![]() Sinovac Wuhan Institute of Biological Products (Sinopharm) MRNA-1273, Phase I, Moderna Pharmaceuticals, NCT04283461 INO-4800, Phase I, Inovio Pharmaceuticals, NCT04336410ĬureVac Stermina Therapeutics, Tongji University, and Chinese Center for Disease Control and Prevention Imperial College London ![]() (11)Ĭlinical candidate, phase, company, and clinical trialĪpplied DNA Sciences, Takis Biotech, and EvviVax Zydus Cadila The FDA has now authorized the first molecular test that uses saliva (instead of nose or throat swabs), which is being developed by Rutgers RUCDR Infinite Biologics. (10) This particular test utilizes isothermal nucleic acid amplification for qualitative detection of SARS-CoV-2 viral RNA collected by the same means as above. Most recently, the same company has developed an even faster test called ID NOW COVID-19, which cuts the processing time from hours to as little as 5 min for a positive result and 13 min for a negative result. Results from these tests, which require in-house clinical amplification and detection machines, can take 4–6 h for a result. (8) One of the first tests to get approved by the FDA was the Abbott RealTime SARS-CoV-2 Assay, (9) which is a real-time RT-qPCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 collected from either nasal, nasopharyngeal (NP), or oropharungeal (OP) swabs. (6a) The majority of NAATs focus on detecting SARS-CoV-2 viral RNA through quantitative reverse-transcriptase polymerase chain reaction (RT-qPCR) tests. suggest that 52 people per thousand have been tested for COVID-19 as of May 30, 2020, a number that continues to grow daily as more people are tested. According to the Foundation for Innovative New Diagnostics (FIND), there are over 590 diagnostics, either developed or under development, for SARS-CoV-2 worldwide. (5)Īt the time of writing, 22 companies have been issued authorization by the FDA to distribute NAATs, and >50 additional companies have notified the FDA that they will be submitting authorization requests. It is primarily spread between humans through small droplets from the nose or mouth when an infected person coughs or sneezes. Epidemiological studies have shown that each infection can result in 1.4–3.9 new cases when no one is immune or preventative measures such as social distancing have not been undertaken. Viral RNA synthesis is then achieved using RNA-dependent RNA polymerase. Viral polyproteins are then synthesized that encode for the replicase–transcriptase complex. The host cellular protease transmembrane protease serine 2 (TMPRSS2) helps cell entry via the S protein. (4) Upon receptor binding, the virus particle uses host cell receptors and endosomes to enter cells. SARS-CoV-2 is an enveloped, positive-sense, single-stranded RNA β-coronavirus that targets cells through the viral structural spike (S) protein that binds to angiotensin-converting enzyme 2 (ACE2). The novel coronavirus is a previously unidentified strain of coronavirus named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (3) by the World Health Organization (WHO), and the resulting coronavirus disease 2019 (COVID-19) has become an ongoing global pandemic since its initial detection in Wuhan, China, in December 2019.
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