Abstract: Systems and methods for use in an in vitro diagnostics setting incorporating existing or additional sensors in an automation system to assess the health and maintenance status of the automation system are disclosed. Such systems include any of a variety of sensors, such as Hall Effect sensors, temperature probes/thermocouples, ohm meters, volt meters, etc., which are in communication with a local or preferably remote monitoring station that can alert a user or maintenance personnel of needed service.

Abstract: Apparatus and methods for eye tracking using an optical coherence tomography (OCT) device are disclosed. Such eye tracking may be performed by using information about the shape of the cornea and the corneal apex or using the iris/pupil border obtained using the OCT device.

Abstract: The present disclosure relates to determining a biological tissue structural marker for diagnosis of a disease using a biological tissue characterization technique. A method for determining a structural marker for a diagnosis of a disease can include measuring a first molecular structure of a biological tissue of a first population of animals, after a carcinogenic or pathogenic substance was introduced into the first population. A second molecular structure of the biological tissue of a second population of animals can be measured, wherein the second population did not receive the carcinogenic or pathogenic substance. A first and a second structural marker of the molecular structures of the biological tissue of the first and second populations, respectively, can be identified and compared to determine that the first structural marker is indicative that the biological tissue of the first population of animals was affected by the disease.

Abstract: The present disclosure relates to determining a therapy efficacy. A method for determining an efficacy of a therapy for a disease in an animal patient can include measuring a molecular structure of a biological tissue of an animal patient at a first time and at a second time using a non-invasive biological tissue characterization technique. The method can further include observing a change of the molecular structure of the biological tissue between the first time and the second time, and determining the efficacy of the therapy based on the observed change in the molecular structure of the biological tissue. Before the first time, or between the first time and the second time, the animal patient received the therapy.

Abstract: A method of manufacturing a high molecular weight heparin (HMWH) compound is disclosed. The method comprises dissolving heparin to form a heparin solution and fractionating the heparin solution via tangential flow filtration (TFF) using a membrane with a molecular weight cut off (MWCO) between about 8 kDa and about 12 kDa. The TFF yields a retentate comprising fractionated heparin with a weight average molecular weight of about 20 kDa or greater, i.e., a high molecular weight heparin compound. A substantial proportion of heparin chains in the fractionated heparin may have a high molecular weight, e.g., 50% of the heparin chains or greater may have a molecular weight of 20 kDa or greater.

Abstract: Methods of scheduling maintenance on a plurality of automated testing apparatus and possibly also on ancillary test processing apparatus are provided. The methods include inputting identification data on the plurality of automated testing apparatus to be maintained, inputting maintenance requirement data for the maintenance of each of the apparatus, inputting demand constraint data, operating on the identification data, maintenance requirement data, and demand constraint data using an optimization program, such as mixed integer linear programming (MILP), subject to demand constraints and at least one objective, and outputting an optimized maintenance schedule for a planning period. Systems and apparatus configured to carry out the methods are also provided, as are other aspects.

Abstract: An assembly for use in a medical diagnostic device and system for analysis of one or more samples is disclosed. In one aspect of the invention, the assembly includes at least one extendable sample tray configured to hold the one or more samples. Additionally, the assembly includes at lease one holding unit coupled to the at least one extendable sample tray, wherein the holding unit is configured to hold a calibration marker. Furthermore, the extendable sample tray and the holding unit are arranged in the same plane and when the extendable sample tray is extended, the at least one holding unit is brought in a field of view of an image capturing unit.

Abstract: A method for determining a subject's risk for developing chronic kidney disease (CKD) combined with determining a subject's pharmacogenomic (PGX) profile is described. The method involves obtaining a sample of genetic material from the subject. The genetic material is amplified using primers specific for the genes underlying CKD and PGX. The DNA sequence of the amplified genetic material is determined and compared with the human reference genome sequence. One or more DNA sequence alterations in the amplified genetic material not present in the human reference genome sequence determines the PGX profile of the subject and may indicate that the subject is at risk for developing CKD.

Abstract: Devices, assemblies, and kits are disclosed for separating and/or metering a plasma sample from a patient's liquid test sample. Also disclosed are methods of producing and using same.

Abstract: A reagent strip and a reagent analyzer for reading the reagent strip is described. The reagent strip includes a substrate, at least one reagent pad positioned on the substrate, and a photo luminescent phosphor spot positioned at a fixed location on the substrate. The photo luminescent phosphor spot is formulated to exhibit a predetermined addressable attribute.

Abstract: Compounds and methods for use in detecting pregabalin in a sample suspected of containing pregabalin are disclosed. Pregabalin derivatives are described for producing pregabalin conjugates. A pregabalin-immunogenic carrier conjugate may be used as an immunogen for the preparation of an anti-pregabalin antibody. A pregabalin-detectable label conjugate may be used in a signal producing system in pregabalin assays.

Abstract: A method of assessing a bodily fluid sample on a test strip may involve applying a periodic signal with a first electrode located at a first location in a microfluidic channel of the test strip, monitoring the applied periodic signal with a second electrode located at a second location in the microfluidic channel, and using a third electrode located at a third location in the microfluidic channel as a reference electrode. The method may also include: collecting the bodily fluid sample in the microfluidic channel; continuing to apply the periodic signal, monitor the periodic signal and use the third electrode as a reference electrode while collecting the bodily fluid sample; and determining that the bodily fluid sample is sufficient for analyzing, based at least in part on the applied and monitored periodic signal.

Abstract: An electrocardiography monitor is provided. A sealed housing includes one end wider than an opposite end of the sealed housing. Electronic circuitry is provided within the sealed housing. The electronic circuitry includes an electrographic front end circuit to sense electrocardiographic signals and a micro-controller interfaced to the electrocardiographic front end circuit to sample the electrocardiographic signals. A buzzer within the housing outputs feedback to a wearer of the sealed housing.

Abstract: An electrocardiography patch is provided. A backing includes an elongated strip with a midsection connecting two rounded ends. The midsection tapers in from each end and is narrower than each of the two ends. An electrode is positioned on each end of the backing on a contact surface to capture electrocardiographic signals. A circuit trace electrically is coupled to each of the electrodes in the pair. A battery is provided on an outer surface of the backing opposite the contact surface. Memory is provided on the outer surface of the backing to store data regarding the electrocardiographic signals. A processor is powered by the battery to write the data into the memory.

Abstract: A test strip for sampling a bodily fluid may include multiple layers of a substrate material, an adhesive between at least some of the multiple layers, and a microfluidic channel formed between at least some of the multiple layers. The test strip may further include multiple electrodes on one of the multiple layers, positioned and partially exposed within the microfluidic channel, an additional material positioned at or near an entrance to the microfluidic channel, to selectively limit the flow of at least one of bubbles or debris into the microfluidic channel, and at least one exit port in at least one of the multiple layers to allow for release of pressure from the test strip. In some embodiments, the test strip is a saliva analysis test strip. In some embodiments, the test strip includes multiple exit ports to prevent blockage of sample flow.

Abstract: Analyzers and methods of use are disclosed, including a blood analyzer comprising a light source to transmit an optical signal; a detector to generate data indicative of optical signal intensity; a transparent sample vessel between the light source and the detector; a dispensing device to pass a first portion of the blood sample comprising whole blood or lysed blood into the vessel at a first instance of time, and to pass a plasma portion of the blood sample into the vessel at a second instance of time; a controller to cause a processor to obtain first and second data generated by the detector, the first data indicative of the optical signal passing through the first portion of the blood sample and the second data indicative of the optical signal passing through the plasma, to determine a total absorbance spectrum in which the first data is adjusted by the second data.