Human umbilical cord blood stem cell detection and screening system

Abstract

The invention relates to the field of umbilical cord blood stem cell detection, and particularly discloses a human umbilical cord blood stem cell detection and screening system which is used for judging whether the quality of umbilical cord blood stem cells is qualified or not by detecting cell viability related indexes, microbiological indexes, immune related indexes and genetic indexes of the umbilical cord blood stem cells. The reliability of umbilical cord blood stem cell detection and screening results is improved, and the safety and effectiveness of umbilical cord blood stem cells in clinical application are ensured; the method comprises the following steps: acquiring operation information of an acquisition link, a transportation and storage link and a detection link of a human umbilical cord blood sample, judging whether the operation of each link meets requirements or not, tracing reasons for unqualified quality detection of umbilical cord blood stem cells, further analyzing each manual misoperation link associated with each unqualified quality detection item of the human umbilical cord blood sample, and determining whether the human umbilical cord blood stem cells are unqualified. A traceability model for abnormal detection of the umbilical cord blood stem cells is constructed, and a certain reference is provided for subsequent detection and screening of the umbilical cord blood stem cells.

Description

Technical Field

[0001] The present invention relates to the field of umbilical cord blood stem cell detection, and more particularly to a human umbilical cord blood stem cell detection and screening system. Background Art

[0002] Umbilical cord blood stem cells are a special type of stem cells extracted from the umbilical cord and placenta of newborns. These stem cells are rich in hematopoietic stem cells and mesenchymal stem cells and can differentiate into various types of cells, such as blood cells, immune cells, bones, cartilage, connective tissue, etc. Umbilical cord blood stem cells are regarded as an important resource for regenerative medicine and transplantation medicine because of their wide sources, painless collection process and low risk.

[0003] Therefore, testing and screening of umbilical cord blood stem cells is a key step and necessary means to ensure their safety and effectiveness in clinical applications, and is also an important guarantee to meet the growing clinical needs.

[0004] However, the existing umbilical cord blood stem cell detection and screening technology still has some limitations and shortcomings in practical applications.

[0005] For example, the existing Chinese patent with publication number CN102618438A discloses a detection and screening system for umbilical cord blood stem cells, including a central control and processing device, an input device, an operating platform, an umbilical cord blood collection unit, a stem cell quantity and proliferation ability detection unit, a microbial detection unit, an epidemiological detection unit, and an HLA tissue matching unit. The central control and processing device is respectively connected to the operating platform, the umbilical cord blood collection unit, the stem cell quantity and proliferation ability detection unit, the microbial detection unit, the epidemiological detection unit, and the HLA tissue matching unit. The detection and screening system of the invention, through the combination of multiple components, enables the umbilical cord blood stem cells to be stored as soon as possible after collection, thereby improving the survival rate of umbilical cord blood stem cells, ensuring the safety of use, and also providing various necessary clinical data for subsequent storage, utilization and use.

[0006] For example, the existing Chinese patent with publication number CN106350449A discloses a detection and screening system for umbilical cord blood stem cells, including: a collector, a separation and purification kit, a cell culture apparatus, a low-temperature centrifuge, a whole blood cell analyzer, an information collection device, and a printing device. The invention uses a collector, a separation and purification kit, a cell culture apparatus, a low-temperature centrifuge, and a whole blood cell analyzer to allow the collected umbilical cord blood to be simply and accurately detected and screened, while also optimizing the detection steps and processes, making the detection of the collected umbilical cord blood faster, more efficient, and more timely, significantly reducing the detection cost, avoiding resource waste, and reducing the total detection time.

[0007] The above patent realizes the collection and detection screening of umbilical cord blood stem cells through a series of technical means. However, after the screening of umbilical cord blood stem cells is completed, there is no further analysis of the umbilical cord blood stem cells that fail the quality inspection, such as tracing the cause of the unqualified umbilical cord blood stem cells. If it is caused by improper human operation during the collection, storage or testing process, corresponding improvement measures need to be taken to standardize the operational procedures for umbilical cord blood stem cell detection and screening. Summary of the invention

[0008] In view of the above problems, the present invention proposes a human umbilical cord blood stem cell detection and screening system to achieve the function of detecting umbilical cord blood stem cells.

[0009] The technical solution adopted by the present invention to solve its technical problem is: the present invention provides a human umbilical cord blood stem cell detection and screening system, including: a detection index information acquisition module: used to detect the collected human umbilical cord blood samples, and obtain cell activity-related index information, microbiological index information, immune-related index information, and genetic index information of the umbilical cord blood stem cells in the human umbilical cord blood samples.

[0010] Cell quality comprehensive assessment and screening module: used to analyze the compliance coefficients of cell activity-related indicators, microbiological indicators, immune-related indicators, and genetic indicators of umbilical cord blood stem cells in human umbilical cord blood samples, and determine whether the quality test of umbilical cord blood stem cells in human umbilical cord blood samples is qualified. If qualified, the human umbilical cord blood samples are placed in the designated area. If unqualified, the cell test failure reason analysis module is executed.

[0011] Cell test failure reason analysis module: used to obtain the operational information of the collection, transportation, storage and testing links of human umbilical cord blood samples, and determine whether the operation of each link meets the requirements. If they all meet the requirements, the reason for the failure of the umbilical cord blood stem cell quality test is the defects of the cells themselves. Otherwise, the reason for the failure of the umbilical cord blood stem cell quality test is improper human operation, and each link of improper human operation is obtained and feedback is provided.

[0012] Cell detection abnormality traceability model construction module: used to obtain each human umbilical cord blood sample that fails the umbilical cord blood stem cell quality test due to improper human operation during the monitoring period, record it as each human umbilical cord blood sample with cell detection abnormality, obtain each quality inspection unqualified item and each corresponding improper human operation link of each human umbilical cord blood sample with cell detection abnormality, analyze each improper human operation link associated with each quality inspection unqualified item of human umbilical cord blood samples, construct a traceability model for umbilical cord blood stem cell detection abnormality, and provide feedback.

[0013] Database: used to store the quality inspection standards of cell activity-related indicators, microbiological indicators, immune-related indicators, and genetic indicators of umbilical cord blood stem cells.

[0014] Compared with the prior art, the human umbilical cord blood stem cell detection and screening system described in the present invention has the following beneficial effects: 1. The present invention determines whether the quality detection of umbilical cord blood stem cells is qualified by obtaining cell activity-related indicator information, microbiological indicator information, immune-related indicator information, and genetic indicator information of umbilical cord blood stem cells in human umbilical cord blood samples, and detects and evaluates umbilical cord blood stem cells from multiple indicators in multiple dimensions, thereby improving the reliability of umbilical cord blood stem cell screening results and ensuring the safety and effectiveness of umbilical cord blood stem cells in clinical applications.

[0015] 2. The present invention obtains the operational information of the collection, transportation, storage and detection links of human umbilical cord blood samples, determines whether the operation of each link meets the requirements, and then traces the cause of unqualified umbilical cord blood stem cells, which is conducive to timely taking corresponding improvement measures, standardizing the operational procedures of umbilical cord blood stem cell detection and screening, and avoiding other factors from interfering with the umbilical cord blood stem cell detection and screening results.

[0016] 3. The present invention trains a traceability model for abnormal cord blood stem cell detection by analyzing the various improper human operation links associated with the unqualified quality inspection items of human cord blood samples, which can provide a certain reference for subsequent cord blood stem cell detection and screening, and is conducive to the targeted optimization and improvement of the detection and screening operation process. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for describing the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying creative work.

[0018] Figure 1 This is a system module connection diagram of the present invention.

[0019] Figure 2 Schematic diagram of the workflow of the cell quality comprehensive evaluation and screening module of the present invention.

[0020] Figure 3 The figure is a schematic diagram of the working process of the cell detection failure cause analysis module of the present invention. DETAILED DESCRIPTION

[0021] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0022] See also Figure 1 As shown, the present invention provides a human umbilical cord blood stem cell detection and screening system, including a detection index information acquisition module, a cell quality comprehensive evaluation and screening module, a cell detection unqualified cause analysis module, a cell detection abnormal tracing model construction module, and a database.

[0023] The cell quality comprehensive evaluation and screening module is respectively connected to the detection index information acquisition module and the cell detection failure cause analysis module, the cell detection abnormality tracing model construction module is connected to the cell detection failure cause analysis module, and the database is connected to the cell quality comprehensive evaluation and screening module.

[0024] The detection index information acquisition module is used to detect the collected human umbilical cord blood samples to obtain cell activity-related index information, microbiological index information, immune-related index information, and genetic index information of umbilical cord blood stem cells in the human umbilical cord blood samples.

[0025] Furthermore, the specific working process of the detection index information acquisition module is as follows: D1: Detecting the collected human umbilical cord blood sample to obtain cell activity-related index information of umbilical cord blood stem cells in the human umbilical cord blood sample, wherein the cell activity-related index information includes cell viability value, cell proliferation generation, and cell proliferation rate.

[0026] As a preferred embodiment, the cell viability value refers to the ratio between the number of live cells and the total number of cells.

[0027] In a specific embodiment, the trypan blue exclusion method is used to detect the cell viability of umbilical cord blood stem cells in human umbilical cord blood samples. The principle of the trypan blue exclusion method for detecting cell viability is that the cell membrane of living cells has selective permeability, and trypan blue cannot enter living cells, while the cell membrane integrity of dead cells is damaged, and trypan blue can enter and dye the cells blue.

[0028] As a preferred solution, cell culture experiments can be used to observe the proliferation of umbilical cord blood stem cells under in vitro culture conditions, detect the proliferation ability of umbilical cord blood stem cells in human umbilical cord blood samples, and obtain the proliferation generations and proliferation rates of umbilical cord blood stem cells in human umbilical cord blood samples. The principle is: use CFSE (carboxyfluorescein succinimidyl ester) to label cells. CFSE can covalently bind to proteins in cells. As cells divide, the fluorescence intensity of daughter cells will gradually halve. By detecting changes in fluorescence intensity using a flow cytometer, the proliferation generations and proliferation rates of cells can be understood.

[0029] D2: Obtaining microbiological indicator information of umbilical cord blood stem cells in human umbilical cord blood samples, wherein the microbiological indicator information includes the colony count of various bacteria, the viral copy number of various viruses, and the colony count of various fungi.

[0030] As a preferred solution, the bacterial detection of umbilical cord blood stem cells in human umbilical cord blood samples can be carried out by using a blood culture bottle culture method, inoculating the umbilical cord blood samples into aerobic and anaerobic blood culture bottles and culturing them at a suitable temperature. If bacteria grow, the culture medium in the blood culture bottle will change color or produce gas, etc., and then the type of bacteria is determined by Gram staining and a bacterial identification system, and further the colony count method is used to obtain the colony count of various bacteria in the umbilical cord blood stem cells in the human umbilical cord blood sample.

[0031] As a preferred embodiment, the types of bacteria in the umbilical cord blood stem cells include but are not limited to: Staphylococcus, Streptococcus, Escherichia coli, etc.

[0032] As a preferred solution, virus detection of umbilical cord blood stem cells in human umbilical cord blood samples can be carried out by nucleic acid detection such as PCR technology to detect viral DNA, or by enzyme-linked immunosorbent assay to detect viral antibodies, thereby determining the type of virus, and further obtaining the number of viruses in the umbilical cord blood through viral load detection, such as through real-time fluorescence quantitative PCR technology, to accurately measure the viral copy number of various viruses in umbilical cord blood stem cells in human umbilical cord blood samples.

[0033] As a preferred embodiment, the viral copy number refers to the number of viral genomes present in the umbilical cord blood stem cells of a human umbilical cord blood sample.

[0034] As a preferred embodiment, the types of viruses in umbilical cord blood stem cells include but are not limited to: cytomegalovirus, rubella virus, herpes simplex virus, hepatitis B virus, human immunodeficiency virus, hepatitis C virus, Epstein-Barr virus, varicella-zoster virus, enterovirus, etc.

[0035] As a preferred option, fungal detection of umbilical cord blood stem cells in human umbilical cord blood samples can identify common fungi through microscopic smear observation and fungal culture, identify rare fungi with the help of advanced molecular biology techniques such as gene sequencing, and further use colony counting methods and other means to determine the colony counts of various fungi in umbilical cord blood stem cells in human umbilical cord blood samples.

[0036] As a preferred embodiment, the types of fungi in the umbilical cord blood stem cells include but are not limited to: Candida, Aspergillus, etc.

[0037] D3: Obtaining immune-related index information of umbilical cord blood stem cells in human umbilical cord blood samples, wherein the immune-related index information includes the proportion of subpopulations of various types of lymphocytes.

[0038] As a preferred embodiment, the subpopulation ratio of each type of lymphocyte refers to the ratio of each type of lymphocyte in the total lymphocytes.

[0039] As a preferred solution, flow cytometry can be used to detect the subpopulation ratios of various types of lymphocytes in umbilical cord blood stem cells in human umbilical cord blood samples.

[0040] As a preferred embodiment, the types of lymphocytes in the umbilical cord blood stem cells include but are not limited to: T lymphocytes, B lymphocytes and NK cells.

[0041] D4: Obtaining genetic indicator information of umbilical cord blood stem cells in human umbilical cord blood samples, wherein the genetic indicator information includes the number and karyotype of chromosomes and the copy number of various pathogenic genes carried.

[0042] As a preferred embodiment, the pathogenic gene refers to a gene associated with a genetic disease.

[0043] As a preferred solution, the number and karyotype of the chromosomes of the cord blood stem cells can be obtained by preparing chromosome specimens of the cord blood stem cells and performing chromosome karyotype analysis.

[0044] As a preferred solution, genetic testing of umbilical cord blood stem cells can be performed using fluorescent quantitative PCR technology, multiplex ligation-dependent probe amplification technology, and the like, thereby obtaining the copy numbers of various pathogenic genes carried by umbilical cord blood stem cells.

[0045] As a preferred embodiment, the copy number of a pathogenic gene refers to the number of times a specific pathogenic gene appears in the genome of a cell.

[0046] As a preferred embodiment, the types of pathogenic genes in umbilical cord blood stem cells include but are not limited to: HER-2 gene, α-globin gene and β-globin gene.

[0047] It should be noted that the detection of cell activity-related indicators, microbiological indicators, immune-related indicators, and genetic indicators of umbilical cord blood stem cells in human umbilical cord blood samples is an existing relatively mature technology and will not be elaborated here.

[0048] The cell quality comprehensive evaluation and screening module is used to analyze the compliance coefficients of cell activity-related indicators, microbiological indicators, immune-related indicators, and genetic indicators of umbilical cord blood stem cells in human umbilical cord blood samples, and determine whether the quality test of umbilical cord blood stem cells in human umbilical cord blood samples is qualified. If qualified, the human umbilical cord blood sample is placed in a designated area; if unqualified, the cell test failure reason analysis module is executed.

[0049] Further, see Figure 2 As shown, the specific working process of the cell quality comprehensive evaluation and screening module includes: recording the cell viability value, cell proliferation generation, and cell proliferation rate of the umbilical cord blood stem cells in the human umbilical cord blood sample as .

[0050] The quality inspection standards of cell activity-related indicators of umbilical cord blood stem cells stored in the database were extracted to obtain the reference values ​​of cell activity value, cell proliferation generation, and cell proliferation rate of umbilical cord blood stem cells, which were recorded as .

[0051] By analyzing the formula Obtain the cell activity related index conformity coefficient of umbilical cord blood stem cells in human umbilical cord blood samples ,in represents a natural constant, They respectively represent the thresholds of the deviation of the preset cell viability value, cell proliferation generation, and cell proliferation rate of the umbilical cord blood stem cells, They represent the preset cell viability value, cell proliferation generation, and cell proliferation rate weights respectively. .

[0052] As a preferred embodiment, the weights of the cell viability value, cell proliferation generation, and cell proliferation rate are set according to their importance in evaluating whether the cell activity of umbilical cord blood stem cells meets the requirements. In a specific embodiment, the weights of the cell viability value, cell proliferation generation, and cell proliferation rate are 0.4, 0.3, and 0.3, respectively.

[0053] It should be noted that high activity of umbilical cord blood stem cells means that the cells have strong metabolic function and better physiological state. At the same time, the higher the cell activity, the better. Too high activity may mean that the cells are in an overactive state and there is a potential risk of abnormal proliferation, such as the possibility of tumor development.

[0054] It should be noted that more proliferation generations mean that more stem cells can be obtained, which is very beneficial for situations where a large number of stem cells are needed for treatment. At the same time, too many cell proliferation generations may also cause problems. As cells continue to proliferate, gene mutations may accumulate, increasing the risk of cell canceration. Excessive proliferation may also cause signs of aging in cells, affecting their functional characteristics.

[0055] It should be noted that rapid proliferation can increase the number of stem cells in a short period of time, which is very important for the treatment of some acute diseases. For example, when patients with acute leukemia undergo umbilical cord blood stem cell transplantation, they can quickly provide enough stem cells to rebuild the immune system. However, if the proliferation rate is too fast and uncontrolled, it will increase the possibility of cell malignancy, just like too many cell generations.

[0056] Furthermore, the specific working process of the cell quality comprehensive evaluation and screening module also includes: recording the colony counts of various bacteria, the virus copy numbers of various viruses, and the colony counts of various fungi in the umbilical cord blood stem cells in the umbilical cord blood sample as , Indicates The number of the bacterial species, , Indicates The virus number, , Indicates The number of the fungus species, .

[0057] Extract the quality inspection standards of microbiological indicators of umbilical cord blood stem cells stored in the database, obtain the influence weights of various bacteria, various viruses, and various fungi on umbilical cord blood stem cells in umbilical cord blood samples, and record them as , , , .

[0058] By analyzing the formula Obtain the microbiological index compliance coefficient of umbilical cord blood stem cells in human umbilical cord blood samples ,in They respectively represent the influencing factors corresponding to the preset unit bacterial colony number, unit viral copy number, and unit fungal colony number.

[0059] It should be noted that in order to ensure the safety and effectiveness of umbilical cord blood stem cells, contamination by microorganisms such as bacteria, viruses, and fungi must be strictly controlled to ensure that the number of these microorganisms is as small as possible.

[0060] Furthermore, the specific working process of the cell quality comprehensive evaluation and screening module also includes: extracting the quality inspection standards of the immune-related indicators of umbilical cord blood stem cells stored in the database, obtaining the reference value of the proportion of each type of lymphocyte subsets in the umbilical cord blood stem cells, comparing the proportion of each type of lymphocyte subsets of the umbilical cord blood stem cells in the human umbilical cord blood sample with the reference value of the lymphocyte subset ratio, and obtaining the deviation of the subpopulation ratio of each type of lymphocyte of the umbilical cord blood stem cells in the human umbilical cord blood sample, which is recorded as , Indicates The number of lymphocytes. .

[0061] By analyzing the formula Obtain the immunological index conformity coefficient of umbilical cord blood stem cells in human umbilical cord blood samples ,in Indicates the preset Threshold for deviation in lymphocyte subset proportions.

[0062] As a preferred embodiment, the deviation of the subpopulation ratio of each type of lymphocytes of umbilical cord blood stem cells in the human umbilical cord blood sample refers to the absolute value of the difference between the ratio of each type of lymphocyte subpopulation of umbilical cord blood stem cells in the human umbilical cord blood sample and the reference value of its lymphocyte subpopulation ratio.

[0063] It should be noted that the normal ratio of lymphocyte subsets is essential for maintaining the body's effective humoral immunity and cellular immunity.

[0064] In a specific embodiment, the proportion of CD4+T cell subsets is 60%-70%, the proportion of CD8+T cell subsets is 30%-40%, the proportion of B lymphocyte subsets is 10%-20%, and the proportion of NK cell subsets is 5%-15%.

[0065] Furthermore, the specific working process of the cell quality comprehensive evaluation and screening module also includes: extracting the quality inspection standards of the genetic indicators of umbilical cord blood stem cells stored in the database, obtaining the reference number and reference karyotype of chromosomes in umbilical cord blood stem cells and the reference copy number of various pathogenic genes carried.

[0066] The chromosome number and karyotype of the umbilical cord blood stem cells in the human umbilical cord blood sample are compared with the reference chromosome number and reference karyotype, respectively, to obtain the chromosome number deviation and chromosome karyotype coincidence of the umbilical cord blood stem cells in the human umbilical cord blood sample, which are recorded as .

[0067] The copy number of various pathogenic genes carried by umbilical cord blood stem cells in human umbilical cord blood samples is compared with the reference copy number of its pathogenic genes to obtain the copy number deviation of various pathogenic genes carried by umbilical cord blood stem cells in human umbilical cord blood samples, which is recorded as , Indicates The number of the pathogenic gene. .

[0068] By analyzing the formula Obtain the genetic index matching coefficient of umbilical cord blood stem cells in human umbilical cord blood samples ,in Indicates the impact factor corresponding to the preset unit chromosome number deviation, Indicates the preset The threshold of copy number deviation of a pathogenic gene.

[0069] As a preferred embodiment, the chromosome number deviation of the cord blood stem cells in the human cord blood sample refers to the absolute value of the difference between the chromosome number of the cord blood stem cells in the human cord blood sample and the reference number of chromosomes.

[0070] As a preferred solution, the chromosome karyotype coincidence of umbilical cord blood stem cells in a human umbilical cord blood sample is obtained. The specific method is: the karyotype of each chromosome of the umbilical cord blood stem cells in the human umbilical cord blood sample is compared with the reference karyotype of its chromosome, the coincidence of the karyotype of each chromosome of the umbilical cord blood stem cells in the human umbilical cord blood sample and the reference karyotype of its chromosome is obtained, and the average value is calculated to obtain the chromosome karyotype coincidence of the umbilical cord blood stem cells in the human umbilical cord blood sample.

[0071] It should be noted that changes in the copy number of pathogenic genes, such as increase or decrease, may lead to abnormal gene expression, thereby causing physiological dysfunction of the body, increasing the risk of disease, and resulting in a variety of adverse consequences such as developmental abnormalities, metabolic disorders, and neurological diseases.

[0072] Furthermore, the specific working process of the cell quality comprehensive evaluation and screening module also includes: comparing the cell activity-related index compliance coefficient, microbiological index compliance coefficient, immune-related index compliance coefficient, and genetic index compliance coefficient of the umbilical cord blood stem cells in the human umbilical cord blood sample with the preset threshold values ​​of their corresponding compliance coefficients, if the cell activity-related index compliance coefficient, microbiological index compliance coefficient, immune-related index compliance coefficient, and genetic index compliance coefficient of the umbilical cord blood stem cells in the human umbilical cord blood sample are all greater than or equal to the threshold values ​​of their corresponding compliance coefficients, then the quality test of the umbilical cord blood stem cells in the human umbilical cord blood sample is qualified, otherwise, it is unqualified.

[0073] It should be noted that the present invention determines whether the quality test of umbilical cord blood stem cells is qualified by obtaining cell activity-related indicator information, microbiological indicator information, immune-related indicator information, and genetic indicator information of umbilical cord blood stem cells in human umbilical cord blood samples, and detects and evaluates umbilical cord blood stem cells from multiple indicators in multiple dimensions, thereby improving the reliability of umbilical cord blood stem cell screening results and ensuring the safety and effectiveness of umbilical cord blood stem cells in clinical applications.

[0074] The cell test failure reason analysis module is used to obtain the operation information of the collection link, transportation and storage link and the test link of the human umbilical cord blood sample, and judge whether the operation of each link meets the requirements. If they all meet the requirements, the reason for the failure of the umbilical cord blood stem cell quality test is the defect of the cells themselves. Otherwise, the reason for the failure of the umbilical cord blood stem cell quality test is improper human operation, and each link of improper human operation is obtained and feedback is given.

[0075] Further, see Figure 3As shown, the specific working process of the cell detection failure reason analysis module includes: S1: obtaining the operation information of the collection link of the human umbilical cord blood sample, obtaining the collection time of the human umbilical cord blood sample collection link and the disinfection record of the collection equipment. If the collection time of the collection link meets the specifications and each collection equipment is thoroughly disinfected, the operation of the collection link meets the requirements. Otherwise, the operation of the collection link does not meet the requirements.

[0076] As a preferred embodiment, the collection time refers to the time taken for collecting human umbilical cord blood samples.

[0077] As a preferred solution, the collection time of the human umbilical cord blood sample collection link can be obtained through the collection process record of the human umbilical cord blood sample, and compared with the preset collection time threshold. If the collection time of the human umbilical cord blood sample collection link is less than or equal to the preset collection time threshold, the collection time of the collection link meets the specifications, otherwise, it does not meet the specifications.

[0078] It should be noted that if the collection time of human umbilical cord blood samples is too long, the umbilical cord blood may be exposed to the external environment for a longer time, thereby increasing the risk of contamination.

[0079] As a preferred solution, the disinfection temperature and disinfection time of the collection device can be obtained through the disinfection record of the collection device, and compared with the preset disinfection temperature and disinfection time thresholds, so as to judge whether the collection device is thoroughly disinfected. If the disinfection temperature and disinfection time of the collection device are both greater than or equal to their corresponding thresholds, the collection device is thoroughly disinfected, otherwise, the collection device is not thoroughly disinfected.

[0080] It should be noted that if the collection equipment is not thoroughly disinfected, microorganisms may enter the umbilical cord blood during the collection process, causing the test results to show positive bacteria, fungi, etc.

[0081] S2: Obtaining the operational information of the transportation and storage links of the human umbilical cord blood sample, and obtaining the transportation temperature, transportation time, transportation vibration severity, storage temperature, and storage time of the transportation and storage links of the human umbilical cord blood sample. If the transportation temperature, transportation time, transportation vibration severity, storage temperature, and storage time of the transportation and storage links are all within their corresponding set reference ranges, then the operation of the transportation and storage links meets the requirements; otherwise, the operation of the transportation and storage links does not meet the requirements.

[0082] As a preferred solution, the operational information of the transportation and storage links of the human umbilical cord blood sample can be obtained through the transportation process records and storage process records of the human umbilical cord blood sample.

[0083] As a preferred solution, a vibration detection sensor can be placed on the surface of the sample container of the human umbilical cord blood sample to detect the vibration amplitude and vibration frequency during the transportation of the human umbilical cord blood sample, and the vibration amplitude and vibration frequency can be substituted into the preset relationship function between the vibration amplitude and vibration intensity, thereby analyzing the transportation vibration intensity of the human umbilical cord blood sample transportation and storage links.

[0084] S3: Obtaining the operation information of the detection link of the human umbilical cord blood sample, obtaining the detection environment cleanliness, detection reagent quality, and detection equipment accuracy of the detection link of the human umbilical cord blood sample. If the detection environment cleanliness, reagent quality, and detection equipment accuracy of the detection link are greater than or equal to their corresponding set thresholds, then the operation of the detection link meets the requirements; otherwise, the operation of the detection link does not meet the requirements.

[0085] As a preferred solution, the number of types of microorganisms in the ambient air of the human umbilical cord blood sample detection environment can be obtained, and substituted into a preset relationship function between the number of types of microorganisms in the ambient air of the detection environment and the cleanliness of the detection environment, thereby evaluating the cleanliness of the detection environment of the human umbilical cord blood sample detection link.

[0086] As a preferred solution, the quality indicators of the human umbilical cord blood sample detection reagent can be obtained and compared with the set standard values ​​of the quality indicators to obtain the deviations of the quality indicators of the human umbilical cord blood sample detection reagent, which are then substituted into the relationship function between the quality of the preset detection reagent and the deviations of the quality indicators of the detection reagent, thereby evaluating the quality of the detection reagent in the human umbilical cord blood sample detection link.

[0087] As a preferred solution, various performance parameters related to the accuracy of the human umbilical cord blood sample detection equipment can be obtained, and compared with the set standard values ​​of the various performance parameters to obtain the deviations of the various performance parameters related to the accuracy of the human umbilical cord blood sample detection equipment, and the deviations are substituted into the relationship function between the accuracy of the preset detection equipment and the deviations of the various performance parameters related to the accuracy in the detection equipment, thereby evaluating the accuracy of the detection equipment in the human umbilical cord blood sample detection link.

[0088] Furthermore, the specific working process of the cell detection failure reason analysis module also includes: if the operations of the collection, transportation, storage and detection links of the human umbilical cord blood sample meet the requirements, then the reason for the failure of the umbilical cord blood stem cell quality test is the cell's own defects; otherwise, the reason for the failure of the umbilical cord blood stem cell quality test is improper human operation, and further obtain the links where the operation does not meet the requirements, record them as the links where the human operation is improper, and provide feedback.

[0089] It should be noted that the present invention obtains the operational information of the collection, transportation, storage and detection links of human umbilical cord blood samples, determines whether the operation of each link meets the requirements, and then traces the cause of unqualified umbilical cord blood stem cells, which is conducive to timely taking corresponding improvement measures, standardizing the operational procedures of umbilical cord blood stem cell detection and screening, and avoiding other factors from interfering with the results of umbilical cord blood stem cell detection and screening.

[0090] The cell detection abnormality traceability model construction module is used to obtain each human umbilical cord blood sample that fails the umbilical cord blood stem cell quality test due to improper human operation during the monitoring period, record it as each human umbilical cord blood sample with cell detection abnormality, obtain each quality inspection unqualified item of each human umbilical cord blood sample with cell detection abnormality and each corresponding improper human operation link, analyze each improper human operation link associated with each quality inspection unqualified item of the human umbilical cord blood sample, construct a traceability model for umbilical cord blood stem cell detection abnormality, and provide feedback.

[0091] Furthermore, the specific working process of the cell detection abnormality tracing model construction module is: setting the duration of the monitoring period, obtaining each human umbilical cord blood sample that fails the umbilical cord blood stem cell quality test due to improper human operation during the monitoring period, recording them as each human umbilical cord blood sample with cell detection abnormalities, and obtaining each link of improper human operation corresponding to each human umbilical cord blood sample with cell detection abnormalities.

[0092] Obtain the compliance coefficients of cell activity-related indicators, microbiological indicators, immune-related indicators, and genetic indicators of umbilical cord blood stem cells in each human umbilical cord blood sample with abnormal cell detection, mark the indicators whose compliance coefficients are less than the corresponding compliance coefficient thresholds as quality inspection unqualified items, and count the quality inspection unqualified items of each human umbilical cord blood sample with abnormal cell detection.

[0093] According to the unqualified quality inspection items of each human umbilical cord blood sample with abnormal cell detection and the corresponding improper human operation links, the machine learning algorithm is used to analyze the improper human operation links associated with the unqualified quality inspection items of human umbilical cord blood samples, train the traceability model of abnormal umbilical cord blood stem cell detection, and provide feedback.

[0094] As a preferred solution, based on the unqualified quality inspection items and the corresponding improper human operation links in each human umbilical cord blood sample with abnormal cell detection, the unqualified quality inspection items of the human umbilical cord blood samples and the corresponding improper human operation links are further classified and counted, and they are recorded as the improper human operation links associated with the unqualified quality inspection items of the human umbilical cord blood samples, thereby obtaining a traceability model for abnormal umbilical cord blood stem cell detection.

[0095] It should be noted that the present invention trains a traceability model for abnormal umbilical cord blood stem cell detection by analyzing the various improper human operation links associated with the unqualified quality inspection items of human umbilical cord blood samples, which can provide a certain reference for the subsequent detection and screening of umbilical cord blood stem cells and is conducive to the targeted optimization and improvement of the detection and screening operation process.

[0096] The database is used to store quality inspection standards for cell activity-related indicators, microbiological indicators, immune-related indicators, and genetic indicators of umbilical cord blood stem cells.

[0097] As a preferred solution, the quality inspection standards of cell activity-related indicators, microbiological indicators, immune-related indicators, and genetic indicators of umbilical cord blood stem cells stored in the database are set according to actual application requirements.

[0098] The above contents are merely examples and explanations of the concept of the present invention. Those skilled in the art may make various modifications or additions to the specific embodiments described or replace them in a similar manner. As long as they do not deviate from the concept of the invention or exceed the scope defined by the present invention, they shall all fall within the protection scope of the present invention.

Claims

1. A human umbilical cord blood stem cell detection and screening system, characterized in that: include: Detection index information acquisition module: used to detect the collected human umbilical cord blood samples, and obtain the cell activity-related index information, microbiological index information, immune-related index information, and genetic index information of the umbilical cord blood stem cells in the human umbilical cord blood samples; Cell quality comprehensive evaluation and screening module: used to analyze the compliance coefficients of cell activity-related indicators, microbiological indicators, immune-related indicators, and genetic indicators of umbilical cord blood stem cells in human umbilical cord blood samples, and determine whether the quality test of umbilical cord blood stem cells in human umbilical cord blood samples is qualified. If qualified, the human umbilical cord blood samples are placed in the designated area. If unqualified, the cell test failure reason analysis module is executed; Cell test failure reason analysis module: used to obtain the operation information of the collection, transportation, storage and testing links of human umbilical cord blood samples, and judge whether the operation of each link meets the requirements. If they meet the requirements, the reason for the failure of the umbilical cord blood stem cell quality test is the defect of the cells themselves. Otherwise, the reason for the failure of the umbilical cord blood stem cell quality test is improper human operation, and each link of improper human operation is obtained and feedback is provided; Cell detection abnormality traceability model construction module: used to obtain each human umbilical cord blood sample that fails the umbilical cord blood stem cell quality test due to improper human operation during the monitoring period, record it as each human umbilical cord blood sample with abnormal cell detection, obtain each quality inspection failure item of each human umbilical cord blood sample with abnormal cell detection and each corresponding improper human operation link, analyze each improper human operation link associated with each quality inspection failure item of human umbilical cord blood sample, construct a traceability model for abnormal umbilical cord blood stem cell detection, and provide feedback; Database: used to store the quality inspection standards of cell activity-related indicators, microbiological indicators, immune-related indicators, and genetic indicators of umbilical cord blood stem cells.

2. A human umbilical cord blood stem cell detection and screening system according to claim 1, characterized in that: The specific working process of the detection index information acquisition module is as follows: D1: Testing the collected human umbilical cord blood samples to obtain cell activity-related index information of umbilical cord blood stem cells in the human umbilical cord blood samples, wherein the cell activity-related index information includes cell viability value, cell proliferation generation, and cell proliferation rate; D2: Obtaining microbiological index information of umbilical cord blood stem cells in human umbilical cord blood samples, wherein the microbiological index information includes the colony count of various bacteria, the viral copy number of various viruses, and the colony count of various fungi; D3: Obtaining immune-related index information of umbilical cord blood stem cells in human umbilical cord blood samples, wherein the immune-related index information includes the proportion of subpopulations of various types of lymphocytes; D4: Obtaining genetic indicator information of umbilical cord blood stem cells in human umbilical cord blood samples, wherein the genetic indicator information includes the number and karyotype of chromosomes and the copy number of various pathogenic genes carried.

3. A human umbilical cord blood stem cell detection and screening system according to claim 2, characterized in that: The specific working process of the cell quality comprehensive evaluation and screening module includes: The cell viability value, cell proliferation generation, and cell proliferation rate of umbilical cord blood stem cells in human umbilical cord blood samples are recorded as ; The quality inspection standards of cell activity-related indicators of umbilical cord blood stem cells stored in the database were extracted to obtain the reference values ​​of cell activity value, cell proliferation generation, and cell proliferation rate of umbilical cord blood stem cells, which were recorded as ; By analyzing the formula Obtain the cell activity related index conformity coefficient of umbilical cord blood stem cells in human umbilical cord blood samples ,in represents a natural constant, They respectively represent the thresholds of the deviation of the preset cell viability value, cell proliferation generation, and cell proliferation rate of the umbilical cord blood stem cells, They represent the preset cell viability value, cell proliferation generation, and cell proliferation rate weights respectively. .

4. A human umbilical cord blood stem cell detection and screening system according to claim 2, characterized in that: The specific working process of the cell quality comprehensive evaluation and screening module also includes: The colony counts of various bacteria, the viral copies of various viruses, and the colony counts of various fungi in the umbilical cord blood stem cells in the umbilical cord blood samples were recorded as , Indicates The number of the bacterial species, , Indicates The virus number, , Indicates The number of the fungus species, ; Extract the quality inspection standards of microbiological indicators of umbilical cord blood stem cells stored in the database, obtain the influence weights of various bacteria, various viruses, and various fungi on umbilical cord blood stem cells in umbilical cord blood samples, and record them as , , , ; By analyzing the formula Obtain the microbiological index compliance coefficient of umbilical cord blood stem cells in human umbilical cord blood samples ,in They respectively represent the influencing factors corresponding to the preset unit bacterial colony number, unit viral copy number, and unit fungal colony number.

5. A human umbilical cord blood stem cell detection and screening system according to claim 2, characterized in that: The specific working process of the cell quality comprehensive evaluation and screening module also includes: The quality inspection standards of immune-related indicators of umbilical cord blood stem cells stored in the database were extracted to obtain the reference values ​​of the proportions of various types of lymphocyte subsets in umbilical cord blood stem cells. The proportions of various types of lymphocyte subsets in umbilical cord blood stem cells in human umbilical cord blood samples were compared with the reference values ​​of their lymphocyte subset proportions to obtain the deviations of the proportions of various types of lymphocyte subsets in umbilical cord blood stem cells in human umbilical cord blood samples, which were recorded as , Indicates The number of lymphocytes. ; By analyzing the formula Obtain the immunological index conformity coefficient of umbilical cord blood stem cells in human umbilical cord blood samples ,in Indicates the preset Threshold for deviation in lymphocyte subset proportions.

6. A human umbilical cord blood stem cell detection and screening system according to claim 2, characterized in that: The specific working process of the cell quality comprehensive evaluation and screening module also includes: Extract the quality inspection standards of the genetic indicators of umbilical cord blood stem cells stored in the database, obtain the reference number and reference karyotype of chromosomes in umbilical cord blood stem cells and the reference copy number of various pathogenic genes carried; The chromosome number and karyotype of the umbilical cord blood stem cells in the human umbilical cord blood sample are compared with the reference chromosome number and reference karyotype, respectively, to obtain the chromosome number deviation and chromosome karyotype coincidence of the umbilical cord blood stem cells in the human umbilical cord blood sample, which are recorded as ; The copy number of various pathogenic genes carried by umbilical cord blood stem cells in human umbilical cord blood samples is compared with the reference copy number of its pathogenic genes to obtain the copy number deviation of various pathogenic genes carried by umbilical cord blood stem cells in human umbilical cord blood samples, which is recorded as , Indicates The number of the pathogenic gene. ; By analyzing the formula Obtain the genetic index matching coefficient of umbilical cord blood stem cells in human umbilical cord blood samples ,in Indicates the impact factor corresponding to the preset unit chromosome number deviation, Indicates the preset The threshold of copy number deviation of a pathogenic gene.

7. A human umbilical cord blood stem cell detection and screening system according to claim 1, characterized in that: The specific working process of the cell quality comprehensive evaluation and screening module also includes: The cell activity-related index compliance coefficient, microbiological index compliance coefficient, immune-related index compliance coefficient, and genetic index compliance coefficient of the umbilical cord blood stem cells in the human umbilical cord blood sample are compared with the preset threshold values ​​of their corresponding compliance coefficients. If the cell activity-related index compliance coefficient, microbiological index compliance coefficient, immune-related index compliance coefficient, and genetic index compliance coefficient of the umbilical cord blood stem cells in the human umbilical cord blood sample are greater than or equal to the threshold values ​​of their corresponding compliance coefficients, the quality test of the umbilical cord blood stem cells in the human umbilical cord blood sample is qualified; otherwise, it is unqualified.

8. The human umbilical cord blood stem cell detection and screening system according to claim 1, characterized in that: The specific working process of the cell detection failure reason analysis module includes: S1: Obtaining the operation information of the human umbilical cord blood sample collection process, obtaining the collection time of the human umbilical cord blood sample collection process and the disinfection record of the collection equipment. If the collection time of the collection process meets the specifications and all the collection equipment are thoroughly disinfected, then the operation of the collection process meets the requirements; otherwise, the operation of the collection process does not meet the requirements; S2: obtaining operation information of the transportation and storage link of the human umbilical cord blood sample, and obtaining the transportation temperature, transportation time, transportation vibration severity, storage temperature, and storage time of the transportation and storage link of the human umbilical cord blood sample. If the transportation temperature, transportation time, transportation vibration severity, storage temperature, and storage time of the transportation and storage link are all within the corresponding set reference ranges, then the operation of the transportation and storage link meets the requirements; otherwise, the operation of the transportation and storage link does not meet the requirements; S3: Obtaining the operation information of the detection link of the human umbilical cord blood sample, obtaining the detection environment cleanliness, detection reagent quality, and detection equipment accuracy of the detection link of the human umbilical cord blood sample. If the detection environment cleanliness, reagent quality, and detection equipment accuracy of the detection link are greater than or equal to their corresponding set thresholds, then the operation of the detection link meets the requirements; otherwise, the operation of the detection link does not meet the requirements.

9. A human umbilical cord blood stem cell detection and screening system according to claim 8, characterized in that: The specific working process of the cell detection failure reason analysis module also includes: If the operations of the collection, transportation, storage and testing of human umbilical cord blood samples meet the requirements, then the reason for the failure of the umbilical cord blood stem cell quality test is the defects of the cells themselves. Otherwise, the reason for the failure of the umbilical cord blood stem cell quality test is improper human operation. Further obtain the links where the operations do not meet the requirements, record them as the links where the human operation is improper, and provide feedback.

10. The human umbilical cord blood stem cell detection and screening system according to claim 1, characterized in that: The specific working process of the cell detection abnormality tracing model construction module is as follows: The duration of the monitoring cycle is set, and each human umbilical cord blood sample that fails the umbilical cord blood stem cell quality test due to improper human operation during the monitoring cycle is obtained, and recorded as each human umbilical cord blood sample with abnormal cell detection, and each link of improper human operation corresponding to each human umbilical cord blood sample with abnormal cell detection is obtained; Obtain the compliance coefficients of cell activity-related indicators, microbiological indicators, immune-related indicators, and genetic indicators of umbilical cord blood stem cells in each human umbilical cord blood sample with abnormal cell detection, mark the indicator with a compliance coefficient less than the corresponding compliance coefficient threshold as a quality inspection unqualified item, and count the quality inspection unqualified items of each human umbilical cord blood sample with abnormal cell detection; According to the unqualified quality inspection items of each human umbilical cord blood sample with abnormal cell detection and the corresponding improper human operation links, the machine learning algorithm is used to analyze the improper human operation links associated with the unqualified quality inspection items of human umbilical cord blood samples, train the traceability model of abnormal umbilical cord blood stem cell detection, and provide feedback.

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