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.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.
3.A novel intracoronary hypothermia device reduces myocardial reperfusion injury in pigs
Zhiqiang PEI ; Jin QIU ; Yongchao ZHAO ; Shuai SONG ; Rui WANG ; Wei LUO ; Xingxing CAI ; Bin LIU ; Han CHEN ; Jiasheng YIN ; Xinyu WENG ; Yizhe WU ; Chenguang LI ; Li SHEN ; Junbo GE
Chinese Medical Journal 2024;137(20):2461-2472
Background::Hypothermia therapy has been suggested to attenuate myocardial necrosis; however, the clinical implementation as a valid therapeutic strategy has failed, and new approaches are needed to translate into clinical applications. This study aimed to assess the feasibility, safety, and efficacy of a novel selective intracoronary hypothermia (SICH) device in mitigating myocardial reperfusion injury.Methods::This study comprised two phases. The first phase of the SICH was performed in a normal porcine model for 30 minutes ( n = 5) to evaluate its feasibility. The second phase was conducted in a porcine myocardial infarction (MI) model of myocardial ischemia/reperfusion which was performed by balloon occlusion of the left anterior descending coronary artery for 60 minutes and maintained for 42 days. Pigs in the hypothermia group ( n = 8) received hypothermia intervention onset reperfusion for 30 minutes and controls ( n = 8) received no intervention. All animals were followed for 42 days. Cardiac magnetic resonance analysis (five and 42 days post-MI) and a series of biomarkers/histological studies were performed. Results::The average time to lower temperatures to a steady state was 4.8 ± 0.8 s. SICH had no impact on blood pressure or heart rate and was safely performed without complications by using a 3.9 F catheter. Interleukin-6 (IL-6), tumor necrosis factor-α, C-reactive protein (CRP), and brain natriuretic peptide (BNP) were lower at 60 min post perfusion in pigs that underwent SICH as compared with the control group. On day 5 post MI/R, edema, intramyocardial hemorrhage, and microvascular obstruction were reduced in the hypothermia group. On day 42 post MI/R, the infarct size, IL-6, CRP, BNP, and matrix metalloproteinase-9 were reduced, and the ejection fraction was improved in pigs that underwent SICH.Conclusions::The SICH device safely and effectively reduced the infarct size and improved heart function in a pig model of MI/R. These beneficial effects indicate the clinical potential of SICH for treatment of myocardial reperfusion injury.
4.Hyperoside nanoparticles loaded with bone marrow mesenchymal stem cells synergistically repair endometrial injury
Rui-Fang HAN ; Hai-Yi ZHOU ; Xing-Shan LIANG ; Si-Yi HE ; Yong-Ge GUAN ; Yang SONG
Chinese Pharmacological Bulletin 2024;40(7):1302-1311
Aim To evaluate the effect of hyperoside/chitosan-nanoparticles(Hyp-NPs)on bone marrow mesenchymal stem cells(BMSCs)in vitro cell experi-ments and the underlying mechanism,and to conduct in vivo animal experiments to investigate the synergistic effect of Hyp-NPs and BMSCs on repairing endometrial damage in rats.Methods BMSCs were identified by flow cytometry.Hyp-NPs were prepared by ion crosslinking method,characterized and evaluated by laser particle size analyzer and transmission electron microscopy.The effects of different concentrations of Hyp-NPs on the migration of BMSCs were evaluated by scratch assay and immunofluorescence.NRF2 lentivir-us vector was constructed to explore the mechanism of Hyp-NPs on BMSCs.In animal experiments,Hyp-NPs loaded with BMSCs were co-transplanted into the uter-ine cavity of a rat model of endometrial injury.HE,Masson,IHC,TUNEL,and ELISA experiments were used to systematically evaluate the repair effect and pregnancy function of the composite formulation on rat endometrial injury from multiple aspects and angles,including general pathology,fibrosis,receptivity,cell proliferation,angiogenesis,stem cell recruitment,and inflammation of the endometrium.Results BMSCs were successfully isolated and cultured.Hyp-NPs with high stability and small particle size were successfully prepared.Scratch experiments indicated that Hyp-NPs could promote the migration of BMSCs.By successfully constructing a lentiviral NRF2 vector and oxidative damage model for BMSCs,immunofluorescence experi-ments showed that Hyp-NPs could regulate the biologi-cal axis of BMSCs by activating NRF2.Animal experi-ments showed that the synergistic administration of Hyp-NPs and BMSCs could increase endometrial thick-ness and glandular quantity,promote stem cell homing through anti-fibrotic,anti-apoptotic,and anti-inflam-matory effects,and restore pregnancy function in rats with endometrial injury.Conclusion The synergistic administration of Hyp-NPs and BMSCs could repair en-dometrial injury.
5.Characteristics of early postural control disorders in elderly patients with Parkinson's disease
Rui-Dong GE ; Haiyang XU ; Jingwei GUO
Chinese Journal of Rehabilitation Medicine 2024;39(11):1620-1624
Objective:To explore the characteristics of early postural control disorders in elderly patients with Parkinson's disease(PD). Method:The sensory organization test(SOT),limits of stability(LOS),and adaptation test(ADT)were performed on 15 patients with early-stage PD and 10 healthy elderly patients using a dynamic and static balance training system. Result:Compared with the healthy group,in the SOT,early PD patients showed no significant differences in the comprehensive score of sensory organization,proprioceptive,visual,and visual dependence(P>0.05).How-ever,there was a significant difference in vestibular balance control(P<0.05).In the LOS,early PD patients exhibited decreased forward and backward max excursions(MXE)(P<0.05),increased reaction time(RT)(P<0.05),and decreased backward directional contro1(DCL)(P<0.05).There were no significant differences in for-ward DCL,left and right MXE,RT,DCL(P>0.05).In the ADT,there were no significant differences in the incidence of the first fall and the incidence of the last four falls in PD patients and healthy groups in the for-ward and backward tilt tests(P>0.05). Conclusion:Early PD elderly patients already have postural control disorders,particularly with decreased limits of stability in forward and backward directions and reduced ability to maintain balance using vestibular input.
6.Clinical and laboratory characteristics of 32 patients with Listeria monocytogenes bacteremia
Ming YANG ; Rui-Yan BAI ; Jin-Ge TAI ; Peng-Juan GUO ; Ke DONG
Chinese Journal of Zoonoses 2024;40(7):652-655
This study was aimed at analyzing the clinical and laboratory characteristics of patients with Listeria monocyto-genes bacteremia,to provide evidence for its diagnosis and treatment.A retrospective analysis was conducted on the clinical data for patients with L.monocytogenes bacteremia at Tangdu Hospital between September 2012 and April 2022.The data included age,sex,underlying diseases,treatments,and prognosis.Changes in indicators such as white blood cell(WBC)count,mono-cyte percentage,neutrophil percentage,monocyte/neutrophil ratio(M/N),C-reactive protein(CRP),and procalcitonin before and after treatment were statistically analyzed.Among the 32 patients with L.monocytogenes bacteremia,the average age was 31.9 years,and three patients were older than 65 years.The incidence rate was highest in summer(11 patients,34.4%),fol-lowed by spring(9 patients,28.1%).A total of 24 patients(75.0%)had underlying diseases.After accurate diagnosis,the treatment plans of 29 patients were adjusted to target antibacterial therapy consisting primarily of penicillins(17 patients,53.1%)and carbapenems(12 patients,37.5%).After treatment,the levels of neutrophils,lymphocytes,and CRP were signifi-cantly lower than those before treatment(P<0.05).A total of 29 patients(90.6%)improved and were discharged,one patient died,and two patients had poor prognosis.The primary risk factors for L.monocytogenes infection were autoimmune diseases,tumors,and pregnancy.Penicillin was the first choice effective empirical treatment for listeriosis.A clear diagnosis of the pathogen and appropriate choice of antibiotics were particularly important for the treatment of L.monocytogenes infection.
7.Arterial stiffness in subclinical atherosclerosis quantified with ultrafast pulse wave velocity measurements: a comparison with a healthy population using propensity score matching
Xuezhong JIANG ; Weiming GE ; Hui HUANG ; Yating LI ; Xiaojing LIU ; Huiyan PANG ; Rui HE ; Hui WANG ; Zhengqiu ZHU ; Ping HE ; Yinping WANG ; Xuehui MA ; Airong REN ; Bixiao SHEN ; Meijuan WANG
Ultrasonography 2024;43(4):263-271
Purpose:
This study aimed to evaluate changes in ultrafast pulse wave velocity (ufPWV) in individuals with arterial stiffness and subclinical atherosclerosis (subAS), and to provide cutoff values.
Methods:
This retrospective study recruited 231 participants, including 67 patients with subAS. The pulse wave velocity was measured at the beginning and end of systole (PWV-BS and PWVES, respectively) using ultrafast ultrasonography to assess arterial stiffness. The right and left common carotid arteries were measured separately, and laboratory metabolic parameters were also collected. Participants were balanced between groups using propensity score matching (PSM) at a 1:1 ratio, adjusting for age, sex, and waist-to-hip ratio as potential confounders. Cutoff values of ufPWV for monitoring subAS were determined via receiver operating characteristic (ROC) curve analysis.
Results:
PWV-ES, unlike PWV-BS, was higher in the subAS subgroup than in the subAS-free group after PSM (all P<0.05). For each 1 m/s increase in left, right, and bilateral mean PWV-ES, the risk of subAS increased by 23% (95% confidence interval [CI], 1.04 to 1.46), 26% (95% CI, 1.07 to 1.52), and 38% (95% CI, 1.12 to 1.72), respectively. According to ROC analyses, predictive potential was found for left PWV-ES (cutoff value=7.910 m/s, P=0.002), right PWV-ES (cutoff value=6.615 m/s, P=0.003), and bilateral mean PWV-ES (cutoff value=7.415 m/s, P<0.001), but not for PWV-BS (all P>0.05).
Conclusion
PWV-ES measured using ultrafast ultrasonography was significantly higher in individuals with subAS than in those without. Specific PWV-ES cutoff values showed potential for predicting an increased risk of subAS.
8.Application of intelligent robots on pain intervention of children:a scoping review
Wenqi FAN ; Rui ZHAO ; Xiaoxia LIU ; Lina GE
Chinese Journal of Nursing 2024;59(18):2277-2282
Objective To review the application of intelligent robots in the pain intervention of children,and identify the elements of the intervention,so as to guide future research and practice.Methods A literature search was performed in the PubMed,Cochrane Library,Embase,Web of Science,CINAHL,CNKI,Wanfang database,and CBM.Following the methodology of the scoping review,the retrieval time was from the establishment of the database to November 2023.The included studies were summarized and analyzed.Results A total of 10 articles were included,including 7 randomized controlled trials,2 quasi-experimental studies,and 1 mixed method research study.The working principles of intelligent robots in pain intervention for pediatric patients include distraction and pain empathy.Functions of intelligent robots included verbal interaction,limb motion,facial expression,and haptic recognition.Interventions included pre-intervention preparation,intervention content,and intervention duration,of which the intervention content included question-and-answer conversations,breathing exercises,recreation,and verbal encouragement,and the duration of the intervention ranged from 3 to 11 minutes.The outcome indicators included pain level,negative emotions,and feasibility.The results showed the positive feasibility of the application of intelligent robots in pain intervention for children,which may help to reduce the level of pain and improve children's negative emotions such as anxiety and distress.Conclusion Intelligent robots in the field of pain intervention of children present preliminary effects and feasibility.It is recommended that researchers should enrich the functions of intelligent robots,enhance human-robot interaction,carry out personalized interventions,and add physiological indexes as effect evaluation indexes to further validate its application effects.
9.A systematic review of two-way referral criteria for diabetes
Min XU ; Xiaoxu GE ; Rui LI ; Liling XU ; Shan HUANG ; Lingmei QIAN ; Jun MA ; Juan DU
Chinese Journal of General Practitioners 2024;23(12):1299-1306
Objective:To investigate the criteria for two-way referral of diabetes in China through systematic review.Methods:According to inclusion and exclusion criteria, articles on two-way referral criteria for diabetes in China were retrieved from databases of PubMed, Embase, Cochrane Library, CNKI and Wanfang from inception to July 15, 2023. The data were extracted, by author′s name, publish year, criteria for rupwards and downwards referral, sample size, study region, study type and main conclusions.Results:A total of 702 relavent articles were retrieved, and 15 of which were included in the analysis. Blood glucose levels were the basic criteria for two-way referral, The criteria for upward referral included fasting blood glucose, 2-h postpradial blood glucose, glycosylated hemoglobin and random blood glucose, but there were variations in measuement values. The criteria for downward referral included fasting blood glucose, 2-h postpradial blood glucose, glycosylated hemoglobin, with the variation in fasting blood glucose. Lipids and blood pressure were also included in the referral criteria in later literature, with the variation of blood pressure values. There was consensus on the upward referral criteria for patients with special types of diabetes and with newly diagnosed diabetes. In contrast, the referral criteria for diabetic complications were relatively vague, especially with the lack of severity classification for chronic complications.Conclusion:The two-way referral criteria for diabetes mellitus have been constantly developing, while the criteria for downwards referral to the community need to be further improved.
10.Arterial stiffness in subclinical atherosclerosis quantified with ultrafast pulse wave velocity measurements: a comparison with a healthy population using propensity score matching
Xuezhong JIANG ; Weiming GE ; Hui HUANG ; Yating LI ; Xiaojing LIU ; Huiyan PANG ; Rui HE ; Hui WANG ; Zhengqiu ZHU ; Ping HE ; Yinping WANG ; Xuehui MA ; Airong REN ; Bixiao SHEN ; Meijuan WANG
Ultrasonography 2024;43(4):263-271
Purpose:
This study aimed to evaluate changes in ultrafast pulse wave velocity (ufPWV) in individuals with arterial stiffness and subclinical atherosclerosis (subAS), and to provide cutoff values.
Methods:
This retrospective study recruited 231 participants, including 67 patients with subAS. The pulse wave velocity was measured at the beginning and end of systole (PWV-BS and PWVES, respectively) using ultrafast ultrasonography to assess arterial stiffness. The right and left common carotid arteries were measured separately, and laboratory metabolic parameters were also collected. Participants were balanced between groups using propensity score matching (PSM) at a 1:1 ratio, adjusting for age, sex, and waist-to-hip ratio as potential confounders. Cutoff values of ufPWV for monitoring subAS were determined via receiver operating characteristic (ROC) curve analysis.
Results:
PWV-ES, unlike PWV-BS, was higher in the subAS subgroup than in the subAS-free group after PSM (all P<0.05). For each 1 m/s increase in left, right, and bilateral mean PWV-ES, the risk of subAS increased by 23% (95% confidence interval [CI], 1.04 to 1.46), 26% (95% CI, 1.07 to 1.52), and 38% (95% CI, 1.12 to 1.72), respectively. According to ROC analyses, predictive potential was found for left PWV-ES (cutoff value=7.910 m/s, P=0.002), right PWV-ES (cutoff value=6.615 m/s, P=0.003), and bilateral mean PWV-ES (cutoff value=7.415 m/s, P<0.001), but not for PWV-BS (all P>0.05).
Conclusion
PWV-ES measured using ultrafast ultrasonography was significantly higher in individuals with subAS than in those without. Specific PWV-ES cutoff values showed potential for predicting an increased risk of subAS.

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