189 results about "Vitro diagnostics" patented technology

The invention relates to a method for the in vitro diagnosis of Alzheimer's disease using a monoclonal antibody. Said antibody can bind at least to amino acids 12-16 of the β-amyloid peptide, specifically detecting the neuritic plaques which are characteristic of Alzheimer's disease, without detecting diffuse plaques which are not defining characteristics of the disease. Within the neuritic plaques, the monoclonal antibody can detect a different sub-group in the composition of the different deposited isoforms of the β-amyloid peptide, which is associated with the disease progression stage. In addition, the antibody can bind to isoforms of the β-amyloid peptide in biological fluids such as urine. As a result, the inventive monoclonal antibody, the cell lines that produce said antibody and compositions containing same can be used in the in vitro diagnosis of Alzheimer's disease and in determining the disease progression stage.

The invention relates to a diagnosing reagent for hepatitis B, disclosing detection grains for e antigens of the hepatitis B virus, which are of the luminous grains coated by anti-HBE antibodies. The invention also discloses preparation and application for the detection grains for e antigens of the hepatitis B virus; moreover, the invention further discloses an outside-body diagnosis reagent box for detecting e antigens of the hepatitis B in a blood serum sample of human beings as well as a method for utilizing the light excitation chemiluminescence principle to quantitatively and qualitatively detect e antigens of the hepatitis B virus. The reagent box of the invention can be jointly used to diagnose the individual acute or chronic hepatitis B together with other blood serums and clinic information, and screen the hepatitis B for women in the perinatal period so as to judge the risk of newborn babies contaminating the hepatitis B.

The present invention relates to a method and kit for in vitro diagnosing a complex disease such as cancer, in particular, acute myeloid leukemia (AML), colon cancer, kidney cancer, prostate cancer; transient ischemic attack (TIA), ischemia, in particular stroke, hypoxia, hypoxic-ischemic encephalopathy, perinatal brain damage, hypoxic-ischemic encephalopathy of neotatals asphyxia; demyelinating disease, in particular, white-matter disease, periventricular leukoencephalopathy, multiple sclerosis, Alzheimer and Parkinson's disease; in a biological sample. For the diagnosis, use is made of measuring at least two different species of biomolecules and classifying the results by means of suitable classifier algorithms and other statistical procedures. With the present invention, a significant improvement of the reliability of e.g. expression profiles alone, are achieved. In other words, in a defined collective, an up to 100% accurate positive diagnosis could be achieved, which renders the method of the present invention superior over the prior art.

The invention relates to a method for the in vitro diagnosis of Alzheimer's disease using a monoclonal antibody. Said antibody can bind at least to amino acids 12-16 of the β-amyloid peptide, specifically detecting the neuritic plaques which are characteristic of Alzheimer's disease, without detecting diffuse plaques which are not defining characteristics of the disease. Within the neuritic plaques, the monoclonal antibody can detect a different sub-group in the composition of the different deposited isoforms of the β-amyloid peptide, which is associated with the disease progression stage. In addition, the antibody can bind to isoforms of the β-amyloid peptide in biological fluids such as urine. As a result, the inventive monoclonal antibody, the cell lines that produce said antibody and compositions containing same can be used in the in vitro diagnosis of Alzheimer's disease and in determining the disease progression stage.

The present invention provides non-small cell lung cancer markers and the use thereof. The non-small cell lung cancer markers in the present invention include at least one of the 26 selected detectable mature microRNAs existing stably in human serum or plasma. The invention also provides a probe combination, kit and biochip for detecting the non-small cell lung cancer markers. The invention further provides a method for detecting microRNAs in the serum of lung cancer patients. By detecting the variations of microRNAs in the serum of lung cancer patients, the disease can be diagnosed in vitro; the progression course of the disease can be predicted; the occurrence of complications, the rate of relapse and the prognosis of the disease can be monitored; the drug efficacy and therapeutic effects can be analyzed. The method in the present invention enables extensive detection spectrum, high sensitivity, low cost, convenient sample taking and preservation. The method can be applied in the general survey of disease, solves problems of the low specificity and sensitivity encountered with previous single markers, and increases significantly the clinical detection rate of diseases, all of which make it an effective means for diagnosing diseases at an early stage.

This invention provides primers for in vitro diagnosis of mutation of autosomal recessive nonsyndromic hearing loss gene GJB2. The primers can be used for completely amplifying the coding region and upstream or downstream important splicing sequences of GJB2 gene. This invention also provides a test kit for containing the primers and ApaI restriction endonuclease and their application for in vitro detection of 233-235delC mutation of the complete GJB2 coding region. The test kit can also be used for detecting the mutation sites of the GJB2 coding region through sequencing by the forward primer, and detecting deletion or insertion heterozygous mutation through sequencing by the reverse primer. The test kit is suitable for large-scale screening of autosomal recessive nonsyndromic hearing loss gene GJB2 mutation and genetic counseling.

The invention relates to the field of medical immunology in vitro diagnosis, and especially provides a detection kit for detecting cystatin C in serum. The detection kit comprises a reagent R1, a reagent R2 and calibration materials. The ingredients of the reagent R1 are a Tris buffer with a concentration of 0.01-0.05mol / L, PEG 6000 with a concentration of 10-40g / L, NaN3 with a concentration of 0.5-1.5g / L, and sodium chloride with a concentration of12-20g / L, and the pH value is 8.0-8.5. The ingredients of the reagent R2 are a Tris buffer with a concentration of 0.01-0.02mol / L, and polystyrene latex granules coated by goat-anti-human cystatin C polyclonal antibodies with a concentration of 0.5-3.0 g / L. The calibration materials are six gradient standards with cystatin C and the contents of cystatin C are 0.1, 0.5, 1.0, 2.0, 4.0 and 8.0mg / L. The solution is a Tris buffer with a concentration of 0.01mol / L. The kit has simple composition, good stability and high accuracy.

The invention belongs to external diagnosis field, and more specifically relates to a test strip card capable of filtering a sample and having a store medium (15) for storing detection information such as standard curve or coefficient parameter of a detected object. The test strip card comprises a card box (3) and a test strip (2). One end of the card box (3) is opened to form a test strip slot opening (12). The test strip (2) is a separated type plug structure of the card box (3). The store medium (15) is arranged on the card box (3). When the sample is detected, one end of a sample suction pad (4) of the test strip (2) inserted in the card box (3) stretches out of an opening end of the card box (3) for dipping and absorbing the sample, an apparatus having signal detection function collects characteristic signal of a detection strip (7) and a quality control strip (8) of the test strip (2), and combines the standard curve or coefficient parameter of the detected object read through the store medium (15) by the apparatus to obtain the concentration of a sample monocomponent or multiple components. The test strip card for detecting the sample has the characteristics of simple and rapid process, high sensitivity, objective result and flexible usage.

The invention relates to a kit and a method for predicting a hepatocarcinogenesis risk, relating to the technical field of medical in-vitro diagnosis. Particularly, the invention relates to a kit anda method for predicting a hepatocarcinogenesis risk through the CpG island methylation states of single genes or multiple genes in SCT, NFIX, IGF2, ABCG5, GSTO2, SARDH, E2F6, SHANK2, GATA4, OPLAH, NR2F1 and ZFHX3. According to the combined methylation detection of the multiple genes, the sensitivity is greatly improved; the free nucleic acids of saliva, urine, blood and the like are detected, drawing materials from cancer tissue is not required, the detection is noninvasive, and the operation is simple and convenient.

The invention belongs to the field of in-vitro diagnosis and particularly relates to a quantum dot immunochromatographic strip for synchronously quantifying multiple tumor markers and a method of the quantum dot immunochromatographic strip. The quantum dot immunochromatographic strip is characterized in that a marking pad (3) is coated with a mixture of various tumor marker antibodies marked corresponding to quantum dots with different wavelengths, a belt T (4) of an analyzing membrane (7) is coated with a mixture of various tumor marker antibodies, and a belt C (5) of the analyzing membrane (7) is coated with secondary antibodies; a standard curve of each tested object is stored in an electronic tag manner and the electronic tags are mounted on the immunochromatographic strip. According to the quantum dot immunochromatographic strip, a detection instrument having a signal detection function is utilized for reading standard curve data stored in the electronic tags and synchronously and quantitatively detecting concentrations of the various tumor markers in a to-be-detected sample by combining the corresponding fluorescence intensity of the to-be-detected sample measured by the detection instrument.

A method for in vitro diagnosis of atherosclerosis, comprising: (a) obtaining a sample from a subject; (b) determining expression levels of one or more microRNAs (miRNAs) as atherosclerotic biomarkers and an internal control RNA; (c) computing the relative expression levels of the one or more miRNAs as atherosclerotic biomarkers; (d) computing a prediction model with one or more variables, wherein the variable includes one or more relative expression levels of the one or more miRNAs as atherosclerotic biomarkers and one or more risk factors of atherosclerosis; and (e) computing a prediction probability by the prediction model, wherein the subject is diagnosed with atherosclerosis if the probability is more than 0.5 is presented. A kit for in vitro diagnosis of atherosclerosis or prognosis of atherosclerosis-inducing diseases is also presented.

The present invention describes a method for the in vitro diagnosis, prognosis and / or treatment monitoring of neurodegenerative, neurological and inflammation-based diseases, wherein the method comprises the steps: a) isolating microglial microvesicles (MVs) from biological fluids obtained from an individual; b) collecting the microRNA (miRNA) contained into said MVs; c) determining the expression profile of a predetermined set of miRNA; d) comparing said expression profile to one or several reference expression profiles, wherein the comparison of said determined expression profile to said one or several reference expression profiles allows for the diagnosis, prognosis and / or treatment monitoring of the disease.

The invention relates to the field of in-vitro diagnosis, particularly a test strip card based on quantum dot labeling. The test strip card comprises a card box (3) and a quantum dot labeling test strip (2), wherein one end of the card box (3) is open to form a test strip slot (13), and the test strip (2) is in a card box (3) instant-plug structure; and the card box (3) is provided with a storage medium (14) in which a sample tested object standard curve and other information are stored. When detecting a sample, one end of a shape suction pad (4) of the test strip (2) inserted into the card box (3) excessively protrudes out of the open end of the card box (3) so as to impregnate and absorb the sample, and an instrument with signal detection function acquires characteristic signals of a test strip (2) detection belt (6) and a quality control belt (7) and calculates the sample single component or multicomponent concentration in combination with tested object standard curve or coefficient parameters simultaneously red from the storage medium (14) by the instrument. The test strip card for detecting samples has is simple and quick, and has the characteristics of high sensitivity, objective result, high use flexibility and the like.

The invention belongs to the technical field of biology, and particularly relates to a compound stabilizer and a kit for in vitro diagnosis reagents. The compound stabilizer comprises a sealing agent, a surfactant, a micromolecule organic reductant, a nucleic acid ingredient stabilizer, a biological active substance protecting agent and a biological preservative. The compound stabilizer can be universally applied to various in vitro diagnosis reagents and has better reagent stabilizing effect, and validity period of the reagents is prolonged effectively.

The invention relates to the field of in-vitro diagnosis, particularly a test strip card based on quantum dot labeling. The test strip card comprises a card box (3) and a quantum dot labeling test strip (2), wherein one end of the card box (3) is open to form a test strip slot (12), and the test strip (2) is in a card box (3) instant-plug structure; and the card box (3) is provided with a storage medium (13) in which a sample tested object standard curve and other information are stored. When detecting a sample, one end of a sample suction pad (4) of the test strip (2) inserted into the card box (3) excessively protrudes out of the open end of the card box (3) so as to impregnate and absorb the sample, and an instrument with signal detection function acquires characteristic signals of a test strip (2) detection belt (6) and calculates the sample single component or multicomponent concentration in combination with tested object standard curve or coefficient parameters simultaneously read from the storage medium (13) by the instrument. The test strip card for detecting samples has is simple and quick, and has the characteristics of high sensitivity, objective result, high use flexibility and the like.

The invention discloses a breast tumor prognosis biomarker LncRNA detection method and clinical application thereof, provides a group of new LncRNA in sequence shown as SEQ ID No1, SEQ ID No2, SEQ ID No3, SEQ ID No4 and SEQ ID No5 and relates to a method of taking specific LncRNA in samples (tissues, serum, urine, body fluid and the like) of patients suffering from breast tumors and corresponding juxtacancerous samples or normal samples as detection markers and biomarkers for prognostic auxiliary detection of breast tumors, related kits and a high-throughput sequencing and screening method. In-vitro diagnosis and judgment of canceration and process of breast tumors are realized by identification of differences of LncRNA expression quantity in the breast tumor samples and the corresponding juxtacancerous samples or normal samples. The invention further provides usage of the LncRNA as a breast tumor marker and probes and primers for LncRNA detection.

The present invention relates to a method for determining the extracellular volume status of a subject. The method comprises determining in a sample obtained from a subject the level of the marker proadrenomedullin (proADM) or a fragment thereof, preferably MR-proADM. Further, based on the level of proADM or a fragment thereof, the fluid balance is determined and wherein said fluid balance determines the extracellular volume status. Further, based on the level of proADM or a fragment thereof, the salt balance is determined and wherein said salt balance determines the extracellular volume status and salt retention. Further, the invention relates to a method for in vitro diagnosis, risk stratification, therapy control and / or operative control of a disorder or medical condition in a subject, wherein said extracellular volume status and salt retention of said subject is determined by the herein provided method. Further, the invention relates to a kit and / or a diagnostic device for carrying out the herein provided method.

The invention relates to the technical field of in vitro diagnosis, and concretely relates to a multiple-detection kit for vaginitis. The kit comprises a kit body and a kit cover, a detection card and a sample processing solution bottle are arranged in kit body, the detection card comprises a card cover and a card body, a Gardnerell avaginalis test strip, a Candida albicans test strip and a Trichomonas vaginalis test strip are arranged in the card body, and each of the Gardnerell avaginalis test strip, the Candida albicans test strip and the Trichomonas vaginalis test strip is provided with a first sample pad layer and a second sample pad layer treated with the sample pad treatment fluid. The kit can decompose and filter out interfering substances in vaginal secretions, so the sensitivity of the kit is improved.

The invention relates to a chemiluminescence immunoassay kit of a hepatitis E virus IgM antibody and a preparation method thereof, which belongs to the technical field of clinical in-vitro diagnosis immunoassay. The preparation method of the kit comprises the following steps: the reference substance is prepared according to the negative and the positive serums of the hepatitis E virus IgM antibody; a solid phase carrier is coated by an anti-human-mu chain anti-body (monoclonal antibody or polyclonal antibody); the recombinant antigen of the hepatitis E virus is labeled by enzyme; a chemiluminescent substrate solution acted by the enzyme is prepared; a concentrated cleaning solution is prepared; the negative reference substance, the positive reference substance, the labeled combination, the chemiluminescent substrate and the concentrated cleaning solution of the hepatitis E virus IgM antibody are subpackaged; and all the components are assembled into finished products. The prepared kit has stable performance indexes (specificity, sensitivity and stability) and can be applied to the early diagnosis of the hepatitis E.

The invention discloses an in-vitro diagnosis analyzer and a reagent card. The reagent card comprises a reagent card body and a mounting body, wherein the mounting body comprises a mounting hole for sleeving a sample tube, a hollow needle arranged in the mounting hole, a sealing part arranged in the mounting hole, and an air inlet channel; one end of the hollow needle can be inserted into the sample tube, the sealing part is in sealing fit with an outer wall of the sample tube, the air inlet channel comprises an air outlet hole, an air inlet hole formed in a surface of the reagent card body and a first flow stopping structure arranged between the air outlet hole and the air inlet hole, and the air outlet hole is used for being communicated with the sample tube arranged on the mounting hole; wherein the reagent card body comprises a sample injection channel communicated with a liquid outlet end of the hollow needle, a detection cavity and a gas receiving end, and the sample injection channel and the gas receiving end are communicated with the detection cavity. The reagent card adopts a new sample liquid on-off control scheme, and can solve the hidden danger that the sample liquid leaks and cannot be extracted. When the in-vitro diagnosis analyzer is used, the reliability of detection can be improved.

The invention belongs to the field of in-vitro diagnosis, and concretely relates to a quantum-dot marking test strip capable of quantitatively determining multiple indexes of blood infectious diseases and a preparation method and a quantitative determination method. A marking pad (3) of the test strip is coated with a quantum-dot marked mixture of HBsAg monoclonal antibody, HIVAg, HCVAg and TPAg, a T band (4) of an analysis membrane (7) is coated with a mixture of HBsAg monoclonal antibody, HIVAg, mouse anti-human antibody and TPAg, and a C band (5) of the analysis membrane (7) is coated with secondary antibody. The standard curves of all detected substances are stored and installed on the test strip by employing electron labels. The test strip employs a detector with signal detection function to read the standard curves stored in the electron labels and combines with the to-be-tested sample corresponding fluorescence intensity measured by the detector, so as to synchronously quantitatively determine the concentration of HBsAg, HIVAb, HCVAb and TPAb in the samples.

The invention belongs to the field of in-vitro diagnosis, and particularly relates to a test strip card which is provided with a storage medium (14) for storing a tested object standard curve, coefficient parameters or other detection information. The test strip card comprises a card box (3) and a test strip (2), wherein one end of the card box (3) is open to form a test strip slot (13), and the test strip (2) is in a card box (3) instant-plug structure; and a storage medium (14) is installed on the card box (3). When detecting a sample, one end of a shape suction pad (4) of the test strip (2) inserted into the card box (3) excessively protrudes out of the open end of the card box (3) so as to impregnate and absorb the sample, and an instrument with signal detection function acquires characteristic signals of a test strip (2) detection belt (6) and a quality control belt (7) and calculates the sample single component or multicomponent concentration in combination with the tested object standard curve or coefficient parameters simultaneously red from the storage medium (14) by the instrument. The test strip card for detecting samples has is simple and quick, and has the characteristics of high sensitivity, objective result, high use flexibility and the like.

The invention relates to a method for rapidly detecting a human leucocyte antigen B27 (HLA-B27) and an in-vitro diagnosis kit, which belong to the technical field of medical biology. In the kit, a pair of HLA-B27 specific primers and a specific fluorescent probe are adopted for rapidly detecting the HLA-B27. In the kit, the pair of HLA-B27 specific primer and the specific fluorescent probe can beused for rapidly and accurately detecting HLA-B27 genes in samples such as human peripheral blood and the like, and the kit has the advantages of high specificity, high sensitivity, time saving, labor saving, low cost, high flux and the like, and can be applied to auxiliary diagnosis of multiple spondyloarthropathies which severely endanger human health such as clinical ankylosing spondylitis, Reiter syndrome, psoriatic arthritis, ulcerative colitis accompanying arthropathy, acute anterior tract uveal, and the like.

Subject of the present invention are assays and in vitro methods for the in vitro diagnosis, prognosis and risk stratification of a patient having a primary, non-infectious disease, whereby the level of Procalcitonin (PCT) in a sample of a body fluid of the patient is indicative for the risk of the patient to contract a further disease or medical condition.

Belonging to the in vitro diagnosis field, the invention in particularly relates to a test strip card with a storage medium (13) for storing a detected object standard curve or coefficient parameter and other information for the detection. The test strip card includes a card box (3) and a test strip (2). One end of the card box (3) is opened to form a test strip slot opening (12). The test strip (2) is a detachment plug structure of the card box (3). The storage medium (13) is mounted on the card box (3). During sample detection, one end of a sample absorbing pad (4) in the test strip (2) inserted into the card box (3) interferes and extends out of the opening end of the card box (3) to soak and absorb the sample. Then an instrument with a signal detection function collects the characteristic signal of a detection band (6) in the test strip (2). And by combining the instrument, the detected object standard curve or coefficient parameter are read at the same time from the storage medium (13), so that a sample single-component or multicomponent concentration can be calculated. The test strip card for sample detection provided by the invention has the characteristics of simplicity, rapidity, high sensitivity, subjective result, and flexible application, etc.

The invention relates to a latex enhanced immunoturbidimetric detection kit for retinol binding protein and an application thereof in clinical detection of content of retinol binding protein (RBP4) inserum, and belongs to the field of in vitro diagnosis of medical immunology. The RBP latex enhanced immunoturbidimetric detection kit provided by the invention adopts recombinant expressed rhRBP4 asa calibration product, a quality control product and related rabbit polyantibody immune antigens, and the rabbit polyantibody, the rhRBP4 calibration product and the quality control product are used for preparing the latex enhanced immunoturbidimetric detection kit, and the content of RBP4 in blood can be accurately detected. Compared with commercial products, the kit has better specificity and higher accuracy, and shows better clinical application prospect. Besides, the recombinant expression method of the rhRBP has the characteristics of short period, large expression amount and low cost, and improves the quality uniformity of related products to a great extent.

The invention discloses a kit for early diagnosis of bladder cancer and a method for preparing the kit, and relates to the field of biomedical immune analysis. The detecting kit, which is fast, sensitive, highly specific in the early diagnosis of the bladder cancer is created by detecting a tumor marker of the bladder cancer tumor marker, namely, abnormally glycosylated integrin AG-alpha3beta, in human urine by means of microplate chemiluminescence immunoassay. The kit provided by the invention has the advantages of simplicity, convenience, quickness, sensitivity, high specificity, stability and the like, can be applied to early screening of the bladder cancer in a routine examination and to tracking observation and prognostic evaluation of the bladder cancer, and can satisfy the need that the existing in-vitro diagnosis of the bladder cancer is lack in specific diagnosis method.

The invention provides an inter-batch quality control method for external diagnostic reagents. The inter-batch quality control method comprises the following steps of printing bar codes including information about external diagnostic reagent kinds and production batch numbers on boxes containing solid or semisolid materials, such as external liquid diagnostic reagents or test paper strips and sheets, and comparing the information carried by the external diagnostic reagents with immediately updated dates of manufacture, batch numbers, correction factors, calculation formulas and formula key coefficients in a storage medium to be corrected. The storage medium comprises a built-in memory disc, a USB flash disk, a mobile hard disk drive or a self-control storage medium. According to the inter-batch quality control method for the external diagnostic reagents provided by the invention, a system can find out relevant information of correction factors and the like to accomplish the marking in the detection process without resetting marks when products of different batches appear, thus the cumbersome work of remarking due to the exchange of the product batch numbers is avoided.

The invention relates to an in-vitro method for diagnosing Von Willebrand Disease (VWD) and an increased bleeding risk associated with Von Willebrand Disease and / or acquired or congenital platelet function defects that reduce the interactions of Von Willebrand Factor (VWF) with platelets. The in-vitro method of the invention may also be used to diagnose further bleeding risks. The test is suitable for use as a screening test based on whole blood and has the additional benefit of being suitable as a point of care test. The method involves the incubation of a sample containing platelets and hemostasis factors with an activator of platelet aggregation and the measurement of the viscoelastic change after inducing coagulation, e.g., by means of thromboelastography (TEG).