To establish the clinical reportable range (CRR) of Sysmex CS-5100 automatic coagulation analyzer for the detection of D-dimer.

According to the EP6-A document issued by the Clinical and Laboratory Standard Institute (CLSI), the polynomial regression analysis method was used to carry out the D-dimer analysis measurement range (AMR) experiment on the Sysmex CS-5100 automatic coagulation analyzer. The statistical analysis of the nonlinear coefficient was used to determine whether there was non-linearity, and the optimal polynomial method was determined by calculating the regression standard error. This study determine the upper limit of the AMR by calculating whether the linear deviation of each concentration point meets the industrial standard, and establish its CRR in combination with the functional sensitivity (FS) and the maximum dilution ratio.

According to FS test, the concentration of D-dimer is 0.065 7 mg/L when CV is close to 20%, so FS is 0.065 7 mg/L. No outliers were found in the experimental data of AMR. The relative error of repeated measurement of experimental samples was 1.89%, which was lower than the in batch imprecision target (2.5%). After the highest two groups of data were discarded in polynomial regression analysis, the best fitting curve was determined to be cubic polynomial after reanalysis of the first to ninth experimental data, and the linear deviation was not beyond the allowable deviation range (7.5%). The determined AMR of D-dimer is 0.065 7~5.26 mg/L; The maximum allowable dilution is 1∶32, and the CRR of D-dimer is 0.065 7~168.32 mg/L.

The CRR was established, which was significant for clinical diagnosis with the high test value.

To analyze the effect of PDCA cycle in improving the biosafety management of pathogenic microorganisms in hospitals.

The pre-implementation control group from April 2018 to March 2019 and the research group after the implementation of the PDCA cycle from April 2019 to March 2021 were compared the correct treatment rate of safety accidents, laboratory disinfection, medical waste, and the infectious disease-positive specimens before and after implementation.

Through PDCA cycle management, compared with the control group, the correct treatment rate of safety accidents in the research group increased by 14.30%, the correct treatment rate of laboratory disinfection increased by 17.40%, the correct treatment rate of medical waste increased by 10.56%, and the correct treatment rate of infectious disease positive specimens increased by 12.48%, and the difference was statistically significant (P＜0.05).

In view of the problems that are easy to occur in the laboratory, the rational use of PDCA cycle management according to the actual situation of the laboratory can reduce laboratory safety problems such as irregular laboratory disinfection, improve laboratory safety quality, and have high application value.

By comparing the performance of two detection systems, imported A and domestic B, in the six detection items of sex hormones, to evaluate whether the automatic chemiluminescence instrument of domestic B meets the clinical requirements and the application value of domestic chemiluminescence analyzer in the detection of sex hormones, and to explore the market advantages of domestic chemiluminescence analyzer.

The domestic B was used to verify the precision and linear range of progesterone (P), estradiol (E₂), luteoprohormone (LH), follicle stimulating hormone (FSH), prolactin (PRL), testosterone (T). Domestic B compares the correlation, recovery test and anti-interference performance with the reference system. The reference system is an imported instrument (imported A) and its supporting reagents.

Domestic B instruments P, E₂, LH, FSH, PRL and T were 0.832~3.586, CV (%) 1.290~3.876,1/4 TEa (±6.25%), total inprecision 1/3 TEa (±8.33%). Linear range validation met the requirements (see Table 2). Correlation coefficient between domestic B and imported A instruments was 0.98~0.99 and R²≥0.95. The recovery rate of domestic B is 96%~107%, imported A is 97%~108%, imported A is slightly better than domestic B, both are within the acceptable range of ±10%; the interference test results of imported A and domestic B meet the requirements of the manufacturer.

The results between imported A and domestic B, which can meet the clinical needs. Domestic chemiluminescence instrument equipment technology to reach a high level, has a unique market advantage.

To provide laboratory evidence for clinical diagnosis and treatment,the laboratory serological test results of neonatal ABO hemolytic disease were analyzed.

From May 2017 to April 2021, 500 neonatal blood samples suspected of neonatal ABO hemolytic disease who were hospitalized in the Fifth Affiliated Hospital of Guangzhou Medical University were used microcolumn gel method for ABO and Rh blood group identification and direct anti-human globulin test (DAT), free antibody test, and erythrocyte antibody emission test for hemolysis.

Among the 500 children, there were 273 positive serological tests with a positive rate of 54.6%. Among them, the positive rate of children with type A blood was higher than that of type B blood, and the difference between the two was statistically significant (P＜0.05). The positive rate of DAT was 8.8% (24/273), the positive rate of free antibody test was 77.3% (211/273), the positive rate of erythrocyte antibody emission test was 100% (273/273), the positive rate of serological test in female children was higher than that in male children, and the difference was statistically significant (P＜0.05), the positive detection rate of ABO hemolytic disease in newborns of different ages was different, and the difference was statistically significant (P＜0.05). The rate in 3 days of age was higher than that of 4 to 7 days, and those with a daily age of 4~7d are higher than the daily age＞7 d, the difference was statistically significant (P＜0.0167).

The three serological hemolysis tests can provide a reliable laboratory basis for the diagnosis of neonatal ABO hemolytic disease. The red blood cell antibody release test is the most valuable test among the three tests. The blood type, gender and age of the newborn have certain influence on the laboratory results.

The six sigma model was used to evaluate the analytical performance of glycosylated hemoglobin (HbA_1c), and the internal quality control (IQC) strategy and quality improvement measures for the HbA_1c was initially established.

The data of external quality assessment (EQA) of HbA_1c from National Center for Clinical Laboratories (NCCL) in 2020 and its IQC data of the two concentration levels from January to June 2020 were collected. And based on the allowable total error (TEa) from four different sources to calculate the sigma level of HbA_1c respectively. Meanwhile, analytical performance of HbA_1c was demonstrated on the standardized sigma performance verification chart. According to the Westgard sigma rule flow chart with batch length and quality goal index (QGI), IQC strategy and quality improvement plan of the HbA_1c were formulated.

The analytical performance of HbA_1c was at the "world-class" level based on the Spanish EQA standard and the German RiliBAK standard, while the quality goals were based on the "desirable" biological variation and EQA standard of China, analytical performance of HbA_1c was at the "unacceptable" and "excellent" levels, respectively. This study was based on EQA standard of China as the quality goal, and combined with the Westgard sigma rule with batch length, and initially established the following IQC strategy: 1_3s/2_2s/R_4s multiple rules (N=2) with batch length of 450 samples was selected as the IQC strategy for HbA_1c. Besides, the calculation of QGI showed that the bias of HbA_1c was the main factor affecting its analytical performance, and it was necessary to prioritize the formulation of corresponding improvement measures in terms of accuracy.

The six sigma model can objectively evaluate the analytical performance of HbA_1c, and has important guiding significance in the design of laboratory quality control strategies and the improvement of detection quality.

To explore the relationship between m6A modification and tumor microenvironment (TME).

The m6A modification pattern of 288 rectal cancer specimens was comprehensively evaluated based on 23 m6A regulators (RC) to determine the m6A modification pattern and m6A related gene characteristics in RC, and to evaluate the correlation between m6A scoring scheme based on PCA algorithm and immunotherapy response.

This study analyzed the expression and mutation of 23 m6A regulatory factors in RC and their relationship with the prognosis of patient. Further, three different m6A modification modes were identified in RC samples, which were related to different clinical characteristics. It was proved that m6A score could predict the clinical response of patients to PD-1/PD-L1 immunotherapy.

This study showed that the abnormal m6A modification was closely related to the occurrence and development of tumors, and played an important role in the formation of diversity and complexity of TME. Evaluating the m6A modification mode in tumors will help to guide more effective immunotherapy strategies.

Analyze the current situation and management prospects of laboratory-developed tests（LDTs）.

This study compares and analyzes the management strategies of LDTs domestically and internationally, encompassing quality control, accuracy, safety, intellectual property protection, economic benefits, career development, and talent training.

To address the management issues associated with LDTs, researchers need to focus on clinical management, funding management, patent management, and operational management. In terms of clinical management, researchers should emphasize the application of LDTs in clinical practice to ensure their practical value for clinicians. Regarding funding management, researchers should ensure compliance with LDTs projects for sustainable development under clinical supervision. With respect to patent management, attention should be given to marketization and patent transfer to safeguard the rights and interests of all parties involved. In operational management aspects; innovation can be stimulated through market competition mechanisms while establishing collaborative platforms for obtaining sufficient clinical data. For daily operations, adherence to relevant provisions such as ISO17511, ISO15189 and CAP is recommended to standardize quality assurance procedures and enhance reliability and accuracy of LDTs.

Furthermore, the future will witness continuous improvement in the regulation and governance surrounding LDTs by bridging barriers between researchers and markets effectively through system reforms that stimulate research innovation momentum leading towards increased production of in vitro diagnostics (IVD) products benefiting patients.

Analyze the risk factors of sepsis in patients with acute pancreatitis, and establish a risk prediction model of sepsis in patients with acute pancreatitis.

Clinical data of patients with acute pancreatitis was extracted from the Medical Information Mart for Intensive Care-Ⅲ (MIMIC-Ⅲ) database. Lasso regression analysis was used to screen potential risk factors for concurrent sepsis in acute pancreatitis. Based on this, logistic regression analysis was used to construct a risk prediction model for concurrent sepsis in acute pancreatitis and a calibration curve was plotted. The predictive ability and clinical applicability of the model were evaluated by calculating the C-index, plotting the calibration curve of the model, and analyzing the clinical decision curve and impact curve.

A risk prediction model for concurrent sepsis in acute pancreatitis was established, which included 10 potential risk factors including clinical signs and laboratory test results. The model had a C-index of 0.800, with a validation C-index of 0.774 after resampling. The calibration curve showed good consistency with the ideal curve. In addition, the clinical decision curve and impact curve analysis showed that this model has good clinical applicability. Acute pancreatitis patients can benefit from using this calibration curve model to obtain clinical net benefits.

The risk prediction model of acute pancreatitis complicated with sepsis based on MIMIC-Ⅲ has good clinical practicability.

To select the appropriate quality control (QC) strategy for the detection of urine forming components through the application of Westgard Sigma analysis batch length rules to reduce the risk of missed and false detection.

The internal quality control (IQC) data of urine forming components analyzer and the data of bias of IQC relative to the group mean values in SNCS (Sysmex Network Communication System) were collected from January to August 2020 in our laboratory. The total allowable error (TEa) of urine visible components stipulated in "Quality Management Standard for Clinical Laboratories of Medical Institutions in Shanghai" was adopted as the quality objective in this study.

The quality control strategy for white blood cell and red blood cell analysis appears "World class", σ=8.19 for WBC and σ=8.00 for RBC, Selected 1_3s (N=2). The analysis batch length of 200 patients were used as the quality control strategy for bacterial detection, and its performance was good (BACT, σ=4.71), Selected1_3s/2_2s/R_4s/4_1s(N=4). The analysis batch length of 45 patients were used as the quality control strategy for epithelial cells tesing, whose results was "critical", σ=3.29, selected 1_3S/2_2S/R_4S/4_1S/6_x(N=6). However, the quality control strategy of CAST, σ＜3, needs to be improved. By the way, the QGI of EC and BACT is less than 0.8 in the detection items with σ＜6, and the precision should be improved as priority.

The Westgard Sigma analysis batch length rule help us to optimize and improve the urine forming components analysis easily. In addition, QGI can be used to identify specific reasons for poor performance and formulate effective and prioritized improvement strategies.

In order to explore the effect of sex chromosome complex abnormality on individual gonadal dysplasia, the formation mechanism of sex chromosome complex variation induced sex reversal was analyzed.

Karyotype analysis chromosome microarray detection whole exome sequencing.

Hromosomekaryotype: 46, X, del(Y)(q11.23)[30]/46, X, add(Y)(q11.23) [30]. Chromosome microarray detection (CMA): The copy number of X chromosome is 1, the copy number of Yp11.32q11.223 is 1-2(including SRY Gene), the copy number of Yq11.223q12 is 1, the copy number of the rest Yq12 is 0, which indicates that the sex chromosome of the sample has complex changes.Total exome sequencing technique: There is no definite conclusion of the results, but it is suggested that the abnormal range and types of the detected data are basically consistent with the results of karyotype and CMA.

The basic cause of the abnormal development of the chimera gonad is the abnormal karyotype, and the complex abnormality of sex chromosome is directly related to the abnormal development of individual gonad.

Nucleic acid detection of SARS-CoV-2 plays an important role in the prevention and control of COVID-19. During the process of the nucleic acid detection of SARS-CoV-2, prevention of laboratory contamination is an important quality issue, which is a key factor to guarantee the quality of nucleic acid detection of SARS-CoV-2. There are many kinds of contamination sources in PCR laboratory, among which contamination caused by positive control is the most difficult to deal with in the experimental process. In this paper, the possible contamination of positive control during the process of nucleic acid detection of SARS-CoV-2 was analyzed and discussed in detail from the aspects of contaminating ways, causes, decontamination measures and effect monitoring, so as to provide some effective decontamination measures and countermeasures for PCR laboratory from the perspective of contamination from positive control.

To explore the epidemiological characteristics of mycoplasma pneumoniae (MP) infection in children's respiratory from 2020 to 2021 in Guangzhou, and to observe the changes in the levels of peripheral blood lymphocyte subsets in infected children.

Serum mycoplasma pneumoniae antibody (MP-IgM) were collected from 17 453 children using indirect immunofluorescence assay (IFA) with respiratory tract infection who visited Guangdong Women and Children Hospital from January 2020 to December 2021. Among them, 443 children who were positive for MP-IgM and had undergone lymphocyte subset testing were selected as the observation group and control group. The levels of peripheral blood lymphocyte subsets (CD3⁺, CD19⁺, CD16⁺CD56⁺, CD4⁺, CD8⁺, CD4⁺/CD8⁺) were analyzed statistically.

Among the 17 453 children with respiratory tract infections, 4388 cases were positive for MP-IgM, with a total positive rate of 25.14%. The positivity rate of MP-IgM is highest in autumn (30.15%) and lowest in winter (19.54%); the positive rate of MP-IgM antibody remained at a high level from June to November, peaking in May. The positive rates of male and female children were 21.94% and 30.39%, respectively. The MP-IgM was lowest in the infant group (0~<1 years old), and highest in the preschool children (3~<7 years old). Among the eight respiratory tract infections, the highest positive rate for influenza virus B (IV-B) was 44% in the mixed infection with MP-IgM, while the lowest positive rate for chlamydia pneumoniae (CPn) was 1%. There were significant differences in the levels of CD4⁺, CD8⁺, CD4⁺/CD8⁺ between the observation group and the control group (P<0.01).

MP infection are most prevalent in autumn, with a higher positive rate in female children than in male children and a higher positive rate in preschool age children. Among the eight other respiratory tract infections associated with MP-IgM, the highest mixed infection rate was found for IV-B. The level of lymphocyte subsets can indicate the infection status. In clinical practice, strengthening the observation and treatment of the immune status of children can provide guidance for clinical medication and treatment.

Influenza is a rapidly spreading and highly infectious human respiratory infectious disease caused by influenza viruses, which can cause huge loss of life and property on a global scale. The World Health Organization has prioritized the development of point-of-care testing (POCT) for respiratory viruses. The rapid and accurate diagnosis of influenza-like patients by POCT is of great significance for preventing and controlling the spread of influenza virus and reducing the occurrence and development of severely ill patients. Influenza POCT based on immunology is fast, simple but low sensitivity. Influenza POCT based on nucleic acid detection is convenient and quick, which makes up for the shortcomings of low sensitivity of immunology POCT. In the future, through optimization of cost-effectiveness, it can be applied in a large number of clinical immediate testing environments. This article summarizes the POCT methods that are currently being applied and developing diagnosis of influenza viruses.

To explore the early diagnostic value of ischemic modified albumin (IMA), heart-type fatty acid binding protein (H-FABP), soluble growth stimulation expression gene 2 protein (sST2) and GRACE score for acute coronary syndrome (ACS).

One hundred patients with ACS treated from July 2021 to February 2022 were enrolled in this study. Serum IMA and H-FABP concentrations were measured by latex-enhanced immunodeficiency, and serum sST2 concentration was measured by immunofluorescence dry quantification. The levels of serum IMA, H-FABP and sST2 in the three groups were compared, and the patients were divided into low-risk group, medium-risk group and high-risk group according to the risk stratification of the Global Registry of Acute Coronary Events (GRACE). The relationship between GRACE score and the three indicators was analyzed. The receiver operating characteristic curve (ROC) was used to evaluate the specificity and sensitivity of each index, and to analyze the relationship between the three indexes and ACS.

The serum levels of IMA, H-FABP and sST2 in the observation group were significantly higher than those in the control group (P＜0.05). There was no significant difference in serum IMA, H-FABP and sST2 levels were compared among three groups, and it was elevated in the low-risk state. Correlation analysis showed that serum IMA, H-FABP and sST2 levels were not correlated with GRACE score (r=-0.028, P=0.785; r=-0.011, P=0.910; r=-0.046, P=0.65). The ROC curve showed that IMA, H-FABP and sST2 had good specificity (89%~96%), but only general sensitivity (54%~76%). The combined detection of the three indexes had a better auxiliary diagnostic efficacy for ACS (AUC=0.962, sensitivity=92%, specificity=94%), which was significantly higher than the individual detection of each index.

The serum levels of IMA, H-FABP and sST2 are abnormally elevated in patients with early ACS, and they are not correlated with GRACE score. However, the combination of the three methods can improve the diagnostic efficiency of ACS, and has certain significance for the early diagnosis of ACS patients.

To explore the application effect of PDCA circulation in nursing management of venous blood specimens.

The information software was used to compare the changes of unqualified venous blood samples from inpatients in our hospital from January to August 2020 (before improvement) and from January to August 2021 (after improvement), and PDCA cycle management was used to manage unqualified venous blood samples, so as to continuously improve specimen quality.

From January to September in 2020, 750 349 inpatients were examined, and the unqualified rate was 21.03/10 000 (1578/750 349). After the application of information software combined with PDCA cycle management from January to September in 2021, the unqualified rate was reduced to 17.78/10 000 (1903/1 070 498). Comparison before and after improvement, there were statistically significant differences in total sample rejection rate, anticoagulant sample agglutination rate, blood culture contamination rate, patient identification error rate, sample damage rate during transportation, and sample collection timing error rate (χ² = 24.4732, 322.9718, 22.0901, 14.9955, 8.4113, 302.7255; P＜0.05). And the unqualified rate of venous blood samples in ICU, neonatology department, pediatric department and infection department showed a trend of gradual decline after rectification.

The application of information software combined with PDCA cycle management can effectively reduce the unqualified rate of venous blood samples of inpatients in our hospital, improve the quality of nursing management and ensure the quality before inspection, greatly reduce the waste of medical resources, and improve the operation efficiency of the hospital, so it is worth popularizing and applying.

The university laboratory is the main place for cultivating students' innovative ability, and its construction and management level are the comprehensive embodiment of the university's scientific research strength, discipline construction strength and talent training ability. In order to provide a safe and secure experimental environment, the Delicacy Management model can be applied to the laboratory safety management, which is more conducive to the smooth development of experiments and the cultivation of talents in colleges and universities. This paper mainly analyzes the main problems existing in laboratory safety management, and based on the Delicacy Management mode, it elaborates the innovative laboratory safety management in terms of strengthening safety education management, ensuring personnel allocation, and introducing modern management methods, so as to provide a new foundation for the modernization of college laboratories.

To analyze the situation of Brucella infection in Shanxi province from 2020 to 2021, and provide a reference basis for the prevention and control of brucellosis in Shanxi province.

A retrospective analysis was conducted on the results of Brucella testing using the Rose-Bengal Plate Test (RBPT) and Standard-tube Agglutination Test (SAT) for 4265 suspected cases awaiting diagnosis.

The annual average positive rate of Brucella in Shanxi province increased from 18.39% in 2020 to 19.41% in 2021. According to regional statistical analysis, the positive rate in Xinzhou and Lyuliang is over 28.17%, while the positive rate in Linfen and Yuncheng areas increased from 15.49% to 24.15%. In the age group analysis, it is mainly concentrated between the ages of 41 to 60, with a positive rate of over 23.81%. The positive rate for the 31~40 age group increased from 13.61% to 20.71%.

Brucella infection is on the rise in Shanxi province, with a trend of increasing positive rates in young and middle-aged population. Brucellosis has the tendency of spreading from the northern regions to the southern regions. As well as the southern areas of Linfen and Yuncheng, active propaganda, education, and control measures needed in the northern areas of Lyuliang and Xinzhou.