12 results about "Laboratory quality control" patented technology

The invention relates to the technical field of genetic engineering, and particularly provides a multi-linked quality control product for quality control of a novel coronavirus nucleic acid detection laboratory and a preparation method of the multi-linked quality control product. The multi-linked quality control product is a multi-component composite system and is formed by mixing three substances, namely pseudovirus, target gene RNA (Ribonucleic Acid) molecules and internal standard plasmid DNA (Deoxyribose Nucleic Acid). Wherein the pseudovirus is pseudovirus particles of novel coronavirus ORF1ab gene RNA (Ribonucleic Acid) wrapped by a vesicular stomatitis virus vector and is used for monitoring virus nucleic acid extraction; the target gene RNA molecule is a novel coronavirus N gene RNA molecule and can monitor the reverse transcriptase activity; the internal standard plasmid is plasmid DNA of a human housekeeping gene RPP30, and whether inhibition or failure exists in an amplification link is monitored. According to the method, the whole process of nucleic acid extraction, reverse transcription and amplification is synchronously and hierarchically monitored, the monitoring blind area of a traditional single-component quality control product is solved, and the accuracy and efficiency of laboratory detection quality control are remarkably improved.

The invention relates to the technical field of chemical analysis, in particular to a high performance liquid chromatography detection method for a mixture of D-mannitol and sodium gluconate. According to the method disclosed by the invention, by changing components of a mobile phase and diluting a sample in a proper proportion, complete separation of the D-mannitol and the sodium gluconate in a liquid chromatogram can be achieved, and meanwhile, the D-mannitol and the sodium gluconate are accurately and quantitatively detected. Linear, precision, repeatability, detection limit, quantitation limit and recovery rate experiments are carried out on the method for determining the content of D-mannitol and sodium gluconate, all the experiments meet the requirements of GB / T27404-2008 Laboratory Quality Control Standards, and it is proved that the method for determining the content is scientific and effective. The method disclosed by the invention is simple to operate, and by adopting the method disclosed by the invention, the detection time of each batch of samples is only 15 minutes, so that the detection efficiency is greatly improved.

The application belongs to the technical field of biological detection, and discloses a cardiovascular marker control article and a preparation method thereof. The cardiovascular marker control article comprises a serum matrix, antigens, a preservative and a stabilizer. The antigens include cardiac troponin I antigens, creatine kinase isoenzyme antigens, myoglobin antigens, amino-terminal brain natriuretic peptide precursor antigens, brain natriuretic peptide antigens, D-dimer antigens, heart-type fatty acid-binding protein antigens, myeloperoxidase antigens and lipoprotein phospholipase A2 antigens. The stabilizer includes at least one of D-trehalose, sucrose, glycine, inositol and polyethylene glycol. The cardiovascular marker control article can cover various cardiovascular disease markers, including heart failure, pulmonary embolism, vasculitis and atherosclerosis, myocardial injury, myocardial infarction and the like. The control article can be used as a third-party control article for indoor and inter-laboratory quality control of a cardiovascular disease screening and auxiliary diagnosis measurement system.

The present application relates to the technical field of genetic engineering, and specifically provides a multi-link quality control product for novel coronavirus nucleic acid detection laboratory quality control and a preparation method thereof. The multi-link quality control product is a multi-component composite system, which is formed by mixing three substances of a pseudo virus, a target gene RNA molecule and an internal standard plasmid DNA. The pseudo virus is a pseudo virus particle of a vesicular stomatitis virus vector wrapping a novel coronavirus ORF1ab gene RNA, which is used for monitoring virus nucleic acid extraction; the target gene RNA molecule is a novel coronavirus N gene RNA molecule, which can monitor reverse transcriptase activity; and the internal standard plasmid is a plasmid DNA of a human source housekeeping gene RPP30, which monitors whether there is inhibition or failure in the amplification link. The present application realizes synchronous layered monitoring of the whole process of nucleic acid extraction, reverse transcription and amplification, solves the monitoring blind area of traditional single-component quality control products, and significantly improves the accuracy and efficiency of laboratory detection quality control.

The invention belongs to the technical field of detection, and particularly discloses a measurement uncertainty evaluation method for measuring immune factors in serum by an ELISA (enzyme-linked immuno sorbent assay) method. According to the method, ELISA detection is carried out on immune factors (such as IL-1beta) in serum of an experimental animal in contact with a medical instrument according to standards such as GB / T16886.20-2015, system analysis comprises nine types of uncertainty sources such as repeated detection, standard substance preparation and sample dilution, the standard uncertainty of each component is calculated through mathematical methods such as rectangular distribution and a least square method, and the standard uncertainty of each component is calculated according to the standard uncertainty. And synthesizing the standard uncertainty and calculating the expansion uncertainty, and finally outputting a standard detection result. The method comprehensively covers the uncertainty source, is rigorous in computational logic and clear in key quality control factors, provides a scientific and complete uncertainty evaluation scheme for medical instrument immunogenicity evaluation and immune factor determination in other experimental scenes, is beneficial to laboratory quality control and detection result optimization, and has wide practicability.

The invention relates to the technical field of chemical analysis and detection, in particular to a high performance liquid chromatography detection method of vitamin C fermentation liquor. According to the method disclosed by the invention, the detection of the raw material sorbitol and the product sorbose in the one-step fermentation process of the vitamin C and the detection of the raw material sorbose and the product L-gulonic acid in the two-step fermentation process of the vitamin C are realized, the complete separation of the sorbitol and the sorbose as well as the sorbose and the L-gulonic acid in a liquid chromatogram can be achieved, and meanwhile, the sorbitol, the sorbose and the L-gulonic acid are quantitatively detected. The linearity, the precision, the repeatability, the stability, the recovery rate, the detection limit and the quantitation limit of the method for measuring the content of the sorbitol, the sorbose and the L-gulonic acid all meet the requirements of GB / T27404-2008 Laboratory Quality Control Standard, and it is proved that the content measuring method is scientific and effective. The method disclosed by the invention is simple to operate, the detection time of each batch of samples is only 12 minutes, and three substances in two-step fermentation are simultaneously detected by one liquid phase, so that machines are saved, and meanwhile, the detection efficiency is greatly improved.

The utility model relates to the technical field of medicine storage devices, in particular to a laboratory quality control product and calibration product subpackage storage box which can well carry out subpackage on quality control products and calibration products, avoids the situation of disordered placement in the storage process, brings convenience to workers for searching and brings convenience to the workers. Comprising a box body, a pick-and-place opening is formed in the front end of the box body, an end cover rotationally covers the pick-and-place opening through a hinge, two sets of lock catches are arranged between the top end of the end cover and the box body in a matched mode, sponge base plates are fixedly connected to the top ends of the two sides of a T-shaped subpackaging table, and multiple rows of positioning holes are formed in the two sets of sponge base plates at equal intervals; sub-packaging distinguishing plates are fixedly arranged on the front sides of the top ends of the two sets of sponge base plates, a plurality of sets of number plates are arranged on the vertical faces of the two sides of the T-shaped sub-packaging table at equal intervals, two sets of medicine bottles are clamped to the multiple sets of sub-packaging clamps through matching of arc-shaped clamping grooves, each set of medicine bottles are inserted into the multiple positioning holes respectively, and bottle caps cover the tops of the multiple sets of medicine bottles in a screwed mode.

The invention relates to the field of intelligent medical treatment, in particular to a construction method and equipment of a laboratory quality control model and a program product. The method includes: acquiring a laboratory detection sample data set; constructing a first-grade quality control grade of laboratory quality, wherein each grade corresponds to different scores; performing index quantification on the score of any one first-level quality control grade to obtain L second-level quantitative indexes; calculating L secondary quantitative index scores of the laboratory sample data, and constructing a weight matrix; calculating and obtaining a quality control score based on the secondary quantitative index score and the weight matrix; based on the quality control score, positioning a second-level quantitative index of the last three digits of contribution degree sorting, and marking the second-level quantitative index as a core optimization factor; and decomposing the core optimization factor into a standard variable and a non-standard variable, optimizing the non-standard variable, and repeating the steps until the quality control score of the laboratory sample reaches a preset quality control score, thereby obtaining the quality control model of the medical examination laboratory. The application has good clinical value.

This invention provides a vibration testing capability verification sample and method based on the test resonant frequency, belonging to the field of capability verification technology. The method includes: participating laboratories fixing the obtained verification sample on the table surface of a vibration testing rig; installing control sensors and monitoring sensors according to pre-compiled capability verification guidelines; wherein, the control sensors are used to detect the test frequency, and the monitoring sensors are used to monitor the resonant frequency; starting the vibration testing rig and conducting the test according to the vibration test conditions, and measuring the resonant frequency through the monitoring sensors; evaluating the resonant frequency measured by each participating laboratory according to pre-established evaluation criteria, thereby verifying the vibration testing capability of each laboratory. Using the verification sample and verification method provided by this invention, a comprehensive examination of the human, machine, material, method, environment, and measurement factors during the vibration testing process in participating laboratories can be conducted, while simultaneously identifying differences between laboratories, promoting the improvement of laboratory vibration testing technology, and enhancing the laboratory quality control level.

The invention relates to the technical field of genetic engineering and molecular detection, and particularly provides a quality control product for nucleic acid detection of bacillus plague and virulence genes thereof as well as a preparation method and application of the quality control product, and comprises a recombinant artificial chromosome vector, an engineering bacterium and a preparation method and an application scene of the engineering bacterium. The artificial chromosome engineering bacteria are constructed by designing and preferably selecting conserved target sequences of four bacillus plague detection key genes, so that the problems of poor biological safety, insufficient stability and limited broad spectrum of a traditional quality control product are solved, clinical sample characteristics can be effectively simulated, nucleic acid stability and batch-to-batch consistency are ensured, and the application prospect is wide. A standardized reference system is provided for nucleic acid detection of the bacillus plague, and the method can be widely applied to the fields of laboratory quality control and public health safety prevention and control.

The invention discloses a laboratory quality control data management method, and relates to the technical field of big data management, and the method comprises the steps: obtaining laboratory quality control data, and carrying out the classification according to the food category, and obtaining a plurality of quality control data sets; performing trend consistency analysis on a plurality of pieces of detection category data in the quality control data sequence to obtain category credibility; performing category integrity analysis on the quality control data sequence to obtain integrity credibility; screening to obtain quality control data sequences of a plurality of same storage places, and performing transverse trend consistency analysis to obtain transverse credibility; and performing weighted calculation on the category credibility, the integrity credibility and the transverse credibility to obtain comprehensive credibility, performing credibility grading on the quality control data sequence, performing hierarchical storage, and performing laboratory quality control data management. The technical problem of poor quality control data management effect in the prior art is solved.