1.Construction and application of a system for rational drug use for prescriptions from internet hospitals and external prescriptions and medical insurance fund control based on a pre-review prescription system
Yi GE ; Xiaolan WANG ; Junping HAN ; Bo LYU ; Yu GUAN ; Feng XU ; Aiming SHI
China Pharmacy 2026;37(5):584-588
OBJECTIVE To ensure the safety of patients’ drug use and control the risk of medical insurance expenditure by upgrading the pre-prescription review system to conduct pre-review on prescriptions from internet hospitals and external prescriptions, as well as to review the payment methods of drugs (including in-hospital and external drug dispensing). METHODS The data interfaces of prescriptions from internet hospitals and external prescriptions were integrated to achieve real-time rational drug use intervention. Additionally, an intelligent review project for payment method was added to precisely intervene in the medical insurance payment methods of drugs. The effect of the system upgrade was evaluated by comparing the qualification rates of prescriptions from internet hospitals and external prescriptions and the suspected amounts of drug violations from January to April 2025 (before the system upgrade) and May to August 2025 (after the system upgrade). RESULTS After the upgrade of the pre-prescription review system, the qualification rates of prescriptions from internet hospitals and external prescriptions increased by 3.5% [95% confidence interval (CI)=0.3%-6.7%, P =0.037 ] ; the suspected amounts of drug violations decreased to 52.9% of the pre-upgrade level (95%CI=31.6%-88.5%, P =0.026), and the average monthly sequential decrease was 29.5% (95%CI=12.2%-43.4%, P =0.012). Moreover, the addition of the intelligent review project for payment methods promoted the management of off-label drug use in our hospital. After the upgrade, a total of 79 filling valid applications for off-label drug use were received and archived. CONCLUSIONS The upgrade of the pre-prescription review system effectively improves the review qualification rates of prescriptions from internet hospitals and external prescriptions and the accuracy of medical insurance payment for drugs, and strengthens the supervision of off-label drug use, achieving dual guarantees of clinical rationality and medical insurance compliance.
2.Analysis of sports supplement usage among grade 9 students and associated factors
GE Meiqin, CUI Yinchen, XUE Yaqi, BA Yi, CHEN Shuo, LAI Fengkun, ZHANG Hongyu, ZHEN Zhiping
Chinese Journal of School Health 2026;47(3):323-326
Objective:
To investigate the status and associated factors of sports supplement usage among grade 9 students, so as to provide a scientific basis for targeted supervision and health education regarding sports supplement usage among junior high school students.
Methods:
From June to September 2025, a stratified cluster random sampling method was used to select 2 261 grade 9 students from 10 provinces (autonomous regions, municipalities) in China. A questionnaire survey was conducted on their sports supplement usage and related factors. The Chi square test was used to compare the usage rates of sports supplements among different groups of students, and binary Logistic regression analysis was employed to investigate the related factors of sports supplement usage among grade 9 students.
Results:
Totally 59.7% of the grade 9 students used sports supplements. The usage rate (62.5%) was higher among boys than girls (56.3%), higher among students from rural areas and towns/counties (66.5%, 66.2%) than those from urban districts (52.9%), higher among boarding students (65.2%) than non resident students (54.3%), higher among students whose parents occupations were businessmen and workers (fathers: 65.0%, 63.7%; mothers: 63.6%, 61.1%) than those whose parents were farmers and civil servants (fathers: 57.5%, 54.1%; mothers: 58.8%, 55.7%), higher among students with a monthly family income of 5 000- 10 000 yuan (66.3%) than those in other income groups, and higher among students in the high score zone for the entrance physical examination to senior high school (67.7%) than those in the medium and low score zones ( 56.3% , 56.5%) ( χ 2=8.99, 42.21, 27.98, 20.55, 8.20, 22.74, 24.70, respectively, all P <0.05). Binary Logistic regression analysis showed that boys ( OR =1.26), those from rural areas ( OR =1.59), boarding students ( OR =1.36), those with a monthly family income of 5 000- 10 000 yuan ( OR =1.41), and those in the high score zone for entrance physical examination to senior high school ( OR =1.34) were more likely to use sports supplements during the entrance physical examination to senior high school; the probability of sports supplement usage was lower among students whose fathers were civil servants ( OR =0.74) (all P <0.05).
Conclusions
The usage of sports supplements is relatively common among grade 9 students. Intervention measures should be targeted at specific populations to reduce the risk of misuse.
3.Clinical Efficacy of Modified Linggui Zhugan Tang in Patients with Obstructive Sleep Apnea-Hypopnea Syndrome of Spleen Deficiency and Dampness Obstruction with Blood Stasis Type and Its Effect on MIF, miR-223, and IL-18
Jun ZHANG ; Mengmei WEI ; Bo LI ; Yi YANG ; Changhui LINGHU ; Mingchang ZHANG ; Zhengxing GE
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(9):171-179
ObjectiveTo investigate the intervention effects of modified Linggui Zhugan Tang (LGZGT) on patients with obstructive sleep apnea-hypopnea syndrome (OSAHS) of the spleen deficiency and dampness obstruction with blood stasis type, reveal its possible mechanisms, and provide a theoretical basis for the clinical treatment of OSAHS with traditional Chinese medicine (TCM). MethodsEighty OSAHS patients with spleen deficiency and dampness obstruction with blood stasis were randomly assigned to a control group and an observation group (1∶1) using a random number table, with 40 patients in each group. The control group received standard basic treatment combined with oral Doxofylline tablets, while the observation group received standard basic treatment combined with modified LGZGT. Serum levels of macrophage migration inhibitory factor (MIF), microRNA-223 (miR-223), and interleukin-18 (IL-18) were measured by enzyme-linked immunosorbent assay (ELISA), and the mRNA expression levels of MIF, miR-223, and IL-18 were measured by real-time quantitative polymerase chain reaction (Real-time PCR). After two months of treatment, the total clinical efficacy, apnea-hypopnea index (AHI), lowest nocturnal oxygen saturation (LSpO2), body mass index (BMI), TCM syndrome scores, and expression levels of MIF, miR-223, and IL-18 before and after treatment were compared between the two groups. Correlations between MIF, miR-223, IL-18 and AHI and LSpO2 were also analyzed. ResultsCompared with the control group, the observation group showed a significantly higher total clinical effective rate (P<0.01, Z=-3.49). Within the control group, no significant changes were observed in AHI, LSpO2, BMI, TCM syndrome scores, or MIF, miR-223, IL-18 levels and their mRNAs after treatment. In the observation group, AHI, BMI, TCM syndrome scores, and MIF and IL-18 levels and their mRNAs decreased significantly, while LSpO2 increased significantly (P<0.01). After treatment, compared with the control group, the observation group exhibited significantly lower AHI, BMI, TCM syndrome scores, and MIF and IL-18 levels and their mRNAs, and significantly higher LSpO2 (P<0.01). Correlation analysis showed that MIF and IL-18 were positively correlated with AHI (P<0.01) and negatively correlated with LSpO2 (P<0.01), whereas miR-223 was negatively correlated with AHI (P<0.01) and positively correlated with LSpO2 (P<0.01). ConclusionModified LGZGT may improve OSAHS of the spleen deficiency and dampness obstruction with blood stasis type by reducing airway inflammatory factors, alleviating airway inflammation, relieving airway edema and stenosis, and improving airway obstruction.
4.Genetic analysis and reproductive intervention for 46 Chinese pedigrees affected with Hereditary multiple exostoses.
Lilan SU ; Xiao HU ; Jing DAI ; Zhengxing WAN ; Duo YI ; Shuangfei LI ; Liang HU ; Yueqiu TAN ; Fei GONG ; Ge LIN ; Guangxiu LU ; Qianjun ZHANG ; Juan DU ; Wenbin HE
Chinese Journal of Medical Genetics 2026;43(4):253-258
OBJECTIVE:
To explore the genetic etiology of 46 Chinese pedigrees affected with Hereditary multiple exostoses (HME) and provide genetic counseling and reproductive intervention.
METHODS:
Whole-exome sequencing and Sanger sequencing were carried out on 87 patients from the 46 pedigrees to analyze the variants of EXT1 and EXT2 genes. Pathogenicity of the variants was assessed based on the guidelines from the American College of Medical Genetics and Genomics and Association for Molecular Pathology (ACMG/AMP). Prenatal diagnosis and preimplantation genetic testing (PGT) were provided for couples with identified pathogenic mutations. This study was approved by the Medical Ethics Committee of the hospital (Ethics No.: LL-SC-SG-2014-010).
RESULTS:
In total 17 and 22 pathogenic variants were respectively identified in the EXT1 and EXT2 genes, among which 5 EXT1 and 12 EXT2 variants were unreported previously. Three patients with no family history were found to harbor de novo variants of the EXT1 gene. Twenty nine couples had opted for PGT or underwent prenatal diagnosis following natural conception, and 17 healthy babies were born.
CONCLUSION
This study has clarified the genetic etiology of 45 HME pedigrees and identified 17 novel variants, which has enriched the mutational spectrum of the EXT1 and EXT2 genes. Reproductive intervention through PGT and prenatal diagnosis have prevented the recurrence of HME in these families.
Humans
;
Female
;
Male
;
Pedigree
;
Exostoses, Multiple Hereditary/diagnosis*
;
N-Acetylglucosaminyltransferases/genetics*
;
Adult
;
Exostosin 1
;
Asian People/genetics*
;
Genetic Testing
;
Exostosin 2
;
Mutation
;
China
;
Prenatal Diagnosis
;
Pregnancy
;
Genetic Counseling
;
Preimplantation Diagnosis
;
Exome Sequencing
;
East Asian People
5.Erk Signaling Pathway in Striatal D2-MSNs: an Essential Pathway for Exercise-induced Improvement in Parkinson’s Disease
Bo GAO ; Yi-Ning LAI ; Yi-Tong GE ; Wei CHEN
Progress in Biochemistry and Biophysics 2025;52(1):61-71
Parkinson’s disease (PD) is a neurodegenerative disorder characterized by the progressive loss of dopamine (DA) neurons in the substantia nigra pars compacta (SNpc), primarily manifesting as motor dysfunctions such as resting tremor, muscle rigidity, and bradykinesia. According to the classical model of basal ganglia motor control, approximately half of the medium spiny neurons (MSNs) in the striatum are D1-MSNs, which constitute the direct pathway. These neurons express D1-dopamine receptor (D1R) and substance P, and they mainly participate in the selection, initiation, and execution of movements. The other half are D2-MSNs, which constitute the indirect pathway. These neurons express D2-dopamine receptor (D2R) and adenosine 2A receptors and are involved in inhibiting unnecessary movements or terminating ongoing movements, thereby adjusting movement sequences to perform more precise motor behaviors. The direct pathway in the striatum modulates the activity of motor cortex neurons by exciting D1-MSNs through neurotransmitters such as glutamate (Glu), allowing the motor cortex to send signals more freely to the motor system, thus facilitating the generation and execution of specific motor behaviors. Studies using D1-Cre and D2-Cre mice with neurons labeled for D1R and D2R have shown that both types of neurons are involved in the execution of movements, with D1-MSNs participating in movement initiation and D2-MSNs in inhibiting actions unrelated to the target movement. These findings suggest that the structural and functional plasticity of D1-MSNs and D2-MSNs in the basal ganglia circuitry enables motor learning and behavioral regulation. Additionally, when SNpc DA neurons begin to degenerate, D1-MSNs are initially affected but do not immediately cause motor impairments. In contrast, when D2-MSNs undergo pathological changes, they are first activated by upstream projecting neurons, leading to the inhibition of most motor behaviors and resulting in motor dysfunction. Therefore, it is hypothesized that motor impairments such as bradykinesia and initiation difficulties are more closely related to the functional activity of D2-MSNs. The extracellular signal-regulated kinase (Erk)/mitogen-activated protein kinase (MAPK) signaling pathway has been identified as a critical modulator in the pathophysiology of PD. Recent findings indicate that Erk/MAPK signaling pathway can mediate DA and Glu signaling in the central nervous system, maintaining normal functional activity of striatal MSNs and influencing the transmission of motor control signals. Within this complex regulatory network, the Erk/MAPK signaling pathway plays a key role in transmitting motor information to downstream neurons, regulating normal movements, avoiding unnecessary movements, and finely tuning motor behaviors. Our laboratory’s previous research found that 4 weeks of aerobic exercise intervention improved motor dysfunction in PD mice by inhibiting the Erk1/2 signaling upstream of striatal MSNs, primarily involving the Erk1/2 signaling in D2-MSNs rather than D1-MSNs. This review summarizes the neurobiological mechanisms of Erk/MAPK signaling pathway in D2-MSNs for the prevention and treatment of motor dysfunction in PD. By exploring the role of this signaling pathway in regulating motor abnormalities and preventing motor dysfunction in the central nervous system of PD, this review provides new theoretical perspectives for related mechanistic research and therapeutic strategies.
6.Physical circumference development in Chinese children aged 3-6 years
ZHEN Zhiping, BA Yi, MA De, XUE Yaqi, GE Meiqin, L Bingchen, GUO Meitong
Chinese Journal of School Health 2025;46(3):412-415
Objective:
To understand the growth and development levels of four physical measurements in children aged 3-6 years in China, so as to provide a reference for child nutrition improvement and health promotion.
Methods:
A stratified random sampling method was used to collect physical measurement data from 120 kindergartens 25 842 children aged 3-6 years across 24 provinces and cities in seven natural geographical regions of North China, Northeast China, East China, Central China, South China, Southwest China and Northwest China from 2020 to 2023. The development levels of head circumference, chest circumference, waist circumference, and hip circumference were evaluated using a grading method. The analysis of gender and age differences was conducted using Mann-Whitney U- test and Kruskal-Wallis test, and the comparison of abnormal detection rates for different genders was conducted using Chi square test.
Results:
The distribution range of children aged 3-6 was 51.74(50.08, 53.33) cm in terms of head circumference, 55.73(52.09, 59.04) cm in terms of chest circumference, 53.04(48.92, 56.40) cm in terms of waist circumference, and 59.36(56.30, 62.32) cm in terms of hip circumference. The detection rate of abnormal head circumference in boys and girls aged 3-6 years old was relatively high (19.71%-42.02%), and the detection rate of abnormal physical circumference development levels in boys was higher than that in girls of all ages ( χ 2=5.63-83.35, P <0.05). The detection rate of abnormal hip circumference (4.89%-6.53%) and chest circumference (4.51%-6.38%) in boys and girls aged 3-6 was relatively low, and there was no statistically significant difference in the abnormal rate between different ages and genders ( χ 2=0.00-1.61, 0.00-3.71, P >0.05). The detection rate of abnormal waist circumference in boys and girls aged 3-6 was relatively high (13.70%-42.45%), and the detection rate of abnormal waist circumference in girls was higher than that in boys aged 4-6 groups ( χ 2=10.49-58.18, P < 0.05).
Conclusions
The overall physical development of children aged 3-6 years in China is improving, but the abnormal detection rates for head circumference and waist circumference are relatively high. Child healthcare should focus on preventing and treating abdominal obesity, with differentiated health intervention strategies based on different age groups and genders.
7.Development status analysis and suggestions of TCM pharmacists in Chinese public TCM hospitals
Baojuan XUE ; Ning WU ; Yang ZHAO ; Junshu GE ; Yi WANG ; Zheyuan LIU ; Zhaoheng YANG ; Ying SUN
China Pharmacy 2025;36(8):903-907
OBJECTIVE To understand the development status and existing problems of traditional Chinese medicine(TCM) pharmacists in public TCM hospitals in China, aiming to provide suggestions for the competent departments to formulate management policies for TCM pharmacists and promote the healthy development of TCM. METHODS The data on the number and professional titles of TCM pharmacists in public TCM hospitals in China from 2019 to 2023 were collected. Descriptive analysis was employed to analyze the number, distribution and professional titles of TCM pharmacists in public TCM hospitals across the country, and to measure the quantity shortfalls of the number of TCM pharmacists in these hospitals. RESULTS From 2019 to 2023, the number of TCM pharmacists in public TCM hospitals in China grew slowly, with an average annual growth rate of 2.56%. However, the proportion of TCM pharmacists to the total number of pharmacists in public TCM hospitals gradually decreased, with an average annual growth rate of -0.65%. In terms of hospital grades, the number of TCM pharmacists in tertiary public TCM hospitals showed positive growth, while those in secondary and primary public TCM hospitals showed negative growth. In terms of hospital types, the average annual growth rate of TCM pharmacists in TCM hospitals was 2.22%, in integrated Chinese and Western medicine hospitals it was 7.97%, and in ethnic minority medicine hospitals it was 2.74%. The development of TCM pharmacists in different provinces was uneven. The annual growth rate of TCM pharmacists in Guizhou exceeded 10%, while the growth rate in Hunan and Heilongjiang was negative. In 2023, the number of TCM pharmacists per thousand population in public TCM hospitals was 0.03, indicating a relatively low staffing level. The professional titles of TCM pharmacists in public TCM hospitals were mainly primary and E-mail:601907549@qq.com intermediate, with a total of 67.33%. According to the calculation that the proportion of TCM pharmacists to pharmacists was not less than 60%, public TCM hospitals and hospitals of integrated TCM and Western medicine should be reconfigured with TCM pharmacists 6 212 and 1 288 people, respectively. CONCLUSIONS The number of TCM pharmacists in public TCM hospitals is growing slowly, with insufficient staffing levels, relatively low professional titles, and uneven distribution and development across provinces. It is suggested that relevant competent departments strengthen policy guidance, increase the attention given by the state level to TCM pharmacists, strengthen the construction of the talent team for TCM pharmacists, improve the quality and optimize the allocation of TCM pharmacist talents in order to promote the high-quality development of TCM services.
8.Study on the current status of emergency management for severe mental disorders in Shanghai
Xiaolei GE ; Yi ZHU ; Chunmei CHEN ; Youwei ZHU ; Yanli LIU ; Jun CAI ; Weibo ZHANG ; Fei XIE
Shanghai Journal of Preventive Medicine 2025;37(3):276-281
ObjectiveTo investigate the current status of emergency management for severe mental disorders in Shanghai, and to provide countermeasures and suggestions for the establishment of a sound emergency management system for severe mental disorders and the enhancement of emergency management capability. MethodsA questionnaire survey and qualitative interviews were used to conduct an investigation into the emergency management in 17 district-level mental illness prevention and control institutions in Shanghai, which includes the basic situation of emergency management for severe mental disorders, the construction of emergency response teams and personnel, emergency preparedness drills and training, emergency management plans and rules and regulations, and problems encountered in emergency management. ResultsIn terms of emergency management mechanism and basic situation, resources such as personnel allocation, security funds and green channel were well equipped in each district-level mental illness prevention and control institution in Shanghai. However, the equipment of some hardware facilities was still insufficient to some extent. Therefore, further improvement on the emergency management mechanism for severe mental disorders was needed. With regard to the construction of emergency team and personnel allocation, the majority were those aged between 35‒<45 years old, with a bachelor’s degree, and more than 10 years of working experience. For example, 90.27% staff in district-level mental illness prevention and control institution had a bachelor’s degree or above, which was higher than that among the staff in community-level (73.60%); staff majored in clinical medicine in district-level institution accounted for the proportion at 52.71%, higher than that among the staff in community-level (28.86%); 57.24% staff in district-level institution had an intermediate professional title, higher than that among the staff in community-level (42.28%); and 69.90% staff in district-level institution had more than 10 years of working experience, higher than that among the staff in community-level (43.62%). In the aspect of emergency drills and training, all district-level mental illness prevention and control institutions in Shanghai had a high demand for emergency training, and the weak aspects mainly focused on lack of emergency service protocols, skills of addressing technical challenges, and construction of effectiveness evaluation system. Moreover, the teaching methods were primarily centered on case analysis, simulation drills, interactive discussions, and so forth. Concerning emergency management plans and rules and regulations, all districts in Shanghai had relatively established well-developed systems for emergency response plans, emergency response leadership groups, and emergency response operational task forces for severe mental disorders. About half of the institutions had established other rules and regulations related to emergency management of severe mental disorders in addition to emergency plans. ConclusionShanghai has initially established an emergency management system for severe mental disorders, but it is still fragile in specialized training for emergency management of severe mental disorders, construction of emergency management mechanisms, and the building-up of grassroots emergency teams. Further priorities should include strengthening emergency management training, enhancing the construction of emergency management personnel teams, and gradually establishing a more comprehensive and integrated emergency management mechanism for severe mental disorders.
9.Novel CD19 Fast-CAR-T cells vs. CD19 conventional CAR-T cells for the treatment of relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia.
Xu TAN ; Jishi WANG ; Shangjun CHEN ; Li LIU ; Yuhua LI ; Sanfang TU ; Hai YI ; Jian ZHOU ; Sanbin WANG ; Ligen LIU ; Jian GE ; Yongxian HU ; Xiaoqi WANG ; Lu WANG ; Guo CHEN ; Han YAO ; Cheng ZHANG ; Xi ZHANG
Chinese Medical Journal 2025;138(19):2491-2497
BACKGROUND:
Treatment with chimeric antigen receptor-T (CAR-T) cells has shown promising effectiveness in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), although the process of preparing for this therapy usually takes a long time. We have recently created CD19 Fast-CAR-T (F-CAR-T) cells, which can be produced within a single day. The objective of this study was to evaluate and contrast the effectiveness and safety of CD19 F-CAR-T cells with those of CD19 conventional CAR-T cells in the management of R/R B-ALL.
METHODS:
A multicenter, retrospective analysis of the clinical data of 44 patients with R/R B-ALL was conducted. Overall, 23 patients were administered with innovative CD19 F-CAR-T cells (F-CAR-T group), whereas 21 patients were given CD19 conventional CAR-T cells (C-CAR-T group). We compared the rates of complete remission (CR), minimal residual disease (MRD)-negative CR, leukemia-free survival (LFS), overall survival (OS), and the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) between the two groups.
RESULTS:
Compared with the C-CAR-T group, the F-CAR-T group had significantly higher CR and MRD-negative rates (95.7% and 91.3%, respectively; 71.4% and 66.7%, respectively; P = 0.036 and P = 0.044). No significant differences were observed in the 1-year or 2-year LFS or OS rates between the two groups: the 1-year and 2-year LFS for the F-CAR-T group vs.C-CAR-T group were 47.8% and 43.5% vs. 38.1% and 23.8% (P = 0.384 and P = 0.216), while the 1-year and 2-year OS rates were 65.2% and 56.5% vs. 52.4% and 47.6% (P = 0.395 and P = 0.540). Additionally, among CR patients who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) following CAR-T-cell therapy, there were no significant differences in the 1-year or 2-year LFS or OS rates: 57.1% and 50.0% vs. 47.8% and 34.8% (P = 0.506 and P = 0.356), 64.3% and 57.1% vs. 65.2% and 56.5% (P = 0.985 and P = 0.883), respectively. The incidence of CRS was greater in the F-CAR-T group (91.3%) than in the C-CAR-T group (66.7%) (P = 0.044). The incidence of ICANS was also greater in the F-CAR-T group (30.4%) than in the C-CAR-T group (9.5%) (P = 0.085), but no treatment-related deaths occurred in the two groups.
CONCLUSION
Compared with C-CAR-T-cell therapy, F-CAR-T-cell therapy has a superior remission rate but also leads to a tolerably increased incidence of CRS/ICANS. Further research is needed to explore the function of allo-HSCT as an intermediary therapy after CAR-T-cell therapy.
10.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.


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