Automatic verification processing method and system

Abstract

Embodiments of automated verification processing systems and methods are disclosed. In one example, an automated verification system includes a cuvette holder, a verification process tube, a magnet, and a controller. The cuvette holder has a plurality of cuvette arms, each configured to support a cuvette, the cuvette holder being driven to rotate. The assay process tube has a right arm having an opening for receiving a reagent transferred from a cuvette supported by one of the cuvette support arms of the cuvette holder, and a left arm, the assay process tube being driven in rotation. The magnet is driven to move vertically. The controller is configured to control coordinated movement of the cuvette holder, the verification process tube, and the magnet to perform a verification process sequence.

Description

This application is a divisional application of the invention patent application entitled “Automatic Verification Processing Method and System” with application number 201980065947.1 filed on October 6, 2019. CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 62 / 742,889, filed on October 8, 2018, the entire contents of which are incorporated herein by reference. Background Art

[0002] Embodiments of the present disclosure relate to automated verification processing systems and methods.

[0003] Assay is an investigative or analytical procedure in laboratory medicine, pharmacology, environmental biology, and molecular biology used to qualitatively assess or quantitatively measure the presence, amount, or functional activity of a target entity (analyte). Assays have become a routine part of modern medicine, environmental, pharmaceutical, forensic, and many other operations at all scales, from industrial to roadside or field. Performing assay procedures manually is labor intensive and prone to error. Automated assays offer many advantages, including lower labor costs, high productivity, and high accuracy. Summary of the invention

[0004] Embodiments of automated assay processing systems and methods are disclosed herein.

[0005] In one example, an automatic testing system includes a test tube holder, a testing processing tube, a magnet, and a controller. The test tube holder has a plurality of test tube arms. Each test tube arm is configured to support a test tube. The test tube holder is driven to rotate. The testing processing tube has a right arm and a left arm. The right arm has an opening for receiving a reagent transferred from a test tube supported in one of the test tube arms of the test tube holder. The testing processing tube is driven to rotate. The magnet is driven to move vertically. The controller is configured to control the coordinated movement of the test tube holder, the testing processing tube, and the magnet to execute a testing processing sequence.

[0006] In another example, an automatic assay processing system includes an assay processing tube assembly of a preconfigured shape, a magnet assembly, and a controller. The assay processing tube assembly includes a plurality of assay processing tubes. Each assay processing tube includes a right arm having an opening for receiving a reagent and a left arm having an opening. The assay processing tube assembly is driven to rotate. The magnet assembly includes a plurality of magnets supported on a magnet support. The number of magnets corresponds to the number of assay processing tubes. The magnet assembly is driven to move vertically. The controller is configured to control the coordinated movement of the assay processing tube assembly and the magnet assembly to execute an assay processing sequence.

[0007] In another example, an automatic reagent delivery system includes a test tube rack, one or more groups of dispensers above the test tube rack, and a controller. The test tube rack has a plurality of test tube arms. Each test tube arm is configured to support a group of multiple test tubes. The test tube rack is driven to rotate. The number of dispensers in each group of dispensers is the same as the number of test tubes in each group of test tubes. The controller is configured to control the coordinated movement of the test tube rack and the dispenser to achieve coordination between the test tube rack and the dispenser.

[0008] In yet another example, an automatic testing system includes a testing process tube assembly having a preconfigured shape, a test tube holder, a magnet assembly, and a controller. The testing process tube assembly includes a plurality of testing process tubes. Each testing process tube includes a right arm having an opening for receiving a reagent and a left arm having an opening. The testing process tube assembly is driven to rotate. The test tube holder has a plurality of arms. Each arm is configured to support a group of a plurality of test tubes. The number of test tubes in each group of test tubes corresponds to the number of testing process tubes of the testing process tube assembly. The test tube holder is driven to rotate. The magnet assembly includes a plurality of magnets supported on the magnet holder. The number of magnets corresponds to the number of testing process tubes. The magnet assembly is driven to move vertically. The controller is configured to control the coordinated movement of the testing process tube assembly, the test tube holder, and the magnet assembly to execute a testing process sequence.

[0009] In yet another example, an automatic assay system includes an assay processing tube assembly having a preconfigured shape, a reagent kit assembly, a magnet assembly, and a controller. The assay processing tube assembly includes one or more assay processing tubes. The reagent kit assembly has one or more fluid channels. Each fluid channel is configured to accommodate a specific reagent in liquid, dry or lyophilized form. The reagent kit assembly is connected to the assay processing tube assembly. Each assay processing tube has a reaction chamber at a central position, a waste liquid chamber attached to one end of the reaction chamber, and a measurement chamber attached to the other end. Each fluid channel has a reagent outlet, through which the reaction chamber can receive reagents from the fluid channel or directly from a user's pipette or other source. The assay processing tube assembly is driven to rotate. The magnet assembly includes a plurality of magnets supported on a magnet support. The number of magnets corresponds to the number of assay processing tubes. The magnet assembly is driven to move vertically. The controller is configured to control the coordinated movement of the assay processing tube assembly, the reagent kit assembly, and the magnet assembly to execute an assay processing sequence.

[0010] In a different example, a method for automated assay processing is disclosed. A first solution having a first reagent and magnetic beads transferred from a test tube is received by a U-shaped assay processing tube in an upright position. The U-shaped assay processing tube has: a right arm having an opening for receiving the first solution having the first reagent and magnetic beads; and a left arm having an opening. The U-shaped assay processing tube is rotated back and forth at a specific rotation speed within a predetermined angle range, and the reagents and magnetic beads are mixed. The magnet is moved from a lower position to an upper position close to the magnetic beads inside the U-shaped assay processing tube. The U-shaped assay processing tube is rotated clockwise until it contacts a discharge platform. The magnetic beads are concentrated in the U-shaped assay processing tube near the top of the magnet, and the first solution with the unbound first reagent flows out of the U-shaped assay processing tube. The U-shaped assay processing tube is rotated counterclockwise back to an upright position. The magnet is moved back from the upper side to the lower side. The second solution with the second reagent transferred from the test tube is received by the U-shaped assay processing tube. The magnet is moved from a lower position to an upper position close to the magnetic beads in the U-shaped assay processing tube. The U-shaped calibration process tube is rotated counterclockwise.

[0011] In another different example, a method for automatically dispensing reagents and mixing is disclosed. A first reagent from a first dispenser is received by a first test tube among a plurality of test tubes supported in a test tube holder. The first test tube contains a first solution. The test tube holder is rotated counterclockwise to a position where a mixture of the first reagent and the first solution flows out of the first test tube into a receiving tube and a second test tube is ready to receive the first reagent from the first dispenser. The second test tube contains a second solution. The first reagent from the first dispenser is received by the second test tube. The test tube holder is rotated counterclockwise to a position where a mixture of the first reagent and the second solution flows from the second test tube into the receiving tube. The test tube holder is rotated clockwise to a position where a third test tube is ready to receive the second reagent from the second dispenser. The third test tube is empty or contains a third solution. The second reagent from the second dispenser is received by the third test tube. The test tube holder is rotated counterclockwise to a position where a second reagent or a mixture of the second reagent and the third solution flows from the third test tube into the receiving tube. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate embodiments of the present disclosure and, together with the description, further serve to explain the principles of the present disclosure and enable those skilled in the relevant art to make and use the present disclosure.

[0013] Figure 1 A schematic diagram of an exemplary automatic verification system according to some embodiments of the present disclosure is shown.

[0014] Figure 2a A schematic diagram of an exemplary test tube holder according to some embodiments of the present disclosure is shown, wherein a test tube is not inserted therein.

[0015] Figure 2bA schematic diagram of an exemplary test tube holder is shown with a test tube inserted therein according to some embodiments of the present disclosure.

[0016] Figure 3-11 Various exemplary authentication process steps are shown according to various embodiments of the present disclosure.

[0017] Fig.12 A perspective view showing the major components of an exemplary automated assay processing system according to various embodiments of the present disclosure is shown.

[0018] Fig.13 Various embodiments according to the present disclosure are shown. Fig.12 A front view of the major components of an exemplary automated assay processing system.

[0019] Fig.14 Shows Fig.12 The automated assay processing system of FIG. 1 is a set of typical actions via coordinated magnet movement and rotation of an assay processing tube having attached electrodes.

[0020] Fig.15 Shows Fig.12 Another typical set of motions of the automated assay processing system of is via coordinated magnet movement and rotation of an assay processing tube that has a different shape and has no attached electrodes.

[0021] Fig.16 The major components of an exemplary automated reagent transfer system are shown in perspective and exploded views according to various embodiments of the present disclosure.

[0022] Fig.17 Shows Fig.16 A typical set of actions for an automated reagent delivery system includes dispensing solutions into test tubes and pouring solutions from test tubes.

[0023] Fig.18 A perspective view showing the main components of an exemplary automatic verification system according to various embodiments of the present disclosure is shown. Fig.12 The automatic verification processing system shown and Fig.16 Combination of the automated reagent transfer system shown in .

[0024] Fig.19 Various embodiments according to the present disclosure are shown. Fig.18 A front view of the main components of an exemplary automated assay system.

[0025] Fig. 20 A flow chart of an exemplary method for automated verification processing according to various embodiments of the present disclosure is shown.

[0026] Fig.21A flow chart of an exemplary method for automated reagent dispensing and mixing according to various embodiments of the present disclosure is shown.

[0027] Fig. 22 A perspective view of another exemplary automated verification system according to some embodiments of the present disclosure is shown.

[0028] Fig.23 Various embodiments according to the present disclosure are shown. Fig. 22 A side view of the major components of an exemplary automated assay system.

[0029] Fig.24 A flow chart of an exemplary method for automated verification processing according to various embodiments of the present disclosure is shown.

[0030] Fig.25 A flow chart of an exemplary method for automated characterization processing and measurements according to various embodiments of the present disclosure is shown.

[0031] Embodiments of the present disclosure will be described with reference to the accompanying drawings. DETAILED DESCRIPTION

[0032] Although specific configurations and arrangements are discussed, it should be understood that this is for illustrative purposes only. Those skilled in the relevant art will recognize that other configurations and arrangements may be used without departing from the spirit and scope of the present disclosure. It will be apparent to those skilled in the relevant art that the present disclosure may also be used in a variety of other applications.

[0033] Note that references in the specification to "one embodiment," "an embodiment," "example embodiment," "some embodiments," etc. indicate that the described embodiments may include a particular feature, structure, or characteristic. However, every embodiment does not necessarily include a particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. In addition, when a particular feature, structure, or characteristic is described in conjunction with an embodiment, it is within the knowledge of those skilled in the art to affect such feature, structure, or characteristic in conjunction with other embodiments, whether or not explicitly described.

[0034] In general, terms may be understood, at least in part, based on the context of use. For example, the term "one or more" as used herein may be used to describe any feature, structure, or characteristic in the singular, or may be used to describe a feature, structure, or combination of features in a plurality of senses, depending, at least in part, on the context. Similarly, terms such as "a," "an," or "the" may again be understood to convey singular usage or to convey plural usage, depending, at least in part, on the context. Additionally, the term "based on" may be understood to not necessarily be intended to convey an exclusive set of factors, and may instead allow for the presence of other factors that are not necessarily explicitly described, depending, at least in part, on the context.

[0035] According to various embodiments of the present disclosure, self-designed components and robotics are used to automate (directly from sample to result) assay processes, including analyte capture, labeling, washing and detection. Compared with other alternatives (e.g., microfluidics, acoustic technology), robotics will be easier to implement and debug, and has production cost-effectiveness. In some embodiments, the system disclosed herein includes an automated magnetic assay subsystem, which utilizes the clockwise (and counterclockwise) rotation of the reaction vessel and the coordinated linear motion of the magnet to manipulate magnetic beads (MB) and other reagents. The automated magnetic assay subsystem can achieve automatic reagent mixing, incubation, magnetic separation, electrochemical reaction and measurement. In some embodiments, the system disclosed herein includes an automated reagent handling subsystem, which utilizes the clockwise (and / or counterclockwise) rotation of a dispenser and a reaction tube to sequentially mix and decant reagents. The system and method disclosed herein can be used in different applications, such as in biotechnology, biochemistry and biomedical fields.

[0036] Figure 1 A schematic diagram of the main components of an exemplary automatic assay system 100 according to some embodiments of the present disclosure is shown. The automatic assay system 100 may include a test tube holder 110, an assay processing tube 120, a magnet 130, and a controller 140.

[0037] The test tube holder 110 has three arms 112, 114, 116 separated by 120 degrees. Each arm 112, 114, 116 can support a test tube 1, 2, 3 (see also FIG. 2). A motor (not shown) such as a stepper motor can be coupled to the test tube holder 110 and can freely rotate it. The additional arms can have different configurations, for example, different angles between adjacent arms.

[0038] In some embodiments, the test processing tube 120 is a U-shaped tube. That is, the test processing tube 120 has a right arm 122 and a left arm 124 formed in a roughly U shape. The U shape can be symmetrical or asymmetrical. The right arm 122 of the test processing tube 120 is a drainage arm having a diagonal opening 121. Through the opening, the drainage arm 122 can receive reagents transferred from test tubes 1, 2, and 3 in the upper area. Electrodes such as screen printed electrodes (SPE) 125 can be fixed to the opening 123 of the left arm 124. The SPE 125 can be connected to a printed circuit board (PCB) 150 via a cable such as a long ribbon cable 155. A motor such as a stepper motor (not shown) can be connected to the test processing tube 120 and can cause it to rotate freely.

[0039] The magnet 130 may be mounted on a rectangular bar (not shown) that may be driven by a motor such as a stepper motor (not shown) to vertically move from a lower position P1 to an upper position P2.

[0040] In some embodiments, the controller 140 is configured to control the coordinated movement of the test tube holder 110, the assay processing tube 120 and the magnet 130 to perform the assay processing sequence. The controller 140 can be, for example, a stepper driver chip used with corresponding peripheral circuits to control a stepper motor. A microcontroller can be programmed to coordinate all automated sequences.

[0041] Figure 2a A schematic diagram of an exemplary test tube holder 110 is shown in which no test tube is inserted, and Figure 2b A schematic diagram of an exemplary test tube holder 110 is shown with test tubes 1, 2, 3 inserted therein.

[0042] Figure 3-11 Various exemplary assay processing steps are shown. Figure 3 As shown, in the initial state, the magnet 130 is at the lowest position P1. According to some embodiments, the test tube 120, the test tube holder 110 and the three test tubes 1, 2, 3 are pre-installed. Figure 3 As shown, the rotation angles of the test tube 120 and the test tube holder 110 can be pre-locked. The user can use a pipette to add the sample directly to the test tube 120. After adding the sample and releasing the pre-lock, all the following steps can be automatically performed.

[0043] Automatic calibration can be achieved by controlling a stepper motor that vertically drives the magnet 130 and rotates the calibration processing tube 120 and the test tube holder 110 .

[0044] The automatic assay system 100 can perform various assay processes. As an example, its use in the automatic magnetoelectronic sensing (iMES) assay process will be demonstrated. The iMES assay includes analyte capture, labeling, washing and detection steps. First, test tube 1 contains magnetic beads (MB) and is sealed; test tube 2 contains concentrated (or lyophilized) antibodies and is sealed. Test tube 3 is empty and not sealed. Before the magnetic beads and antibodies are transferred to the assay processing tube 120 respectively, they can be diluted with dilution buffer from a dispenser.

[0045] In the analyte capture step, the dispenser ( Figure 3 , the dispenser is not shown) to dispense the buffer into the test tube 1 to dilute the magnetic beads. After diluting / mixing the test tube 1, the test tube holder 110 is slowly rotated until the test tube 1 contacts the assay processing tube 120 ( Figure 4). The test tube holder 110 can knock the test processing tube 120 one or more times so that most of the reagents in the test tube 1 can break free from the surface tension and transfer to the test processing tube 120. This step transfers the magnetic beads from the test tube 1 to the test processing tube 120, and the magnetic beads can capture the analyte in the sample. In order to achieve a better capture effect, the test processing tube 120 can be rotated back and forth at a specific rotation speed (e.g., alternating between 240RPM and 90RPM) within a predetermined angle range (e.g., about 10-30 degrees) to help mix the magnetic beads with the sample.

[0046] In the marking step, the test tube holder 110 is rotated to Figure 5 The position shown in the figure, and a dispenser (not shown) dispenses a buffer into the test tube 2. The buffer dilutes the antibody in the test tube 2.

[0047] After diluting / mixing test tube 2, slowly rotate the test tube holder 110 until test tube 2 contacts the assay processing tube 120 ( Figure 6 ). The test tube holder 110 can knock the test processing tube 120 once or more, so that the surface tension of most of the reagents in the test tube 2 can be broken and transferred to the test processing tube 120. This step transfers the antibody from the test tube 2 to the test processing tube 120. The analyte in the test processing tube 120 can be labeled with the antibody. In order to obtain a better labeling result, the test processing tube 120 can be rotated back and forth within a predetermined angle range at a specific rotation speed to promote mixing.

[0048] One or more magnetic washes may be performed after labeling. Before the wash step, the magnetic beads may be adsorbed by the magnet 130 to avoid loss. This is achieved by the coordinated movement of the magnet 130 and the assay processing tube 120. When the assay processing tube 120 contacts the drainage platform 160, its rotation may be stopped (see Figure 7 ). The magnetic beads can be concentrated in the assay processing tube 120 near the top of the magnet 130. During this drainage process, the solution with unbound reagents can flow out of the assay processing tube 120. The absorbent material on the drainage platform 160 can further assist in the drainage. Once the drainage is complete, the assay processing tube 120 and the magnet 130 can be returned to their original positions. Depending on the situation, the assay processing tube 120 can be repeatedly performed. Figure 5 , 6 The washing steps are repeated multiple times as shown in the steps of 7.

[0049] To initiate the detection step, an electron mediator, such as TMB (3,3',5,5'-tetramethylbenzidine), can be dispensed into an empty test tube 3 ( Figure 8 ). Similar to the previous transfer step, rotate test tube 3 to Fig. 9 The TMB is then transferred to the assay processing tube 120 ( Fig.10 ).

[0050] The assay processing tube 120 can then be rotated counterclockwise until the SPE 125 becomes horizontal (see Fig.11 ). At the same time, the magnet 130 is raised to the upper position and the magnetic beads are attracted and gathered to the working electrode. The current generated by the reduction-oxidation reaction can be automatically measured.

[0051] Although the iMES assay workflow is used to describe how to use this automated system, the automated steps can be customized to support other sequences. Different combinations of analyte capture, labeling, washing, and detection steps can achieve similar sample-to-result automation.

[0052] Figure 12-19 An exemplary automatic assay handling system, an automated reagent transfer system and an exemplary automatic assay system are shown, which is a combination of an automatic assay handling system and an automated reagent transfer system. These systems utilize clockwise and counterclockwise rotation of reaction vessels and coordinated linear motion of magnets to manipulate magnetic beads (MB) and other reagents. These systems can achieve automatic mixing, incubation, magnetic separation, electrochemical reactions and measurements of reagents, etc. The present invention can be used in different applications, particularly in the fields of biotechnology, biochemistry and biomedicine.

[0053] Figure 12-13 2 shows the main components of an exemplary automated assay processing system 200, which includes an assay processing tube assembly 220, a magnet assembly 230, and a drainage platform 260. The assay processing tube assembly 220 may have a plurality of assay processing tubes ( Fig.12 Each assay processing tube may include: a right arm 222 having a diagonal opening 221 for receiving reagents and decanting solutions; and a left arm 224 having an opening 223. An electrode 225 such as an SPE can be secured to the opening 223 of the left arm 224. Through the diagonal opening 221, the right arm 222 can receive reagents from a dispenser or directly from a user's pipette or other source. The assay processing tube assembly is driven to rotate by a stepper motor (not shown). The assay processing tube assembly may have a special shape ( Fig.12 Shown as a U shape, but other shapes such as V, N, W, L, C, etc. are also possible).

[0054] The magnet assembly 230 may include a plurality of magnets supported on a magnet support 235. The number of magnets ( Fig.12 The magnet assembly 230 is driven by a stepper motor (not shown) to move vertically.

[0055] Fig.12 Eight copies of the arms and magnets along the axis are shown, but other numbers of copies, such as 2, 16, etc., are possible.

[0056] Stepper driver chips can be used with corresponding peripheral circuits to control stepper motors. A microcontroller can be programmed to coordinate all automation sequences.

[0057] As an example, the use of an automated assay processing system for sequencing sample preparation with automated cleanup and fragment size selection will be described. For this application, SPE is not used, but another assay processing tube is used, the left arm of which is symmetrical to the right arm (see Fig.15 ). The application may include the following steps:

[0058] 1. Add binding buffer ( Fig.15 , step 1).

[0059] 2. Transfer the DNA sample to the assay tube and mix it with the magnetic beads and binding buffer.

[0060] 3. Incubate at room temperature for 10 minutes and rotate back and forth within a predetermined angle range at a specific rotation speed.

[0061] 4. Raise the magnet and use the magnet to collect the beads. Rotate the assay tube clockwise to decant unbound reagent ( Fig.15 , steps 1-2-3-4). After decanting, recover the test tube ( Fig.15 , steps 4-5-6-7).

[0062] 5. Add washing solution (supplemented with ethanol). Mix by rotating back and forth within a predetermined angle range and collect the beads by the magnet. When the solution is clear, raise the magnet again and rotate the tube to pour off the washing solution ( Fig.15 , steps 1-2-3-4-5-6-7).

[0063] 6. Repeat step 5.

[0064] 7. In the final wash step, place the assay tube in the decant position ( Fig.15 , step 4) and hold for another two minutes to drain the remaining detergent.

[0065] 8. Rotate the test tube counterclockwise to the reagent loading position ( Fig.15 , steps 4-5-6-7), air-dry the magnetic beads at room temperature for 5 minutes, or until there are no droplets of washing solution on the wall of the assay tube.

[0066] 9. Add elution buffer.

[0067] 10. Mixing is performed by rotating the test process tube back and forth with a motor at a specific speed within a predetermined angular range.

[0068] 11. Raise the magnet ( Fig.15 , steps 7-8) to collect the beads. Rotate the assay tube counterclockwise ( Fig.15 , steps 8-9-10), transfer the eluate without magnetic beads to a storage tube (not shown).

[0069] As another example, the use of the systems and methods of the present invention in automated negative isolation (cell depletion) will be described.

[0070] For this application, SPE is not used. The assay processing tubes are prepackaged with custom magnetic beads specific to the target cells to be depleted. The application can include the following steps:

[0071] 1. Add the heterogeneous cell mixture to the right arm of the assay tube to mix with the magnetic beads ( Fig.15 , step 1).

[0072] 2. Incubate at room temperature for 15 minutes, rotating back and forth at a specific rotation speed within a predetermined angle range. The target cells to be depleted can be bound to the magnetic beads.

[0073] 3. Raise the magnet and collect the beads / cells with the magnet.

[0074] 4. After the solution is clear, rotate the assay tube counterclockwise to decant the unbound cells through the left arm opening into a new receiving tube (not shown). Fig.15 , steps 8-9-10).

[0075] As yet another example, the use of the systems and methods of the present invention for positive isolation and lysis of target cells will be described.

[0076] For this application, SPE is not used. The assay processing tubes are prepackaged with custom magnetic beads specific for the target cells. The application can include the following steps:

[0077] 1. Add the heterogeneous cell mixture to the right arm of the assay tube to mix with the magnetic beads ( Fig.15 , step 1).

[0078] 2. Incubate at room temperature for 15 minutes and rotate back and forth within a predetermined angle range at a specific rotation speed.

[0079] 3. Raise the magnet and collect the beads using the magnet. Rotate the assay tube clockwise to decant unbound cells and solution ( Fig.15 , steps 1-2-3-4). After decanting, recover the test tube ( Fig.15 , steps 4-5-6-7).

[0080] 4. Add the wash solution to the right arm of the assay tube. Mix by intermittent tube shaking and collect the beads by passing them through the magnet. Once the solution is clear, raise the magnet again and rotate the assay tube clockwise to pour out the wash solution ( Fig.15 , steps 1-2-3-4-5-6-7).

[0081] 5. Add lysis buffer to the right arm of the assay tube. Mix by intermittent tube shaking and collect the beads by magnet. Once the solution is clear, rotate the assay tube counterclockwise with the magnet ( Fig.15 , steps 8-9-10). This allows the cell lysate without magnetic beads to be transferred through the left arm opening into a new receiving tube (not shown).

[0082] Fig.16 The main components of an exemplary automated reagent delivery system 300 are shown, which may include a test tube support arm ( Fig.16 The test tube support 310 is a test tube support 310 having three arms 312, 314, 316 (shown as three arms 312, 314, 316) separated by 120 degrees. One or more sets of dispensers 370 are located above the test tube support 310. Each test tube support arm 312, 314, 316 is configured to support a set of multiple test tubes 315 ( Fig.16 The test tube rack 310 is driven by a stepper motor (not shown) to rotate. Each set of distributors 370 has the same number of distributors as in each set of test tubes 315 (e.g., eight). Fig.16 eight shown).

[0083] The automated reagent transfer system 300 can utilize multiple clockwise or counterclockwise rotations of the dispenser 370 and the test tube 315 to sequentially mix and pour reagents. Fig.16 As shown, the test tube holder 310 has three arms, and each arm can support eight test tubes. Additional arms having different configurations may be employed.

[0084] The stepper driver chip can be used together with the corresponding peripheral circuit to control the stepper motor. The test tube holder 310 can rotate and stop at a certain angle so that a specific dispenser group is just above a specific test tube group.

[0085] As an example, the application of an automatic reagent delivery system in automatically mixing multiple reagents in sequence will be described. In many types of applications, different reagents need to be stored separately and can only be mixed together before the experiment. The automated reagent delivery system can automatically carry out the sequential mixing or dilution of multiple reagents.

[0086] For example, test tube 1 contains solution A and is placed in Fig.17 The angle shown in step 1 of FIG. 2 is shown; test tube 2 contains solution B and test tube 3 is empty. The dispenser on the left is configured to dispense solution C. The dispenser on the right is configured to dispense solution D.

[0087] First, the dispenser on the left dispenses solution C into test tube 1 and mixes it with solution A ( Fig.17 , step 1); then, rotate the test tube 1 counterclockwise to Fig.17 Angle shown in step 2. Mixture A+C is transferred to a new receiving tube (not shown) initially containing reagent R.

[0088] Then, rotate the test tube 2 clockwise to Fig.17 The angle shown in step 3. Then, the dispenser on the left dispenses solution C into test tube 2 and mixes it with solution B. Then, test tube 2 is rotated counterclockwise to the angle shown in step 3. Fig.17 Angle shown in step 4. Mixture B+C flows out of test tube 2 and mixes with reagents in a receiving tube (not shown).

[0089] Similarly, rotate test tube 3 clockwise to Fig.17 Then, the right group dispenser dispenses solution D into test tube 3. Then, test tube 3 is rotated counterclockwise to the angle shown in step 5. Fig.17 Angle shown in step 6. Solution D flows out of test tube 3 and mixes with the reagent in the receiving tube (not shown).

[0090] In the last step, the receiving tube contains solution R+A+B+C+D.

[0091] The above workflow can be configured for different mixing and dilution schemes.

[0092] Fig.18 and 19 The main components of an exemplary automated verification system 400 are shown. Fig.12 The automatic verification processing system 200 and Fig.16 A combination of an automated reagent transfer system 300 is shown.

[0093] As shown in the figure, the automatic testing system 400 may include a testing processing tube assembly 420 having multiple testing processing tubes, a test tube holder 410 having multiple arms for supporting multiple testing tubes, a magnet assembly 430, a liquid discharge platform 460, and one or more sets of dispensers 470 above the test tube holder 410.

[0094] Initially, the magnet assembly 430 is in the lowest position. The user can use a pipette to add the sample directly to the test tube. After adding the sample, all the following steps will be performed automatically. Automatic calibration is achieved by controlling a stepper motor, which drives the magnet assembly 430 to move vertically and rotate the calibration processing tube assembly 420 and the test tube holder 410.

[0095] The automatic assay system 400 can perform various assay processes. As an example, its use in the iMES assay process will be demonstrated. As described above, the iMES assay can include analyte capture, labeling, washing and detection steps. First, test tube 1 contains magnetic beads (MB) and is sealed; test tube 2 contains concentrated (or lyophilized) antibodies and is sealed. Test tube 3 is empty and not sealed. Before the magnetic beads and antibodies are transferred to the assay processing tube assembly 420 respectively, the dilution buffer from the dispenser can be used to dilute the magnetic beads and antibodies.

[0096] During the analyte capture step, the assay processing tube assembly 220 is in a Fig.14 The angle shown in step 1, and the test tube support 310 is at Fig.17 Angle shown in step 1. The dispenser dispenses buffer into tube 1 to dilute the beads.

[0097] After diluting / mixing test tube 1, slowly rotate the test tube holder 310 counterclockwise ( Fig.17 , step 2), so that the reagent in test tube 1 can break free from surface tension and flow into the right arm opening of the test tube. This step transfers the magnetic beads from test tube 1 to the test tube, and the magnetic beads can capture the analyte in the sample. In order to achieve a better capture effect, the test tube can be rotated back and forth within a predetermined angle range (e.g., about 10-30 degrees) at a specific rotation speed (e.g., alternating between 240RPM and 90RPM) to help mix the magnetic beads with the sample.

[0098] In the marking step, the test tube holder 310 is rotated clockwise to Fig.17 At the angle shown in step 3, the dispenser dispenses the buffer into test tube 2. This dispensing dilutes the antibody in test tube 2.

[0099] After diluting / mixing the test tube 2, the test tube holder 310 is slowly rotated counterclockwise ( Fig.17 , step 4), so that the reagent in test tube 2 can break free from surface tension and flow into the right arm opening of the test processing tube. This step transfers the antibody from test tube 2 to the test processing tube. The analyte in the test processing tube can be labeled with the antibody. In order to obtain better labeling results, the test processing tube can be rotated back and forth at a specific speed within a predetermined angle range to promote mixing.

[0100] After labeling, one or more magnetic washes can be performed. Before the wash step, the beads can be attracted to a magnet to prevent loss. The wash step is performed by the coordinated movement of the magnet and the assay tube ( Fig.14 , steps 1-2-3-4). When the test tube contacts the liquid discharge platform 260, its clockwise rotation stops ( Fig.14, step 4). The beads can be concentrated in the assay tube near the top of the magnet. During the draining process, solution without bound reagent will flow out of the assay tube. Absorbent material on the draining platform can further assist in draining. Once draining is complete, the assay tube and magnet are returned to the ( Fig.14 , steps 4-5-6-7) to its original position. At the end of the wash cycle, the tube holder 310 transfers the buffer from the dispenser to the assay processing tube ( Fig.17 , steps 3-4 and Fig.14 , step 7).

[0101] Depending on the situation, repeat Fig.14 , steps 1-2-3-4-5-6-7 and Fig.17 , the steps shown in steps 3-4, the washing steps can be repeated multiple times.

[0102] To start the detection step, TMB can be dispensed into an empty tube 3 ( Fig.17 , step 5). TMB is centrally dispensed from other dispensers. Then, rotate test tube 3 counterclockwise to Fig.17 Position as shown, step 6, and transfer TMB to the assay processing tube.

[0103] The assay tube can then be rotated counterclockwise until the SPE becomes horizontal (see Fig.14 , steps 7-8-9-10-11). At the same time, the magnet can be raised to a higher position to focus the magnetic beads onto the working electrode. The current generated by the reduction-oxidation reaction can be automatically measured.

[0104] Although the iMES assay workflow describes how to use an automated system, the automated steps can be customized to support other sequences. Similar sample-to-result automation can be achieved with different combinations of analyte capture, labeling, washing, and detection steps.

[0105] Fig. 20 A flow chart of an exemplary method 500 for automated assay processing according to various embodiments of the present disclosure is shown. In step 502, a U-shaped assay processing tube in an upright position can receive a first solution having a first reagent and magnetic beads transferred from a test tube. The U-shaped assay processing tube can rotate back and forth at a specific rotation speed within a predetermined angle range to promote mixing. The U-shaped assay processing tube has: a right arm having an opening for receiving a first solution having a first reagent and magnetic beads; and a left arm having an opening. Electrodes such as screen-printed electrodes can be attached to the opening of the left arm. The U-shaped assay processing tube can be symmetrical or asymmetrical.

[0106] In step 504, the magnet can be moved from a lower position to an upper position near the magnetic beads inside the U-shaped assay processing tube. In step 506, the U-shaped assay processing tube is rotated clockwise until it contacts the drainage platform. The magnetic beads are concentrated in the U-shaped assay processing tube near the top of the magnet, and the first solution with the unbound first reagent can flow out of the U-shaped assay processing tube.

[0107] In step 508, the U-shaped assay process tube may be rotated counterclockwise back to the vertical position in step 510, and the magnet may be moved from the upper position back to the lower position.

[0108] In step 512, the U-shaped test tube can receive the second solution with the second reagent transferred from the test tube, and in step 514, the magnet can be moved from the lower position to the upper position near the internal magnetic beads. U-shaped test tube. In step 516, the U-shaped test tube is rotated counterclockwise until the first solution flows out of the opening of the left arm, during which the magnetic beads are adsorbed by the magnet in the U-shaped test tube, or until the electrode becomes horizontal. The U-shaped test tube and the magnet can be driven by a motor controlled by a controller.

[0109] Fig.21 A flow chart of an exemplary method 600 for automatic reagent dispensing and mixing according to various embodiments of the present disclosure is shown. In step 602, a first test tube containing a first solution among a plurality of test tubes supported in a test tube holder can receive a first reagent from a first dispenser. In step 604, the tube holder can be rotated counterclockwise to a position where a mixture of the first reagent and the first solution flows out of the first test tube into a receiving tube and a second test tube is ready to receive the first reagent from the first dispenser, and the second test tube can contain a second solution.

[0110] In step 606, the second test tube may receive the first reagent from the first dispenser. In step 608, the tube rack may be rotated counterclockwise to a position where a mixture of the first reagent and the second solution flows from the second test tube into the receiving tube.

[0111] In step 610, the test tube holder may be rotated clockwise to a position where a third test tube, which may be empty or contain a third solution, is ready to receive a second reagent from a second dispenser.

[0112] In step 612, the third test tube may receive the second reagent from the second dispenser. In step 614, the tube rack may be rotated counterclockwise to a position where the second reagent or a mixture of the second reagent and the third solution flows from the third test tube into the receiving tube.

[0113] The above steps can be repeated to obtain a mixture of multiple reagents and multiple solutions.

[0114] It should be understood that some steps may be optional when performing the disclosure disclosed herein. In addition, some steps may be performed simultaneously or in combination. Fig. 20 and 21 Execute in a different order than shown.

[0115] Figure 22-23 Another exemplary automatic assay processing system, an automated reagent transfer system and an exemplary automatic assay system are shown, which are a combination of an automatic assay processing system and an automated reagent transfer system. These systems utilize clockwise and counterclockwise rotation of reaction vessels and coordinated linear motion of magnets to manipulate magnetic beads (MB) and other reagents. These systems can achieve automatic mixing, incubation, magnetic separation, electrochemical reactions and measurements of reagents, etc. The present invention can be used in different applications, especially in biotechnology, biochemistry and biomedical fields.

[0116] Figure 22-23 The main components of an exemplary automated assay system 700 are shown, which include a reagent kit assembly 701, a pre-configured assay processing tube assembly 702, a magnet assembly 708, and an electrode assembly 703. The assay processing tube assembly 702 may have a plurality of assay processing tubes ( Fig. 22 705). Each test processing tube may include a reaction chamber 705 in a central position, a waste chamber 704 attached to one end of the reaction chamber 705, and a measurement chamber 706 attached to the other end of the reaction chamber 705. The reaction chamber 705 is used to receive reagents and also pour solutions into the waste chamber 704 or the measurement chamber 706. The electrode assembly 703, such as SPE, can be fixed to the measurement chamber 706. The test kit assembly 701 has a plurality of fluid channels. Each fluid channel is configured to accommodate a specific reagent in liquid, dry or lyophilized form. The test kit assembly 701 is connected to the test processing tube assembly 702. Each fluid channel has a reagent outlet 707. Through the reagent outlet 707, the reaction chamber 705 can receive reagents from the fluid channel or directly from the user's pipette or other sources. The magnet assembly 708 includes a plurality of magnets supported on a magnet support. The number of magnets corresponds to the number of test processing tubes. The magnet assembly 708 can be driven by a stepper motor (not shown) to move vertically. The test tube assembly 702 is driven by a stepper motor (not shown) to rotate. The test tube assembly can have a special shape ( Fig. 22 Shown as a U-shape, but other shapes (e.g., V, N, W, L, C, etc.) are possible. The controller can be configured to control the coordinated movement of the assay processing tube assembly 702, the reagent cartridge assembly 701, and the magnet assembly 708 to execute the assay processing sequence.

[0117] Fig.24A flow chart of an exemplary method for automatic assay processing 800 according to various embodiments of the present disclosure is shown. In step 802, a first solution having a first reagent and magnetic beads transferred from a test kit is received by a U-shaped assay processing tube in an upright position. In step 804, the U-shaped assay processing tube can be rotated back and forth within a predetermined angle range at a specific rotation speed within a predetermined angle range to promote mixing. The U-shaped assay processing tube has a reaction chamber having an opening for receiving a first solution having a first reagent (e.g., magnetic beads). In step 806, a magnet is moved from a lower position to an upper position close to the U-shaped assay processing tube. In step 808, the U-shaped assay processing tube is rotated counterclockwise to discharge the reagent into a waste chamber. The magnetic beads are concentrated in the U-shaped assay processing tube near the magnet, and the first solution with the unbound first reagent flows out of the U-shaped assay processing tube. In step 810, the U-shaped assay processing tube is rotated clockwise back to an upright position. In step 812, the magnet is moved from the upper position back to the lower position. In step 814, the second solution with the second reagent transferred from the test tube is received by the U-shaped assay processing tube.

[0118] Fig.25 A flow chart of an exemplary method 900 for automatic assay processing and measurement according to various embodiments of the present disclosure is shown. In step 902, a solution with a measuring reagent transferred from a test kit is received by a U-shaped assay processing tube in an upright position. The U-shaped assay processing tube has a reaction chamber having an opening for receiving a solution containing a measuring reagent (e.g., TMB). In step 904, the U-shaped assay processing tube is rotated back and forth at a specific speed within a predetermined angle range, and the reagents in the reaction chamber are mixed. In step 906, after mixing, the U-shaped assay processing tube is rotated clockwise to transfer the reagents into the measuring chamber. In step 908, a magnet is moved to a position close to the measuring chamber. The magnetic beads are concentratedly adsorbed on the working electrode in the measuring chamber by the magnet. In step 910, measurement is started.

[0119] According to one aspect of the present disclosure, an automatic testing system includes a test tube holder having a plurality of test tube arms. Each test tube arm is configured to support a test tube, and the test tube holder is driven to rotate. The automatic testing system also includes a testing processing tube having a right arm and a left arm. The right arm has an opening for receiving a reagent transferred from a test tube supported in one of the test tube arms of the test tube holder. The testing processing tube is driven to rotate. The automatic testing system also includes a magnet driven to move vertically and a controller configured to control the coordinated movement of the test tube holder, the testing processing tube and the magnet to execute a testing processing sequence.

[0120] In some embodiments, the test tube holder has three test tube arms that are 120 degrees apart. In some embodiments, the assay process tube has a U-shape.

[0121] In some embodiments, the left arm of the assay processing tube has an opening into which an electrode can be mounted. In some embodiments, the electrode is a screen printed electrode. According to some embodiments, the screen printed electrode is connected to the circuit board via a cable.

[0122] In some embodiments, the magnet is vertically movable between a lower position and an upper position.

[0123] In some embodiments, the test tube support, the assay processing tube and the magnet are driven by motors controlled by a controller, respectively. In some embodiments, the magnet is supported on a magnet support, which is driven by a motor controlled by a controller.

[0124] In some embodiments, the automated assay system includes a drainage platform for removing reagents during the drainage process. In some embodiments, the drainage platform has an absorbent material deposited on a surface of the drainage platform.

[0125] According to another aspect of the present disclosure, an automatic assay processing system includes an assay processing tube assembly of a preconfigured shape. The assay processing tube assembly includes a plurality of assay processing tubes. Each assay processing tube includes a right arm having an opening for receiving a reagent and a left arm having an opening. The assay processing tube assembly is driven to rotate. The automatic assay processing system also includes a magnet assembly, which includes a plurality of magnets supported on a magnet support. The plurality of magnets correspond to the plurality of assay processing tubes, and the magnet assembly is driven to move vertically. The automatic assay processing system also includes a controller, which is configured to control the coordinated movement of the assay processing tube assembly and the magnet assembly to execute an assay processing sequence.

[0126] In some embodiments, the pre-configured shape of the certification process tube assembly is one of a U-shape, a V-shape, an N-shape, a W-shape, an L-shape, or a C-shape.

[0127] In some embodiments, pre-configured shapes of the certification process tube assembly are selected based on different certification processes.

[0128] In some embodiments, the preconfigured shape of the test process tube assembly is a U-shape. In some embodiments, the U-shape is symmetrical. In some embodiments, the U-shape is asymmetrical.

[0129] In some embodiments, the assay processing tube assembly has 1 to 16 assay processing tubes, and the magnet assembly has magnets corresponding to the number of assay processing tubes. In some embodiments, the assay processing tube assembly has 8 assay processing tubes, and the magnet assembly has 8 corresponding magnets.

[0130] In some embodiments, the electrode is attached to the opening of the left arm of each assay processing tube. In some embodiments, the electrode is a screen printed electrode. In some embodiments, the screen printed electrode is connected to the circuit board via a cable.

[0131] In some embodiments, the magnet assembly is vertically movable between a lower position and an upper position.

[0132] In some embodiments, both the assay process tube assembly and the magnet assembly are driven by motors controlled by a controller.

[0133] In some embodiments, the automated assay processing system further comprises a drainage platform for removing reagents during the drainage process. In some embodiments, the drainage platform has an absorbent material deposited on a surface of the drainage platform.

[0134] According to another aspect of the present disclosure, an automated reagent transfer system includes a test tube rack having a plurality of test tube arms. Each test tube arm is configured to support a plurality of test tubes and drive the test tube rack to rotate. The automated reagent transfer system also includes one or more groups of distributors located above the test tube rack. Each group of distributors has the same number of distributors as the plurality of test tubes in each group of test tubes. The automated reagent transfer system also includes a controller configured to control the coordinated movement of the test tube rack and the distributor to achieve coordination between the test tube rack and the distributor.

[0135] In some embodiments, the test tube holder has three arms that are 120 degrees apart.

[0136] In some embodiments, each arm is configured to support 1 to 16 test tubes. In some embodiments, each set of dispensers has 1 to 16 dispensers, corresponding to the number of test tubes supported by each arm of the test tube holder. In some embodiments, each arm is configured to accommodate 8 test tubes, and each set of dispensers has 8 dispensers.

[0137] In some embodiments, the one or more groups of dispensers include multiple groups of dispensers arranged in a horizontal direction.

[0138] In some embodiments, the test tube rack and one or more sets of dispensers are driven by motors controlled by a controller.

[0139] According to another aspect of the present disclosure, an automatic calibration system includes a calibration processing tube assembly having a preconfigured shape. The calibration processing tube assembly includes a plurality of calibration processing tubes. Each calibration processing tube includes a right arm having an opening for receiving a reagent and a left arm having an opening, and the calibration processing tube assembly is driven to rotate. The automatic calibration system also includes a test tube holder having a plurality of arms. Each arm is configured to support a group of a plurality of test tubes, and a plurality of test tubes in each group of test tubes correspond to a plurality of calibration processing tubes of the calibration processing tube assembly. The test tube holder is driven to rotate. The automatic calibration system also includes a magnet assembly, which includes a plurality of magnets supported on the magnet holder. The plurality of magnets correspond to a plurality of calibration processing tubes, and the magnet assembly is driven to move vertically. The automatic calibration system also includes a controller configured to control the coordinated movement of the calibration processing tube assembly, the test tube holder and the magnet assembly to execute a calibration processing sequence.

[0140] In some embodiments, the automatic assay system further comprises one or more groups of dispensers above the test tube rack, wherein each group of dispensers has the same number of dispensers as the number of test tubes in each group of test tubes.

[0141] In some embodiments, the preconfigured shape of the authentication process tube assembly is one of a U-shape, a V-shape, an N-shape, a W-shape, an L-shape, or a C-shape. In some embodiments, the preconfigured shape of the authentication process tube assembly is selected based on different authentication processes.

[0142] In some embodiments, the preconfigured shape of the test process tube assembly is a U-shape. In some embodiments, the U-shape is symmetrical. In some embodiments, the U-shape is asymmetrical.

[0143] In some embodiments, the assay processing tube assembly has 1 to 16 assay processing tubes, and the magnet assembly has magnets corresponding to the number of assay processing tubes. In some embodiments, the assay processing tube assembly has 8 assay processing tubes, and the magnet assembly has 8 corresponding magnets.

[0144] In some embodiments, the electrode is attached to the opening of the left arm of each assay processing tube. In some embodiments, the electrode is a screen printed electrode. In some embodiments, the screen printed electrode is connected to the circuit board via a cable.

[0145] In some embodiments, the magnet assembly is vertically movable between a lower position and an upper position.

[0146] In some embodiments, the assay processing tube assembly, the test tube holder, and the magnet assembly are all driven by motors controlled by a controller.

[0147] In some embodiments, the automated assay system further comprises a drainage platform for removing reagents during the drainage process. In some embodiments, the drainage platform has an absorbent material deposited on a surface of the drainage platform.

[0148] In some embodiments, the test tube holder has three arms separated by 120 degrees. In some embodiments, each arm is configured to support 1 to 16 test tubes. In some embodiments, each set of dispensers has 1 to 16 dispensers, corresponding to the number of test tubes supported by each arm of the test tube holder.

[0149] In some embodiments, each arm is configured to hold 8 test tubes and each set of dispensers has 8 dispensers.

[0150] In some embodiments, the one or more groups of dispensers include multiple groups of dispensers arranged in a horizontal direction.

[0151] According to another aspect of the present disclosure, an automatic assay system includes an assay processing tube assembly having a preconfigured shape, a reagent kit assembly, a magnet assembly, and a controller. The assay processing tube assembly includes one or more assay processing tubes. The reagent kit assembly has one or more fluid channels. Each fluid channel is configured to accommodate a specific reagent in liquid, dry or lyophilized form. The reagent kit assembly is connected to the assay processing tube assembly. Each assay processing tube has a reaction chamber at a central position, a waste liquid chamber attached to one end of the reaction chamber, and a measurement chamber attached to the other end. The assay processing tube assembly is driven to rotate. The magnet assembly includes one or more magnets supported on a magnet support. The number of magnets corresponds to the number of assay processing tubes. The magnet assembly is driven to move vertically. The controller is configured to control the coordinated movement of the assay processing tube assembly, the reagent kit assembly, and the magnet assembly to execute an assay processing sequence.

[0152] In some embodiments, the automated assay system further comprises one or more sets of reagent reservoirs connected to the fluid pathway. In some embodiments, the reagent container is a syringe or a blister pack.

[0153] In some embodiments, the preconfigured shape of the test process tube assembly is one of a U-shape, a V-shape, an N-shape, a W-shape, an L-shape, or a C-shape. In some embodiments, the preconfigured shape of the test process tube assembly is selected based on different test processes. In some embodiments, the preconfigured shape of the test process tube assembly is a U-shape. In some embodiments, the U-shape is symmetrical. In some embodiments, the U-shape is asymmetrical.

[0154] In some embodiments, the assay processing tube assembly has 1 to 16 assay processing tubes, and the magnet assembly has magnets corresponding to the number of assay processing tubes. In some embodiments, the assay processing tube assembly has 8 assay processing tubes, and the magnet assembly has 8 corresponding magnets.

[0155] In some embodiments, electrodes are attached to the measurement chamber of each assay process tube. In some embodiments, the electrodes are screen printed electrodes. In some embodiments, the screen printed electrodes are connected to the circuit board via a cable.

[0156] In some embodiments, the magnet assembly is vertically movable between a lower position and an upper position.

[0157] In some embodiments, the assay processing tube assembly, reagent cartridge, and magnet assembly are all driven by motors controlled by a controller.

[0158] In some embodiments, the waste chamber is used to remove reagents during the drainage process. In some embodiments, the waste chamber has an absorbent material deposited in the waste chamber.

[0159] According to different aspects of the present disclosure, a method for automatic calibration processing includes: receiving a first solution having a first reagent and magnetic beads transferred from a test tube through a U-shaped calibration processing tube in an upright position. The U-shaped calibration processing tube has: a right arm having an opening for receiving the first solution having a first reagent and magnetic beads; and a left arm having an opening. The method for automatic calibration processing includes rotating the U-shaped calibration processing tube back and forth within a predetermined angle range at a specific rotation speed, moving the magnet from a lower position to an upper position close to the magnetic beads inside the U-shaped calibration processing tube. The method for automatic calibration processing also includes rotating the U-shaped calibration processing tube clockwise until the liquid discharge platform stops. The magnetic beads are concentrated in the U-shaped calibration processing tube near the top of the magnet, and the first solution with unbound first reagent flows out of the U-shaped calibration processing tube. The method for automatic calibration processing also includes: rotating the U-shaped calibration processing tube counterclockwise back to the upright position and moving the magnet from the upper position back to the lower position. The method for automated assay processing also includes receiving a second solution having a second reagent transferred from a test tube through a U-shaped assay processing tube, moving a magnet from a lower position to an upper position close to magnetic beads in the U-shaped assay processing tube, and rotating the U-shaped assay processing tube counterclockwise.

[0160] In some embodiments, the U-shaped assay processing tube is rotated counterclockwise until the first solution flows out of the opening of the left arm and the magnetic beads are attracted by the magnet in the U-shaped assay processing tube.

[0161] In some embodiments, the electrode is attached to the opening of the left arm. In some embodiments, the electrode is a screen printed electrode.

[0162] In some embodiments, the U-shaped assay processing tube is rotated counterclockwise until the electrodes become horizontal and the magnetic beads are attracted to the electrodes by the magnet.

[0163] In some embodiments, the U-shaped assay processing tube is symmetrical. In some embodiments, the U-shaped assay processing tube is asymmetrical.

[0164] In some embodiments, the U-shaped assay processing tube and the magnet are each driven by a motor controlled by a controller.

[0165] According to another different aspect of the present disclosure, a method for automatically distributing and mixing reagents includes: receiving a first reagent from a first dispenser by supporting a first test tube among a plurality of test tubes in a test tube holder. The first test tube contains a first solution. The method for automatically distributing and mixing reagents also includes: rotating the tube holder counterclockwise to a position where a mixture of the first reagent and the first solution flows out of the first test tube into a receiving tube and the second test tube is ready to receive the first reagent from the first dispenser. The second test tube contains a second solution. The method for automatically distributing and mixing reagents also includes: receiving the first reagent from the first dispenser through the second test tube, and rotating the tube holder counterclockwise to a position where a mixture of the first reagent and the second solution flows out of the second test tube into the receiving tube. The method for automatically distributing and mixing reagents also includes: rotating the test tube holder clockwise to a position where a third test tube is ready to receive a second reagent from the second dispenser, and receiving the second reagent from the second dispenser through the third test tube. The third test tube is empty or contains a third solution. The method for automatically dispensing and mixing reagents further includes rotating the tube rack counterclockwise to a position where the second reagent or a mixture of the second reagent and the third solution flows out of the third test tube into the receiving tube.

[0166] In some embodiments, the method for automated reagent dispensing and mixing further comprises repeating steps to obtain a mixture of multiple reagents and multiple solutions.

[0167] The foregoing description of specific embodiments will therefore reveal the general characteristics of the present disclosure, and others can easily modify and / or adapt various applications such as specific embodiments without departing from the general concepts of the present disclosure by applying knowledge within the technical scope of the art, without undue experimentation. Therefore, based on the teachings and guidance set forth herein, such modifications and modifications are intended to be within the meaning and range of equivalents of the disclosed embodiments. It should be understood that the wording or terminology herein is for the purpose of description rather than limitation, so that the terms or wording of this specification will be interpreted by those skilled in the art based on the teachings and guidance.

[0168] The Summary and Abstract sections may set forth one or more but not all exemplary embodiments of the present disclosure as contemplated by the inventor(s), and thus, are not intended to limit the present disclosure and the appended claims in any way.

[0169] The breadth and scope of the present disclosure should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

Claims

1. An automatic verification system, comprising: a test tube support having a plurality of test tube supporting arms, each test tube supporting arm being configured to support at least one test tube, and the test tube support being driven to rotate by a first driving mechanism; An assay processing tube assembly, comprising at least one assay processing tube, each assay processing tube having a preset shape, and each assay processing tube comprising a first arm having an opening for receiving a reagent and a second arm having an opening, the assay processing tube assembly being driven by a second driving mechanism to rotate clockwise and counterclockwise; A magnet assembly, comprising at least one magnet, the magnet assembly being driven by a third driving mechanism to move in a vertical direction so that the magnet can move between a lower position and an upper position, thereby adsorbing and aggregating magnetic beads inside the assay processing tube; A controller configured to control the coordinated movement of the first drive mechanism, the second drive mechanism and the third drive mechanism to execute an automatic verification processing sequence, wherein the automatic verification processing sequence includes: Transferring reagents from test tubes held in a test tube holder to assay processing tubes; Rotating the assay processing tube back and forth within a predetermined angle range at a specific rotation speed to mix the reagents and magnetic beads; magnetically separating the beads using the magnet assembly in an upper position and decanting unbound reagents; and The assay processing tube is rotated to a predetermined position for further washing, detection or measurement steps.

2. The automatic verification system according to claim 1, wherein: The preset shape is a U-shape, so that the assay processing tube includes a symmetrical or asymmetrical U-shaped first arm and a second arm, and the first arm has an oblique diagonal opening for receiving reagents or decanting solutions.

3. The automatic verification system according to claim 2, wherein: The opening of the second arm is provided with an electrode, which is a screen-printed electrode and is connected to a circuit board through a cable for electrochemical measurement.

4. The automatic verification system according to claim 1, wherein: The multiple test tube support arms are distributed at equal angles on the test tube support, and a 120-degree interval is formed between every two adjacent test tube support arms.

5. The automatic verification system according to claim 1, wherein: The magnet assembly includes a plurality of magnets, the number of which corresponds to the number of assay processing tubes, so as to independently control the magnetic beads in each assay processing tube.

6. The automatic testing system as described in claim 1 further includes a drainage platform, which is arranged at a predetermined position below the testing processing tube. When the testing processing tube is rotated to a position in contact with the drainage platform, unbound reagent solution flows out of the testing processing tube and is absorbed by the absorption material on the surface of the drainage platform.

7. The automatic verification system according to claim 1, wherein: The controller is electrically connected to the first, second and third drive mechanisms driven by the stepper motors and is programmed to coordinate the movement of the test tube support, the assay processing tube assembly and the magnet assembly according to a predetermined program.

8. The automatic verification system according to claim 3, wherein: When the U-shaped assay processing tube is rotated counterclockwise to the electrode horizontal position, the magnet assembly lifts the magnet to the upper position, adsorbing the magnetic beads on the electrode surface, thereby performing electrochemical detection.

9. The automatic testing system as described in claim 1 further includes one or more groups of dispensers, the number of dispensers in each group being the same as the number of test tubes supported by one test tube support arm of the test tube rack, so as to dispense specific reagents from the dispensers into corresponding test tubes.

10. The automatic assay system of claim 9, wherein the controller is configured to control the test tube holder to rotate after the reagent is dispensed, so that the solution of the mixed reagent is decanted from the test tube into the opening of the assay processing tube or transferred to other receiving tubes.

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