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.

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.

Objective To investigate the karyotypes and the correlation of chromosomal abnormalities in the fetuses with increased nu-chal translucency(NT),so as to provide a basis for prenatal genetic counseling.Methods The clinical data of 386 singleton pregnant women with NT≥2.5mm who underwent invasive prenatal diagnosis at the First Affiliated Hospital of Nanjing Medical University from January 2018 to April 2022 were retrospectively analyzed.The fetuses were grouped according to NT thickness(2.5-3.4,3.5-3.9,4.0-4.9,5.0-5.9,and ≥6.0 mm),fetal ultrasound abnormalities(isolated increased NT,non-isolated increased NT),and maternal age(advanced age ≥35 years,non-advanced age＜35 years).The chi-square test was used to compare the differences of the incidence of fetal chromosomal abnormalities among various groups.Results Among the 386 fetuses with increased NT,chromosomal abnormalities were detected in 87 cases with an overall detection rate of 22.5％(87/386),including chromosomal numerical abnormalities accounted for 82.8％(72/87)and copy number variations(CNVs)accounted for 17.2％(15/87).The detection rates of chromosomal abnormal-ities and numerical abnormalities increased with NT thickness(P＜0.05),while no statistically significant difference of CNV abnormali-ty rates was found(P=0.41).The detection rates of chromosomal abnormalities(36.5％)and CNV abnormalities(14.1％)in the non-isolated increased NT group were significantly higher than those in the isolated increased NT group(18.6％and 1.0％,respective-ly,both P＜0.05).The detection rates of chromosomal abnormalities(34.7％)and numerical abnormalities(31.6％)in the fetuses of advanced maternal age mothers with increased NT were significantly higher than those in the non-advanced age group(18.4％and 14.2％,respectively,both P＜0.05).However,the difference of CNV abnormality rates between the two groups was not statistically sig-nificant(P=0.62).Conclusion The detection rate of fetal chromosomal abnormalities elevated with increased NT thickness.Ad-vanced maternal age and the presence of other ultrasound abnormalities were the high-risk factors for fetal chromosomal abnormalities.The risks of CNV abnormalities may not be significantly correlated with NT thickness or maternal age but associated with the presence of other ultrasound abnormalities.

Objective To explore the application values of different detection methods in monitoring the decline pattern of syphilis-spe-cific antibody in the non-congenital syphilis children.Methods A total of 80 non-congenital syphilis children were included in the study.The serum specimens were collected after birth,and the syphilis-specific antibodies were detected using electrochemilumines-cence immunoassay(ECLIA),western blotting(WB),treponema pallidum particle agglutination assay(TPPA),enzyme-linked im-munosorbent assay(ELISA),and toluidine red unheated serum test(TRUST).Follow-up was conducted every three months until the positive results of ELISA and TRUST turned to negative.Results The results of ECLIA showed that the syphilis-specific antibody lev-els in the non-congenital syphilis children declined to 25％of the level at birth within 2 to 3 months,and the rate of decline was inde-pendent of the initial concentration.WB analysis indicated that the specific IgG bands in non-congenital syphilis children at birth were consistent with those of their mother,and the sequence of specific antibodies decline was as follows:TPN47,TPN15,TPN45,and TPN17.Due to methodological limitations,the absorbance values of ELISA showed no significant change during the first three months after birth when high concentrations of antibodies were present in the samples,but it showed high sensitivity in the detection for the samples with low-concentration of syphilis antibodies.The detection rates of ECLIA,TPPA,and WB were compared by using ELISA as the reference method.At birth,the detection rates of syphilis antibodies were 100％,100％,and 90％,respectively.In 3 months after birth,the detection rates were 100％,100％,and 75％.In 6 months after birth,,they were 100％,46％,and 15％.In 9 months after birth,they were 83％,33％,and 0％.The positive rate of TRUST was 17.5％at birth.and turned to negative in 3 month of follow-up.Conclusion Syphilis specific IgG antibodies may fully transferred to the fetus and decline in a predictable pattern after birth.The comprehensive analysis for the results of the four methods suggested that dynamic detection using ECLIA method could be used to pre-dict the risk of non-congenital syphilis or terminate the follow-up at 3 months,while the seroconversion detected by WB was earlier than that by TPPA,while ELISA required the longest follow-up period.

Objective To explore the diagnostic value of the phenomenon of protein-cell separation in cerebrospinal fluid(CSF),as well as the single and combined detections of CSF immunoglobulin G(CSF-IgG),CSF albumin(CSF-ALB)and serum immunoglobu-lin G(S-IgG)for Guillain-Barre syndrome(GBS).Methods A retrospective analysis was conducted on the clinical data of 65 GBS patients(GBS group)and 65 patients with other neurological diseases(non-GBS group).CSF and serum samples were collected from both the groups to analyze the diagnostic efficacy of protein-cell separation phenomenon in CSF,as well as the single and combined de-tections of CSF-IgG,CSF-ALB,and serum-IgG(S-IgG)in GBS.Results CSF protein-cell separation phenomenon was observed in 60.00％(39/65)of GBS patients.Prodromal events were presented in 67.69％(44/65)of GBS patients,which mainly were upper re-spiratory tract infection(43.08％,28/65),digestive tract infection(9.23％,6/65),and herpetic virus infection(7.69％,5/65).The levels of CSF-IgG,CSF-ALB,and S-IgG in the GBS group were significantly higher than those in non-GBS group(P＜0.05).The areas under the ROC curves(AUCROC)for single CSF-IgG,CSF-ALB,S-IgG,protein-cell separation phenomenon IN CSF,and the combination of all the four parameters in diagnosis of GBS were 0.754,0.705,0.682,0.708,and 0.840,respectively.The diagnostic specificities were 87.7％,75.4％,87.7％,81.5％,and 96.9％,respectively.Conclusion Most of the GBS patients were found to have CSF protein-cell separation phenomenon and history of prodromal infection.CSF-IgG,CSF-ALB,S-IgG,and CSF protein-cell separation phenomenon exhibited independent diagnostic value for GBS.The combined detection of the four indicators could improve the diagnostic efficacy for GBS.