1.Preliminary study on an improved method for constructing internal quality control framework of ELISA
Youbin DUAN ; Rui WANG ; Le CHANG ; Changwen QIU ; Zhiqiang LI ; Gengrui CHEN ; Jingjuan YANG ; Qing HE ; Lunan WANG
Chinese Journal of Blood Transfusion 2026;39(1):103-108
Objective: To propose an improved method for constructing the internal quality control (IQC) framework for ELISA assays and validate its efficacy by statistically analyzing IQC data from nine blood center laboratories. Methods: 1) IQC data was collected from nine blood centers and analyzed using a domestic HBsAg ELISA detection kit as an example. 2) Differences between IQC values across batches within Blood Center 1 were assessed. 3) Statistical analyses were performed on batch usage, number of batches used, days of use, number of QC points, batch-specific means, and coefficients of variation (CV) across all nine centers. 4) Using the improved construction method for IQC framework, provisional and permanent frames were established for batches within Blood Center 1 and Blood Center 9, followed by outlier determination. Results: 1) Statistically significant differences were observed in IQC data between batches within Blood Center 1 (P<0.01). It is recommended that both the control material/reagents and the control chart framework be replaced simultaneously. 2) There were substantial differences among 9 blood centers regarding the control material/reagent lot numbers used, the number of QC runs per batch, and the QC values for identical lots. Therefore, individual laboratories should establish their own IQC chart frameworks. 3) The improved IQC framework construction method for ELISA assays is as follows: provisional frames are established via frame-shifting, using the pre-experimental mean and cumulative coefficient of variation (CV) from the preceding batch. For batches used >20 days with >20 QC points, permanent frames are constructed by aggregating in-control data accumulated over ≥20 days with ≥20 points to calculate cumulative mean and standard deviation. The provisional and permanent frames constructed by this method identified all 26 extreme outliers across Blood Centers 1 and 9 as out-of-control. Among the 218 general outliers, 10 were classified as normal by the provisional frames, while the remainder were designated as warnings or out-of-control. This method effectively monitors assay stability. Conclusion: Based on the statistical analysis of IQC practices across blood centers of varying scales, combined with the inherent characteristics of ELISA assays and the batch-to-batch instability of reagents/QC materials, it is recommended to reconstruct QC charts upon lot changes. The proposed method—utilizing frame-shifting for provisional frames and establishing permanent frames based on cumulative data—is applicable to blood center laboratories of differing sizes and effectively monitors the stability of the ELISA assay process.
2.Psoriasis-atopic dermatitis overlap phenotype: immune dysregulation mechanisms and emerging clinical insights
Zhiqiang SONG ; Yuanxiong HE ; Anqi CHEN
Chinese Journal of Dermatology 2025;58(11):1009-1014
Atopic dermatitis and psoriasis are two chronic inflammatory skin diseases with distinct immune mechanisms, primarily driven by Th2-type inflammation and Th1/Th17 pathways, respectively. However, some patients may simultaneously or sequentially exhibit overlapping phenotypes of atopic dermatitis and psoriasis (psoriasis-atopic dermatitis overlap, PAO), characterized by the coexistence of scaly erythema and eczematous lesions. Currently, the nomenclature, diagnostic criteria, and pathogenesis of PAO remain unclear, and its incidence is increasing due to the widespread use of targeted therapies. The diagnosis of PAO requires an integrated assessment of clinical features, histopathological findings, and biomarker profiles, while treatment necessitates a balance between immune modulation and individualized strategies. This article summarizes the characteristic manifestations of and genetic-immune interactions involved in PAO based on clinical practice, and explores diagnostic challenges and therapeutic options to address this complex and increasingly prominent clinical issue.
3.Comparative analysis of clinical characteristics between psoriasis-atopic dermatitis overlap phenotype and psoriasis vulgaris: a single-center retrospective exploratory study
Yuanxiong HE ; Sisi DENG ; Zhiqiang SONG
Chinese Journal of Dermatology 2025;58(11):1027-1033
Objective:To analyze the clinical characteristics between patients with psoriasis-atopic dermatitis overlap (PAO) and those with psoriasis vulgaris (PSO), and to enhance the understanding of the diagnosis and treatment of this overlap phenotype.Methods:A retrospective exploratory study was conducted on clinical data from patients who were diagnosed with PAO or PSO at the Department of Dermatology, Southwest Hospital, Army Medical University between January 2018 and June 2025. Clinical characteristics, laboratory examination results, comorbidities, and treatment regimens were compared between the two groups. Categorical data were compared using the chi-square test or Fisher's exact test; for non-normally distributed measurement data, intergroup comparisons were conducted using the Mann-Whitney U test. Results:A total of 103 PSO patients and 13 PAO patients were included. Patients in the PAO group were older than those in the PSO group ( M [ Q1, Q3]:63.00 [54.00, 71.50] years vs. 50.00 [38.00, 61.00] years; Z = 2.75, P = 0.006]. No significant differences were found between the two groups in terms of gender distribution, body mass index, disease duration, personal or family history of atopic diseases (all P > 0.05). Skin lesions involved the whole body in both PAO and PSO groups, with the trunk and limbs being commonly affected sites, and no significant difference in the lesion distribution was observed ( P > 0.05). Compared with the PSO group, the PAO group had fewer plaque lesions (5/13 [38.5%] vs. 70/103 [68.0%]), but more eczematous changes such as erosions and exudation, as well as scratches and crusts due to pruritus (all P < 0.05). Laboratory tests revealed that the PAO group showed increased peripheral blood neutrophil counts, eosinophil counts, serum IgE levels, eosinophil-to-lymphocyte ratios (ELRs), and neutrophil-to-lymphocyte ratios (NLRs) compared with the PSO group (all P < 0.05) ; moreover, the proportions of patients with elevated eosinophil counts (5/13 [38.5%] vs. 8/103 [7.8%], P < 0.001) and those with elevated serum IgE levels (10/13 [76.9%] vs. 39/103 [37.9%], P = 0.014) were significantly higher in the PAO group than in the PSO group. Compared with the PSO group, the PAO group had a higher overall comorbidity rate (11/13 [84.6%] vs. 52/103 [50.5%], P = 0.035), including a higher prevalence of hypertension. Regarding topical treatments, no significant differences were found in the use frequency of topical glucocorticoids (96 [93.2%] vs. 11 [84.6%]) or vitamin D3 analogs between the two groups (both P > 0.05) ; for systemic treatments, immunosuppressants such as cyclosporine (4/13 [30.8%] vs. 2/103 [1.9%], P = 0.001) and Tripterygium wilfordii (4/13 [30.8%] vs. 7/103 [6.8%], P = 0.021) were more commonly used in the PAO group compared with the PSO group; for targeted therapies, the PSO group received interleukin (IL) -17A inhibitors (13 cases, 12.6%), IL-23 inhibitors (4 cases, 3.9%), or tumor necrosis factor-α inhibitors (5 cases, 4.9%), while the PAO group received Janus kinase inhibitors (2 cases, 15.4%) or an IL-23 inhibitor (1 case, 7.7%) . Conclusions:PAO exhibited characteristics of both PSO and atopic dermatitis, with distinct differences in skin manifestations, laboratory findings, and treatment approaches compared with PSO. Topical glucocorticoids were the primary topical treatment for PAO, while systemic treatment was centered on immunosuppressants, highlighting the need for personalized treatment strategies.
4.Effect of minimally invasive interbody fusion device height on lumbar biomechanics in patients with adolescent lumbar disc herniation
Ruofan ZHANG ; Huanhuan GUAN ; Zhuoqun HE ; Yunfeng ZHANG ; Feng JIN ; Zhiqiang WANG ; Jianzhong WANG ; Xiaohe LI ; Yong ZHU ; Haiyan WANG ; Kai ZHANG
Chinese Journal of Tissue Engineering Research 2025;29(21):4421-4429
BACKGROUND:Adolescent lumbar disc herniation is the main cause of low back pain in adolescents. At present,most of them are treated by conservativetreatment. When long-term non-surgical treatment attempts,surgery may be necessary to prevent further injury when the patient's symptoms are notsufficiently relieved or when the patient has symptoms of single nerve paralysis or compression of the cauda equina,it is very important to choose a suitable interbody fusion device for the surgical treatment of the patients.OBJECTIVE:To explore the effects of minimally invasive interbody fusion with different heights on lumbar biomechanics in patients with adolescent lumbar disc herniation.METHODS:CT scans of a 17-year-old male patient with adolescent lumbar disc herniation (L4-5 segment herniation) were collected. After the three-dimensional reconstruction of MIMICS,the interbody fusion device equal to and 3 mm higher than the intervertebral space was selected for analysis,so two expandablemixed material interbody fusion devices were designed and reconstructed. Fusion device L:11 mm high front,9 mm high posterior,9 mm wide,28 mmlong,and fusion device H:14 mm high front,11 mm high posterior,11 mm wide,28 mm long and the lumbar fusion device was modeled. The fusion deviceand lumbar spine model were optimized,inversely modeled,and then imported into ABAQUS,and finally the 3D model of lumbar fusion was obtained.The physiological activities of the human body were simulated,such as lumbar extension,forward bending,right bending,and left bending,to obtain thecorresponding stress contours. The biomechanical characteristics of the L4-5 vertebra under seven different working conditions were observed.RESULTS AND CONCLUSION:(1) The maximum stress of the two kinds of fuses was in the condition of forward bending and backward extension,the stress value of H fuses was (18.27±3.80) Mpa and (15.02±3.24) Mpa;the stress value of L fuses was (9.16±0.05) Mpa and (9.17±1.83) Mpa. The stress values of the end plate of the H-fusion in the extension station were (19.11±4.03) Mpa and (16.32±3.72) Mpa respectively. The stress values of the L-fusion end plate were (9.13±0.01) Mpa and (4.92±1.01) Mpa respectively. (2) The stress of H-type fusing end plate was higher than that of L-type fusing end plate except for L-5 end plate at neutral position (P<0.05). (3) Choosing an interbody fusion device with a height of more than 3 mm in the same intervertebral space has a more stable biomechanics.
5.Development and application of a digital PCR-based assay for rapid diagnosis of common fetal chromosomal aneuploidies.
Xuejiao CHEN ; Yanfeng YANG ; Yuanyuan YING ; Feiyan PAN ; Zhiqiang GU ; Weimeng JIAO ; Zehang HE ; Huihui XU
Chinese Journal of Medical Genetics 2025;42(5):592-596
OBJECTIVE:
To assess the clinical value of digital PCR (dPCR) for the prenatal diagnosis of common fetal aneuploidies.
METHODS:
A dPCR-based assay was developed for detecting trisomies 21, 18, and 13. A retrospective analysis was carried out on 173 amniotic fluid samples collected by the Prenatal Diagnosis Center of Taizhou Hospital between January 2017 and December 2023. By using chromosomal karyotyping as the gold standard, the diagnostic performance of the multiplex dPCR system was evaluated in a double-blind manner. This study has been approved by the Ethics Committee of Taizhou Hospital (Ethics No. K20250339).
RESULTS:
Chromosomal karyotyping has identified 59 cases of trisomy 21, 5 cases of trisomy 18, 2 cases of trisomy 13, 6 cases with chromosomal structural abnormalities or mosaicisms, and 101 cases with a normal karyotype. The dPCR results (Z-score cutoff = 4.0, CI = 99.997%) showed full concordance with karyotyping (sensitivity = 100%, specificity = 100%, Kappa = 1). Among the 6 structurally abnormal or mosaicism samples, dPCR has accurately detected 4 cases, but mis-classified 2 cases of trisomy 21 with very low-level mosaicisms (3.3%, 6.9%, respectively) as normal.
CONCLUSION
The established multiplex dPCR system demonstrated high diagnostic accuracy for common chromosomal aneuploidies, with results available within 24 hours. It can serve as an efficient supplementary tool to conventional chromosomal karyotyping, providing reliable support for time-sensitive clinical decision-making in prenatal diagnosis.
Humans
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Female
;
Pregnancy
;
Aneuploidy
;
Prenatal Diagnosis/methods*
;
Karyotyping
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Retrospective Studies
;
Polymerase Chain Reaction/methods*
;
Chromosome Disorders/genetics*
;
Adult
;
Trisomy 13 Syndrome/diagnosis*
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Trisomy 18 Syndrome/genetics*
;
Down Syndrome/genetics*
6.Epidemiological characteristics analysis of pulmonary tuberculosis among children aged 0-14 in Shaanxi Province from 2010 to 2024
HE Zhiqiang, ZHAO Yan, LI Kaikai, ZHANG Hongwei
Chinese Journal of School Health 2025;46(9):1346-1350
Objective:
To analyze the epidemiological characteristics and incidence trends of pulmonary tuberculosis (TB) in children aged 0-14 years in Shaanxi Province from 2010 to 2024, so as to provide a reference for optimizing child TB prevention and control strategies.
Methods:
Data on pulmonary TB cases in children aged 0-14 years and demographic information in Shaanxi Province from 2010 to 2024 were collected from Surveillance and Reporting Management System with Disease Prevention and Control Information Management System under the National Health Security Informatization Project Disease Prevention and Control Information System. A Joinpoint regression model was established to analyze the temporal, spatial, and population distribution trends of child pulmonary TB incidence.
Results:
A total of 2 954 cases of pulmonary TB in children aged 0-14 years were reported in Shaanxi Province from 2010 to 2024, accounting for 0.97% of all TB cases in the general population. The average annual reported incidence rate in children was 3.32 per 100 000. Among these cases, 804 were pathogenetically positive, showing a increasing trend ( χ 2 trend =420.94, P < 0.01 ). The overall reported incidence rate of pulmonary TB in children aged 0-14 years in Shaanxi Province showed a decreasing trend, dropping from 5.35 per 100 000 in 2010 to 2.41 per 100 000 in 2024. Joinpoint regression analysis identified three distinct phases for the reported incidence rate of TB:a rapid decline from 2010 to 2013 (APC=-20.02%, 95% CI = -33.64% to -10.42%), a slight increase from 2013 to 2017 (APC=11.18%, 95% CI =3.07%-24.17%) and a slight decline again from 2017 to 2024 (APC= -7.27 %, 95% CI =-12.73% to -4.30%) (all P <0.01). Among children aged 0-14 years, the age group with the highest average annual reported incidence rate was 10-14 years (8.02 per 100 000), followed by 5-9 years (1.44 per 100 000), and 0-4 years had the lowest rate (0.95 per 100 000). The difference in reported incidence rates among the three age groups was statistically significant ( χ 2= 51.91, P <0.01). The average annual reported incidence rate of TB was 3.25 per 100 000 in boys and 3.39 per 100 000 in girls, with no statistically significant difference ( χ 2=2.01, P >0.05). There was no obvious periodic variation in the annual case reporting. Among all cities in Shaanxi Province, Ankang City had the highest average annual reported incidence rate (5.16 per 100 000).
Conclusions
From 2010 to 2024, the reported incidence rate of pulmonary TB in children aged 0-14 years in Shaanxi Province showed an overall decreasing trend. However, it is still necessary to strengthen active surveillance, implement targeted measures in high incidence areas such as Ankang City, and maintain continuous attention to child TB prevention and control.
7.Changes of brain excitation/inhibition balance and gray matter volume and their correlations with clinical features in benign childhood epilepsy with centrotemporal spikes
Xinhe YAO ; Qiang XU ; Yiwen CHEN ; Qirui ZHANG ; Jianrui LI ; Zhaojie WANG ; Yuzhuo LI ; Fang YANG ; Yan HE ; Chunfeng WU ; Gang YANG ; Guangming LU ; Zhiqiang ZHANG
Chinese Journal of Neuromedicine 2025;24(4):378-384
Objective:To explore the changes of brain excitation/inhibition balance and gray matter volume (GMV) and their correlations with clinical features in benign childhood epilepsy with centrotemporal spikes (BECTS).Methods:A cross-sectional study was performed; 83 BECTS children enrolled from Department of Diagnostic Radiology, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University from January 2015 to January 2024 were selected as BECTS group. During the same period, 101 age- and gender-matched healthy children were recruited as healthy control group through advertisements in local primary schools. Data of conventional MRI and resting-state functional MRI (rs-fMRI) of the two groups were collected. Whole brain GMV was analyzed by voxel-based morphometry (VBM), and Hurst index was calculated based on time series data of blood oxygen level dependent (BOLD) signal of rs-fMRI. Correlations of GMV and Hurst index with disease duration and onset age in children with BECTS were explored by Pearson correlation analysis.Results:Compared with the healthy control group, the BECTS group had significantly increased GMV and decreased Hurst index in the bilateral Rolandic region ( P<0.05). Pearson correlation analysis showed that in the BECTS group, GMV in bilateral Rolandic region was negatively correlated with onset age ( r=-0.267, P=0.015) and positively correlated with disease course ( r=0.267, P=0.015); Hurst index in bilateral Rolandic region was positively correlated with onset age ( r=0.323, P=0.003) and negatively correlated with disease course ( r=-0.240, P=0.029); Hurst index was negatively correlated with GMV in bilateral Rolandic region ( r=-0.328, P=0.003). Conclusion:BECTS children have excitation/inhibition imbalance in epilepsy-related regions and cortical structural delay, and both of them are related to onset age and disease course.
8.Prevalence Characteristics and Disease Burden of Lung Cancer in Hebei Cancer Registration Areas from 2012 to 2020
Yanfang FU ; Daojuan LI ; Yanyu LIU ; Zhiqiang YAN ; Yaxian PANG ; Yutong HE
China Cancer 2025;34(6):452-463
[Purpose]To analyze the prevalence characteristics and disease burden of lung cancer in Hebei cancer registration areas from 2012 to 2020.[Methods]Lung cancer data were collected from the Hebei Provincial Cancer Registry from 2012 to 2020.The crude incidence/mortality rates,age-standardized incidence/mortality rates by Chinese standard population(ASIRC/ASMRC)and by world standard population(ASIRW/ASMRW)were calculated.The Joinpoint model was used to calculate the annual percentage change(APC)and average annual percentage change(AAPC).Years of life lost(YLL)and years lived with disability(YLD)and the disability-adjusted life years(DALY)were calculated.[Results]From 2012 to 2020,the ASIRW of lung cancer in Hebei can-cer registration areas was 33.13/105,44.56/105 for men and 22.54/105 for women,respectively;the incidence rates of urban and rural areas were 29.05/105 and 33.52/105,respectively.The incidence rates increased with ages,reaching a peak in the age group of 80~84 years old.There was a de-creasing trend in the ASIRW of lung cancer(AAPC=-3.99%,P<0.05).From 2012 to 2020,the ASMRW of lung cancer was 25.80/105,36.56/105 for men and 15.96/105 for women,respectively;the mortality rates of urban and rural areas were 25.14/105 and 26.12/105,respectively.The mor-tality rates increase with ages,reaching a peak in the age group of 85 and above years old.There was a decreasing trend in the mortality of lung cancer(AAPC=-4.65%,P<0.001)from 2012 to 2020.The DALY of lung cancer in Hebei Province from 2012 to 2020 was 484 194 person-years,with male accounting for 66.77%,female accounted for 33.23%,the DALY rate of lung cancer was 3.31‰,of which 35.57%in urban areas and 64.43%in rural areas.[Conclusion]Lung can-cer incidence and mortality rate in Hebei cancer registration areas from 2012 to 2020 showed a decreasing trend.The disease burden is gradually increasing with age in middle-aged and el-derly population.
9.Development and characterization of 18F-SQKJ-2: a novel PET tracer for the diagnosis of fear memory disorders
Wanli HE ; Chenxin MA ; Xinghai CAO ; Junwei CHEN ; Yan GU ; Shuxia CAO ; Zhiqiang WANG ; Dilong MAO ; Qinggang HE
Chinese Journal of Nuclear Medicine and Molecular Imaging 2025;45(11):672-677
Objective:To develop and validate a novel PET tracer, N-cyclohexyl-4-((2, 4-dichlorophenyl)(4-(fluoro- 18F)phenyl)methyl)piperazine-1-carboxamide ( 18F-SQKJ-2), targeting cannabinoid type 1 (CB1) receptors for diagnosing psychiatric disorders associated with fear memory. Methods:18F-SQKJ-2 was prepared using a nucleophilic substitution radiochemical synthesis method. For the CB1 receptor blocking experiment, 7 ICR mice were divided into blocking group ( n=4; rimonabant for blocking treatment) and control group 1 ( n=3; no rimonabant blocking treatment). The affinity and specificity of 18F-SQKJ-2 for CB1 receptors were analyzed based on the differences in 18F-SQKJ-2 uptake (percentage injected dose per gram of tissue, %ID/g) by various organs between two groups. The metabolic stability of 18F-SQKJ-2 in vitro was studied using animal tissue homogenates. Ten C57 mice were used to establish fear memory mouse models (fear group, n=6; control group 2, n=4), and the percentage of freezing time was compared between 2 groups. MicroPET scans were used to detect the intracranial distribution of 18F-SQKJ-2, and the relative uptake in each brain region compared to total brain uptake was calculated. Statistical analysis was conducted to compare the differences in CB1 receptor relative total brain uptake in fear-related brain regions between 2 groups. Independent-sample t test and Mann-Whitney U test were used to analyze the data. Results:18F-SQKJ-2 was successfully synthesized with a radiochemical purity ≥98.0% and a corrected radioactive yield of (12.3±6.0)%( n=4). In vitro metabolic stability experiments showed that 18F-SQKJ-2 was basically stable in the liver, blood, and brain within 60min. The CB1 receptor blocking experiment demonstrated that the uptake of 18F-SQKJ-2 in the brains of mice in blocking group was significantly lower than that in control group 1 ((0.95±0.28) vs (3.44±1.16) %ID/g; t=-3.57, P=0.023). The percentage of freezing time in fear group was significantly higher than that in control group 2 (43.28%(39.46%, 52.93%) vs 2.74%(1.52%, 4.85%); Z=-2.45, P=0.010). 18F-SQKJ-2 microPET imaging showed that the uptake of 18F-SQKJ-2 in the cerebral cortex of mice in fear group was significantly increased compared with that in control group 2 ((5.83±0.47)% vs (5.00±0.52)%; t=2.42, P=0.046). Conclusion:18F-SQKJ-2 is successfully prepared with acceptable radiochemical purity and metabolic stability, demonstrating potential for visualizing and quantifying fear memory.
10.Development and application of a digital PCR-based assay for rapid diagnosis of common fetal chromosomal aneuploidies
Xuejiao CHEN ; Yanfeng YANG ; Yuanyuan YING ; Feiyan PAN ; Zhiqiang GU ; Weimeng JIAO ; Zehang HE ; Huihui XU
Chinese Journal of Medical Genetics 2025;42(5):592-596
Objective:To assess the clinical value of digital PCR (dPCR) for the prenatal diagnosis of common fetal aneuploidies.Methods:A dPCR-based assay was developed for detecting trisomies 21, 18, and 13. A retrospective analysis was carried out on 173 amniotic fluid samples collected by the Prenatal Diagnosis Center of Taizhou Hospital between January 2017 and December 2023. By using chromosomal karyotyping as the gold standard, the diagnostic performance of the multiplex dPCR system was evaluated in a double-blind manner. This study has been approved by the Ethics Committee of Taizhou Hospital (Ethics No. K20250339).Results:Chromosomal karyotyping has identified 59 cases of trisomy 21, 5 cases of trisomy 18, 2 cases of trisomy 13, 6 cases with chromosomal structural abnormalities or mosaicisms, and 101 cases with a normal karyotype. The dPCR results ( Z-score cutoff = 4.0, CI = 99.997%) showed full concordance with karyotyping (sensitivity = 100%, specificity = 100%, Kappa = 1). Among the 6 structurally abnormal or mosaicism samples, dPCR has accurately detected 4 cases, but mis-classified 2 cases of trisomy 21 with very low-level mosaicisms (3.3%, 6.9%, respectively) as normal. Conclusion:The established multiplex dPCR system demonstrated high diagnostic accuracy for common chromosomal aneuploidies, with results available within 24 hours. It can serve as an efficient supplementary tool to conventional chromosomal karyotyping, providing reliable support for time-sensitive clinical decision-making in prenatal diagnosis.


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