Tuesday, December 13, 2022

I have covid and it sucks

Ellume Health <noreply@ellumehealth.com>
To:sherwoods7@verizon.net
Tue, Dec 13 at 2:40 PM

 

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COVID-19 home test logo

Test Result: Your test is POSITIVE for COVID-19

Patient: Nancy Sherwood
Test Taken: 12/13/2022 2:40:04 PM -05:00
Analyzer ID: 101699197
Lot Number: 22198-819
Hi Nancy Sherwood ,
Thank you for using the Ellume COVID-19 Home Test.
Here is a copy of your test results.
Please also find a link to:
What to do now:
More information about your result:
A positive test result indicates it is very likely that you currently have COVID-19 disease because proteins which are small parts of the virus that causes COVID-19 were found in your sample. Therefore, it is also likely that you may be placed in self-isolation to avoid spreading the virus to others. You should follow CDC guidance to reduce the potential transmission of disease. There is a chance that this test can give a positive result that is wrong (a false positive result) especially if you use the test when there are very few COVID-19 infections in your local community. Your healthcare professional will work with you to determine how best to care for you based on the test results along with medical history, and your symptoms.
Can I have a false positive test result?
There is a chance that this test can give a positive result that is incorrect (a false positive result).
Anyone who receives a positive test result needs to consult a healthcare professional. This is especially important if you belong to a high-risk group or develop emergency warning signs. If you have any doubt about your test result, please discuss it with your healthcare professional. Your healthcare professional will work with you to determine how best to care for you based on your test result along with your medical history and symptoms.
The percent of positive test results that are true positives (also known as Positive Predictive Value or PPV) varies with how common infection is in a population. As the number of infections in the community decreases, the number of test results that are false positives increases. When the number of infections is low, false positive results may be more likely than true positive results. For example, if prevalence of infection in a community is 5%, 37 out of 100 positive results from the Ellume COVID-19 Home Test would be false positives. If disease prevalence is only 1%, 75 out of 100 positive results would be false positives. It is difficult to determine how many infections are in asymptomatic individuals and false positive results may be more likely if you do not have symptoms of infection.
If you do not have symptoms of COVID-19 and get a positive result, your test results may need to be confirmed with a molecular SARS-CoV-2 Test. Positive results from the Ellume COVID-19 Home Test are presumptive in asymptomatic patients, and have a higher risk of being false positives, particularly if you do not have a known SARS-CoV-2 exposure and/or live in an area known to have low numbers of SARS-CoV-2 infections. For low-risk individuals, the CDC recommends that persons who receive a positive antigen test should isolate until they can be confirmed by a molecular test.
When can I be with others again?
If you have symptoms at time of testing or develop symptoms:
  • After self-isolating for at least 10 days since symptoms first appeared
AND
  • At least 24 hours with no fever (without fever-reducing medications)
AND
  • Other symptoms of COVID-19 are improving (excluding loss of taste and smell, which may persist for weeks or months after recovery).
If you have no symptoms at time of testing and continue to have no symptoms:
  • After self-isolating for 10 days since your positive test.
If you tested Positive and have no symptoms at the time of testing:
  • After self-isolating for 10 days since your positive test.
For more information on when you can be around people again, please visit the CDC website:
https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/end-home-isolation.html
Test accuracy
In a clinical study conducted in the USA from October 2020 to November 2020, the Ellume COVID-19 Home Test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms. In people without symptoms the test correctly identified 91% of positive samples and 96% of negative samples (please see FAQ ‘How accurate is the Ellume COVID-19 Home Test?’ on our website).
Sincerely,
Ellume
In USA - This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
 
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