These COVID-19 tests fall into three main categories: PCR, antigen and antibody. Dr. Aneesh Mehta, chief of infectious diseases services at Emory University Hospital in Atlanta, Ga., broke down the differences between them—and what to keep in mind if you decide to get tested.

PCR tests

The majority of COVID-19 testing happening in the U.S. right now uses polymerase chain reaction (PCR) technology. These tests detect disease by looking for traces of the virus’ genetic material on a sample most often collected via a nose or throat swab. The U.S. Centers for Disease Control and Prevention (CDC) considers PCR tests the “gold standard” of COVID-19 testing, but, like all tests, they’re not perfect. Studies have suggested as many as 30% of COVID-19 PCR test results are inaccurate. (For comparison, the CDC in 2018 estimated that rapid flu tests have about the same rate of incorrect results.)

With COVID-19 tests, false negatives seem to be much more common than false positives—so if you get a positive result, you very likely do have the virus. If you get a negative result but have coronavirus symptoms or recently encountered someone sick with the virus, you should still self-isolate until symptoms subside…

Read More

Font: BY JAMIE DUCHARME  AUGUST 20, 2020 8:00 AM EDT

• AstraZeneca dismisses reports it is in talks with the US government over a potential Emergency Use Authorisation for its COVID-19 vaccine, AZD1222. AstraZeneca “has not discussed emergency use authorization with the US government and it would be premature to speculate on that possibility,” the company says in a statement.

24 August:

• Moderna says it has concluded advanced exploratory talks with the European Commission to supply 80 million doses of its COIVD-19 vaccine candidate, mRNA-1273. The potential purchase agreement provides for an option for Member States to purchase an additional 80 million doses for a total of up to 160 million doses. The Phase 3 study of mRNA-1273 began on July 27 and enrollment of approximately 30,000 participants is on track to complete in September. Moderna is scaling up global manufacturing to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021.

• Catalent Cell & Gene Therapy says it will provide drug substance manufacturing to AstraZeneca for the University of Oxford’s adenovirus vector-based COVID-19 vaccine, AZD1222, at Catalent’s commercial gene therapy manufacturing facility located in Harmans, Maryland. Catalent will prepare the facility to enable multiple production trains to run in parallel to produce the vaccine candidate drug substance starting late in the third quarter of 2020. The agreement expands on Catalent’s previous agreement with AZ that its facility in Anagni, Italy, will provide large-scale vial filling and packaging of AZD1222.

23 August:

• The US Food and Drug Administration issues an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients. The agency says that “based on scientific evidence available, …this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.” The EUA authorizes the distribution of COVID-19 convalescent plasma in the US and its administration by health care providers to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19…

Read More

Font: https://www.globalpharmainsights.com/

FDA has issued guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency.

The guidance provides recommendations on the following:

• pathways for use of investigational COVID-19 convalescent plasma
• patient eligibility
• collection of COVID-19 convalescent plasma, including donor eligibility and donor qualifications
• labeling, and
• record keeping

Because COVID-19 convalescent plasma has not yet been approved for use by FDA, it is regulated as an investigational product.  A health care provider must participate in one of the pathways described below.  FDA does not collect COVID-19 convalescent plasma or provide COVID-19 convalescent plasma.  Health care providers or acute care facilities should instead obtain COVID-19 convalescent plasma from an FDA-registered blood establishment.

Excerpts from the guidance document are provided below. 

Background

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States (U.S.) from threats including emerging infectious diseases, such as the Coronavirus Disease 2019 (COVID-19) pandemic.  FDA is committed to providing timely guidance to support response efforts to this pandemic.

One investigational treatment being explored for COVID-19 is the use of convalescent plasma collected from individuals who have recovered from COVID-19.  Convalescent plasma that contains antibodies to severe acute respiratory syndrome coronavirus 2 or SARS-CoV-2 (the virus that causes COVID-19) is being studied for administration to patients with COVID-19. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic.

Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19. Therefore, it is important to study the safety and efficacy of COVID-19 convalescent plasma in clinical trials…

Read More

Font: https://www.fda.gov/

On January 30, 2020, the WHO declared the COVID-19 outbreak a public health emergency of international concern and, in March 2020, began to characterize it as a pandemic in order to emphasize the gravity of the situation and urge all countries to take action in detecting infection and preventing spread. Unfortunately, there is no medication that has been approved by the FDA, gone through controlled studies and demonstrated an effect on the virus for this global pandemic. Although there are cures for illnesses and developments made by leaps and bounds in our day, the strongest and most effective weapon that society has against this virus that is affecting not just health but also economics, politics, and social order, is the prevention of its spread. The main points in preventing the spread in society are hand hygiene, social distancing and quarantine. With increased testing capacity, detecting more COVID-19 positive patients in the community will also enable the reduction of secondary cases with stricter quarantine rules.Keywords: COVID-19, Turkey, prevention, quarantine, social distancing, community

1. Introduction

In late 2019, a novel coronavirus, now designated SARS-CoV-2, was identified as the cause of an outbreak of acute respiratory illness in Wuhan, a city in the Hubei province of China. In February 2020, the World Health Organization (WHO) designated the disease COVID-19, which stands for coronavirus disease 2019. The clinical presentation of 2019-nCoV infection ranges from asymptomatic to very severe pneumonia with acute respiratory distress syndrome, septic shock and multi-organ failure, which may result in death [1]. On January 30, 2020, the WHO declared the COVID-19 outbreak a public health emergency of international concern and, in March 2020, began to characterize it as a pandemic in order to emphasize the gravity of the situation and urge all countries to take action in detecting infection and preventing spread.

The virus that causes COVID-19 is thought to spread mainly from person to person, mainly through respiratory droplets produced when an infected person coughs or sneezes. These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs. Other routes have also been implicated in the transmission of coronaviruses, such as contact with contaminated fomites and inhalation of aerosols, produced during aerosol generating procedures. Transmission of SARS-CoV-2 from asymptomatic individuals (or individuals within the incubation period) has also been described. However, the extent to which this occurs remains unknown [2]…

Read More

Font: Articles from Turkish Journal of Medical Sciences are provided here courtesy of The Scientific and Technological Research Council of Turkey