Objective: To validate the analytical performance, operational performance, and process control measures of a domestic fully automatic nucleic acid testing (NAT) system, thereby ensuring an efficient and orderly blood screening workflow. Methods: The concordance rate and sensitivity of WanTag-Vortex Plus system were verified using WHO standard reference panels of HIV-1, HCV and HBV, while precision was assessed using weak positive samples of HIV-1, HCV and HBV. As for its operational performance evaluation, cross-contamination resistance was assessed using strong positive samples, and throughput and stress testing were conducted using negative samples. Reagent stability was verified using weak positive samples, and inter-system performance consistency was assessed using verification panels. In addition, the process control measures were verified using the laboratory quality control demand scale. Results: 1) Verification of concordance rate: The detection results of negative and positive samples of HIV-1, HCV and HBV by WanTag-Vortex Plus system were all consistent with expectations, and the concordance rate was 100%. 2) Precision verification: the repeatability and intermediate precision were extremely high, and the coefficient of variation was less than 5%. 3) Verification of analytical sensitivity: The detection limit of 95% for standard strains of HIV-1, HCV and HBV by WanTag-Vortex Plus system in our laboratory was consistent with the analytical sensitivity provided by reagent manufacturers. 4) Verification of cross-contamination resistance: Five strong positive samples and 87 negative samples were placed according to the actual working conditions and equipment operation design, and the test results were consistent with expectations, with no cross-contamination in the testing system. 5) Throughput and stress testing: Each system completed the individual donor-nucleic acid amplification testing (ID-NAT) of 276 samples in three batches within 12 hours, and successfully completed the ID-NAT test of 828 samples in three consecutive days. 6) Verification of reagent stability: After extreme storage (unsealed storage for 1 week with 4 freeze-thaw cycles), the reagents maintained 100% detection rate in the weak positive samples of HIV-1, HCV, and HBV, showing no significant differences from the control group (Kappa=1). 7) Verification of inter-system performance consistency: The system has stable operation performance, and the performance comparison results across the four devices were consistent (Kappa=1). 8) Process control measures: WanTag-Vortex Plus system software accurately controlled the equipment operation process with strict quality control measures, and correctly interpreted and safely reported the test results. Conclusion: The analytical and operational performance of the WanTag-Vortex Plus system complies with manufacturer design standards and essential laboratory workflow requirements. Integrated with laboratory information system (LIS), the system's control software meets standard process control requirements, yet requires further improvement.

Objective: To validate the analytical performance, operational performance, and process control measures of a domestic fully automatic nucleic acid testing (NAT) system, thereby ensuring an efficient and orderly blood screening workflow. Methods: The concordance rate and sensitivity of WanTag-Vortex Plus system were verified using WHO standard reference panels of HIV-1, HCV and HBV, while precision was assessed using weak positive samples of HIV-1, HCV and HBV. As for its operational performance evaluation, cross-contamination resistance was assessed using strong positive samples, and throughput and stress testing were conducted using negative samples. Reagent stability was verified using weak positive samples, and inter-system performance consistency was assessed using verification panels. In addition, the process control measures were verified using the laboratory quality control demand scale. Results: 1) Verification of concordance rate: The detection results of negative and positive samples of HIV-1, HCV and HBV by WanTag-Vortex Plus system were all consistent with expectations, and the concordance rate was 100%. 2) Precision verification: the repeatability and intermediate precision were extremely high, and the coefficient of variation was less than 5%. 3) Verification of analytical sensitivity: The detection limit of 95% for standard strains of HIV-1, HCV and HBV by WanTag-Vortex Plus system in our laboratory was consistent with the analytical sensitivity provided by reagent manufacturers. 4) Verification of cross-contamination resistance: Five strong positive samples and 87 negative samples were placed according to the actual working conditions and equipment operation design, and the test results were consistent with expectations, with no cross-contamination in the testing system. 5) Throughput and stress testing: Each system completed the individual donor-nucleic acid amplification testing (ID-NAT) of 276 samples in three batches within 12 hours, and successfully completed the ID-NAT test of 828 samples in three consecutive days. 6) Verification of reagent stability: After extreme storage (unsealed storage for 1 week with 4 freeze-thaw cycles), the reagents maintained 100% detection rate in the weak positive samples of HIV-1, HCV, and HBV, showing no significant differences from the control group (Kappa=1). 7) Verification of inter-system performance consistency: The system has stable operation performance, and the performance comparison results across the four devices were consistent (Kappa=1). 8) Process control measures: WanTag-Vortex Plus system software accurately controlled the equipment operation process with strict quality control measures, and correctly interpreted and safely reported the test results. Conclusion: The analytical and operational performance of the WanTag-Vortex Plus system complies with manufacturer design standards and essential laboratory workflow requirements. Integrated with laboratory information system (LIS), the system's control software meets standard process control requirements, yet requires further improvement.

Objective To explore the relationship between triglyceride-glucose index(TyG)and acute ischemic stroke with large vessel occlusion(AIS-LVO)of anterior circulation.Methods A retrospective study was conducted on patients with anterior circulation AIS-LVO who underwent emergency endovascular thrombectomy at Neurovascular Center of The First Affiliated Hospital of Naval Medical University from Jan.2018 to Dec.2019.According to modified Rankin scale(mRS)score 90 d after operation,the patients were assigned to favorable outcome group(mRS score 0-2)or unfavorable outcome group(mRS score 3-6),and the TyG was compared.According to the median of TyG,the patients were assigned to low-TyG group(TyG＜8.57)or high-TyG group(TyG ≥8.57),and the clinical data,laboratory indexes,and imaging characteristics were compared.Receiver operating characteristic curve was used to evaluate the predictive value of TyG for poor prognosis.Results A total of 135 patients were enrolled,with 72 in the favorable outcome group and 63 in the unfavorable outcome group.The TyG of the unfavorable outcome group was significantly higher than that of the favorable outcome group(8.82+0.63 vs 8.43+0.60,P＜0.001).There were 67 patients in the low-TyG group and 68 in the high-TyG group.Compared with the low-TyG group,the proportion of patients with hyperlipidemia history(P=0.003),systolic blood pressure at admission(P=0.018),fasting blood glucose level(P＜0.001),and triglyceride level(P＜0.001)were significantly higher in the high-TyG group,the infarct core volume was significantly larger(P=0.025),the high density lipoprotein-cholesterol level was significantly lower(P=0.013),and the mRS score 90 d after operation was significantly higher(3[1,5]vs 1[0,5],P=0.049).The TyG had certain predictive value for poor prognosis in anterior circulation AIS-LVO patients(area under curve value=0.662,95％confidence interval 0.571-0.753).Conclusion TyG is elevated in anterior circulation AIS-LVO patients with poor prognosis,and may be a potential prognostic indicator for anterior circulation AIS-LVO patients.

Objective To explore the effect of scalp combined with intradermal-needle acupuncture synchronized rehabilitation ther-apy on upper limb motor function in stroke patients.Methods From December,2022 to December,2023,144 stroke patients with upper limb motor dysfunction in the Affili-ated Hospital of Shandong University of Traditional Chinese Medicine were randomly divided into control,intra-dermal-needle,scalp-acupuncture and acupuncture groups(36 cases repectively).All groups received convention-al treatment and upper limb rehabilitation training,the intradermal-needle group added intradermal-needle thera-py,the scalp-acupuncture group added scalp-acupuncture therapy,and the acupuncture group added both scalp-and intradermal-needle therapies,for four weeks.They were assessed with Fugl-Meyer Assessment-Upper Ex-tremities(FMA-UE),Wolf Motor Function Test(WMFT)and modified Barthel Index(MBI)before and after treatment.Twenty cases were selected randomly from each group,fractional anisotropy(FA)values and ratio of fractional anisotropy(rFA)of the lesion area and the posterior limb of the internal capsule were also measured with diffusion tensor imaging.Results Two cases dropped out in both the control group and the intradermal-needle group,while one case dropped out in both the scalp-acupuncture group and the acupuncture group.All groups showed significant improvement in FMA-UE,WMFT and MBI scores,as well as in the FA and rFA values of the lesion area and the posterior limb of the internal capsule(t>5.532,P<0.001)after treatment.The acupuncture group demonstrated the greatest pre-to post-treatment differences in FMA-UE scores,lesion-area FA and rFA values,and posterior-limb rFA val-ues compared with the other three groups(|Z|>3.256,P<0.05),and more WMFT and MBI improvements than those of the intradermal-needle group and the control group(|Z|>5.483,P<0.001).A significant interaction ef-fect was observed between intradermal and scalp acupuncture in improving FMA-UE scores(partial η2=0.035,P=0.029).The change in FMA-UE scores was positively correlated with the change in FA values of the posteri-or limb of the internal capsule(r>0.453,P<0.05)across four groups.Conclusion Scalp combined with intradermal-needle acupuncture synchronized rehabilitation therapy can more effec-tively improve upper-limb motor function in stroke patients,which may associate with the recovery of internal capsule.

Objective To explore the effect of scalp combined with intradermal-needle acupuncture synchronized rehabilitation ther-apy on upper limb motor function in stroke patients.Methods From December,2022 to December,2023,144 stroke patients with upper limb motor dysfunction in the Affili-ated Hospital of Shandong University of Traditional Chinese Medicine were randomly divided into control,intra-dermal-needle,scalp-acupuncture and acupuncture groups(36 cases repectively).All groups received convention-al treatment and upper limb rehabilitation training,the intradermal-needle group added intradermal-needle thera-py,the scalp-acupuncture group added scalp-acupuncture therapy,and the acupuncture group added both scalp-and intradermal-needle therapies,for four weeks.They were assessed with Fugl-Meyer Assessment-Upper Ex-tremities(FMA-UE),Wolf Motor Function Test(WMFT)and modified Barthel Index(MBI)before and after treatment.Twenty cases were selected randomly from each group,fractional anisotropy(FA)values and ratio of fractional anisotropy(rFA)of the lesion area and the posterior limb of the internal capsule were also measured with diffusion tensor imaging.Results Two cases dropped out in both the control group and the intradermal-needle group,while one case dropped out in both the scalp-acupuncture group and the acupuncture group.All groups showed significant improvement in FMA-UE,WMFT and MBI scores,as well as in the FA and rFA values of the lesion area and the posterior limb of the internal capsule(t>5.532,P<0.001)after treatment.The acupuncture group demonstrated the greatest pre-to post-treatment differences in FMA-UE scores,lesion-area FA and rFA values,and posterior-limb rFA val-ues compared with the other three groups(|Z|>3.256,P<0.05),and more WMFT and MBI improvements than those of the intradermal-needle group and the control group(|Z|>5.483,P<0.001).A significant interaction ef-fect was observed between intradermal and scalp acupuncture in improving FMA-UE scores(partial η2=0.035,P=0.029).The change in FMA-UE scores was positively correlated with the change in FA values of the posteri-or limb of the internal capsule(r>0.453,P<0.05)across four groups.Conclusion Scalp combined with intradermal-needle acupuncture synchronized rehabilitation therapy can more effec-tively improve upper-limb motor function in stroke patients,which may associate with the recovery of internal capsule.

【Objective】 To analyze the effect of sample hemolysis on ELISA test results in blood screening laboratory, so as to determine the acceptable tolerance of hemolysis specific to laboratory test items and detection system, and provide reference for the formulation of tolerance standard of sample hemolysis. 【Methods】 Negative and weakly positive (S/CO was about 2) samples with different hemolysis degrees were tested by several commonly used domestic reagents for HBsAg, HIV Ag/Ab, anti-HCV and anti-TP, respectively. The effects of various degrees of hemolysis on the test results of negative and weakly positive samples for each item were analyzed. 【Results】 1) Hemolysis had no effect on the test results (reactive/non-reactive) of negative and weakly positive samples for HBsAg, anti-HCV and anti-TP ELISA items; 2) Hemolysis affected the test results (reactive/non-reactive) of negative and weakly positive samples for HIV Ag/Ab ELISA item. A tolerance of Hb 2 g/L was taken as the acceptable hemolysis degree for HIV Ag/Ab ELISA item. 【Conclusion】 In this study, the acceptable tolerance of hemolytic samples for corresponding test items and detection system in our laboratory were determined. The influence of hemolysis on ELISA test result is related to the reagent, equipment, environment and other factors, therefore the acceptable tolerance of hemolysis should be determined scientifically and reasonably based on the specific evaluation of each laboratory.

Background: The testis has been reported to be a naturally O 2 -deprived organ, dimethyloxaloylglycine (DMOG) can inhibit hypoxia inducible factor-1alpha (HIF-1α) subject to degradation under normal oxygen condition in cells. Objectives: The objective of this study is to detect the effects of DMOG on the proliferation and differentiation of spermatogonial stem cells (SSCs) in Bama minipigs. Methods: Gradient concentrations of DMOG were added into the culture medium, HIF-1αprotein in SSCs was detected by western blot analysis, the relative transcription levels of the SSC-specific genes were analyzed using quantitative reverse transcription polymerase chain reaction (qRT-PCR). Six days post-induction, the genes related to spermatogenesis were detected by qRT-PCR, and the DNA content was determined by flow cytometry. Results: Results revealed that the levels of HIF-1α protein increased in SSCs with the DMOG treatment in a dose-dependent manner. The relative transcription levels of SSCspecific genes were significantly upregulated (p < 0.05) by activating HIF-1α expression. The induction results showed that DMOG significantly increased (p < 0.05) the spermatogenesis capability of SSCs, and the populations of haploid cells significantly increased (p < 0.05) in DMOG-treated SSCs when compared to those in DMOG-untreated SSCs. Conclusion We demonstrate that DMOG can promote the spermatogenesis activity of SSCs.

Objective: To assess the diagnostic value of sweat conductivity testing in Chinese children with cystic fibrosis (CF). Methods: This is a retrospective study. Sweat conductivity tests were conducted in 45 CF children (CF group) and 200 non-CF children (non-CF group) diagnosed with other chronic pulmonary diseases at the No. 2 Department of Respiratory Medicine, Beijing Children′s Hospital from May 2014 to June 2018. Pearson′s chi-square test was used to assess the differences between CF and non-CF groups. A receiver operating characteristic curve was constructed to calculate the best cut-off value to diagnose or rule out CF. The pulmonary function parameters (forced expiratory volume in the first second, forced vital capacity,forced expiratory flows at 75% of exhaled vital capacity) of CF children over 6 years old were analyzed. The relationship between sweat conductivity and pulmonary function was compared between the two groups (80-120mmol/L vs.>120mmol/L). Results: The age of CF group was 9 (7,12) years old, 19 males (42%) and 26 females(58%); the age of non-CF group was 8 (5,11) years old, 106 males (53%) and 94 females(47%). The results of sweat conductivity test showed that sweat conductivity in CF group 108(99, 122) mmol/L was significantly higher than that in non-CF group 43(36, 52) mmol/L (χ²=207, P<0.01). A cut-off value of 80 mmol/L for CF diagnosis showed a sensitivity of 93.3% and a specificity of 98.5%. The receiver operating characteristic curve analysis suggested the best conductivity cut-off value for the diagnosis of CF was at 83.5 mmol/L,with a sensitivity of 93.3% and a specificity of 100%,and an area under the curve of 0.993 (95% confidence interval 0.985-1.000). The best conductivity cut-off value to rule out CF diagnosis was at 63.5 mmol/L,with a sensitivity of 97.8% and a specificity of 90.5%. There was no correlation between the level of sweat conductivity and the extent of pulmonary function decline. Conclusions Sweat conductivity testing can be used for the screening of CF in Chinese children. A diagnosis of CF should be considered if the value is greater than 80 mmol/L.

Objective To assess the diagnostic value of sweat conductivity testing in Chinese children with cystic fibrosis (CF). Methods This is a retrospective study. Sweat conductivity tests were conducted in 45 CF children (CF group) and 200 non‐CF children (non‐CF group) diagnosed with other chronic pulmonary diseases at the No. 2 Department of Respiratory Medicine, Beijing Children′s Hospital from May 2014 to June 2018. Pearson′s chi‐square test was used to assess the differences between CF and non‐CF groups. A receiver operating characteristic curve was constructed to calculate the best cut‐off value to diagnose or rule out CF. The pulmonary function parameters (forced expiratory volume in the first second, forced vital capacity,forced expiratory flows at 75% of exhaled vital capacity) of CF children over 6 years old were analyzed. The relationship between sweat conductivity and pulmonary function was compared between the two groups (80‐120mmol/L vs.>120mmol/L). Results The age of CF group was 9 (7, 12) years old, 19 males (42%) and 26 females(58%); the age of non‐CF group was 8 (5,11) years old, 106 males (53%) and 94 females(47%). The results of sweat conductivity test showed that sweat conductivity in CF group 108(99, 122) mmol/L was significantly higher than that in non‐CF group 43(36, 52) mmol/L (χ2=207, P<0.01). A cut‐off value of 80 mmol/L for CF diagnosis showed a sensitivity of 93.3% and a specificity of 98.5%. The receiver operating characteristic curve analysis suggested the best conductivity cut‐off value for the diagnosis of CF was at 83.5 mmol/L,with a sensitivity of 93.3% and a specificity of 100%,and an area under the curve of 0.993 (95% confidence interval 0.985-1.000). The best conductivity cut‐off value to rule out CF diagnosis was at 63.5 mmol/L,with a sensitivity of 97.8% and a specificity of 90.5%. There was no correlation between the level of sweat conductivity and the extent of pulmonary function decline. Conclusions Sweat conductivity testing can be used for the screening of CF in Chinese children. A diagnosis of CF should be considered if the value is greater than 80 mmol/L.