scholarly journals Key points of technical review for the registration of SARS-CoV-2 nucleic acid tests in China

Bioanalysis ◽  
2021 ◽  
Author(s):  
Hongran Li ◽  
Tong Jiao ◽  
Peirong Wang ◽  
Juanjuan An ◽  
Gang Deng ◽  
...  

In response to the outbreak of COVID-19, in accordance with the principles of ‘unified command, early involvement, prompt review and scientific approval’ as well as the requirements of ensuring product safety, effectiveness and controllable quality, the Center for Medical Device Evaluation (CMDE) has issued Key Points of Technical Review for the Registration of SARS-CoV-2 Nucleic Acid Tests ( Key Points) to provide the requirements of tests. Because of the sustainability of the pandemic, more efforts and attempts are needed for SARS-CoV-2 detection and control. This article interprets the Key Points issued by the CMDE and provides certain refinements to wider audiences.

Author(s):  
Yanfei He ◽  
Yu-Chao Dong

ABSTRACT Objectives: There have been reports on re-detectable positive nucleic acid tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in recovered coronavirus disease (COVID-19) patients. In this study, we look at the clinical characteristics, possible causes, pathogenesis, and infectivity of re-detectable positive patients and provide up-to-date information to public health policy planners and clinicians. Methods: By consulting the latest research data and related progress data of re-detectable positive patients, this study addresses the implications that this special group brings to clinical work and disease prevention and control. Results: We discuss in detail the phenomenon of re-detectable positive nucleic acid tests for recovered patients. There are many possible causes of a re-detectable positive, but there is no 1 factor that can fully explain this phenomenon. Conclusions: It can’t be completely ruled out that the re-detectable positive patients are infectious. We should be alert to these re-detectable positive patients becoming chronic virus carriers, and virus serological IgM and IgG antibody tests should be added before patient discharge. It is urgent to find a more powerful evidence-based and virological basis for the integrity of viral ribonucleic acid and the variation of viral virulence with time through cell experiments in vitro and animal experiments in vivo.


The Analyst ◽  
2021 ◽  
Author(s):  
Shasha Li ◽  
Hongmin Meng ◽  
Hong Zong ◽  
Juan Chen ◽  
Jianjun Li ◽  
...  

Accurate, sensitive and rapid nucleic acid tests are important to implement timely treatment measures and control the spread of disease. In this work, we developed a novel portable platform for...


Bioanalysis ◽  
2021 ◽  
Author(s):  
Hongran Li ◽  
Jingyun He ◽  
Wen Bao ◽  
Peirong Wang ◽  
Yunfeng Lv ◽  
...  

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.


2020 ◽  
Vol 7 ◽  
Author(s):  
Xi-Min Qiao ◽  
Xiao-Feng Xu ◽  
Hao Zi ◽  
Guo-Xiong Liu ◽  
Bing-Hui Li ◽  
...  

2021 ◽  
Vol 30 ◽  
pp. 096368972098545
Author(s):  
Tao Hu ◽  
Xiao Liu ◽  
Qinan Yin ◽  
Xingting Duan ◽  
Li Yan

In this work, we discovered a new phenomenon—asymptomatic COVID-19 infection, or covert case, during the pandemic. All the 3 patients had a history of exposure, with no symptoms, and no abnormalities were found in computed tomography scan or lab tests. Except for case 2, the other patients’ severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) nucleic acid tests were negative. But their anti-SARS-COV-2 nucleocapsid antibody showed a dynamic trend, consistent with the process of virus infection and clearance. A growing number of asymptomatic or covert cases need more attention. Lack of surveillance may lead to another outbreak. We hope to demonstrate our cases to attract the attention of governments or health authorities that covert cases should be the focus as well.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Georgios Chondrogiannis ◽  
Shirin Khaliliazar ◽  
Anna Toldrà ◽  
Pedro Réu ◽  
Mahiar M. Hamedi

AbstractEnzymes are the cornerstone of modern biotechnology. Achromopeptidase (ACP) is a well-known enzyme that hydrolyzes a number of proteins, notably proteins on the surface of Gram-positive bacteria. It is therefore used for sample preparation in nucleic acid tests. However, ACP inhibits DNA amplification which makes its integration difficult. Heat is commonly used to inactivate ACP, but it can be challenging to integrate heating into point-of-care devices. Here, we use recombinase polymerase amplification (RPA) together with ACP, and show that when ACP is immobilized on nitrocellulose paper, it retains its enzymatic function and can easily and rapidly be activated using agitation. The nitrocellulose-bound ACP does, however, not leak into the solution, preventing the need for deactivation through heat or by other means. Nitrocellulose-bound ACP thus opens new possibilities for paper-based Point-of-Care (POC) devices.


2021 ◽  
Vol 6 (2) ◽  
Author(s):  
Dipti Chavan ◽  
Aniket Kamble ◽  
Aditya Khadsare ◽  
Vaibhav Chougule ◽  
Vaibhav Chougule

Electronics and communication is the most important field. In this paper, we can describe how much safety is in the Automobile industry. In this paper, we are using uno-Arduino. The different types of sensors facilities are also provided using key points. The different sensors are provided to check visitor count. In this system, we can monitor and control all the safety precautions their one IoT web platform. This helps in the proper utilization of drivers and helps in avoiding accidents. This paper can be implemented in any two-wheelers, heavily loaded trucks, small SUVs, compact cars. In our paper, the electronics machine/components will be automatically working with using of Arduino program. The proposed wireless sensor platform is an attempt to develop more safety devices that can be used in multiple areas such as homes, schools, and public utilities to reduce accidents. This Advanced Driver Assists system will provide real-time accident detections and monitoring usage information that helps in real-time by using GSM, GPS, and sensors.


Author(s):  
Ariella Meltzer ◽  
Helen Dickinson ◽  
Eleanor Malbon ◽  
Gemma Carey

Background: Many countries use market forces to drive reform across disability supports and services. Over the last few decades, many countries have individualised budgets and devolved these to people with disability, so that they can purchase their own choice of supports from an available market of services.Key points for discussion: Such individualised, market-based schemes aim to extend choice and control to people with disability, but this is only achievable if the market operates effectively. Market stewardship has therefore become an important function of government in guiding markets and ensuring they operate effectively.The type of evidence that governments tend to draw on in market stewardship is typically limited to inputs and outputs and has less insight into the outcomes services do or do not achieve. While this is a typical approach to market stewardship, we argue it is problematic and that a greater focus on outcomes is necessary.Conclusions and implications: To include a focus on outcomes, we argue that market stewards need to take account of the lived experience of people with disability. We present a framework for doing this, drawing on precedents where people with disability have contributed lived experience evidence within other policy, research, knowledge production and advocacy contexts.With the lived experience evidence of people with disability included, market stewardship will be better able to take account of outcomes as they play out in the lives of those using the market and, ultimately, achieve greater choice and control for people with disability.<br />Key messages<br /><ul><li>Market stewardship is key to guiding quasi-markets, including in the disability sector;</li><br /><li>Evidence guiding market stewardship is often about inputs and outputs only;</li><br /><li>It would be beneficial to also include lived experience evidence from people with disability;</li><br /><li>We propose a framework for the inclusion of lived experience evidence in market stewardship.</li></ul>


2018 ◽  
Vol 50 (8) ◽  
pp. 2489-2492
Author(s):  
Y.-L. Chang ◽  
Y.-T. Cheng ◽  
T.-C. Chen ◽  
Y.-S. Chien ◽  
W.-C. Lee ◽  
...  

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