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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the strain of coronavirus that causes coronavirus disease 2019 (COVID-19), the respiratory illness responsible for the COVID-19 pandemic. Colloquially known as simply the coronavirus, it was previously referred to by its provisional name, 2019 novel coronavirus (2019-nCoV), and has also been called human coronavirus 2019 (HCoV-19 or hCoV-19). The World Health Organization declared the outbreak a Public Health Emergency of International Concern on 30 January 2020, and a pandemic on 11 March 2020.
SARS-CoV-2 is a positive-sense single-stranded RNA virus that is contagious in humans. As described by the U.S. National Institutes of Health, it is the successor to SARS-CoV-1, the strain that caused the 2002–2004 SARS outbreak.
Taxonomically, SARS-CoV-2 is a strain of severe acute respiratory syndrome-related coronavirus (SARSr-CoV). It is believed to have zoonotic origins and has close genetic similarity to bat coronaviruses, suggesting it emerged from a bat-borne virus. There is no evidence yet to link an intermediate animal reservoir, such as a pangolin, to its introduction to humans. The virus shows little genetic diversity, indicating that the spillover event introducing SARS-CoV-2 to humans is likely to have occurred in late 2019. On 3 July 2020, scientists reported finding that a major genetic risk factor of the Covid-19 virus was inherited from archaic Neanderthals 60,000 years ago.
Epidemiological studies estimate each infection results in 1.4 to 3.9 new ones when no members of the community are immune and no preventive measures taken. The virus primarily spreads between people through close contact and via respiratory droplets produced from coughs or sneezes. It mainly enters human cells by binding to the receptor angiotensin converting enzyme 2 (ACE2).
FAQs on Testing for SARS-CoV-2
MORE INFO available on the FDA.gov website:
https://www.fda.gov/medical-devices/...ing-sars-cov-2
Serology/Antibody Test FAQs
Q: Are antibody, or serology, tests used to diagnose SARS-CoV-2 infection? (Updated 5/4)
Q: If antibody tests are not used for diagnosis or exclusion of COVID-19 infection, what is their purpose? (Updated 5/4)
Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA. Does FDA expect my SARS-CoV-2 antibody test to have an EUA if I offer it in the United States? (Updated 5/4)
Q: I am a commercial manufacturer. Does FDA expect my SARS-CoV-2 antibody test kit to have an EUA if I distribute it in the United States? (Updated 5/4)
Q: I am developing a SARS-CoV-2 antibody test and want to pursue an EUA. Do I need to have all of my validation and documentation completed and submitted in an EUA request to FDA before engaging with the FDA? (Updated 5/4)
Q: I am developing a SARS-CoV-2 antibody test and want to pursue an EUA. What is FDA's policy if my validation is complete, and I notify FDA and begin offering my test for patient testing while I prepare and submit an EUA? (Updated 5/4)
Q: I am developing a SARS-CoV-2 antibody test and preparing to submit an EUA request. Is there an EUA template for SARS-CoV-2 antibody tests? (Updated 5/11)
Q: What are the current validation study recommendations for a new SARS-CoV-2 antibody assay? (Updated 5/11)?
Q: I have developed a serology test kit for SARS-CoV-2 antibodies. Is there an opportunity to have my serology test independently validated? Can I use this for an EUA request? (Updated 5/4)
Q: If I send my tests to NCI for evaluation, can I use the data they collect to support an EUA request? (Updated 5/5)
Q: How is FDA using NCI validation data for SARS-CoV-2 serology (antibody) tests? (New 5/30)
Other Common Questions
How is the presence of COVID-19 detected in testings?
Who should get an antibody test for COVID-19?
Which are the first symptoms of the coronavirus disease?
How long does it take for symptoms of the coronavirus disease to appear?
Is headache a symptom of the coronavirus disease?
What should I do if I test positive for the coronavirus disease?
Can I breastfeed my child if I am severely ill with coronavirus disease?
What happens when you get the coronavirus disease?
Does drinking lots of water help flush out COVID-19?
How long do COVID-19 patients need to be isolated for?
Should coronavirus disease patients be isolated in hospitals?
Will I get more severe symptoms of COVID-19 if I drink alcohol?
At what point are COVID-19 patients most infective?
Who is more likely to get seriously ill from the coronavirus disease?
Can the coronavirus disease spread through feces?
Can the coronavirus disease spread through food?
Is there asymptomatic transmission of the coronavirus disease?
Is the coronavirus disease more severe than the flu?
Should I wear a mask during the coronavirus disease pandemic?
How to prevent coronavirus disease infection?
What is the usual body temperature in coronavirus disease patients?
Is temperature screening effective to detect the coronavirus disease?
Can the coronavirus disease be transmitted in hot or humid climates?
How sensitive are the rapid diagnostic tests for coronavirus disease?
How could smoking affect COVID-19?
What are the different levels of coronavirus disease transmission?
What is a safe distance from others to protect against the coronavirus disease?
How is the transmission of COVID-19 in children different from flu?
How dangerous is COVID-19?
What percentage of patients with COVID-19 need to be hospitalized?
Can COVID-19 be fatal?
What are the dangers of smoking my waterpipe during the coronavirus disease pandemic?
Can the coronavirus disease be contracted by eating frozen foods and ice-cream?
Do people develop immunity to the coronavirus disease after being infected?
What is asymptomatic case of COVID-19?
Are the elderly more vulnerable to the coronavirus disease?
What are signs and symptoms of the coronavirus disease?
Can smoking waterpipes spread the coronavirus disease?
SARS-CoV-2 is a positive-sense single-stranded RNA virus that is contagious in humans. As described by the U.S. National Institutes of Health, it is the successor to SARS-CoV-1, the strain that caused the 2002–2004 SARS outbreak.
Taxonomically, SARS-CoV-2 is a strain of severe acute respiratory syndrome-related coronavirus (SARSr-CoV). It is believed to have zoonotic origins and has close genetic similarity to bat coronaviruses, suggesting it emerged from a bat-borne virus. There is no evidence yet to link an intermediate animal reservoir, such as a pangolin, to its introduction to humans. The virus shows little genetic diversity, indicating that the spillover event introducing SARS-CoV-2 to humans is likely to have occurred in late 2019. On 3 July 2020, scientists reported finding that a major genetic risk factor of the Covid-19 virus was inherited from archaic Neanderthals 60,000 years ago.
Epidemiological studies estimate each infection results in 1.4 to 3.9 new ones when no members of the community are immune and no preventive measures taken. The virus primarily spreads between people through close contact and via respiratory droplets produced from coughs or sneezes. It mainly enters human cells by binding to the receptor angiotensin converting enzyme 2 (ACE2).
FAQs on Testing for SARS-CoV-2
- What Laboratories and Manufacturers are Offering Tests for COVID-19?
- What Tests Should No Longer Be Distributed for COVID-19?
- General FAQs
- What If I Do Not Have...?
- 3D Printed Swab FAQs
- Test Validation FAQs
- COVID-19 Related Test Data and Reporting FAQs
- Clinical Laboratory Diagnostic Test FAQs
- Test Kit Manufacturer Diagnostic Test FAQs
- Serology/Antibody Test FAQs
MORE INFO available on the FDA.gov website:
https://www.fda.gov/medical-devices/...ing-sars-cov-2
Serology/Antibody Test FAQs
Q: Are antibody, or serology, tests used to diagnose SARS-CoV-2 infection? (Updated 5/4)
Q: If antibody tests are not used for diagnosis or exclusion of COVID-19 infection, what is their purpose? (Updated 5/4)
Q: I am a clinical laboratory certified to perform high-complexity testing under CLIA. Does FDA expect my SARS-CoV-2 antibody test to have an EUA if I offer it in the United States? (Updated 5/4)
Q: I am a commercial manufacturer. Does FDA expect my SARS-CoV-2 antibody test kit to have an EUA if I distribute it in the United States? (Updated 5/4)
Q: I am developing a SARS-CoV-2 antibody test and want to pursue an EUA. Do I need to have all of my validation and documentation completed and submitted in an EUA request to FDA before engaging with the FDA? (Updated 5/4)
Q: I am developing a SARS-CoV-2 antibody test and want to pursue an EUA. What is FDA's policy if my validation is complete, and I notify FDA and begin offering my test for patient testing while I prepare and submit an EUA? (Updated 5/4)
Q: I am developing a SARS-CoV-2 antibody test and preparing to submit an EUA request. Is there an EUA template for SARS-CoV-2 antibody tests? (Updated 5/11)
Q: What are the current validation study recommendations for a new SARS-CoV-2 antibody assay? (Updated 5/11)?
Q: I have developed a serology test kit for SARS-CoV-2 antibodies. Is there an opportunity to have my serology test independently validated? Can I use this for an EUA request? (Updated 5/4)
Q: If I send my tests to NCI for evaluation, can I use the data they collect to support an EUA request? (Updated 5/5)
Q: How is FDA using NCI validation data for SARS-CoV-2 serology (antibody) tests? (New 5/30)
Other Common Questions
How is the presence of COVID-19 detected in testings?
Who should get an antibody test for COVID-19?
Which are the first symptoms of the coronavirus disease?
How long does it take for symptoms of the coronavirus disease to appear?
Is headache a symptom of the coronavirus disease?
What should I do if I test positive for the coronavirus disease?
Can I breastfeed my child if I am severely ill with coronavirus disease?
What happens when you get the coronavirus disease?
Does drinking lots of water help flush out COVID-19?
How long do COVID-19 patients need to be isolated for?
Should coronavirus disease patients be isolated in hospitals?
Will I get more severe symptoms of COVID-19 if I drink alcohol?
At what point are COVID-19 patients most infective?
Who is more likely to get seriously ill from the coronavirus disease?
Can the coronavirus disease spread through feces?
Can the coronavirus disease spread through food?
Is there asymptomatic transmission of the coronavirus disease?
Is the coronavirus disease more severe than the flu?
Should I wear a mask during the coronavirus disease pandemic?
How to prevent coronavirus disease infection?
What is the usual body temperature in coronavirus disease patients?
Is temperature screening effective to detect the coronavirus disease?
Can the coronavirus disease be transmitted in hot or humid climates?
How sensitive are the rapid diagnostic tests for coronavirus disease?
How could smoking affect COVID-19?
What are the different levels of coronavirus disease transmission?
What is a safe distance from others to protect against the coronavirus disease?
How is the transmission of COVID-19 in children different from flu?
How dangerous is COVID-19?
What percentage of patients with COVID-19 need to be hospitalized?
Can COVID-19 be fatal?
What are the dangers of smoking my waterpipe during the coronavirus disease pandemic?
Can the coronavirus disease be contracted by eating frozen foods and ice-cream?
Do people develop immunity to the coronavirus disease after being infected?
What is asymptomatic case of COVID-19?
Are the elderly more vulnerable to the coronavirus disease?
What are signs and symptoms of the coronavirus disease?
Can smoking waterpipes spread the coronavirus disease?
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