamber of the reagent kit 08 from the sample tube 12. The aspirated sample to be tested is held within the TIP head 13 under the action of negative pressure, so as to keep the sample to be tested within the TIP head 13 before the sampling head 031 is transferred to the sample mixing position 08215. It can be understood that here the specific volume value of the aspirated sample to be tested can also be controlled by controlling the operating parameters of the fourth motor 0324, thereby achieving precise quantitative sampling. The sampling volumes for different detection items can be the same or different.

[0216] Subsequently, the mobile platform module 01 transports the reagent kit 08 so that the sample mixing position 08215 of the reagent kit 08 is directly below the TIP head 13 assembled on the sampling section 0313.

[0217] After that, control the operating parameters of the third motor 0331 in the lifting drive mechanism 033 to lower the sampling head 031 so that the TIP head 13 assembled below the sampling section 0313 enters the sample mixing position 08215 of the reagent kit 08.

[0218] Next, the operating parameters of the fourth motor 0324 in the plunger pump 032 can be controlled to move the plunger rod 0322 in the second direction, thereby controlling the movement of the plunger rod 0322 to add the sample to be tested in the TIP head 13 to the sample mixing position 08215. Here, the operating parameters of the fourth motor 0324 in the plunger pump 032 can also be controlled to move the plunger rod 0322 to quantitatively add the liquid in the TIP head 13 to the sample mixing position 08215 according to the specific addition volume in the detection item information. The addition volumes for different detection items can be the same or different.

[0219] Finally, the mobile platform module 01 transports the reagent kit 08 so that the TIP head discard position 08212 of the reagent kit 08 is directly below the sampling head 031, and then control the operating parameters of the third motor 0331 in the lifting drive mechanism 033 to release the TIP head 13 assembled on the sampling head 031 to the TIP head discard position 08212.

[0220] The third and fifth steps are the same as the first step and will not be elaborated here.

[0221] Step 4: Aspirate the diluent and then eject the sample: Use the sampling head 031 and the TIP head 13 to aspirate the diluent with the volume of the diluent taken in the test item information from the test reagent position 08214 of the test kit 08, and then add the sample to the sample mixing position 08215 indicated by the test item information to complete sample dilution. Then, release the TIP head 13 assembled on the sampling head 031 to the TIP head discard position 08212.

[0222] First, the mobile platform module 01 transports the test kit 08 so that the test reagent position 08214 of the test kit 08 is directly below the TIP head 13 assembled on the sampling section 0313.

[0223] After that, control the operating parameters of the third motor 0331 in the lifting drive mechanism 033 so that the sampling head 031 descends to make the TIP head 13 assembled below the sampling section 0313 enter the test reagent position 08214 of the test kit 08.

[0224] Next, the operating parameters of the fourth motor 0324 in the plunger pump 032 can be controlled so that the plunger rod 0322 moves in the second direction, and then control the movement of the plunger rod 0322 to evacuate the gas in the plunger chamber 0321, so as to form a negative pressure in the sampling head 031 and the TIP head 13. Then, control the movement of the plunger rod 0322 to aspirate the diluent from the test reagent position 08214 of the test kit 08 through the TIP head 13. The sample to be tested is kept within the TIP head 13 under the action of the negative pressure, so that the diluent is kept within the TIP head 13 before the sampling head 031 is transferred to the sample mixing position 08215. It can be understood that the specific volume value of the aspirated diluent can also be controlled by controlling the operating parameters of the fourth motor 0324 here, so as to achieve accurate quantitative sampling. The volume of the diluent taken for different test items can be the same or different.

[0225] Then, the mobile platform module 01 transports the test kit 08 so that the sample mixing position 08215 of the test kit 08 is directly below the TIP head 13 assembled on the sampling section 0313.

[0226] After that, control the operating parameters of the third motor 0331 in the lifting drive mechanism 033 so that the sampling head 031 descends to make the TIP head 13 assembled below the sampling section 0313 enter the sample mixing position 08215 of the test kit 08.

[0227] Next, the operating parameters of the fourth motor 0324 in the plunger pump 032 can be controlled to move the plunger rod 0322 in the second direction, thereby controlling the movement of the plunger rod 0322 to achieve adding the diluent in the TIP head 13 to the sample mixing position 08215. Here, the operating parameters of the fourth motor 0324 in the plunger pump 032 can also be controlled to move the plunger rod 0322 to achieve quantitatively adding the diluent in the TIP head 13 to the sample mixing position 08215 according to the specific diluent addition volume in the test item information. The diluent addition volumes for different test items can be the same or different.

[0228] Finally, the mobile platform module 01 transports the reagent kit 08 so that the TIP head discard position 08212 of the reagent kit 08 is directly below the sampling head 031, and then the operating parameters of the third motor 0331 in the lifting drive mechanism 033 are controlled to release the TIP head 13 assembled on the sampling head 031 to the TIP head discard position 08212.

[0229] In the sixth step, the diluted sample is aspirated from the sample mixing position 08215 using the sampling head 031 and the TIP head 13 and then added to the test strip sample addition hole 0811 indicated by the test item information.

[0230] First, the mobile platform module 01 transports the reagent kit 08 so that the sample mixing position 08215 of the reagent kit 08 is directly below the TIP head 13 assembled on the sampling section 0313.

[0231] After that, the operating parameters of the third motor 0331 in the lifting drive mechanism 033 are controlled to lower the sampling head 031 so that the TIP head 13 assembled below the sampling section 0313 enters the sample mixing position 08215 of the reagent kit 08.

[0232] Next, the operating parameters of the fourth motor 0324 in the plunger pump 032 can be controlled to move the plunger rod 0322 in the second direction, thereby controlling the movement of the plunger rod 0322 to evacuate the gas in the plunger chamber 0321 to create a negative pressure in the sampling head 031 and the TIP head 13, and then controlling the movement of the plunger rod 0322 to aspirate the diluted sample from the sample mixing position 08215 of the reagent kit 08 through the TIP head 13. The aspirated diluted sample is held within the TIP head 13 under the action of the negative pressure so that the diluted sample is held within the TIP head 13 before the sampling head 031 is transferred to the test strip sample addition hole 0811. It can be understood that the specific volume value of the aspirated diluted sample can also be controlled by controlling the operating parameters of the fourth motor 0324 here, thereby achieving precise quantitative sampling. The volumes of the sampled and diluted samples for different test items can be the same or different.

[0233] Subsequently, the mobile platform module 01 transports the kit 08 such that the test strip sample addition hole 0811 indicated by the test item information of the kit 08 is directly below the TIP head 13 assembled on the sample aspiration section 0313.

[0234] After that, the operating parameters of the third motor 0331 in the lifting drive mechanism 033 are controlled such that the sample aspiration head 031 descends to cause the TIP head 13 assembled below the sample aspiration section 0313 to enter the test strip sample addition hole 0811 indicated by the test item information of the kit 08.

[0235] Next, the operating parameters of the fourth motor 0324 in the plunger pump 032 can be controlled such that the plunger rod 0322 moves in the second direction, thereby controlling the movement of the plunger rod 0322 to achieve adding the diluent in the TIP head 13 to the sample mixing position 08215. Here, the operating parameters of the fourth motor 0324 in the plunger pump 032 can also be controlled such that the plunger rod 0322 moves to achieve quantitatively adding the diluted sample in the TIP head 13 to the test strip sample addition hole 0811 indicated by the test item information according to the specific volume of the diluted sample for addition in the test item information. The volumes of the diluted samples for addition for different test items can be the same or different.

[0236] Finally, the mobile platform module 01 transports the kit 08 such that the TIP head discard position 08212 of the kit 08 is directly below the sample aspiration head 031, and then the operating parameters of the third motor 0331 in the lifting drive mechanism 033 are controlled such that the TIP head 13 assembled on the sample aspiration head 031 is released to the TIP head discard position 08212.

[0237] After step 705, the sample addition areas of each test strip are all added with the diluted sample to be tested.

[0238] Step 706, the mobile platform module 01 transports the kit 08 to the preset incubation position.

[0239] Similarly, in a similar manner to step 504, the mobile platform module 01 can transport the kit 08 to the preset incubation position. Specifically, the target can be detected by the temperature control board in-place sensor 0426 of the lower incubation module 042, indicating that the kit 08 enters the interior of the third base 013 of the mobile platform module 01, and other parts of the lower incubation module 042 except the temperature control adapter board 0425 and the temperature control board in-place sensor 0426 also enter the internal hollow cavity 0823 of the kit 08, and the first heat conducting block 0412 is directly above the test strip detection hole 0812 of the kit 08, and the second heat conducting block 0422 reaches directly below the display areas of each test strip, indicating that the kit 08 reaches the preset incubation position, and the mobile platform module 01 stops transporting the kit 08.

[0240] Step 707, the temperature control module 04 performs constant temperature incubation on N test strips.

[0241] After the test kit 08 reaches the preset incubation position, that is, after the temperature control board in-place sensor 0426 detects the target, the message that the temperature control board in-place sensor 0426 detects the target can be transmitted to the data processing module 06. Furthermore, the data processing module 06 can control the first temperature control circuit board 0413 to turn on the power supply of the first heating film 0411, and control the second temperature control circuit board 0423 to turn on the power supply of the second heating film 0421, so as to heat the display areas of the test strips above the internal hollow cavity 0823 of the test kit 08 to achieve constant temperature incubation.

[0242] Optionally, the temperature control module 04 performs constant temperature incubation on the display areas of N test strips as follows: the temperature control module 04 heats the display areas of N test strips at a preset heating power for a preset incubation duration. The applicant has found through practice that using the above method to perform constant temperature incubation on the display areas of N test strips can simplify the complexity of the incubation operation and keep the display areas of N test strips at the common incubation temperature of 37°C.

[0243] It should be noted that in practice, the display area in the length direction of various test strips for detection approximately occupies one-third of the length of the test strip. If the entire test strip is incubated, it will affect the movement of the liquid on the test strip. At the same time, if the incubation time is too long, it may cause the test sample to be dried out due to the influence of temperature during the incubation process, which will lead to inaccurate test results. And the immune reaction of the test sample only occurs in the display area. Therefore, by only incubating the display area of the test strip and not heating the whole test strip, the incubation duration can be reduced, thereby avoiding the test sample from being dried out and improving the accuracy of the test results.

[0244] Step 708, for each of the N detection items, the mobile platform module 01 transports the test kit 08 so that the display area of the test strip for this detection item is located at the preset detection position, and the optical detection module 05 performs photoelectric signal conversion to obtain the photoelectric signal conversion result for this detection item.

[0245] Here, after the constant temperature incubation of the display areas of each test strip is completed, the data processing module 06 can control the execution of the photoelectric signal conversion operation for each of the N detection items. Specifically, the photoelectric signal conversion operation can include: controlling the mobile platform module 01 to transport the test kit 08 to make the display area of the test strip for this detection item located at the preset detection position, and controlling the optical detection module 05 to perform photoelectric signal conversion to obtain the photoelectric signal conversion result for this detection item. That is, the photoelectric signal conversion is performed on the display area of each test strip one by one.

[0246] Here, the preset detection position is the detection position corresponding to the optical detection module 05. When the display area of the test strip is located at the preset detection position, the optical detection module 05 can perform excitation light irradiation and perform photoelectric conversion through a photoelectric sensor to obtain a photoelectric signal conversion result.

[0247] Step 709, the data processing module 06 performs fluorescence immunoassay analysis on the photoelectric signal conversion results of each detection item to obtain the detection results of the sample to be tested for this detection item.

[0248] Here, various methods known now or developed in the future for performing fluorescence immunoassay analysis based on the photoelectric signal conversion results can be used to obtain the detection results of the sample to be tested for each detection item. For example, it may include but is not limited to the following methods: converting the photoelectric signal into a concentration value using calibration curve information, wavelet analysis for denoising and peak recognition method, etc. The present disclosure does not make specific limitations on this.

[0249] It should be noted that the implementation details and technical effects of each step in the sample detection method provided in the embodiments of the present disclosure can refer to the descriptions of other embodiments in the present disclosure, and will not be elaborated here.

[0250] The flowcharts and block diagrams in the accompanying drawings illustrate the possible architectures, functions, and operations of systems, methods, and computer program products according to various embodiments of the present disclosure. In this regard, each block in the flowchart or block diagram may represent a module, a program segment, or a part of code that contains one or more executable instructions for implementing the specified logical function. It should also be noted that in some alternative implementations, the functions marked in the blocks may occur in a different order than marked in the accompanying drawings. For example, two consecutive blocks shown may actually be executed substantially in parallel, and they may sometimes be executed in the reverse order, depending on the functions involved. It should also be noted that each block in the block diagram and / or flowchart, and combinations of blocks in the block diagram and / or flowchart, can be implemented by a dedicated hardware-based system for performing the specified functions or operations, or can be implemented by a combination of dedicated hardware and computer instructions.

[0251] The units or modules involved in the embodiments described in the present disclosure can be implemented in software or in hardware. Among them, the name of the unit or module does not constitute a limitation to the unit or module itself in some cases.

[0252] The above description is only a preferred embodiment of the present disclosure and an explanation of the applied technical principles. Those skilled in the art should understand that the scope of disclosure involved in the present disclosure is not limited to the technical solutions formed by the specific combination of the above technical features, and should also cover other technical solutions formed by any combination of the above technical features or their equivalent features without departing from the above disclosure concept. For example, the technical solutions formed by mutually replacing the above features with the technical features (but not limited to) disclosed in the present disclosure that have similar functions.

Claims

1. A fully automatic fluorescent immunochromatographic analyzer, comprising: A mobile platform module (01), a sample loading module (03), an information acquisition module (02), a temperature control module (04), an optical detection module (05), a data processing module (06), a power supply (07) and a reagent kit (08); The kit (08) is provided with N test strips corresponding to each of the N test items, wherein N is a positive integer; The mobile platform module (01) is used to transport the test kit (08) carrying the sample to be tested; The information collection module (02) is used to collect N types of detection item information corresponding to the test kit (08); The sample adding module (03) is used to sample and dilute the sample to be tested according to the N types of detection item information, and to add the sample to the sample adding areas of the N test strips respectively; The temperature control module (04) is used to incubate the N test strips at a constant temperature; The optical detection module (05) is used to convert photoelectric signals on the color development area of ​​each test strip one by one; The data processing module (6) is used to control the mobile platform module (01), the sample adding module (03), the information acquisition module (02), the temperature control module (04) and the optical detection module (05) to perform fluorescent immunochromatography analysis on the sample to be tested, and obtain the test result of each test item of the sample to be tested in the N test items; The power supply (07) is used to provide electrical energy to the mobile platform module (01), the sample loading module (03), the information acquisition module (02), the temperature control module (04), the optical detection module (05) and the data processing module (06).

2. The fully automatic fluorescent immunochromatography analyzer according to claim 1, wherein: The test kit (08) comprises: an upper cover (081) and a main body (082), wherein the N test strips are arranged between the upper cover (081) and the main body (082); The upper cover (081) is provided with N test strip sample addition holes (0811) and N test strip detection holes (0812), and the N test strip sample addition holes (0811) and the N test strip detection holes (0812) penetrate the upper and lower surfaces of the upper cover (081); The sample application areas of the N test strips are respectively exposed from the N test strip sample application holes (0811), and the display areas of the N test strips are respectively exposed from the N test strip detection holes (0812); The main body (082) is provided with an internal hollow cavity, and at least part of the temperature control module (04) is arranged in the internal hollow cavity; The top of the main body (082) includes a sample operation area (0821) and a test strip channel area (0822); the sample operation area (0821) is provided with a TIP head grabbing position (08211), a TIP head discarding position (08212), a sample suction position (08213), a detection reagent position (08214) and a sample mixing position (08215); the N test strips are arranged in the test strip channel area (0822).

3. The fully automatic fluorescent immunochromatography analyzer according to claim 2, wherein: The reagent kit (08) is provided with an RFID electronic tag (083); and The information collection module (02) is used to collect N types of detection item information corresponding to the test kit (08), including: The information acquisition module (02) is used to identify the RFID electronic tag (083) provided on the test kit (08) to obtain N types of detection item information corresponding to the test kit (08).

4. The fully automatic fluorescent immunochromatographic analyzer according to claim 1, wherein: The mobile platform module (01) comprises: a first base (011), a second base (012), a third base (013), a first sliding guide rail (014), a second sliding guide rail (015), a first motor (016) and a second motor (017); The second base (012) is installed on the first base (011), the first sliding guide rail (014) connects the first base (011) and the second base (012), and the second base (012) can slide along the extension direction of the first sliding guide rail (014), and the extension direction of the first sliding guide rail (014) is a first direction; The third base (013) is installed on the second base (012), the second sliding guide rail (015) connects the second base (012) and the third base (013), and the third base (013) can slide along the extension direction of the second sliding guide rail (015), and the extension direction of the second sliding guide rail (015) is the second direction; The second base (012) is driven by the first motor (016), and the third base (013) is driven by the second motor (017).

5. The fully automatic fluorescent immunochromatographic analyzer according to claim 4, wherein: The mobile platform module (01) further comprises a first in-position sensor (018) and a second in-position sensor (019), wherein the first in-position sensor (018) is used to identify whether the second base (012) has reached an initial position in the first direction, and the second in-position sensor (019) is used to identify whether the third base (013) has reached an initial position in the second direction.

6. The fully automatic fluorescent immunochromatographic analyzer according to claim 1, wherein: The temperature control module (04) comprises an upper incubation module (041) and a lower incubation module (042), wherein the upper incubation module (041) and the lower incubation module (042) are respectively used to perform constant temperature incubation above and below the display areas of the N test strips.

7. The fully automatic fluorescent immunochromatography analyzer according to claim 1, wherein: The fully automatic fluorescent immunochromatographic analyzer also includes: The housing (09) includes the mobile platform module (01), the sample loading module (03), the information acquisition module (02), the temperature control module (04), the optical detection module (05), the data processing module (06) and the power supply (07) which are arranged inside the housing (09).

8. The fully automatic fluorescent immunochromatographic analyzer according to claim 7, wherein: The housing (09) is provided with a door (10), and the reagent box (08) can enter the interior of the housing (09) through the door (10).

9. The fully automatic fluorescent immunochromatographic analyzer according to claim 8, wherein: The warehouse door (10) comprises: a door panel (101), a rotating shaft mounting hole (102) arranged on the door panel (101), a warehouse door rotating shaft (103), a torsion spring limiting groove (104) and a torsion spring (105); the rotating shaft mounting hole (102) is used to assemble the warehouse door rotating shaft (103); the door panel (101) can rotate along the warehouse door rotating shaft (103); the torsion spring limiting groove (104) is used to clamp the torsion spring (105); and the door panel (101) can automatically reset under the action of the torsion force of the torsion spring (105).

10. The fully automatic fluorescent immunochromatography analyzer according to claim 7, wherein: The fully automatic fluorescent immunochromatographic analyzer also includes: A display module (11), wherein the display module (11) is embedded in the housing (09), and the display module (11) is used to display information output by the data processing module (06); optionally, the display module (11) is also used to receive data input by a user and send it to the data processing module (06).

11. The fully automatic fluorescent immunochromatography analyzer according to claim 1, wherein: The sample adding module (03) comprises: A sample suction head (031), a plunger pump (032) and a lifting drive mechanism (033), wherein the sample suction head (031) is used to suck negative pressure, suck TIP head, suck sample and add sample under the control of the plunger pump (032), and the lifting drive mechanism (033) is used to control the moving distance of the sample suction head (031).

12. The fully automatic fluorescent immunochromatographic analyzer according to claim 11, wherein: The sample suction head (031) is an internal hollow pipe structure, and the sample suction head (031) comprises a connecting section (0311), a boss (0312) and a sample suction section (0313) which are connected to each other by gas in sequence.

13. The fully automatic fluorescent immunochromatography analyzer according to claim 12, wherein: The plunger pump (032) comprises a plunger cavity (0321) and a plunger rod (0322), wherein the plunger rod (0322) is sleeved inside the plunger cavity (0321), the plunger rod (0322) has a first end (0322a), and the extension direction of the plunger cavity (0321) and the plunger rod (0322) is a second direction. The connecting section (0311) comprises a partial first connecting section (03111) extending along the second direction and a second connecting section (03112) extending along a third direction perpendicular to the first direction and the second direction. The second connecting section (03112), the boss (0312) and the sample suction section (0313) extend along the third direction.

14. The fully automatic fluorescent immunochromatographic analyzer according to claim 13, wherein: The first connecting section (03111) is fixedly and sealedly connected to the plunger cavity (0321), and the plunger rod (0322) can move along the second direction within the plunger cavity (0321) and the first connecting section (03111).

15. The fully automatic fluorescent immunochromatography analyzer according to claim 13, wherein: The lifting drive mechanism is used to drive the sample suction head (031) to move along the third direction.

16. The fully automatic fluorescent immunochromatographic analyzer according to claim 15, wherein: The plunger rod (0322) also has a second end (0322b) opposite to the first end (0322a), and the plunger pump (032) also includes a plunger sensor plate (0323) fixedly arranged on the second end (0322b).

17. The fully automatic fluorescent immunochromatographic analyzer according to claim 16, wherein: The sample loading module (03) is further provided with a third in-position sensor (034), and the third in-position sensor (034) is used to identify whether the sample suction head (031) and the plunger pump (032) have reached an initial position in the third direction.

18. The fully automatic fluorescent immunochromatographic analyzer according to claim 13, wherein: The sample loading module (03) is further provided with a fourth in-position sensor (035), and the fourth in-position sensor (035) is used to identify whether the plunger rod (0322) has reached an initial position in the second direction.

19. The fully automatic fluorescent immunochromatographic analyzer according to claim 13, wherein: The sample adding module (03) is also provided with a star-shaped sealing ring (0391), an O-shaped sealing ring (0392) and a negative pressure sealing ring (0393); The inner wall of the first connecting section (03111) in contact with the plunger rod (0322) is provided with a first groove, and the plunger rod (0322) slides along the first direction in the first connecting section (03111) along the first groove, and a star-shaped sealing ring (0391) is provided at the first groove to achieve a motion seal between the first connecting section (03111) and the plunger rod (0322); The O-ring (0392) is arranged on the end surface of the plunger cavity (0321) close to the first connecting section (03111) to achieve static sealing between the plunger cavity (0321) and the first connecting section (03111); The negative pressure sealing ring (0393) is arranged on the sample suction section (0313) of the sample suction head (031) and is used to form a negative pressure seal between the sample suction head (031) and the surface to be sucked when the sample suction section contacts the surface to be sucked.

20. A sample detection method, applied to the fully automatic fluorescent immunochromatography analyzer according to any one of claims 1 to 19, the method comprising: Preparing a test kit (08) having a sample tube (12) placed therein, wherein the sample tube (12) contains a sample to be tested; The mobile platform module (01) transports the reagent kit (08) to a preset information collection position; The information collection module (02) collects N types of detection item information corresponding to the test kit (08); The mobile platform module (01) transports the reagent box (08) to a preset negative pressure suction position, and the sample loading module (03) applies negative pressure to the reagent box (08); The sample adding module (03) samples and dilutes the sample to be tested according to the N types of detection item information, and adds the sample to the sample adding area of ​​each test strip respectively; The mobile platform module (01) transports the reagent kit (08) to a preset incubation position; The temperature control module (04) incubates the N test strips at a constant temperature; For each of the N types of detection items, the mobile platform module (01) transports the test kit (08) so that the test strip display area of ​​the detection item is located at a preset detection position, and the optical detection module (05) performs photoelectric signal conversion to obtain a photoelectric signal conversion result of the detection item; The data processing module (06) performs fluorescent immunochromatography analysis on the photoelectric signal conversion result of each detection item to obtain the detection result of the sample to be tested in the detection item.

21. The method according to claim 20, wherein: The temperature control module (04) performs constant temperature incubation on the N test strips, comprising: The temperature control module (4) incubates the display areas of the N test strips at a constant temperature.

22. The method according to claim 21, wherein: The temperature control module (04) performs constant temperature incubation on the display areas of the N test strips, comprising: The temperature control module (04) heats the display areas of the N test strips according to a preset heating power for a preset incubation time.

Images