Objective: Application of Clinical and Laboratory Standards Institute evaluation protocols-12 approved guideline 2^nd edition (CLSI EP12-A2) and EP15-A2 documents in the performance evaluation of Adenovirus IgM CLIA microparticles. Methods: Referring to the EP15-A2 method , three samples of high and low concentration were selected. Each sample test was repeated 4 times one day for 5 days, and the total imprecision was calculated. Referring to the EP12-A2 method , samples of C₅₀, C₅₀-20% and C₅₀+ 20% were prepared and repeated 40 times, to verify C₅₀±20% bounds the C₅~C₉₅ interval. Compared with diagnostic accuracy criteria, the sensitivity and specificity were calculated. Compared with ELISA method , the concordance rate and Kappa value were calculated. Results: The total imprecision CV (%) was less than 8%, lower than that announced by manufacturer. C50±20% concentration fall outside the C5~C95 interval. Compared with diagnostic accuracy criteria, the sensitivity was 100% (95%CI: 79.6%~100%), specificity was 97.8% (95%CI: 94.5%~99.1%), Kappa value was 0.871. Compared with ELISA method , the positive concordance rate was 66.7%(95%CI: 53.6%~77.7%), negative concordance rate was 97.4%(95%CI: 95.4%~98.5%)total concordance rate was 93.9%(95%CI: 91.6%~95.6%), Kappa value was 0.678. Conclusions The performance of Adenovirus IgM CLIA microparticles can meet clinical requirements.

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.

Objective To assess the association of polymorphism at rs12645561 locus of Nei endonuclease Ⅷ-like 3 ( NEIL3) gene with the severity of coronary atherosclerosis in Han population of Hubei and Henan regions in central China. Methods In 947 cases undergoing coronary angiography, the severity of coronary atherosclerosis was calculated by lesion vessel number scores and Gensini scores.The genotypes of rs12645561 were analyzed by high resolution melting curve. The plasma NEIL3 levels were measured by en-zyme-linked immunosorbent assay. Results The minor allele T of rs12645561 was significantly associated with the risk of coronary ar-tery disease (χ2=12.165, P<0.05) including increased lesion vessel scores and Gensini scores (χ2=14.745 and 15.615,P<0.05). The variant risk genotypes ( CC+CT) of rs12645561, body mass index of more than 25 kg/m2 , hypelipidemia and smoking habit were all the independent risk factors for higher Gensini scores ( OR=1.50, 1.54, 2.01 and 1.42, respectively, P<0.05) . There were signifi-cantly inverse correlations of plasma NEIL3 levels with the distribution of rs12645561, lesion vessel number scores and Gensini scores ( P<0.05) . Conclusion rs12645561 may correlate with the severity of coronary atherosclerosis, and contribute to the development of coronary atherosclerosis of Han population of Henan and Hubei regions. rs12645561 may also affect the levels of NEIL3 protein.

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 preliminary evaluate the validity and reliability of the Comprehensive International Classification of Functioning,Disability and Health(ICF)Core Set for Knee Arthroplasty Perioperative Period.Methods:Patients diagnosed with knee osteoarthritis and undergoing knee arthroplasty(n=41)were recrui-ted for study of criterion validity,internal consistency,interclass reliability and intraclass reliability.The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC),Mos 36-item Short Form Health Survey(SF-36),Self-rating Anxiety Scale(SAS)and Self-rating Depression Scale(SDS)were used to test criterion validity.Results:The scores of body structure and function and activity and participation components were positive-ly correlated with the WOMAC pain,physical function and total scores(ICC=0.59-0.92),as well as scores of SF-36(ICC=0.46-0.89).The scores of b130,b134,b152,d230 and d240 categories were positively correlated with the SAS scores(ICC=0.41-0.73),and the score of b530 category was positively correlated with the SDS scores(ICC=0.47),Ps＜0.05.The Cronbach α of the body structure and function,activity and participation,and environmental factors components were 0.93,0.93 and 0.53 respectively.The ICCs of interclass reliability ranged from 0.44 to 0.99,the ICCs of intraclass reliability ranged from 0.66 to 0.97.Conclusion:The Comprehensive ICF Core Set for Knee Arthroplasty Perioperative Period has a relatively good validity and reliability.

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.