1.Feasibility study of a domestic fully automated NAT system for blood screening in blood donors
Fenglan YAO ; Rui WANG ; Jinghui HU ; Hongwei GE ; Chan LENG ; Yi ZHA ; Zifu ZHAO ; Zhengmin LIU
Chinese Journal of Blood Transfusion 2025;38(7):941-949
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.
2.A comparative study of the intraoperative neurophysiological monitoring results during 3-column os-teotomy surgery in severe congenital scoliosis with or without intraspinal anomalies
Dengxu JIANG ; Yuanxian LENG ; Fei WANG ; Deng ZHAO ; Rui ZHONG ; Zhong ZHANG ; Yijian LIANG ; Zhengjun HU
Chinese Journal of Spine and Spinal Cord 2025;35(4):350-358
Objectives:To compare the intraoperative neurophysiological monitoring(IONM)results during 3-column osteotomy surgery in severe congenital scoliosis(CS)patients with or without intraspinal anomalies,and to explore the effect of intraspinal anomaly on the incidence of IONM alarm events and postoperative out-comes in CS patients.Methods:Clinical data of patients with severe CS who underwent 3-column osteotomy surgery in our hospital from September 2020 to May 2023 were retrospectively analyzed.The patients were divided into two groups according to whether combined with intraspinal anomalies.The basic information,the latency and amplitude of somatosensory evoked potentials(SSEPs)of both lower extremities,amplitude of tran-scranial electric motor evoked potentials(TCeMEPs),as well as the sensitivity and specificity of multimodal IONM were compared between the two groups.The incidence of IONM alarm events and postoperative out-comes were analyzed.Results:A total of 37 patients who met the criteria were included in the study,of which 14 patients combined with intraspinal anomalies,including 8 cases of syringomyelia,2 case of tethered cord,1 case of diastematomyelia,1 case of diastematomyelia combined with tethered cord,and 2 cases of sy-ringomyelia combined with tethered cord.The latency of SSEPs-P3 7 in the concave side lower extremity of CS patients with intraspinal anomalies was significantly longer than that of CS patients without intraspinal anomalies(40.9±3.3ms vs 38.0±3.7ms,P=0.03).In addition,the sensitivity and specificity of multimodal IONM were comparable between the two groups.There was no significant difference in the incidence of abnormal SSEPs,the incidence of IONM alarm events and the incidence of postoperative neurological symptoms between the two groups(P>0.05).Conclusions:Multimodal IONM provides excellent monitoring effects in severe CS paitents undergoing 3-column osteotomy surgery.The latency of SSEPs-P37 in the concave side lower ex-tremity of CS patients with intraspinal anomalies was significantly longer than that of CS patients without in-traspinal anomalies.Intraspinal anomalies don't increase the incidence of intraoperative IONM alarm events or the incidence of postoperative neurological complications.
3.Intestinal flora,exercise intervention and respiratory diseases
Yue YIN ; Siyi LENG ; Pan JIN ; Ziyang CHEN ; Rui PU
Chinese Journal of Tissue Engineering Research 2025;29(14):3034-3042
BACKGROUND:Intestinal flora is a diverse and dynamic microbial community located in the human gastrointestinal tract,which plays a crucial role in maintaining human immunity and health.In recent years,the concept of"gut-lung axis"has been proposed,suggesting that intestinal flora is closely related to the lung,and exercise can regulate respiratory diseases by maintaining the balance of intestinal flora.OBJECTIVE:To review the relationship between intestinal flora and different respiratory diseases such as pneumonia,lung cancer,asthma and chronic pulmonary obstruction,and the influence of different exercise modes on intestinal flora and respiratory diseases,providing new ideas for an in-depth exploration of the mechanisms by which exercise regulates the role of intestinal flora in respiratory diseases.METHODS:CNKI and PubMed databases were searched for relevant literature published from 1944 to 2024,using the search terms of"intestinal flora,gut bacteria,respiratory illness,pneumonia,lung cancer,asthma,chronic obstructive pulmonary diseases,aerobic exercise,resistance training"in Chinese and English,respectively.Totally 101 documents were included according to inclusion and exclusion criteria.RESULTS AND CONCLUSION:(1)Intestinal flora plays an important role in the regulation of respiratory diseases such as pneumonia,lung cancer,asthma and chronic pulmonary obstruction diseases.(2)Different exercise modes are closely related to intestinal flora.Aerobic exercise can play a beneficial role in the regulation of intestinal flora by improving insulin sensitivity,increasing microbial diversity and inhibiting systemic chronic inflammation.Resistance exercise can decrease the permeability of intestinal mucosa and promote the production of short-chain fatty acids.Aerobic exercise combined with resistance exercise can also increase the diversity of intestinal flora and affect the composition of intestinal flora.(3)Exercise can improve respiratory diseases by regulating inflammatory response and reducing oxidative stress damage as well as improving cardiopulmonary function and exercise performance.(4)Exercise plays a key role in the prevention and treatment of respiratory diseases by regulating intestinal flora,inhibiting inflammatory response,regulating oxidative stress,improving intestinal barrier permeability and maintaining intestinal flora homeostasis.
4.Shengmai Yin alleviates myocardial ischemia/reperfusion injury via inhibiting Calpains expression
Rong MIAO ; Jing-wen GUO ; Ming HUANG ; Hai-shuo REN ; Rui LIU ; Xiao-yu SUN ; Opoku Bonsu FRANCIS ; Qi-long WANG ; Shi-ming FANG ; Ling LENG
Chinese Pharmacological Bulletin 2025;41(8):1569-1577
Aim To investigate the protective effect of Shengmai Yin on myocardial ischemia/reperfusion in-jury(MI/RI)in vitro and in vivo and to unravel the underlying mechanism.Methods SD rats were divid-ed into the sham group,model group,and Shengmai Yin group(SM).Rat MI/RI model was established.Cardiac function,infarct area,pathological changes,cardiomyocyte apoptosis,macrophage infiltration,and serum cTnT and CK-MB levels were measured.The mRNA and protein expressions of Calpain-1 and Cal-pain-2 were assessed.The hypoxia/reoxygenation(H/R)model was constructed in H9c2 cells.The active ingredients of Shengmai Yin were screened using net-work pharmacology and verified by CCK-8.In the car-diomyocytes H/R model,Fluo-4 AM staining was used to detect the changes of Ca2+levels.Results Com-pared with model group,LVEF and LVFS of Shengmai Yin-treated rats increased,myocardial infarction area was reduced,while myocardial tissue injury was allevi-ated.Myocardial apoptosis rate and the number of macrophages were reduced.Similarly,cTnT and CK-MB levels decreased.In addition,the expression lev-els of Calpain-1 and Calpain-2 mRNA and protein de-creased in the SM treatment group.Under the H/R model,all the active ingredients of Shengmai decoction had protective effects on cardiomyocytes,and the treat-ment could reduce the level of Ca2+in cardiomyocytes.Conclusions Shengmai Yin has protective effects on MI/RI in rats.This effect may be related to the de-crease in Ca2+levels,as well as Calpain-1 and Calap-in-2 mRNA and protein expression.
5.Feasibility study of a domestic fully automated NAT system for blood screening in blood donors
Fenglan YAO ; Rui WANG ; Jinghui HU ; Hongwei GE ; Chan LENG ; Yi ZHA ; Zifu ZHAO ; Zhengmin LIU
Chinese Journal of Blood Transfusion 2025;38(7):941-949
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.
6.Shengmai Yin alleviates myocardial ischemia/reperfusion injury via inhibiting Calpains expression
Rong MIAO ; Jing-wen GUO ; Ming HUANG ; Hai-shuo REN ; Rui LIU ; Xiao-yu SUN ; Opoku Bonsu FRANCIS ; Qi-long WANG ; Shi-ming FANG ; Ling LENG
Chinese Pharmacological Bulletin 2025;41(8):1569-1577
Aim To investigate the protective effect of Shengmai Yin on myocardial ischemia/reperfusion in-jury(MI/RI)in vitro and in vivo and to unravel the underlying mechanism.Methods SD rats were divid-ed into the sham group,model group,and Shengmai Yin group(SM).Rat MI/RI model was established.Cardiac function,infarct area,pathological changes,cardiomyocyte apoptosis,macrophage infiltration,and serum cTnT and CK-MB levels were measured.The mRNA and protein expressions of Calpain-1 and Cal-pain-2 were assessed.The hypoxia/reoxygenation(H/R)model was constructed in H9c2 cells.The active ingredients of Shengmai Yin were screened using net-work pharmacology and verified by CCK-8.In the car-diomyocytes H/R model,Fluo-4 AM staining was used to detect the changes of Ca2+levels.Results Com-pared with model group,LVEF and LVFS of Shengmai Yin-treated rats increased,myocardial infarction area was reduced,while myocardial tissue injury was allevi-ated.Myocardial apoptosis rate and the number of macrophages were reduced.Similarly,cTnT and CK-MB levels decreased.In addition,the expression lev-els of Calpain-1 and Calpain-2 mRNA and protein de-creased in the SM treatment group.Under the H/R model,all the active ingredients of Shengmai decoction had protective effects on cardiomyocytes,and the treat-ment could reduce the level of Ca2+in cardiomyocytes.Conclusions Shengmai Yin has protective effects on MI/RI in rats.This effect may be related to the de-crease in Ca2+levels,as well as Calpain-1 and Calap-in-2 mRNA and protein expression.
7.A comparative study of the intraoperative neurophysiological monitoring results during 3-column os-teotomy surgery in severe congenital scoliosis with or without intraspinal anomalies
Dengxu JIANG ; Yuanxian LENG ; Fei WANG ; Deng ZHAO ; Rui ZHONG ; Zhong ZHANG ; Yijian LIANG ; Zhengjun HU
Chinese Journal of Spine and Spinal Cord 2025;35(4):350-358
Objectives:To compare the intraoperative neurophysiological monitoring(IONM)results during 3-column osteotomy surgery in severe congenital scoliosis(CS)patients with or without intraspinal anomalies,and to explore the effect of intraspinal anomaly on the incidence of IONM alarm events and postoperative out-comes in CS patients.Methods:Clinical data of patients with severe CS who underwent 3-column osteotomy surgery in our hospital from September 2020 to May 2023 were retrospectively analyzed.The patients were divided into two groups according to whether combined with intraspinal anomalies.The basic information,the latency and amplitude of somatosensory evoked potentials(SSEPs)of both lower extremities,amplitude of tran-scranial electric motor evoked potentials(TCeMEPs),as well as the sensitivity and specificity of multimodal IONM were compared between the two groups.The incidence of IONM alarm events and postoperative out-comes were analyzed.Results:A total of 37 patients who met the criteria were included in the study,of which 14 patients combined with intraspinal anomalies,including 8 cases of syringomyelia,2 case of tethered cord,1 case of diastematomyelia,1 case of diastematomyelia combined with tethered cord,and 2 cases of sy-ringomyelia combined with tethered cord.The latency of SSEPs-P3 7 in the concave side lower extremity of CS patients with intraspinal anomalies was significantly longer than that of CS patients without intraspinal anomalies(40.9±3.3ms vs 38.0±3.7ms,P=0.03).In addition,the sensitivity and specificity of multimodal IONM were comparable between the two groups.There was no significant difference in the incidence of abnormal SSEPs,the incidence of IONM alarm events and the incidence of postoperative neurological symptoms between the two groups(P>0.05).Conclusions:Multimodal IONM provides excellent monitoring effects in severe CS paitents undergoing 3-column osteotomy surgery.The latency of SSEPs-P37 in the concave side lower ex-tremity of CS patients with intraspinal anomalies was significantly longer than that of CS patients without in-traspinal anomalies.Intraspinal anomalies don't increase the incidence of intraoperative IONM alarm events or the incidence of postoperative neurological complications.
8.Intestinal flora,exercise intervention and respiratory diseases
Yue YIN ; Siyi LENG ; Pan JIN ; Ziyang CHEN ; Rui PU
Chinese Journal of Tissue Engineering Research 2025;29(14):3034-3042
BACKGROUND:Intestinal flora is a diverse and dynamic microbial community located in the human gastrointestinal tract,which plays a crucial role in maintaining human immunity and health.In recent years,the concept of"gut-lung axis"has been proposed,suggesting that intestinal flora is closely related to the lung,and exercise can regulate respiratory diseases by maintaining the balance of intestinal flora.OBJECTIVE:To review the relationship between intestinal flora and different respiratory diseases such as pneumonia,lung cancer,asthma and chronic pulmonary obstruction,and the influence of different exercise modes on intestinal flora and respiratory diseases,providing new ideas for an in-depth exploration of the mechanisms by which exercise regulates the role of intestinal flora in respiratory diseases.METHODS:CNKI and PubMed databases were searched for relevant literature published from 1944 to 2024,using the search terms of"intestinal flora,gut bacteria,respiratory illness,pneumonia,lung cancer,asthma,chronic obstructive pulmonary diseases,aerobic exercise,resistance training"in Chinese and English,respectively.Totally 101 documents were included according to inclusion and exclusion criteria.RESULTS AND CONCLUSION:(1)Intestinal flora plays an important role in the regulation of respiratory diseases such as pneumonia,lung cancer,asthma and chronic pulmonary obstruction diseases.(2)Different exercise modes are closely related to intestinal flora.Aerobic exercise can play a beneficial role in the regulation of intestinal flora by improving insulin sensitivity,increasing microbial diversity and inhibiting systemic chronic inflammation.Resistance exercise can decrease the permeability of intestinal mucosa and promote the production of short-chain fatty acids.Aerobic exercise combined with resistance exercise can also increase the diversity of intestinal flora and affect the composition of intestinal flora.(3)Exercise can improve respiratory diseases by regulating inflammatory response and reducing oxidative stress damage as well as improving cardiopulmonary function and exercise performance.(4)Exercise plays a key role in the prevention and treatment of respiratory diseases by regulating intestinal flora,inhibiting inflammatory response,regulating oxidative stress,improving intestinal barrier permeability and maintaining intestinal flora homeostasis.
9.Influence of sample hemolysis on ELISA test results in blood screening laboratory
Qianqian QIN ; Hongwei GE ; Jing ZHANG ; Zifu ZHAO ; Chan LENG ; Rui WANG
Chinese Journal of Blood Transfusion 2024;37(4):417-424
【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.
10.Role and mechanism of intestinal flora metabolites in obesity regulation
Qihang YANG ; Rui PU ; Ziyang CHEN ; Siyi LENG ; Yongjing SONG ; Hui LIU ; Guangyou DU
Chinese Journal of Tissue Engineering Research 2024;28(2):308-314
BACKGROUND:Gut microbiota is closely related to host energy balance and metabolism.The metabolites of intestinal flora can regulate the occurrence and development of obesity and can be a new target for the prevention and treatment of obesity. OBJECTIVE:To summarize the interaction between the intestinal flora and obesity,as well as the specific mechanism underlying regulation of obesity by metabolites of intestinal flora,thereby providing a new reference and basis for the prevention and treatment of obesity. METHODS:"Intestinal microbiota,intestinal bacteria,intestinal microbiota metabolites,short-chain fatty acids,bile acids,ipopolysaccharide,trimethylamine N-oxide,medium-chain fatty acids,tryptophan derivatives,obesity"were used as search terms in Chinese and English.Literature related to obesity from 1990 to 2022 was retrieved in PubMed and CNKI databases.According to inclusion and exclusion criteria,88 articles were finally selected. RESULTS AND CONCLUSION:Intestinal flora is closely related to the occurrence and development of obesity.For example,changes in the Firmicutes to Bacteroidetes ratio can be used as a biomarker for the diagnosis of obesity,and the occurrence of obesity can be delayed by the colonization of probiotics such as Bifidobacterium breve,Lactobacillus and Akkermansia.Intestinal flora is mainly mediated by the metabolites of intestinal flora to participate in the regulation of obesity.For example,short-chain fatty acid can regulate adipogenesis by regulating signaling pathways such as G protein-coupled receptors 41,43 and peroxisome proliferator-activated receptor γ,thus delaying the occurrence and development of obesity.Bile acids can increase insulin sensitivity and body energy expenditure by promoting the activation of G protein-coupled receptor 5 and farnesol X receptor.In addition,lipopolysaccharide,trimethylamine oxide,medium-chain fatty acids and tryptophan derivatives are also widely involved in the occurrence and development of obesity through various signaling pathways.Further studies have found that metabolites of the same bacterial community exert heterogeneous effects in the specific process of regulating obesity via different signaling pathways.For example,under the influence of high-fat diet,acetic acids can activate the parasympathetic nervous system,leading to hyperphagia and liver insulin resistance and thus accelerating the physiological course of obesity.

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