Objective To develop a competitive immunoassay for quantitative determination of total immunoglobin E (tIgE) in human serum based on light-initiated chemiluminescent assay (LICA).Methods The LICA-tIgE assay was performed by incubating serum samples or calibrator with anti-human IgE antibody-coated chemiluminescet beads,biotinylated human IgE and streptavidin-coated sensitizer beads.The working conditions of this assay were optimized,analytical performance was detected and the correlation of tIgE results between LICA and Beckman Coulter IMMAGE 800 was evaluated.Results The precision of intra-assay and inter-assay (coefficient of variation) ranged from 5.50％ to 7.73％ and 6.45％ to 9.90％,respectively.The functional sensitivity of this assay was 12.65 IU/mL.The recovery rates measured by adding IgE calibrators to human sera with different IgE concentrations were ranged from 104.15％ to 109.37％.The disturbing rates measured by adding total bilirubin,hemoglobin and triacylglycerol to human sera with different IgE concentrations were ranged from-4.49％ to 8.46％.Also,the tIgE results of 111 patients measured by LICA correlated well with those by Beckman Coulter IMMAGE 800 (r2 =0.959).Conclusion LICA developed in this study for detecting tIgE of human serum showed effective perfomance and could meet the basic requirements of clinical diagnostic reagents.

Objective:This study intended to explore the current sexual and childbearing stigma, experienced by chronic hepatitis B patients in China, and to develop related preventive strategies.Methods:We used a self-made questionnaire to investigate the sexual and childbearing stigma suffered by chronic hepatitis B patients in four provinces of China. Analysis of variance and chi-square test were used to compare the differences on sexual and childbearing stigma indexes between different demographic variables.Results:We surveyed 797 chronic hepatitis B patients in four provinces. Among them, 4.15 % (28/675) of the patients were persuaded not to give birth to children, and 4.67 % (10/210) of patients were told to stop pregnancy, by their medical care takers or by members from the family planning institutions. 3.62 % (25/690) and 3.48 % (24/690) of the patients were not able to enjoy the family planning or reproductive health services as they were stigmatized,suffered, as having HBV infection. Among the male chronic hepatitis B patients, the under 30 years group suffered less sexual and childbearing stigma than those who were aged 31- ( P=0.011) or 51 and above year-olds ( P=0.009). Among female chronic hepatitis B patients, the 31- year-olds group suffered less sexual and childbearing stigma than those under 30 years group but higher than those aged 41- ( P=0.001) or 51 and above ones ( P<0.001). Patients with knowledge on route of sexual transmission for HBV, were more likely to practice less related sexual behaviors than those without such knowledge ( P=0.022). Patients who were aware or not that condoms could reduce the risk of HBV infection did not show statistically significant difference on sex behaviors ( P=0.612). Conclusions:Chronic hepatitis B patients did suffer from sexual and childbearing related stigma, with women aged 31-40 years old the most. It is necessary to advocate on the advantage of condom use for prevention of HBV transmission among pregnant women, both horizontally and vertically. Strategies on protection the rights of patients with hepatitis B should be developed and strengthened.

Human challenge trial (HCT) is a test in which human volunteers are intentionally infected with pathogens in order to evaluate the efficacy of candidate preventive or therapeutic drugs. During the COVID-19 pandemic, the HCT of vaccines has aroused people's attention due to its significant advantages over clinical trial. This paper introduces the concept, development and application of HCT, the advantages and limitations of HCT for vaccine evaluation, and the consideration of future HCT of COVID-19 vaccine in China.

Objective:To construct a combined radiomics model based on preoperative enhanced computed tomography (CT) examination for predicting microvascular invasion (MVI) in hepatocellular carcinoma (HCC), and provide biological explanations for the radiomics model.Methods:The retrospective cohort study was conducted. The messenger RNA (mRNA) of 424 HCC patients, the clinicopathological data of 39 HCC patients entered into the Cancer Genome Atlas database from its establishment until January 2023, and the clinicopathological data of 53 HCC patients who were admitted to the Gansu Provincial People′s Hospital from January 2020 to January 2023 were collected. The 92 HCC patients were randomly divided into a training dataset of 64 cases and a test dataset of 28 cases with a ratio of 7∶3 based on a random number table method. The CT images of patients in the arterial phase and portal venous phase as well as the corresponding clinical data were analyzed. The 3Dslicer software (version 5.0.3) was used to register the CT images in the arterial phase and portal venous phase and delineate the three-dimensional regions of interest. The original images were preprocessed and the corresponding features were extracted by the open-source software FAE (version 0.5.5). After selecting features using the Least Absolute Shrinkage and Selection Operator, the radiomics model was constructed and the radiomics score (R-score) was calculated. The nomogram was constructed by integrating clinical parameters, imaging features and R-score based on Logistic regression. The gene modules related to radiomics model were obtained and subjected to enrichment analysis by conducting weighted gene co-expression network analysis and correlation analysis. Observation indicators: (1) comparison of clinical characteristics of patients with different MVI properties; (2) establishment of MVI risk model; (3) evaluation of MVI risk model; (4) clustering of gene modules; (5) functional enrichment of feature-correlated gene modules. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the independent sample t test. Measurement data with skewed distribution were represented as M(range), and comparison between groups was conducted using the Mann-Whitney U test. Comparison of count data was conducted using the chi-square test. The intra-/inter-class correlation coefficient (ICC) was used to assess the inter-observer consistency of radiomics feature extracted by different observers. ICC >0.75 indicated a good consistency in feature extraction. The Logistic regression model was used for univariate and multivariate analyses. The receiver operating characteristic curve was drawn, and the area under curve (AUC), the decision curve and the calibration curve were used to evaluate the diagnostic efficacy and clinical practicality of the model. Results:(1) Comparison of clinical characteristics of patients with different MVI properties. Of 92 HCC patients, there were 47 cases with MVI-positive and 45 cases with MVI-negative, and there were significant differences in hepatitis, tumor diameter, peritumoral enhancement, intratumoral arteries, pseudocapsule and smoothness of tumor margin between them ( χ2=5.308, 9.977, 47.370, 32.368, 21.105, 31.711, P<0.05). (2) Establishment of MVI risk model. A total of 1 781 features were extrac-ted from arterial and portal venous phases of the intratumoral and peritumoral regions. After feature dimension reduction, 8 radiomics features were selected from arterial and portal venous phases to construct the combined model. Results of multivariate analysis showed that peritumoral enhancement, intratumoral arteries, pseudocapsule, smoothness of tumor margins, and R-score were independent risk factors for MVI in patients with HCC [ hazard ratio=0.049, 0.017, 0.017, 0.021, 2.539, 95% confidence interval ( CI) as 0.005-0.446, 0.001-0.435, 0.001-0.518, 0.001-0.473, 1.220-5.283, P<0.05]. A nomogram model was constructed incorporating peritumoral enhancement, intratumoral arteries, pseudocapsule, smoothness of tumor margins, and R-score. (3) Evaluation of the MVI risk model. The AUC of radiomics model was 0.923 (95% CI as 0.887-0.944) and 0.918 (95% CI as 0.894-0.945) in the training dataset and test dataset, respectively. The AUC of nomogram model, incorpora-ting both the R-score and radiomics features, was 0.973 (95% CI as 0.954-0.988) and 0.962 (95% CI as 0.942-0.987) in the training dataset and test dataset, respectively. Results of decision curve showed that the nomogram had better clinical utility compared to the R-score. Results of calibration curve showed good consistency between the actual observed outcomes and the nomogram or the R-score. (4) Clustering of gene module. Results of weighted gene co-expression network analysis showed that 8 gene modules were obtained. (5) Functional enrichment of feature-related gene modules. Results of correlation analysis showed 4 gene modules were significantly associated with radiomics features. The radiomics features predicting of MVI may be related to pathways such as the cell cycle, neutrophil extracellular trap formation, and PPAR signaling pathway. Conclusions:The combined radiomics model based on preoperative enhanced CT imaging can predict the MVI status of HCC. By obtaining mRNA gene expression profiles associated with radiomics features, a biological interpretation of the radiomics model is provided.

Objective: To develop and evaluate a beads-based light-initiated chemiluminescent assay (LICA) for quantitation of cow milk component (Bos d 5) specific IgG 4 antibody in human serum. Methods: The sIgG 4 -LICA was performed by incubated serum samples with biotinylated allergens, emission beads coated with mouse anti-human IgG 4 antibody and streptavidin-coated sensitizer beads. The reaction conditions of sIgG 4 -LICA were optimized and the analytical performance was evaluated. Results: The precision of intra-assay, within-day and inter-assay (coefficient of variation) were 1.78% to 3.13%, 6.65% to 8.41% and 7.94% to 12.30%, respectively. The functional sensitivity of this assay was 4.71 ng/mL. For the linear range, the sIgG 4 -LICA had a good linear relationship within the range between 28.13 and 1 800 ng/mL, and the linear regression equation was Y=0.98X-1.31(r 2 =0.997). Maximum dilution limit was 1∶64. The disturbing rates measured by adding hemoglobin, triacylglycerol, total bilirubin, acid resistance and biotin to human sera with different concentrations of Bos d 5 sIgG 4 were from -6.38% to 8.60%. Conclusions The sIgG 4 -LICA introduced in this study was demonstrated to have effective performance for quantitation of allergen-specific IgG 4 and can meet the need of clinical requirement.

Objective:To investigate the incidence and determinants of vaccine hesitancy towards national immunization program in China and understand the current status of parents' hesitancy to different vaccines used in national immunization program.Methods:A cross-sectional survey was conducted in Beijing, Sichuan and Gansu. The methods of proportional probability sampling and convenience sampling were used to select the eligible study subjects for questionnaire surveys.Results:A total of 3 592 parents were enrolled in the study, in whom 38.22% fully accepted all the vaccines, 59.35% agreed to let their children to receive all the vaccines but showed slight concern, and 2.42% had hesitancy to the vaccines. The vaccine with the most hesitancy was polio vaccine (0.89%), followed by diphtheria pertussis tetanus vaccine (0.70%) and hepatitis A vaccine (0.64%). The dominant reason for vaccine hesitancy was the risk-benefit perception of vaccination (31.03%), followed by the low awareness of the parents (21.84%) and the inconvenience caused by distance and time (21.84%).Conclusions:The incidence of vaccine hesitancy towards national immunization program was low in parents in China, but over 50% of the parents showed concern to the vaccines. It is essential to improve the service quality of national immunization program and strengthen the health education about the vaccination to reduce the incidence of vaccine hesitancy in parents.

Objective:To explore the coverage of influenza and pneumonia vaccination and factors influencing the vaccination in children.Methods:A cross-sectional questionnaire survey was conducted in children's parents in Beijing and Gansu by using two-stage cluster-sampling to investigate the influenza and pneumonia vaccination rates and influencing factors in children.Results:A total of 2 377 parents were included in the study, and the results indicated that the influenza vaccination coverage was 35.93% and the pneumonia vaccination coverage was 16.58% in children in survey areas, the vaccination rate of both vaccines was 11.65%. The top three reasons for vaccination for both vaccines were being aware of severity of the diseases (influenza vaccine: 36.02%; pneumonia vaccine: 49.61%), being required by school or organization (influenza vaccine: 28.76%; pneumonia vaccine: 25.45%) and being aware of the susceptibility of the diseases (influenza vaccine: 26.41%; pneumonia vaccine: 13.88%). The top three reasons for having no vaccinations were personal unwillingness, concern about vaccine and vaccine accessibility. Families with multi children, living in rural areas and lower family income were the negative factors for both types of vaccinations.Conclusions:The influenza and pneumonia vaccination coverage in children need further improvement, and rural families and families with multi children are the key concern groups for expanding vaccination coverage. Health education about influenza and pneumonia vaccinations, coordinating vaccine supply and decreasing vaccine prices play an important role in improving influenza and pneumonia vaccination coverage.