Objective To investigate the value of serum miR-196b-5p and miR-199a-3p levels in the diagnosis of non-small cell lung cancer(NSCLC).Methods A total of 202 patients with NSCLC admitted to Nantong First People's Hospital from January 2022 to March 2024 were retrospectively selected as the study objects,and 195 healthy subjects in the same period were selected as the controls.General baseline data and pathological features of NSCLC patients were collected.The expression levels of serum miR-196b-5p and miR-199a-3p were analyzed by quantitative reverse transcription polymerase chain reaction.The cor-relation between the expression levels of miR-196b-5p and miR-199a-3p and the concentration of cytokeratin 19 fragment anti-gen 21-1(Cyfra21-1)was analyzed by Pearson's correlation analysis.According to the mean expression levels of miR-196b-5p and miR-199a-3p,NSCLC patients were divided into high and low expression groups,and their clinical baseline and pathological characteristics were analyzed.Receiver operating characteristic(ROC)curves were drawn to analyze the diagnostic efficacy of se-rum Cyfra21-1,miR-196b-5p,miR-199a-3p and their combination in patients with NSCLC.Results Compared with the control group,the expression level of miR-196b-5p was increased and the expression level of miR-199a-3p was decreased in patients with NSCLC.Compared with stage Ⅰ/Ⅱ patients,the serum relative expression level of miR-196b-5p in stage Ⅲ/Ⅳ patients was significantly increased,and the relative expression level of miR-199a-3p was significantly decreased(all P＜0.01).Serum miR-196b-5p levels in NSCLC patients were positively correlated with Cyfra21-1,and serum miR-199a-3p levels were negatively correlated with Cyfra21-1(all P＜0.01).The expression differences of miR-196b-5p and miR-199a-3p were correlated with fam-ily history,pathological stage,tumor size,Cyfra21-1 level and lymph node metastasis of NSCLC patients(all P＜0.05).The are-a-under-the-curve(AUC)of serum miR-196b-5p level for the diagnosis of NSCLC was 0.882(sensitivity 75.25％,specificity 95.38％),and the AUC of serum miR-199a-3p level for the diagnosis of NSCLC was 0.857(sensitivity 68.32％,specificity 88.21％).The AUC of traditional biomarker Cyfra21-1 in the diagnosis of NSCLC patients was 0.818(sensitivity 63.86％,spe-cificity 87.18％).The diagnostic efficacy of the combined detection of miR-196b-5p and miR-199a-3p was significantly higher than that of serum Cyfra21-1(P＜0.01),miR-196b-5p(P＜0.01)and miR-199a-3p(P＜0.01)alone in patients with early stage(stage Ⅰ/Ⅱ)NSCLC.Conclusion The expression level of serum miR-196b-5p in NSCLC patients is significantly increased,and the expression level of miR-199a-3p is decreased,and the combined detection of miR-196b-5p and miR-199a-3p has a high effi-ciency in the diagnosis of NSCLC.

Objective:To investigate the current status of preimplantation genetic testing for aneuploidies (PGT-A) in China in 2024 and to provide recommendations for ensuring the consistency of PGT-A results.Methods:This study was a nationwide external quality assessment research. The National Center for Clinical Laboratories of the National Health Commission conducted two surveys in June and December 2024, with participation from 31 laboratories across China. During each survey, quality control samples of varying concentrations were distributed: the first survey distributed 6 samples (Batch Nos. 202401-202406) and the second survey distributed 3 samples (Batch Nos. 202431-202433). Participating laboratories were required to submit information including detection platforms, single-cell amplification methods, library construction methods, sequencing instruments, and test results. Collected data were statistically analyzed using Microsoft Excel to evaluate laboratories' PGT-A testing capabilities and determine whether results met predefined quality control requirements.Results:All 31 laboratories submitted results for both surveys. In the first survey, 90.3% (28/31) met qualification criteria with a 9.7% failure rate (3/31). For individual batches, pass rates were 90.3% (28/31) for batches 202401-202403 and 100% (31/31) for batches 202404-202406. The second survey achieved 100% (31/31) compliance across all three batches (202431-202433), with each batch maintaining a 100% pass rate.Conclusion:The detection quality of PGT-A in China is generally good, but with differences, and factors such as sample concentration, transportation conditions and detection methods affect the consistency of the results. The study highlights the urgent need for nationwide external quality assessment of PGT-A in China. This will help identify issues in laboratories in a timely manner and ensure the consistency of PGT-A test results.

Objective To explore the application value of three-dimensional T1-weighted multi-echo DIXON(3D-T1W-mDIXON)with three-dimensional T2-weighted driven imaging with variable excitation(3D-T2W-DRIVE)in unilateral vascular compressive hemifacial spasm(HFS),and to improve the accuracy of preoperative imaging diagnosis of microvascular decompression(MVD).Methods The clinical and imaging data of 235 patients with unilateral vascular compressive HFS treated with MVD from July 2018 to August 2024 in Xuzhou City Hospital of Traditional Chinese Medicine were analyzed retrospectively.Before MVD,3D-T1W-mDIXON and 3D-T2W-DRIVE sequence image,multiplanar reconstruction were used to analyze the spatial walking relationship between facial nerve and offending vessels.The differences between the affected side and the healthy side were compared,and then compared with the MVD;By using paired chi square test,image result of 3D-T1W-mDIXON combined with 3D-T2W-DRIVE sequence with either sequence alone were compared to evaluate the superiority of two combined sequences in the diagnosis of vascular compressive HFS.Results Among 235 cases HFS on the affected side,there were 149 cases of vascular compression and 68 cases with specific neurovascular contacts,and 15 cases with dubious contacts,with a positive rate of 92.34％;In the 235 cases HFS of the healthy side,there were 21 cases of vascular compression and 25 cases with specific neurovascular contacts,and 77 cases with dubious contacts,with a positive rate of 19.57％.By using the findings during facial nerve MVD procedure as the gold standard,the positive rate of diagnosing HFS using 3D-T1W-mDIXON combined with 3D-T2W-DRIVE sequence was 92.34％.The ability of 3D-T1W-mDIXON combined with 3D-T2W-DRIVE sequence to identify offending vessels(92.34％)is superior to using 3D-T1W-mDIXON sequence alone(83.00％,x2=9.52,P＜0.05)or using 3D-T2W-DRIVE sequence alone(86.38％,x2=4.30,P＜0.05).Conclusion 3D-T1W-mDIXON combined with 3D-T2W-DRIVE sequence image can clearly show the relationship between facial nerve and peripheral blood vessels,and the diagnostic efficacy is higher than that of any sequence alone,can provide better imaging evidence for clinical diagnosis and treatment of HFS.

Objective:To prepare domestic 64Cu-1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraacetic acid- D-Phe1-Tyr3-Thr8-octreotide (DOTATATE), and to verify its distribution and preliminary diagnostic value in neuroendocrine tumors (NETs). Methods:DOTATATE was labeled with the domestic 64Cu to obtain 64Cu-DOTATATE. The lipophilicity, in vitro stability, and pharmacokinetics were studied. Biodistribution experiments and microPET imaging were performed on NCI-H727 (somatostatin receptor (SSTR)2 positive expression) tumor-bearing nude mice. The preliminary clinical applications were conducted on 10 NETs patients (5 males, 5 females; age (58.5±13.0) years) from Chinese PLA General Hospital between May 2023 and April 2024. Data were analyzed by using independent-sample t test. Results:64Cu-DOTATATE was successfully prepared with the radiochemical purity greater than 98%, log P of -2.609±0.051 and good stability. Pharmacokinetic experiments in BALB/c mice suggested rapid blood clearance of the drug (elimination half-time of 22.78min). Biodistribution results in tumor-bearing mice showed that 64Cu-DOTATATE was mainly metabolized through the liver and kidneys, with significant tumor uptake at 1h ((2.519±0.273) percentage activity of injection dose per gram of tissue (%ID/g)) and sustained high uptake at 24h ((4.331±0.549)%ID/g). MicroPET imaging of tumor-bearing mice showed a slight increase in uptake and good retention at 24h, with a significant statistical difference compared to the blocked group ((2.197±0.250) vs (0.985±0.064) % ID/g; t=6.40, P=0.008). The tumor/liver ratios were 0.075±0.007, 0.083±0.011, 0.118±0.005, 0.263±0.031 at 1, 2, 6 and 24h, respectively. Preliminary clinical application indicated that 64Cu-DOTATATE exhibited good targeting in patients, and the liver radioactivity distribution was moderate (SUV max=10.62±3.46), providing good image quality. Conclusion:Domestic 64Cu-DOTATATE PET/CT imaging is a promising imaging evaluation method in NETs with the value for further clinical research.

Objective To understand and evaluate the overall status of nucleic acid detection efficacy for influenza A virus in the na-tionwide clinical laboratories of China,and discover and identify the potential issues to further improve the detection quality.Methods During 2024,the National Center for Clinical Laboratories distributed five samples to nationwide 1 367 participating laboratories.The detection efficacy of each participating laboratory was evaluated by calculating the overall percent agreement(OPA)of the test results using different detection reagents.Results The results of OPA,positive percent agreement(PPA)and negative percent agreement(NPA)of the five samples were 99.87％(6 826/6 835),99.89％(5 462/5 468),and 99.78％(1 364/1 367),respectively.No statistical difference of PPAs was observed between the H3N2 samples with different concentrations,between H1N1(2009)and H3N2 samples with equivalent concentration(1.0×104 copies/mL),and between seasonal H1N1 and H3N2 samples with equivalent concen-tration(1.0×105 copies/mL)(P＞0.05).Conclusion The results indicated the clinical laboratories in China exhibited robust efficacy in the molecular detection for two prevalent influenza A virus subtypes,i.e.,H1N1(2009)and H3N2.However,false-negative and false-positive results were encountered in a few laboratories.

Objective To investigate the value of serum miR-196b-5p and miR-199a-3p levels in the diagnosis of non-small cell lung cancer(NSCLC).Methods A total of 202 patients with NSCLC admitted to Nantong First People's Hospital from January 2022 to March 2024 were retrospectively selected as the study objects,and 195 healthy subjects in the same period were selected as the controls.General baseline data and pathological features of NSCLC patients were collected.The expression levels of serum miR-196b-5p and miR-199a-3p were analyzed by quantitative reverse transcription polymerase chain reaction.The cor-relation between the expression levels of miR-196b-5p and miR-199a-3p and the concentration of cytokeratin 19 fragment anti-gen 21-1(Cyfra21-1)was analyzed by Pearson's correlation analysis.According to the mean expression levels of miR-196b-5p and miR-199a-3p,NSCLC patients were divided into high and low expression groups,and their clinical baseline and pathological characteristics were analyzed.Receiver operating characteristic(ROC)curves were drawn to analyze the diagnostic efficacy of se-rum Cyfra21-1,miR-196b-5p,miR-199a-3p and their combination in patients with NSCLC.Results Compared with the control group,the expression level of miR-196b-5p was increased and the expression level of miR-199a-3p was decreased in patients with NSCLC.Compared with stage Ⅰ/Ⅱ patients,the serum relative expression level of miR-196b-5p in stage Ⅲ/Ⅳ patients was significantly increased,and the relative expression level of miR-199a-3p was significantly decreased(all P＜0.01).Serum miR-196b-5p levels in NSCLC patients were positively correlated with Cyfra21-1,and serum miR-199a-3p levels were negatively correlated with Cyfra21-1(all P＜0.01).The expression differences of miR-196b-5p and miR-199a-3p were correlated with fam-ily history,pathological stage,tumor size,Cyfra21-1 level and lymph node metastasis of NSCLC patients(all P＜0.05).The are-a-under-the-curve(AUC)of serum miR-196b-5p level for the diagnosis of NSCLC was 0.882(sensitivity 75.25％,specificity 95.38％),and the AUC of serum miR-199a-3p level for the diagnosis of NSCLC was 0.857(sensitivity 68.32％,specificity 88.21％).The AUC of traditional biomarker Cyfra21-1 in the diagnosis of NSCLC patients was 0.818(sensitivity 63.86％,spe-cificity 87.18％).The diagnostic efficacy of the combined detection of miR-196b-5p and miR-199a-3p was significantly higher than that of serum Cyfra21-1(P＜0.01),miR-196b-5p(P＜0.01)and miR-199a-3p(P＜0.01)alone in patients with early stage(stage Ⅰ/Ⅱ)NSCLC.Conclusion The expression level of serum miR-196b-5p in NSCLC patients is significantly increased,and the expression level of miR-199a-3p is decreased,and the combined detection of miR-196b-5p and miR-199a-3p has a high effi-ciency in the diagnosis of NSCLC.

Objective:To prepare domestic 64Cu-1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraacetic acid- D-Phe1-Tyr3-Thr8-octreotide (DOTATATE), and to verify its distribution and preliminary diagnostic value in neuroendocrine tumors (NETs). Methods:DOTATATE was labeled with the domestic 64Cu to obtain 64Cu-DOTATATE. The lipophilicity, in vitro stability, and pharmacokinetics were studied. Biodistribution experiments and microPET imaging were performed on NCI-H727 (somatostatin receptor (SSTR)2 positive expression) tumor-bearing nude mice. The preliminary clinical applications were conducted on 10 NETs patients (5 males, 5 females; age (58.5±13.0) years) from Chinese PLA General Hospital between May 2023 and April 2024. Data were analyzed by using independent-sample t test. Results:64Cu-DOTATATE was successfully prepared with the radiochemical purity greater than 98%, log P of -2.609±0.051 and good stability. Pharmacokinetic experiments in BALB/c mice suggested rapid blood clearance of the drug (elimination half-time of 22.78min). Biodistribution results in tumor-bearing mice showed that 64Cu-DOTATATE was mainly metabolized through the liver and kidneys, with significant tumor uptake at 1h ((2.519±0.273) percentage activity of injection dose per gram of tissue (%ID/g)) and sustained high uptake at 24h ((4.331±0.549)%ID/g). MicroPET imaging of tumor-bearing mice showed a slight increase in uptake and good retention at 24h, with a significant statistical difference compared to the blocked group ((2.197±0.250) vs (0.985±0.064) % ID/g; t=6.40, P=0.008). The tumor/liver ratios were 0.075±0.007, 0.083±0.011, 0.118±0.005, 0.263±0.031 at 1, 2, 6 and 24h, respectively. Preliminary clinical application indicated that 64Cu-DOTATATE exhibited good targeting in patients, and the liver radioactivity distribution was moderate (SUV max=10.62±3.46), providing good image quality. Conclusion:Domestic 64Cu-DOTATATE PET/CT imaging is a promising imaging evaluation method in NETs with the value for further clinical research.

Objective:To analyze the quality level of maternal mid-trimester serum prenatal screening in China from 2019 to 2023.Methods:A questionnaire survey was conducted to collect information from laboratories participating in the National Health Commission′s Clinical Laboratory Center inter-laboratory quality assessment program for prenatal screening from 2019 to 2023. The collected data included screening protocols, detection methods, testing systems, and monthly laboratory screening quality indicators. The Chi-square test was used to compare the initial screening positive rates among different screening protocols, provinces, detection methods, and testing systems. A log-transformed linear regression analysis was performed to evaluate the relationship between the average annual sample size and the out-of-control rate of various median multiple of the median (mMoM) values.Results:This study included 806 laboratories from 29 provinces (including autonomous regions and municipalities). The five-year average out-of-control rates for mMoM values across indicators ranged from 15.8% to 31.3%. The initial positive rates of dual, triple, and quadruple screening protocols were statistically different ( χ2=760.2, P<0.001). The initial positive rates across different provinces ranged from 4.7% to 10.3%, with statistically significant differences ( χ2=35 388.0, P<0.001). There were also statistically significant differences in initial positive rates between different testing systems ( χ2=2 493.2, P<0.001). Testing systems using chemiluminescence methods had significantly higher initial positive rates compared to systems using time-resolved fluorescence methods (7.2% vs. 6.5%, χ2=533.6, P<0.001). Log-linear regression analysis showed that testing systems with larger annual average sample sizes had lower out-of-control rates for mMoM values (AFP: β=-0.100, P=0.005; hCG: β=-0.123, P=0.008; uE3: β=-0.139, P=0.007). Conclusion:There are significant differences in the quality of maternal mid-trimester serum screening across different detection methods, testing systems and provinces in China.

Objective:To investigate the current status of preimplantation genetic testing for aneuploidies (PGT-A) in China in 2024 and to provide recommendations for ensuring the consistency of PGT-A results.Methods:This study was a nationwide external quality assessment research. The National Center for Clinical Laboratories of the National Health Commission conducted two surveys in June and December 2024, with participation from 31 laboratories across China. During each survey, quality control samples of varying concentrations were distributed: the first survey distributed 6 samples (Batch Nos. 202401-202406) and the second survey distributed 3 samples (Batch Nos. 202431-202433). Participating laboratories were required to submit information including detection platforms, single-cell amplification methods, library construction methods, sequencing instruments, and test results. Collected data were statistically analyzed using Microsoft Excel to evaluate laboratories' PGT-A testing capabilities and determine whether results met predefined quality control requirements.Results:All 31 laboratories submitted results for both surveys. In the first survey, 90.3% (28/31) met qualification criteria with a 9.7% failure rate (3/31). For individual batches, pass rates were 90.3% (28/31) for batches 202401-202403 and 100% (31/31) for batches 202404-202406. The second survey achieved 100% (31/31) compliance across all three batches (202431-202433), with each batch maintaining a 100% pass rate.Conclusion:The detection quality of PGT-A in China is generally good, but with differences, and factors such as sample concentration, transportation conditions and detection methods affect the consistency of the results. The study highlights the urgent need for nationwide external quality assessment of PGT-A in China. This will help identify issues in laboratories in a timely manner and ensure the consistency of PGT-A test results.

Sepsis and septic shock are common emergencies in pediatric intensive care unit with high mortality.The existence of sepsis-related acute kidney injury and multiple organ dysfunction syndrome further increases the risk of death in children with sepsis.Currently，continuous renal replacement therapy（CRRT）is employed to continuously remove toxins and excess fluid from the body，helping to maintain hemodynamic stability and fine-tuning electrolyte and acid-base balance.It has emerged as an important adjuvant therapy for sepsis and septic shock.Although the absolute indications for CRRT initiation have been clearly defined in domestic and foreign guidelines，there is no consensus on the optimal timing of CRRT initiation in children with septic shock.Both early and late CRRT initiation have their own advantages and disadvantages.