Fully automated immunoassay device

Abstract

The present disclosure relates to a fully automated immunoassay device configured to directly perform immunoassay detection on a whole blood sample without pre-treatment. The device includes a detection assembly, a sample supply assembly, a reagent supply assembly, and a reaction cup supply assembly. The detection assembly includes a probe mechanism including an excitation light source and a photon detector. One or more reagent components and a target in the whole blood sample to be detected undergo an immuno-reaction in a reaction cup at the detection assembly to produce a long-persistence luminescent complex. The excitation light source is configured to excite the long-persistence luminescent complex in the reaction cup and to turn off after excitation is complete, and the photon detector is configured to collect a luminescence signal emitted by the long-persistence luminescent complex after the excitation light source turns off. The device directly detects the whole blood sample in a blood collection tube and enables fully automated detection.

Description

Technical Field

[0001] This disclosure belongs to the field of immunoassay technology, and specifically relates to a fully automated immunoassay device. Background Technology

[0002] Disease diagnostic testing is of great significance to human health and environmental safety, and is widely used in various medical settings. In the immune responses used for disease diagnostic testing, antigens stimulate the animal's immune system, inducing an immune response and producing antibodies with immune functions in body fluids. Antibodies bind to antigens in an immune reaction that can occur both in vivo and in vitro, and has the advantage of high specificity. Based on this, immunoassay techniques have been developed and are currently applied in the biomedical field. Among the many immunoassay techniques, luminescent immunoassay detects luminescent signals. With the significant advancements in photon detection technology, luminescent immunoassay theoretically offers higher detection sensitivity and has therefore attracted widespread attention.

[0003] The detection of biological samples such as blood plays a crucial role in immunoassays. Traditional chemiluminescence immunoassays suffer from biological background interference and excitation light scattering, making direct detection of whole blood samples difficult and requiring pretreatment. However, whole blood sample pretreatment is cumbersome and carries potential risks of human infection or sample contamination. For example, most existing immunoassay instruments utilize serum for detection, requiring the cap of the blood collection tube to be opened and the collected blood to be centrifuged before testing, thus making it impossible to directly test whole blood samples from blood collection tubes routinely used in hospitals. The pretreatment process for serum testing leads to a series of potential problems: high labor costs, human error, and the risk of infection of medical personnel by substances in the blood.

[0004] In addition, most existing immunoassay analyzers cannot continuously and automatically change reaction cups during operation and do not have the function of continuous testing of large batches of whole blood samples, thus making it difficult to achieve high-throughput fully automated testing of large batches of continuous samples.

[0005] Existing chemiluminescence immunoassay analyzers not only fail to meet the requirements for fully automated immunoassay analysis of whole blood samples, but also generally suffer from drawbacks such as complex structure, large size, high cost, low test throughput, small total number of continuous tests, and inconvenient operation. Summary of the Invention

[0006] One of the purposes of this disclosure is to provide a fully automated immunoassay apparatus that can overcome at least one defect in the prior art.

[0007] The subject matter of this disclosure is illustrated by the aspects described below. For convenience, various examples of the aspects of the subject matter are described as terms labeled (1, 2, 3, etc.). These terms are provided by way of example and are not intended to limit the subject matter of this disclosure.

[0008] 1. A fully automated immunoassay analyzer, wherein the analyzer is configured to directly perform immunoassay on whole blood samples without requiring pretreatment, the analyzer comprising:

[0009] The detection component includes an excitation source and a photon detector.

[0010] A sample supply component configured to automatically supply a whole blood sample to be tested to the detection component;

[0011] A reagent supply assembly configured to automatically supply one or more reagent components to a detection assembly;

[0012] A reaction cup supply assembly configured to automatically supply reaction cups to a detection assembly;

[0013] In this process, one or more reagent components and the target analyte in the whole blood sample to be tested undergo an immune reaction in the reaction cup at the detection component to generate a long-afterglow luminescent complex.

[0014] The excitation source is configured to excite the long-afterglow luminescent complex in the reaction cup and is turned off after excitation is completed. The photon detector is configured to collect the luminescent signal emitted by the long-afterglow luminescent complex after the excitation source is turned off.

[0015] 2. The fully automated immunoassay apparatus according to Clause 1, wherein the one or more reagent components comprise: a first reagent component containing a first antibody of the target and a second reagent component containing a second antibody of the target, wherein the first reagent component comprises one or more of a light absorber, a buffer, and a luminescent agent, and the second reagent component comprises the remaining of a light absorber, a buffer, and a luminescent agent.

[0016] 3. The fully automated immunoassay apparatus according to Clause 2, wherein the one or more reagent components further include a third reagent component for diluting whole blood samples.

[0017] 4. The fully automated immunoassay apparatus according to Clause 1, wherein the one or more reagent components contain additive components for hemolysis and / or signal amplification in the immunoassay reaction, and the additive components are selected from one or more of the group consisting of hemolysins, salts, stabilizers, nanospheres, antibodies, antigens, proteins, surfactants, water, preservatives, nucleic acids, and peptides.

[0018] 5. The fully automated immunoassay apparatus according to any one of Clauses 1-4, wherein the detection mechanism further includes a filter disposed between the excitation source and the photon detector, the filter being configured to filter out excitation light when the excitation source is turned on.

[0019] 6. The fully automated immunoassay apparatus according to any one of Clauses 1-4, wherein the detection mechanism is configured to obtain the concentration of the target substance in a whole blood sample from the intensity of the luminescence signal emitted by the photochemical long-afterglow luminescence complex based on a preset relationship curve between the intensity of the long-afterglow luminescence signal and the concentration of the target substance.

[0020] 7. The fully automated immunoassay apparatus according to any one of Clauses 1-4, wherein the detection component further comprises an incubation mechanism adjacent to the detection mechanism, the incubation mechanism being configured to incubate the one or more reagent components and the whole blood sample in the reaction vessel to a specified temperature.

[0021] 8. The fully automated immunoassay apparatus according to Clause 7, wherein the incubation mechanism includes an incubation tray having a plurality of reaction cup holders spaced apart circumferentially and receiving reaction cups.

[0022] 9. The fully automated immunoassay apparatus according to Clause 7, wherein the detection component further includes a movable gripper configured to move the reaction cup between the incubation mechanism, the detection mechanism, and the reaction cup supply assembly.

[0023] 10. The fully automated immunoassay apparatus according to any one of Clauses 1-4, wherein the excitation light source comprises one or more selected from the group consisting of: solid-state lasers, gas lasers, semiconductor lasers, photodiodes, D65 standard light sources, light-emitting diodes, ultraviolet lamps, xenon lamps, sodium lamps, mercury lamps, tungsten filament lamps, incandescent lamps, and fluorescent lamps.

[0024] 11. The fully automated immunoassay apparatus according to any one of Clauses 1-4, wherein the wavelength of the excitation light source covers the range of 300 nm to 1000 nm.

[0025] 12. The fully automated immunoassay apparatus according to any one of Clauses 1-4, wherein the wavelength of the excitation light source covers 600 nm to 800 nm.

[0026] 13. The fully automated immunoassay apparatus according to any one of Clauses 1-4, wherein the light emitted by the excitation source is a focused beam, a divergent beam, a ring beam, or a collimated beam.

[0027] 14. The fully automated immunoassay apparatus according to any one of Clauses 1-4, wherein the photon detector comprises one or more selected from the group consisting of: single-photon counters, photomultiplier tubes, silicon photocells, photometric integrating spheres, and imaging devices.

[0028] 15. The fully automated immunoassay apparatus according to any one of Clauses 1-4, wherein the reaction cup supply assembly includes a cup storage compartment configured to receive disordered mixed reaction cups to be used, and a sieve mechanism configured to automatically sort the reaction cups in the cup storage compartment.

[0029] 16. The fully automated immunoassay apparatus according to Clause 15, wherein the reaction cup includes a cup body and a flange extending outward from the upper part of the outer surface of the cup body.

[0030] 17. The fully automated immunoassay apparatus according to Clause 16, wherein the screening cup mechanism includes an inclined guide tube with the inlet at the top and the outlet at the bottom, and an inclined double-bar slide with the inlet at the top and the outlet at the bottom, the inlet of the inclined double-bar slide being located at the outlet of the inclined guide tube, the inner diameter of the inclined guide tube being slightly larger than the outer diameter of the flange of the reaction cup, and the distance between the two bars of the inclined double-bar slide being larger than the outer diameter of the cup body of the reaction cup but smaller than the outer diameter of the flange.

[0031] 18. The fully automated immunoassay apparatus according to Clause 17, wherein the screening cup mechanism further includes a sorting tray located at the exit of the double-bar slide, the sorting tray being configured to rotate to transfer reaction cups exiting the inclined double-bar slide.

[0032] 19. The fully automated immunoassay apparatus according to Clause 15, wherein the reservoir is funnel-shaped and its outlet leads to the sieve cup mechanism.

[0033] 20. The fully automated immunoassay apparatus according to any one of Clauses 1-4, wherein the reagent supply assembly includes a reagent reservoir configured to contain one or more reagent components, and a reagent transfer mechanism configured to transfer the one or more reagent components in the reagent reservoir to a reaction cup at the detection assembly.

[0034] 21. The fully automated immunoassay apparatus according to Clause 20, wherein the reagent reservoir comprises a plurality of compartments configured to contain one or more reagent components.

[0035] 22. The fully automated immunoassay apparatus according to Clause 20, wherein the reagent transfer mechanism includes a reagent needle and a support arm supporting the reagent needle, the reagent needle being configured to draw and release the one or more reagent components, and the support arm being configured to move the reagent needle between a reagent reservoir and a reaction cup at a detection assembly.

[0036] 23. The fully automated immunoassay apparatus according to Clause 22, wherein the reagent needle is equipped with a self-cleaning mechanism to prevent cross-contamination between two samplings.

[0037] 24. The fully automated immunoassay apparatus according to any one of Clauses 1-4, wherein the sample supply assembly includes an injection mechanism and a sampling mechanism, the injection mechanism being configured to sequentially deliver one or more blood collection tubes containing a whole blood sample to a blood collection tube holder, and the sampling mechanism being configured to sample the blood collection tubes on the blood collection tube holder and deliver the whole blood sample to a reaction cup at the detection assembly.

[0038] 25. The fully automated immunoassay apparatus according to Clause 24, wherein the sample introduction mechanism includes an inlet chamber, the blood collection tube seat, and an outlet chamber connected in series, the inlet chamber being configured to receive multiple rows and columns of blood collection tubes to be sampled, and the outlet chamber being configured to receive multiple rows and columns of post-sampled blood collection tubes.

[0039] 26. The fully automated immunoassay apparatus according to Clause 25, wherein the tube inlet includes a lateral pusher and / or a longitudinal pusher for pushing the blood collection tube to the blood collection tube seat.

[0040] 27. The fully automated immunoassay apparatus according to Clause 25, wherein the blood collection tube holder is provided with a scanning mechanism for scanning identification information on the blood collection tube.

[0041] 28. The fully automated immunoassay apparatus according to Clause 24, wherein the sampling mechanism includes a guide rail, a sample needle, and a drive mechanism located above the reaction cup of the sample introduction mechanism and the detection component, the drive mechanism driving the sample needle to move on the guide rail between the blood collection tube seat and the reaction cup at the detection component.

[0042] 29. The fully automated immunoassay apparatus according to Clause 28, wherein the sample needle is equipped with a self-cleaning mechanism to prevent cross-contamination between two samplings.

[0043] 30. The fully automated immunoassay apparatus according to Clause 24, wherein the sample supply assembly further includes a sample mixing mechanism for mixing whole blood samples in blood collection tubes, the sample mixing mechanism being disposed adjacent to the blood collection tube seat.

[0044] 31. The fully automated immunoassay apparatus according to Clause 24, wherein the sample supply assembly further includes a cleaning mechanism configured to clean the sample needle and / or the reagent needle of the reagent supply assembly, the cleaning mechanism being located between the sample injection mechanism and the detection assembly.

[0045] 32. The fully automated immunoassay apparatus according to Clause 31, wherein the cleaning mechanism includes a cleaning cup and a cleaning line, and the cleaning line is configured to add cleaning solution into the cleaning cup.

[0046] 33. The fully automated immunoassay apparatus according to Clause 32, wherein the cleaning cup is equipped with a self-cleaning mechanism to prevent contamination of the sample needle and / or reagent needle between cleaning cycles.

[0047] 34. The fully automated immunoassay apparatus according to Clauses 1-4, wherein the detection component, sample supply component, reagent supply component and reaction cup supply component are mounted on the same support.

[0048] 35. A detection method using a fully automated immunoassay analyzer, wherein the analyzer is configured to directly perform immunoassay on whole blood samples without requiring pretreatment, the method comprising:

[0049] The sieving cup mechanism receives multiple randomly mixed reaction cups from the storage cup bin, and sorts the multiple reaction cups in sequence with the cup openings facing upwards and delivers them to the cup outlet position;

[0050] The movable gripper transports the sorted reaction cups in the sieve cup mechanism from the cup outlet position to the reaction cup holder in the incubation mechanism;

[0051] The sample introduction mechanism receives one or more blood collection tubes containing whole blood samples in the tube inlet chamber and sequentially delivers the one or more blood collection tubes to the blood collection tube holder;

[0052] The sample is obtained by puncturing the blood collection tube on the blood collection tube holder and transferring the collected whole blood sample into the reaction cup on the reaction cup holder;

[0053] The reagent needle adds one or more reagent components from different compartments of the reagent reservoir to a whole blood sample in a reaction cup on the reaction cup holder, wherein the one or more reagent components and the target in the whole blood sample undergo an immune reaction in the reaction cup on the reaction cup holder to produce a long-afterglow luminescent complex.

[0054] The incubation apparatus incubates the one or more reagent components and whole blood sample in the reaction vessel at a set temperature and time; and

[0055] A moving gripper transports the reaction cup from the incubation mechanism to the detection mechanism. The excitation light source of the detection mechanism excites the long-afterglow luminescent complex in the reaction cup and turns off after excitation is completed. The photon detector collects the long-afterglow luminescent signal emitted by the photochemical long-afterglow luminescent complex in the reaction cup.

[0056] 36. The detection method according to Clause 35, wherein the detection mechanism fits a preset relationship curve between the intensity of the long-afterglow emission signal collected by the photon detector and the concentration of the target substance to obtain the concentration of the target substance in the whole blood sample.

[0057] 37. The detection method according to Clause 35, wherein the gripper of the sample mixing mechanism picks up the blood collection tube from the blood collection tube holder and mixes the whole blood sample in the blood collection tube, and then puts it back into the blood collection tube holder.

[0058] 38. The detection method according to Clause 35, wherein after the sample needle punctures the blood collection tube on the blood collection tube seat to collect the whole blood sample, the sample needle transfers the collected whole blood sample to the reaction cup, and the reagent needle draws a reagent component from one or more reagent components to dilute the whole blood sample in the reaction cup.

[0059] 39. The detection method according to Clause 35, wherein the device is a fully automated immunoassay device according to any one of Clauses 1-34.

[0060] Other features and advantages of the subject matter of this disclosure will be set forth in the description which follows, and will be apparent in part from the description, or may be learned by practicing the subject matter of this disclosure. The advantages of the subject matter of this disclosure will be realized and obtained through the structures particularly pointed out in the written description, its claims, and the accompanying drawings.

[0061] It should be understood that the foregoing general description and the following detailed description are exemplary and illustrative, and are intended to provide further explanation of the subject matter of this disclosure. Attached Figure Description

[0062] Many aspects of this disclosure will be better understood after reading the following detailed description in conjunction with the accompanying drawings, in which:

[0063] Figures 1 to 4 A top view, a front view, and two side views of a fully automated immunoassay apparatus according to embodiments of the present disclosure are shown.

[0064] Figure 5 and Figure 6 Show Figure 1 Front and top views of the sample introduction mechanism of a fully automated immunoassay analyzer;

[0065] Figure 7 Show Figure 1 A front view of the sampling mechanism of a fully automated immunoassay analyzer;

[0066] Figure 8 and Figure 9 Show Figure 1 Front and side views of the sample mixing mechanism of a fully automated immunoassay analyzer;

[0067] Figure 10 and Figure 11 Show Figure 1 Two side views of the cleaning mechanism and support frame of the fully automated immunoassay analyzer;

[0068] Figure 12 and Figure 13 Show Figure 1 Top and front views of the reagent reservoir of a fully automated immunoassay analyzer;

[0069] Figure 14 and Figure 15 Show Figure 1 Front and side views of the reagent transfer mechanism of a fully automated immunoassay analyzer;

[0070] Figure 16 and Figure 17 Show Figure 1 Front and side views of the sieve cup mechanism of a fully automated immunoassay analyzer;

[0071] Figure 18 and Figure 19 Show Figure 1 Top and front views of the incubation mechanism of a fully automated immunoassay analyzer;

[0072] Figure 20 Show Figure 1 A 3D view of the moving gripper of a fully automated immunoassay analyzer;

[0073] Figure 21 and Figure 22 Show Figure 1 Front and side views of the detection mechanism of a fully automated immunoassay analyzer;

[0074] Figure 23 Show Figure 1 The operation flowchart of the fully automated immunoassay analyzer. Detailed Implementation

[0075] The present disclosure will now be described with reference to the accompanying drawings, which illustrate several embodiments of the present disclosure. However, it should be understood that the present disclosure can be presented in many different ways and is not limited to the embodiments described below; in fact, the embodiments described below are intended to make the disclosure more complete and to fully illustrate the scope of protection of the present disclosure to those skilled in the art. It should also be understood that the embodiments disclosed herein can be combined in various ways to provide further additional embodiments.

[0076] It should be understood that the same reference numerals denote the same elements in all the accompanying drawings. For clarity, the dimensions of certain features may be modified in the drawings.

[0077] It should be understood that the terminology used in this specification is for describing specific embodiments only and is not intended to limit this disclosure. All terms used in this specification (including technical and scientific terms) have the meanings commonly understood by those skilled in the art unless otherwise defined. For the sake of brevity and / or clarity, well-known functions or structures may not be described in detail.

[0078] Unless otherwise specified, the singular forms “a,” “the,” and “the” used in this specification include the plural forms. The terms “comprising,” “including,” and “containing” used in this specification indicate the presence of the claimed feature but do not exclude the presence of one or more other features. The term “and / or” used in this specification includes any and all combinations of one or more of the related listed items. The terms “between X and Y” and “between approximately X and Y” used in this specification should be interpreted as including both X and Y. The term “between approximately X and Y” used in this specification means “between approximately X and approximately Y,” and the term “from approximately X to Y” used in this specification means “from approximately X to approximately Y.”

[0079] In the specification, when an element is described as being "on," "attached," "connected," "coupled," or "in contact" with another element, the element can be directly located on, attached to, connected to, coupled to, or in contact with the other element, or there may be intermediate elements present. Conversely, when an element is described as being "directly" located on, directly attached to, directly connected to, directly coupled to, or directly in contact with another element, no intermediate elements are present. In the specification, the description of a feature being arranged "adjacent" to another feature can mean that a feature has a portion overlapping with the adjacent feature or a portion located above or below the adjacent feature.

[0080] In the specification, spatial relation terms such as "up," "down," "left," "right," "front," "back," "high," and "low" describe the relationship between one feature and another in the accompanying drawings. It should be understood that spatial relation terms include not only the orientation shown in the drawings but also the different orientations of the device during use or operation. For example, when the device in the drawings is inverted, a feature previously described as "below" other features can now be described as "above" other features. The device can also be oriented in other ways (rotated 90 degrees or in other orientations), in which case the relative spatial relationships will be explained accordingly.

[0081] The fully automated immunoassay device disclosed herein utilizes the properties of long-persistent luminescent materials for immunoassay detection. Long-persistent luminescent materials are a special type of luminescent material that continues to emit light for a period of time after the excitation source is removed. The luminescence lifetime of long-persistent luminescent materials is typically greater than one hundred milliseconds (even reaching the second level and above), and they have significant application value in biomedicine, life sciences, and other fields. Unlike existing inorganic long-persistent luminescent materials based on photophysical processes, the newly developed long-persistent luminescent materials suitable for immunoassay detection are based on organic systems. This organic system utilizes the characteristics of photochemical reactions, introducing photochemical reactions between light energy input and output, organically integrating photophysics and photochemistry. In long-persistent luminescent materials based on this organic system, the luminescence process involves photochemical interactions between various chemical substances. Through a series of photochemical energy conversion and metabolic processes, the input excitation light energy is ultimately released in the form of luminescence, thus achieving long-persistent luminescence. The photochemical energy conversion and metabolic processes include energy input, energy buffering, energy extraction, energy transfer, and energy release. The originally very rapid photon radiation transition process (on the order of nanoseconds to microseconds) is changed, and the energy is slowly released and eventually emitted in the form of light energy, thereby obtaining an ultra-long luminescence time (on the order of milliseconds to hours), which greatly improves the limitation of the short luminescence lifetime of organic molecules and enhances the intensity of long afterglow luminescence.

[0082] The fully automated immunoassay apparatus disclosed herein improves the luminescence system of photochemical long-afterglow luminescent materials. The photochemical long-afterglow luminescent material introduces a photochemical reaction between light energy input and output, causing the photon radiative transition energy to be slowly released and ultimately emitted as light energy. This results in an ultra-long luminescence time, significantly improved long-afterglow luminescence performance, and prevents quenching by oxygen or water. The photochemical long-afterglow luminescent material includes an absorber, a buffer, and a luminescent agent. These three components can be arbitrarily placed in various reagent components. The reagent forms an immunobinding complex with the target substance (e.g., antigen) in the blood sample to be tested. This immunobinding complex constitutes the photochemical long-afterglow luminescent complex and serves as a signal indicator probe in immunoassay detection, avoiding interference from excitation light and background fluorescence, and achieving fully automated, wash-free homogeneous detection.

[0083] Figures 1 to 4Various angle views of the fully automated immunoassay analyzer 1 according to embodiments of the present disclosure are shown. The fully automated immunoassay analyzer 1 directly detects the concentration of a target substance in a whole blood sample in a fully automated manner. As shown, the fully automated immunoassay analyzer 1 includes a sample supply assembly 10, a reagent supply assembly 20, a reaction cup supply assembly 30, and a detection assembly 40, all of which are mounted on a support 50. The sample supply assembly 10 provides the whole blood sample to be tested to the detection assembly 40. The reagent supply assembly 20 provides one or more reagent components to the detection assembly 40. The reaction cup supply assembly 30 provides a reaction cup containing the whole blood sample and reagent components to the detection assembly 40. The detection assembly 40 performs immunoassay detection on the whole blood sample in the reaction cup.

[0084] The sample supply assembly 10 includes a sample introduction mechanism 11 and a sampling mechanism 12. The sample introduction mechanism 11 sequentially delivers one or more blood collection tubes 13 to a blood collection tube holder 112, and the sampling mechanism 12 samples the blood collection tubes 13 on the blood collection tube holder 112 and delivers the whole blood sample to the detection assembly 40. Figure 5 and Figure 6 As shown, the sample introduction mechanism 11 includes an inlet compartment 111, a blood collection tube holder 112, and an outlet compartment 113 connected in series. The inlet compartment 111 can receive multiple rows and columns of blood collection tubes 13 to be sampled, and each blood collection tube 13 can hold a whole blood sample. The inlet compartment 111 includes a lateral pusher and a longitudinal pusher. The lateral pusher sequentially pushes multiple blood collection tubes 13 to be sampled in each row to the sampling row aligned with the blood collection tube holder 112, while the longitudinal pusher sequentially pushes multiple blood collection tubes 13 located in the sampling row to the blood collection tube holder 112. After being sampled by the sampling mechanism 12, the blood collection tubes 13 on the blood collection tube holder 112 are pushed to the outlet compartment 113. The outlet compartment 113 can receive multiple rows and columns of post-sampled blood collection tubes 13. The outlet compartment 113 includes a lateral pusher and pushes the post-sampled blood collection tubes 13 located in the sampling row out of the sampling row. In some embodiments, the blood collection tube seat 112 may be provided with a scanning mechanism for scanning identification information on the blood collection tube 13, thereby obtaining traceability information of the whole blood sample in the blood collection tube 13.

[0085] like Figure 7As shown, the sampling mechanism 12 includes a guide rail 121, a sample needle 122, and a drive mechanism 123 located above the sample injection mechanism 11 and the incubation mechanism 41 (described in detail below) of the detection component 40. The drive mechanism 123 drives the sample needle 122 to move on the guide rail 121 to switch between multiple different positions (including the blood collection tube seat position, the reaction cup seat position, etc.). For example, the drive mechanism 123 can drive the sample needle 122 to the blood collection tube seat position, so that the sample needle 122 punctures the blood collection tube 13 on the blood collection tube seat 112 to collect a sample. The drive mechanism 123 can also drive the sample needle 122 to the reaction cup seat position of the detection component 40 to transfer the whole blood sample collected by the sample needle 122 into the reaction cup.

[0086] In some embodiments, the sample supply assembly 10 may further include a sample mixing mechanism 14 for mixing the sample in the blood collection tube 13, such as... Figure 8 and Figure 9 As shown. The sample mixing mechanism 14 is positioned adjacent to the blood collection tube holder 112 and includes a gripper 141. The gripper 141 can pick up the blood collection tube 13 on the blood collection tube holder 112, mix the whole blood sample in the blood collection tube 13, and then put it back into the blood collection tube holder 112.

[0087] In some embodiments, the sample supply assembly 10 may further include a cleaning mechanism 15 for cleaning the sample needle 122, such as... Figure 10 and Figure 11 As shown. The cleaning mechanism 15 is located between the sample injection mechanism 11 and the detection component 40. The cleaning mechanism 15 includes a cleaning cup 151 and a cleaning line 152, the cleaning line 152 being used to add cleaning solution into the cleaning cup 151. The sample needle 122 is driven by the drive mechanism 123 to transfer the whole blood sample collected from the blood collection tube 13 to the reaction cup at the reaction cup seat position of the detection component 40, and then the sample needle 122 moves to the cleaning cup 151 for cleaning to prevent cross-contamination between two samplings. In some embodiments, the cleaning cup 151 may be equipped with a self-cleaning mechanism (e.g., cleaning with a cleaning solution prepared with a strong acid or strong alkali) to prevent contamination of the sample needle 122 between two cleanings. In some embodiments, the sample needle 122 may be equipped with a self-cleaning mechanism (e.g., cleaning with a cleaning solution prepared with a strong acid or strong alkali).

[0088] The reagent supply assembly 20 includes a reagent reservoir 21 and a reagent transfer mechanism 22. The reagent reservoir 21 contains reagent components that react with the target substance in the whole blood sample, and the reagent transfer mechanism 22 transfers the reagent components from the reagent reservoir 21 to the reaction cup at the reaction cup holder position of the detection assembly 40. Figure 12 and Figure 13As shown, reagent reservoir 21 includes multiple compartments for containing reagent components, with the temperature within each compartment maintained at approximately 4°C to approximately 8°C. Each compartment contains one or more reagent components, such as absorbers, buffers, and luminescent agents for achieving photochemical long-persistence luminescence. The reagent components can undergo an immune reaction with the target analyte in the whole blood sample to be tested, forming an immune-binding complex through immune reaction coupling, thereby generating a photochemical long-persistence luminescence signal detectable by detection component 40.

[0089] In some embodiments, an absorber is placed in reagent component R1, and a buffer and a luminescent agent are placed in reagent component R2. Reagent component R1 contains a first antibody capable of reacting with the target analyte; reagent component R2 contains a second antibody capable of reacting with the target analyte. That is, reagent components R1 and R2 contain components necessary for photochemical long-afterglow luminescence, such as absorbers, buffers, and luminescent agents. Reagent component R1 contains the first antibody against the target analyte and the absorber for photochemical long-afterglow; reagent component R2 contains the second antibody against the target analyte and the buffer and luminescent agent for photochemical long-afterglow. Reagent components R1 and R2 also contain additives commonly used in immune reactions for hemolysis and / or signal amplification, such as hemolysins, salts, stabilizers, signal amplification components, nanospheres, antibodies, antigens, proteins, surfactants, water, preservatives, nucleic acids, peptides, etc. Some embodiments also include an R3 reagent component for diluting whole blood samples. The R3 reagent component may be at least one of PB, PBS, PBST, BBS, MES, Tris, TES, and HEPES. The above-mentioned additive components commonly used in immune reactions are also included in the R3 reagent component.

[0090] like Figure 14 and Figure 15 As shown, the reagent transfer mechanism 22 includes a reagent needle 221 and a support arm 222 supporting the reagent needle 221. The reagent needle 221 can extract and release reagent components. The support arm 222 can move the reagent needle 221 in both vertical and horizontal directions to switch between multiple different positions (e.g., reagent positions, reaction cup positions, etc.). For example, the support arm 222 can move the reagent needle 221 to the reagent positions in multiple chambers of the reagent reservoir 21 to collect the corresponding reagent components. The support arm 222 can move the reagent needle 221 to the reaction cup position of the detection component 40 to transfer the reagent components collected by the reagent needle 221 into the reaction cup. In some embodiments, the support arm 222 is inverted L-shaped and includes a horizontal support arm and a vertical support arm. The free end of the horizontal support arm is provided with a reagent needle 221 perpendicular to it, while the vertical support arm is driven by a motor to rotate, thereby moving the reagent needle 221 between the reagent positions in multiple chambers of the reagent reservoir 21 and the reaction cup position of the detection component 40.

[0091] The reagent needle 221 may also be equipped with Figure 1 The reagent needle self-cleaning mechanism 223 shown (e.g., cleaning with a cleaning solution prepared with acid, alkali, and / or surfactant) prevents cross-contamination between two samplings. In some embodiments, the reagent needle 221 can be moved to the cleaning mechanism 15 for cleaning.

[0092] The reaction cup supply assembly 30 includes a storage container and a sieving mechanism 32. The storage container receives reaction cups to be used, and the sieving mechanism 32 sorts the disordered reaction cups in the storage container. Each reaction cup includes a cup body and a flange extending outward from the upper part of the outer surface of the cup body. The storage container is funnel-shaped, and its outlet is located at the inlet of the sieving mechanism 32. Figure 16 and Figure 17 As shown, the sieving cup mechanism 32 includes a guide tube 321, a double-bar slide 322, and a sorting tray 323. The guide tube 321 is placed at an angle, with the inlet at the top and the outlet at the bottom, and its inner diameter is slightly larger than the outer diameter of the flange of the reaction cup. The reaction cup can be conveyed within the guide tube 321, with its opening facing either upwards or downwards. The double-bar slide 322 is placed at an angle, with the inlet at the top and the outlet at the bottom, and its inlet is located at the outlet of the guide tube 321. The distance between the two bars of the double-bar slide 322 is greater than the outer diameter of the reaction cup body but less than the outer diameter of the flange. After the reaction cup leaves the guide tube 321, it slides on the double-bar slide 322 using its extended flange, and under the action of gravity, the cup openings automatically flip upwards. The sorting tray 323 is located at the outlet of the double-bar slide 322 and can rotate to convey the reaction cups leaving the double-bar slide 322 to the cup exit position.

[0093] The detection assembly 40 includes an incubation mechanism 41 and a detection mechanism 42. The incubation mechanism 41 is used to incubate the whole blood sample in the reaction vessel to a specified temperature (e.g., 37.5°C), and the detection mechanism 42 is used to detect the optical signal generated by the whole blood sample in the reaction vessel. Figure 18 and Figure 19 As shown, the incubation mechanism 41 includes an incubation tray 411, and the incubation tray 411 is provided with a plurality of reaction cup holders 412 spaced apart circumferentially to receive reaction cups. The plurality of reaction cup holders 412 are rotatable about the central axis of the incubation mechanism 41. A movable gripper 43 (e.g.) Figure 20 As shown, the reaction cups at the outlet position of the reaction cup supply assembly 30 are sequentially transported to the reaction cup holder 412, and the sample needle 122 and reagent needle 221 transfer diluted whole blood samples and reagent components to the reaction cups, respectively. The movable gripper 43 can pick up the reaction cups from the reaction cup holder 412, mix them, and then put them back into the reaction cup holder 412 or transport them to the detection mechanism 42.

[0094] like Figure 21 and Figure 22As shown, the detection mechanism 42 is disposed adjacent to the incubation mechanism 41. The detection mechanism 42 includes an excitation light source, a photon detector, and a filter disposed between the two. The excitation light source is used to excite the photochemical long-afterglow luminescent complex in the whole blood sample and is turned off after excitation is completed. The filter is used to filter out the excitation light and protect the photon detector. The photon detector is used to collect the luminescence signal emitted by the photochemical long-afterglow luminescent complex.

[0095] As described above, reagent components R1 and R2 form an immunobinding complex with the target analyte in the whole blood sample within the reaction vessel. This immunobinding complex constitutes a photochemical long-persistent luminescence complex, and the intensity of its long-persistent luminescence signal is positively correlated with the concentration of the target analyte in the whole blood sample. The detection mechanism stores a preset relationship curve between the intensity of the long-persistent luminescence signal and the concentration of the target analyte. The detection mechanism 42 can detect the concentration of the target analyte based on the intensity of the photochemical long-persistent luminescence signal collected by the photon detector.

[0096] In some embodiments, the excitation source can be a solid-state laser, gas laser, semiconductor laser, photodiode, D65 standard light source, light-emitting diode, ultraviolet lamp, xenon lamp, sodium lamp, mercury lamp, tungsten filament lamp, incandescent lamp, fluorescent lamp, or a combination of these sources. In some embodiments, the excitation source can be a laser or a light-emitting diode, which output light with good monochromaticity and high brightness, and can selectively and rapidly excite and charge. The light emitted by the excitation source can be a focused, divergent, annular, or collimated beam. The wavelength of the excitation source can cover 300 nm to 1000 nm, more particularly covering 600 nm to 800 nm. For example, a photodiode can be used as an excitation source, with a wavelength of approximately 730 nm. After excitation for 1 second, it is turned off, and the photochemical long-afterglow luminescent complex in the reaction vessel then emits an upconversion type long-afterglow luminescence signal of approximately 610 nm.

[0097] In some embodiments, the photon detector may be a single-photon counter, a photomultiplier tube, a silicon photocell, a photometric integrating sphere, or a photographic imaging device.

[0098] The following reference Figure 23 The sample testing steps of the fully automated immunoassay analyzer 1 according to an embodiment of the present disclosure are described. The sieving cup mechanism 32 of the reaction cup supply assembly 30 receives disordered mixed reaction cups from the storage cup chamber. The reaction cups sequentially pass through the guide tube 321, the double-bar slide 322 and the sorting tray 323 of the sieving cup mechanism 32, thereby being sorted in sequence with the cup openings facing upwards and reaching the cup dispensing position.

[0099] The moving gripper 43 of the detection component 40 transports the sorted reaction cups in the sieve cup mechanism 32 from the cup outlet position to the reaction cup holder 412 of the incubation mechanism 41.

[0100] The sample supply component 10 uses its lateral and longitudinal pushers to sequentially transport one or more blood collection tubes 13 containing whole blood samples to the blood collection tube seat 112.

[0101] The gripper 141 of the sample mixing mechanism 14 picks up the blood collection tube 13 on the blood collection tube seat 112 and mixes the whole blood sample in the blood collection tube 13, and then puts it back into the blood collection tube seat 112.

[0102] The driving mechanism 123 of the sampling mechanism 12 of the sample supply assembly 10 drives the sample needle 122 to move on the guide rail 121 to the blood collection tube seat position. The sample needle 122 punctures the blood collection tube 13 on the blood collection tube seat 112 to collect a sample, and the driving mechanism 123 drives the collected whole blood sample (e.g., 10 μL of blood sample) to the reaction cup at the reaction cup seat 412. Then, the sample needle 122 moves to the cleaning cup 151 for cleaning.

[0103] The reagent needle 221 of the reagent supply assembly 20 adds reagent component R3 from reagent reservoir 21 to the whole blood sample in the reaction cup to dilute the whole blood sample. After uniform dilution, the reagent needle 221 moves to the washing cup 151 for washing.

[0104] The reagent needle 221 adds reagent components R1 and R2 from reagent reservoir 21 to the diluted whole blood sample in the reaction cup.

[0105] The mobile gripper 43 picks up the reaction cup and mixes the reagents and dilutes the whole blood sample by rotating it at high speed in situ, and then puts it back into the reaction cup holder 412 of the incubation mechanism 41.

[0106] The incubation tray 411 of the incubation mechanism 41 rotates to incubate the reagents and diluted whole blood samples in the reaction cup at the set temperature and time.

[0107] After incubation, the movable gripper 43 transports the reaction cup to the detection mechanism 42. The excitation source of the detection mechanism 42 (e.g., a photodiode with an emission wavelength of approximately 730 nm) excites the reaction cup for several seconds (e.g., 1 second) and then turns it off. The photochemical long-persistence luminescent complex in the reaction cup emits a long-persistence luminescent signal (e.g., a red long-persistence luminescent signal at approximately 610 nm). The detection mechanism 42 fits the intensity of the long-persistence luminescent signal collected by the photon detector to a preset relationship curve between the intensity of the stored long-persistence luminescent signal and the concentration of the target analyte, thereby obtaining the concentration of the target analyte in the whole blood sample. After detection, the reaction cup is discarded.

[0108] The fully automated immunoassay analyzer according to embodiments of this disclosure can directly test whole blood samples without requiring the opening of blood collection tubes or blood centrifugation. The target substance (e.g., antigen) is present in the whole blood sample, which is directly collected, stored, and loaded using blood collection tubes commonly used in medical settings. Therefore, the fully automated immunoassay analyzer can directly perform a series of detection operations on whole blood samples in blood collection tubes and has the capability for continuous batch testing.

[0109] The fully automated immunoassay apparatus according to embodiments of this disclosure employs long-persistence luminescence detection technology to detect whole blood samples. Since only the immunobinding substance emits a light signal after the excitation light is turned off, the intensity of the light signal corresponds to the concentration of the analyte. Long-persistence luminescence detection technology avoids interference from background light and the light source, resulting in high-quality detection results.

[0110] The fully automated immunoassay apparatus according to embodiments of this disclosure can achieve fully automated immunoassay detection, effectively saving the workload of medical personnel.

[0111] The fully automated immunoassay analyzer according to embodiments of this disclosure uses a sieve cup mechanism. Simply by pouring reaction cups into the reservoir, the sieve cup mechanism can sequentially sort the randomly mixed reaction cups with their rims facing upwards. Compared to the prior art where reaction cups are manually placed, the sieve cup mechanism achieves fully automated sorting of the reaction cups. By periodically replenishing the reaction cups in the reservoir, the fully automated immunoassay analyzer according to embodiments of this disclosure can achieve uninterrupted detection.

[0112] The fully automated immunoassay analyzer according to embodiments of this disclosure uses disposable reaction cups, reducing the possibility of cross-contamination between tests and allowing for simultaneous performance of multiple analyses. This design significantly increases test accuracy and repeatability (due to the use of disposable reaction cups, the background of the photochemiluminescence signal does not increase after multiple tests) and improves instrument testing efficiency (e.g., up to 180 tests per hour). Given my country's large population and relatively scarce medical resources, the fully automated immunoassay analyzer according to embodiments of this disclosure can largely adapt to the requirements of existing testing projects that involve long testing times, numerous projects, and heavy workloads.

[0113] The fully automated immunoassay analyzer according to embodiments of this disclosure is constructed with streamlined modular components, and its size is desktop-level, avoiding the drawbacks of large space occupation and inconvenience in movement. Compared with existing devices, the fully automated immunoassay analyzer according to embodiments of this disclosure has lower testing costs, faster operation, and is more convenient for testing.

[0114] While exemplary embodiments of this disclosure have been described, those skilled in the art will understand that various changes and modifications can be made to the exemplary embodiments of this disclosure without departing from the spirit and scope thereof. Therefore, all changes and modifications are included within the scope of protection of this disclosure as defined by the claims. This disclosure is defined by the appended claims, and equivalents of those claims are also included.

Claims

1. A fully automated immunoassay device, characterized by, The device is configured to directly perform immunoassay detection on a whole blood sample without pretreatment of the whole blood sample, the device comprising: a detection assembly, a probing mechanism of the detection assembly comprising an excitation light source and a photon detector; a sample supply assembly configured to automatically supply the detection assembly with a whole blood sample to be detected; a reagent supply assembly configured to automatically supply the detection assembly with one or more reagent components, the one or more reagent components comprising a first reagent component containing a first antibody of a target and a second reagent component containing a second antibody of the target, the first reagent component comprising one or more of an absorbent, a buffer and a luminescent agent, the second reagent component comprising the remaining one of the absorbent, the buffer and the luminescent agent; a reaction cup supply assembly configured to automatically supply the detection assembly with a reaction cup; wherein the one or more reagent components and the target in the whole blood sample to be detected react in the reaction cup at the detection assembly to produce a long-persistent luminescence complex, wherein the excitation light source is configured to excite the long-persistent luminescence complex in the reaction cup and to be turned off after excitation is completed, and the photon detector is configured to collect a luminescence signal emitted by the long-persistent luminescence complex after the excitation light source is turned off.

2. The fully automated immunoassay analyzer according to claim 1, characterized by The one or more reagent components further comprise a third reagent component for diluting the whole blood sample.

3. The fully automated immunoassay analyzer according to claim 1, wherein The one or more reagent components contain an additive component for hemolysis and / or signal amplification in the immunoassay, and the additive component is selected from one or more of a group comprising a hemolytic agent, a salt, a stabilizer, a nanosphere, an antibody, an antigen, a protein, a surfactant, water, a preservative, a nucleic acid, a polypeptide.

4. The fully automated immunoassay analyzer according to any one of claims 1 to 3, characterized in that, The probing mechanism further comprises a filter disposed between the excitation light source and the photon detector, the filter being configured to filter out excitation light when the excitation light source is turned on.

5. The fully automated immunoassay analyzer according to any one of claims 1 to 3, characterized in that, The probing mechanism is configured to obtain a concentration of the target in the whole blood sample from an intensity of the luminescence signal emitted by the photochemical long-persistent luminescence complex according to a preset relationship curve between the intensity of the long-persistent luminescence signal and the concentration of the target.

6. The fully automated immunoassay analyzer according to any one of claims 1 to 3, characterized in that, The detection assembly further comprises an incubation mechanism adjacent to the probing mechanism, the incubation mechanism being configured to incubate the one or more reagent components and the whole blood sample in the reaction cup to a specified temperature.

7. The fully automated immunoassay analyzer according to claim 6, wherein The incubation mechanism comprises an incubation tray provided with a plurality of reaction cup seats spaced apart in a circumferential direction and receiving the reaction cup.

8. The fully automated immunoassay analyzer according to claim 6, wherein The detection assembly further comprises a moving gripper configured to move the reaction cup between the incubation mechanism, the probing mechanism and the reaction cup supply assembly.

9. The fully automated immunoassay analyzer according to any one of claims 1 to 3, characterized in that, The excitation light source comprises one or more selected from a group consisting of a solid-state laser, a gas laser, a semiconductor laser, a photodiode, a D65 standard light source, a light-emitting diode, an ultraviolet lamp, a xenon lamp, a sodium lamp, a mercury lamp, a tungsten lamp, an incandescent lamp, a fluorescent lamp.

10. The fully automated immunoassay analyzer according to any one of claims 1 to 3, characterized in that, The excitation light source has a light wavelength covering 300 nm-1000 nm.

11. The fully automated immunoassay analyzer according to any one of claims 1 to 3, characterized in that, The excitation light source has a light wavelength covering 600 nm-800 nm.

12. The fully automated immunoassay analyzer according to any one of claims 1 to 3, characterized in that, The light emitted by the excitation light source is a focused light beam, a divergent light beam, a ring-shaped light beam, or a collimated light beam.

13. The fully automated immunoassay analyzer according to any one of claims 1 to 3, characterized in that, The photon detector includes one or more selected from the group consisting of a single photon counter, a photomultiplier tube, a silicon photodiode, a photometric integrating sphere, and a photographic imaging device.

14. The fully automated immunoassay analyzer according to any one of claims 1 to 3, characterized in that, The reaction cup feeding assembly includes a cup storage bin configured to receive a plurality of reaction cups to be used in disordered arrangement, and a cup screening mechanism configured to automatically arrange the reaction cups in the cup storage bin in order.

15. The fully automated immunoassay analyzer according to claim 14, wherein The reaction cup includes a cup body and a flange extending outwardly from an upper portion of an outer surface of the cup body.

16. The fully automated immunoassay analyzer according to claim 15, wherein The cup screening mechanism includes an inclined guide tube with an upper inlet and a lower outlet, and an inclined double-bar slide with an upper inlet and a lower outlet, the upper inlet of the double-bar slide being located at the outlet of the inclined guide tube, the inner diameter of the inclined guide tube being slightly larger than the outer diameter of the flange of the reaction cup, and the distance between the double bars of the double-bar slide being greater than the outer diameter of the cup body of the reaction cup but less than the outer diameter of the flange.

17. The fully automated immunoassay analyzer according to claim 16, wherein The cup screening mechanism further includes a cup arranging disc located at the lower outlet of the double-bar slide, the cup arranging disc being configured to be rotatable to deliver the reaction cup out of the inclined double-bar slide.

18. The fully automated immunoassay analyzer according to claim 14, wherein The cup storage bin is funnel-shaped, and its outlet is connected to the cup screening mechanism.

19. The fully automated immunoassay analyzer according to any one of claims 1 to 3, characterized in that, The reagent feeding assembly includes a reagent storage configured to contain the one or more reagent components, and a reagent transfer mechanism configured to transfer the one or more reagent components in the reagent storage into the reaction cup at the detection assembly.

20. The fully automated immunoassay analyzer according to claim 19, wherein, The reagent storage includes a plurality of compartments configured to contain the one or more reagent components.

21. The fully automated immunoassay analyzer according to claim 19, wherein The reagent transfer mechanism includes a reagent needle configured to be able to draw and release the one or more reagent components, and a support arm supporting the reagent needle and configured to be able to move the reagent needle between the reagent storage and the reaction cup at the detection assembly.

22. The fully automated immunoassay analyzer according to claim 21, wherein The reagent needle is provided with a self-cleaning mechanism to prevent cross-contamination between two samplings.

23. The fully automated immunoassay analyzer according to any one of claims 1 to 3, characterized in that, The sample feeding assembly includes a sample feeding mechanism configured to sequentially deliver one or more blood collection tubes containing whole blood samples to a blood collection tube seat, and a sampling mechanism configured to sample the blood collection tubes on the blood collection tube seat and send the whole blood samples to the reaction cup at the detection assembly.

24. The fully automated immunoassay analyzer according to claim 23, wherein The sample feeding mechanism includes a tube feeding bin, the blood collection tube seat and a tube discharging bin connected in series with each other, the tube feeding bin being configured to receive a plurality of rows and columns of blood collection tubes to be sampled, and the tube discharging bin being configured to receive a plurality of rows and columns of sampled blood collection tubes.

25. The fully automated immunoassay analyzer according to claim 24, wherein The tube feeding bin includes a horizontal pusher and / or a vertical pusher configured to push the blood collection tubes to the blood collection tube seat.

26. The fully automated immunoassay analyzer of claim 24, wherein, The blood collection tube seat is provided with a scanning mechanism configured to scan identification information on the blood collection tubes.

27. The fully automated immunoassay analyzer according to claim 23, characterized in that, The sampling mechanism includes a guide rail located above the tube feeding mechanism and the reaction cup of the detection assembly, a sample needle and a driving mechanism configured to drive the sample needle to move on the guide rail between the blood collection tube seat and the reaction cup at the detection assembly.

28. The fully automated immunoassay analyzer of claim 27, wherein, The sample needle is provided with a self-cleaning mechanism to prevent cross-contamination between two samplings.

29. The fully automated immunoassay analyzer of claim 23, wherein, The sample feeding assembly further includes a sample mixing mechanism configured to mix the whole blood samples in the blood collection tubes, the sample mixing mechanism being arranged adjacent to the blood collection tube seat.

30. The fully automated immunoassay analyzer of claim 23, wherein, The sample feeding assembly further includes a cleaning mechanism configured to clean the sample needle and / or the reagent needle of the reagent feeding assembly, the cleaning mechanism being located between the sample feeding mechanism and the detection assembly.

31. The fully automated immunoassay analyzer of claim 30, wherein, The cleaning mechanism includes a cleaning cup and a cleaning pipeline, and the cleaning pipeline is configured to add cleaning liquid into the cleaning cup.

32. The fully automated immunoassay analyzer of claim 31, wherein, The washing cup is provided with a self-cleaning mechanism to prevent the sample needle and / or the reagent needle from being contaminated between two washings.

33. The fully automated immunoassay analyzer according to any one of claims 1 to 3, characterized in that, The detection assembly, the sample supply assembly, the reagent supply assembly and the reaction cup supply assembly are arranged on the same support.

34. A detection method of a fully automated immunoassay device, characterized by, The device is configured to directly perform immune analysis detection on a whole blood sample without pretreatment of the whole blood sample, and the method comprises: The sifting cup mechanism receives a plurality of reaction cups in disordered mixing from a storage cup magazine, and sequentially sorts and delivers the plurality of reaction cups in a cup opening upward manner to a cup outlet position; The moving gripper transports the plurality of reaction cups sorted in the sifting cup mechanism from the cup outlet position to the reaction cup seat of the incubation mechanism; The sample needle pierces the blood collection tube on the blood collection tube seat to sample and transfers the sampled whole blood sample into the reaction cup on the reaction cup seat; The reagent needle adds one or more reagent components in different chambers of the reagent reservoir into the whole blood sample in the reaction cup on the reaction cup seat, wherein the one or more reagent components include a first reagent component containing a first antibody of a target object and a second reagent component containing a second antibody of the target object, the first reagent component contains one or more of an absorbent, a buffer and a luminescent agent, and the second reagent component contains the remaining one of the absorbent, the buffer and the luminescent agent, the one or more reagent components and the target object in the whole blood sample in the reaction cup on the reaction cup seat have an immune reaction to generate a long-afterglow luminescent compound; The incubation mechanism incubates the one or more reagent components and the whole blood sample in the reaction cup at a set temperature and time; and The moving gripper transports the reaction cup from the incubation mechanism to the detection mechanism, the excitation light source of the detection mechanism excites the long-afterglow luminescent compound in the reaction cup and is turned off after excitation is completed, and the photon detector collects the long-afterglow luminescent signal emitted by the photochemical long-afterglow luminescent compound in the reaction cup. The detection mechanism fits a preset relationship curve between the long-afterglow luminescent signal intensity and the target object concentration according to the intensity of the long-afterglow luminescent signal collected by the photon detector, to obtain the concentration of the target object in the whole blood sample.

35. The method of claim 34, wherein, The gripper of the sample mixing mechanism picks up the blood collection tube on the blood collection tube seat and mixes the whole blood sample in the blood collection tube, and then returns the blood collection tube to the blood collection tube seat.

36. The method of claim 34, wherein, After the sample needle pierces the blood collection tube on the blood collection tube seat to sample, the sample needle transfers the sampled whole blood sample into the reaction cup, and the reagent needle extracts a reagent component in the one or more reagent components to dilute the whole blood sample in the reaction cup.

37. The method of claim 34, wherein the detecting is performed by a method selected from the group consisting of mass spectrometry, nuclear magnetic resonance, and chromatography. The device is an automatic immune analysis device according to any one of claims 1-3.

38. The method of claim 34, wherein, ​

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