Comparison of requirements for clinical study of SARS-CoV-2 antigen test kits in China, the USA and Europe.

Aims: This study was designed to analyze the requirements for clinical trials of SARS-CoV-2 antigen testing to explore the rationality and scientific rigor of clinical trials. Methods: The guidelines for the listing of SARS-CoV-2 antigen tests were compared and the requirements for clinical trials were analyzed to find similarities and differences between China, the USA and Europe. Results: The requirements for clinical trials of SARS-CoV-2 antigen tests in China, the USA and Europe were consistent in terms of methods. However, differences were found in the requirements for protocol design. Conclusion: The differences in clinical trial requirements stem from regulations and the actual conditions across regions, but all clinical trials are designed to obtain valid clinical performance of products.

Relationship between psychological capital and depression in Chinese physicians: The mediating role of organizational commitment and coping style.

Background: It is well known that the medical profession is a high-risk practice, with intense work and complex situations. The physicians are prone to suffer from depression due to occupational stress under high workloads for long periods of time. Depression not only impairs physicians' mental health, but also affects the quality of health services, so it is important to explore the factors and mechanisms affecting depression among physicians. Methods: In this cross-sectional study, 1,139 physicians from Heilongjiang Province were surveyed by cluster sampling procedures. The questionnaires included Psychological Capital Questionnaire, Chinese Employee Organizational Commitment Questionnaire, Trait Coping Style Questionnaire and Self-rating Depression Scale. Pearson correlation analysis and Bootstrap were used for statistical analysis. Results: This study found that 41.6% of physicians suffering from depression. Among them, 17.0% of physicians showed moderate depression, and 2.6% of physicians exhibited severe depression. The serial-multiple mediation of organizational commitment and positive coping styles in the relationship between psychological capital and depression was significant. Conclusion: The results showed that the psychological capital was sequentially associated with increased organizational commitment, and then increased positive coping styles, which resulted in reduced depression among physicians.

Association of the Combined Effects between Insulin-Like Growth Factor-1 Gene Polymorphisms and Negative Life Events with Major Depressive Disorder among Chinese population in the Context of Oxidative Stress.

Background: Oxidative stress may be increased in a number of psychiatric disorders, including major depressive disorder (MDD). MDD has been shown to be related to insulin-like growth factor-1 (IGF-1) as well as to negative life events; exploring the interaction of IGF-1 polymorphisms and negative life events on the risk of MDD is needed. The aim of this study was to analyze the single and combined effects of IGF-1 polymorphisms (rs972936 and rs978458) and negative life events with MDD among Chinese population. Methods: 420 MDD patients (according to DSM-V) and 420 age- and gender-matched control subjects were recruited in a case-control study. Negative life events were assessed using standard rating scales. IGF-1 rs972936 and rs978458 were identified by sequencing. The chi-square (χ 2) tests were performed to explore the association of negative life events and IGF-1 polymorphisms with MDD. Results: Our results found that the negative life events were associated with the risk of MDD (P < 0.001; OR = 3.28, 95% CI: 2.19-4.85). The genotypes of IGF-1 were associated with the risk of MDD (P < 0.001); carrying the IGF-1 rs972936 C allele (OR = 1.53, 95% CI: 1.26-1.85) and rs978458 T allele (OR = 1.92, 95% CI: 1.58-2.34) had a higher risk of MDD. The combined effects between IGF-1 rs978458 and negative life events were associated with the risk of MDD (P < 0.05; OR = 2.94, 95% CI: 1.23-7.03), but IGF-1 rs972936 was not associated (P > 0.05). Conclusions: Based on the oxidative stress hypothesis, we confirm that carrying IGF-1 rs972936 C allele and rs978458 T allele have a higher risk of MDD and the combined effects between IGF-1 rs978458 and negative life events were associated with the risk of MDD among Chinese population.

China's NMPA perspective on the clinical performance of SARS-CoV-2 antigen test reagents.

The COVID-19 pandemic continues to spread all over the world. In the process of emergency use authorization, the Center for Medical Device Evaluation of the China National Medical Products Administration issued 'Key Points of Technical Review for the Registration of SARS-CoV-2 Antigen/Antibody Detection Reagents' as the guidance of registration of antigen and antibody test reagents for the industry. In this document, clinical evaluation requirements of antigen detection reagents are elaborated. Based on the Key Points document and the authors' review practice, this article explains the evaluation methods and requirements of clinical performance of SARS-CoV-2 antigen-detecting rapid diagnostic tests, then analyzes the application scenarios and intended use of antigen detection reagents.

Psychological Impact of COVID-19 Epidemic on Adolescents: A Large Sample Study in China.

Background: The COVID-19 pandemic is a major public health emergency. However, little is known about the psychological impact of this pandemic on adolescents. We aim to assess the prevalence and influencing factors of depression, anxiety, and posttraumatic growth (PTG) among adolescents in a large sample study. Methods: This cross-sectional study collected demographic data and mental health measurements from 175,416 adolescents covering 31 provinces, centrally administered municipalities, and autonomous regions in mainland China from February 23 to March 8, 2020. The status of depression, anxiety, and PTG was assessed by the nine-item Patient Health Questionnaire, seven-item generalized anxiety disorder questionnaire, and post-traumatic growth inventory. Results: The prevalence of depression, anxiety, and PTG in adolescents was 35.9, 28.0, and 45.6%, respectively. The prevalence of depression and anxiety in the slight or severe epidemic areas was similar. Regression analysis showed that female sex and older age were associated with higher levels of depression, anxiety, and lower levels of PTG. Symptoms related to COVID-19, excessive attention to epidemic information, living in urban or severe epidemic areas, and conflicts with parents during home quarantine were risk factors for depression, anxiety, and PTG. Frequent communication with peers, exercise, and receiving public welfare psychological assistance were protective factors. Poor family economic status was a significant risk factor for depression and PTG. Conclusion: Our findings suggested that positive and negative psychological reactions coexist in adolescents faced with the pandemic. The factors associated with psychological problems and PTG provide strategic guidance for maintaining adolescents' mental health in China and worldwide during any pandemic such as COVID-19.

Cost-effectiveness of Anbainuo plus methotrexate compared to conventional disease-modifying antirheumatic drugs for rheumatoid arthritis patients in China.

BACKGROUND: This study aimed to evaluate the cost-effectiveness of Anbainuo (ABN) plus methotrexate (MTX) vs. conventional disease-modifying antirheumatic drugs (cDMARDs) in Chinese rheumatoid arthritis (RA) patients. METHODS: A total of 90 RA patients who underwent ABN + MTX [assigned as ABN + MTX group (n=47)] or cDMARDs [assigned as control group (n=43)] treatment were analyzed. Disease activity was assessed at baseline (M0), 3rd month (M3), 6th month (M6), and 12th month (M12) after treatment. Drug, other medical, indirect, and total costs were calculated. Then, pharmacoeconomic analyses were performed with the threshold of cost-effectiveness set as 3 times of the mean gross domestic product (GDP) per capita in China during the study period. RESULTS: Treatment response rate was similar between the 2 groups, while disease remission and low disease activity (LDA) rates were increased in the ABN + MTX group compared to control group. Drug cost, other medical costs, and total cost were higher in the ABN + MTX group than control group, while indirect cost was similar between the 2 groups. Meanwhile, the quality-adjusted life-years (QALY) in ABN + MTX group and control group were 0.72 and 0.48 years, respectively. The incremental cost-effectiveness ratios (ICER) of ABN + MTX group compared to control group among the entire participant cohort, moderate-disease-activity participants, and severe-disease-activity participants were ¥135,486.7, ¥146,450.4, and ¥124,987.2/QALY, respectively, which were all below the cost-effectiveness threshold. Further sensitivity analyses revealed that the cost-effectiveness of ABN + MTX vs. cDMARDs was relatively robust, while among all the indexes, ABN price and Health Assessment Questionnaire Disability Index (HAQ-DI) score change for the ABN + MTX group affected ICER most. CONCLUSIONS: Treatment with ABN + MTX offers acceptable cost-effectiveness compared to cDMARDs treatment in Chinese RA patients.

Key points of technical review for the registration of SARS-CoV-2 antigen/antibody tests.

Coronavirus disease-2019 (COVID-19), caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread globally since its first report and become a worldwide pandemic. In response to the outbreak of COVID-19, Center for Medical Device Evaluation, NMPA (CMDE) initiated emergency review and approval procedures to accelerate the process of reviewing emergent medical products and issued the Key Points of Technical Review for the Registration of SARS-CoV-2 Antigen/Antibody Tests (Key Points) to provide the requirements on the technical review of the tests. With uncontrolled spread and evolution of COVID-19 in the world, continuous prevention and measurements are necessary for fighting this pandemic and SARS-CoV-2 antigen/antibody tests are still urgently needed. This article is an attempt to expand clarification of the Key Points to wider audiences based on current understanding of SARS-CoV-2 to facilitate the development and application of SARS-CoV-2 antigen/antibody tests.

China NMPA perspective on clinical evaluation of SARS-CoV-2 antibody test reagents in the process of emergency approval.

Coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The SARS-CoV-2 antibody testing an important supplement to nucleic acid testing. In the process of emergency approval, the Center for Medical Device Evaluation of the China National Medical Products Administration released The Key Points of Technical Review for the Registration of SARS-CoV-2 Antigen/Antibody Detection Reagents. The Clinical Study Requirement section of the Key Point has put forward requirements in terms of reference methods and subject enrolment among others, which can ensure that the test results can meet the clinical needs. This article draws on the experience of the China NMPA in evaluating diagnostic reagents used to supplement the gold standard test method in the early stage of an epidemic of an infectious disease, as well as to serve as reference for clinicians and regulators.

Comparison and application of different immunoassay methods for the detection of SARS-CoV-2.

The detection data of IgM and IgG antibodies in 169 patients with coronavirus disease-2019 (COVID-19) were analyzed to evaluate differences in clinical performance between the colloidal gold method and chemiluminescence method. In this study, chemiluminescence detection of IgM antibody showed a positive conversion earlier (about 1-2 days earlier), positive conversion rates higher in different stages of disease, and a trend of declining positive rate later than colloidal gold method. For IgG antibody, the chemiluminescence method showed a positive conversion earlier and the positive rate climbing more quickly than the colloidal gold method. No obvious negative-converting tendency of IgG detection was observed within 35 days after the onset of disease. Although colloidal gold method is generally less sensitive than chemiluminescence method, it shows advantages of shorter turn-around time, more simple procedure, and no special equipment required. The two methodologies can be chosen according to different laboratory conditions. A reasonable understanding of the performance of reagents with different methodologies can help in clinical disease diagnosis effectively and assist in the diagnosis of the progression of COVID-19, for which the dynamic changes of antibody will provide reliable evidence.

A novel etanercept biosimilar Anbainuo plus methotrexate exhibits increased cost-effectiveness compared to conventional disease-modifying anti-rheumatic drugs in treating rheumatoid arthritis patients.

The aim of this study was to evaluate the cost-effectiveness of Anbainuo (ABN) plus methotrexate (MTX) (ABN + MTX) versus conventional disease-modifying anti-rheumatic drugs (cDMARDs) in rheumatoid arthritis (RA) patients.Forty-eight moderate to severe RA patients underwent ABN + MTX or cDMARDs treatment were consecutively enrolled and assigned to ABN + MTX group (n = 26) and control group (n = 22). Patients were followed up and their disease activity and quality of life (QoL) were evaluated at 3rd month, 6th month and 12th month after initiation of treatment. Treatment costs of 2 groups were calculated, then pharmacoeconomic analysis was performed.ABN + MTX increased drug cost and total cost while decreased indirect cost compared with cDMARDs after 12-month treatment. ABN + MTX group gained additional 0.22 quality-adjusted life years (QALY) and yielded an incremental cost-effectiveness ratio (ICER) of ¥104,293.6 per QALY after treatment. Sensitivity analysis reveals that rising ABN price by 20% produced an ICER of ¥130,403.6 per QALY, which was still lower than 3 times of the mean gross domestic product (GDP) per capita during the same period in China (¥165,960). Besides, ABN + MTX was more cost-effective in severe RA patients compared to moderate RA patients.ABN + MTX is cost-effective in treating moderate to severe RA patients compared with cDMARDs, although the total cost of ABN + MTX is relatively higher.

Real-world cost-effectiveness of infliximab for moderate-to-severe rheumatoid arthritis in a medium-sized city of China.

AIM: To assess the cost-effectiveness of infliximab-containing therapy (ICT) for moderate-to-severe rheumatoid arthritis (RA) in a medium-sized Chinese city. METHODS: A Chinese prospective cohort study comparing ICT (25 patients) versus conventional disease-modified antirheumatic drugs (24 patients) for RA was used to assess the cost-effectiveness of ICT. RESULTS: The cohort study observed significantly reduced disease activity score of 28 joints (coefficient -2.718, p < 0.001), improved EQ-5D (coefficient 0.453, p < 0.001) and increased medical costs (coefficient 1.289, p < 0.001) associated with ICT. The incremental cost-effectiveness ratio per gained quality-adjusted life year for ICT versus disease-modified antirheumatic drugs was 1.897-times of the local gross domestic product per capita. CONCLUSION: Infliximab was a favorable cost-effective alternative option for moderate-to-severe RA in a medium-sized city of China.