1.The management of blood donors tested reactive to HCV in blood screening based on confirmation of HCV infection
Xuelian DENG ; Liang ZANG ; Xiaofang GONG ; Lei ZHOU ; Xiaochun LIU ; Lin WANG ; Lunan WANG
Chinese Journal of Blood Transfusion 2026;39(4):444-451
Objective: To explore the management of blood donors tested reactive to HCV in blood screening based on confirmation of HCV infection. Methods: Multiple HCV antibody assays, repeating HCV RNA testing, follow-up of blood donors and retesting of archive samples were performed to confirm HCV infection, identify infection status, and exclude false positives in blood donors reactive to HCV in blood screening. Results: From 2011 to 2024, the unqualified rate of HCV detection in blood screening was 2.45‰(2 751/1 122 026). Among these, anti-HCV+-&NAT-accounted for 1.85‰, followed by anti-HCV++ at 0.60‰. The proportion of anti-HCV+-&NAT-and HCV RNA yields was extremely low (0.007‰). The positive rate of anti-HCV+-&NAT-samples tested by electrochemiluminescence method (ELCIA) was approximately 7.5%, differing among reagents (P<0.05). The follow-up of anti-HCV+-&NAT-donors showed that 96.2% (202/210) were false positives, but 51.4% of donors remained anti-HCV+-&NAT-during follow-up. Among them, 8 donors (3.8%) could not be ruled out from HCV infection due to positive retesting by ELCIA. Of the anti-HCV+-&NAT-donors who were reactive at the first follow-up, 86.8% remained anti-HCV+-&NAT-at the second follow-up. The sampling confirmation data showed that all of 260 anti-HCV++ donors were confirmed as anti-HCV positive, and the proportion of false positives or missed detections by NAT was very low. Two occult HBV infections (OBIs) and one HBsAg carrier were identified among the 3 anti-HCV +-&NAT+ donors, and no HCV infection was confirmed in 5 anti-HCV--&HCV RNA + donors. Conclusion: The prevalence of HCV among blood donors in Dalian was about 0.06%, with extremely low proportion of window-period infection and slightly higher proportion of resolved infections than that of current infections. The majority of anti-HCV+-&NAT-were false positive. Blood donors confirmed as false positive should be qualified in blood screening 3 months later before next donation. In order to reduce the false positive results, it was advisable to avoid the same type of supplementary reagents as the initial reagents when performing confirmation.
2.Evaluation of repeated testing with blood screening platform in confirmation of NAT non-discriminatory reactive samples
Mengfan LI ; Xuelian DENG ; Liang ZANG ; Lei ZHOU ; Xiaochun LIU ; Xiaohua LIANG ; Lunan WANG
Chinese Journal of Blood Transfusion 2026;39(4):458-464
Objective: To evaluate repeated testing on blood screening platforms in confirmation of non-discriminatory reactive (NDR) samples in nucleic acid testing (NAT). Methods: A total of 102 HBsAg-negative/NAT NDR samples were collected from voluntary blood donors at Dalian Blood Center between January 2021 and December 2023. Repeated testing was performed using two NAT platforms (Cobas s201 and Panther). For the first round of repeated testing, all samples were tested 12 times on each system; for the second round, the samples which were non-reactive or only reactive once in the first round were tested an additional 8 times. Anti-HBc and anti-HBs was detected using electrochemiluminescence assay (ECA). Meanwhile, blood donors were followed up. Results: The proportion of anti-HBc+ in 102 NDR samples was 88.2%. Forty-one samples (40.2%, 41/102) and 7 samples were confirmed HBV DNA+ in first-round and second-round repeated testing, respectively. The cumulative confirmation rate of HBV DNA+ was 47.1% (48/102) after repeated testing. Extra five blood donors detected HBV DNA+ in follow-up were identified as anti-HBc+ occult hepatitis B virus infection (OBI), while no window period infection was observed. Ultimately, there were 53 HBV infected donors confirmed, 46 HBV infection-unconfirmed, and 3 HBV uninfected. No significant difference was observed between the confirmation rate of the first-round testing and the cumulative confirmation rate after the second-round testing (P>0.05). The proportion of anti-HBc+ donors was quite high in both HBV infection-confirmed (98.1%) and unconfirmed group (82.6%), and donors with seronegative and anti-HBs-only occupied a high proportion in the latter (P<0.05). Conclusion: Numerous repeated testing of NDR samples using NAT platforms cannot achieve complete confirmation of HBV infection. Supplementary anti-HBc testing can minimize potential OBI risk among NDR donors, and is low-cost and efficient.
3.Clinical efficacy and mechanism of Zishen Shujing Decoction in treating premature ovarian failure with kidney deficiency and liver depression
Ziqiong ZHOU ; Xuelian DU ; Jianmei HUANG ; Shuyi LING ; Yuehui ZHENG
China Modern Doctor 2025;63(14):49-52
Objective To observe the clinical efficacy of Zishen Shujing decoction in the treatment of kidney deficiency and liver depression type premature ovarian failure(POF).Methods A total of 70 female POF patients who visited the Fourth Clinical Medical College of Guangzhou University of Traditional Chinese Medicine from July 2023 to April 2024 were selected as the research subjects,they were divided into traditional Chinese medicine(TCM)treatment group(n=35)and Western medicine treatment group(n=35)by using a random number table method.Western medicine treatment group was treated with femostone,and TCM treatment group was treated with Zishen Shujing decoction.Differences of TCM syndrome scores and clinical efficacy were compared between two groups before and after treatment,and changes of peripheral blood follicle-simulating hormone(FSH),anti-Müllerian hormone(AMH),anal follicle count(AFC)and interleukin(IL)-4,IL-6 before and after treatment were compared.Results The effective rate of TCM treatment group was higher than that of Western medicine treatment group,the difference was statistically significant(P<0.05).The TCM syndrome scores after treatment were lower than before treatment,and TCM treatment group was lower than Western medicine treatment group,the difference was statistically significant(P<0.05).After treatment,FSH levels in two groups were lower than before treatment,AMH and AFC levels were higher than before treatment,and improvement of hormone levels,AMH and AFC in TCM treatment group was better than that in Western medicine treatment group,with statistical significance(P<0.05).After treatment,the anti-inflammatory factors IL-4 were increased,and the pro-inflammatory factors IL-6 were decreased,and the increase effect of anti-inflammatory factors and the decrease effect of pro-inflammatory factors in TCM treatment group were better than those in Western medicine treatment group with statistical significance(P<0.05).Conclusion Zishen Shujing decoction can improve the clinical symptoms,serum hormone levels of POF patients with kidney deficiency and liver depression,improve ovarian function,reduce immune inflammation,reduce oxidative stress,and effectively improve the quality of life of patients.
4.Comparative analysis of the influencing factors of hematoma enlargement and the prediction effect of related scales in patients with hypertensive cerebral hemorrhage
Qiannan LI ; Lingmin FENG ; Xuelian ZHOU ; Xiao MIAO
Clinical Medicine of China 2025;41(1):59-66
Objective:To explore the influencing factors of hematoma enlargement in patients with hypertensive intracerebral hemorrhage and construct a corresponding risk prediction nomogram. The screening effects of the constructed model and different hematoma enlargement risk assessment tools were compared and analyzed.Methods:Two hundred and thirty-two patients with hypertensive intracerebral hemorrhage from the Department of Neurosurgery, Lianyungang First People's Hospital from April 2021 to February 2022 were selected as the research subjects. Multivariate Logistic regression was used to analyze the risk factors of hematoma expansion in patients with hyperhemamic intracerebral hemorrhage, and R software was used to construct a nomo diagram. The receiver operating characteristic curve (ROC) and Hosmer-Lemeshow (H-L) goodness-of-fit were used to evaluate the discrimination and calibration of the model, and the decision curve was used to analyze the clinical validity of the model. The constructed Nomo diagram, nine-point method and BRAIN score were used to assess the risk of hematoma enlargement in the included patients and used them as test variables, and the ROC curve was plotted to compare and analyze the area under the ROC curve, sensitivity and specificity of the constructed Nomo diagram, nine-point method and BRAIN score. The Kappa test was used to analyze the consistency between the Nomo diagram, the nine-point method, and the BRAIN score and the hematoma expansion results.Results:The results of multivariate logistic regression analysis showed that blood pressure was poorly controlled ( OR=13.290, 95% CI: 3.676-48.049), ventricular penetration ( OR=4.825, 95% CI: 1.458-15.975), early neurological deterioration ( OR=27.740, 95% CI: 8.713-88.314), Glasgow Coma Scale(GCS)≤8 points ( OR=25.883, 95% CI: 6.542-102.404) was the main influencing factor for hematoma expansion in patients with hypertensive intracerebral hemorrhage (The P values were <0.001, 0.010, <0.001, and <0.001, respectively). The H-L test results of Nomogram for predicting hematoma enlargement were χ2=3.20, P=0.525, the calibration curve was close to the ideal curve, and the mean absolute error was 0.015, and the decision curve analysis showed that the model had good clinical validity. The ROC results showed that the area under the ROC curve of the constructed Neumo diagram, nine-point method and BRAIN score were 0.971 (95% CI: 0.941-0.989), 0.696 (95% CI: 0.632-0.755), and 0.778 (95% CI: 0.719-0.830)(all P<0.001). The sensitivities were 94.37%, 71.83%, and 84.51%, and the specificities were 90.68%, 58.39%, and 65.84%, respectively. The results of Kappa test showed that the Kappa values of Nuomo diagram, nine-point method and BRAIN score were 0.806 , 0.264 and 0.429 (all P<0.001). Conclusion:The main influencing factors of hematoma enlargement in patients with hypertensive intracerebral hemorrhage were poor blood pressure control, intraventricular hemorrhage, early neurological deterioration, and GCS score. The effect of the constructed Nuomo diagram model in predicting hematoma expansion in patients with hypertensive intracerebral hemorrhage is better than that of the nine-point method and the BRAIN score, which has clinical application value.
5.Research on the prevalence of overweight and obesity among children
Xinyi LIANG ; Jingnan CHEN ; Xuelian ZHOU ; Ruimin CHEN ; Jingsi LUO ; Rongxiu ZHENG ; Chunxiu GONG ; Chunlin WANG ; Zhe SU ; Mireguli MAIMAITI ; Yan LIANG ; Hui YAO ; Haiyan WEI ; Hongwei DU ; Shaoke CHEN ; Yu YANG ; Feihong LUO ; Pin LI ; Min ZHU ; Wei WU ; Ke HUANG ; Guanping DONG ; Junfen FU
Chinese Journal of Pediatrics 2025;63(6):612-619
Objective:To investigate the prevalence and risk factors of overweight and obesity among Chinese children aged 3-18 years from 11 provinces, antonomous regions, or municipalities.Methods:This national cross-sectional community health survey utilized a multistage stratified cluster-random sampling method to recruit 193 997 nationally representative participants from 11 provinces, autonomous regions, or municipalities between January 2017 and December 2019. All participants underwent physical examinations, and their caregivers completed questionnaires assessing participants′ dietary, lifestyle, familial, and perinatal information. Multilevel multinomial logistic regression models were employed to identify the potential risk factors.Results:The cohort comprised 193 997 children (102 178 boys, 91 819 girls),aged (10±4) years. Overall prevalence rates were 30 574(15.8%)overweight children and 17 217(8.9%) obesity children. Boys exhibited higher overweight and obesity rates than girls (17.0% (17 368/102 178) vs. 14.4% (13 206/102 178), 11.3% (11 553/91 819) vs. 6.2% (5 664/91 819), χ2=249.12,1 578.69,both P<0.001). The detection rates of obesity in Tanner stage 2 and 3 were the highest in boys and girls, with 13.4%(2 231/16 665) and 8.6%(880/10 221) respectively. Risk factors for obesity included parental overweight (paternal OR=2.34 and maternal OR=2.29), annual household income of 100 000-200 000 yuan (compared with<100 000 yuan, OR=1.04), higher paternal education (compared with below high school,high school and a college education OR=1.09,1.14), birth weight >4.0 kg (≤5 and>5 years old OR=1.74, 1.44,respectively), and western food consumption≥1 time/month (compared with<1, 1-2, 3-4,>4 times/month OR=1.36, 1.30, 1.67(≤5 years), 1.19, 1.16, 1.15 (>5 years), respectively) (all P<0.05). Conversely, coarse grain intake≥1 times/week (compared with<1 times/week, every day, 3-4, 1-2 times/week OR=0.74, 0.80, 0.71 (≤5 years), 0.75, 0.87, 0.90(>5 years), respectively, all P<0.05) was associated with reduced obesity risk. Conclusions:Obesity epidemiology in children demonstrates significant heterogeneity across age, gender, geographic regions, and pubertal stages. It is necessary to establish a personalized prevention and control strategy.
6.Establishing reference interval for uric acid in normal weight children
Guohua LI ; Yuanyuan MENG ; Yangxi LI ; Ke HUANG ; Wei WU ; Guanping DONG ; Li ZHANG ; Xuelian ZHOU ; Xiaoqiang HAO ; Junfen FU
Chinese Journal of Pediatrics 2025;63(12):1349-1353
Objective:To investigate the reference intervals of serum uric acid levels in normal-weight children and analyze the factors influencing these levels.Methods:In this cross-sectional study, clinical data were collected from 7 910 normal-weight children, aged 1 month to 15 years, who underwent health check-ups at the Children′s Hospital of Zhejiang University School of Medicine between August 2013 and August 2023. Data included sex, age, pubertal signs, blood pressure, and serum uric acid levels. The participants were categorized into 4 age groups: 1-<12 months, 1-<6 years, 6-<11 years, and 11-<16 years, and were further analyzed by sex. The P5 and P95 percentiles of uric acid values were defined as the lower and upper limits of the reference interval, respectively. Correlation analysis and partial correlation analysis were used to assess the relationship between uric acid and other variables such as age, body mass index Z value, and Tanner stage. Multivariate linear regression was used to compare uric acid levels across gender and age groups, respectively. Results:Among the 7 910 children, the distribution across age groups was as follows: 562 (317 boys) in 1-<12 months, 4 120 (2 366 boys) in 1-<6 years, 2 357 (1 432 boys) in 6-<11 years, and 871 (536 boys) in 11-<16 years, the uric acid levels in boys were significantly higher than those in girls ( P<0.05). Uric acid levels exhibited a positive correlation with age ( r=0.47 , 0.20, both P<0.001), and a weak positive correlation with BMI Z-scores(both r=0.11, P<0.001). Among participants aged 6-<11 years and 11-<16 years, uric acid levels in boys were positively correlated with Tanner stage ( r=0.10, 0.27, both P<0.05), but no significant correlation was observed in girls (all P>0.05). The uric acid levels were significantly higher in boys than in girls in the 1-<12 months, 1-<6 years and 11-<16 years age groups (all P<0.05), but no significant gender difference was found in the 6-<11 years groups ( P>0.05). Uric acid levels exhibited statistically significant variations among age groups ( P<0.001). The reference intervals of uric acid values were as follows in 1-<12 months age group, 157-335 μmol/L for boys and 160-315 μmol/L for girls; in 1-<6 years age group, 180-359 μmol/L for boys and 180-355 μmol/L for girls; in 6-<11 years group, 190-375 μmol/L; in 11-<16 years age group, 237-480 μmol/L for boys and 218-410 μmol/L for girls. Conclusions:Reference intervals for uric acid varying significantly across different pediatric age groups. Sex, and pubertal development status are closely related to uric acid levels.
7.Process Optimization and Health Risk Assessment of Calcined Haematitum Based on QbD Concept
Yue YANG ; Jingwei ZHOU ; Jialiang ZOU ; Guorong MEI ; Yifan SHI ; Lei ZHONG ; Jiaojiao WANG ; Xuelian GAN ; Dewen ZENG ; Xin CHEN ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):187-196
ObjectiveTo investigate the processing technology of calcined Haematitum based on the concept of quality by design(QbD) and to assess its health risk. MethodsTaking whole iron content, Fe2+ dissolution content and looseness as critical quality attributes(CQAs), and calcination temperature, calcination time, spreading thickness and particle size as critical process parameters(CPPs) determined by the failure mode and effect analysis(FMEA), the processing technology of calcined Haematitum was optimized by orthogonal test combined with analytic hierarchy process-criteria importance through intercriteria correlation(AHP-CRITIC) hybrid weighting method. The contents of heavy metals and harmful elements were determined by inductively coupled plasma mass spectrometry, and the health risk assessment was carried out by daily exposure(EXP), target hazard quotient(THQ) and lifetime cancer risk(LCR), and the theoretical value of the maximum limit was deduced. ResultsThe optimal processing technology for calcined Haematitum was calcination at 650 ℃, calcination time of 1 h, particle size of 0.2-0.5 cm, spreading thickness of 1 cm, and vinegar quenching for 1 time[Haematitum-vinegar(10:3)]. The contents of 5 heavy metals and harmful elements in 13 batches of calcined Haematitum were all decreased with reductions of up to 5-fold. The cumulative THQ of 2 batches of samples was>1, while the cumulative THQ of all batches of Haematitum was>1. The LCR of As in 1 batches of Haematitum was 1×10-6-1×10-4, and the LCR of the rest was<1×10-6, and the LCRs of calcined Haematitum were all<1×10-6, indicating that the carcinogenic risk of calcined Haematitum was low, but special attention should still be paid to Haematitum medicinal materials. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg were formulated as 1 014, 25, 17, 27, 7 mg·kg-1. ConclusionThe optimized processing technology of calcined Haematitum is stable and feasible, and the contents of heavy metals and harmful elements are reduced after processing. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg are formulated to provide a scientific basis for the formulation of standards for the limits of harmful elements in Haematitum.
8.Process Optimization and Health Risk Assessment of Calcined Haematitum Based on QbD Concept
Yue YANG ; Jingwei ZHOU ; Jialiang ZOU ; Guorong MEI ; Yifan SHI ; Lei ZHONG ; Jiaojiao WANG ; Xuelian GAN ; Dewen ZENG ; Xin CHEN ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):187-196
ObjectiveTo investigate the processing technology of calcined Haematitum based on the concept of quality by design(QbD) and to assess its health risk. MethodsTaking whole iron content, Fe2+ dissolution content and looseness as critical quality attributes(CQAs), and calcination temperature, calcination time, spreading thickness and particle size as critical process parameters(CPPs) determined by the failure mode and effect analysis(FMEA), the processing technology of calcined Haematitum was optimized by orthogonal test combined with analytic hierarchy process-criteria importance through intercriteria correlation(AHP-CRITIC) hybrid weighting method. The contents of heavy metals and harmful elements were determined by inductively coupled plasma mass spectrometry, and the health risk assessment was carried out by daily exposure(EXP), target hazard quotient(THQ) and lifetime cancer risk(LCR), and the theoretical value of the maximum limit was deduced. ResultsThe optimal processing technology for calcined Haematitum was calcination at 650 ℃, calcination time of 1 h, particle size of 0.2-0.5 cm, spreading thickness of 1 cm, and vinegar quenching for 1 time[Haematitum-vinegar(10:3)]. The contents of 5 heavy metals and harmful elements in 13 batches of calcined Haematitum were all decreased with reductions of up to 5-fold. The cumulative THQ of 2 batches of samples was>1, while the cumulative THQ of all batches of Haematitum was>1. The LCR of As in 1 batches of Haematitum was 1×10-6-1×10-4, and the LCR of the rest was<1×10-6, and the LCRs of calcined Haematitum were all<1×10-6, indicating that the carcinogenic risk of calcined Haematitum was low, but special attention should still be paid to Haematitum medicinal materials. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg were formulated as 1 014, 25, 17, 27, 7 mg·kg-1. ConclusionThe optimized processing technology of calcined Haematitum is stable and feasible, and the contents of heavy metals and harmful elements are reduced after processing. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg are formulated to provide a scientific basis for the formulation of standards for the limits of harmful elements in Haematitum.
9.Analysis of factors related to peritoneal dialysis-associated peritonitis in patients with diabetic nephropathy and establishment of a risk model
Chinese Journal of Primary Medicine and Pharmacy 2025;32(8):1152-1158
Objective:To analyze the factors associated with the occurrence of peritoneal dialysis-associated peritonitis (PDAP) in patients with diabetic nephropathy and to establish a risk model.Methods:The clinical data of 90 patients with diabetic nephropathy who underwent peritoneal dialysis using Einkorn dextrin dialysate at Yiwu Central Hospital from January 2021 to December 2023 were analyzed retrospectively. Patients were classified into the PDAP group and the non-PDAP group based on the occurrence of PDAP as recorded in the medical records system. The clinical data and laboratory indicators of the two patient groups were collected and compared. Collinearity analysis was performed on the significantly different variables, and those without collinearity issues were included in a logistic regression model to identify factors associated with infection. The statistically significant variables from the regression analysis were used as predictors to construct a nomogram risk prediction model for the occurrence of infections in patients, and the model was subsequently validated.Results:Among the 90 patients, 21 (23.33%) developed PDAP and were included in the PDAP group, while the remaining 69 patients (76.67%) did not develop PDAP and were included in the non-PDAP group. The differences in baseline systemic inflammatory response index (SIRI), serum albumin (ALB), blood potassium levels, hemoglobin (Hb) levels, and dialysis duration between the two groups were statistically significant [(1.53 ± 0.45) vs. (1.31 ± 0.32), (28.67 ± 3.64) g/L vs. (34.61 ± 4.13) g/L, (3.13 ± 0.47) mmol/L vs. (3.97 ± 0.51) mmol/L, (90.83 ± 10.15) g/L vs. (107.27 ± 10.66) g/L, 43.00 (38.50, 48.00) months vs. 34.00 (32.00, 38.00) months, t/ Z = 3.17, 5.92, 6.72, 6.25, 7.03, all P < 0.05]. None of the indicators exhibited collinearity issues (variance inflation factor ≤ 10, tolerance ≥ 0.1), allowing for their inclusion in the logistic regression model. According to the logistic regression analysis, baseline SIRI ( OR = 5.816, 95% CI: 1.404-24.097) and dialysis duration ( OR = 1.412, 95% CI: 1.214-1.643) were identified as independent risk factors for the occurrence of PDAP in patients with diabetic nephropathy. In contrast, ALB ( OR = 0.653, 95% CI: 0.533-0.801), blood potassium levels ( OR = 0.025, 95% CI: 0.005-0.132), and Hb levels ( OR = 0.867, 95% CI: 0.811-0.926) were protective factors against the occurrence of PDAP. A prediction model incorporating these five predictors was established using logistic regression, and corresponding nomograms were plotted along with a decision curve and calibration curve. The net benefit rate of the prediction model within the threshold range was high, indicating that the accuracy of the model was good. Conclusions:Baseline SIRI, ALB, blood potassium levels, Hb levels, and dialysis duration in patients with diabetic nephropathy are all related risk factors for the occurrence of PDAP after peritoneal dialysis treatment. The nomogram model constructed based on these indicators can aid in the clinical screening of high-risk populations and provide a theoretical basis for the implementation of preventive and therapeutic measures.
10.Research on hepatitis E virus antigen screening among voluntary blood donors
Li ZHANG ; Xuelian DENG ; Lei ZHOU ; Dan LIU ; Liang ZANG
Chinese Journal of Blood Transfusion 2025;38(8):1083-1088
Objective: To investigate prevalence of hepatitis E virus (HEV) infection among voluntary blood donors in Dalian and provide evidence for enhancing blood screening strategies. Methods: A total of 3 277 blood donor samples collected between December 2023 and February 2024 at Dalian Blood Center underwent routine blood screening (ALT, HBsAg, anti-HCV, HIV Ag/Ab, anti-TP, and HBV/HCV/HIV NAT). Subsequently, HEV antigen (Ag) was detected using chemiluminescence immunoassay (CLIA). HEV-Ag reactive samples were further tested for HEV RNA, IgM and IgG antibodies. Blood donors with repeated reactive HEV Ag results were followed up to clarify the status of infection. Results: Among the 3 277 blood donor samples, 6 (0.18%) were repeatedly reactive for HEV Ag. However, supplemental testing for HEV RNA, anti-HEV IgM, and anti-HEV IgG on these samples yielded non-reactive results. One of these six blood donors was successfully followed up. On day 218 after the initial detection of HEV Ag reactivity, HEV Ag, HEV RNA, HEV IgM and IgG antibody were found to be non-reactive. Conclusion: The reaction rate for HEV antigen screening among voluntary blood donors in Dalian is low. CLIA method for detecting HEV antigen is easy to operate and cost-effective, but demonstrates some false reactivity. Improving the specificity of the assay and combining it with nucleic acid testing (NAT) would be valuable for implementing a selective HEV screening strategy for blood donors.

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