Abstract: Disclosed herein are methods of eliciting an immune response against a polyomavirus (for example, BKV serotype I (BKV-I), BKV serotype II (BKV-II), BKV serotype III (BKV-III) and/or BKV serotype IV (BKV-IV)) and methods of treating or inhibiting polyomavirus-associated pathology (such as polyomavirus-associated nephropathy, BKV-associated hemorrhagic cystitis, or JC virus-associated progressive multifocal leukoencephalopathy; PML). Further disclosed are immunogenic compositions of use in the disclosed methods. Also disclosed are methods of selecting an organ transplant donor and/or recipient including detecting whether the prospective donor and/or recipient has BKV serotype-specific (such as BKV serotype IV-specific) neutralizing antibodies.

Abstract: A slot die shim for use with a slot die, the slot die shim including a first channel configured to receive a first coating, a second channel configured to receive a second coating, and a third channel configured to receive a third coating. The slot die shim simultaneously dispenses the first coating through the first channel, the second coating through the second channel, and the third coating through the third channel onto a substrate. The coatings can be applied at different flow rates and include different test reagents. A vacuum force is applied to the first, second, and third coatings to control a width and a thickness of each of the coatings and a gap or distance between the coatings. The first, second, and third coatings are placed near one another or directly in contact with one another to minimize the area required for the coatings.

Abstract: A biosensor including a capillary chamber having an inner boundary, a working electrode including an effective working electrode portion positioned within the capillary chamber, and a counter electrode including an effective counter electrode portion positioned within the capillary chamber, and with the working and counter electrodes each having a neck that constitutes the sole portion of the electrodes that extends across the inner boundary and out of the capillary chamber. In one embodiment, the effective working electrode portion defines an average working electrode width, and the working electrode neck defines a working electrode neck width that is reduced relative to the average working electrode width.

Abstract: A support for use with tissue or bone is described, the support having one or more spaced apart brace members, and at least one elongated linking member for linking to the one or more spaced apart brace members. The support may be provided in use in combination with a biologic glue, the biologic glue comprising a first portion containing stabilized blood product, and a second portion containing a growth factor, the first portion and the second portion comingled when or after the support is introduced to the tissue or bone in a subject in need thereof. The support is fabricated by actively producing the support through an additive manufacturing process, in which the support is customized specifically to the tissue or bone by creating a computer-generated construct of the support on a three-dimensional volume rendering of the tissue or bone, and the computer generated construct is interpretable via software directing the additive manufacturing process.

Abstract: A medical system is disclosed, which can be useable in particular for monitoring and/or controlling at least one bodily function of a user. The medical system comprises a control device and at least one medical user element embodied separately from the control device. The medical user element and the control device are designed to exchange data wirelessly. The medical system is designed to enable an automatic assignment step, wherein an exchange of personal data between the medical user element and the control device is enabled by the automatic assignment step. The medical system is furthermore designed to automatically initiate the automatic assignment step by means of an assignment coupling between the medical user element and the control device. The medical system is furthermore designed to enable a separation of the assignment coupling for medical operation of the medical system after the assignment step.

Abstract: A slot die shim for use with a slot die, the slot die shim including a first channel configured to receive a first coating, a second channel configured to receive a second coating, and a third channel configured to receive a third coating. The slot die shim simultaneously dispenses the first coating through the first channel, the second coating through the second channel, and the third coating through the third channel onto a substrate. The coatings can be applied at different flow rates and include different test reagents. A vacuum force is applied to the first, second, and third coatings to control a width and a thickness of each of the coatings and a gap or distance between the coatings. The first, second, and third coatings are placed near one another or directly in contact with one another to minimize the area required for the coatings.

Abstract: Methods and systems are disclosed for estimating a glucose level of a person having diabetes and selecting automatically open-loop and closed-loop control for a connected therapy delivery device. The method may comprise analyzing measured glucose results and corresponding impedance values received from a glucose sensor coupled to the person with a probability analysis tool implemented by a microcontroller to determine a total quality score that is based on the minimum constraint of a probability of glucose sensor accuracy determined measured glucose results and a probability of sensing quality determined from the impedance values. The microcontroller may estimate the glucose level of the person with a recursive filter based on the plurality of measured glucose results weighted with the total quality score and select automatically either open-loop control or closed-loop control for the connected therapy delivery device based on the value of the total quality score.

Abstract: The invention features immunogenic compositions and methods useful for eliciting an immune response. In preferred embodiments, papillomavirus or adenovirus vectors are used to elicit exceptionally potent antibody and T cells responses in disrupted epithelium. The methods are useful in preventing or treating a subject having a disease or an infection. In particular examples, the methods are useful for preventing or treating a viral infection.

Abstract: Methods are disclosed for scaling body fluid analysis data to correct and/or compensate for confounding variables such as hematocrit (Hct), temperature, variations in electrode conductivity or combinations thereof before providing an analyte concentration. The scaling methods utilize current response data obtained from an AC block applied prior to a DC block to minimize the impact of such confounding variables upon the observed DC current response before creating descriptors or algorithms. The scaling methods therefore compensate the measured DC current by using data from the AC block made on the same sample. Also disclosed are devices, apparatuses and systems incorporating the various scaling methods.

Abstract: A biosensor including a capillary chamber having an inner boundary, a working electrode including an effective working electrode portion positioned within the capillary chamber, and a counter electrode including an effective counter electrode portion positioned within the capillary chamber, and with the working and counter electrodes each having a neck that constitutes the sole portion of the electrodes that extends across the inner boundary and out of the capillary chamber. In one embodiment, the effective working electrode portion defines an average working electrode width, and the working electrode neck defines a working electrode neck width that is reduced relative to the average working electrode width.

Abstract: Methods are disclosed for scaling body fluid analysis data to correct and/or compensate for confounding variables such as hematocrit (Hct), temperature, variations in electrode conductivity or combinations thereof before providing an analyte concentration. The scaling methods utilize current response data obtained from an AC block applied prior to a DC block to minimize the impact of such confounding variables upon the observed DC current response before creating descriptors or algorithms. The scaling methods therefore compensate the measured DC current by using data from the AC block made on the same sample. Also disclosed are devices, apparatuses and systems incorporating the various scaling methods.

Abstract: A support 70 for use with tissue or bone is described, the support 70 having one or more spaced apart brace members 72, and at least one elongated linking member 80 for linking to the one or more spaced apart brace members 72. The support 70 may be provided in use in combination with a biologic glue, the biologic glue comprising a first portion containing stabilized blood product, and a second portion containing a growth factor, the first portion and the second portion comingled when or after the support is introduced to the tissue or bone in a subject in need thereof. The support 70 is fabricated by actively producing the support through an additive manufacturing process, in which the support 70 is customized specifically to the tissue or bone by creating a computer generated construct of the support 70 on a three-dimensional volume rendering of the tissue or bone, and the computer generated construct is interpretable via software directing the additive manufacturing process.

Abstract: Methods are disclosed for scaling body fluid analysis data to correct and/or compensate for confounding variables such as hematocrit (Hct), temperature, variations in electrode conductivity or combinations thereof before providing an analyte concentration. The scaling methods utilize current response data obtained from an AC block applied prior to a DC block to minimize the impact of such confounding variables upon the observed DC current response before creating descriptors or algorithms. The scaling methods therefore compensate the measured DC current by using data from the AC block made on the same sample. Also disclosed are devices, apparatuses and systems incorporating the various scaling methods.

Abstract: Methods of eliciting an immune response to a JC polyomavirus (JCV) by administering an effective amount of an immunogenic composition including an isolated JCV VP1 polypeptide or a nucleic acid encoding the VP1 polypeptide to a subject are provided. VP1 polypeptides and immunogenic compositions suitable for use in the methods are provided, including JCV genotype 2 VP1 polypeptides and/or JCV genotype 3 polypeptides. Methods of identifying a subject at risk of developing progressive multifocal leukoencephalopathy (PML) are also provided. In some embodiments, the methods include obtaining a biological sample from a subject, detecting presence or absence of JCV neutralizing antibodies in the sample from the subject, and identifying that the subject is at risk of developing PML if there is an absence of detectable JCV neutralizing antibodies in the sample from the subject.

Abstract: Disclosed herein are methods of eliciting an immune response against a polyomavirus (for example, BKV serotype I (BKV-I), BKV serotype II (BKV-II), BKV serotype III (BKV-III) and/or BKV serotype IV (BKV-IV)) and methods of treating or inhibiting polyomavirus-associated pathology (such as polyomavirus-associated nephropathy, BKV-associated hemorrhagic cystitis, or JC virus-associated progressive multifocal leukoencephalopathy; PML). Further disclosed are immunogenic compositions of use in the disclosed methods. Also disclosed are methods of selecting an organ transplant donor and/or recipient including detecting whether the prospective donor and/or recipient has BKV serotype-specific (such as BKV serotype IV-specific) neutralizing antibodies.

Abstract: A medical system is disclosed, which can be useable in particular for monitoring and/or controlling at least one bodily function of a user. The medical system comprises a control device and at least one medical user element embodied separately from the control device. The medical user element and the control device are designed to exchange data wirelessly. The medical system is designed to enable an automatic assignment step, wherein an exchange of personal data between the medical user element and the control device is enabled by the automatic assignment step. The medical system is furthermore designed to automatically initiate the automatic assignment step by means of an assignment coupling between the medical user element and the control device. The medical system is furthermore designed to enable a separation of the assignment coupling for medical operation of the medical system after the assignment step.

Abstract: A medical system is disclosed, which can be useable in particular for monitoring and/or controlling at least one bodily function of a user. The medical system comprises a control device and at least one medical user element embodied separately from the control device. The medical user element and the control device are designed to exchange data wirelessly. The medical system is designed to enable an automatic assignment step, wherein an exchange of personal data between the medical user element and the control device is enabled by the automatic assignment step. The medical system is furthermore designed to automatically initiate the automatic assignment step by means of an assignment coupling between the medical user element and the control device. The medical system is furthermore designed to enable a separation of the assignment coupling for medical operation of the medical system after the assignment step.

Abstract: Disclosed herein are methods of eliciting an immune response against a polyomavirus (for example, BKV serotype I (BKV-I), BKV serotype II (BKV-II), BKV serotype III (BKV-III) and/or BKV serotype IV (BKV-IV)) and methods of treating or inhibiting polyomavirus-associated pathology (such as polyomavirus-associated nephropathy, BKV-associated hemorrhagic cystitis, or JC virus-associated progressive multifocal leukoencephalopathy; PML). Further disclosed are immunogenic compositions of use in the disclosed methods. Also disclosed are methods of selecting an organ transplant donor and/or recipient including detecting whether the prospective donor and/or recipient has BKV serotype-specific (such as BKV serotype IV-specific) neutralizing antibodies.

Abstract: Methods and systems are disclosed for estimating a glucose level of a person having diabetes and selecting automatically open-loop and closed-loop control for a connected therapy delivery device. The method may comprise analyzing measured glucose results and corresponding impedance values received from a glucose sensor coupled to the person with a probability analysis tool implemented by a microcontroller to determine a total quality score that is based on the minimum constraint of a probability of glucose sensor accuracy determined measured glucose results and a probability of sensing quality determined from the impedance values. The microcontroller may estimate the glucose level of the person with a recursive filter based on the plurality of measured glucose results weighted with the total quality score and select automatically either open-loop control or closed-loop control for the connected therapy delivery device based on the value of the total quality score.

Abstract: A sensor may include a first substrate having a sensing portion defining a sensor thereon and configured to be percutaneously inserted into a patient, and an extracorporeal circuit mounting portion defining at least one electrically conductive pad that is electrically connected to the sensor. The sensor may produce a signal indicative of a condition of the patient. An anisotropic medium may be disposed on the circuit mounting portion and may be electrically conductive in a direction through the medium and electrically insulating in directions along the medium. A second substrate may be mechanically mounted to the circuit mounting portion of the first substrate via the anisotropic medium with at least one electrically conductive terminal juxtaposed over the at least one electrically conductive pad. The anisotropic medium may establish local electrical contact between the at least one electrically conductive terminal and the at least one electrically conductive pad.