Abstract: Compositions are disclosed that include a support having on a surface thereof at least an inner polysaccharide layer and an outer polysaccharide layer. The outer polysaccharide layer has pendant moieties each comprising a terminal amine functionality. The point of linkage of the pendant moiety to the outer polysaccharide layer does not comprise an amide bond. The composition may be employed in a method of conjugating a member of a specific binding pair to a particle. The method comprises reacting the terminal amine functionality of the composition with the member of the specific binding pair, which comprises an amine-reactive functionality.

Abstract: An integrated automation system for use in transporting samples between modules, the system can include a plurality of modules configured to be connected to one another for processing samples, each of the plurality of modules having an internal transport system. Each internal transport system includes one or more periphery track portions integrated within a respective module, each of the periphery track portions having two ends and one or more transverse track portions integrated within the respective module, the one or more transverse track portions intersecting at least one of the one or more periphery track portions. The internal transport systems can be configured to connect to one another via one end of the two ends connecting to one end of the two ends of adjacent periphery track portions, thereby forming a continuous periphery track running through and connecting the plurality of modules. Samples are transported along the continuous periphery track and the one or more transverse track portions.

Abstract: A random access, high-throughput system and method for preparing a biological sample for polymerase chain reaction (PCR) testing are disclosed. The system includes a nucleic acid isolation/purification apparatus and a PCR apparatus. The nucleic acid isolation/purification apparatus magnetically captures nucleic acid (NA) solids from the biological sample and then suspends the NA in elution buffer solution. The PCR testing apparatus provides multiple cycles of the denaturing, annealing, and elongating thermal cycles. More particularly, the PCR testing apparatus includes a multi-vessel thermal cycler array that has a plurality of single-vessel thermal cyclers that is each individually-thermally-controllable so that adjacent single-vessel thermal cyclers can be heated or cooled to different temperatures corresponding to the different thermal cycles of the respective PCR testing process.

Abstract: Disclosed are methods and systems adapted to provide mixing of a liquid reagent in an automated clinical analyzer. The methods include aspirating an air separator (e.g., an air slug) into the interior of a probe. A relatively small volume of reagent liquid is also aspirated into the probe adjacent to the air separator; the volume of liquid reagent being entirely contained within the probe. The volume of liquid reagent may be repeatedly aspirated and dispensed at a relatively high frequency to accomplish reagent mixing in the reagent container. Improved sample and reagent mixing may be promoted using a similar method. Systems carrying out the methods are provided, as are other aspects.

Abstract: The present invention discloses a section of tubing including a fluoropolmer tubular body which has an interior surface defining a fluid passage through the tubular body. At least a first portion of the interior surface has a first hydrophobicity which is less than that of the remainder of the tubular body. At least a first portion of the interior surface can have a molar ratio of fluorine to oxygen of no greater than 30 to 1. Products can include the tubular bodies of the present invention attachable to fluid processing instruments such as immunodiagnostic instruments. The present invention also discloses methods for manufacturing the disclosed tubular bodies.

Abstract: A networked clinical diagnostic analyzer is disclosed with support for monitoring by a remote back office. The disclosed analyzer includes a module to detect in real-time events of interest while allowing the back office to modify the definitions of the events. The module may be networked using virtual private networking into the back office network, which is usually different from the network at the site of the clinical diagnostic analyzer's deployment. The real-time alerts allow both a quick response to actual or expected error conditions and the downloading of logged data that is likely of most interest and relevance.

Abstract: An application for providing interactive reports of medical test results that may be integrated with other medical information and services on a mobile device.

Abstract: Methods of detecting nucleic acids, including methods of detecting two or more nucleic acids in multiplex branched-chain DNA assays, are provided. Nucleic acids captured on a solid support are detected, for example, through cooperative hybridization events that result in specific association of a label with the nucleic acids. Compositions, kits, and systems related to the methods are also described.

Abstract: The invention relates to a method of detecting nucleic acid molecules by immunoassay detection. Detection of a specific nucleic acid molecule of interest is achieved by using a nucleic acid probe in solution which hybridizes in solution to the nucleic acid molecule of interest. Immunoassay detection is achieved by using an antibody specific for the hybrid formed by hybridization of the nucleic acid probe to the nucleic acid molecule of interest.

Abstract: Compositions incorporating small interfering ribonucleic acid (siRNA) and certain lipid-conjugated polyamide compound-based delivery vehicles that are particularly useful in the delivery siRNA and other polynucleotides to cells. Also, methods of making and using the compositions.

Abstract: A method for calibrating an imager of a reagent analyzer, comprises positioning a dry reagent pad at a first read position in a field of view of the imager, the first read position illuminated by an illumination source with a first intensity, detecting a reference optical signal by the imager, indicative of a first reflectance value of the dry reagent pad at the first read position, positioning the dry reagent pad at a second read position, the second read position illuminated with a second intensity different from the first intensity, detecting a first optical signal by the imager, indicative of a second reflectance value of the dry reagent pad at the second read position, and calculating, by a processor, a calibration factor for the dry reagent pad at the second read position based on a difference between the reference optical signal and the first optical signal.

Abstract: Systems and methods are provided though which a transaction, e.g., in a multi-tier, distributed application may be initiated from a portable or hand-held device, such as a smartphone. A computer system or systems, possibly remote from the device, may approve the transaction, complete it, or both, and the remote computer system or systems may cause a document to be printed, e.g., by a printer physically proximate to the device. Aspects of the invention are illustrated by embodiments in which a drug prescription may be created electronically using a hand-held device. In such an embodiment, the prescription may be transmitted to one or more remote computer systems, such as an application server, for processing. If specified, the remote computer systems may cause a prescription to be printed, e.g., at a printer near the prescriber's location. The prescriber may sign the printed prescription and give it to a patient or pharmacy.

Abstract: Provided are oligonucleotides that are capable of detecting KRAS and PIK3CA mutations in both cancer patients and healthy individuals with high specificity in kPCR assays. When the oligonucleotides are used as forward primers in conjunction with a defined genotyping algorithm spreadsheet, the primers are capable of enhancing detection of KRAS codon 12, 13, and 61 and PIK3CA codon 542, 545, and 1047 single nucleotide polymorphisms (SNPs) in a background of wild-type sequences. The oligonucleotides of the present invention are also capable of preventing pseudogene amplification when the oligonucleotides are hybridized as reverse primers or detection probes to the mismatch sequences.

Abstract: Disclosed herein are compositions and methods comprising two or more proteins in which at least one of the proteins has been altered to reduce their mutual recognition and binding. Such compositions are useful as reference, calibrators or controls in methods and assays for determining the amount of one or more of the proteins that may be present in a sample of interest or in confirming the presence of one or more of the proteins in the sample. More particularly, it relates to compositions and methods comprising altered placental growth factor-1 (PlGF-1) and soluble fms-like tyrosine kinase (sFlt-1) and methods for determining the amount or confirming the presence of sFlt-1 and/or PlGF-1 in a sample of interest.

Abstract: A system for diagnostic testing may include a meter for performing a diagnostic test on a sample applied to a test media, the meter having a housing and an interface for receiving a signal representing coding information, and a container configured to contain test media compatible with the meter, the container having a coding element associated therewith. Additionally, the system may provide a mechanism for removing the meter from an interconnected test container and reattaching it to a new container using on-container coding methods that can recalibrate the meter for the new container of test strips.

Abstract: An automation system for an in vitro diagnostics environment includes a plurality of intelligent carriers that include onboard processing and navigation capabilities. A central management controller can communicate wirelessly with the carriers to direct the carriers to carry a fluid sample to testing stations along a track within the automation system. The carriers control local motion and navigate decision points, such as forks in the track, to reach the appropriate testing station independently. The carriers can utilize landmarks and distance encoding to reach destinations accurately and quickly, including, for example, within less than the time for a single operation cycle of an automated clinical analyzer.

Abstract: Devices and systems for active thermal control of sample holding devices for bDNA testing, polymerase chain reaction testing, chemiluminescent immuno-assay testing, and so forth. The thermal control subsystem includes a fluidic circuit, first and second heater assemblies, a centrifugal pump, and a heat exchange device. The first and second heater assemblies include a heat removal device and a controllable thermo-electric device. One or both of the heater assemblies can include a heat spreader. A controller actively controls the pump, the heat removal device, and the thermo-electric devices, to thermally-control sample-containing vessels retained in the holding device.

Abstract: The invention features sincalide formulations that include an effective amount of sincalide, a bulking agent/tonicity adjuster, a stabilizer, a surfactant, a chelator, and a buffer. The invention also features kits and methods for preparing improved sincalide formulations as well as methods for treating, preventing, and diagnosing gall bladder-related disorders using sincalide formulations.

Abstract: Verification of patient sample electrolyte results using a separate quantitative measurement of sample resistivity. Sample resistivity may be used to measure small differences in resistivity of one sample to the next, and in comparison to a standard solution, in order to verify the results of sample electrolyte measurements being measured at the same time by, for example, individual ion selective electrodes (ISE) in a clinical analyzer. Providing a separate or secondary quantitative means for verification of the measured results of sample electrolytes using sample resistivity solves the problem of electrolyte result variability in sample electrolyte measurements. The process may compare a measured sample resistivity to an expected resistivity value as a verification of the accuracy of individual electrolyte results. Suspect samples—e.g., where the electrolyte resistivity results do not fit the expected resistivity—may be flagged.

Abstract: An automation system for an in vitro diagnostics environment includes a plurality of intelligent carriers that include onboard processing and navigation capabilities. A central scheduler can communicate wirelessly with the carriers to direct the carriers to carry a fluid sample to testing stations along a track within the automation system. The carriers can utilize landmarks and distance encoding to reach destinations accurately and quickly, including, for example within less than the time for a single operation cycle of an automated clinical analyzer. The distance encoding can include optical marks repeated at regular intervals (pitch), where the intervals are conveyed to the carriers wirelessly or via optical encoding. The pitch of the encoding can differ for different sections of track depending on the position precision desired.