890 results about "In vitro diagnostic" patented technology

A method for separating, or removing, particulate material, e.g., blood cells, from a sample of fluid, e.g., whole blood of a patient, in which the particulate material is suspended. In the case of separating blood cells from blood plasma or blood serum, the resulting samples of blood plasma or blood serum can be used for in vitro diagnostic applications. In normal practice, a whole blood sample of a patient are provided and then introduced into an apparatus that contains a flow channel. An acoustic field, which contains acoustic standing waves from external ultrasonic transducers, is located within the flow channel. Laminar flow is maintained in the flow channel. Blood cells and platelets are separated from blood plasma or blood serum at the end of the flow channel and collected. The method described herein allows fluid components to differentially migrate to areas of preferred acoustic interaction. The parameters that affect separation of particles are size, density, compressibility of the particles, and the fluid surrounding the particles.

Methods, computer program products and apparatus automate clinical NMR in vitro diagnostic analyzers. The clinical analyzer can automatically electronically monitor selected parameters and automatically electronically adjust parameters to maintain the analyzer within desired operational ranges. The clinical NMR analyzers can be configured as a networked system with a plurality of clinical NMR analyzers located at different use sites; and at least one remote control system in communication with one or a plurality of clinical NMR analyzers, the at least one remote system configured to monitor selected local operating parameters associated with a respective clinical NMR analyzer.

The present invention relates to an in vitro diagnostic method for malaria in an individual comprising placing a tissue or a biological fluid taken from an individual in contact with a molecule or polypeptide composition, wherein said molecule or polypeptide composition comprises one or more peptide sequences bearing all or part of one or more T epitopes of the proteins resulting from the infectious activity of P. falciparum, under conditions allowing an in vitro immunological reaction to occur between said composition and the antibodies that may be present in the tissue or biological fluid, and in vitro detection of the antigen-antibody complexes formed. The invention further relates to a polypeptide comprising at least one T epitope from a liver-stage specific protein produced by P. falciparum and a vaccine composition directed against malaria comprising a molecule having one or more peptide sequences bearing all or part of one or more T epitopes resulting from the infectious activity of P. falciparum in the hepatic cells.

The invention relates to a method of collecting saliva from the oral cavity for detecting a test substance, comprising the steps of (a) cleaning the oral cavity, (b) stimulating saliva secretion with a saliva-collecting solution, (c) removing the saliva-saliva collecting solution mixture from the oral cavity and collecting it in a container (1), (d) transferring the saliva-saliva collecting solution mixture into a sealable collection vessel.

The subject invention relates to the detection, diagnosis and risk stratification of clinical events such as acute coronary syndrome, in patients with signs and symptoms of suspected cardiac origin. In one embodiment, a clinical event in a patient is diagnosed by obtaining the patient's ECG, and at least one in vitro diagnostic assay, preferably an assay for a marker of ischemia, and optionally in vitro diagnostic assays for necrotic markers or other cardiac indicators, and combining the foregoing results in an algorithm to provide a diagnosis or a risk stratification of the clinical condition.

An adhesive is provided containing at least one synthetic polymer with receptor sites that enable the selective capture or release of a target molecule. A polymer is synthesized by polymerizing and cross-linking a functional monomer or functional copolymers in the presence of a target or template molecule allowing for reversible interactions between the polymer and the target molecule. The target molecule may be extracted from the polymer creating receptor sites complimentary to the target molecule. Alternatively, the target molecule may remain in the polymer network and be controllably released. The molecularly imprinted polymer is formulated into an adhesive. The adhesive can be used as a component in an in-vitro diagnostic device to release template molecules or to capture target molecules in vacated receptor sites in the synthetic polymer.

The present invention relates generally to methods of in vitro diagnostics, in particular the use of a compound selected from the group consisting of fibroblast growth factor 23 (FGF23), inorganic phosphorus (P), the product of inorganic phosphorus and total calcium (P×tCa), osteopontin (OPN) and parathyroid hormone (PTH) as biomarker. Said biomarkers can be used to monitor the modulation of fibroblast growth factor receptor (FGFR) kinase activity, in particular its inhibition, and/or the occurrence of secondary effects of FGFR inhibition. The invention further provides methods and kits relating to these uses.

The invention relates to an in vitro diagnostic kit for the determination of activated partial thromboplatin time (APTT) in clinical test. The invention consists of a partial thromboplatin reagent and a calcium chloride solution, which is used for the detection of the defects of the intrinsic coagulation pathway factors and the screening test of the related inhibitors, and the invention is also a primary means for the current coagulation factor and heparin anticoagulant treatment and the detection of lupus anticoagulant. The invention has the advantages of long stability time and good repeatability of the partial thromboplatin reagent after a re-dissolution, at the same time, the invention has better consistency of the measurement results of a blood coagulation analyzer by using an optical method and a magnetic bead method, therefore, the invention is applicable to large, medium and small hospitals, and the test results of different hospitals have comparability, therefore the invention has important meaning for implementing the one general report of test reports, provides the reliable experimental data for the clinical diagnosis and the treatment of diseases and improves the efficiency and value of the basic studies of thrombosis and hemostasis.

The invention relates to a diluent being capable of maintaining the high stability of enzyme marker solution and also relates to a method for preparing the diluent and applications thereof. The diluent comprises buffer solution, protein matrix solution, amino acid solution, sugar solution, a specific additive and a preservative. The diluent is a novel enzyme marker solution developed based on the characteristics of antibody protein and enzyme protein. With the adoption of the dilution, the stability of enzyme markers in storage and application can be effectively maintained. Tests show that the enzyme marker diluent can be stored at temperature of 37 DEG C for more than one week to fully meet the requirements for the quality of in-vitro diagnostic reagent kits. The diluent can be directly applied to the preparation of the in-vitro diagnostic reagent kits and meet the increasingly growing market demand for the in-vitro diagnostic reagent kits.

The present invention relates to an exemplary in vitro diagnostic (IVD) device used to detect the presence of and/or severity of neural injuries or neuronal disorders in a subject. The IVD device relies on an immunoassay which identifies biomarkers that are diagnostic of neural injury and/or neuronal disorders in a biological sample, such as whole blood, plasma, serum, cerebrospinal fluid (CSF). The inventive IVD device may measure one or more of several neural specific markers in a biological sample and output the results to a machine readable format wither to a display device or to a storage device internal or external to the IVD.

The present invention relates to a method for the early diagnosis of neoplastic disorders such as cancers as well as their precursor stages, particularly cancers of the respiratory tract, the urinary system, the reproductive tract, cancer associated with HPV infection or cancer of the anogenital tract, from solubilized body samples. The invention is also directed to test kits usable for this purpose as well as in-vitro diagnostic devices. The development of the kits and in-vitro diagnostic devices for the above purpose is also one aspect of the present invention.

A system is disclosed in which a plurality of in-vitro diagnostic (IVD) devices each include a network communication device for connecting to a publicly accessible data network. For example, IVD devices are provided with a cellular modern for connecting to a public cellular network. These IVD devices connect to the data network upon completion of a diagnostic test, and upload results of the test, as well as other appropriate data, to a remote device which is also on the network. The IVD devices also download appropriate data from remote network elements. The remote network element may be a network element such as a Hospital Information System (HIS) or Laboratory Information System (LIS) database. Alternatively, the remote device may be a remote server or another IVD device. This connectivity enables the system to accumulate diagnostic test data, and to analyze, report, and/or update the IVD devices based on the accumulated data.

The present invention provides processes for preparing freeze-dried platelets, freeze-dried platelets made by those processes, platelets reconstituted from those freeze-dried platelets, and kits comprising those freeze-dried platelets. The freeze-dried platelets of the invention have similar characteristics to fresh platelets, have an exceptionally long shelf-life, and can be used for all standard procedures in which fresh platelets are used, including both in vitro diagnostic and research procedures and in vivo therapies.

A repeatable method for detecting circulating tumor cells in vitro is provided. The method involves combining a test sample from a patient suspected of having circulating tumor cells, and a non-lytic adenoviral system, and culture media for the cells. The adenoviral system utilizes (i) a first replication-defective adenoviral particle in which an expression cassette is packaged, said expression cassette comprising an adenoviral 5′ and 3′ ITRs and a tumor-specific promoter; and (ii) a coding sequence for a reporter protein which is expressed in the presence of circulating tumor cells, and an adenoviral 3′ ITR. The test sample and the non-lytic adenoviral system are incubated for a sufficient time to permit expression of the reporter protein, and measuring reporter protein expression in the test samples, whereby presence of reporter expression indicates the presence of circulating tumor cells in the sample.

A portable apparatus for measuring a glucose level of a user having: a card-like member; a processor within the card-like member; at least one glucose sensor comprising a reagent, the glucose sensor generating a signal indicative of a measured glucose level upon application of a blood sample to the glucose sensor, wherein the glucose sensor is fixed to the card-like member and operably coupled to the processor; and at least one cover alterable between a first position in which the glucose sensor is covered and a second position in which the glucose sensor is exposed for use.

The present invention provides matched antibody pairs for the specific detection of one or more of the four dengue virus serotypes in a biological sample that may contain one or more of such dengue virus serotypes. Each matched antibody pair is capable of detecting not more than one serotype of dengue virus NS1 protein that may be present in the sample and will not cross react with other serotypes that may be present in the sample. Multiple matched pairs may be used to detect one or more dengue virus serotypes that may be present in a sample. Such matched pair antibodies, facilitate the development of confirmatory in vitro diagnostic tests such as sandwich immunoassays, that detect and distinguish the presence of one or more dengue virus serotypes in a biological sample, preferably a sample derived from human subject. The invention also provides kits comprising the matched antibody pairs of the invention and methods for using the kits for immunoassays for the specific detection of one or more serotypes of dengue virus in a patient population. The present invention also provides monoclonal antibodies specific for the NS1 protein of dengue virus and therapeutic compositions and methods for treating dengue virus infection.

A torque limiting tool is provided that has a handle and a body, which in certain embodiments may be assembled by an operator. The body of the torque limiting tool has a side portion with a tubing slot for allowing tubing to exit the torque limiting tool. The handle and body have one or more abutments, designed to allow the torque limiting tool to deliver a maximum amount of torque. The torque limiting tool may be used with an adapter to allow coupling with a variety of fitting sizes and shapes. The torque limiting tool may be adapted for use with a flat bottom port, such as in an analytical instrument, like liquid chromatography, gas chromatography, ion chromatography, or in in vitro diagnostic systems.