1.Construction and validation of predictive model for acute respiratory failure in adult patients with community-acquired pneu-monia
Ziming WANG ; Yue QU ; Dandan LI ; Huicong ZHOU ; Binbin WU ; Wei YU
Chinese Journal of Clinical Laboratory Science 2025;43(8):586-590
Objective To explore the risk factors of acute respiratory failure(ARF)in adult patients with community-acquired pneu-monia(CAP),and thereby construct and validate the efficacy of nomogram model.Methods The clinical and laboratory data of 172 adult CAP patients admitted to Taikang Xianlin Drum Tower Hospital affiliated to Nanjing University School of Medicine from January 2018 to December 2021 were retrospectively collected.The patients were divided into two groups based on whether they had concurrent ARF.After the comparison for the differences of single factor between the two groups,collinearity analysis was assessed.The risk fac-tors were then screened by binary logistic regression analysis with forward stepwise regression method.A nomogram model was subse-quently constructed and the discrimination and accuracy of the model were evaluated by ROC and colibration curves.Results Among the 172 CAP patients,53 cases(30.8%)developed ARF.The results of univariate analysis showed that the CAP patients with concur-rent ARF group had higher age,CURB-65 score and inflammatory markers than the non-concurrent ARF group,and the incidence of complex infection(culturing two or more pathogenic bacteria)was high.The values of CRP(C-reactive protein)and BUN/Alb(blood urea nitrogen/albumin)were significantly different between the two groups(53.910[25.900,101.200]vs.23.300[6.800,48.930],0.231[0.160,0.302]vs.0.123[0.089,0.171],P<0.05).Multivariate analysis indicated:glucose(Glu)≥6.06 mmol/L(odds ra-tio(OR):2.737,95%confidence interval(CI):1.116-7.037),AST(aspartate aminotransferase)≥22.5 U/L(OR:4.291,95%CI:1.779-11.120),fibrinogen(Fib)≤3.83 g/L(OR:3.955,95%CI:1.631-10.237),uric acid(UA)188.07 μmol/L(OR:4.617,95%CI:1.859-12.489),BUN/Alb≥0.15 mmol/g(OR:6.381,95%CI:2.423-18.513),total number of multicomor-bidity≥3(OR:6.191,95%CI:2.088-21.905)were the risk factors(P<0.05).All the screened indicators were incorporate into the nomogram model and its efficacy was verified.The results showed that the area under the curve of the model was 0.888[95%CI:0.840-0.935](P<0.05),the sensitivity was 0.868,and the specificity was 0.790.The calibration curve showed that the predicted probability of adult CAP patients-associated with ARF was in good consistency with the observed probability(Briser Score:0.125;H-L test:x2=7.563,P=0.477).Conclusion The established model has a good ability to predict adult CAP associated with ARF,and can provide a reference basis for early clinical prediction and intervention treatment.
2.Survey on current cognition status of patient-based real-time quality control
Xia LOU ; Mengxue LV ; Xueling SHANG ; Xueying TONG ; Yan JIANG ; Hongping BA ; Rui ZHOU
Chinese Journal of Clinical Laboratory Science 2025;43(8):574-578
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.
3.Evaluating the relationship between glucose metabolic status and neonatal weight by using regression discontinuity analysis
Ran ZHANG ; Shanshan HOU ; Junfeng MA ; Ying MENG ; Mingyuan JIAO
Chinese Journal of Clinical Laboratory Science 2025;43(8):591-595
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.
4.Management practice of internal audit for homogeneous assay in multi-campus hospitals
Meiyun CHEN ; Changai HU ; Dagan YANG
Chinese Journal of Clinical Laboratory Science 2025;43(8):619-623
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.
5.Investigation of 16 quality indicators in clinical laboratory of Guangdong province during 2023
Lichao ZHANG ; Jialing CHEN ; Zengwen LIN ; Qiaoxuan ZHANG ; Zheng LIANG ; Kefeng JIANG ; Jiaqi LI
Chinese Journal of Clinical Laboratory Science 2025;43(8):614-618
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.
6.Genotype and drug susceptibility phenotype analysis of carbapenem-resistant Enterobacter cloacae in Taizhou area
Haohao LI ; Donglian WANG ; Qingxin SHI ; Sufei YU ; Qingfeng YU ; Yingying CAI
Chinese Journal of Clinical Laboratory Science 2025;43(1):7-12
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.
7.Clinical application value of serum LncRNA P53RRA in hepatocellular carcinoma
Yafang PAN ; Jing YANG ; Wenqi SHAO ; Te LIU ; Baishen PAN ; Beili WANG ; Wei GUO
Chinese Journal of Clinical Laboratory Science 2025;43(1):20-24
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.
8.Analysis of risk factors for fever with thrombocytopenia syndrome-associated encephalitis
Jinqiu RAN ; Yuxin CHEN ; Chao WU
Chinese Journal of Clinical Laboratory Science 2025;43(8):596-601
Objective To analyze the risk factors for severe fever with thrombocytopenia syndrome(SFTS)-associated encephalitis and the risk factors for mortality in patients with SFTS-associated encephalitis.Methods The general data and laboratory indicators of 266 SFTS patients hospitalized at Nanjing Drum Tower Hospital from October 2010 to October 2022 were retrospectively collected.Logistic regression was used to analyze the risk factors for the occurrence of encephalitis in SFTS patients and the risk factors for the death of SFTS-related encephalitis patients,and a nomogram graph model was constructed to predict the risk of encephalitis in SFTS patients based on the results of multifactorial logistic regression analysis.Results Among the 266 SFTS patients included,84(31.6%)devel-oped encephalitis.Logistic regression analysis of general data and laboratory indicators indicated that age,gamma-glutamyl γ-transpep-tidase(GGT),and low levels of platelets(PLT)were the independent risk factors for the occurrence of encephalitis in SFTS patients.Among the 84 SFTS patients with encephalitis,47 cases(56.0%)died.Logistic regression analysis showed that activated partial thromboplastin time(APTT)was the independent risk factors for mortality in SFTS-related encephalitis patients.A nomogram model for predicting the occurrence of encephalitis in SFTS patients was constructed based on the above three independent risk factors.The area under the ROC curve(AUCROC)for the training and validation sets under the model was 0.755 and 0.778,respectively,suggesting good predictive performance.Conclusion Age,GGT,and low PLT levels were the independent risk factors for the occurrence of en-cephalitis in SFTS patients,and APTT was the independent risk factors for mortality in SFTS-related encephalitis patients.The nomo-gram model constructed based on the independent risk factors for the occurrence of encephalitis in the patients with SFTS demonstrated high predictive efficacy.
9.Correlations of PTTG1 and UBE2C with prognosis of liver cancer based on bioinformatics analysis
Lichao CAO ; Ying BA ; Fang CHEN ; Long XU ; Chendi YU ; Xiaoping LU ; Hezi ZHANG
Chinese Journal of Clinical Laboratory Science 2025;43(1):50-58
Objective To explore the T/NK cell-related differentially expressed genes(T/NK-DEGs)related to the prognosis of liver cancer based on the single-cell RNA-seq data,gene expression data and clinical information in the GEO and TCGA databases,and construct the prognostic model of liver cancer.Methods The single-cell RNA-seq data and gene expression matrices of liver cancer were obtained from the GEO database.The TCGA-LIHC cohorts,including mRNA expression data,clinical information,survival infor-mation,and somatic mutation data,were obtained from the TCGA database.Based on the two databases,the prognostic model of liver cancer patients was constructed by the bioinformatics method,and the performance of the model was predicted.Results Two T/NK-DEGs,PTTG1 and UBE2C,were identified to be associated with the prognosis of liver cancer and a prognostic model of liver cancer was constructed based on them.According to the risk score,the patients were divided into the high-risk score group and low-risk score group,in which the patients with high-risk score had a worse prognosis than those with low-risk score.The areas under the receiv-er operating characteristics(ROC)curve(AUCROC)of the prognostic model at 1-year,3-year and 5-year time points were 0.685,0.647 and 0.594,respectively.The higher risk score was correlated with the advanced pathological stage(Ⅰstage,Ⅱstage,andⅢstage)and T-stage(T1,T2,and T3)(P<0.05).The prognostic model was able to predict the proportion of tumor infiltrating immune cells,and the sensitivity of immunotherapy and chemotherapy drugs in patients with liver cancer.Conclusion The constructed prog-nostic model in this study has an important role in the prediction of individualized survival and clinical treatment response of patients with liver cancer.
10.Analysis of screening results for galactocerebrosidase gene in 12 744 newborns
Xianwei GUAN ; Yun SUN ; Tao JIANG ; Jingjing ZHANG ; Xin WANG
Chinese Journal of Clinical Laboratory Science 2025;43(1):59-64
Objective To analyze the results of newborn screening for galactocerebrosidase(GALC)gene and enzyme activity and pro-vide a basis for the clinical diagnosis and genetic counseling of Krabbe disease.Methods The dried blood samples on filter paper from 12 744 newborns born at Nanjing Women and Children's Healthcare Hospital from March 18,2022 to December 31,2022 were collect-ed.The pathogenic variant sites of GALC gene were detected using the chip capture next-generation sequencing technology and Sanger sequencing was used for family validation.The tandem mass spectrometry was used to determine the enzyme activity of GALC in dried blood spots.The comparison of GALC enzyme activity between the carriers with GALC variants and negative group was conducted using the independent sample t-test.Results Among the 12 744 newborns,315 were identified as the carriers with GALC variants,with a carrier rate of 1/40.The most common variant was c.1901T>C(269 cases,1/47),followed by c.1592G>A(12 cases,1/1 062).Four newborns(P1-P4)were found to have two pathogenic variant sites and 2 cases were homozygous variants of c.1901T>C.Family validation showed that the two variant sites in the four newborns were inherited from their parents,leading to a diagnosis of Krabbe dis-ease.Meanwhile,the family validation of the potential P2 patient's sister revealed that they had the same genotype,and the diagnosis of Krabbe disease was made.A preliminary threshold of 0.42 μmol/(L·h)for the enzyme activity of GALC detected by the tandem mass spectrometry was established based on 200 newborn samples.The GALC enzyme activities of 4 children with Krabbe disease were 0.74,0.21,0.17,and 0.29 μmol/(L·h),respectively.The GALC enzyme activity of the P2 patient's sister was 0.28 μmol/(L·h).Except for the P1 patient,the GALC enzyme activities of the P2,P3,and P4 patients and the P2 patient's sister were reduced,indica-ting a positive result.Conclusion The carrier rate of pathogenic variants in the GALC gene is relatively high,with the hotspot mutation being c.1901T>C.The estimated prevalence of Krabbe disease is 1/3 186.The screening strategy using genetic testing as the primary screening and enzyme activity testing as the second screening can effectively improve the diagnostic efficiency of Krabbe disease,provi-ding a reference for the clinical diagnosis and genetic counseling of Krabbe disease.

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