Abstract: Film seal assemblies that seal one or more reagents within a sample cartridge, which allow for single lid cartridge designs. Such film seal assemblies can include one or more layers, a bottom-most layer that permanently seals with a sample cartridge having multiple chambers for one or more reagents, and top-most layer that releasably seals vent opening(s) in the film seal assembly and is removable by the end user. This configuration allows use of a single lid, which can be integrally formed with cartridge body or a separate component attached atop the cartridge body. The film seal assembly can include peelable liner(s) or can releasably attached to an underside of the single lid. Such film assemblies can include multiple layers that include a polypropylene layer for permanently sealing to a rigid propylene cartridge body and polyester top layers for releasably and hermetically sealing with a liner or the lid.

Abstract: Sample cartridge, valve assembly and processing methods for providing mechanical lysis, chemical lysis or both for a given fluid sample are provided herein. Such systems can include a sample processing cartridge having a valve assembly configured for transport of the processing of fluid sample within the sample cartridge. The valve assembly can include a valve body and cap that secure a filter therebetween and facilitate inflow of mechanical or chemical lysing agents as needed for a fluid sample. Assay workflows for performing both mechanical and chemical lysis of a fluid sample within the same workflow of a single universal sample cartridge are also provided.

Abstract: Systems and methods for monitoring, characterizing and controlling operation of LEDs are provided herein. Methods includes measuring a voltage across the LED, and correlating the voltage to a junction temperature of the LED. This correlation can be used to improve operation of the LED by increasing the signal to noise ratio of the LED signal, characterize the LED by comparing to an I-V curve, control LED operation to compensate for LED degradation and avoid crosstalk, and/or to generally improve performance and life expectancy of the LED. Improved performance of the LED can include stabilizing the photon output during performance of an assay to provide a desired dye reporter signal required for the assay and/or reducing an intra-shot during of the LED output during the assay. System and device with control units configured to perform these methods are also described herein.

Abstract: A biological sample processing apparatus having an enclosure and a plurality of sample processing modules held within an enclosure with a tiltable graphical user interface screen. In one aspect, the individual modules that are readily removable for repair, replacement or upgrade. Each module is configured to be independently operable and readily inserted into the enclosure for connection with a processing unit of the enclosure. Each module can include quick-release mechanisms so that the module can be readily removed and replaced manually or with minimal tools through the front of the enclosure without requiring substantial or total disassembly of the module or entire enclosure. In another aspect, the user interface screen can display identifying information, such as a barcode, that can be scanned by a user's portable device so as to monitor the progress of an assay remotely.

Abstract: Methods and systems for estimating force and motor torque in a mechatronic system are provided herein. Such methods and system are suited for improved control of small-scale mechatronic system, particularly a syringe, valve, and cartridge loader or door opening/closing mechanism of a diagnostic assay system. The methods can compensate for friction and account for various second-order effects, thereby allowing for more accurate pressure estimation, thereby allowing improved syringe operation. The methods can further allow for improved estimation of force or motor torque to allow for improved control of an actuatable valve interfacing the sample cartridge and cartridge loader or door opening/closing system. Methods of calibrating such systems are also provided.

Abstract: An analytic system for carrying out a chemical assay, the system having a bay with an opening on one side, the bay of a size and shape to enclose a cartridge carrying a sample material to be analyzed, one or more mechanisms within the bay through which the cartridge and or material within the cartridge is influenced, a door of a size to cover the opening, a securing mechanism associated with the bay and the door, by which the door is secured when closed.

Abstract: RFID-based operations management systems and methods are provided herein, particularly RFID based Kanban systems. Such system can realize increased efficiencies, improved visibility of inventory throughout the workflow and improved response to variations in demand. RFID based solutions can automatically transact consumption of Kanban inventory in real-time and trigger replenishment signals to warehouses automatically, resulting in increased Kanban inventory accuracy and lower manual efforts for replenishment and consumption posting. This approach can interface with existing operational management software (e.g. ERP systems, such as SAP) seamlessly integrating with product manufacturing workflows. Such systems are uniquely applicable to manufacture of biological testing kits, where demands fluctuate considerably in response to crises, disasters, epidemics and pandemics.

Abstract: Methods of determining methylation of DNA are provided that include filtering a biological sample comprising a nucleic acid with a first matrix material to purify the DNA; eluting and denaturing the DNA to produce eluted denatured DNA; heating the DNA in the presence of bisulfite ions to produce deaminated nucleic acid; optionally contacting said deaminated nucleic acid with a second matrix material; desulphonating and eluting the bound deaminated nucleic acid; and performing methylation specific PCR, nucleic acid sequencing, and/or high resolution melting analysis (HRM) on said bisulfite-converted nucleic acid to determine the methylation of said nucleic acid, wherein multiple steps may be performed in a single reaction cartridge.

Abstract: A lid apparatus for a multi-chambered container. The lid apparatus has a top-lid that is hingedly attached to a bottom-cap. The top-lid includes one or more openings for fluid filling multiple passages that extend from the bottom-cap. A lower bottom-cap includes welding features for welding to the multi-chambered container. The bottom-cap further includes one or more auxiliary ports for injecting a reagent when the lid apparatus is in a closed configuration sealingly attached to the multi-chambered sample container.

Abstract: Thermal control devices and methods to provide improved control, speed and efficiency in temperature cycling are provided herein. Such thermal control device and methods can include one or more active elements, such a thermoelectric cooler device, that is controlled by an algorithm that regulates a temperature distribution of an adjacent reaction-vessel according to a temperature distribution command trajectory and estimated reaction-vessel temperature distribution. Some embodiments include two active elements that are bilaterally applied to opposing sides of the reaction-vessel. In some embodiments, the estimated reaction-vessel temperature is determined based on a state of power electronics of the element and a temperature output of one or more sensors of a portion of the element and/or an ambient environment of the reaction-vessel. Methods of calibration of such systems utilizing a thermal calibrator as a proxy for the reaction-vessel are also provided herein.

Abstract: Thermal control devices adapted to provide improved control and efficiency in temperature cycling are provided herein. Such thermal control device can include a thermoelectric cooler controlled in coordination with another thermal manipulation device to control an opposing face of the thermoelectric cooler and/or a microenvironment. Some such thermal control devices include a first and second thermoelectric cooler separated by a thermal capacitor. The thermal control devices can be configured in a planar configuration with a means for thermally coupling with a planar reaction vessel of a sample analyzer for use in thermal cycling in a polymerase chain reaction of the fluid sample in the reaction vessel. Methods of thermal cycling using such a thermal control devices are also provided.

Abstract: Non-ionic polyether surfactants with improved resistance to hydrolysis are provided.

Abstract: Compositions and methods for detecting Trichomonas vaginalis are provided.

Abstract: Compositions and methods for detecting bladder cancer are provided. In some embodiments, methods of monitoring recurrence of bladder cancer are provided. In some embodiments, the methods comprise detecting a set of markers consisting of CRH, IGF2, KRT20, and ANXA10.

Abstract: The present disclosure relates to aptamers for temperature-dependent reversible inhibition of thermostable polymerase activity in order to improve sensitivity and specificity of various reactions and assays involving hot start polynucleotide synthesis. Methods for use of the aptamers and related compositions and kits are also provided.

Abstract: Diagnostic chip devices, and methods and devices for assembly and manufacture, are described. Such chip device includes a chip carrier device that includes a frame having a fluidic interface, one or more fluidic channels and a gasket that forms a flowcell sealed against an active surface of a diagnostic chip. The gasket can be overmolded into the frame, or can be separately applied and compressed by the chip, which can be secured to the frame by cold swaging, hot swaging or heat staking, adhesive or any suitable means. The chip carrier device can further include a window over the flowcell to allow for optical detection of the active face of the chip. The window can be formed by a transparent lid or glass insert attached to the frame by laser welding, overmolding, adhesive or any suitable means. The carrier and lid can also be formed as a single integral component.

Abstract: Methods and compositions for isolation of nucleic acids from biological samples are provided.

Abstract: Described herein are methods and compositions that provide highly efficient nucleic acid amplification. In some embodiments, this allows a 3-fold or greater increase of amplification product for each amplification cycle and therefore increased sensitivity and speed over conventional PCR. Modified bases can be employed in primers to provide this base-3 or greater amplification with satisfactory PCR cycle times, which are improved, as compared to those observed in the absence of modified bases.

Abstract: Thermal control devices and methods to provide improved control, speed and efficiency in temperature cycling are provided herein. Such thermal control device and methods can include one or more active elements, such a thermoelectric cooler device, that is controlled by an algorithm that regulates a temperature distribution of an adjacent reaction-vessel according to a temperature distribution command trajectory and estimated reaction-vessel temperature distribution. Some embodiments include two active elements that are bilaterally applied to opposing sides of the reaction-vessel. In some embodiments, the estimated reaction-vessel temperature is determined based on a state of power electronics of the element and a temperature output of one or more sensors of a portion of the element and/or an ambient environment of the reaction-vessel. Methods of calibration of such systems utilizing a thermal calibrator as a proxy for the reaction-vessel are also provided herein.

Abstract: The present disclosure provides three-phase, nested amplification methods that facilitate multiplex amplification and multi-phasic detection, particularly multiplex amplification assays that employ target-specific melt probes and/or high-resolution melt (HRM) analysis using an intercalating dye.