Objective To investigate the effects of sample transport and sorting system on the detection results of common clinical bio-chemical and immunological items carried out in our laboratory.Methods A total of 25 patients admitted to Zidong Hospital of Jiangsu Provincial Hospital of Traditional Chinese Medicine in June 2024 were included in this study,and four blood samples were collected from each patients using vacuum blood vessels with separation gel containing coagulant.These samples were transferred to the laboratory department through manual transport or pneumatic logistics transmission,and the manual sorting approach or intelligent blood vessel sorting system was used to encode the samples.The effects of different sample transportation methods and sorting methods on the detec-tion results of 46 clinical biochemical parameters,12 tumor markers and 5 thyroid hormone items,which were carried out in our labora-tory,were analyzed and compared.Results No significant change on hemolytic index(HI)was found through pneumatic tube system(PTS)and intelligent blood vessel sorting system(P＞0.05).The results of AST,CK-MB,α-HBDH,and LDH in clinical biochemical parameters following PTS were significantly different from those in artificial transport group(all P＜0.05).Both the results of Cyfra21-1 and NSE in immunological items in the samples after PTS transport were significantly different from those obtained by either manual transport or intelligent sorting system,with statistical significance(all P＜0.05).Conclusion PTS basically meets the requirements of clinical laboratories,but it can lead to the increase of AST,CK-MB,α-HBDH and LDH in clinical biochemistry,as well as Cyfra21-1 and NSE in immunology,which needs to be further improved,refined,and validated in order to meet the clinical requirements.

Objective To evaluate the recognition capability of AI-enabled Cellsee CS-BM1 automatic cell morphology analyzer for pe-ripheral blood smears and its roles in assisting manual classification,and explore the application value of AI system in the diagnosis network of tiered primary medical units.Methods The blood samples which triggered the re-examination rules were collected from six primary medical units,including the Laboratory Department of Shanghai Jiahui International Hospital,and so on,from March to No-vember 2023.The smears of peripheral blood were prepared and AI analyzer was used for pre-classification to evaluate its recognition performance in identifying the samples with abnormal WBC and RBC.The sensitivity,specificity,and accuracy of WBC classification by six junior and intermediate technicians,both with and without AI assistance,were analyzed.Additionally,the roles of the AI system in tiered diagnosis of primary medical units were also evaluated.Results The sensitivity,specificity,and accuracy of AI system in recognizing malignant primitive cells were 92.86％,95.16％,and 95.10％,respectively.The sensitivities of AI system in recognizing immature granulocytes,reactive lymphocytes,and nucleated RBCs were all greater than 90％.The sensitivity of AI system in identif-ying abnormal morphology of RBCs reached 99.59％,along with rapid quantitative analysis for various anomalous types of RBCs.In AI-assisted mode,the sensitivity of recognition for all cell types was improved to varying degrees by junior and intermediate technicians,and the sensitivity for recognizing malignant primitive cells,reactive lymphocytes,and immature granulocytes increased to 58.24％,53.39％,and 62.37％for junior technicians,and to 92.06％,83.24％,and 83.12％for intermediate technicians,respectively.The improvements for junior technicians were particularly significant,with increases of 12.46％,10.61％,and 3.71％for each cell type,respectively.Both groups achieved higher specificity and accuracy.Through AI pre-classification and manual review,a variety of pe-ripheral blood cell-related diseases were accurately diagnosed in the tiered healthcare practice of primary medical units,including 339 cases(11.13％)of red blood cell diseases,5 cases(0.16％)of platelet diseases,2 343 cases(76.90％)of infection-related disea-ses,and 28 cases(0.92％)of malignant hematological diseases.In addition,332 cases(10.90％)which lacked an obvious related cause or required further examinations were identified as well.Conclusion AI pre-classification has demonstrated strong cell recogni-tion capabilities and may assist technicians in improving the sensitivity,specificity,and accuracy of blood cell classification.AI could en-hance the disease-screening capabilities in the tiered diagnosis network of primary medical units,presenting a broad application prospect.

Objective To investigate the value of patient data-based real-time quality control(PBRTQC)in internal quality control(IQC)for blood cells analysis based on the data from patients.Methods The data of patients'blood cells,including white blood cell count(WBC),hemoglobin(Hb),red blood cell count(RBC),hematocrit(HCT),mean corpuscular volume(MCV),mean cor-puscular hemoglobin(MCH),mean corpuscular hemoglobin concentration(MCHC),and platelet(PLT)were collected from August 1,2023 to February 26,2024,and the extracted patient data were analyzed on the AI-based real-time quality control intelligent moni-toring platform.The corresponding IQC data for this period were reviewed,and the results of PBRTQC and IQC were compared and an-alyzed.The causes of the emerging warning or alarm prompts were checked and analyzed to explore the application value of PBRTQC in the IQC process of blood cell analysis.Results It is found that when the quality control product was unstable due to overlong opening time of the reagent or improper storage conditions,and the performance changes of the operating system during the detection process,the PBRTQC intelligent monitoring platform was able to issue risk warning or alarm prompt in advance.PBRTQC may have certain limi-tations,such as the error of red blood cell count,which need to be identified.Conclusion PBRTQC is superior to IQC in blood cell analysis and may play a complementary role in IQC.Meanwhile,it is necessary to exclude the possibility that PBRTQC is significantly influenced by the patient population in medical laboratories.

Objective To explore the value of peripheral blood monocyte subsets and their CD169 expression levels in the diagnosis of common respiratory viral infections and the immune mechanism of the infection in children.Methods A total of 125 children with re-spiratory viral infections(virus infection group),71 children with bacterial respiratory infections(bacteria infection group),and 35 healthy children(healthy control group)admitted to the Third Affiliated Hospital of Zhengzhou University from February 2022 to Octo-ber 2023 were included in this study.The counts of peripheral blood monocytes and lymphocytes were detected by hematologic analyzer.The proportions of lymphocyte subsets,monocyte subsets,and the expression levels of CD169 were detected by a flow cytometry.Mono-cyte subsets were classified into three types:classical monocytes(CM),intermediate monocytes(IM),and non-classical monocytes(NCM).ANOVA and Kruskal-Wallis H tests were used to screen for differentially expressed indicators among the three groups,and the receiver operator characteristic(ROC)curve was used to evaluate their diagnostic performance.Paired t-tests were used to analyze the differences in the indicators between the first day and the seventh day of hospitalization in the virus group.Spearman rank correlation a-nalysis was used to explore the relationship between CD 169 expression levels in monocyte subsets and the quantity of lymphocyte sub-sets.Results Statistically significant differences in the expression levels of CD169 in monocytes of CM,IM,and NCM types were ob-served in peripheral blood between the children's respiratory viral infection group and the healthy control group(all P＜0.01).In con-trast,no statistically significant differences in CD169 expression levels were found in monocytes of CM and IM type between the respira-tory viral infection group and the bacterial infection group(all P＞0.05).The differences in CD 169 expression levels among the groups were statistically significant in the NCM subset(P=0.008).The area under the ROC curve(AUC)of CD169 expression level in NCM type monocytes for diagnosing respiratory viral infections was 0.897(P＜0.01),with a cutoff point of ≥ 62.75％,sensitivity of 68.60％,and specificity of 91.80％.The quantity and proportion of CM,IM,and NCM type monocytes did not show statistically signif-icant differences between the respiratory viral infection group and the bacterial infection group(all P＞0.05).However,there were sig-nificant differences in the quantity and proportion of CM and IM type monocytes,as well as the proportion of NCM type monocytes,be-tween the virus infection group and the healthy control group(all P＜0.05).The proportions of CM,IM,and NCM type monocytes,the quantity of IM type monocytes,and the CD169 expression levels of monocyte subsets showed statistically significant differences between the first day and the seventh day after admission(all P＜0.05).There were no statistically significant differences in the quantity of CM and NCM type monocytes between the first day and the seventh day after admission(all P＞0.05).The expression levels of CD169 in peripheral blood CM,IM,and NCM type monocytes were negatively correlated with the number of CD8+T cells with correlation coeffi-cients of-0.65,-0.63,and-0.66,respectively(all P＜0.01).Conclusion The expression level of CD169 in NCM type monocytes could be used as an auxiliary diagnostic marker for the children with respiratory viral infection.The changes of monocyte subsets during respiratory viral infection course in children may involve that more CM type monocytes differentiate into IM type monocytes,and some IM type monocytes do not differentiate into NCM type monocytes in proportion.IM and NCM type monocytes may play important roles in the early stage of respiratory viral infections in children.CD169 serves as a marker of monocyte activation.

Objective To survey the awareness and intended adoption of patient-based real-time quality control(PBRTQC)among medical laboratories,thereby providing a basis for subsequent research and promotion efforts.Methods An electronic questionnaire was distributed via the Questionnaire Star system to collect participants' general information,their knowledge,attitudes,and practices regarding PBRTQC,as well as their implementation willingness.Results A total of 161 valid questionnaires were collected.The sur-vey revealed that fewer than 50％of laboratory staff had basic knowledge of PBRTQC,and their confidence in establishing and applying PBRTQC in their own laboratories was low.However,they acknowledged its potential to enhance quality management.Key concerns and support needs for PBRTQC promotion include professional implementation guidelines and policy support,reliable third-party evalu-ations,software and hardware support,and user training.Conclusion The laboratory staff accepted the value of PBRTQC and gener-ally held a positive attitude toward its application.Future efforts should focus on developing standardized guidelines,refining evaluation methods,advancing software and hardware,and enhancing knowledge dissemination,technical training and other actions related to guiding the practical implementation thereby facilitating the wider adoption of PBRTQC.

Objective To explore relationship between glucose metabolism and neonatal weight in high-risk gestational diabetes melli-tus(GDM).Method A retrospective study was conducted on 779 pregnant women who underwent prenatal examinations at Tongzhou Maternity and Child Health Care Hospital in Beijing from March to June 2022.The data on pre-pregnancy weight,mid-and late-preg-nancy glycated albumin(GA)and glycated hemoglobin(HbA1c),pre-delivery weight,gestational weight gain,and neonatal birth weight were collected.A GDM risk assessment model was established using multivariate logistic regression to classify pregnant women into high-risk and low-risk groups for GDM,followed by separate management strategies.Regression discontinuity(RD)analysis was applied to evaluate the relationship between gestational glucose metabolism status and neonatal birth weight.Results Among the 779 pregnant women,the overall incidence of macrosomia was 7.32％.The high-risk GDM group exhibited significantly higher pre-pregnan-cy weight,late-pregnancy HbA1c,and GA levels compared to the low-risk group(all P＜0.001).Neonatal birth weight in the high-risk group was significantly higher than that in the low-risk group(P＜0.05),with a significantly increased macrosomia incidence(13.55％vs 5.77％,P＜0.05).RD analysis revealed a jump reduction of 199.59 g(P=0.029)in neonatal birth weight at the risk score thresh-old.Conclusion Lifestyle glucose metabolism management in high-risk GDM pregnant women may effectively reduce neonatal birth weight,mitigated the trend of excessive gestational weight gain,and improved late-pregnancy HbA1c and GA levels,providing evi-dence-based support for maternal and child health services.

Objective To explore the internal audit for homogeneous assay in a multi-campus hospital and provide references for the homogeneous quality management of clinical laboratory.Methods We adopted the unified process of internal audit and the inspection criteria(CNAS-CL02:Guidelines for the Accreditation of Quality and Competence of Medical Laboratories),and collected the non-con-forming items of 3 internal audits in a public hospital with 4 campuses from 2022 to 2024.The non-conforming items and the distribu-tion were statistically analyzed and then the corrective actions were discussed.Results A total of 294 non-conforming items were col-lected in 3 internal audits,and the median of professional group(25th percentile,75th percentile)was 39(34,49).The non-confor-ming items were mainly concentrated in"7.3 testing process"(98),"6.2 personnel"(36),and"6.6 reagents and consumables"(28).Among them,28 non-conforming items related to 2 or 3 different professional areas,and 14 items related to 4 or more areas.The 14 non-conforming items occurred repeatedly in 3 internal audits and crossed multiple areas and multiple campuses simultaneously and involved 6 clauses.Conclusion The homogeneous internal audit for multi-campus hospital could find the shared problems,formulate effective rectification measures,and promote quality management of homogenized assays in clinical laboratories.

Objective To achieve a preliminary understanding of the current situation of clinical laboratories in Guangdong Province,and discuss how to establish a sound investigation system,and utilize quality indicators to improve laboratory quality through the inves-tigation and analysis of data from 16 clinical laboratory quality indicators issued by the National Center for Clinical Laboratories.Meth-ods The questionnaire was issued by Clinet-EQA system and the basic information and quality indicator information during 2023 were collected.SPSS 20.0 software was used for statistical analysis according to different specialty categories and hospital grades.The 13 quality indicators measured in rate-based units were evaluated by sigma measurement.The P75,P50 and P25 percentiles of the overall distribution of each quality index were used to explore the optimal,appropriate and minimum quality specifications.Results A total of 577 laboratories participated in this survey.In addition to the implementation rate of internal quality assessment and the inter-laboratory comparison rate,the median sigma(σ)value of 11/13 quality indicators was greater than 3σ,and some of them even reach the level of 6σ,and there were disparities between hospital laboratories at different grades.The turnaround time(TAT)of the whole process of emergency examination was significantly less than those of inpatient and outpatient,TAT before emergency examination was controlled within 20 min,TAT before outpatient examination was within 30 min,and TAT before inpatient examination was within 42 min.The optimal quality specifications of 8 out of 13 indicators reached 6σ level,while the minimum quality specifications of 2 out of 13 indica-tors were lower than 3σ level.Conclusion In Guangdong Province,the overall level of quality indicators in the post-analytical of clin-ical laboratories was superior to that in the pre-analytical and analytical process.It should be essential to continuously monitor quality indicators and actively adopt improvement measures for those laboratories with unsatisfactory results,so as to enhance the examination quality of laboratories.

Objective To investigate the distribution of carbapenem-resistant genes and their drug susceptibility in vitro on carbapen-em-resistant Enterobacter cloacae(CRECC)in Taizhou area,and provide evidence for effective anti-infective treatment in clinical prac-tice.Methods Forty-seven strains of CRECC isolated from Enze Hospital,Taizhou Enze Medical Center(Group)and Luqiao Reha-bilitation Hospital during January 2015 and November 2022 were retrospectively analyzed.The enzyme types and resistance genes of carbapenemase were detected by the NG-Test Carba 5 and Carba-R Xpert,respectively,and the susceptibility of CERCC to common drugs was tested in vitro.Results Among 47 strains of CRECC,27 were detected to produce carbapenemase,including 24 producing New Delhi metallo-β-lactamase(NDM)type,1 producing both Klebsiella pneumoniae carbapenemase(KPC)and NDM types,and 2 producing imipenemase(IMP)type.One strain belonged to NDM genotype but no NDM enzyme type was detected.The CRECC strains had the highest sensitivity to polymyxin B(95.7%),followed by tigecycline(93.6%),fosfomycin(61.7%),and ceftazidime/avibac-tam(40.4%).In addition,the CRECC strains producing carbapenemase were more sensitive to polymyxin B,fosfomycin and aztreo-nam than those without producing carbapenemase.Conclusion The CRECC strains in Taizhou area are mainly NDM type,which has high sensitivity to polycolistin B,tigecycline and fosfomycin.NG-Test Carba 5 can not cover some strains that do not produce carbapen-emase or carry mutations in carbapenemase.

Objective To detect the expression level of serum LncRNA P53RRA in patients with primary hepatocellular carcinoma(HCC)and explore its clinical application value in the diagnosis of HCC.Methods Ninety-three patients with primary HCC visited Zhongshan Hospital Affiliated to Fudan University from November 2019 to December 2020 were selected as the HCC group and 88 healthy individuals undergone physical examination as the control group.Their serum samples were collected and the expression levels of serum LncRNA P53RRA were detected by real-time fluorescence quantitative PCR(qRT-PCR).The correlations of serum P53RRA levels with clinicopathological parameters and clinical biochemical indicators such as alanine aminotransferase(ALT),glutamate amin-otransferase(AST),gamma-glutamyl transpeptidase(GGT),and alkaline phosphatase(ALP)in HCC patients were analyzed.The diagnostic value of serum P53RRA for HCC was evaluated by the receiver operating characteristic(ROC)curve.Results The expres-sion levels of serum P53RRA in HCC patients(2.15±0.22)were significantly lower than that in healthy controls(3.54±0.33),and the difference was statistically significant(t=3.489,P＜0.05).The analysis of clinicopathological parameters showed that the expres-sion levels of serum P53RRA in HCC patients were correlated with tumor staging(χ2=9.590,P＜0.05),α-fetoprotein(AFP,χ2=5.732,P＜0.05),and GGT(χ2=5.732,P＜0.05).ROC curve analysis showed that the area under the ROC curve(AUCROC)of ser-um P53RRA in the diagnosis of HCC was 0.750(95%CI:0.679-0.821),with a sensitivity of 65.6%and specificity of 64.8%.The AUCROC,sensitivity and specificity of P53RRA combined with AFP and GGT in the diagnosis of HCC were 0.911(95%CI:0.867-0.953),88.2%and 70.5%,respectively,which were higher than those of single indicator.Conclusion LncRNA P53RRA is expec-ted to serve as a novel non-invasive biomarker,effectively assisting in the clinical diagnosis of HCC.