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.

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.

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 investigate the impact of different proportions of sodium citrate anticoagulation and corrected blood collection volume on the results of thromboelastography (TEG) test in normal people and anemia patients respectively, so as to provide guidance for clinical blood collection.

29 patients with anemia admitted to The Third Affiliated Hospital of Guangzhou Medical University from July 2022 to March 2023 were selected as the observation group, and 20 normal individuals were selected for TEG test as normal group. The anemia patients were divided into two groups according to the correction formula, which were the pre-correction group and the post-correction group. The difference of TEG results before and after adjustment of blood collection volume was analyzed. The normal subjects were divided into four groups according to the ratio of anticoagulant to whole blood: group A (1:4), group B (1:9), group C (1:12) and group D (1:14). The TEG test was performed and the results of each group were statistically analyzed.

Reaction time (R) and coagulation time (K) in group A were significantly higher than those in group B (P<0.05). The angle and maximal amplitude (MA) in group A were lower than those in group B, and the differences were statistically significant (P<0.05). There was no significant difference between group C, D and group B (P<0.05); In patients with anemia (HCT>0.2), angle in the corrected group was higher than that in the pre-corrected group. In patients with anemia (HCT≤0.2), R and MA in the corrected group were higher than that in the pre-corrected group.

When the blood collection volume was insufficient, the results of TEG test were significantly different from the normal ratio (1:9), suggesting that the blood collection volume must be proper in clinical blood collection to ensure the accuracy of experimental results. There was a significant difference in TEG test before and after correction in anemia patients. In order to improve the accuracy of the test, the blood collection test should be conducted after correcting the amount of anticoagulant or blood collection.

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.

Experimental teaching is an important part of medical undergraduate and postgraduate education. In the process of teaching and scientific research experiments, various dangerous chemicals are inevitably used. Based on the requirements of hazardous chemicals management and the current situation of hazardous chemicals in school of basic medical sciences, this paper puts forward corresponding management suggestions and countermeasures. Through the formulation of a three-level management system for university, colleges and laboratories, promoting the use of intelligent hazardous chemical cabinets, strengthening the organization of hazardous chemical emergency drills and improving the safety awareness of teachers and students, etc, the safety risks of hazardous chemicals are reduced and safety accidents do not occur during the storage and use of various hazardous chemicals.

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.

To explore the application of the recommended standards of different analytical performance specifications in the external quality assessment (EQA) of complete blood cell count.

A total of 8 times of EQA data in Shanxi province from 2019 to 2022 were collected. The pass rates of WBC, RBC, Hb, hematocrit (HCT), PLT, meancorpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobinconcentration (MCHC) were analyzed using national standards, health industry standards, and limits based on biological variation (BV) (minimum, desirable and optimal). The differences between the pass rates of different evaluation limits were compared.

The overall pass rate of complete blood count EQA in Shanxi province was 88.82% to 97.32%. There were significant differences in the pass rates of different rounds for 6 projects (WBC, RBC, HCT, MCV, MCH, and MCHC) (P<0.05). Using different evaluation limits, the difference of the pass rates were statistically significant (P<0.05).

Appropriate evaluation limits should be selected to assess the quality of testing based on current testing levels and different modes of analytical performance specifications. The evaluation limits based on BV (desirable) should be selected to evaluate WBC, RBC, and Hb. The evaluation limits recommended by health industry standards should be selected to evaluate HCT, PLT, MCV, MCH, and MCHC.

Radio frequency identification (RFID) technology has been applied to the whole process management of clinical pathology department, and its feasibility and high efficiency have been verified.

RFID technology was employed to manage the workflow in clinical pathology department.

Compared to the traditional pathological process management, the use of RFID technology greatly reduces the detection errors, and markedly improves the efficiency of pathological work and the overall quality of pathological detection, further ensuring the safety of patients.

The application of RFID technology will automate the entire information management process of pathological detection.

To explore the active ingredients and mechanism of Sangjuganmao Granules against influenza A (H1N1) based on network pharmacology and molecular docking technology.

The active ingredients and related targets of Sangjuganmao Granules were collected by TCMSP, BATMAN-TCM, SwissTargetPrediction databases and literature review. The related targets of influenza A (H1N1) were collected from GeneCards, OMIM, DisGeNET and other databases. Venny diagram was drawn in order to obtain the intersection targets. Then the intersection targets were input into DAVID database for GO function and KEGG pathway enrichment analysis, and were imported into the STRING database to construct the protein intersection(PPI) network. The core targets and the main active ingredients were captured by the MCC algorithm of Cytoscape 3.9.1 software. This software was also used to draw the traditional Chinese medicine-component-target-disease network diagram. Finally, molecular docking software was used to verify the interaction between main active ingredients and core targets.

A total of 153 active ingredients and 336 potential targets were obtained from Sangjuganmao Granules, and 765 targets of influenza A (H1N1) were identified, with a total of 58 intersection targets. GO functional analysis abtained 414 GO entries, the biological processes were mainly involved in the positive tegulation of RNA polymerase Ⅱ promoter transcription, positive regulation of gene expression and apoptosis. The cellular components were mainly involved extracellular regions, exosomes and mitochondria. The molecular functions were mainly involved in protein binding and cytokine activity. KEGG pathway enrichment analysis obtained 126 results, which mainly involved in IL-17, TNF and C-type lectin receptor signaling pathways. The core active ingredients such as quercetin, luteolin, and kaempferol were captured by further analysis, and the core targets were involved in IL-6, IL-1B, TNF, JUN, TP53, PTGS2, VEGFA, ALB, MMP9, IL-10, etc. Molecular docking results showed that the core active ingredients of Sangjuganmao Granules had good binding activity with the core targets of anti-influenza A (H1N1).

Sangjuganmao Granules mainly acts on core targets IL-6, IL1-B, TNF, JUN, TP53, PTGS2, VEGFA, ALB, MMP9 and IL-10 through quercetin, luteolin, kaferol and other active ingredients, and plays an important role in anti-influenza A (H1N1) by participating in multiple signaling pathways such as IL-17, TNF and C-type lectin receptor.

To analyze the antimicrobial resistance profiles(ARPs) of Staphylococcus aureus (SAU) isolated from primary medical institutions in Guangdong region from 2017 to 2021, to provide a basis for the use of antibiotics in the treatment of SAU infections.

The SAU strains were collected from Guangdong region from 2017 to 2021 and inspected by Guangzhou Kingmed Center for Clinical Laboratory. Identification and antibiotic susceptibility tests were carried out by BioMérieux VITEK^® MS microbial mass spectrometry system and Vitek-2 compact antibiotic susceptibility analysis system. Statistical analysis of the distribution and drug resistance of pathogenic bacteria were carried out using WHONET 5.6 software.

A total of 9713 non-replicating SAU were collected from 2017 to 2021, in which 4959 strains (51.06%)were identified as methicillin-resistant Staphylococcus aureus (MRSA). The main specimen sources of SAU were sputum 41.50%, wound secretions 31.87%, pus 8.87%, pharyngeal swabs 5.34%, and blood 4.74%. Sputum, urine, alveolar lavage fluid, blood, puncture fluid and pharyngeal swab MRSA isolation rate exceeded 50.00%. For SAU, the resistance to penicillin, oxacillin, erythromycin and clindamycin were all up to 50.00%. The isolation rate of multidrug-resistant methicillin-susceptible Staphylococcus aureus (MSSA) was 20.09%, and showed a decreasing trend yearly. The isolation rate of penicillin-sensitive MSSA (MSSA-PEN^S) showed an increasing trend. Among the MRSA strains, 41.51% were resistance to ten antibiotics, 12.54% were resistant to four antibiotics and 11.57% were resistant to five antibiotics. There were 105 ARPs of MRSA, 59 of which had more than two isolates, and 10 ARPs with more than 100 isolates. The dominant ARPs were ARPs Ⅶ: PEN/OXA/ERY/CLI/CIP; ARPs Ⅷ: PEN/OXA; ARPs Ⅸ: PEN/OXA/ERY/CLI; ARPs Ⅹ: PEN/OXA/TET/CIP/LEV/MXF/ERY/CLI/GEN. The isolation rate of MRSA on ARPs Ⅶ and Ⅸ were decreasing, while the isolation rate of MRSA strains on ARPs Ⅷ and Ⅹ were increasing.

The rate of MRSA isolation in primary care institutions in Guangdong Province is high, the susceptibility of MSSA bacteria to antibiotics such as penicillin is increasing, and the APRs of MRSA are changing. The primary medical institutions need to strengthen nosocomial infection surveillance and drug resistance tests, as well as raise awareness of medical workers about prevention. Clinical departments should further make reasonable use of antibiotics to prevent the prevalence and outbreaks of SAU and MRSA.

To investigate the effect of mixed cells with different concentrations of Rh CcEe on serological detection methods.

21 Rh CcEe mixed test cell samples were prepared using irregular antibody screen reagents (human red blood cells) with a 5% gradient concentration difference. Rh CcEe blood groups were detected by microcolumn agglutination method and serological test tube method, and the differences between the two methods were analyzed and compared.

There was no significant difference between the two methods in double population (DP) and mixed field (MF) results for Rh CcEe blood group samples (P＜0.05). When detecting Rh CcEe blood group samples, 10% or more of mixed cells can result in DP by microcolumn agglutination, and 5% or more of the mixed cells can result in MF by serological test tube. The MF intensity grading of serological test tube method has a certain corresponding relationship with the gradient concentration.

The DP results of microcolumn agglutination method had no intensity grading, and failed to determine the proportion of mixed cells. By simulating different concentrations of Rh CcEe mixed test cells, a standard curve for serological in MF intensity grading can be established, which helps to infer the proportion of Rh CcEe mixed cells in the sample.