ABSTRACT
Objective This multicenter clinical evaluation analyzed the clinical performance of five fast nucleic acid detection systems for 2019-nCoV. Methods Clinical performance of the five fast nucleic acid detection reagents approved in China was evaluated in the present study. Fifty-seven throat swabs samples from COVID-19 patients and fifteen throat swabs samples from healthy people were collected from the First Affiliated Hospital of Zhejiang University school of Medicine, Tongji Hospital of Tongji Medical College of HUST, and National Institute of Viral Disease Control and Prevention of CDC to evaluate the positive coincidence rate, negative coincidence rate, total coincidence rate, the detection time and retest rate as well as the relation between positive intensity and positive coincidence rate of the five fast nucleic acid detection systems in November 2020. Results The positive coincidence rates of the five kits were 92.59% (50/54), 83.64% (46/55), 98.25% (56/57), 94.44% (51/54) and 98.18% (54/55);and the negative coincidence rates were 93.33% (14/15), 93.33% (14/15), 86.67% (13/15), 100% (14/14) and 93.33% (14/15);and the total coincidence rates were 92.75% (64/69), 85.71% (60/70), 95.83% (69/72), 94.20% (65/69) and 97.14% (68/70), respectively. The positive coincidence rate of the five kits reached 100% for the strong-positive (90/90) and medium-positive samples (84/84), but only 82.18% (83/101) for weak-positive samples (cycle threshold value>33), and the retest rate of two kits were 15.28% (11/72) and 12.50% (9/72), which were both higher than 10%. Total time from sample extraction to amplification was between 32.33-65.33 minutes for these five kits. Conclusion The five fast nucleic acid detection reagents have good performance and can be used as a supplement to routine nucleic acid detection reagents.Copyright © 2022 Chinese Journal of Laboratory Medicine. All rights reserved.
ABSTRACT
Objective This multicenter clinical evaluation analyzed the clinical performance of five fast nucleic acid detection systems for 2019-nCoV. Methods Clinical performance of the five fast nucleic acid detection reagents approved in China was evaluated in the present study. Fifty-seven throat swabs samples from COVID-19 patients and fifteen throat swabs samples from healthy people were collected from the First Affiliated Hospital of Zhejiang University school of Medicine, Tongji Hospital of Tongji Medical College of HUST, and National Institute of Viral Disease Control and Prevention of CDC to evaluate the positive coincidence rate, negative coincidence rate, total coincidence rate, the detection time and retest rate as well as the relation between positive intensity and positive coincidence rate of the five fast nucleic acid detection systems in November 2020. Results The positive coincidence rates of the five kits were 92.59% (50/54), 83.64% (46/55), 98.25% (56/57), 94.44% (51/54) and 98.18% (54/55);and the negative coincidence rates were 93.33% (14/15), 93.33% (14/15), 86.67% (13/15), 100% (14/14) and 93.33% (14/15);and the total coincidence rates were 92.75% (64/69), 85.71% (60/70), 95.83% (69/72), 94.20% (65/69) and 97.14% (68/70), respectively. The positive coincidence rate of the five kits reached 100% for the strong-positive (90/90) and medium-positive samples (84/84), but only 82.18% (83/101) for weak-positive samples (cycle threshold value>33), and the retest rate of two kits were 15.28% (11/72) and 12.50% (9/72), which were both higher than 10%. Total time from sample extraction to amplification was between 32.33-65.33 minutes for these five kits. Conclusion The five fast nucleic acid detection reagents have good performance and can be used as a supplement to routine nucleic acid detection reagents.
ABSTRACT
Objective This multicenter clinical evaluation analyzed the clinical performance of five fast nucleic acid detection systems for 2019-nCoV. Methods Clinical performance of the five fast nucleic acid detection reagents approved in China was evaluated in the present study. Fifty-seven throat swabs samples from COVID-19 patients and fifteen throat swabs samples from healthy people were collected from the First Affiliated Hospital of Zhejiang University school of Medicine, Tongji Hospital of Tongji Medical College of HUST, and National Institute of Viral Disease Control and Prevention of CDC to evaluate the positive coincidence rate, negative coincidence rate, total coincidence rate, the detection time and retest rate as well as the relation between positive intensity and positive coincidence rate of the five fast nucleic acid detection systems in November 2020. Results The positive coincidence rates of the five kits were 92.59% (50/54), 83.64% (46/55), 98.25% (56/57), 94.44% (51/54) and 98.18% (54/55);and the negative coincidence rates were 93.33% (14/15), 93.33% (14/15), 86.67% (13/15), 100% (14/14) and 93.33% (14/15);and the total coincidence rates were 92.75% (64/69), 85.71% (60/70), 95.83% (69/72), 94.20% (65/69) and 97.14% (68/70), respectively. The positive coincidence rate of the five kits reached 100% for the strong-positive (90/90) and medium-positive samples (84/84), but only 82.18% (83/101) for weak-positive samples (cycle threshold value>33), and the retest rate of two kits were 15.28% (11/72) and 12.50% (9/72), which were both higher than 10%. Total time from sample extraction to amplification was between 32.33-65.33 minutes for these five kits. Conclusion The five fast nucleic acid detection reagents have good performance and can be used as a supplement to routine nucleic acid detection reagents. © 2022 Chinese Journal of Laboratory Medicine. All rights reserved.
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The massive spread of the COVID-19 outbreak has widely disrupted business activities around the world. In such a context, more manufacturing enterprises have to turn to online sales to restore sales and workforce. However, the actual effects of above relationships are still unknown. The aim of this study is to analyze whether and how online sales affect sales and workforce recovery from COVID-19. Meanwhile, we deeply explore the mediating effect of cash flow adequacy and the moderating effect of firm size. Drawing from a cross-country survey with 2714 manufacturing enterprises during the COVID-19 pandemic and controlling for self-selection bias, we find an inverted U-shaped effect of online sales on sales and workforce recovery. Online sales also exert an inverted U-shaped effect on cash flow adequacy, whereas this effect is weaker for small and medium enterprises (SMEs). Furthermore, cash flow adequacy positively facilitates sales and workforce recovery, indicating the role of cash flow adequacy in partially mediating the relationship between online sales and recovery. In addition, we confirm that firm size moderates the indirect effect of online sales on sales and workforce recovery through cash flow adequacy. This study not only expands e-commerce and emergency management research domain and enriches the results of related research, but also provides management implications for the recovery of manufacturing enterprises from the perspective of online sales during the COVID-19 pandemic. © 2022, Kauno Technologijos Universitetas. All rights reserved.
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Traditional Chinese medicine (TCM) has been widely used to prevent and treat Coronavirus Disease 2019 (COVID-19). In the absence of any miracle drug or vaccine, TCM was applied to all stages of the COVID-19 prevention and treatment for the first time and played a significant role. In addition to the first-line clinical treatment for the COVID-19, TCM scholars have also carried out various types of clinical research to evaluate the efficacy and safety of TCM. However, the lack of high-quality research evidence has led to TCM not being included in the list of treatment options recommended by the World Health Organization (WHO), which makes it difficult to provide references for TCM treatment protocols for the prevention and treatment of the COVID-19 for other countries, which significantly limits its promotion and internationalization. Evidence-based medicine has been operative in the TCM research field for more than 20 years. How best to combine the methods of evidence-based medicine with the characteristics and advantages of TCM so that the effect of TCM can be "clarified and understood" has always been a big challenge. The emergence of COVID-19 has highlighted the importance of this issue. Based on the concept of evidence-based medicine, this paper has elicited the shortcomings of TCM clinical research and efficacy evaluation during the COVID-19, such as design flaws, replicated research, insufficient professional involvement and lack of information sharing. It discusses the strategies of TCM clinical research on new emergent diseases in the new era from the aspects of research design and implementation. It is worth emphasizing that in future research, we should pay attention to the individualized efficacy evaluation of TCM, introduce the design concept of the master protocol platform, strengthen the overall planning of clinical research resources, retain the involvement of professionals, and establish a data-sharing mechanism. It is necessary to promote the integration of evidence-based norms and TCM differentiation and treatment, provide new ideas for clinical efficacy evaluation of TCM, enhance the ability of TCM clinical evidence to support decision-making, promote the development of the TCM industry and present TCM to the world. At the same time, we suggest that in response to the challenge of emerging infectious diseases, we should strengthen the clinical research into integrated Traditional Chinese and Western medicine, quickly collect high-quality research evidence, formulate evidence-based emergency intervention protocols, and build a more scientifically coordinated Traditional Chinese and Western medicine treatment system. In the meantime, we need to pay attention to multi-disciplinary and multi-knowledge integration, combined with modern science and technology such as big data and artificial intelligence, build a new paradigm of clinical research into traditional Chinese medicine, and improve the level and efficiency of TCM clinical research. © 2022, Science Press. All right reserved.
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Background: To examine the outcomes heterogeneity of clinical trial protocols of coronavirus disease 2019 (COVID-19) to prioritize the establishment of a core outcome set. Methods: Databases of the International Committee of Medical Journal Editors - accepted clinical trial registry platforms were searched on February 14, 2020 and May 31, 2020. Randomized controlled trials and non-randomized controlled trials of COVID-19 were considered. Patient condition was classified as common, severe, or critical. Interventions included traditional Chinese medicine and Western medicine. We excluded trials that involved discharged patients, psychological intervention, and complications of COVID-19. The general information and outcomes, outcome measurement instruments, and measurement times were extracted. The results were analyzed by descriptive analysis. Results: In all, 19 registry platforms were searched. A total of 97 protocols were selected from among 160 protocols for the first search. For protocols of traditional Chinese medicine clinical trials, 76 outcomes from 16 outcome domains were reported, and almost half (34/76, 44.74%) of the outcomes were reported only once;the most frequently reported outcome was time taken for severe acute respiratory syndrome coronavirus 2 RNA to become negative. Twenty-seven (27/76, 35.53%) outcomes provided one or more outcome measurement instruments. Ten outcomes provided one or more measurement time frame. For protocols of Western medicine clinical trials, 126 outcomes from 17 outcome domains were reported;almost half (62/126, 49.21%) of the outcomes were reported only once;the most frequently reported outcome was proportion of patients with negative severe acute respiratory syndrome coronavirus 2. Twenty-seven outcomes provided one or more outcome measurement instruments. Forty (40/126, 31.75%) outcomes provided one or more measurement time frame. There were > 40 duplicated outcomes between the clinical trials protocols of traditional Chinese medicine and western medicine protocols. All of them were included in the Delphi survey when developing core outcome set for COVID-19. A total of 1,027 protocols were selected from 2,741 protocols for the second search. Forty-two new outcomes and 47 new outcome measurement instruments were reported. Conclusion: Outcome reporting in clinical trial protocols of COVID-19 is inconsistent. Thus, establishing a core outcome set is necessary for diagnosis and management.
ABSTRACT
The master protocol platform trial is a trial in which multiple treatments or different combinations of treatments are consistently evaluated in the context of a single disease, possibly within several sub-studies for different disease subtypes, allowing multiple treatments to enter or exit the trial platform based on a certain decision algorithm. Compared with the traditional clinical trial design, the master protocol platform trial as a scientific innovative model of clinical trial can accelerate drug evaluation to deal with the contradiction between the awaited evaluation of numerous drugs and lack of effective therapy for diseases. By using the large-scale randomized controlled clinical trial for COVID-19 inpatients (RECOVERY) led by the University of Oxford in the UK in 2020 as an illustration, this paper introduced the concept, design principle, and basic trial process of the master protocol platform trial to provide methodological references for clinical research of drugs. © 2021 West China University of Medical Science. All rights reserved.
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To prevent the spread of coronavirus disease 2019 (COVID-19), which emerged in late December 2019, the Chinese government immediately adopted lockdown measures, such as restricting traffic and closing factories. By analyzing the spatiotemporal distribution of the air quality index (AQI) values in Dongying, a city dominated by the petrochemical industry (specifically, petroleum exploration), during February 2020, when the strictest measures were in force, this study investigates the effect of short-term lockdowns on air quality. We observed a statistically significant reduction in the monthly average AQI—24.6%, or an absolute decrease of 25.4—compared to February 2019. Additionally, the difference between the maximum and the minimum hourly average AQI dropped to almost one-third of the value that in the normal time during winter. We also assessed the influence of meteorological factors and industrial exhaust emissions. Quantitative analysis revealed a strong positive correlation (p < 0.01) between the AQI and exhaust emissions, confirming the latter’s contribution to air pollution. However, this contribution shrunk by approximately 38.3% during February 2020. Our results indicate that the improvement in air quality was related to traffic reduction and enterprise closures during the lockdown, which only marginally affected the spatial distribution of the AQI values. This research serves as a reference for controlling air pollution in Dongying and areas with similar conditions. © The Author(s).
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Laboratory medicine has learnt a lot in response to COVID-19. This experience would be beneficial to the development of laboratory medicine.
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A large number of traditional Chinese medicine (TCM) prescriptions have played an active role in the prevention and treatment of emerging epidemic diseases, which contain huge potential of research and development (R&D). However, in recent years, few TCM new drugs have been approved for market and the industry is in a downturn. With examples of the recent drug review policies and the "three Chinese patent medicines and three TCM prescriptions" for Corona Virus Disease 2019 (COVID-19), this article proposed a series of strategies from the perspectives of review and R&D of TCM new drugs as well as resource allocation. The strategies are improving the R&D layout of TCM new drugs, clarifying the evaluation criteria of human experience evidence, supervising the syndrome indications for TCM new drugs other than diseases, implementing differentiation competitive strategy, applying multi-disciplinary methods in prescription screening, applying integrated research design, increasing investment in high-quality clinical research, and integrating resources to break through international barriers. © 2020, Chinese Journal of New Drugs Co. Ltd. All right reserved.
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Since December 2019 the Coronavirus Disease 2019 (COVID-19) has erupted in many places around the world, which is strong infectious and highly epidemic. After the outbreak of COVID-19 in China, traditional Chinese medicine (TCM) has been in the front line of the fight against the epidemic. It has shown characteristics and advantages in the prevention and treatment of COVID-19. TCM also played an important role in the winter of 2002 and in the spring of 2003 during the outbreak of severe acute respiratory syndrome (SARS). This article compares the strategies, programs, measures, resource investments, and effects of TCM for the prevention and treatment of COVID-19 with those for SARS. At present, the involvement of TCM has been earlier, faster, and more comprehensive in the fight against the epidemic and has shown good clinical efficacy and treatment prospects.