Instruments, devices and consumables for use in workflow of smart molecular analysis system

Abstract

To provide a system for performing a molecular analysis workflow.SOLUTION: The system includes: a reaction holder or a reaction substrate, such as a multi-well reaction plate, a reaction holder / substrate RFID tag, and / or a reagent container with a reagent container RFID tag; and an instrument and / or device that includes an RFID reader / writer operable to read information from and / or write information to the reaction holder / substrate RFID tag and / or the reagent container RFID tag. The reaction holder / substrate RFID tag and the reagent container RFID tag can be utilized separately or together to send and receive and store information, e.g., for a workflow of a molecular analysis, such as a polymerase chain reaction (PCR).SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to instruments, devices and consumables for use in the workflow of smart molecular analytical systems. (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 62 / 624,080, filed Jan. 30, 2018. The entire contents of the above-referenced application are incorporated herein by reference. [Background technology]

[0002] Molecular analysis can be a time-consuming and error-prone task. Users may spend hours planning and defining an experiment, determining the assays, reagents, equipment, and protocols that need to be used. Additional barriers are presented by the need to ensure that reagents are functional (e.g., not expired) and are used in the correct protocol. A variety of molecular analyses can be utilized to evaluate biomolecules. One type of analysis involves performing nucleic acid amplification and / or nucleic acid detection. One type of nucleic acid amplification involves quantitative polymerase chain reaction (qPCR) to identify and quantify the presence of targets within a sample, typically in real time. These analyses utilize materials or items, also known as consumables, such as reaction plates and reagents, that interact in complex ways in the analytical workflow. In some cases, consumables are not stored correctly, may deteriorate, and may be problematic for use in the analysis.

[0003] Molecular analysis typically involves many manual steps of transfer of liquids, reagents, and / or samples onto specific reaction sites of a reaction substrate or reaction holder, such as a reaction chamber, channel, card, array, conduit, slide, plate, etc. Each step may require calculating and measuring the correct volume and / or concentration of the liquid, reagent, and / or sample being used before transferring to the correct reaction site, which is typically, but not necessarily, a defined area, location, or field located in or on the reaction substrate or reaction holder. Manually measuring and transferring to multiple reaction sites may increase the likelihood of analytical errors, which may result in difficult to interpret results. Additionally, scheduling the use of equipment used in an analysis may be difficult, as various users compete for the same equipment and / or one or more users manage the equipment from a remote location. Summary of the Invention [Problem to be solved by the invention]

[0004] Thus, a need exists to facilitate the tracking and use of instruments and consumables used in molecular analysis, and to improve the overall ease of use, flexibility, and reliability of the molecular analysis workflow. [Means for solving the problem]

[0005] The present invention is directed to a system for performing molecular analysis. The molecular analysis can involve a workflow for polymerase chain reaction (PCR). For example, a workflow for PCR molecular analysis can include quantitative PCR (qPCR), end-point PCR (epPCR), reverse transcription-PCR (RT-PCR), or proximity ligation assay (PLA) with PCR. The system disclosed herein can include smart consumables. The smart consumables can include, for example, one or more smart reaction substrates or reaction holders (e.g., reaction plates or reaction arrays), and / or one or more smart reagent containers. The smart consumables can be smart reagent holders, such as reaction plates or reaction arrays, and / or smart reagent containers. Each of the smart reaction substrates or reaction holders can include a reaction substrate or reaction holder RFID tag. Similarly, each of the reagent containers can include a reagent container RFID tag. Working together or separately, the reaction substrate or reaction holder RFID tag(s) and the reagent container RFID tag(s) can accumulate and share various data or information. The reaction substrate or reaction holder RFID tag(s) and the reagent container RFID tag(s) can transmit and / or receive information. RFID tag readers can read information stored on RFID tags. RFID writers can write (or rewrite) information to RFID tags.

[0006] The reaction substrate or reaction holder may include at least one reaction field. Alternatively, the reaction substrate or reaction holder may include multiple reaction fields. One or more reaction fields of the reaction substrate or reaction holder may include a first reagent. In some cases, the first reagent of each reaction field of the reaction substrate or reaction holder is the same. In some other cases, the first reagent of each reaction field of the reaction substrate or reaction holder is different. Some (e.g., one or more) or all of the multiple reaction fields of the reaction substrate or reaction holder may include the first reagent. In some cases, some portions of the multiple reaction fields may be left blank or empty. The first reagent of the reaction fields of the reaction substrate or reaction holder may be pre-spotted onto the reaction substrate or reaction holder. The first reagent may be dry spotted onto the reaction substrate or reaction holder.

[0007] If one or more reaction sites of the reaction substrate or reaction holder include a first reagent, the reaction substrate or reaction holder RFID tag can include an identifier of each reaction site and the corresponding first reagent contained by each reaction site. In some cases, the first reagent includes at least one primer and / or at least one probe. The at least one primer and / or at least one probe in the first reagent of each reaction site can be the same or different. Thus, one or more reagent containers can include a second reagent, a third reagent, a fourth reagent, etc., that are added to the first reagent of the reaction substrate or reaction holder. The reaction substrate or reaction holder RFID tag can encode or store data regarding the characteristics of the first reagent and / or a reagent container RFID tag that encodes data regarding the characteristics of the second reagent. For example, the reaction substrate or reaction holder RFID tag can store an expiration date of the first reagent and / or a reagent container RFID tag can store an expiration date of the second reagent, a third reagent, a fourth reagent, etc., contained by the reagent container(s).

[0008] The reaction substrate or reaction holder and / or reagent container of the system may also include sensors for detecting changes in temperature, motion, light, and / or airflow. The sensors may be coupled to the reaction substrate or reaction holder RFID tag and / or the reagent container RFID tag. In this way, the reaction plate RFID tag and / or the reagent container RFID tag may accumulate temperature history, light exposure history, and / or motion detection history for the reaction plate and / or the reagent container, respectively, through coupling to one or more sensors. In some cases, the RFID tag itself may include one or more sensors. In other cases, the sensors are spatially separated from the RFID tag. The reaction substrate or reaction holder RFID tag and / or the reagent container RFID tag may also include a barcode or be coupled (directly or indirectly) to a barcode.

[0009] The system may further include a smart instrument and / or a smart device. The smart instrument or smart device may include logic operable to provide visual and / or verbal guides for molecular analysis based on workflow information received from the reaction substrate or reaction holder RFID tag and / or the reagent container RFID tag. The instrument / device may include an RFID reader operable to read workflow information from the reaction plate RFID tag and / or the reagent container RFID tag. The instrument / device may include logic operable to access a network server system and / or a cloud to download a workflow for molecular analysis. For example, the workflow may include an analysis protocol for the reaction substrate or reaction holder and / or the reagent container. The analysis protocol may include instructions for the transfer of liquids, reagents, or samples to the reaction substrate or reaction holder. Similarly, the instrument / device may include an RFID writer and logic operable on the RFID writer to record on the reaction substrate or reaction holder RFID tag a record of the liquid, reagent, or sample transfer to the reaction substrate or reaction holder RFID tag. The record may include a reaction volume for the transfer of liquids, reagents, or samples. Additionally, the instrument may include logic operable on the RFID writer to record the reaction field of the reaction substrate or reaction holder to which the liquid, reagent, or sample transfer is applied. The instrument may also include logic operable on the RFID writer to record the date and / or time the liquid, reagent, or sample transfer is applied to the reaction substrate or reaction holder, logic operable to apply information stored by the reaction substrate or reaction holder RFID tag and / or reagent container RFID tag to provide instructions for mixing a first reagent on the reaction substrate or reaction holder with a second reagent stored by the reagent container, and / or logic operable to read the reaction plate RFID tag for an analysis protocol for a workflow.The instructions may include a reaction field on the reaction plate containing a first reagent and transfer instructions for applying a liquid, another reagent, or sample to the reaction field, and / or a reaction volume of the liquid, other reagent, or sample. The analysis protocol may include liquid, reagent, or sample transfer instructions for applying the reagent to the reaction substrate or reaction holder. The reaction substrate or reaction holder RFID tag may include an identifier of the first reagent included in the reaction field on the reaction substrate or reaction holder. The first reagent included in the reaction field may include at least one primer pair and / or at least one probe. The reaction substrate or reaction holder RFID tag may include an identifier of the next reaction substrate or reaction holder in a workflow for molecular analysis.

[0010] Also provided herein is a method for performing molecular analysis. The method may include reading a reaction substrate or reaction holder RFID tag on a reaction substrate or reaction holder and / or reading a reagent container RFID tag on a reagent container, and applying information read from the reaction substrate or reaction holder RFID tag and / or the reagent container RFID tag to perform a workflow for molecular analysis. The method may also include reading an identifier of a first reagent and a reaction site for the first reagent from the reaction substrate or reaction holder RFID tag, reading an identifier of a second reagent from the reagent container RFID tag, reading a temperature history for the reaction substrate or reaction holder, an exposure history for the reaction substrate or reaction holder, and / or a motion detection history for the reaction substrate or reaction holder from the reaction substrate or reaction holder RFID tag, reading a temperature history for the reagent container, an exposure history for the reagent container, and / or a motion detection history for the reagent container from the reagent container ..., and reading a temperature history for the reagent container, an exposure history for the reagent container, and a motion detection reading an identifier of a corresponding first reagent for storing a reagent container from the reaction substrate or reaction holder RFID tag, reading an expiration date for a second reagent stored by the reagent container from the reagent container RFID tag, reading data regarding characteristics of the reaction substrate or reaction holder from the reaction plate RFID tag, reading data regarding characteristics of the second reagent from the reagent container RFID tag, reading information for a workflow from the reaction substrate or reaction holder RFID tag, and / or the reagent container RFID tag, and providing a visual and / or verbal guide for the workflow based on the information.

[0011] The method may involve downloading a workflow for molecular analysis from a network server system, the workflow including an analysis protocol for a reaction substrate or reaction holder. The analysis protocol may include instructions for liquid reagents and / or sample transfer of one or more reagents to the reaction substrate or reaction holder. The method may involve operating an RFID writer to record on the reaction substrate or reaction holder RFID tag a record of the liquid, reagent, and / or sample transfer to the reaction substrate or reaction holder. The record may include reaction volumes of the liquid, reagent, or sample transfer.

[0012] The method may include operating an RFID writer to record an identifier of a reaction field on a reaction substrate or reaction holder to which a liquid reagent and / or sample transfer is applied, and operating the RFID writer to record a date and / or time that the liquid, reagent, and / or sample transfer is applied to the reaction substrate or reaction holder. The method may involve applying information stored by a reaction substrate or reaction holder RFID tag and / or a reagent container RFID tag to provide instructions for mixing a first reagent and a second reagent in a workflow for molecular analysis. The instructions may include a reaction field on the reaction substrate or reaction holder containing a first reagent, and instructions for a liquid reagent, and / or a sample transfer of a second reagent to the reaction field and / or a reaction volume of the second reagent.

[0013] The method may include reading the reaction substrate or reaction holder RFID tag for an analysis protocol for the workflow. The analysis protocol may include, for example, instructions for one or more reagent liquid, reagent, or sample transfer to the reaction substrate or reaction holder. In some methods, reading may be performed from the reaction substrate or reaction holder RFID tag and / or reagent container RFID tag for an identifier of a reagent included in the reaction field on the reaction container or reaction holder, for an identifier of at least one primer pair, for an identifier of at least one probe, for an identifier of the next reaction substrate or reaction holder in the workflow for the molecular analysis, and / or a reagent container. In some methods, writing may be performed to the reaction substrate or reaction holder RFID tag and / or reagent container RFID tag to write information regarding the molecular analysis to the reaction plate, the reagent container, the first reagent, the second reagent, and / or the reaction substrate or reaction holder RFID tag and / or the reagent container RFID tag.

[0014] Also provided herein is a smart consumable for performing a molecular analysis workflow. The smart consumable may include at least one of a reaction substrate or reaction holder including a reaction holder RFID tag, the reaction holder RFID tag transmits and receives and / or stores information related to a workflow for molecular analysis, and / or a reagent container including a reagent container RFID tag, the reagent container RFID tag transmits and receives and / or stores information related to a workflow for molecular analysis. The reaction substrate or reaction holder may include a plurality of reaction sites, the plurality of one or more reaction sites including a first reagent, the first reagent being the same or different in different reaction sites on the same reaction substrate or reaction holder. The plurality of reaction sites may include at least 96 reaction sites, at least 384 reaction sites, at least 1536 reaction sites, at least 3072 reaction sites, or at least 12,288 reaction sites. The reaction substrate or reaction holder RFID tag may include an identifier for each reaction site and a corresponding first reagent for each reaction site.

[0015] In some cases, the first reagent is dry spotted. In some cases, the first reagent is pre-spotted. As used herein, "pre-spotted" refers to a reaction substrate or reaction holder containing a first reagent that has been added (or pre-loaded) to the reaction substrate or reaction holder by the manufacturer of the reaction substrate or reaction holder, and is not added directly to the reaction substrate or reaction holder by the user. A pre-spotted reaction substrate or reaction holder can also be considered ready to use. As used herein, "ready to use" means that a limited number of additional reagents need to be added to the first reagent for the reaction to occur, or that water or buffer, and / or the test sample need to be added to the first reagent for the reaction to occur.

[0016] The reaction substrate or reaction holder RFID tag can store data regarding the characteristics of the reaction substrate or reaction holder, and / or the reagent container RFID tag can store data regarding the characteristics of the reagent in the reagent container. The reaction substrate or reaction holder RFID tag and / or the reagent container RFID tag can store information to provide a visual or verbal guide for the workflow. The reaction substrate or reaction holder RFID tag can store a record of the reagent that has been applied to the reaction substrate or reaction holder. The record can include a reaction volume of the reagent that has been applied to the reaction substrate or reaction holder, an identifier of the reaction field of the reaction substrate or reaction holder to which the reagent is being applied, a date and / or time that the reagent is being applied to the reaction substrate or reaction holder, and / or an interaction between a first reagent and a second reagent in a workflow for molecular analysis. The interaction can include a separate reaction field on the reaction substrate or reaction holder that contains the first reagent, and instructions for the transfer of the second reagent to the separate reaction field. The instructions for the transfer of the second reagent can include instructions for liquid transfer and can include the reaction volume of the second reagent. The reaction substrate or reaction holder RFID tag and / or the reagent container RFID tag can store an analysis protocol for a molecular analysis workflow. The analysis protocol can include instructions for liquid transfer of one or more reagents to the reaction substrate or reaction holder. The reaction substrate or reaction holder RFID tag can store an identifier of a reagent contained in a reaction field on the reaction substrate or reaction holder. The reagent contained in the reaction field can include at least one primer pair and / or at least one probe. The reaction substrate or reaction holder RFID tag and / or the reagent container RFID tag can store an identifier of a next reaction substrate or reaction holder and / or a reagent container being used in the workflow for molecular analysis.

[0017] The reaction substrate or reaction holder may further include a temperature sensor, a light sensor, and / or a motion sensor coupled to the reaction substrate or reaction holder RFID tag, which accumulates a temperature history, an exposure history, and a motion detection history for the reaction substrate or reaction holder. The reagent container may further include a temperature sensor, a light sensor, and / or a motion sensor coupled to the reagent container RFID tag, which accumulates a temperature history, an exposure history, and a motion detection history for the reagent container. In some cases, the reaction substrate or reaction holder and / or the reagent container further include a bar code. The temperature sensor, the light sensor, and / or the motion sensor may be directly or indirectly coupled to the reaction substrate or reaction holder RFID tag and / or the reagent container RFID tag.

[0018] The data regarding the characteristics of the reaction substrate or reaction holder and / or reagent container can include one or more of ID number, expiration date, part number, bar code, lot number, part type, accumulation temperature and / or accumulation temperature range, reagent concentration, recommended reagent concentration and / or volume for use in the workflow, rules for liquid transfer support, order number, reagent name, assay name, assay location for the reagent used on the reaction holder, assay ID, recommended or required protocol for molecular analysis, sample name, master mix name, internet link or address (url), reaction and / or reagent volume, test sample name, analysis settings for molecular analysis, sample type, molecular analysis type, and instrument run protocol. The data regarding the characteristics of the reaction substrate or reaction holder and / or reagent container can be written and / or rewritten to the reaction substrate or reaction holder RFID tag and / or reagent container RFID tag. The reaction substrate or reaction holder RFID tag, and / or the reagent container RFID tag may have a capacity to store at least 8 kilobytes of information.

[0019] To easily identify the description of a particular element or act, the most significant digit(s) in a reference number refers to the figure number in which that element is first introduced. [Brief description of the drawings]

[0020] [Figure 1] 1 illustrates a system 100 according to one embodiment. [Diagram 2] 2 illustrates a molecular analysis routine 200 according to one embodiment. [Diagram 3] 3 illustrates another routine 300 for performing molecular analysis according to one embodiment. [Figure 4] 4 illustrates a user interface 400 according to one embodiment. [Diagram 5] 5 illustrates a user interface 500 according to one embodiment. [Figure 6] 6 illustrates a user interface 600 according to one embodiment. [Figure 7] 7 illustrates a user interface 700 according to one embodiment. [Figure 8] 8 illustrates a user interface 800 according to one embodiment. [Figure 9] 9 illustrates a user interface 900 according to one embodiment. [Figure 10] 7 illustrates a user interface 700 according to one embodiment. [Figure 11] 11 illustrates a user interface 1100 according to one embodiment. [Figure 12] A user interface 1100 is further illustrated according to one embodiment. [Figure 13] 13 illustrates a user interface 1300 according to one embodiment. [Figure 14] 14 illustrates a user interface 1400 according to one embodiment. [Figure 15] 15 illustrates a user interface 1500 according to one embodiment. [Figure 16]1 illustrates an RFID tagged, multi-well reaction plate according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] Disclosed herein is a "smart" system that provides a connected workflow for performing molecular analysis. In one embodiment, the molecular analysis is a polymerase chain reaction (PCR) workflow. In yet other embodiments, the molecular analysis is a real-time or quantitative PCR (qPCR), end-point PCR (epPCR), proximity ligation assay with PCR (PLA), or reverse transcriptase-PCR (RT-PCR) workflow. In some embodiments, the PCR is singleplex PCR. In some embodiments, the PCR is multiplex PCR.

[0022] A smart system for molecular analysis as disclosed herein may be utilized according to various embodiments, including, but not limited to, the use of a smart instrument and various smart consumables. In some embodiments, the smart instrument is an instrument used for polymerase chain reaction (PCR). In some embodiments, the smart consumables are reaction substrates or reaction holders and / or reaction reagents used for PCR. Thus, in some embodiments, the molecular analysis system includes a smart PCR instrument, on which embodiments of the present teachings may be implemented or used, including various smart consumables. In some embodiments, the PCR instrument optionally includes a heated cover that is disposed over multiple reactions or samples contained in a smart reaction substrate or reaction holder ("reaction substrate / holder"). In some embodiments, one or more reagents associated with the smart instrument may be included in one or more smart reagent containers. In some embodiments, one or more reagents disposed on or in a reaction substrate or reaction holder may be included in one or more smart reagent containers.

[0023] As disclosed herein, the system includes one or more reaction substrates or one or more reaction holders, e.g., reaction arrays, reaction slides, or reaction plates, that are "smart" or have automatic identification and data capture (AIDC) capabilities (are "AIDC-enabled"). In some embodiments, the system also includes one or more "smart" reagent container(s) (e.g., conduits, bottles, tubes, vials, wells, or chambers) that include AIDC capabilities. In some embodiments, the system also includes one or more "smart" instruments or devices (e.g., scanners, displays, or thermocyclers) that include AIDC capabilities.

[0024] As used herein, "smart" refers to equipment, devices, materials or items, components, and / or parts that are connected to other equipment, devices, materials or items, components, and / or parts as part of a larger network and / or network cloud. Typically, smart equipment, devices, materials or items, components, and / or parts can operate interactively and autonomously to some degree, for example, can connect to other smart equipment, devices, materials or items, components, and / or parts through different wireless protocols or data transmissions, such as Bluetooth, NFC, Wi-Fi, LiFi, 3G, etc. As used herein, "network cloud," "cloud," or "the cloud" refers to the private, public, or semi-public space that exists between the endpoints of data transmission. Generally, transmitted data enters the network cloud from one endpoint using a standard protocol and shares the space in the network cloud with other data communications. Often, data can exit the network cloud, be encapsulated there, transformed, and transported in a myriad of ways in the same form as it entered the network cloud.

[0025] In some embodiments, the AIDC method used in either or both of the smart reaction substrate / holder and / or the smart reagent container is a smart label. In some embodiments, the AIDC method used in either or both of the reaction substrate / holder and / or the reagent container is a radio frequency identification (RFID) tag. Thus, in some embodiments, the system includes a reaction substrate / holder that includes a smart label or RFID tag, and / or a reagent container that includes a reagent container smart label or RFID tag. In some embodiments, when the system includes both a reaction substrate / holder, such as a reaction plate that includes a reaction substrate / holder smart label or RFID tag, and one or more reagent container(s) that include a reagent container smart label or RFID tag, the reaction substrate / holder smart label / RFID tag, and the reagent container(s) smart label / RFID tag(s) together or collectively can accumulate and share information about the molecular analysis system. For example, system information can be accumulated or shared about the samples, reagents, assays, users, and / or workflows used for a particular molecular analysis, such as a qPCR molecular analysis.

[0026] As used herein, "RFID tag" or "tag" refers to a component, such as a chip, that stores digital data and / or information. In some embodiments, the tag includes an integrated circuit and an antenna, and a protective material that holds the components together and protects them from various environmental conditions. The protective material can depend on the application, and the RFID tag can be of various shapes and sizes. The integrated circuit can store data that can be communicated (e.g., transmitted or received) by radio frequencies transmitted by an antenna. The integrated circuit and antenna circuit can be printed on the chip. The RFID tag can be read by an RFID reader using an antenna that emits radio frequencies to interrogate the RFID tag. In some embodiments, the RFID tag is a "passive RFID tag" that does not have its own energy source, but responds to a signal from a reader to transmit a signal. In other embodiments, the RFID tag is an "active RFID tag" that includes its own power source, such as a battery. A "writeable RFID tag" is an RFID tag that has memory space that can be written by an RFID writer. "Smart labels" are similar to RFID tags and can incorporate both RFID and barcode technology. In some embodiments, smart labels are made of adhesive labels embedded with RFID tags and can include barcodes and / or other information. Some examples of RFID tags can be found in 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 their disclosure of RFID tags, chips, labels or devices, RFID readers, and RFID systems, their design and use.

[0027] In some embodiments, the reaction substrate or reaction holder disclosed herein includes, but is not limited to, a chamber, a channel, a card, an array, a conduit, a slide, or a plate. In various embodiments, the reaction substrate or reaction holder can be a reaction substrate / holder with multiple reaction sites. Some examples of reaction substrates or reaction holders with multiple reaction sites can include, but are not limited to, multi-well plates, such as standard microtiter 96-well, 384-well plates, or microcards, or substantially planar supports, such as slides, open arrays, or arrays. In some embodiments, the reaction substrate or reaction holder can be made of glass or plastic, or any other suitable material apparent to those skilled in the art. The reaction sites can include depressions, indentations, ridges, and combinations thereof, patterned in regular or irregular arrangements, formed on the surface of the reaction substrate or reaction holder in various embodiments of the reaction substrate or reaction holder.

[0028] In various embodiments, one or more of the reagent containers disclosed herein may include, but are not limited to, a conduit, a bottle, a tube, a vial, a well, or a chamber, or any combination thereof. In some embodiments, the reagent container(s) may be made of glass or plastic, or any other suitable material apparent to one of ordinary skill in the art. The reagent container(s) may be of any size or dimension, and may vary from one reagent container to another within the same system.

[0029] In some embodiments, the AIDC-compatible reaction substrate or reaction holder as disclosed herein is a reaction plate or reaction array. In some embodiments, the AIDC-compatible reaction plate is an RFID-tagged plate, or the AIDC-compatible reaction array is an RFID-tagged array. In various embodiments, the reaction plate or reaction array typically includes multiple reaction sites, such as through holes or wells (e.g., "multi-well reaction plate"). Multiple reaction sites can include, for example, two or more reaction sites. For example, a reaction plate can have multiple reaction sites of 2, 10, 50, 100, 250, 500, 1000, 1500, or 3000, 10,000, 15,000, or more (or any number in between). In some preferred embodiments, a rectangular reaction plate or reaction array (e.g., 2×3 configuration) may have 6, 12, 24, 32, 48, 96, 384, 1536, 3072, or 12,288 reaction sites, although other configurations are contemplated by this disclosure and will be apparent to one of skill in the art. In some embodiments, the multi-well reaction plate is a 96-well plate or a 384-well plate. In some embodiments, the reaction plate is a polyethylene, polypropylene, or polycarbonate multi-well plate. In some embodiments, the reaction plate is a MicroAmp™ plate or a MicroAmp™ Endura™ plate. In some embodiments, the reaction plate or reaction array is characterized by wells or holes with a volume capacity of 0.01 microliters (μL) / well or hole to 500 μL / well or hole. In some embodiments, the volume capacity of the wells or holes can be 0.01 μl or more. In some embodiments, the volume capacity of the wells or holes is between 0.5 μL and 1 milliliter (mL). In some embodiments, the size of the wells or holes is characterized as having a reaction volume of 0.001 mL, 0.02 mL, 0.03 mL, 0.1 mL, or 0.2 mL.

[0030] In some embodiments, some or all of the reaction fields of a reaction substrate or reaction holder, such as a multi-well reaction plate, may include a first reagent. In some embodiments, the reaction plate is pre-spotted (and, optionally, made ready to use) with the first reagent. The first reagent in each reaction field or well that includes the first reagent may be the same, or the first reagent may (and often does) vary across different reaction fields. As used herein, "first reagent" refers to one or more reagents, which may be the same or different reagents from one reaction field to the next, such as on a reaction plate. In some embodiments, the first reagent includes a single reagent, such as a sample, buffer, primer, probe, enzyme, or dideoxynucleotide (dNTP), for use in molecular analysis, such as qPCR. In some other embodiments, the first reagent may include any combination of reagents, such as, but not limited to, a sample, buffer, primer, probe, enzyme, and / or dNTP. In some embodiments, the first reagent may include a combination of reagents, which may constitute a master mix or storage mix, for use in molecular analysis, such as qPCR. Thus, in some embodiments, a first reagent in one reaction area can be a combination of reagents that is the same as or a different combination of reagents as a first reagent in another reaction area within the same multiwell plate.

[0031] In some embodiments of the disclosed systems, there may also be one or more AIDC-compatible reagent container(s) used in addition to or separate from an AIDC-compatible reaction substrate or reaction holder (e.g., a reaction plate). In some embodiments, the reagent containers may be used in place of or in lieu of a reaction plate. In some embodiments, the reagent containers may be used in combination with a reaction plate. In some embodiments where the reagent containers are used without a reaction plate, the reagent container(s) hold a first reagent, a second reagent, a third reagent, etc. In some embodiments where the reaction containers are used in addition to a reaction plate that includes a first reagent, the reagent container(s) may hold a second reagent, a third reagent, etc. In some other embodiments, the second, third, fourth, etc. reagents are added to at least one of the reaction sites of the reaction plate at one or more specific points in a molecular analysis, e.g., at one or more specific points in a qPCR workflow. As used herein, the terms "second reagent", "third reagent", "fourth reagent", etc. refer in part to any reagent that is added to a first reagent, such as the first reagent on a reaction plate or a first reagent in another reagent container, and the analysis does not necessarily have to be in a particular order, and each of the "first reagent", "second reagent", "third reagent", "fourth reagent", etc. may include the same or different reagents in each of the different reagent containers. In some embodiments, the first, second, third, fourth, etc. reagents may each include a single reagent or a mixture of different reagents, for example in a master mix or storage mix.

[0032] As mentioned above, either or both of the reaction substrate or reaction holder and / or reagent container(s) may be coupled to an automatic identification and data capture (AIDC) technology, such as radio frequency identification (RFID), and may include a smart label and / or an RFID tag. In general, "RFID technology" or "RFID" refers to a technology in which digital data and / or information encoded in an RFID tag or smart label is captured by a reader via radio waves. RFID is similar to a barcode in that data from the tag or label can be captured by a device that reads the data and / or information. However, RFID has several advantages over systems that use barcode asset tracking software. One of the most notable is that RFID data / information can be read without line of sight, whereas barcodes typically need to be at least partially aligned with an optical scanner.

[0033] In some embodiments, the RFID tags or smart labels disclosed herein can transmit and receive information. In some embodiments, such information can be stored in the RFID tag or smart label for subsequent use or recall. In some embodiments, information can be written (or rewritten) to the RFID tag or smart label. In some embodiments of the disclosed systems, the RFID tag or smart label can have a capacity to hold 2 kilobytes (kB) or more of information. In some embodiments, the RFID tag or smart label has a capacity of at least 2 kilobytes, 3 kilobytes, 4 kilobytes, 5 kilobytes, 6 kilobytes, 7 kilobytes, 8 kilobytes, 10 kilobytes, 12 kilobytes, 16 kilobytes, 32 kilobytes, 64 kilobytes, 128 kilobytes, 256 kilobytes, 512 kilobytes (or any number in between). In some embodiments, the RFID tag or smart label has a capacity to hold at least 8 kilobytes of information. In some other embodiments, the RFID tag or smart label has a capacity to hold between 4 and 512 kilobytes of information. In some other embodiments, the RFID tag or smart label has a capacity to hold between 8 and 64 kilobytes of information.

[0034] In some additional embodiments, the reaction substrate or reaction holder and / or reagent container(s) disclosed herein may further include a temperature sensor, a light sensor, and / or a motion sensor coupled to the reaction substrate or reaction holder and / or reagent container(s). In some embodiments, the temperature sensor, light sensor, and / or motion sensor may be part of a smart label or RFID tag, for example, the reaction substrate or reaction holder RFID tag and / or reagent container RFID tag reads and stores the temperature, light, and / or motion history of the reaction substrate or reaction holder and / or reagent container obtained from the temperature sensor, light sensor, and / or motion sensor coupled to the reaction substrate or reaction holder and / or reagent container. In some embodiments, a temperature sensor coupled to the reaction substrate or reaction holder and / or reagent container, either as a separate component or as part of an RFID tag on the reaction substrate or reaction holder and / or reagent container, senses or stores the temperature exposure history for the reaction substrate or reaction holder and / or reagent container. In some embodiments, an optical sensor coupled to the reaction substrate or reaction holder, and / or reagent container, either as a separate component or as part of an RFID tag, senses or stores an exposure history for the reaction substrate or reaction holder, and / or reagent container. In some embodiments, a motion sensor coupled to the reaction substrate or reaction holder, and / or reagent container, either as a separate component or as part of an RFID tag on the reaction substrate or reaction holder, and / or reagent container, senses or stores a motion or shock exposure history for the reaction substrate or reaction holder, and / or reagent container.

[0035] In some embodiments, each reaction field of the reaction substrate or reaction holder may include a first reagent deposited on the reaction substrate / holder, and the reaction substrate / holder RFID tag may include an identifier for each reaction field on the reaction substrate / holder and the corresponding reagent, sample, or assay contained by each reaction field. The reagents disposed in each reaction field may include at least one assay including at least one primer and at least one probe. In some embodiments, the reagents are dry spotted (i.e., dried) onto the reaction field of the reaction substrate / holder. In some embodiments, the reagents are lyophilized. The reaction substrate or reaction holder RFID tag, and / or the reagent container(s) RFID tag(s) may also store expiration dates of the first, second, third, etc. reagent(s) disposed or stored in or on the reaction, the substrate or reaction holder, and / or the reagent container(s), as described in more detail below, and other information regarding the reagent(s), workflow, and / or analysis. For example, in some embodiments, a reaction substrate or reaction holder RFID tag, such as a reaction plate RFID tag, may contain information including, but not limited to, a plate layout defining the assay(s) contained in each well, a recommended protocol to be run for a particular assay or analysis, a recommended dye set to be run for a particular assay or analysis, a plate barcode, a url (a link to a World Wide Web page, www site), a Material Safety Data Sheet (MSDS), a Certificate of Analysis (COA), protocol(s), and other related documentation, and / or a unique ID that can be used for purposes such as sorting or tracking usage. In some embodiments, the RFID tag or smart label may contain some security information, including manufacturer-specific, lab-specific, and / or user-specific information or a digital security lock to encrypt the experimental data as a means to support items that customers may deem sensitive and / or to provide anti-counterfeiting measures.

[0036] In some embodiments, a reaction substrate or reaction holder (e.g., reaction plate) RFID tag may encode data regarding characteristics of a first reagent, and a reagent container RFID tag may encode data regarding characteristics of a second reagent. These characteristics may include, for example, assay information for a molecular analysis, expiration dates for various reagents involved in the molecular analysis, accumulation conditions of the reaction substrate or reaction holder, and / or reagent container (including temperature accumulation, light exposure, motion / shock detection history), part / lot / catalog numbers of the reaction substrate or reaction holder or various reagents, detailed information regarding which assays, samples, or reagents were dispensed into which reaction sites of the reaction substrate or reaction holder, and usage rates or amounts of reagents applied to the reaction substrate(s) or reaction holder(s) or contained in the reagent containers (e.g., based on the volume used per reaction or in each reaction site).

[0037] In some embodiments, an instrument including a smart label or RFID tag reader (i.e., smart-enabled) is used to read workflow information from the smart label or RFID tag of the reaction substrate or reaction holder and / or the smart label(s) or RFID tag(s) of the reagent container(s), and a visual and / or verbal guide of the workflow is provided based on the workflow information received from the label or tag. The smart-enabled instrument may access a network server system to download the workflow of the molecular analysis, including the analysis protocol of the reaction substrate or reaction holder and / or the reagent container, and other useful information, for example, for performing an experimental protocol or data analysis. In some embodiments, the protocol may include instructions for liquid reagent or sample transfer to the reaction substrate or reaction holder. In some embodiments, the instructions are for transferring a second reagent, for example, from a reagent container to a reaction field of the reaction substrate or reaction holder that contains or is pre-loaded with the first reagent. In some other embodiments, the instructions are for liquid transfer of a second, third, fourth, etc. reagent from one or more reagent container(s) to a first, second, third, fourth, etc. reagent in another reagent container. In some cases, the instrument may directly read a reaction substrate or reaction holder, or a smart label or RFID tag on a reagent container to obtain information such as an analytical protocol of a workflow, instead of accessing a network server system for the information.

[0038] In some embodiments, the information stored on the smart label or RFID tag includes information or attributes about the reaction substrate or reaction holder, and / or the reagent(s) themselves. Such information may include, for example, ID numbers, part numbers, lot numbers, vendor names and / or locations, part types (e.g., 96-well plates or 384-well plates, 96-well 0.1 mL reaction volume plates or 96-well 0.2 mL reaction volume plates, etc.), stored temperatures such as recommended temperature ranges, and / or sales order numbers. Any of this information may additionally or alternatively be downloaded from a network based on reaction substrate or reaction holder IDs or reagent IDs read from smart labels or RFID tags on the reaction substrate or reaction holder, and / or reagent containers.

[0039] In some embodiments, the information stored by the smart label or RFID tag may go beyond the characteristics of the reaction substrate or reaction holder, and / or reagents, and may include information such as who ran the reaction substrate or reaction holder, which instrument(s) was used, and possible sources of error in the experiment, the type of instrument on which the reaction substrate or reaction holder was run, the next step(s) in the analytical workflow (e.g., qPCR-CE instrument, etc.), the run protocol, analytical instrument settings, an identifier for the person who designed the experiment, the physical reaction or assay, the assay type (e.g., gene expression, microRNA, etc.), etc. Any of this information may additionally or alternatively be downloaded from a network based on the reaction substrate or reaction holder ID or reagent ID read from the smart label or RFID tag on the reaction substrate or reaction holder, and / or reagent container(s).

[0040] Additional data that may be accumulated by the smart label or RFID tag may include analytical objectives and hypotheses, analytical methodology, results and conclusions, identifiers of analytical materials such as pipettes and protocols for their use, replicates and controls used, templates to use for a particular assay, product recommendations based on new releases / enhancements of the chemistry the user is running or alternative products that may produce better run quality based on what has been observed from the equipment used, related publications, active studies, and post-run quality metrics published by research trials, community networks interested in the same studies, and trend analysis. Any of this information may additionally or alternatively be downloaded from the network based on reaction substrate or reaction holder ID or reagent ID read from smart labels or RFID tags on the reaction substrate or reaction holder, and / or reagent container(s).

[0041] As used herein, the term "lab bench assistant" or "lab assistant" refers to an instrument or device that includes logic to read smart labels and / or RFID tags on reaction substrates or reaction holders and / or reagent container(s) using a smart label or RFID reader. In some embodiments, the lab assistant can visually display and / or verbally communicate information stored on the smart label or RFID tag (or provide such information to an external device, such as a computer system for display or verbal communication). In some embodiments, the lab assistant can write information thereon using a smart label or RFID writer to facilitate and improve workflow for molecular analysis. In some embodiments, the lab assistant can also additionally or alternatively download information from a network and / or transmit information to a network for storage or retrieval from another component or device on the network.

[0042] Thus, as mentioned above, the lab bench assistant may include a smart label or RFID writer to write (record) information to a reaction substrate or reaction holder smart label or RFID tag, and / or a reagent container(s) smart label or RFID tag, including any of the information described above and further herein. For example, one or more liquid, reagent, or sample transfers to a reaction substrate or reaction holder, and / or a reagent container may be recorded, and the record may include information such as the reaction volume of the liquid, reagent, or sample transfer, the reaction site on the reaction substrate or reaction holder, and / or the reagent container to which the liquid, reagent, or sample transfer is applied, the date and / or time the liquid, reagent, or sample transfer is applied to the reaction substrate or reaction holder, and / or the reagent container, and / or by which the liquid, reagent, or sample transfer is applied.

[0043] In some embodiments, the lab assistant may apply information stored by the reaction substrate or reaction holder smart label or RFID tag and the reagent container smart label or RFID tag to provide instructions for mixing a first reagent on the reaction substrate or reaction holder with a second reagent stored by the reagent container(s). The instructions may include identifying the reaction field on the reaction substrate or reaction holder where the first reagent is deposited, and transfer instructions for applying the second reagent to the reaction field, and / or the reaction volume of the second reagent to apply.

[0044] Thus, reaction substrates or reaction holders, like reagent containers, can be "smart." In complex molecular analyses involving multiple reaction substrates or reaction holders, one or more of the reaction substrate or reaction holder smart labels or RFID tags can contain an identifier for the next reaction substrate or reaction holder in the workflow, thereby forming a chain or sequence of reaction substrates or reaction holders and / or reagent containers used in the molecular analysis.

[0045] Similar to the reagent containers, the reaction substrate or reaction holder may include a temperature sensor (either in combination with other sensors or by itself) coupled to the reaction substrate or reaction holder RFID tag, which reads the temperature sensor and accumulates the temperature history of the reaction substrate or reaction holder. The reaction substrate or reaction holder may also include a light sensor (either in combination with other sensors or by itself) coupled to the reaction substrate or reaction holder RFID tag, which reads the light sensor and accumulates the light exposure history of the reaction substrate or reaction holder. The reaction substrate or reaction holder may also include a motion sensor (either in combination with other sensors or by itself) coupled to the reaction substrate or reaction holder RFID tag, which reads the motion sensor and accumulates the motion or shock exposure history of the reaction substrate or reaction holder. In some embodiments, the temperature sensor, light sensor, and / or motion sensor may be separate components located on the reaction substrate or reaction holder, or they may be part of the RFID tag component itself.

[0046] At various points in the molecular analysis workflow, the system provides notifications to the user based on the accumulated smart label or RFID information. The notifications may suggest, for example, that it is time to reorder a particular consumable, such as a reagent added to a reaction plate, and may suggest a particular product code or other instructions for the reagent to order. The notifications, and other information that facilitates the molecular analysis workflow, may be delivered in a conversational interface from the lab instrument, for example, using a chatbot or voice application. Machine learning may be utilized to improve and update information for various analyses, which is then accumulated in the smart labels, RFID tags, and / or network cloud system.

[0047] In one embodiment, referring to FIG. 1, a molecular analysis system 100 optionally includes any one or more of the following components: a display device 102, a network 104, a controlled memory data structure 108, a heuristic engine 118, a reaction plate 116, a reagent container 114, a liquid transfer device 128, an instrument 106, and an instrument controller 120, in any combination and in any order. Of course, additional consumables and instruments may be used, but for the sake of brevity, the set in FIG. 1 is limited to those shown. In some embodiments, the molecular analysis system includes an instrument, a reaction plate, and / or a reagent container. In some embodiments, the molecular analysis system includes an instrument, an instrument controller, a reaction plate, and / or a reagent container. In some embodiments, the molecular analysis system includes an instrument, an instrument controller, a reaction plate, and / or a reagent container, and a display device.

[0048] In some embodiments, the display device 102 displays a user interface 132 to the user 126 that conveys information to the user, for example, about consumables, assays, and protocols utilized in the experiment. The display device 102 may include an RFID reader 124 that reads information stored in the reagent container RFID tag 110 and / or the reaction plate RFID tag 122. After scanning the reagent container RFID tag 110, the display device 102 may display information about the reagent in the reagent container 114, such as name, characteristics, product information, and storage or sensor history information, as well as any of the other information described herein. The display device 102 may also communicate the scanned information from the reagent container RFID tag 110 through the network 104 to retrieve protocol instructions for using the reagent. In some specific embodiments, this information and other information for molecular analysis is stored in a controlled memory data structure 108.

[0049] After reading the reaction plate RFID tag 122, the display device 102 may display information about the reaction plate 116, such as the plate's name, characteristics, assay information, reaction field template information, manufacturing information, and accumulated or sensor history 138, as well as other information described herein. Accumulated information of the reaction plate 116 may be collected through the temperature sensor 140, the light sensor 142, and / or the motion sensor 143, and may be accumulated as sensor history information 138, including light exposure history, temperature history, motion history, and / or other history information (e.g., exposure to air). The display device 102 may also communicate information scanned from the reaction plate RFID tag 122 through the network 104 to retrieve protocol information, assay information, or any other information as disclosed herein. The display device 102 may also communicate aggregate information scanned from the reaction plate RFID tag 122 and information scanned from the reagent container RFID tag 110 through the network 104 to retrieve protocol information, assay information, or any other information as disclosed herein.

[0050] The display device 102 may also receive information from the heuristic engine 118 regarding improvements or suggestions based on scientific literature and past experiments utilizing the scanned reagent and plate combinations. This information may be obtained from the network 104 or from any one or more RFID tags used in the system. The heuristic engine 118 may learn from the analysis results to improve future suggestions.

[0051] The reaction plate 116, e.g., a microtiter plate, may contain 6, 12, 24, 48, 96, 384, or 1536 sample wells or through-holes arranged in a 2:3 rectangular matrix of reaction fields. Each reaction field may act as a conduit for conducting a molecular reaction. During analysis, each field may contain any combination of reagents and / or test samples used to perform a molecular reaction, as well as the use of laboratory equipment to control the kinetics of the reaction and measure the resulting reaction products.

[0052] In some embodiments, the reaction plate 116 includes a reaction plate RFID tag 122 that, in various embodiments, is utilized by the instrument to read any of the information described herein. In some embodiments, this information includes a history 138 for the reaction plate, such as, for example, a temperature history, an exposure history, and / or a motion detection history. The reaction plate 116 may be configured as a pre-spotted plate that includes multiple "assays" (e.g., primers and probes), each assigned to a particular field of the reaction plate. In some embodiments, scanning the reaction plate RFID tag 122 may provide the user with a layout of the assays in the field. The user may also scan the reagent container RFID tag 110 of the reagent container 114 for information about reagents to add to the reaction fields of the reaction plate 116.

[0053] In some embodiments, the probes disclosed herein are hydrolysis probes that utilize the 5' exonuclease activity of certain DNA polymerases, such as Taq, to ​​cleave the labeled probe during PCR. One specific example of a hydrolysis probe is the TaqMan probe. In one embodiment, the disclosed probes are hydrolysis probes that further comprise a reporter dye at the 5' end of the probe and a quencher dye at the 3' end of the probe. During PCR, cleavage of the probe results in the separation of the reporter dye and the quencher dye, and an increase in reporter fluorescence. The accumulation of PCR products can then be directly detected by monitoring the increase in reporter dye fluorescence. When the probe is intact, the reporter fluorescence is suppressed primarily by Forster-type energy transfer due to the proximity of the reporter dye to the quencher dye (Forster, 1948; Lakowicz, 1983). During PCR, if the target of interest is present, the probe specifically anneals between the forward primer field and the reverse primer field. For example, the 5' to 3' nucleolytic activity of Taq DNA polymerase cleaves the probe between the reporter and the quencher only if the probe hybridizes to the target. Such probes are referred to as "TaqMan" probes. In some embodiments of the probes disclosed herein, the 3' end of the probe is blocked to prevent extension of the probe during PCR. Examples of such hydrolysis probes are described in Holland and Gelfand (1991) Proc. Natl. Acad. Sci. USA 88:7376-80, Heid et al. (1996) Genome Methods 6:986-94, U.S. Patent No. 7,205,105, U.S. Patent No. 6,927,024, and U.S. Patent No. 5,210,015, each of which is incorporated herein by reference in its entirety for its disclosure of 5' exonuclease or hydrolysis probes, their design, and use.

[0054] In some additional embodiments, the system may include a single or multiple (e.g., 2, 3, 4, or more) built-in antennas and / or RFID writers and / or RFID readers. In some embodiments, the multiple built-in antennas and / or RFID writers and / or RFID readers are spatially separated. In some embodiments, for example, the multiple built-in antennas and / or RFID writers and / or RFID readers are positioned opposite each other. In some embodiments, the system includes two built-in (e.g., left and right) antennas and / or two (e.g., left and right) RFID readers, each of which may be capable of reading the RFID tag information of the RFID tag attached to the reaction plate. In some embodiments, the multiple antennas and / or multiple RFID readers are used, for example, to pre-confirm the correct orientation of the reaction substrate or reaction holder in the instrument and / or to confirm that the user is performing the correct assay or protocol on a given reaction plate. In some embodiments, the orientation of the reaction plate is determined based on which of the multiple antennas and / or RFID readers receives a signal from the reaction plate RFID tag. In some embodiments, after execution, one or more RFID writers can write information onto the RFID tag to mark the reaction plate as "used," which can prevent the reaction on the reaction plate from being rerun or repeated. In some embodiments, the information can also be transmitted to a remote location, for example, for inventory control and procurement purposes. In some embodiments, the two or more RFID tag readers also allow detection of the orientation of the reaction plate. For example, if a user does not place the reaction plate in the expected or normal orientation, the system software can account for the error for display and analysis purposes and reset the template information and label accordingly, and / or notify the user of the distorted orientation.For example, if a user places a reaction plate on the instrument in an orientation that is 180 degrees off from the orientation in which the user intended to place the plate, the RFID reader can detect the placement and orientation of the plate and notify the user of the potential error. The user can also be provided with the option to rewrite the location of various labels for each of the wells and / or layout templates in the opposite direction, e.g., used to track multiple reaction sites.

[0055] In some embodiments, the reagent container 114 optionally stores a reagent that is identifiable by the reagent container RFID tag 110. The reagent container RFID tag 110 can be utilized to transmit various information to the RFID reader, including, but not limited to, specific information about the reagent (e.g., name, concentration, instructions, available stock, etc.), production of the reagent (e.g., lot number, date of manufacture, etc.), and storage information (e.g., storage temperature, light exposure history, motion history, etc.). The storage information of the reagent container 114 can be collected through the use of the temperature sensor 130, the light sensor 136, and / or the motion sensor 137 and can be stored as sensor history information 134, including light exposure history, temperature history, motion history, and / or other history information (e.g., exposure to air). In some embodiments, an RFID writer can write this information onto the reagent container RFID tag 110 to be read by the RFID reader 124. After the reagent container RFID tag 110 is scanned by the RFID reader 124 , the display device 102 may display or communicate information for the particular reagent, reaction, or assay read from the RFID tag 110 .

[0056] In some embodiments, after the reagent container RFID tag 110 and / or the reaction plate RFID tag 122 are scanned, the display device 102 may retrieve protocol information regarding the specific volumes of reagents that need to be transferred to each well of the reaction plate. The protocol information may be retrieved from information stored in a controlled memory data structure 108 communicated to the display device 102 via the network 104 or from the reaction plate 116 and / or the reagent containers 114 themselves. The protocol information may be used to configure a liquid transfer device 128 (e.g., E1-ClipTip™ Bluetooth™ Electronic Single or Multi-Channel Pipettes) to transfer the reagents into the wells of the reaction plate 116. The protocol information may also be utilized to inform the user of which reaction sites the reagents or samples should be transferred to.

[0057] Reagents stored in the reagent containers 114 may be transferred to the reaction plate 116 through the use of a liquid transfer device 128. The liquid transfer device 128 may be a pipette (e.g., E1-ClipTip™ Bluetooth™ Electronic Single or Multi-Channel Pipettes). The liquid transfer device 128 may be configured to deliver calculated amounts of reagents into predefined reaction fields of the reaction plate 116 according to a protocol for the experiment / investigation displayed through the display device 102. After the liquid transfer has occurred, the display device 102 may receive an indication from a user that the reaction plate 116 is ready to be run on the instrument (e.g., for PCR). The indication provided by the user may signal the display device 102 to communicate details to the control memory data structure 108 stored for the particular reaction plate RFID tag 122. In some configurations, the user may input liquid transfer information 112 about the reaction fields to which the reagents were added as well as any notes regarding the liquid transfer process. In some embodiments, the RFID tag on the reaction plate can be read by one or more RFID tag readers and / or one or more antennas to determine whether the orientation of the plate is correct or whether adjustment is required. In some embodiments, the first RFID tag reader and the second RFID tag reader can search for a signal from the RFID tag on the reaction plate. Depending on which RFID tag reader receives the signal (or receives a stronger signal, e.g., received by multiple RFID readers), the orientation of the reaction plate can then be determined, and if necessary, the reaction field information can be rewritten to the RFID tag and / or the signal sent to the user to indicate that the reaction plate is not correctly positioned (i.e., facing 180 degrees in the wrong direction in the horizontal position).

[0058] In some embodiments, after one or more reagents have been added to the reaction plate 116, the user 126 can schedule a time on the instrument 106 to begin an experiment. In some configurations, the analysis can involve quantitative polymerase chain reaction (qPCR). The user can utilize an RFID reader 146 included within the instrument 106 to scan the reaction plate RFID tag 122 and communicate / receive information for the particular reaction plate RFID tag 122, either from the tag itself or via the network 104. The instrument 106 can utilize the information in the reaction plate RFID tag 122 to set operating parameters. The user can utilize a scheduling tool displayed within the user interface 132 of the display device 102 to set both the time to run the reaction plate 116 on the instrument as well as the particular parameters (e.g., duration, temperature) for running the analysis on the instrument. In some embodiments, after the instrument 106 is scheduled to run the reaction plate 116, the instrument controller 120 can be configured with instructions to operate the instrument 106. For example, when the scheduled time is detected, the instrument controller 120 starts the experiment on the reaction plate 116. The instrument controller 120 may then detect the results of the analysis, communicate the information to a user across the network 104 and / or write them to the reaction plate RFID tag 122. In some embodiments, the results of the analysis may later be analyzed by the heuristic engine 118. In some other embodiments, the information stored in the controlled memory data structure 108 may be communicated to a user group 144 for purposes of analytical collaboration and / or to check progress / resource utilization by users within the lab.

[0059] In some embodiments, a user may access digital information (see above for examples) related to analytical materials such as pre-spotted plates, reagents, etc. from a lab bench assistant (a wet lab or digital touch point located, for example, on a computer system).

[0060] The Lab Bench Assistant may track time capsule / historical information related to an analysis regarding who planned the analysis and prepared the physical plate, which reagents, buffers, assays, etc. were used in the analysis, detailed information about which assays, reagents were used, and which samples were utilized in which reaction field, what type of instrument the plate was run in, as well as the next step(s) in the workflow (examples include qPCR-CE instruments, etc.). Other information available to the Lab Bench Assistant includes who ran the plate on which instrument and tracking down the cause of errors by reviewing all relevant information used in the analysis. This information may be written back to the plate 116 by the Lab Bench Assistant for traceability, or written or recorded to a network server and / or other storage medium.

[0061] Lab Bench Assistant may provide notifications to users for reagents / assays that are on the recall list or require reordering or replacement with improved products. User notifications may be delivered automatically at all stages of Lab Bench Assistant scanning for reagents that are on the recall list or are not available in the reagent's history.

[0062] The Lab Bench Assistant can provide notifications of expiring and already expired reagents. Error rates can be reduced so that expired reagents are not added to plates. The Lab Bench Assistant allows users to easily reorder reagents / assays / plates, with all information such as order numbers, lot numbers, part numbers, etc. readily available and recorded and maintained by the system.

[0063] The Lab Bench Assistant may track reagent usage based on the dose used per reaction field of plates across all runs in the lab, and in so doing may proactively notify users about running out of reagent. In some cases, the Lab Bench Assistant may automatically order reagent from the user(s).

[0064] Lab Bench Assistant may be equipped with machine learning capabilities to reduce reagent wastage. Based on the user's inventory and usage, Lab Bench Assistant may be able to predict when certain consumables will expire. Lab Bench Assistant may provide modified execution plans to the user to optimize usage of reagents on hand. It also looks at inventory used by users from the same organization (location based) as well as the current user, and subsequently optimizes reagent usage and reduces waste from lab to organization.

[0065] When providing a modified execution plan, the Lab Bench Assistant may identify the modified execution plan based not only on the plate layout but also on the optimal instrument type to execute the particular execution protocol.

[0066] The Lab Bench Assistant may provide a workflow to calculate reaction volumes of samples, reagents, buffers, etc. based on the required concentrations and reaction volumes / reaction fields. Once volumes are calculated for each reaction, samples and reagents can be assigned to specific reaction fields, and electronic protocols are provided for use with various consumables, such as those disclosed herein, as well as liquid transfer devices, such as those disclosed herein, such as the E1-ClipTip™ Bluetooth™ Electronic Pipette.

[0067] A lab bench assistant can guide the user through the liquid dispensing steps to avoid errors. Guidance can be enabled by a conversational interface (chatbot / voice, etc.).

[0068] The Lab Bench Assistant may enable smart instruments to automatically create run files. When a "smart" reaction plate is created, its RFID tag may contain information, or links to information, for the reagents, protocols, and assay information for the reaction plate. As the reaction plate moves to each downstream instrument, each instrument records the use of this reaction plate and, whenever applicable, automatically runs the instrument run protocol using information from the reaction plate.

[0069] As described above, information received and / or transmitted by the lab bench assistant may be received and / or transmitted by the instrument 106 and the instrument controller 120. In some embodiments, the instrument 106 and / or the instrument controller 120 and / or the lab assistant collectively share information obtained from the reaction plate RFID tag and / or the reagent container RFID tag. Using a mobile lab assistant, a user can be notified of the reception of information from the reaction plate and / or the reagent container RFID tag even when the user is remote from the instrument 106 and / or the instrument controller 120. Intercommunication between the instrument 106 and / or the instrument controller 120 and / or the lab assistant also allows a user to remotely communicate with the instrument 106 and / or the instrument controller 120, for example, using the lab assistant, and to send user requests or information directly to the instrument 106 and / or the instrument controller 120 related to the instrument execution protocol.

[0070] After the instrument run protocol, the user can generate a publication-ready template that includes the instrument run protocol and the data packet used for the analysis. The data packet can be reused by scientists from inside and outside the organization to reproduce the analysis. The data packet can include the analytical objectives / hypothesis, materials and methods, results / conclusions, run protocol, electronic liquid transfer (e.g., E1-ClipTip™ Bluetooth™ Electronic Pipette) protocol, part numbers of products used, number of replicates and controls used.

[0071] The Lab Bench Assistant may have the ability to provide the user with product recommendations based on new releases / enhancements of the chemistry the user is running, or with alternative products that may produce better run quality based on what is observed from post-run quality metrics exposed by the smart equipment.

[0072] The Lab Bench Assistant may have the ability to provide users with a community network of like-minded researchers with relevant publications, active research and research trials. This information may be stored or written directly to the RFID tags of reaction plates and / or reagent containers, or may be accessed from a network or network cloud.

[0073] The Lab Bench Assistant or an attached computer system may present a dashboard user interface for the analysis. The user may perform trend analysis on the results (e.g., reagent quality control by lot number, operator actions, etc.).

[0074] Using the Lab Bench Assistant, a user can scan a pre-spotted plate and access relevant information for performing an analysis. A user can scan a reagent container and access relevant information for the reagents that are applied to the analysis. After the plate and / or reagents are scanned, the user can assign and replicate samples to multiple reaction sites on the plate. The user can also operate a qPCR reaction calculator, which suggests volumes and concentrations for the reaction mix based on the assay and reagents used in the analysis. The user can then be guided to perform liquid, reagent, or sample transfers to the plate.

[0075] One option for performing liquid, reagent, or sample transfers utilizes the E1-ClipTip™ Bluetooth™ Electronic Pipette. The E1-ClipTip Pipette utilizes digital pipetting protocols with setups for currently designed plates that can be automatically downloaded into the E1-ClipTip Pipette to efficiently transfer liquids, reagents, and samples. Another option is to use a regular pipette where the user is guided with audio and / or visual instructions as to which sample doses go / go into which reaction fields of the reaction plate.

[0076] In some embodiments, after the reaction plate is prepared, the user can schedule the instrument for a run protocol from a location, including a remote location. In some embodiments, the user loads the reaction plate into the instrument and the analysis setup information is automatically downloaded by the instrument based on the information provided by the reaction plate RFID tag. In some embodiments, the required run protocol can be automatically assigned to the reaction plate. Once the run is started, the user can monitor the run results from anywhere and perform quality control in real time as the results are obtained.

[0077] Once a run is finished, the instrument may push the results to a cloud service. Users may access and review the results in the cloud. Users may perform further analysis by changing settings for normalization, performing quality control, etc. Users may collaborate with others through the cloud service.

[0078] The overall system of smart instruments, smart consumables (including smart reaction plates and / or reagent containers), and smart lab bench assistants may facilitate an integrated smart workflow for molecular analysis. The integrated smart workflow may eliminate the need for manual and repetitive input of data elements from consumables, reagents to instruments, thus making the analysis less error-prone. The integrated smart workflow as part of the analytical ecosystem may further include the E1-ClipTip Pipette, an electronic lab notebook (ELN), and / or a digital laboratory information management system (LIMS).

[0079] In some additional embodiments, the instrument or connected network cloud may include algorithms for real-time amplification and prediction of results based on (for example) amplification curves. Early prediction can reduce run time and improve results or repeat analysis. Trained models (e.g., based on machine learning from past analyses) can help detect the amplification process, thus reducing the need for tuning and correction.

[0080] 2, a smart molecular analysis (in this non-limiting example, qPCR) may begin with a user acquiring (202) a smart reagent including, for example, a first reagent (e.g., an assay including one or more probes / primers) and / or a reaction plate pre-spotted with reagents contained in one or more reagent containers. Optionally, the user then operates a lab bench assistant application (204) to design a qPCR analysis plan. In some embodiments, the user then scans (206) one or more multi-well plates to access assay reagents and layout information for the analysis (e.g., which reagents to use in multiple reaction sites, etc.) (208).

[0081] In some embodiments, the user can then scan the reagents (210) to add them to the plate, for example by liquid transfer. In some embodiments, the user then accesses (212) assay protocol information and assigns (214) test samples to the plate.

[0082] Following these steps, the user optionally operates a qPCR reaction calculator (218) to calculate starting volumes, starting concentrations, and reaction mixes of the assay and reagents, and follows instructions for fluid transfer (220). After scanning a smart consumable, such as an RFID tagged plate (206), and before or during other optional steps (e.g., 204, 208, 210, 212, 214, 216, 218, 220), the reaction can be run by the instrument (222) to generate molecular analytical results.

[0083] 3, in block 302, the RFID tag on the reaction plate is read by the instrument and / or lab bench assistant. In block 304, the instrument and / or lab bench assistant reads the reagent container RFID tag on the reagent container. In some embodiments, only the RFID tag on the reaction plate is read (302). In some other embodiments, only the RFID tag(s) on the reagent container(s) are read (304). In still some other embodiments, both the RFID tag on the reaction plate and the RFID tag on the reagent container(s) are read (302 and 304). In block 306, the information read from either or both of the RFID tags on the reaction plate and / or one or more reagent container(s) is applied to facilitate qPCR molecular analysis.

[0084] 4-10, the display device 102 can be utilized to display various user interface screens to assist a user in configuring an analysis that they wish to perform on an instrument using the system 100. These user interface elements are only one example of a smart user-driven molecular analysis available to a lab bench assistant, and many others will be apparent to those skilled in the art.

[0085] The user interface 400 may be displayed through the display device 102 showing a start icon 402, at least one reaction plate icon 404, and at least one inventory icon 406. The at least one reaction plate icon 404 may indicate that a reaction plate has recently been utilized by a user. The reaction plate icon 404 may display information such as the name of the analysis in which the reaction plate was used, the number of runs performed with the reaction plate, and a timestamp for the last instance the reaction plate was used in an analysis.

[0086] The inventory icon 406 may provide information about the consumables in the lab. The inventory icon 406 may include information such as the name of the consumable, the consumable ID number, an icon representing the type of consumable such as assay, reagent, or sample, the amount of the consumable remaining in each particular substrate, holder, container, etc., and an icon identifying the last and current owner of the consumable in the lab. A user may select the inventory icon 406 to quickly locate a consumable they wish to use in an analysis.

[0087] A start icon 402 may be provided to allow a user to begin configuring an assay. When the start icon 402 is selected, the display device 102 may display a user interface 500 that prompts the user to scan the reaction plate RFID tag 122 of the reaction plate 116 that the user is going to utilize in the assay.

[0088] After the reaction plate RFID tag 122 is scanned, a user interface 600 may be displayed through the display device 102. In some embodiments, the user interface 600 provides the user with specific information about the scanned plate, such as name, ID, part type, production information (e.g., lot number, expiration date, etc.), order information (e.g., catalog number, cost, etc.), and specific characteristics such as operation and / or accumulation temperature. In some configurations, the user interface 600 may display information such as sensor history for the reaction plate, such as temperature history, exposure history, motion detection, and / or impact history. After reviewing the information, the user may choose to continue configuring the analysis by selecting a continue option displayed through the user interface 600.

[0089] The display device 102 displays a user interface 700 with a plate layout 708 corresponding to the location of assays, reagents, and samples within a matrix of multiple reaction sites. When utilizing pre-spotted plates, for example, the user interface 700 may display a matrix of reaction sites with color-coded indicators within each site. Then, in some embodiments, each color-coded indicator may correspond to an assay displayed in a list of color-coded assays 702 shown in the user interface 700. In the case of unspotted plates, the user may be able to configure the location of the assays being used. This can be done, for example, by writing / editing information directly onto the reaction plate and / or reagent container RFID tags (e.g., using an RFID writer) and / or onto the cloud. While utilizing the user interface 700, the user may wish to assign samples to a plate or a set of reaction sites. The user may interact with a set of icons 704 and a sample list 706 displayed within the user interface 700 to assign, edit, and store configurations of plates for use in the instrument. An icon 704 in the user interface 700 allows a user to scan a reagent container RFID tag 110 for a reagent that the user wants to add to a reaction vessel.

[0090] The user interface 800 shows an indication to the user that they may use the RFID reader 124 of the display device to scan the reaction plate RFID tags 122 and / or reagent container RFID tags 110. In some configurations, the user may be able to scan multiple reaction plate RFID tags and / or reagent container RFID tags that they wish to use with the system 100.

[0091] The user interface 900 shows a list of scanned reagent information 904 including characteristics, manufacturing information, and sensor history information such as temperature history 902 .

[0092] The display device 102 may return to displaying the user interface 700 after the reagents have been scanned. The user interface 700 may display a reagent icon 1004 for each reagent scanned or selected by the user. The user interface 700 may display an indicator 1002 that identifies a particular reaction site for the user to transfer the reagent according to the protocol utilized in the assay.

[0093] 11 and 12 show pictures of a user configuring a reaction plate through a user interface 1100. The user can indicate the location of assays, samples, and / or reagents to be placed within each reaction field of the reaction plate.

[0094] 13 shows a user interface 1300 displaying an instrument scheduler 1302 that is displayed to a user through a display device 1304 of a personal computer / workstation. After a reaction plate has been configured, for example, a user may utilize the user interface 1300 to view the instrument scheduler 1302 for availability of an instrument on which the user wishes to run an analysis. In some embodiments, the instrument scheduler 1302 allows the user to set the date and time on which the user wishes to run the analysis.

[0095] 14 and 15, a user may schedule or view a list of analyses scheduled on an instrument through a mobile device such as a display device 1402. The display device 1402 allows the user to view scheduler entries 1404 indicating scheduled runs for the instrument. The display device 1402 may also show a scheduler notification 1502 to the user after scheduling an instrument, and a reminder to start the experiment.

[0096] "Logic" herein refers to mechanical memory circuits, non-transitory machine-readable media, and / or circuits that may be applied to affect the operation of a device via its material and / or material-energy configurations with control and / or procedural signals and / or settings and values ​​(e.g., resistance, impedance, capacitance, inductance, current / voltage ratings, etc.). Magnetic media, electronic circuits, electrical and optical memory (both volatile and non-volatile), and firmware are examples of logic. Logic specifically excludes pure signals or software per se, but does not exclude machine memory, which includes software and thereby forms the configuration in question.

Claims

1. 1. A system for performing molecular analysis, comprising: a reaction plate including a reaction plate RFID tag, and / or a reagent container including a reagent container RFID tag; the reaction plate RFID tag and / or the reagent container RFID tag store and / or share information for the molecular analysis workflow.

2. The system of claim 1 , wherein the molecular analysis is a polymerase chain reaction (PCR).

3. The system of claim 1 , wherein the PCR is selected from the group consisting of qPCR, epPCR, RT-PCR, and PLA with PCR.

4. The system of claim 1 , wherein the reaction plate comprises at least one reaction field.

5. The system of claim 4 , wherein the reaction plate comprises a plurality of reaction sites.

6. The system of claim 5 , wherein each reaction site comprises a first reagent, the first reagent being the same or different in different reaction sites.

7. The system of claim 1 , wherein the reagent container contains a second reagent.

8. 2. The system of claim 1, wherein the reaction plate and / or the reagent container further comprises a temperature sensor, the temperature sensor coupled to the reaction plate RFID and / or the reagent container RFID tag, and the reaction plate RFID tag and / or the reagent container RFID tag are each capable of accumulating a temperature history for the reaction plate and / or the reagent container, respectively.

9. 2. The system of claim 1, wherein the reaction plate and / or the reagent container further comprises an optical sensor, the optical sensor coupled to the reaction plate RFID and / or the reagent container RFID tag, and the reaction plate RFID tag and / or the reagent container RFID tag are each capable of accumulating an exposure history for the reaction plate and / or the reagent container, respectively.

10. 2. The system of claim 1, wherein the reaction plate and / or the reagent container further comprises a motion sensor, the motion sensor being coupled to the reaction plate RFID and / or the reagent container RFID tag, and the reaction plate RFID tag and / or the reagent container RFID tag are each capable of accumulating a motion detection history for the reaction plate and / or the reagent container, respectively.

11. moreover, Each reaction space contains a first reagent; 6. The system of claim 5, wherein the reaction plate RFID tag includes an identifier for each reaction field and the corresponding first reagent contained by each reaction field.

12. The system of claim 6 , wherein the first reagent comprises at least one primer and / or at least one probe.

13. The system of claim 12 , wherein the at least one primer and / or the at least one probe in the first reagent in each reaction space are the same or different.

14. The system of claim 6 , wherein the reagent container contains a second reagent.

15. moreover, the reaction plate RFID tag encodes data relating to characteristics of the reaction plate; and / or The system of claim 1 , wherein the reagent container RFID tag encodes data regarding a characteristic of the reagent container.

16. moreover, The system of claim 1 , comprising an instrument including an RFID reader operable to read the information for the workflow from the reaction plate RFID tag and / or the reagent container RFID tag.

17. The system of claim 16, wherein the instrument includes logic operable to access a network server system and / or a cloud network to download information for a workflow for the molecular analysis, including an analysis protocol for the reaction plate, and / or the instrument includes logic operable to provide a visual and / or verbal guide for the molecular analysis based on the information for the workflow.

18. The system of claim 17 , wherein the analysis protocol includes instructions for liquid transfer to the reaction plate.

19. The system of claim 16, wherein the instrument further includes an RFID writer and logic operable on the RFID writer to record a record of the liquid transfer to the reaction plate on the reaction plate RFID tag and / or to record a record of the liquid transfer from the reagent container on the reagent container RFID tag.

20. 20. The system of claim 19, wherein the record comprises a reaction volume of the liquid transfer.

21. 20. The system of claim 19, wherein the instrument further comprises logic operable on the RFID writer to record the reaction field of the reaction plate to which the liquid transfer is applied.

22. 20. The system of claim 19, wherein the instrument further comprises logic operable on the RFID writer to record the date and / or time the liquid transfer is applied to the reaction plate and / or from the reagent container.

23. moreover, 17. The system of claim 16, wherein the instrument includes logic operable to apply information stored by the reaction plate RFID tag and the reagent container RFID tag to provide instructions for mixing a first reagent on the reaction plate with a second reagent stored by the reagent container.

24. 24. The system of claim 23, wherein the instructions include a reaction field on the reaction plate containing the first reagent, and fluid transfer instructions for applying the second reagent to the reaction field.

25. 25. The system of claim 24, wherein the fluid transfer instructions include a reaction volume of the second reagent.

26. 17. The system of claim 16, wherein the instrument includes logic operable to read the reaction plate RFID tag and / or the reagent container RFID tag for an analytical protocol of the workflow.

27. 27. The system of claim 26, wherein the analysis protocol includes fluid transfer instructions for applying reagents to the reaction plate and / or from the reagent containers.

28. The system of claim 1 , wherein the reaction plate RFID tag includes an identifier for a first reagent contained in a reaction field on the reaction plate.

29. The system of claim 12 , wherein the first reagent contained in the reaction space comprises at least one primer pair.

30. 13. The system of claim 12, wherein the first reagent contained in the reaction space comprises at least one probe, the probe comprising a fluorophore moiety and a quencher moiety, optionally a 5' nuclease probe.

31. The system of claim 1 , wherein the reaction plate RFID tag includes an identifier for a next reaction plate in the workflow of the molecular analysis.

32. 10. The system of claim 1, wherein the reaction plate further comprises a temperature sensor coupled to the reaction plate RFID tag, the reaction plate RFID tag storing a temperature history of the reaction plate.

33. 10. The system of claim 1, wherein the reaction plate further comprises a light sensor coupled to the reaction plate RFID tag, the reaction plate RFID tag storing an exposure history of the reaction plate.

34. The system of claim 6 , wherein the first reagent is dry spotted.

35. The system of claim 6 , wherein the first reagent is pre-spotted.

36. 1. A system for performing molecular analysis, comprising: a reaction plate including at least one reaction field containing a first reagent; the reaction plate includes a reaction plate RFID tag; the reaction plate RFID tag encoding data relating to a characteristic of the reaction plate; an instrument including an RFID reader operable to read the reaction plate RFID tag to obtain the characteristic of the reaction plate; the instrument including logic operable to apply the characteristic of the reaction plate to interact with a second reagent in a workflow for the molecular analysis.

37. moreover, at least one reagent container including a second reagent and a reagent container RFID tag; 37. The system of claim 36, wherein the reagent container RFID tag encodes data regarding a characteristic of the second reagent.

38. 37. The system of claim 36, wherein the reaction plate further comprises one or more selected from: (i) an optical sensor coupled to the reaction plate RFID tag, the reaction plate RFID tag storing an exposure history for the reaction plate; (ii) a temperature sensor coupled to the reaction plate RFID tag, the reaction plate RFID tag storing a temperature history for the reaction plate; and (iii) a motion sensor coupled to the reaction plate RFID tag, the reaction plate RFID tag storing a motion detection history for the reaction plate.

39. 38. The system of claim 37, wherein the reagent container(s) further comprises one or more selected from: (i) an optical sensor coupled to the reagent container(s) RFID tag(s), where the reagent container(s) RFID tag(s) accumulate an exposure history for the reagent container(s); (ii) a temperature sensor coupled to the reagent container(s) RFID tag(s), where the reagent container(s) RFID tag(s) accumulate a temperature history for the reagent container(s); and (iii) a motion sensor coupled to the reagent container(s) RFID tag(s), where the reagent container(s) RFID tag(s) accumulate a motion detection history for the reagent container.

40. 40. The system of claim 37, wherein the characteristic of the second reagent comprises an expiration date for the second reagent.

41. moreover, the instrument including logic operable to read the characteristic of the second reagent from the reagent container RFID tag; The system of claim 37, wherein the instrument comprises logic operable to apply the characteristics of the second reagent and the characteristics of the reaction plate to provide instructions for applying the second reagent to the first reagent in the workflow for the molecular analysis.

42. 42. The system of claim 41, wherein the instructions identify the reaction field containing the first reagent on the reaction plate and / or instructions for transferring the second reagent to the reaction field.

43. 43. The system of claim 42, wherein the transfer instructions include a reaction volume of the second reagent.

44. 37. The system of claim 36, wherein the characteristic of the reaction plate includes an identifier for the first reagent in the reaction field.

45. 37. The system of claim 36, wherein the first reagent comprises at least one primer pair.

46. 37. The system of claim 36, wherein the first reagent comprises at least one probe.

47. 37. The system of claim 36, wherein the characteristic of the reaction plate identifies each of the reaction fields and a corresponding first reagent contained by each of the reaction fields.

48. 37. The system of claim 36, wherein the first reagent in each of the reaction fields is a dry spot reagent.

49. 37. The system of claim 36, wherein the characteristics of the reaction plate include an identifier of a next reaction plate in the workflow for the molecular analysis.

50. 38. The system of claim 37, wherein the instrument includes an RFID writer and logic operable on the RFID writer to record on the reaction plate RFID tag a record of the liquid transfer of the second reagent to the reaction plate.

51. 51. The system of claim 50, wherein the record includes a reaction volume of the second reagent that has been applied to the reaction plate.

52. 51. The system of claim 50, wherein the instrument includes logic operable on the RFID writer to record an identifier of the second reagent and a distinct reaction field of the reaction plate to which the second reagent has been applied.

53. 51. The system of claim 50, wherein the instrument includes logic operable on the RFID writer to record the date and / or time that the second reagent is applied to the reaction plate.

54. 37. The system of claim 36, wherein the instrument further comprises logic operable to access a network server system to download the workflow for the molecular analysis, the workflow comprising an analysis protocol for the reaction plate.

55. 55. The system of claim 54, wherein the analysis protocol includes instructions for liquid transfer of the second reagent to the reaction plate.

56. 37. The system of claim 36, wherein the instrument further comprises logic operable to read the characteristic of the reaction plate for a protocol from the reaction plate.

57. 57. The system of claim 56, wherein the protocol includes instructions for liquid transfer of the second reagent to the reaction plate.

58. 1. A method for performing molecular analysis, comprising: Reading a reaction plate RFID tag on the reaction plate; and / or reading a reagent container RFID tag on the reagent container; and applying information read from the reaction plate RFID tag and / or the reagent container RFID tag to perform a workflow for the molecular analysis.

59. moreover, 60. The method of claim 58, comprising reading an identifier of a first reagent and a reaction field for the first reagent from the reaction plate RFID tag.

60. moreover, 60. The method of claim 58, comprising reading an identifier of a second reagent from the reagent container RFID tag.

61. moreover, 60. The method of claim 58, comprising reading a temperature history for the reaction plate, an exposure history for the reaction plate, and / or a motion detection history for the reaction plate from an RFID tag of the reaction plate.

62. moreover, 60. The method of claim 58, comprising reading a temperature history for the reagent container, an exposure history for the reagent container, and / or a motion detection history for the reagent container from the reagent container RFID tag.

63. moreover, 60. The method of claim 58, comprising reading an identifier of a plurality of reaction fields on the reaction plate and a corresponding first reagent for each reaction field from the reaction plate RFID tag.

64. moreover, 60. The method of claim 58, comprising reading an expiration date for a second reagent stored by the reagent container from the reagent container RFID tag.

65. moreover, reading data relating to the characteristics of the reaction plate from the reaction plate RFID tag; and / or 61. The method of claim 60, comprising reading data regarding a characteristic of the second reagent from the reagent container RFID tag.

66. moreover, reading information for the workflow from the reaction plate RFID tag and / or the reagent container RFID tag; and / or 60. The method of claim 58, comprising providing a visual and / or verbal guide for the workflow based on the information.

67. moreover, 59. The method of claim 58, comprising downloading the workflow of the molecular analysis from a network server system, the workflow including an analysis protocol for the reaction plate.

68. 68. The method of claim 67, wherein the analysis protocol includes instructions for liquid reagents and / or sample transfer of one or more reagents to the reaction plate.

69. moreover, 60. The method of claim 58, comprising operating an RFID writer to record a record on the reaction plate RFID tag of liquid, reagent, and / or sample transfer to the reaction plate.

70. 70. The method of claim 69, wherein the record comprises a reaction volume of the liquid transfer.

71. moreover, 70. The method of claim 69, comprising operating the RFID writer to record an identifier of a reaction field of the reaction plate to which the liquid reagent and / or sample transfer is applied.

72. moreover, 70. The method of claim 69, comprising operating the RFID writer to record the date and / or time that the liquid, reagent and / or sample transfer is applied to the reaction plate.

73. moreover, 60. The method of claim 59, comprising applying the information stored by the reaction plate RFID tag and the reagent container RFID tag to instructions for mixing a first reagent and a second reagent in the workflow for the molecular analysis.

74. 69. The method of claim 68, wherein the instructions include a reaction field on the reaction plate containing the first reagent, and instructions for a liquid reagent, and / or sample transfer of the second reagent to the reaction field.

75. 75. The method of claim 74, wherein the instructions include a reaction volume of the second reagent.

76. moreover, 60. The method of claim 58, comprising reading the reaction plate RFID tag for an analysis protocol for the workflow.

77. 77. The method of claim 76, wherein the assay protocol includes instructions for the fluidic transfer of one or more reagents to the reaction plate.

78. moreover, 60. The method of claim 58, comprising reading the reaction plate RFID tag for identifiers of reagents contained in reaction fields on the reaction plate.

79. moreover, 80. The method of claim 78, comprising reading the reaction plate RFID tag for at least one primer pair identifier.

80. moreover, 80. The method of claim 78, comprising reading the reaction plate RFID tag for an identifier of at least one probe.

81. moreover, 60. The method of claim 58, comprising reading the reaction plate RFID tag for an identifier of a next reaction plate in the workflow for the molecular analysis.

82. moreover, 60. The method of claim 59, comprising writing information about the reaction plate, the reagent container, the first reagent, the second reagent, and / or the molecular analysis to the reaction plate RFID tag and / or the reagent container RFID tag(s).

83. 1. A smart consumable for performing a molecular analysis workflow, comprising: a reaction holder including a reaction holder RFID tag, the reaction holder RFID tag transmitting and receiving and / or storing information regarding a workflow for the molecular analysis; and / or A smart consumable comprising at least one of: a reagent container including a reagent container RFID tag, the reagent container RFID tag transmitting, receiving and / or storing information regarding the workflow for the molecular analysis.

84. 84. The smart consumable of claim 83, wherein the reaction holder comprises a plurality of reaction fields, one or more of the plurality of reaction fields comprising a first reagent, the first reagent being the same or different in different reaction fields on the same reaction holder.

85. 85. The smart consumable of claim 84, wherein the reaction holder RFID tag includes an identifier for each reaction field and a corresponding first reagent for each reaction field.

86. 85. The smart consumable of claim 84, wherein the first reagent is dry spotted.

87. 84. The smart consumable of claim 83, wherein the reaction holder RFID tag stores data regarding characteristics of the reaction holder and / or the reagent container RFID tag stores data regarding characteristics of a reagent in the reagent container.

88. 84. The smart consumable of claim 83, wherein the reaction holder RFID tag and / or the reagent container RFID tag store information to provide a visual and / or verbal guide for the workflow.

89. 84. The smart consumable of claim 83, wherein the reaction holder RFID tag stores a record of the reagents that have been applied to the reaction holder.

90. 90. The smart consumable of claim 89, wherein the record comprises a reaction volume of the reagent that has been applied to the reaction holder.

91. 90. The smart consumable of claim 89, wherein the record includes an identifier for the reaction field of the reaction holder to which the reagent is applied.

92. 90. The smart consumable of claim 89, wherein the record includes a date and / or a time that the reagent is applied to the reaction holder.

93. 90. The smart consumable of claim 89, wherein the record comprises an interaction of a first reagent and a second reagent in the workflow for the molecular analysis.

94. 94. The smart consumable of claim 93, wherein the interaction includes a separate reaction field on the reaction holder containing the first reagent, and instructions for liquid transfer of the second reagent to the separate reaction field.

95. 95. The smart consumable of claim 94, wherein the fluid transfer instructions include a reaction volume of the second reagent.

96. 84. The smart consumable of claim 83, wherein the reaction holder RFID tag and / or the reagent container RFID tag store an analysis protocol for the workflow.

97. 97. The smart consumable of claim 96, wherein the analysis protocol includes instructions for fluid transfer of one or more reagents to the reaction holder.

98. 84. The smart consumable of claim 83, wherein the reaction holder RFID tag stores an identifier for a reagent contained in a reaction field on the reaction holder.

99. 99. The smart consumable of claim 98, wherein the reagent contained in the reaction field comprises at least one primer pair.

100. 99. The smart consumable of claim 98, wherein the reagent contained in the reaction field comprises at least one probe.

101. 84. The smart consumable of claim 83, wherein the reaction holder RFID tag and / or the reagent container RFID tag store an identifier of the next reaction holder and / or reagent container being used in the workflow for the molecular analysis.

102. 84. The smart consumable of claim 83, wherein the reaction holder further comprises a temperature sensor coupled to the reaction holder RFID tag, the reaction holder RFID tag storing a temperature history for the reaction holder, a light sensor coupled to the reaction holder RFID tag, the reaction holder RFID tag storing an exposure history for the reaction holder, and / or a motion sensor coupled to the reaction holder RFID tag, the reaction holder RFID tag storing a motion detection history for the reagent container.

103. 84. The smart consumable of claim 83, wherein the reagent container further comprises: a temperature sensor coupled to the reagent container RFID tag, the reagent container RFID tag storing a temperature history for the reagent container; a light sensor coupled to the reagent container RFID tag, the reagent container RFID tag storing an exposure history for the reagent container; and / or a motion sensor coupled to the reagent container RFID tag, the reagent container RFID tag storing a motion detection history for the reaction holder.

104. The smart consumable of claim 180, wherein the smart consumable further comprises a barcode.

105. Data relating to the characteristics of the reaction holder and / or the reagent containers, An ID number; Expiration date, Part number and A bar code and Lot number, Part type, an accumulation temperature and / or an accumulation temperature range; Reagent concentration, Recommended reagent concentrations and / or volumes for use in the workflow; Provisions for liquid transfer support; The order number, The name of the reagent, Assay name, an assay location for a reagent being used on said reaction holder; Assay ID; A recommended or required protocol for said molecular analysis; Sample name, Master mix name, an internet link or address (url); reaction and / or reagent volumes; Test sample name; an analysis setup for said molecular analysis; Sample type, Molecular analysis type, and an instrument execution protocol.

106. 88. The smart consumable of claim 87, wherein data relating to characteristics of the reaction holder and / or the reagent container can be written to the reaction holder RFID tag and / or the reagent container RFID tag.

107. 103. The smart consumable of claim 102, wherein the temperature sensor, the light sensor, and / or the motion sensor are directly or indirectly coupled to the reaction holder RFID tag.

108. 104. The smart consumable of claim 103, wherein the temperature sensor, the light sensor, and / or the motion sensor are directly or indirectly coupled to the reagent container RFID tag.

109. 84. The smart consumable of claim 83, wherein the reaction holder RFID tag and / or the reagent container RFID tag have a capacity to store at least 8 kilobytes of information.

110. 85. The smart consumable of claim 84, wherein the plurality of reaction fields comprises at least 96 reaction fields, at least 384 reaction fields, at least 1536 reaction fields, at least 3072 reaction fields, or at least 12,288 reaction fields.

Images