Bioanalysis systems and methods

Abstract

The present disclosure relates to a system for biological analysis, comprising: a housing; a block assembly having a sample block and a base plate, the block assembly being within the housing; a heating cover; and a cover carrier. The sample block receives a sample holder, the sample holder comprising an RFID tag. A first drive mechanism generates relative movement between the sample block and the base plate along a first axis. A second drive mechanism generates relative movement between the heating cover and the cover carrier along a second axis different from the first axis. Based on a first command, the first drive mechanism releasably engages the sample block and operates the second drive mechanism to releasably engage the heating cover with the cover carrier. The system also includes a first RFID antenna and a second RFID antenna, the first RFID antenna and the second RFID antenna receiving RFID data from the sample holder RFID tag, the sample holder RFID tag being read by at least one RFID reader.

Description

Technical Field

[0001] The present disclosure relates broadly, but not exclusively, to bioanalytical systems and related methods, including polymerase chain reaction (PCR) systems. Background Art

[0002] Bioanalytical systems, such as PCR systems, are useful tools for diagnostics and research on biological or biochemical samples. PCR systems typically have a thermal cycler that heats and cools the sample over multiple cycles to achieve the desired amplification of one or more target molecules. Real-time PCR systems, also called qualitative PCR (qPCR) systems, allow the PCR assay to be monitored during each thermal cycle of the process.

[0003] In general, there is a growing need to simplify the installation and setup of bioanalytical systems so that operators can use the bioanalytical systems more quickly and efficiently for their intended purposes. However, existing systems often require manual operation or intervention, which can lead to inefficiencies and inconsistencies.

[0004] It would therefore be desirable to provide a bioanalysis system that solves at least one of the above problems. BRIEF DESCRIPTION OF THE DRAWINGS

[0005] The embodiments of the present disclosure will be better understood and apparent to those skilled in the art through the following written description which is given by way of example only and in conjunction with the accompanying drawings, in which:

[0006] FIG. 1 shows a block diagram illustrating a PCR instrument upon which embodiments of the present teachings may be implemented.

[0007] FIG. 2 shows a block diagram illustrating a computer system that may be used to perform processing functions according to some exemplary embodiments of the present disclosure.

[0008] 3A-3B illustrate exploded and assembled views, respectively, of a block assembly according to an exemplary embodiment.

[0009] 3C-3D illustrate perspective views of a sample block and a sample holder according to an exemplary embodiment.

[0010] 4A-4B illustrate a retracted position and an extended position, respectively, of the block assembly of FIGS. 3A-3B according to an exemplary embodiment.

[0011] 5A-5B illustrate a sample block of the block assembly of FIGS. 3A-3B with a base in a disengaged state and an engaged state, respectively, according to an exemplary embodiment.

[0012] 6A-6B illustrate enlarged views of portions of the block assembly of FIGS. 3A-3B .

[0013] 7 illustrates a perspective view of an optical assembly with a cover carrier attached thereto, according to an exemplary embodiment.

[0014] 8A to 8D illustrate cross-sectional views illustrating the operation of a cover carrier according to an exemplary embodiment.

[0015] 9A-9K illustrate various views of a cover carrier according to an exemplary embodiment.

[0016] 10A-10B illustrate exploded and assembled views, respectively, of a bioanalysis system and a reagent having an RFID tag according to an exemplary embodiment.

[0017] 11A-11B illustrate close-up cross-sectional views of the interior of the assembled system of FIGS. 10A-10B , according to an exemplary embodiment.

[0018] 12 illustrates a partial cross-sectional view of the assembled system of FIGS. 10A-10B , according to an exemplary embodiment.

[0019] FIG. 13 shows a flow chart of a method according to an exemplary embodiment.

[0020] FIG. 14 shows a flow chart of a method according to an exemplary embodiment.

[0021] FIG. 15 shows a flow chart of a method according to an exemplary embodiment. DETAILED DESCRIPTION

[0022] To provide a more thorough understanding of the present disclosure, the following description sets forth many specific details, such as specific configurations, parameters, examples, etc. However, it should be recognized that such description is not intended as a limitation on the scope of the present invention, but is intended to provide a better description of exemplary embodiments.

[0023] It should also be recognized that the methods and systems described herein can be implemented in various types of systems, instruments, and machines (such as bioanalysis systems). For example, various embodiments can be implemented in an instrument, system, or machine that performs a polymerase chain reaction (PCR) on multiple samples. Although generally applicable to quantitative polymerase chain reactions (qPCR) for processing a large number of samples, it should be recognized that any suitable PCR method can be used according to the various embodiments described herein. Suitable PCR methods include, but are not limited to, digital PCR, allele-specific PCR, asymmetric PCR, ligation-mediated PCR, multiplex PCR, nested PCR, qPCR, genome walking, and bridge PCR. In addition, as used herein, thermal cycling may include the use of a thermal cycler, isothermal amplification, thermal convection, infrared-mediated thermal cycling, or helicase amplification.

[0024] As used herein, the terms "radio frequency identifier," "radio frequency identifier tag," or "RFID tag" may refer to a chip that includes an integrated circuit and an antenna. The integrated circuit may store data that may be transmitted by radio frequencies that may be transmitted by the antenna. The integrated circuit and antenna circuit may be printed on the chip. An RFID "tag" or "transponder" may be read by an RFID reader using an antenna that transmits radio frequencies to interrogate the transponder. "Passive RFID" has no energy source of its own, but transmits a signal in response to a signal from a reader. "Active RFID" includes a battery as a power source. Some examples of RFID tags may be found in the following patents: U.S. Patent Nos. 6,147,662; 6,917,291; 5,949,049; 6,652,812; 6,112,152; and U.S. Patent Application No. 2003 / 0183683, all of which are incorporated herein by reference in their entirety for the disclosure of RFID tags, chips, labels or devices, RFID readers, and RFID systems, their design and use. A "writable radio frequency identifier" or "writable RFID" is an RFID tag that has a memory space that can be written to by an RFID writer.

[0025] As used herein, the term "sample holder" may refer to a structure for directly or indirectly supporting one or more reaction sites, each reaction site being configured to contain a biological sample and any associated reagents, dyes, probes, detergents, enzymes, master mixes, etc. Examples of sample holders include, but are not limited to, reaction plates, tubes, tube carriers, surface plasmon resonance arrays, slides, tapered low volume tubes, microfluidic cards, microarray chips, plates or boxes, through-hole arrays, sample preparation devices, assay preparation devices, electrophoresis type devices, electroosmotic type devices, immunoassays, combinatorial libraries, molecular libraries, phage display libraries, DNA libraries, DNA fingerprinting devices, SNP detection devices, vacuum containers, and other types of containers for supporting biological reagents or assays. The sample holder may be a multi-well tray or microtiter plate, comprising, for example, 4, 12, 24, 48, 96, 192, 384, 768, 1536, 3072, 6144, 12288 or more wells or sample holding areas. A sample holder can hold a fluid if the sample holder can be used to transfer, contain, surround or otherwise permanently or temporarily hold the fluid. The sample holder material can include any material used in chemical and biochemical synthesis. The sample holder material can include polymeric materials compatible with chemical and biological synthesis and determination, and include glass, silicates, cellulose, polystyrene, polysaccharides, sand and synthetic resins and polymers, including acrylamide, particularly cross-linked polymers, cotton, and other such materials. The sample holder material can be in granular form or in a continuous design, such as a test tube or microtiter plate.

[0026] As used herein, the terms "communication," "electrical communication," or "electronic communication" generally refer to communication between two or more electronic components (e.g., electronic devices or electronic systems). Communication may be achieved via a physical connection, such as between wires, cables, optical cables, etc., connected to the two electronic components, or via a third electronic component (e.g., a network system such as a local area network (LAN) or a wide area network (WAN)) to which the first communication component and the second communication component are commonly connected. Additionally or alternatively, electrical communication may be achieved via a transmitter / receiver configuration (e.g., direct wireless communication between devices (e.g., direct wireless communication between antennas in the two communication components, a Bluetooth connection, etc.), or via a wireless network (e.g., a wireless router system, a Wi-Fi connection, or a wireless data communication system, such as provided by a telecommunications provider). Additionally or alternatively, electrical communication may be provided via communication between the device and a public database (such as a cloud database).

[0027] System Overview

[0028] As mentioned above, instruments according to embodiments of the present teachings can be used to perform various types of biological assays, experiments, tests, etc. In the present disclosure, embodiments of instruments for performing polymerase chain reaction (PCR) assays are described using microtiter plates. However, embodiments of the present teachings can be extended to other types of instruments (e.g., capillary electrophoresis instruments, sequencing instruments such as next generation sequencing (NGS) instruments, microarray systems, flow cytometers, etc.), sample holders (e.g., as discussed herein above), and assays (e.g., capillary electrophoresis, gene sequencing, genotyping, etc.).

[0029] FIG. 1 shows a block diagram showing elements of an instrument 100 (such as a real-time PCR instrument 100) on which embodiments of the present teachings may be implemented. The real-time PCR instrument 100 may include a heated cover 110 placed above a plurality of samples 112 contained in a substrate, plate, or sample holder (not shown here). In various embodiments, the sample holder may be a glass or plastic slide having a plurality of sample zones, the sample zones of which have a cover between the sample zones and the heated cover 110. In various embodiments, the sample holder may include one or more reaction sites, which may include pits, grooves, through holes, indentations, surface discontinuities, ridges, and combinations thereof, which may be patterned into regular or irregular arrays formed on the surface of the sample holder. The PCR instrument also includes a sample block 114 for holding or maintaining a plurality of samples and a heat block 116 for heating and / or cooling the sample block 114 and the samples contained therein. Blocks 114 and 116 may be coupled or connected together to form an integral sample block or sample block assembly 114.

[0030] The real-time PCR instrument 100 has an optical system 124. In FIG. 1 , the optical system 124 may have an illumination source (not shown) that emits electromagnetic energy, an optical sensor, detector or imaging device (not shown) for receiving electromagnetic energy from the sample 112 in the sample holder, and an optical device 140 for directing electromagnetic energy from each DNA sample to the imaging device. For the embodiment of the PCR instrument / real-time PCR instrument 100 in FIG. 1 , the control system 120 may be used to control the functions of the detection system, the heated cover and the heat block. The control system 120 may be accessed by an end user through the user interface 122 of the PCR instrument / real-time PCR instrument 100 in FIG. 1 . In addition, as depicted in FIG. 2 , the computer system 100 may be used to provide control of the functions of the PCR instrument 100 in FIG. 1 and the user interface functions. In addition, the computer system 200 of FIG. 2 may provide data processing, display and report preparation functions. All such instrument control functions may be local to the PCR instrument, or the computer system 200 of FIG. 2 may provide remote control of some or all of the control, analysis, and reporting functions, as will be discussed in greater detail subsequently.

[0031] Computer-implemented systems

[0032] The methods according to the embodiments described herein may be implemented using a computer system.

[0033] Those skilled in the art will recognize that the operations of the various embodiments can be implemented using hardware, software, firmware, or a combination thereof as desired. For example, some processing can be performed using a processor or other digital circuit under the control of software, firmware, or hard-wired logic. (The term "logic" herein refers to fixed hardware, programmable logic, and / or a suitable combination thereof as recognized by those skilled in the art to perform the described functions.) Software and firmware can be stored on non-transient computer-readable media. As is well known to those skilled in the art, some other processing can be implemented using analog circuits. In addition, memory or other storage devices and communication components can be used in embodiments of the present invention.

[0034] FIG2 shows a block diagram of a computer system 200 that can be used to perform processing functions according to various embodiments. Instruments for performing experiments can be connected to the exemplary computing system 200. The computing system 200 can include one or more processors, such as a processor 204. For example, the processor 204 can be implemented using a general or special processing engine, such as a microprocessor, a controller, or other control logic components. In this example, the processor 204 is connected to a bus 202 or other communication medium.

[0035] In addition, it should be understood that the computing system 200 of FIG. 2 may be embodied in any of several forms, such as a rack computer, a mainframe, a supercomputer, a server, a client, a desktop computer, a laptop computer, a tablet computer, a handheld computing device (e.g., a PDA, a cell phone, a smart phone, a palmtop computer, etc.), a cluster grid, a netbook, an embedded system, or any other type of special or general computing device that may be desirable or suitable for a given application or environment. In addition, the computing system 200 may include a conventional network system, the network system including a client / server environment and one or more database servers, or integrated with a LIS / LIMS infrastructure. A variety of conventional network systems including local area networks (LANs) or wide area networks (WANs) and including wireless and / or wired components are known in the art. In addition, client / server environments, database servers, and networks are well documented in the art. According to various embodiments described herein, the computing system 200 may be configured to connect to one or more servers in a distributed network. The computing system 200 may receive information or updates from the distributed network. Computing system 200 may also transmit information to be stored within the distributed network, where it may be accessed by other clients connected to the distributed network.

[0036] Computing system 200 may include a bus 202 or other communication mechanism for communicating information, and a processor 204 coupled with bus 202 for processing information.

[0037] The computing system 200 also includes a memory 206, which may be a random access memory (RAM) or other dynamic memory, coupled to the bus 202 for storing instructions to be executed by the processor 204. The memory 206 may also be used to store temporary variables or other intermediate information during the execution of instructions to be executed by the processor 204. The computing system 200 additionally includes a read-only memory (ROM) 208 or other static storage device coupled to the bus 202 for storing static information and instructions for the processor 204.

[0038] The computing system 200 may also include a storage device 210, such as a magnetic disk, optical disk, or solid-state drive (SSD), which is provided and coupled to the bus 202 for storing information and instructions. The storage device 210 may include a media drive and a removable storage interface. The media drive may include a drive or other mechanism that supports fixed or removable storage media, such as a hard disk drive, a floppy disk drive, a tape drive, an optical disk drive, a CD or DVD drive (R or RW), a flash drive, or other removable or fixed media drive. As shown in these examples, the storage medium may include a computer-readable storage medium having specific computer software, instructions, or data therein.

[0039] In alternative embodiments, storage device 210 may include other similar means for allowing computer programs or other instructions or data to be loaded onto computing system 200. Such means may include, for example, removable storage units and interfaces, such as program cartridges and cartridge interfaces, removable memory (e.g., flash memory or other removable storage modules) and memory slots, and other removable storage units and interfaces for allowing software and data to be transferred from storage device 210 to computing system 200.

[0040] The computing system 200 may also include a communication interface 218. The communication interface 218 may be used to allow software and data to be transferred between the computing system 200 and external devices. Examples of the communication interface 218 may include a modem, a network interface (such as an Ethernet or other NIC card), a communication port (such as a USB port, an RS-232C serial port), a PCMCIA slot and PCMCIA card, Bluetooth, etc. The software and data transmitted via the communication interface 218 are in the form of electronic, electromagnetic, optical or other signals that can be received by the communication interface 218. These signals may be sent and received by the communication interface 218 through a channel such as a wireless medium, wire or cable, optical fiber, or other communication medium. Some examples of a channel include a telephone line, a cellular phone link, an RF link, a network interface, a local area network or a wide area network, and other communication channels.

[0041] The computing system 200 may be coupled to a display 212, such as a cathode ray tube (CRT) or a liquid crystal display (LCD), via the bus 202 for displaying information to a computer user. For example, an input device 214 including alphanumeric keys and other keys is coupled to the bus 202 for transmitting information and command selections to the processor 204. The input device may also be a display with a touch screen input function, such as an LCD display. Another type of user input device is a cursor control 216, such as a mouse, trackball, or cursor direction keys, for transmitting direction information and command selections to the processor 204 and for controlling the movement of a cursor on the display 212. This input device typically has two degrees of freedom on two axes to allow the device to specify a position in a plane, the two axes being a first axis (e.g., an x-axis) and a second axis (e.g., a y-axis). The computing system 200 provides data processing and provides a confidence level for such data. Consistent with certain implementations of the embodiments of the present teachings, computing system 200 provides data processing and confidence values ​​in response to processor 204 executing one or more sequences of one or more instructions contained in memory 206. Such instructions may be read into memory 206 from another computer-readable medium, such as storage device 210. Execution of the sequences of instructions contained in memory 206 enables processor 204 to perform the processing states described herein. Alternatively, hard-wired circuitry may be used in place of or in combination with software instructions to implement embodiments of the present teachings. Therefore, implementation of embodiments of the present teachings is not limited to any specific combination of hardware circuitry and software.

[0042] As used herein, the terms "computer-readable medium" and "computer program product" generally refer to any media associated with providing one or more sequences or one or more instructions to processor 204 for execution. These instructions, generally referred to as "computer program code" (which may be grouped in the form of a computer program or other grouping), when executed, enable computing system 200 to perform features or functions of embodiments of the present invention. These and other forms of non-transitory computer-readable media can take a variety of forms, including but not limited to non-volatile media, volatile media, and transmission media. Non-volatile media include, for example, solid-state disks, optical disks, or magnetic disks, such as storage device 210. Volatile media include dynamic memory, such as memory 206. Transmission media include coaxial cables, copper wire, and optical fiber, including the wires that comprise bus 202.

[0043] Common forms of computer readable media include, for example, a floppy disk, a floppy disk, a hard disk, magnetic tape or any other magnetic medium, a CD-ROM, any other optical medium, punch cards, paper tape, any other physical medium with a pattern of holes, a RAM, a PROM and EPROM, a FLASH-EPROM, any other memory chip or cartridge, a carrier wave as described below, or any other medium from which a computer can read.

[0044] Various forms of computer-readable media may be involved in carrying one or more sequences of one or more instructions to the processor 204 for execution. For example, the instructions may first be carried on a disk of a remote computer. The remote computer may load the instructions into its dynamic memory and send the instructions via a telephone line using a modem. A modem local to the computing system 200 may receive the data on the telephone line and convert the data into an infrared signal using an infrared transmitter. An infrared detector coupled to the bus 202 may receive the data carried in the infrared signal and place the data on the bus 202. The bus 202 carries the data to the memory 206, from which the processor 204 retrieves and executes the instructions. The instructions received by the memory 206 may optionally be stored on the storage device 210 before or after execution by the processor 204.

[0045] It should be appreciated that, for clarity, the above description has described embodiments of the present invention with reference to different functional units and processors. However, it will be apparent that any suitable distribution of functions between different functional units, processors or domains may be used without departing from the present invention. For example, the functions shown to be performed by an independent processor or controller may be performed by the same processor or controller. Therefore, references to specific functional units should only be considered as references to suitable devices that provide the functions, rather than indicating a strict logical or physical structure or organization.

[0046] FIG. 10A shows an exploded perspective view of a bioanalysis system or instrument 1000 according to an exemplary embodiment. FIG. 10B shows an assembled perspective view of the system 1000 of FIG. 10A . The system 1000 may include a base plate, frame, or support structure 301, and a housing, enclosure, or shell 1001 for housing, isolating, and / or protecting various components, assemblies, and subassemblies of the system 1000. The system 1000 may further include a frame 704 that may be attached, secured, coupled to, and / or supported by the support structure 301. As discussed herein, the system or instrument 1000 includes elements and systems related to a qPCR system or instrument. However, the scope of the various embodiments disclosed herein may cover other types of systems or instruments, such as other types of bioanalysis systems or instruments, such as those listed above.

[0047] 3A and 3B , the system 1000 may include a block assembly 300. FIG. 3A shows an exploded perspective view of the block assembly 300 according to an exemplary embodiment. FIG. 3B shows an assembled perspective view of the block assembly 300 of FIG. 3A . With additional reference to FIG. 3C and 3D , the block assembly 300 includes a sample block 302 including an upper surface 303 and a plurality of containers or sample wells or receiving elements 304. For example, when the block 302 is configured to receive a standard 96-well or 384-well microtiter plate, the receiving elements may be disposed within a rectangular area having a long side of dimension “L” and a short side of dimension “S”, the dimension “S” being smaller than the dimension “L”. The sample block 302 may include a thermal block 305 mounted to and in thermal contact with an upper portion of the sample block 302, the sample block being configured to receive a sample holder or carrier. The thermal block 305 may include one or more elements (not shown) for heating and / or cooling, such as thermoelectric elements, one or more heat sinks or radiators, one or more heat exchangers or fins, and / or one or more fans. The sample block 302 may be disposed in or on a movable support or base 308, which may include a carrier, base, or tray 306 configured to support, hold, or lock the sample block 302. The carrier 306 may be a separate component that is attached to the movable base 308 or may be integrally formed with the movable base 308.

[0048] Still referring to FIGS. 3A to 3D , and additionally referring to FIGS. 4A and 4B , the sample block 302 can be configured to receive a sample holder 316. In the illustrated embodiment, the sample holder 316 comprises a microtiter plate comprising a plurality of reaction sites 317 in the form of grooves, reaction volumes in a fluid card, through-holes, surface indentations or other surface discontinuities, etc. In other embodiments, the sample holder 316 can comprise a linear strip of one or more reaction sites, a plurality of individual vials, a sample card, a microfluidic card, an array of through-holes, etc. Alternatively, the reaction site 317 can comprise a plurality of through-holes or other forms discussed above herein. In certain embodiments, the block assembly 300 can also include a cover 800, which can be configured to cover the sample holder 316 and / or protect and / or provide optical access to the reaction site 317. In the illustrated embodiment, the cover 800 is a heated cover 800 configured to heat the top of the sample holder 316, the top of the thermal block 302, and / or the volume above the sample holder 316 and / or the thermal block 302. Alternatively, the cover 800 may be a non-heated cover, such as a cover plate for protecting the contents of the sample holder 316, a plate with openings to provide optical access to the reaction sites 317, and / or a lenslet array configured to focus light into or onto the reaction sites 317.

[0049] In certain embodiments, the sample block 302 may be located on or in a removable base 308 that is configured to move or transport the sample block 302 from a location inside the housing 1001, such as along a horizontal axis as indicated by the double arrows in FIG. 4B, to a suitable location. The removable base 308 may be configured to move or transport the sample block 302, together with the sample holder 316 (when present), from a location inside the housing 1001 to a location that is fully or partially outside the housing 1001, such as for replacing the sample block 302 with a different sample block 302 (e.g., having a different format and / or reaction site density) and / or for replacing the sample holder 316 with a different sample holder 316 (e.g., having a different number of samples or reaction sites).

[0050] 6A and 6B, the sample block 302 may include at least one locking member 310, and the carrier, base or tray 306 may include at least one corresponding locking member 312. Preferably, the locking members 310, 312 are configured to engage each other to prevent removal from the carrier 306. Additionally or alternatively, the locking members 310, 312 may be configured to register and / or align the sample block 302 to the carrier 306. In the illustrated embodiment, the locking member 310 includes a track member 310a and a pair of two latch members 310b attached to or integral with the track member 310a. Alternatively, the locking member 310 may include a single latch member 310b or three or more latch members 310b. In the illustrated embodiment, the locking member 312 includes a track member 312a and a pair of two latching members 312b attached to or integral with the track member 312a, wherein each latching member 312b is configured to slide over and / or interlock with a corresponding latching member 310b. Alternatively, the locking member 312 may include a single latching member 312b or three or more latching members 312b. As seen in the illustrated embodiment, the sample block 302 preferably includes two locking members 310 located on opposite sides of the sample block 302, while the carrier 306 includes two corresponding locking members 312 located on opposite sides of the carrier 306. In certain embodiments, the sample block 302 includes a single locking member 310 located on one side of the sample block 302, while the carrier 306 includes a corresponding locking member 312 located on the same side of the carrier 306. As discussed further herein, locking members 310, 312 may be controlled by a controller to be in a locked configuration (e.g., when sample holder 316 is being replaced), or an unlocked configuration (e.g., when sample block 302 and / or a matching heated cover (e.g., cover 800) is being replaced).

[0051] Additionally, the sample holder 316 may include a sample holder radio frequency identification (RFID) tag 318 that contains information or data about the sample holder 316, reagents, dyes, or other chemicals contained in or on the sample holder 316, sample holder usage history, assay parameters or instructions, etc. In certain embodiments, the sample block 302 and / or the sample holder 316 include a sensor 320 and / or 320' that communicates with the sample holder RFID tag 318. Additionally or alternatively, the sensor 320' may be located on the thermal block 305.

[0052] 10B, in some embodiments, system 1000 may optionally include at least one reagent container 1030 including a reagent container RFID tag 1032. The contents of reagent container 1030 may be added to at least some of reaction sites 317 to prepare for an assay.

[0053] FIG. 4A shows a cross-sectional view of the block assembly 300 of FIGS. 3A-3B in a closed position or configuration (e.g., retracted or engaged) according to an exemplary embodiment. When the block assembly 300 is in the closed position, the sample block 302 and the heated cover 800 are in place to perform an assay on the sample holder 316. FIG. 4B shows a cross-sectional view of the block assembly 300 in an open position or configuration (e.g., extended or disengaged). In certain embodiments, when the block assembly 300 is in the open position, the sample holder 316 can be replaced with a different sample holder 316; however, the sample block 302 remains locked to the carrier 306 and the cover 800 is held by the cover carrier 710 and is held inside the housing 1001 of the system 1000. In an alternative embodiment, when the block assembly 300 is in the open position, the sample block 302 and the heated cover 800 are disengaged from their respective carriers, so that the sample holder 316, the sample block 302 and the heated cover 800 are all available for replacement. In one embodiment, the driver, actuator or drive mechanism 402 (e.g., in the form of a stepper motor and a worm gear) is operable to drive the movable base 308 and the carrier, base or tray 306 and the sample block 302 mounted thereon to slide back and forth one or more predetermined distances between the open position and the closed position relative to the support structure 301. A controller can be used to automatically operate the drive mechanism. At least one sensor can be used to detect the position of the block assembly 300 to provide feedback to the drive mechanism 402. In the open position, the sample block 302 can be placed on or removed from the carrier 306, thereby allowing one sample block to be replaced or exchanged for another sample block having a different configuration and / or configured to accommodate a different type of sample holder while the system 1000 is still powered on (e.g., while power is still being supplied to the current sample block 302 and / or the heated cover 800). In the closed position, normal operations involving the sample block 302 can be performed.

[0054] FIG5A shows a cross-sectional view of the block assembly 300 of FIGS. 3A-3B with the sample block 302 disengaged from the movable base 308, according to an exemplary embodiment. FIG5B shows a cross-sectional view of the block assembly 300 with the sample block 302 engaged with the movable base 308. For example, a driver, actuator, or drive mechanism 502 (e.g., in the form of a stackable linear actuator) can horizontally drive a first connector member 504 (e.g., a female connector) connected to the movable base 308 back and forth to engage / disengage with a second connector member 506 connected to the sample block 302. When the first connector member 504 and the second connector member 506 are engaged with each other, movement of the sample block 302 relative to the movable base 308 is prevented or minimized.

[0055] To further secure the sample block 302 in position relative to the base and prevent the sample block 302 from falling out during operation, additional locking features are provided in the exemplary embodiment, as described above with reference to FIGS. 3A to 3D and also shown in FIGS. 6A to 6B. In one embodiment, when the drive mechanism 502 (see FIGS. 5A to 5B) moves the first connector member 504 (see FIGS. 5A to 5B) toward the second connector member 506 (see FIGS. 5A to 5B), the locking members 310, 312 engage each other. Together with the connector members 504, 506, the locking members 310, 312 help secure the sample block 302 in place.

[0056] FIG. 7 shows a perspective view of an optical module or assembly 700 and a cover carrier 710 according to an exemplary embodiment. The cover carrier 710 and / or the optical assembly 700 may be attached to and / or supported by a frame 704. A retractable bellows 708 is disposed between the optical assembly 700 and the cover carrier 710. For example, the bellows 708 is connected to the optical assembly 700 at one end and to the cover carrier 710 at the other end. A drive, actuator, or drive mechanism 712 is configured to move the cover carrier 710 vertically up and down, as will be described in further detail below with reference to FIGS. 8A to 8D.

[0057] As the lid carrier 710 is lowered, the bellows 708 extends, and as the lid carrier 710 is raised, the bellows 708 collapses. The bellows 708 provides a housing between the top of the lid carrier 710 and the optical module 700, so that when the lid carrier is in the extended, lowered position, the bellows 708 provides optical isolation from entrapped light from external sources that might otherwise introduce noise at the optical sensor during an assay. Advantageously, the bellows 708 facilitates the disclosed configuration, which allows the heavier sample block 302 to be translated along a horizontal axis for placement or replacement of a sample holder and / or sample block, while the lighter heated lid can be translated along an orthogonal axis for preparation and use of the system 1000 for a run or assay. As seen in FIG10A , the frame 704 (which includes the optical assembly 700 and the lid carrier 710) can be attached or mounted to a support structure 301 that is used to hold and transport the thermal block assembly 300. This provides two separate single-axis translation systems (one for transporting the thermal block assembly 300 and the other for placing the lid 800 over the thermal block assembly 300). It has been found that this arrangement provides more precise alignment of the lid 800 with the reaction sites 317 of the sample holder 316 than more complex systems including dual-axis arrangements.

[0058] 8A-8D illustrate cross-sectional views illustrating the operation of the cover carrier 710 according to an exemplary embodiment. FIG. 8A-8B illustrate alternative cross-sectional views when the cover carrier 710 is lowered onto a heated cover 800 disposed on a block assembly (not shown), such as the block assembly 300 discussed above. In one embodiment, the cover carrier 710 includes a plurality of alignment pins 802a, 802b (typically at least 2 such alignment pins are used) to align or approximately align the cover carrier 710 with the heated cover 800. Specifically, the alignment pins 802a, 802b help ensure alignment between the third connector member 804 on the cover carrier 710 and the fourth connector member 806 on the heated cover 800. Additionally or alternatively, the alignment pins 802a, 802b are used to register or align the sample block 302 to the cover carrier 710. In certain embodiments, the upper portions of the alignment pins 802a, 802b are inserted into corresponding through holes or cylinders of the system 1000 to register or align the cover carrier 710 and the sample block 302 to the system 1000 (e.g., the optical assembly 700). The connector members 804, 806 may include electrical contacts to provide electrical connectivity and / or power to the heated cover 800. The cover carrier 710 also includes a clamping mechanism that includes clamping arms 808a, 808b driven by a driver, actuator, or drive mechanism 810. As the cover carrier 710 moves downward toward the heated cover 800, the clamping arms 808a, 808b open. As seen in FIG. 9B, there are two clamping arms 808a and two clamping arms 808b in the illustrated embodiment. In other embodiments, there may be one, three, or more clamping arms 808a, 808b.

[0059] FIG8C shows a cross-sectional view when the cover carrier 710 is in contact with the heating cover 800. At this time, the third connector member 806 is engaged with the fourth connector member 808 (not shown in FIG8C). In addition, the clamping arms 808a, 808b are actuated to close and generate an active clamping force on the heating cover 800 to firmly clamp the heating cover 800. Therefore, the heating cover 800 is fully engaged with the cover carrier 710 through both the connector members 804, 806 and the clamping arms 808a, 808b. The drive mechanism 712 can move both the cover carrier 710 and the engaged heating cover 800 upward from this state to the raised position shown in FIG8D.

[0060] 9A to 9K illustrate various views of the cover carrier 710, the drive mechanism 810, and the clamping arms 804, 806. Referring to FIGS. 9A to 9C, the cover carrier 710 includes a carrier plate 900 that cooperates with the top surface of the heated cover 800 and a drive mechanism 810 that is configured to rotate the clamping arm 808 via a link 905. FIG. 9A illustrates a partial cross-sectional view of the drive mechanism 810 according to an exemplary embodiment. The drive mechanism 810 can control the movement of the clamping arms 808a, 808b via corresponding links, wherein the link 905 is shown in FIG. 9. In addition, the drive mechanism can actuate the ejector rod 910 to apply a downward force to the corresponding portion 915. The portion 915 is connected to the fourth connector member 806. Thus, the drive mechanism 810 can disengage the third and fourth connector members 804, 806 while opening the clamp arms 808a, 808b, thereby disengaging the heated cover 800 from the cover carrier 710. In some embodiments, the carrier plate 900 includes an ejector rod 910, which can be coupled to the carrier plate 900 (e.g., using adhesive, bolts, fasteners, etc.) as part of an integral structure with the carrier plate 900. Additionally or alternatively, the third connector member 804 and the fourth connector member 806 can be disengaged by using the drive mechanism 712, for example, by separating the cover carrier 710 from the heated cover 800, which can be achieved by lifting the cover carrier 710 from the heated cover 800.

[0061] 9E-9H illustrate preferred embodiments of the operation of the drive mechanism 810. For simplicity, the mating heated cover 800 is not shown. FIG. 9E illustrates a first configuration of the drive mechanism 810 and cover carrier 710, wherein the clamp arms 808a, 808b are in a closed position, suitable for holding the heated cover 800, for example, during an assay or biological test. FIG. 9F illustrates a second configuration of the drive mechanism 810 and cover carrier 710, wherein the drive mechanism 810 is lowered relative to the axis of rotation of the clamp arms 808a, 808b. As a result of this relative movement, the clamp arms 808a, 808b are now in an open position, suitable for releasing the heated cover 800, for example, in preparation for replacing the heated cover 800 and / or sample block 302 with a different heated cover 800 and / or sample block 302 (e.g., replacing a 96-well format heated cover 800 and sample block 302 with a 384-well or 384-array card format heated cover 800 and sample block 302). FIG. 9G shows a third configuration of the drive mechanism 810 and the cover carrier 710, wherein the drive mechanism 810 is even further lowered relative to the axis of rotation of the clamp arms 808a, 808b. As a result of this relative movement, the clamp arms 808a, 808b can now extend beyond the open position in the second configuration. As described above, movement between the second configuration and the third configuration results in actuation of the ejector rod 910 to apply a downward force, thereby disengaging the third connector member 804 and the fourth connector member 806.

[0062] With further reference to FIG. 9H , it has been found that by properly designing the interface between the heated cover 800 and the clamping arm 808, the heated cover 800 can be more accurately aligned to the optical assembly 700. For example, it has been found that the tilted interface angle θ can be selected to provide a desired lateral accuracy or repeatability in the X-axis and Y-axis positions of the plane parallel to the upper surface 303. That is, the sample block 302 can be removed from the system 1000 and then subsequently placed back into the system 1000 with an accuracy or repeatability within a predetermined range. For example, in a preferred embodiment, it has been found that a tilted interface angle from 30 degrees θ to 50 degrees provides a lateral accuracy or repeatability of less than or equal to 200 microns. For an optical system with a 20x demagnification, this is equivalent to an accuracy or repeatability of an imaging sensor of 10 microns. In another preferred embodiment, it has been found that a tilted interface angle from θ30 degrees to 50 degrees provides a lateral accuracy or repeatability of less than or equal to 100 microns.

[0063] With further reference to FIGS. 9I-9K , it has been discovered that initial alignment of the cover carrier 710 with the optical assembly 700 and the block assembly 300 is critical. For example, in certain embodiments, the cover 800 includes a lenslet array that focuses excitation light or electromagnetic radiation from an excitation source into each reaction site 317 of the sample holder 316. The lateral positioning of the lenslet array on two axes in a horizontal plane determines the location of the focal point of each lenslet within the corresponding reaction zone 317. To facilitate initial alignment of the lenslet array with the block assembly 300 and / or the sample block 300, the cover carrier 710 may include an upper plate or assembly 920 and a lower plate or assembly 925. During installation and / or alignment of the cover carrier 710 into the system 1000, the upper plate 920 may be mounted or secured to a frame of the system 1000 (e.g., the optical assembly 700). The lower plate 925 to which the heated cover 800 is mounted or engaged during use is movably mounted or attached to the upper plate 920. The lower plate 925 can then be moved in a horizontal direction in one or two axes, for example, while the heated cover 800 or its alternative positions the lower plate to a position such that light or radiation from the excitation source is properly positioned within the slots or reaction sites 317 of the sample holder 316. Once the lenslet array of the heated cover 800 is aligned to the slots or reaction sites 317, the lower plate can be locked or secured to the upper plate.

[0064] In certain embodiments, the lower plate 925 includes at least two alignment pins 930 that are used to register or align the heated cover 800 to the lower plate. As discussed above, the upper portions of the alignment pins 802a, 802b are inserted into corresponding through holes or cylinders of the system 1000 to register or align the cover carrier 710 (more specifically, the upper plate 920) to the system 1000 (e.g., the optical assembly 700). Additionally or alternatively, the alignment pins 802a, 802b are used to register or align the sample block 302 to the upper plate 920, and thus to the system 1000. The lower plate 925 is used to adjust the alignment lenslet array of the heated cover 800 to the groove or reaction area of ​​the sample block 302, as discussed above. In this manner, pins 802a, 802b are used to approximately align the lenslet array to the wells or reaction areas of sample block 302, and the adjustable lower plate is used to provide a more accurate or precise alignment of the lenslet array to the wells or reaction areas of sample block 302.

[0065] Systems according to the present teachings can perform automated operations to install and replace / remove sample blocks 302 and heated covers 800 as needed. Some examples are now described with reference to FIGS.

[0066] In one example of installing the sample block 302 and the heating cover 800, the block assembly 300 is initially in an open position when the user initiates the installation sequence. Depending on the configuration, the heating cover 800 may have been pre-placed on the sample block 302, or they may be placed together in situ. Alignment features may help to properly position the heating cover 800 relative to the sample block 302. One or more sensors may also be used to determine the presence and / or orientation of the heating cover 800 on top of the sample block 302. The sample block 302 is then placed in a carrier, base, or tray 306 of the block assembly 300 along with the heating cover 800 thereon.

[0067] It should be understood that the above steps can be performed by a human operator, or alternatively, by an articulated arm. In the latter case, the articulated arm can be remotely controlled by a human operator or can be programmed to perform tasks autonomously.

[0068] Once the system can confirm the presence of the sample block 302 and the heated cover 800, the remaining steps of the installation sequence can be automatically performed. For example, the drive mechanism 402 (see FIG. 4A) pulls the block assembly 300 to the closed position. In the closed position, the drive mechanism 712 (see FIG. 7) moves the cover carrier 710 (see FIG. 7) downward to engage the heated cover 800. When the clamp arms 808a, 808b approach the heated cover 800 and the cover carrier 710 applies a clamping force to the heated cover 800 mounted on the sample block 302, the sample block 302 is effectively fixed.

[0069] While the sample block 302 remains in place, the drive mechanism 502 (see FIG. 5A ) moves the first connector member 504 to engage with the second connector member 506 . The same movement causes the locking members 310 , 312 to engage with each other. Thus, the sample block 302 is secured to the movable base 308 .

[0070] After engagement is complete, the drive mechanism 712 moves the lid carrier 710 engaged with the heated lid 800 to a raised position, ready for deployment. For example, an operator may begin a PCR experiment, and the block assembly 300 may be extended to an open position to load a sample holder and then pulled to a closed position before the lid carrier 710 is lowered to begin thermal cycling.

[0071] In another example of removing the sample block 302 and the heated cover 800, when the operator initiates the removal sequence, the block assembly 300 may initially be in a closed position and the heated cover 800 may be in a raised position. The system may automatically operate the drive mechanism 712 to lower the heated cover 800 onto the sample block 302. Once the heated cover 800 is detected to be on top of the sample block 302, the clamp arms 808a, 808b open to release the heated cover 800. In addition, the drive mechanism 810 (see FIG. 8) causes the ejector rod 910 to apply a downward force to disengage the third connector member 804 and the fourth connector member 806 from each other. After the cover carrier 710 is separated from the heated cover 800, it can be pulled to the raised position.

[0072] Separately, the drive mechanism 502 automatically causes the first connector member 504 and the second connector member 506 to disengage from each other and the locking members 310, 312 to fall off from each other. Thus, the sample block 302 with the heating cover 800 on top is disengaged from the movable base 308, and the drive mechanism 402 can move the sample block 302 to an open position, in which both the sample block 302 and the heating cover 800 can be retrieved / removed, for example, by an operator or an articulated arm.

[0073] As shown in FIG3A , the system 1000 may also include electronic components 314, which may include or be part of one or more controllers configured to control movement and / or engagement of various components of the system 1000. For example, at least some of the electronic components 314 may be configured alone or in conjunction with electronic devices of the system external to the housing 1001 that communicate with the system 1000 to control movement or engagement of any or all of the following: the sample block 302, the carrier 306, the removable base 308, the connector members 504 and / or 506, the cover 800, the connectors 804 and / or 806, the locking members 310 and / or 312, the clamp arms 808a, 808b, the cover carrier 710, and the bellows 708. For example, at least some of the electronic components 314 may be configured alone or in conjunction with the electronics of the system external to the housing 1001 that communicates with the system 1000 to control movement of the sample block 302 and / or the removable base 308 relative to the support structure 301, as shown in FIGS. 4A and 4B. Additionally or alternatively, the electronic components 314 may be configured to move the cover 800 and / or the cover carrier 710 relative to the sample holder 316 and / or the sample block 302. In certain embodiments, the electronic components 314 may be configured to operate the locking member 312 to engage the locking member 310 of the sample block 302, for example, to secure or lock the sample block 302 to the removable base 308 or the carrier 306. In some embodiments, the electronic component 314 can be configured to secure or lock the cover 800 to the cover carrier 710, for example using the clamp arms 808a and / or 808b, wherein the cover carrier 710 can be used to lift the cover 800 from the sample block 302 and then move the sample block outside the housing 1001 to replace or adjust the sample holder 316. Alternatively, the electronic component 314 can be configured to be disengaged from the cover 800.

[0074] System Integration

[0075] In addition to the block assembly 300, optical assembly 700, and cover carrier 710 as described above, the system 1000 also includes a rear chassis assembly 1002 that can provide electrical and thermal management for the system 1000. As shown in Figures 10A and 10B, a housing 1001 can enclose any or all of the block assembly 300, optical assembly 700, cover carrier 710, and / or rear chassis assembly 1002. The housing 1001 can be formed of various components (e.g., components 1004, 1006, 1008, 1010) attached to each other, together with a front housing 1012 shown in Figure 10B.

[0076] The front housing 1012 also includes a drawer face 1014 and a door face 1015 disposed above the drawer face. During operation, the drawer face moves forward when the block assembly moves from a closed position to an open position. If only the sample holder 316 is inserted or replaced, the door face 1015 remains stationary. If the sample block 302 and / or the heating cover 800 are being replaced, the drawer face 1014 moves forward and the door face 1015 flips open from the top to allow the heating cover 800 to pass. Alternatively, the door face 1015 may be raised and / or retracted into the system 1000 during this operation to allow the heating cover 800 to pass. As a safety or precautionary feature, the door face 1015 may be configured to move to an open position (e.g., flip or raise) during startup of the system 1000. This eliminates possible damage to the system 1000 if, for example, the block assembly 300 was in an open position during a recent power outage (whether intentional or unintentional, such as due to a power failure). In this case, during or after system startup, during the retraction of the block assembly 300 into the housing 1001 to the closed position, no damage will occur to the door face 1015 because the door face 1015 will be opened or retracted.

[0077] The front housing 1012 includes several input / output features. A display screen 1016 capable of receiving touch input is mounted on the front housing 1012. In one embodiment, the front housing 1012 includes an imaging system 1017 that includes one or more cameras that can be configured to detect or recognize the face of a perspective user of the system 1000. The imaging system 1017 can be configured to provide or generate one or more outputs if one or more predetermined criteria are met (e.g., if the perspective user's face matches stored data of an individual authorized to use the system 1000 and / or has access to certain capabilities of the instrument or information stored in the system 1000 or in a database to which the system 1000 has access). In certain embodiments, the imaging system 1017 can include a 3-dimensional (3D) camera module 1017. The 3D camera module 1017 is capable of detecting facial expressions and body postures, and can be equipped with facial recognition software to automatically recognize the face of a registered user. Additionally or alternatively, imaging system 1017 may be located elsewhere, such as in or on a top or side panel of system 1000 .

[0078] Alternatively or in addition, the system 1000 may include a speech system 1018 including, for example, one or more microphones 1018 mounted on the front housing 1012. The speech system 1018 may be equipped with speech recognition software to automatically recognize speech commands from registered users.

[0079] The system 1000 and / or the front housing 1012 may also have a proximity sensor 1020 to detect an object or individual (e.g., a user) at a predetermined distance to turn on the 3D camera module 1017 and activate the microphone 1018. The proximity sensor may be any proximity sensor, probe, or device known in the art. Thus, in some exemplary embodiments, the system 100 may be operated in a hands-free mode, for example, by voice commands or body gestures. In certain embodiments, the output from the proximity sensor 1012 may be used to enable the imaging system 1017 and / or the voice system 1018. The proximity sensor 1012 may be used in an environment where two or more instruments 1000 are located in the same laboratory or room. Additionally or alternatively, the output from the proximity sensor 1020 may be used to determine whether the output from the imaging system 1017 and / or the voice system 1018 will be used to start, power on, or activate the system 1000 and / or allow access to certain capabilities of the instrument or information stored in the system 1000 or a database accessible to the system 1000.

[0080] In this manner, it may be determined which system 1000 a user accessing two or more instruments 1000 will respond to a voice command or facial recognition signal. For example, if a user provides a voice command to activate or start one of the instruments 1000, or to implement certain functions of the systems 1000, only the system 1000 to which the user is closest will respond. In certain embodiments, multiple authorized users may be in the same lab or room, and each system 1000 will respond to each user based on the proximity of each user to one of the corresponding instruments. It is contemplated that such capabilities may be used for other types of biological analysis instruments or non-biological analysis instruments that have capabilities and features different from those disclosed herein, but have proximity sensors 1020 used in the manner just described according to the embodiments discussed herein.

[0081] A pair of speakers 1022 may also be mounted to the front housing 1012 to provide audio updates, warnings, etc., so that a human operator does not need to check the display screen 1016 regularly.

[0082] The system 1000 may also include several features to further enhance performance. Referring to FIGS. 3C , 3D , and 6A , the block assembly 300 further includes at least one ejection member 600 configured to at least partially lift the sample holder 316 off the sample block 302 when in the open position. This prevents the sample holder from sticking to the sample block 302 (as is the case in some prior systems) and facilitates removal of the sample holder from the sample block 302 after an experiment, particularly when removal is performed by an articulated arm (i.e., a robot). The inventors have found that manual and / or robotic removal of the sample holder 316 is better facilitated when the ejection member 600 is positioned along the long side of the sample holder 316 corresponding to the L dimension in FIG. 3 , rather than on the short side corresponding to the S dimension. For example, after performing a PCR assay using the system 1000, the edges of the sample holder 316 bend downward toward the center. It has been found that the long sides of the sample holder 316 have a greater bend depth than the short sides. By placing the ejector member 600 along the long edge corresponding to the L dimension in Figure 3C, the gap between the edge of the sample holder 316 and the surface 303 of the sample block 302 is greater than when the ejector member 600 is placed on the short edge corresponding to the S dimension in Figure 3C. This may be because the depth of the bend along the short edge of the sample holder 316 is less, or it may be because the greater bend on the long edge will tend to cause the sample holder 316 to protrude away from the surface 303.

[0083] FIG. 11A shows an improved seal in the form of a double lip seal 1100 attached to the lower surface of the heating cover 800. FIG. 11B shows an enlarged view of the seal 1100. The double lip design of the seal 1100 can avoid the flaring problem and corresponding poor sealing problem that occurs in existing systems when using single edge or single blade seals of the prior art. It has been found that these prior art single blade designs cause higher pressures in the four corners of the seal during compression when the heating cover 800 is in the downward position. As a result, the seal degrades over time and repeated use. The disclosed double lip seal 1100 is configured to provide uniform contact with the surface 303 of the sample block 302, thereby reducing or minimizing heat loss / disturbance to or from the external environment. In addition to providing an excellent seal at the surface 303, the bellows formed by the double lip seal also provides additional insulating properties to the seal itself because the air between the inner and outer walls of the seal provides additional insulation.

[0084] The system 1000 according to the present teachings can also detect the presence of a sample holder on the sample block 302 and read relevant information about the sample holder. For example, when the cover carrier 710 is lowered onto the sample block 302 together with the heating cover 800 before an experiment is run, the actual height of the heating cover 800 is monitored through feedback from one or more encoders. Due to the thickness of the sample holder, the height of the heating cover 800 is greater when the sample holder is present than when the sample holder is not present. Therefore, the presence or absence of the sample holder can then be determined. In certain embodiments, one or more such encoders can be used to distinguish between different types and / or brands of sample holders that have been located in the sample block 302 based on the thickness difference between different types or brands. Similarly, the encoders can be used to determine whether the correct or preferred sample holder has been located in the sample block 302.

[0085] Referring to FIG. 3C , FIG. 3D , and FIG. 12 , the system 1000 may include a first RFID antenna 1200a and a second RFID antenna 1200b that communicate with a corresponding first device 1202a and a second device 1202b. The devices 1202a, 1202b may be an RFID reader, an RFID writer, or a combination of RFID readers / writers. In some embodiments, the devices 1202a, 1202b may be combined into a single device that communicates with the two antennas 1200a, 1200b. The devices 1202a, 1202b, alone or in combination with the system 1000 and / or another system that communicates with the system 1000, may be configured to read the RFID tag 318. RFID tag 318 and the data contained therein may be used to confirm the presence of the RFID, confirm that the correct sample holder is being used, perform a pre-run check prior to using system 1000 to conduct an assay, control system 1000 and / or an assay run on system 1000 (e.g., by providing information about sample holder 316 and / or reaction site 317 to generate a protocol for use by system 1000 to run an assay, experiment, or test on sample holder 316). In some embodiments, devices 1202a and / or 1202b may be configured to write data generated during an assay conducted on system 1000. Additionally, data recorded on RFID tag 318 during an assay and / or data already contained on the RFID tag prior to placement in system 1000 may be used to process data generated during an assay.

[0086] After a run, the RFID writer / reader 1202a, 1202b can write information onto the sample holder RFID tag to mark the sample holder as used, which can prevent the sample holder from being re-run. This information can also be transmitted to a remote location, such as for inventory control and purchasing purposes. The 2 readers can also detect the orientation of the sample holder. If the user position does not place the sample holder in the normal orientation, the system software can account for the angle offset for display and analysis.

[0087] Referring to FIG. 13 , in certain embodiments, a method 1300 is provided for performing a biological analysis in an automated manner without user intervention or any further input after sending an initial instruction to start the assay. The inventors have discovered that the method 1300 produces unexpected advantages over current practices, in which a user must manually enter assay protocol information / instructions into the system to run the assay (e.g., by cross-referencing a sample holder ID to look up a database) and / or obtain assay protocol information / instructions by connecting to a network (such as a LAN or cloud database). These current practices are not only time-consuming, but also less secure because proprietary information resides and / or is sent to a site that is remote from the instrument performing the assay. In many applications, it is critical to store input and / or output data related to the assay in a secure environment to prevent unauthorized access to such data. Using embodiments of the current teachings, all inputs required to configure the assay protocol are retained locally with the sample holder and sample holder RFID tag. In addition, the sample holder RFID tag according to embodiments of the present teachings can be configured to receive information related to the output of the assay run, such as operating parameters and conditions and / or data generated during the assay run.

[0088] Method 1300 may be used in conjunction with a sample holder RFID tag and / or a reagent container RFID tag (e.g., sample holder RFID tag 318 and / or reagent container RFID tag 1032). When reagent container RFID tags are not present or utilized, method 1300 includes: element 1310, which includes placing a sample holder (e.g., sample holder 316) in or on a bioanalysis system (e.g., system 1000); and element 1320, which includes receiving an initial user input from a user to initiate an assay. In some embodiments, the initial input from the user may also initiate transport and / or positioning of the sample holder, as discussed above with respect to movement of sample holder 302 / heat block 305 after the sample holder is placed in carrier, base, or tray 306.

[0089] Method 1300 also includes element 1330, which includes using one or more antennas associated with the sample holder RFID tag (e.g., one or both of RFID antennas 1200a, 1200b) to read at least some of the RFID data. Method 1300 further includes element 1340, which includes generating instructions to perform an assay based at least in part on the read RFID data. After receiving the initial user input, method 1300 additionally includes element 1350, which includes executing a set of steps to perform the assay on the sample holder without any further input or intervention by the user until the assay is completed. The set of steps may include or be provided by a protocol that may be configured at least in part based on the data contained on the sample holder RFID tag. Optionally, additional input is made to the assay protocol after the initial user input, for example, to further customize the protocol.

[0090] In certain embodiments of method 1300, system 1000 may include one or more reagent containers, each of which has its own RFID tag (e.g., reagent container 1030 and reagent container RFID tag 1032). In such embodiments, method 1300 may also include element 1360, which includes reading information from the reagent container RFID tag for the one or more reagent containers. Method 1300 then includes any or all of elements 1310 to 1350.

[0091] 14, in certain embodiments, a method 1400 for performing a bioanalysis is utilized to determine the orientation of a sample holder within a system or instrument, such as the orientation of a sample holder 316 within a sample block 302. Advantageously, this allows for loading of sample holders in certain embodiments without having to orient the sample holders to match a key. Additionally or alternatively, this can allow the same sample block (e.g., sample block 302) to be compatible with different types of sample holders (such as different types of plates), or with various plates having different shape features (compatible with both 96-well microtiter plates and 4, 8, or 12 well strips).

[0092] Using system 1000 as an example, method 1400 includes element 1410, which includes placing sample holder 316 in or on sample block 302. Method 1400 also includes elements 1420 and 1430, which include determining whether RFID data from sample holder RFID tag 318 is detected from either or both of RFID antennas 1200a, 1200b. If neither antenna 1200a, 1200b receives RFID data, method 1400 includes element 1440, which: (1) generates or produces a signal indicating that sample holder 316 does not contain an RFID tag; or (2) generates or produces a signal indicating that a sample holder is not present. If other means (active or passive) are used to determine the presence of sample holder 316, the system will be configured to utilize the second option. Additionally or alternatively, if the possibility of a faulty RFID tag is suspected (eg, based on ambiguous antenna signals, or if there are other means for verifying the presence of an RFID tag on a sample holder), the system may be configured to produce or generate an uncertainty signal.

[0093] Optionally, method 1400 may include element 1450, which includes generating at least one of the following if the RFID data is received by one of the RFID antennas: (1) a signal indicating that sample holder 302 contains sample holder RFID 318; or (2) a signal indicating the orientation of sample holder 316. In certain embodiments, the inventors have discovered that detection of orientation is achieved by configuring antennas 1200a, 1200b, sample holder 316, and RFID tag 318 such that when sample holder 316 is oriented as shown in FIG. 3C and FIG. 3D, the signal from RFID tag 318 is strong enough to be received by antenna 1200a, but the signal to antenna 1200b is too weak to be received. Conversely, if the sample holder 316 is rotated 180 degrees from that shown in FIG. 3C, FIG. 3D, the signal from the RFID tag 318 is strong enough to be received by the antenna 1200b, but the signal to the antenna 1200a is too weak to be received. In this way, the orientation of the sample holder 316 can be detected based on the signal or signal absence in the antennas 1200a, 1200b. Additionally or alternatively, a single RFID device 1202a or 1202b, and / or a single RFID antenna 1200a or 1200b, can be used to determine the orientation of the sample holder 316 based on the signal strength received from the RFID tag 318.

[0094] The inventors have found that it is advantageous to separate the antennas 1200a, 1200b from the RFID devices 1202a, 1202b. In certain embodiments, communication between the antennas 1200a, 1200b and the RFID devices 1202a, 1202b is provided by wires between each antenna and the corresponding RFID device. By separating in this manner, the inventors have found that relatively small antennas 1200a, 1200b (compared to the devices 1202a, 1202b) can be placed above the sample holder 316 and / or sample block 302, so that relatively weak signals from the RFID tags can be received by antennas that are closer to the RFID tags.

[0095] Optionally, method 1400 may include element 1460, which includes generating: (1) a signal indicating that sample holder 316 contains two sample holder RFID tags 318; or (2) a signal indicating that two sample holders 316 with sample holder RFID tags 318 are present if RFID data is received by two RFID antennas 1200a, 1200b.

[0096] In some embodiments, a method 1500 of using an apparatus or system (e.g., system 1000) includes an element 1510 that includes querying an activation and / or recognition system to produce a first output, the activation and / or recognition system including one or more of a voice activation and / or recognition system or a facial activation and / or recognition system. For example, the activation and / or recognition system may include the image system 1017 and / or the voice system 1018 discussed above herein.

[0097] The method 1500 further includes an element 1520 that includes determining whether the first output satisfies one or more first predetermined criteria.

[0098] The method 1500 further includes an element 1530 that includes interrogating the proximity sensor to generate a second output. For example, the proximity sensor may include the proximity sensor 1020 discussed herein above.

[0099] Method 1500 further includes element 1540 , which includes determining whether the second output satisfies one or more second predetermined criteria.

[0100] Method 1500 further includes element 1550, which includes starting, powering on, activating or otherwise using the capabilities or data of the instrument when: (1) a first output satisfies one or more first predetermined criteria and; (2) a second output satisfies one or more second predetermined criteria.

[0101] In certain embodiments, the method 1500 of using an instrument includes a method of starting, powering on or activating an instrument and / or a method of utilizing or initiating certain capabilities of an instrument or utilizing or granting access to information stored in a system or in a database to which the instrument has access.

[0102] It will be appreciated by those skilled in the art that many changes and / or modifications may be made to the present disclosure as shown in the specific embodiments without departing from the scope of the present disclosure as broadly described. Therefore, the present embodiments should be considered in all aspects only as illustrative and not restrictive.

[0103] The following is a list of illustrative examples and / or embodiments of the present disclosure:

[0104] 1. A biological analysis system, comprising:

[0105] a sample block and a base, the sample block configured to hold a biological sample, the base configured to hold the sample block, the sample block comprising a first connector;

[0106] a first driver, the first driver comprising a second connector;

[0107] a cover and a cover carrier, the cover being arranged to cover the sample block, the cover carrier being configured to hold the cover, the cover comprising a third connector;

[0108] a second driver, the second driver comprising a fourth connector;

[0109] a controller communicatively coupled to the first driver and the second driver, the controller being configured to:

[0110] aligning the cover and / or the sample block to the cover carrier using the second actuator;

[0111] engaging the third connector with the fourth connector using the second actuator;

[0112] engaging the first connector with the second connector using the first actuator; and

[0113] The sample block is secured and / or locked to the base using the first actuator.

[0114] 2. The system according to 1, wherein the connector is an electrical connector configured to provide power and / or communication between the system and the sample block and between the system and the cover.

[0115] 3. The system according to 1 or 2, further comprising:

[0116] a third drive, the controller being communicatively coupled to the third drive;

[0117] Wherein the controller is configured to secure and / or lock the cover to the cover carrier using the third actuator.

[0118] 4. The system according to claim 3, wherein the controller is configured to:

[0119] disengaging the cover from the cover carrier using the third actuator; and

[0120] The cover carrier is separated from the cover using the second actuator to disconnect the third electrical connector from the fourth electrical connector.

[0121] 5. A system according to any one of 1 to 4, wherein the controller is configured to use the third drive to disengage the third electrical connector from the fourth electrical connector by moving a connecting rod from a first position to release the cover from the cover carrier to a second position, thereby separating the third electrical connector from the fourth electrical connector.

[0122] 6. A biological analysis system comprising:

[0123] a sample block and a base, the sample block configured to hold a biological sample, the base configured to hold the sample block, the sample block comprising a first connector;

[0124] a first driver, the first driver comprising a second connector;

[0125] a controller communicatively coupled to the first driver, the controller being configured to:

[0126] engaging the first connector with the second connector using the first actuator; and

[0127] The sample block is secured and / or locked to the base using the first actuator.

[0128] 7. The system according to 6, wherein the connector is an electrical connector configured to provide power and / or communication between the system and the sample block.

[0129] 8. A biological analysis system comprising:

[0130] a sample block configured to hold a biological sample;

[0131] a cover and a cover carrier, the cover being arranged to cover the sample block, the cover carrier being configured to hold the cover, the cover comprising a first connector;

[0132] a first driver, the first driver comprising a second connector;

[0133] a controller communicatively coupled to the first driver, the controller being configured to:

[0134] aligning the cover and / or the sample block to the cover carrier using the first actuator; and

[0135] The first connector is engaged with the second connector using the first actuator.

[0136] 9. The system of claim 8, wherein the connector is an electrical connector configured to provide power and / or communication between the system and the cover.

[0137] 10. The system according to 8 or 9, further comprising:

[0138] a second driver, the controller being communicatively coupled to the second driver;

[0139] Wherein the controller is configured to secure and / or lock the cover to the cover carrier using the second actuator.

[0140] 11. The system according to claim 10, wherein the controller is configured to:

[0141] disengaging the cover from the cover carrier using the second actuator; and

[0142] The first electrical connector is disconnected from the second electrical connector by separating the cover carrier from the cover using the first actuator.

[0143] 12. A system according to any one of 8 to 11, wherein the controller is configured to use the third drive to disengage the third electrical connector from the fourth electrical connector by moving a connecting rod from a first position to release the cover from the cover carrier to a second position, thereby separating the third electrical connector from the fourth electrical connector.

[0144] 13. The system according to any one of 1 to 12, wherein the cover is a heated cover.

[0145] 14. A biological analysis system comprising:

[0146] a sample block and a base configured to hold the sample block;

[0147] a heating cover and a cover carrier, the cover carrier being configured to hold the heating cover;

[0148] a first drive mechanism configured to engage the sample block;

[0149] a second drive mechanism configured to engage the heated cover; and

[0150] a controller communicatively coupled to the first drive mechanism and the second drive mechanism,

[0151] Wherein the controller is configured to automatically operate the first drive mechanism to releasably engage the sample block with the base and automatically operate the second drive mechanism to releasably engage the heated cover with the cover carrier based on a first command.

[0152] 15. The system of claim 14, wherein the controller is configured to automatically operate the first drive mechanism to disengage the sample block from the base, and automatically operate the second drive mechanism to disengage the heated cover from the cover carrier based on a second command.

[0153] 16. The system of claim 14, further comprising a third drive mechanism and a fourth drive mechanism, and wherein based on the first command, the third drive mechanism is configured to move the base and the sample block to an open position, and the fourth drive mechanism is configured to move the heating cover and the cover carrier to a raised position.

[0154] 17. The system of claim 15, wherein based on the second command, a third drive mechanism is configured to move the base and the sample block to an open position, and a fourth drive mechanism is configured to move the heated cover and the cover carrier to a lowered position.

[0155] 18. The system of claim 17, wherein the heated cover is disposed on top of the sample block between the closed position and the open position.

[0156] 19. The system of claim 18, further comprising at least one sensor configured to determine the presence of the heating cover on top of the sample block.

[0157] 20. The system of claim 16, further comprising at least one first locking member connected to the sample block and at least one second locking member connected to the base, and wherein the first locking member and the second locking member are configured to engage with each other to fix the sample block in position when the sample block is engaged with the base.

[0158] 21. The system of claim 16, further comprising a plurality of alignment pins configured to align the cover carrier with the sample block in the closed position.

[0159] 22. The system of claim 14, further comprising an optical assembly and a retractable bellows, wherein the bellows is disposed between the optical assembly and the cover carrier.

[0160] 23. The system according to claim 17, wherein:

[0161] The sample block includes a top surface, the top surface including a two-dimensional array of reaction zones, the array defining a periphery at the top surface surrounding the reaction zones, the periphery including a pair of relatively long sides having a first length and a pair of relatively short sides having a second length shorter than the first length;

[0162] The sample block includes a pair of ejection members adjacent to and substantially parallel to respective ones of the long sides;

[0163] The sample block is configured to receive a sample holder;

[0164] The ejection member is configured to at least partially raise the sample holder relative to the sample block when the sample block is in the open position.

[0165] 24. The system of claim 23, further comprising an RFID reader configured to read a sample holder RFID tag attached to the sample holder.

[0166] 25. The system of claim 23, further comprising a detector configured to detect the presence of the sample holder on the sample block.

[0167] 26. The system of claim 23, further comprising a double-lip seal attached to a lower surface of the heating cover, wherein in use, the double-lip seal is configured to contact the sample block and sealingly surround the sample holder.

[0168] 27. The system of claim 15, wherein the first command comprises an installation command to install the sample block and the heated cover, and the second command comprises a removal command to remove the sample block and the heated cover.

[0169] 28. The system of claim 15, wherein the first command or the second command comprises one of a touch input, a keyboard input, a voice command, or a gesture.

[0170] 29. A method of installing a sample block and a heated cover in a bioanalysis system, the method comprising:

[0171] placing a sample block and a heated cover on a base;

[0172] positioning a cover carrier to engage the heated cover;

[0173] In response to confirmation of the presence of the sample block and the heated cover, the cover carrier is automatically moved to engage the heated cover.

[0174] 30. The method of claim 29, further comprising raising the cover carrier with the engaged heating cover to separate the heating cover from the sample block.

[0175] 31. The method of claim 29, wherein engaging the heating cover with the sample block comprises simultaneously aligning the heating cover with the sample block.

[0176] 32. The method of claim 29, wherein automatically engaging the heated cover with the cover carrier comprises moving the cover carrier toward the heated cover and simultaneously aligning the cover carrier with the heated cover.

[0177] 33. A method of removing a sample block and a heated cover from a bioanalysis system, the sample block being supported by a base, the method comprising:

[0178] automatically lowering the heated cover onto the sample block using a cover carrier;

[0179] disengaging the heated cover from the cover carrier so that the heated cover is positioned on top of the sample block; and

[0180] automatically moving the sample block together with the heated cover from a closed position to an open position; and

[0181] The sample block is removed from the base of the block assembly.

[0182] 34. The method according to 33, further comprising removing the sample block together with the heating cover in the open position.

[0183] 35. The method of claim 33, wherein automatically lowering the heated cover onto the sample block comprises aligning the heated cover with the sample block.

[0184] 36. A biological analysis system comprising:

[0185] case;

[0186] a sample block disposed within the housing and configured to receive a sample holder including a sample holder RFID tag;

[0187] a first RFID antenna and a second RFID antenna, the RFID antennas being configured during use to receive RFID data from the sample holder RFID tag;

[0188] At least one RFID reader is configured to receive the RFID data from the first RFID antenna and configured to receive the RFID data from the second RFID antenna.

[0189] 37. The bioanalysis system according to 36, further comprising at least one RFID writer configured to write data on the sample holder RFID tag.

[0190] 38. The bioanalysis system according to any one of 36 to 37, wherein the RFID antenna is spatially separated from the at least one RFID reader.

[0191] 39. The bioanalysis system according to 38, wherein the RFID antenna communicates with the at least one RFID reader via a wire or cable.

[0192] 40. The bioanalysis system according to any one of 38 to 39, wherein the first RFID antenna is disposed proximate to one side of the sample block and the second RFID antenna is disposed proximate to a different side of the sample block.

[0193] 41. The bioanalysis system according to any one of 38 to 40, wherein the first RFID antenna is disposed proximate to one side of the sample block and the second RFID antenna is disposed proximate to an opposite side of the sample block.

[0194] 42. The bioanalysis system according to any one of claims 38 to 41, wherein the sample block has an uppermost surface, the at least one RFID reader is disposed below the uppermost surface, and the RFID antenna is disposed above the uppermost surface.

[0195] 43. The bioanalysis system of any one of claims 36 to 42, wherein the system comprises the sample holder and the sample holder RFID tag.

[0196] 44. The bioanalysis system according to claim 43, wherein:

[0197] The sample holder comprises a plurality of spatially separated reaction sites, each of the plurality of spatially separated reaction sites comprising a plurality of characteristics;

[0198] the sample holder RFID tag comprising RFID data including data of the plurality of characteristics of each of the reaction locations;

[0199] Wherein the RFID data comprises at least 8 kilobytes, at least 64 kilobytes or at least 128 kilobytes.

[0200] 45. The bioanalysis system of claim 44, wherein the plurality of spatially separated reaction positions comprises at least 96 reaction positions, at least 384 reaction positions, at least 1536 reaction positions, at least 3072 reaction positions, or at least 12,288 reaction positions.

[0201] 46. ​​A bioanalysis system according to any one of 43 to 45, wherein the RFID writer is configured to write assay information generated during an assay onto the sample holder RFID tag, and optionally, the system is configured to use the assay information to analyze data obtained during the assay.

[0202] 47. The bioanalysis system of any one of 43 to 46, wherein the plurality of characteristics comprises one or more of the following:

[0203] Sample holder ID;

[0204] Sample holder expiration date;

[0205] Sample holder part number;

[0206] Sample holder barcode;

[0207] Sample holder batch number;

[0208] Sample holder type;

[0209] Storage temperature and / or storage temperature range;

[0210] Sample concentration – recommended range; Is the E1 pipette support available?

[0211] Sales order number;

[0212] Assay name and / or location on the sample holder;

[0213] Assay ID;

[0214] Proposed agreement or requested agreement;

[0215] Sample name

[0216] Master Mix Name;

[0217] master mix changes;

[0218] Dye name;

[0219] recommended or required filters or filter sets for use on the sample holder during an assay;

[0220] EDT file format and / or EDF file format;

[0221] Internet link or address;

[0222] Passive reference dyes;

[0223] Reaction Volume:

[0224] Target name;

[0225] Dye name;

[0226] Sample name;

[0227] Analysis settings;

[0228] Mark settings;

[0229] Sample type;

[0230] Target type;

[0231] A run protocol comprising one or more of a heating lid temperature, a reaction volume, a temperature step value, and a temperature step value; or

[0232] Slot information for one or more slots, the slot information including one or more of a target name, a dye name, or a sample name; a reagent name.

[0233] 48. The bioanalysis system according to 47, wherein the plate type is characterized by 48 slots, 96 slots, 384 slots, 1536 slots, 3072 slots or through holes.

[0234] 49. The bioanalysis system according to any one of 47 to 48, wherein the plate type is characterized by a groove volume of 0.1 ml or 0.2 ml.

[0235] 50. The bioanalysis system of any one of claims 47 to 49, wherein the RFID data on the sample holder RFID comprises rewritable data comprising one or more of:

[0236] Passive reference dyes;

[0237] Reaction Volume:

[0238] Target name;

[0239] Dye name;

[0240] Sample name;

[0241] Analysis settings;

[0242] Mark settings;

[0243] Sample type;

[0244] Target type;

[0245] A run protocol comprising one or more of a heating lid temperature, a reaction volume, a temperature step value, and a temperature step value; or

[0246] Slot information for one or more slots, the slot information including one or more of a target name, a dye name, or a sample name; a reagent name.

[0247] 51. The bioanalysis system of any one of claims 36 to 50, further comprising a sensor disposed on, or embedded in, one or more of the sample holder RFID tag, the sample block, or a thermal block coupled to the sample block.

[0248] 52. The bioanalysis system of claim 51, wherein the sensor communicates with the sample holder RFID tag.

[0249] 53. The bioanalysis system according to any one of 51 to 52, wherein the sensor comprises one or more of the thermal sensor, accelerometer, vibration sensor, light sensor, light detector.

[0250] 54. A bioanalysis system according to any one of claims 51 to 53, wherein information from the sensor is written to the sample holder RFID tag at least once during the life of the sample holder.

[0251] 55. A bioanalysis system according to any one of 51 to 54, wherein the sensor is a temperature sensor, the sample holder is configured for use in a PCR assay, and the sample holder RFID tag is configured to record the temperature of the sample holder within one or more thermal cycles during the PCR assay.

[0252] 56. The bioanalysis system according to any one of 36 to 55, wherein the at least one RFID reader comprises a first RFID reader configured to receive the RFID data from the first RFID antenna and a second RFID reader configured to receive the RFID data from the second RFID antenna.

[0253] 57. The bioanalysis system of any one of claims 36 to 56, wherein the system is configured such that during use, when the sample holder is received by the sample block, only one of the RFID antennas is capable of receiving the RFID data.

[0254] 58. The bioanalysis system according to any one of 36 to 57, further comprising a processor and a memory connected to the processor.

[0255] 59. The bioanalysis system of claim 58, wherein the memory comprises instructions for performing the following operations:

[0256] verifying whether at least one of the first RFID antenna or the second RFID antenna is receiving RFID data or signals;

[0257] Do at least one of the following:

[0258] If neither the first RFID antenna nor the second RFID antenna receives RFID data or signals, generating (1) a signal indicating that the sample holder does not contain an RFID tag, and / or (2) a signal indicating that no sample holder is present;

[0259] If at least one of the RFID antennas receives RFID data, generating at least one of: (1) a signal indicating that the sample holder contains a sample holder RFID tag, and / or (2) a signal indicating an orientation of the sample holder; and

[0260] If both of the RFID antennas receive RFID data, a signal is generated indicating (1) that the sample holder contains two sample holder RFID tags and / or (2) that two sample holders with sample holder RFID tags are present.

[0261] 60. The bioanalysis system of claim 59, wherein the orientation of the sample holder is based on the strength of the data or signal from the RFID tag.

[0262] 61. The bioanalysis system of any one of 58 to 60, wherein the memory comprises instructions for performing the following operations:

[0263] receiving an initial user input from a user, the initial user input comprising at least one of: (1) an input to load or receive a sample holder into the system; or (2) an input to initiate an assay;

[0264] reading at least some of the RFID data;

[0265] generating an assay protocol based at least in part on the read RFID data;

[0266] Upon receiving the initial user input, (1) executing the assay protocol to perform the assay without any further input or intervention from the user until the assay is completed or (2) modifying the assay protocol based on the additional input and then executing the modified assay protocol to perform the assay without any further input or intervention from the user until the assay is completed.

[0267] 62. The bioanalysis system of claim 61, further comprising a reagent container, the reagent container comprising a reagent container RFID tag, wherein the memory comprises instructions for: reading information from the reagent container RFID tag; and generating the assay protocol based at least in part on the information from the reagent container RFID tag.

[0268] 63. The bioanalysis system of any one of 58 to 62, wherein the memory comprises instructions for:

[0269] Prior to performing an assay, the assay protocol is confirmed or validated using an alternative data source, and if the alternative data source is different from the RFID data, at least one of: modifying the assay protocol; sending an alert; or aborting the assay protocol.

[0270] 64. The bioanalysis system of any one of 58 to 63, wherein the memory comprises one or more of instructions to:

[0271] rewriting at least a portion of the RFID data using the at least one RFID writer;

[0272] encrypting at least a portion of the RFID data using the at least one RFID writer;

[0273] erasing at least a portion of the RFID data using the at least one RFID writer;

[0274] generating a signal indicating completion of an assay or run;

[0275] modify data generated during or after the determination; or

[0276] Analyze data generated during or after the assay is completed.

[0277] 65. A method for performing a biological analysis, comprising:

[0278] A bioanalysis system is provided, comprising:

[0279] case;

[0280] a sample block disposed within the housing and configured to receive a sample holder including a sample holder RFID tag;

[0281] a first RFID antenna configured, during use, to receive RFID data from the sample holder RFID tag; and

[0282] at least one RFID reader configured to receive the RFID data from the first RFID antenna;

[0283] placing a sample holder in or on the bioanalytical system;

[0284] receiving initial user input from a user to initiate an assay;

[0285] reading at least some of the RFID data using the first RFID antenna;

[0286] generating instructions to perform an assay based at least in part on the read RFID data;

[0287] Upon receiving the initial user input, a set of steps are performed to perform the assay on the sample holder without any further input or intervention from the user until the assay is completed, or (2) additional input is received and then a set of steps are performed to perform the assay on the sample holder without further input or intervention from the user until the assay is completed.

[0288] 66. The method according to 65, further comprising:

[0289] providing a reagent container, the reagent container comprising a reagent container RFID tag;

[0290] reading information from the reagent container RFID tag; and

[0291] The assay protocol is generated based at least in part on the information read from the reagent container RFID tag.

[0292] 67. A method for performing a biological analysis, comprising:

[0293] A bioanalysis system is provided, comprising:

[0294] case;

[0295] a sample block, the sample block being disposed in the housing;

[0296] a first RFID antenna;

[0297] a second RFID antenna; and

[0298] at least one RFID reader configured to receive the RFID data from the first RFID antenna and from the second RFID antenna;

[0299] placing a sample holder in or on the sample block, the sample holder possibly including a sample holder RFID tag;

[0300] verifying whether at least one of the first RFID antenna or the second RFID antenna is receiving RFID data or signals from the sample holder;

[0301] Do at least one of the following:

[0302] If neither the first RFID antenna nor the second RFID antenna receives RFID data, generating (1) a signal indicating that the sample holder does not contain an RFID tag, and / or (2) a signal indicating that no sample holder is present;

[0303] If at least one of the RFID antennas receives RFID data, generating at least one of: (1) a signal indicating that the sample holder contains a sample holder RFID tag, and / or (2) a signal indicating an orientation of the sample holder; and

[0304] If both of the RFID antennas receive RFID data, a signal is generated indicating (1) that the sample holder contains two sample holder RFID tags and / or (2) that two sample holders with sample holder RFID tags are present.

[0305] 68. The method of any one of claims 65 to 67, further comprising:

[0306] receiving an initial user input from a user, the initial user input comprising at least one of: (1) an input to load or receive a sample holder into the system; or (2) an input to initiate an assay;

[0307] reading at least some of the RFID data;

[0308] Generate a measurement protocol based on the read RFID data;

[0309] Upon receiving the initial user input, (1) executing the assay protocol to perform the assay without any further input or intervention from the user until the assay is completed or (2) modifying the assay protocol based on the additional input and then executing the modified assay protocol to perform the assay without any further input or intervention from the user until the assay is completed.

[0310] 69. The method of any one of claims 65 to 68, further comprising:

[0311] Prior to performing an assay, the assay protocol is confirmed or validated using an alternative data source, and if the alternative data source is different from the RFID data, at least one of: modifying the assay protocol; sending an alert; or aborting the assay protocol.

[0312] 70. The method of any one of claims 65 to 69, further comprising:

[0313] rewriting at least a portion of the RFID data using the at least one RFID writer;

[0314] encrypting at least a portion of the RFID data using the at least one RFID writer;

[0315] erasing at least a portion of the RFID data using the at least one RFID writer;

[0316] generating a signal indicating completion of an assay or run;

[0317] modify data generated during or after the determination; or

[0318] Analyze data generated during or after the assay is completed.

[0319] 71. The method of any one of 65 to 70, writing information generated during a first assay on the sample holder RFID tag, and optionally using the written information to analyze data obtained during the first assay.

[0320] 72. The method according to any one of 65 to 71, wherein the first assay is a PCR assay.

[0321] 73. The method of claim 72, wherein the sample holder comprises a temperature sensor, the method further comprising recording the temperature of the sample holder during one or more thermal cycles of the PCR assay.

[0322] 74. A biological analysis system comprising:

[0323] case;

[0324] a sample block disposed within the housing and configured to receive a sample holder including a sample holder RFID tag;

[0325] an RFID antenna configured, during use, to receive RFID data from the sample holder RFID tag;

[0326] an RFID reader configured to receive the RFID data from the first RFID antenna;

[0327] The RFID antenna is spatially separated from the RFID reader.

[0328] 75. The bioanalysis system according to 74, wherein the RFID antenna communicates with the at least one RFID reader via a wire or cable.

[0329] 76. The bioanalysis system according to any one of 74 to 75, wherein the first RFID antenna is disposed proximate to one side of the sample block and the second RFID antenna is disposed proximate to a different side of the sample block.

[0330] 77. The bioanalysis system according to any one of 74 to 76, wherein the first RFID antenna is disposed proximate to one side of the sample block and the second RFID antenna is disposed proximate to an opposite side of the sample block.

[0331] 78. The bioanalysis system according to any one of 74 to 76, wherein the sample block has an uppermost surface, the at least one RFID reader is disposed below the uppermost surface, and the RFID antenna is disposed above the uppermost surface.

[0332] 79. The bioanalysis system of any one of 74 to 77, wherein the memory comprises instructions for:

[0333] Verify that the RFID antenna is receiving RFID data or signals;

[0334] Do at least one of the following:

[0335] If the RFID antenna does not receive the RFID data or signal, generating (1) a signal indicating that the sample holder does not contain an RFID tag and / or (2) a signal indicating that no sample holder is present;

[0336] If the RFID antenna receives the RFID data, generating at least one of: (1) a signal indicating that the sample holder contains a sample holder RFID tag and / or (2) a signal indicating an orientation of the sample holder; or

[0337] If the RFID antenna receives the RFID data, it generates (1) a signal indicating that the sample holder contains two sample holder RFID tags, or (2) a signal indicating that two sample holders with sample holder RFID tags are present.

[0338] 80. The bioanalysis system of claim 79, wherein the orientation of the sample holder is based on the strength of the data or signal from the RFID tag.

[0339] 81. A sample holder for biological analysis, comprising:

[0340] a holder comprising a plurality of spatially separated reaction sites, each of the plurality of spatially separated reaction sites comprising a plurality of characteristics;

[0341] a sample holder RFID tag disposed in or on the sample holder, the sample holder RFID tag comprising RFID data including data of the plurality of characteristics of each of the reaction locations;

[0342] Wherein the RFID data comprises at least 8 kilobytes, at least 64 kilobytes or at least 128 kilobytes.

[0343] 82. The sample holder of 81, wherein the plurality of spatially separated reaction positions comprises at least 96 reaction positions, at least 384 reaction positions, at least 1536 reaction positions, at least 3072 reaction positions, or at least 12,288 reaction positions.

[0344] 83. The sample holder according to any one of 81 to 82, wherein the RFID data on the sample holder RFID comprises one or more of the following:

[0345] Sample holder ID;

[0346] Sample holder expiration date;

[0347] Sample holder part number;

[0348] Sample holder barcode;

[0349] Sample holder batch number;

[0350] Sample holder type;

[0351] Storage temperature and / or storage temperature range;

[0352] Sample concentration – recommended range; Is the E1 pipette support available?

[0353] Sales order number;

[0354] Assay name and / or location on the sample holder;

[0355] Assay ID;

[0356] Proposed agreement or requested agreement;

[0357] Sample name

[0358] Master Mix Name;

[0359] master mix changes;

[0360] Dye name;

[0361] recommended or required filters or filter sets for use on the sample holder during an assay;

[0362] EDT file format and / or EDF file format;

[0363] Internet link or address;

[0364] Passive reference dyes;

[0365] Reaction Volume:

[0366] Target name;

[0367] Dye name;

[0368] Sample name;

[0369] Analysis settings;

[0370] Mark settings;

[0371] Sample type;

[0372] Target type;

[0373] Reagent name;

[0374] An operating protocol, the operating protocol comprising one or more of a heating cover temperature, a reaction volume, a temperature step value, and a temperature level value;

[0375] Slot information for one or more slots, the information including one or more of a target name, a dye name, or a sample name.

[0376] 84. The sample holder of 83, wherein the plate type is characterized by 48 slots, 96 slots, 384 slots, 1536 slots, 3072 slots, or through holes.

[0377] 85. A sample holder according to any one of 83 to 84, wherein the plate type is characterized by having a groove with a volume of 0.1 ml or 0.2 ml.

[0378] 86. A sample holder according to any one of 83 to 85, wherein the RFID data on the sample holder RFID comprises rewritable data, the rewritable data comprising one or more of the following:

[0379] Passive reference dyes;

[0380] Reaction Volume:

[0381] Target name;

[0382] Dye name;

[0383] Sample name;

[0384] Analysis settings;

[0385] Mark settings;

[0386] Sample type;

[0387] Target type;

[0388] Reagent name;

[0389] An operating protocol, the operating protocol comprising one or more of a heating cover temperature, a reaction volume, a temperature step value, and a temperature level value;

[0390] Slot information for one or more slots, the information including one or more of a target name, a dye name, or a sample name.

[0391] 87. A sample holder according to any one of 81 to 86, wherein the sample holder comprises a sensor.

[0392] 88. A sample holder according to 87, wherein the sensor communicates with the sample holder RFID tag.

[0393] 89. A sample holder according to any one of 87 to 88, wherein the sensor comprises one or more of the thermal sensor, accelerometer, vibration sensor, light sensor, light detector.

[0394] 90. A sample holder according to any one of 87 to 89, wherein information from the sensor is written to the sample holder RFID tag at least once during the life of the sample holder.

[0395] 91. A sample holder according to any one of 87 to 90, wherein the sensor is a temperature sensor, the sample holder is configured for use in a PCR assay, and the sample holder RFID tag is configured to record the temperature of the sample holder within one or more thermal cycles during the PCR assay.

[0396] 92. A biological analysis system comprising:

[0397] case;

[0398] a sample block, the sample block being disposed in the housing;

[0399] The sample holder according to any one of 81 to 91, wherein the sample holder is arranged in or on the sample block;

[0400] an RFID antenna configured, during use, to receive RFID data from the sample holder RFID tag;

[0401] An RFID reader is configured to receive the RFID data from the first RFID antenna.

[0402] 93. The bioanalysis system of claim 92, wherein the RFID writer is configured to write assay information generated during an assay onto the sample holder RFID tag, and optionally, the system is configured to use the assay information to analyze data obtained during the assay.

[0403] 94. A biological analysis system comprising:

[0404] case;

[0405] a block assembly comprising a sample block and a base configured to receive the sample block;

[0406] a first drive mechanism configured to produce relative movement between the sample block and the housing along a first axis between a closed position and an open position;

[0407] a lock configured to lock the sample block to the base;

[0408] A processor and a memory, the memory coupled to the processor, the memory comprising instructions for performing the following operations:

[0409] based on a first command, operating the lock to provide a locked position in which the sample block is locked to the tray;

[0410] based on a second command, operating the lock to provide an unlocked position in which the sample block is not locked to the tray;

[0411] The sample block and the base are moved from a closed position to an open position while the lock is in the locked position or the unlocked position.

[0412] 95. The bioanalysis system of claim 79, wherein at least one of the commands is provided by a user of the bioanalysis system.

[0413] 96. A method for biological analysis, comprising:

[0414] A system is provided, the system comprising:

[0415] Sample block;

[0416] a base configured to receive the sample block;

[0417] a heated cover configured to be placed over the sample block;

[0418] a carrier configured to receive the heating cover;

[0419] a processor and a memory coupled to the processor, the memory including instructions for moving the sample block and the base between an open position and a closed position;

[0420] attaching the heating cover to the carrier;

[0421] separating the heating cover from the sample block by lifting the carrier;

[0422] using the drive mechanism, moving the sample block and the base from the closed position to the open position;

[0423] placing the sample plate in the sample block;

[0424] using the drive mechanism, moving the sample block from the open position to the closed position;

[0425] The heated cover is placed onto the sample block by lowering the carrier.

[0426] 97. A method for biological analysis, comprising:

[0427] A system is provided, the system comprising:

[0428] Sample block;

[0429] a base configured to receive the sample block;

[0430] a heated cover configured to be placed over the sample block;

[0431] a carrier configured to engage the heating cover using an engagement device;

[0432] a processor and a memory coupled to the processor, the memory including instructions for moving the sample block and the base between an open position and a closed position;

[0433] separating the carrier from the first heating cover; and

[0434] separating the first heating cover from the carrier by lifting the carrier;

[0435] Using the drive mechanism, moving the first sample block and the first heating cover from a closed position to an open position;

[0436] A second block configuration is provided by replacing at least one of the first sample block or the first heating cover, the first sample block being replaced with a second sample block and the first heating cover being replaced with a second heating cover.

[0437] 98. A method according to 82, wherein the joining device includes one or more clamping arms, and the one or more clamping arms are arranged on opposite sides of the carrier.

[0438] 99. The method according to any one of 82 to 83, further comprising:

[0439] optionally placing a sample plate in the sample block;

[0440] using the drive mechanism, moving the sample block from the open position to the closed position;

[0441] lowering the carrier;

[0442] locking the carrier to the heated cover using the clamp arms;

[0443] Perform qPCR assays;

[0444] The heated cover is retracted from the sample block by lifting the carrier.

[0445] 100. A bioanalytical instrument comprising:

[0446] a proximity sensor configured to determine the presence or distance of a perspective user of the apparatus;

[0447] an activation and / or recognition system, the activation and / or recognition system comprising at least one of a voice activation and / or recognition system or a facial activation and / or recognition system;

[0448] A processor and a memory, the memory coupled to the processor, the memory comprising instructions for performing the following operations:

[0449] querying the activation and / or identification system to produce a first output;

[0450] determining whether the first output satisfies one or more first predetermined criteria;

[0451] querying the proximity sensor to generate a second output;

[0452] determining whether the second output satisfies one or more second predetermined criteria;

[0453] The instrument is started, powered on, or activated if (1) the first output satisfies the one or more first predetermined criteria and (2) the second output satisfies the one or more second predetermined criteria.

[0454] 101. A method for starting, powering on or activating a bioanalytical instrument, comprising:

[0455] querying an activation and / or recognition system to produce a first output, the activation and / or recognition system comprising one or more of a voice activation and / or recognition system or a facial activation and / or recognition system;

[0456] determining whether the first output satisfies one or more first predetermined criteria;

[0457] querying a proximity sensor to generate a second output;

[0458] determining whether the second output satisfies one or more second predetermined criteria;

[0459] The instrument is started, powered on, or activated if (1) the first output satisfies the one or more first predetermined criteria and (2) the second output satisfies the one or more second predetermined criteria.

[0460] 102. A method for starting, powering on or activating a bioanalytical instrument, comprising:

[0461] querying an activation and / or recognition system to produce a first output, the activation and / or recognition system comprising one or more of a voice activation and / or recognition system or a facial activation and / or recognition system;

[0462] determining whether the first output satisfies one or more first predetermined criteria;

[0463] querying a proximity sensor to generate a second output;

[0464] determining whether the second output satisfies one or more second predetermined criteria;

[0465] The instrument is started, powered on, or activated if (1) the first output satisfies the one or more first predetermined criteria and (2) the second output satisfies the one or more second predetermined criteria.

[0466] It will be appreciated by those skilled in the art that many changes and / or modifications may be made to the present disclosure as shown in the specific embodiments without departing from the scope of the present disclosure as broadly described. Therefore, the present embodiments should be considered in all aspects only as illustrative and not restrictive.

Claims

1. A biological analysis system, comprising: a sample block and a base, the sample block configured to hold a biological sample, the base configured to hold the sample block, the sample block comprising a second connector; a first driver coupled to the first connector; a cover configured to cover the sample block, the cover comprising a third connector; a cover carrier configured to hold the cover, the cover carrier comprising a fourth connector; a second driver coupled to the cap carrier; as well as a controller communicatively coupled to the first driver and the second driver, the controller being configured to: engaging the third connector with the fourth connector using the second actuator to engage the cover and / or the sample block with the cover carrier; A first connector connected to the base is driven into engagement with a second connector connected to the sample block using the first actuator, thereby engaging the first connector with the second connector and securing the sample block to the base.

2. The system of claim 1, wherein the connector is an electrical connector configured to provide power and / or communication between the system and the sample block and between the system and the cover.

3. The system according to claim 1 or 2, further comprising: a third driver communicatively coupled to the controller; Wherein the controller is configured to secure the cover to the cover carrier using the third actuator.

4. The system of claim 3, wherein the controller is further configured to: disengaging the cover from the cover carrier using the third actuator; and The third connector is disengaged from the fourth connector by separating the cover carrier from the cover using the third actuator.

5. The system of claim 3, wherein the controller is configured to use the third actuator to disengage the third connector from the fourth connector by moving a linkage from a first position to release the cover from the cover carrier to a second position, thereby separating the third connector from the fourth connector.

6. A biological analysis system comprising: a sample block including a second connector and a base configured to hold the sample block; a heating cover and a cover carrier, the heating cover comprising a third connector, the cover carrier comprising a fourth connector, the cover carrier configured to hold the heating cover; a first drive mechanism coupled to a first connector, the first drive mechanism configured to engage the sample block; a second drive mechanism coupled to the cover carrier, the second drive mechanism configured to engage the heated cover; as well as a controller communicatively coupled to the first drive mechanism and the second drive mechanism, The controller is configured to automatically operate the first driving mechanism based on a first command to drive the first connector connected to the base to engage with the second connector connected to the sample block so as to releasably engage the sample block with the base, and automatically operate the second driving mechanism to combine the third connector with the fourth connector so as to releasably engage the heating cover with the cover carrier.

7. The system of claim 6, wherein the controller is configured to automatically operate the first drive mechanism to disengage the sample block from the base and automatically operate the second drive mechanism to disengage the heated cover from the cover carrier based on a second command.

8. The system of claim 6, further comprising a third drive mechanism and a fourth drive mechanism, and wherein based on the first command, the third drive mechanism is configured to move the base and the sample block to an open position, and the fourth drive mechanism is configured to move the heated cover and the cover carrier to a raised position.

9. The system of claim 7, wherein based on the second command, a third drive mechanism is configured to move the base and the sample block to an open position, and a fourth drive mechanism is configured to move the heated cover and the cover carrier to a lowered position.

10. The system of claim 9, wherein the heated cover is disposed on top of the sample block between a closed position and the open position.

11. The system of claim 10, further comprising at least one sensor configured to determine the presence of the heating cover on top of the sample block.

12. The system of claim 8, further comprising at least one first locking member connected to the sample block and at least one second locking member connected to the base, and wherein the first locking member and the second locking member are configured to engage with each other to secure the sample block in position when the sample block is engaged with the base.

13. The system of claim 8, further comprising a plurality of alignment pins configured to align the cover carrier with the sample block in a closed position.

14. The system of claim 6, further comprising an optical assembly and a retractable bellows, wherein the bellows is disposed between the optical assembly and the cover carrier.

15. The system of claim 9, wherein: The sample block includes a top surface, the top surface including a two-dimensional array of reaction zones, the array defining a periphery at the top surface surrounding the reaction zones, the periphery including a pair of relatively long sides having a first length and a pair of relatively short sides having a second length shorter than the first length; The sample block includes a pair of ejection members adjacent to and substantially parallel to respective ones of the long sides; The sample block is configured to receive a sample holder; The ejection member is configured to at least partially raise the sample holder relative to the sample block when the sample block is in the open position.

16. The system of claim 15, further comprising an RFID reader configured to read a sample holder RFID tag attached to the sample holder.

17. The system of claim 15, further comprising a detector configured to detect the presence of the sample holder on the sample block.

18. The system of claim 15, further comprising a double-lip seal attached to a lower surface of the heating cover, wherein in use, the double-lip seal is configured to contact the sample block and sealingly surround the sample holder.

19. The system of claim 7, wherein the first command comprises an installation command to install the sample block and the heated cover, and the second command comprises a removal command to remove the sample block and the heated cover.

20. The system of claim 7, wherein the first command or the second command comprises one of a touch input, a keyboard input, a voice command, or a gesture.

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