1.Performance validation of a novel multiplex detection reagent for screening transfusion-associated infectious diseases
Miao LIU ; Qian ZHAO ; Na YAO ; Jing LI ; Jiahui ZHANG ; Ning YE ; Yuena XIE
Chinese Journal of Blood Transfusion 2026;39(5):650-655
Objective: To validate the performance of the Procleix UltrioPlex E assay (Grifols, Spain) on the Procleix Panther automated nucleic acid detection platform, which employs the TMA method to simultaneously detect HIV-1/HIV-2/HCV/HBV/HEV viruses, and to evaluate its value for screening transfusion-associated infectious diseases. Methods: In accordance with the requirements of ISO15189"Application of the Guidelines for the Accreditation of Quality and Capabilities of Medical Laboratories in the Field of Molecular Diagnostics (CNAS-CL02-A009: 2018)", "Guidelines for Performance Validation of Molecular Diagnostic Testing Procedures (CNAS-GL039: 2019)", and the "Technical Operating Procedures for Blood Banks (2019 Edition)", this study validated the reagent's performance in terms of analytical sensitivity validation, performance consistency validation, interference resistance, and cross-contamination resistance. Results: Probit analysis revealed that the 95% detection limits (95% confidence interval) for HBV, HCV, HIV, and HEV were 2.0 IU/mL, 1.5 IU/mL, 18.0 IU/mL and 3.7 IU/mL, respectively, which were consistent with the minimum detection limits stated in the kit's package insert and were comparable to the Procleix Ultrio Elite kit. Both kits were used to test the performance validation serum plate simultaneously, yielding results consistent with the serum plate (Kappa=1), indicating stable performance. Detection of medium-and low-concentration lipemia and weakly positive hemolysis samples demonstrated good interference resistance. Cross-contamination performance validation showed that the kit exhibited excellent cross-contamination resistance. Conclusion: The Procleix UltrioPlex E nucleic acid detection kit enables combined detection of HIV-1, HIV-2, HCV, HBV, and HEV, allowing single-test screening for multiple viruses in donor blood. The kit's analytical performance is stable and meets basic laboratory requirements, making it suitable for screening transfusion-associated infectious diseases in blood banks.
2.Rapid selection and characterization of antibodies against monkeypox virus E8L based on mRNA immunization and single-cell sequencing
Yiqi MIAO ; Huisheng SUN ; Xingsheng YANG ; Zhen ZHANG ; Jing YANG
Military Medical Sciences 2025;49(6):413-420
Objective To screen and identify specific monoclonal antibodies targeting the surface envelope protein E8L of the monkeypox intracellular mature virus based on mRNA immunization and single-cell sequencing.Methods E8L-mRNA was synthesized in vitro and encapsulated into lipid nanoparticles(LNPs)for immunization to induce immune responses.The antibody level in blood serum was detected to find out when the mice had produced sufficient antibodies.B cells in the spleen of the mice were isolated by flow cytometry sorting,followed by library construction and sequencing.Based on the analysis of light and heavy chain sequences of the antibodies from the sequencing data,E8L candidate monoclonal antibodies were screened according to the abundance ranking and expressed.The affinity of these monoclonal antibodies was detected by enzyme-linked immunosorbent assay(ELISA).Candidate antibodies with high affinity for E8L were applied to immunochromatographic assays to detect the monkeypox virus(MPXV)E8L protein.Results Mice were immunized by lipid nanoparticles encapsulating E8L-mRNA.Approximately 1.5 million B cells were selected by flow cytometry.After single-cell sequencing,17 candidate monoclonal antibodies for E8L were identified and expressed.Two high affinity monoclonal antibodies were obtained for monkeypox virus E8L protein by ELISA.These two antibodies were used as the basis for immunochromatographic assays to detect E8L protein,with a sensitivity of 0.5 ng/mL.Conclusion Two monoclonal antibodies with high affinity for the MPXV E8L protein are obtained,which can be potentially used for detecting monkeypox virus.
3.Altered Cerebral Blood Flow in Type 2 Diabetes Mellitus Without Cognitive Impairment.
Jia-Ying YANG ; Xue-Wei ZHANG ; Xue-Qing LIU ; Jia-Min ZHOU ; Miao HE ; Jing LI ; Xia-Li SHAO ; Wen-Hui LI ; Yu-Zhou GUAN ; Wei-Hong ZHANG ; Feng FENG
Acta Academiae Medicinae Sinicae 2025;47(2):219-225
Objective To investigate the alterations of cerebral blood flow(CBF)in type 2 diabetic mellitus(T2DM) patients without cognitive impairment by using arterial spin labeling(ASL)technique.Methods A total of 23 T2DM patients without cognitive impairment and 23 healthy controls(HC)matched by age,sex,and education attainment were recruited.Their clinical data were collected,and neuropsychological tests and cerebral magnetic resonance imaging were performed.Then,the outcomes of clinical features,neuropsychological tests,and global and regional CBF were compared between the two groups.The significant regional zCBF(z-transformed relative CBF)values were extracted and correlated with clinical data and neuropsychological scores in T2DM patients,controlling age,sex,and education.Results No significant difference was found in whole brain CBF between the two groups(P=0.155),while significantly higher CBF was identified in the left superior temporal gyrus and left insula in the T2DM group(Gaussian random field correction,initial threshold P < 0.001,cluster level P < 0.05).No correlation was observed between the significant regional zCBF values and the clinical data or the neuropsychological scores in T2DM patients(all P>0.05).Conclusion Alterations in cerebral hemodynamics may precede cognitive function changes in T2DM,suggesting that the ASL technique is promising for early monitoring of cerebral hemodynamic changes associated with cognitive impairment in patients with T2DM.
Humans
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Diabetes Mellitus, Type 2/physiopathology*
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Cerebrovascular Circulation
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Middle Aged
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Male
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Female
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Magnetic Resonance Imaging
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Case-Control Studies
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Cognitive Dysfunction
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Neuropsychological Tests
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Aged
4.Reasonable management and control practice of prophylactic use of antibiotics in urinary system lithotripsy
Yijun CHEN ; Zhuo WANG ; Miao HE ; Yu ZHANG ; Jing TIAN
Journal of Pharmaceutical Practice and Service 2025;43(12):614-618
Objective To analyze the effectiveness of reasonable control measures for prophylactic use of antibiotics in urinary system lithotripsy. Methods By antimicrobial stewardship, strengthening special comments on antibiotics and information notification on rational use of antibiotics, adding and improving the pre-review rules for antibiotics prescriptions, conducting in-depth clinical training and consultation by clinical pharmacists, strengthening innovation in rational use of drugs, and taking various measures to actively improve rational use of prophylactic antibiotics of lithotripsy in urology department, the changes of indexes related to antibiotics in urology department from 2019 to 2022 were analyzed. Results After active and reasonable control, Antibiotics Use Density in urology department decreased year by year. The utilization rate of antibiotics in inpatients decreased from 94.27% in 2019 to 77.47% in 2022. Various rate of microbial inspection reached the standard in 2022. The imipenem and cilastatin sodium for injection ranking of prophylactic use of antibiotics consumption DDDs for urinary system lithotripsy decreased from the 4th place in 2019 to the 8th place in 2022. The ranking of the urology department on carbapenem consumption DDDs in the whole hospital decreased from the 8th place in 2019 to the 12th place in 2022. At the same time, the incidence of urinary tract lithotripsy postoperative infection showed a decreasing trend year by year, from 0.84% in 2019 to 0.49% in 2022. Conclusion Positive control measures can promote the rational use of prophylactic antibiotics for urinary system lithotripsy.
5.Study on the clinical value of dynamic AI ultrasonic intelligent assisted diagnosis system for preoperative evaluation of thyroid nodules with diameter≤1.0 cm
Xin MIAO ; Shaoteng XIE ; Zheng WAN ; Wen TIAN ; Bing WANG ; Jing YAO ; Zelong YANG ; Yanbing JIAN ; Junwen DING ; Linlin ZHANG ; Chen LI
Chinese Journal of Endocrine Surgery 2025;19(1):24-29
Objective:To investigate the clinical value of dynamic AI ultrasonic intelligent assisted diagnosis system for preoperative evaluation of thyroid nodules with diameter ≤1.0 cm.Methods:From Apr. 1, 2023, to Dec. 30, 2023, 742 thyroid nodules with diameter ≤1.0 cm were removed from 532 patients with thyroid nodule disease who received surgical treatment in the Department of Thyroid (hernia) of the First Medical Center of the Chinese People’s Liberation Army General Hospital. Among them, 423 were d≤0.5 cm. 319 cases (235 males and 507 females) with 0.5
6.Development and application on a full process disease diagnosis and treatment assistance system based on generative artificial intelligence.
Wanjie YANG ; Hao FU ; Xiangfei MENG ; Changsong LI ; Ce YU ; Xinting ZHAO ; Weifeng LI ; Wei ZHAO ; Qi WU ; Zheng CHEN ; Chao CUI ; Song GAO ; Zhen WAN ; Jing HAN ; Weikang ZHAO ; Dong HAN ; Zhongzhuo JIANG ; Weirong XING ; Mou YANG ; Xuan MIAO ; Haibai SUN ; Zhiheng XING ; Junquan ZHANG ; Lixia SHI ; Li ZHANG
Chinese Critical Care Medicine 2025;37(5):477-483
The rapid development of artificial intelligence (AI), especially generative AI (GenAI), has already brought, and will continue to bring, revolutionary changes to our daily production and life, as well as create new opportunities and challenges for diagnostic and therapeutic practices in the medical field. Haihe Hospital of Tianjin University collaborates with the National Supercomputer Center in Tianjin, Tianjin University, and other institutions to carry out research in areas such as smart healthcare, smart services, and smart management. We have conducted research and development of a full-process disease diagnosis and treatment assistance system based on GenAI in the field of smart healthcare. The development of this project is of great significance. The first goal is to upgrade and transform the hospital's information center, organically integrate it with existing information systems, and provide the necessary computing power storage support for intelligent services within the hospital. We have implemented the localized deployment of three models: Tianhe "Tianyuan", WiNGPT, and DeepSeek. The second is to create a digital avatar of the chief physician/chief physician's voice and image by integrating multimodal intelligent interaction technology. With generative intelligence as the core, this solution provides patients with a visual medical interaction solution. The third is to achieve deep adaptation between generative intelligence and the entire process of patient medical treatment. In this project, we have developed assistant tools such as intelligent inquiry, intelligent diagnosis and recognition, intelligent treatment plan generation, and intelligent assisted medical record generation to improve the safety, quality, and efficiency of the diagnosis and treatment process. This study introduces the content of a full-process disease diagnosis and treatment assistance system, aiming to provide references and insights for the digital transformation of the healthcare industry.
Artificial Intelligence
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Humans
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Delivery of Health Care
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Generative Artificial Intelligence
7.Qualitative study on behavioral intentions of Operating Room nurses to implement isolation techniques in tumor surgery based on the theory of planned behavior
Na KONG ; Jing WANG ; Yun ZHANG ; Yujun JIANG ; Chengqiong MIAO ; Lin ZHAO
Chinese Journal of Modern Nursing 2025;31(9):1171-1177
Objective:To explore Operating Room nurses' behavioral intentions regarding the implementation of isolation techniques in tumor surgery based on the theory of planned behavior (TPB) .Methods:This study was a qualitative research. A purposive sampling method was used to select 14 Operating Room nurses from the Affiliated Hospital of Qingdao University for semi-structured interviews from July to October 2023. An interview outline was developed based on TPB, and the Colaizzi 7-step method was used for data organization and analysis.Results:Among the 14 Operating Room nurses interviewed, two were male and 12 were female, with work experience ranging from one to 36 years and ages between 23 and 59 years. Based on TPB's three dimensions, including behavioral attitude, subjective norm, and perceived behavioral control, eight themes were identified: positive evaluation, negative evaluation, pressure from Operating Room managers and colleagues, pressure from surgeons, pressure from patients, lack of cognitive and skill motivation, work-related stressors as barriers, and analysis of real-world difficulties.Conclusions:Operating Room nurses hold a positive evaluation of implementing isolation techniques in tumor surgery, and their behavioral intention is influenced by nursing managers, surgeons, colleagues, and patients. However, there are also barriers such as a lack of knowledge and skill motivation, multiple work-related stressors, and incomplete institutional processes and standards.
8.Experimental study of kidney lesions associated with autoimmune thyroiditis
Xin ZHANG ; Rongli SUN ; Miao LIU ; Li LI ; Jing LI
Journal of China Medical University 2025;54(5):396-400
Objective To establish an experimental autoimmune thyroiditis(EAT)mouse model using mouse thyroglobulin(mTg)immunization and investigate kidney injury presence and characteristics in order to explore the underlying mechanisms of renal injury in autoimmune thyroiditis(AIT).Methods To induce EAT,female CBA/J mice were immunized with mTg,while control mice received subcutaneous injections of distilled water.Serum and kidney homogenate levels of Tg-specific autoantibodies(TgAbs)were measured using enzyme-linked immunosorbent assay(ELISA).The thyroid tissue was analyzed using hematoxylin and eosin(HE)staining.Urine protein levels were assessed at post-immunization weeks three and four.Kidney tissues were examined using HE staining and electron microscopy.Direct and indirect immunofluorescence was used to detect immune complex deposition and serum anti-kidney tissue autoan-tibodies,respectively.Results EAT mice exhibited significantly increased serum TgAb levels,mononuclear cell infiltration in the thyroid tissues,and increased urine protein levels.Light microscopy revealed glomerular hypercellularity and narrowed lumen.Electron microscopy unraveled electron-dense subendothelial deposits in the glomeruli.IgG immune complexes and TgAbs were detected in the glomeruli and kidney homogenates,respectively.Serum samples from EAT mice contained IgG antibodies targeting kidney tissue antigens.Conclusion TgAb-Tg immune complex depositions in the glomeruli might be a key mechanism of renal injury in AIT,while cross-reac-tive autoimmune responses to shared thyroid and kidney antigens could also contribute to kidney damage.
9.Study on the clinical value of dynamic AI ultrasonic intelligent assisted diagnosis system for preoperative evaluation of thyroid nodules with diameter≤1.0 cm
Xin MIAO ; Shaoteng XIE ; Zheng WAN ; Wen TIAN ; Bing WANG ; Jing YAO ; Zelong YANG ; Yanbing JIAN ; Junwen DING ; Linlin ZHANG ; Chen LI
Chinese Journal of Endocrine Surgery 2025;19(1):24-29
Objective:To investigate the clinical value of dynamic AI ultrasonic intelligent assisted diagnosis system for preoperative evaluation of thyroid nodules with diameter ≤1.0 cm.Methods:From Apr. 1, 2023, to Dec. 30, 2023, 742 thyroid nodules with diameter ≤1.0 cm were removed from 532 patients with thyroid nodule disease who received surgical treatment in the Department of Thyroid (hernia) of the First Medical Center of the Chinese People’s Liberation Army General Hospital. Among them, 423 were d≤0.5 cm. 319 cases (235 males and 507 females) with 0.5
10.Interpretation of Evidence-based Expert Consensus on the Clinical Management of Safety of Bruton′s Tyrosine Kinase Inhibitors (2024)
Dan JIANG ; Zaiwei SONG ; Yuan GAO ; Daobin ZHOU ; Yue LI ; Lingli ZHANG ; Liyan MIAO ; Qun SHAO ; Jun MA ; Jun ZHU ; Hongmei JING ; Rongsheng ZHAO
Adverse Drug Reactions Journal 2025;27(7):385-396
Bruton's tyrosine kinase inhibitors (BTKi) are a class of novel small-molecule targeted antitumor drugs used to treat B-cell malignancies. However, safety issues associated with BTKi may lead to treatment interruption, compromising their efficacy. To promote the standardized management of safety in BTKi treatment, Evidence-Based Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Hospital Pharmacy Professional Committee of the Chinese Pharmaceutical Association, Division of Therapeutic Drug Monitoring of Chinese Pharmacological Society, Expert Committee on Lymphoma of Chinese Society of Clinical Oncology, Expert Committee on Leukemia of Chinese Society of Clinical Oncology, Integrated Cancer Cardiology Branch of China Anti-Cancer Association, Hematology Branch of the Chinese Medical Association, and Hospital Pharmacy Professional Committee of the Cross-Straits Medicine Exchange Association formulated the Evidence-based Expert Consensus on the Clinical Management of Safety of Bruton′s Tyrosine Kinase Inhibitors (2024), which was published in the Chinese Journal of Cancer Research in June 2024. It covered 9 clinical issues in the following 3 domains: (1) the management of common adverse reactions of BTKi such as bleeding, cardiovascular events, hematological toxicity, infections, rashes, diarrhea, and arthralgia; (2) the management of drug-drug interactions; (3) management guidance for special populations. This consensus provides evidence-based recommendations for the safety management of BTKi medication in clinical practice. This article provides an interpretation and evidence summary of the consensus in Chinese, aiming to facilitate its implementation in China, enhance the safety management of BTKi treatment, and improve patient outcomes.

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