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

Bioanalysis ◽  
2021 ◽  
Author(s):  
Hongran Li ◽  
Jingyun He ◽  
Wen Bao ◽  
Peirong Wang ◽  
Yunfeng Lv ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Medical Device ◽  
Current Understanding ◽  
The Novel ◽  
Medical Products ◽  
Technical Review ◽  
Key Points ◽  
The World ◽  
Antigen Antibody ◽  
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.

scholarly journals Emerging pandemic COVID-19: myths and facts

2020 ◽  
Vol 6 (7) ◽  
pp. 283
Author(s):  
Rohit Vadala ◽  
Isabella Princess
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Clinical Presentation ◽  
Surface Protein ◽  
Respiratory Viruses ◽  
The Novel ◽  
Nucleocapsid Proteins ◽  
The World ◽  
The Common ◽  
Human Infections ◽  
Relationship Of

<p>The first theory which has established itself across the world is that COVID-19 is a “new virus”. It is rather wise to call it a “new strain” of a pre-existing coronavirus since history clearly denotes cases of coronavirus surfacing the world in past years beginning as early as mid-1960s.Including this novel strain of the virus, seven strains of coronaviruses have been commonly associated with human infections. Coronaviruses are primarily respiratory viruses causing infections ranging from mild to severe involvement of the respiratory tract. The common cold strains of coronavirus are 229E alpha coronavirus, NL63 alpha coronavirus, OC43 beta coronavirus and HKU1 beta coronavirus.The acute respiratory distress causing strains are severe acute respiratory syndrome (SARS) beta CoV causing SARS, MERS beta CoV causing Middle East respiratory syndrome (MERS) and the very novel COVID-19. Researchers and molecular biologists have confirmed phylogenetic relationship of COVID-19 with a 2015 Chinese bat strain of SARS CoV.<sup> </sup>Mutations to the surface protein as well as nucleocapsid proteins were demonstrated. These two mutations predicts the characteristics such as higher ability to infect as well as enhanced pathogenicity of COVID-19 as compared to older SARS strain. For this reason and with similarities in clinical presentation the novel strain has been named as SARS-CoV-2.</p>

scholarly journals Does the novel coronavirus 2019 like heart more than the other family members of coronaviruses?

2020 ◽  
Vol 12 (2) ◽  
pp. 156-157
Author(s):  
Mohammad Mostafa Ansari Ramandi ◽  
Mohammadreza Baay ◽  
Nasim Naderi
Keyword(s):  
Middle East ◽  
Severe Acute Respiratory Syndrome ◽  
Family Members ◽  
Middle East Respiratory Syndrome ◽  
The Other ◽  
The Novel ◽  
The World ◽  
Future Challenges ◽  
Novel Coronavirus ◽  
Coronavirus Infections

The disaster due to the novel coronavirus disease 2019 (COVID-19) around the world has made investigators enthusiastic about working on different aspects of COVID-19. However, although the pandemic of COVID-19 has not yet ended, it seems that COVID-19 compared to the other coronavirus infections (the Middle East Respiratory Syndrome [MERS] and Severe Acute Respiratory Syndrome [SARS]) is more likely to target the heart. Comparing the previous presentations of the coronavirus family and the recent cardiovascular manifestations of COVID-19 can also help in predicting possible future challenges and taking measures to tackle these issues.

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 ◽  
...  
Keyword(s):  
Nucleic Acid ◽  
Medical Device ◽  
Product Safety ◽  
Technical Review ◽  
Key Points ◽  
Safety Effectiveness ◽  
Unified Command ◽  
And Control ◽  
Nucleic Acid Tests

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.

Tri-primer-enhanced strand exchange amplification combined with rapid lateral flow fluorescent immunoassay to detect SARS-CoV-2

The Analyst ◽  
2021 ◽  
Author(s):  
Linlin Zhuang ◽  
Jiansen Gong ◽  
Ming Ma ◽  
Yongxin Ji ◽  
Peilong Tian ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Lateral Flow ◽  
Strand Exchange ◽  
The Novel ◽  
The World ◽  
Novel Coronavirus

The novel coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been surging rapidly around the world, which exposes humanity to unprecedented economic, social and...

scholarly journals SARS-CoV-2: Structure, Biology, and Structure-Based Therapeutics Development

2020 ◽  
Vol 10 ◽  
Author(s):  
Mei-Yue Wang ◽  
Rong Zhao ◽  
Li-Juan Gao ◽  
Xue-Fei Gao ◽  
De-Ping Wang ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Protein Structures ◽  
The Novel ◽  
Recognition Mechanism ◽  
Antiviral Compounds ◽  
The World ◽  
Receptor Recognition ◽  
Epidemiological Characteristics ◽  
Therapeutics Development

The pandemic of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been posing great threats to the world in many aspects. Effective therapeutic and preventive approaches including drugs and vaccines are still unavailable although they are in development. Comprehensive understandings on the life logic of SARS-CoV-2 and the interaction of the virus with hosts are fundamentally important in the fight against SARS-CoV-2. In this review, we briefly summarized the current advances in SARS-CoV-2 research, including the epidemic situation and epidemiological characteristics of the caused disease COVID-19. We further discussed the biology of SARS-CoV-2, including the origin, evolution, and receptor recognition mechanism of SARS-CoV-2. And particularly, we introduced the protein structures of SARS-CoV-2 and structure-based therapeutics development including antibodies, antiviral compounds, and vaccines, and indicated the limitations and perspectives of SARS-CoV-2 research. We wish the information provided by this review may be helpful to the global battle against SARS-CoV-2 infection.

scholarly journals Optimization of the CDC Protocol of Molecular Diagnosis of COVID-19 for Timely Diagnosis

Diagnostics ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. 333 ◽  
Author(s):  
Chao-Ju Chen ◽  
Li-Ling Hsieh ◽  
Shu-Kai Lin ◽  
Chu-Feng Wang ◽  
Yi-Hui Huang ◽  
...  
Keyword(s):  
Public Health ◽  
Infectious Disease ◽  
Severe Acute Respiratory Syndrome ◽  
Reverse Transcriptase ◽  
Gold Standard ◽  
Health Needs ◽  
The Novel ◽  
Assay Optimization ◽  
The World ◽  
Polymerase Chain

Coronavirus disease 2019 (COVID-19), the current uncontrolled outbreak of infectious disease, has caused significant challenges throughout the world. A reliable rapid diagnostic test for COVID-19 is demanded worldwide. The real-time reverse transcriptase polymerase chain was one of the most quickly established methods in the novel viral pandemic and was considered as the gold standard for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In this report, we illustrate our experience of applying a protocol from the Taiwan CDC and achieving assay optimization in the immediate circumstances to meet the urgent medical and public health needs.

scholarly journals Coronavirus Pandemic: a major public health crisis for the developed and developing world

2021 ◽  
Vol 15 (03) ◽  
pp. 366-369
Author(s):  
Rooh Ullah ◽  
Muhammad Suleman Rana ◽  
Mehmood Qadir ◽  
Muhammad Usman ◽  
Niaz Ahmed
Keyword(s):  
Public Health ◽  
Severe Acute Respiratory Syndrome ◽  
Viral Infection ◽  
The Novel ◽  
Global Public Health ◽  
Health Crisis ◽  
Public Health Crisis ◽  
The World ◽  
Novel Coronavirus ◽  
Day By Day

Pandemic of novel Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infections in China is now become global public health crisis. At present 87.64% of the world is infected by this deadly illness. The risk from this epidemic depends on the nature of the virus, including how well it transmits from person to person, and the complications resulting from this current illness. The novel coronavirus has killed thousands of people in China and other countries as well; its rate of mortality is increasing day by day. There is an urgent need to control the virus by developing vaccine or any other antiviral drugs to save the world from this deadly viral infection.

scholarly journals How to Face COVID-19 in Ophthalmology Practice

2020 ◽  
Vol 9 (3) ◽  
pp. 164-171 ◽  
Author(s):  
Xiaoting Pei ◽  
Xinwei Jiao ◽  
Dingli Lu ◽  
Di Qi ◽  
Shenzhen Huang ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Severe Acute Respiratory Syndrome ◽  
Search Strategy ◽  
International Community ◽  
The Novel ◽  
The World ◽  
Novel Coronavirus

Background: The novel coronavirus pneumonia has attracted considerable attention from the international community. With the spread of outbreaks around the world, the WHO characterized COVID-19 as a pandemic. Methods: Relevant studies in PubMed were searched from January 1, 2020 to April 12, 2020, using the following search strategy: (“novel coronavirus pneumonia” OR “severe acute respiratory syndrome coronavirus 2” OR “coronavirus disease 2019” OR “COVID-19” OR “novel coronavirus pneumonia”) AND (“ophthalmology” OR “ophthalmologist” OR “eye” OR “conjunctiva” OR “conjunctivitis” OR “corneal” OR “keratitis”). Results: SARS-CoV-2 can spread through aerosol and is detected in tears of patients with COVID-19 infection. Notably, some infected patients had conjunctivitis, and conjunctivitis was the first symptom in some patients later diagnosed to have COVID-19 infection. This would increase the risk for ophthalmologists through inpatient consultations or regular clinical practice. When dealing with seemingly regular ophthalmic patients, the vigilance of ophthalmologists and associated staff tends to be reduced. Conclusion: Ophthalmologists must continuously update their knowledge regarding COVID-19 and take effective measures to prevent COVID-19 transmission.

scholarly journals Genomic epidemiology of the first epidemic wave of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Palestine

2021 ◽  
Vol 7 (6) ◽  
Author(s):  
Nouar Qutob ◽  
Zaidoun Salah ◽  
Damien Richard ◽  
Hisham Darwish ◽  
Husam Sallam ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
The Novel ◽  
Public Health Burden ◽  
Genomic Epidemiology ◽  
Health Burden ◽  
The World ◽  
Significant Public Health ◽  
Novel Coronavirus ◽  
The Uk ◽  
Epidemic Wave

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel coronavirus responsible for the COVID-19 pandemic, continues to cause a significant public-health burden and disruption globally. Genomic epidemiology approaches point to most countries in the world having experienced many independent introductions of SARS-CoV-2 during the early stages of the pandemic. However, this situation may change with local lockdown policies and restrictions on travel, leading to the emergence of more geographically structured viral populations and lineages transmitting locally. Here, we report the first SARS-CoV-2 genomes from Palestine sampled from early March 2020, when the first cases were observed, through to August of 2020. SARS-CoV-2 genomes from Palestine fall across the diversity of the global phylogeny, consistent with at least nine independent introductions into the region. We identify one locally predominant lineage in circulation represented by 50 Palestinian SARS-CoV-2, grouping with genomes generated from Israel and the UK. We estimate the age of introduction of this lineage to 05/02/2020 (16/01/2020–19/02/2020), suggesting SARS-CoV-2 was already in circulation in Palestine predating its first detection in Bethlehem in early March. Our work highlights the value of ongoing genomic surveillance and monitoring to reconstruct the epidemiology of COVID-19 at both local and global scales.

scholarly journals Alternate primers for whole-genome SARS-CoV-2 sequencing

2021 ◽  
Author(s):  
Matthew Cotten ◽  
Dan Lule Bugembe ◽  
Pontiano Kaleebu ◽  
My V T Phan
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Information Content ◽  
Genome Sequence ◽  
Virus Genome ◽  
Control Measures ◽  
Effective Control ◽  
Whole Genome ◽  
The Novel ◽  
Essential Information ◽  
The World

Abstract As the world is struggling to control the novel Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), there is an urgency to develop effective control measures. Essential information is encoded in the virus genome sequence with accurate and complete SARS-CoV-2 sequences essential for tracking the movement and evolution of the virus and for guiding efforts to develop vaccines and antiviral drugs. While there is unprecedented SARS-CoV-2 sequencing efforts globally, approximately 19 to 43% of the genomes generated monthly are gapped, reducing their information content. The current study documents the genome gap frequencies and their positions in the currently available data and provides an alternative primer set and a sequencing scheme to help improve the quality and coverage of the genomes.

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