Fact Sheet for Patients, Logix Smart Coronavirus Disease 2019 (COVID-19) Kit — Co-Diagnostics, Inc.
Summary
A Fact Sheet for Patients for the Logix Smart Coronavirus Disease 2019 (COVID-19) Kit from Co-Diagnostics, Inc., updated March 14, 2023. It explains that the test is designed to detect the virus that causes COVID-19 in lower and upper respiratory tract specimens and why a patient's sample may have been tested. It lists potential risks, such as discomfort during sample collection and incorrect results, and potential benefits of testing. The fact sheet explains what positive and negative results mean, including the possibility of false positive and false negative results. It states that the test is not approved or cleared by the FDA but has been issued an Emergency Use Authorization (EUA), and it points readers to CDC and FDA resources.
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“Fact Sheet for Patients, Logix Smart Coronavirus Disease 2019 (COVID-19) Kit — Co-Diagnostics, Inc.”
Original at www.fda.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/fda-codx-logix-smart-covid-19-kit-patient-factsheet-bde234fdb8/
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FACT SHEET FOR PATIENTS Coronavirus
Co-Diagnostics, Inc. Updated: March 14, 2023 Disease 2019
Logix Smart Coronavirus Disease 2019 (COVID-19) Kit (COVID-19)
You are being given this Fact Sheet because your What is the Logix Smart Coronavirus Disease 2019
sample(s) was tested for the Coronavirus Disease 2019 (COVID-19) Kit?
(COVID-19) using the Logix Smart Coronavirus Disease The test is designed to detect the virus that causes
2019 (COVID-19) Kit. COVID-19 in the following respiratory specimens: lower
respiratory tract fluids (e.g. bronchoalveolar lavage,
This Fact Sheet contains information to help you sputum, tracheal aspirate), and upper respiratory tract
understand the risks and benefits of using this test for fluids (e.g. nasopharyngeal and oropharyngeal swabs).
the diagnosis of COVID-19. After reading this Fact
Sheet, if you have questions or would like to discuss the Why was my sample tested?
information provided, please talk to your healthcare You were tested because your healthcare provider
provider. believes you may have been exposed to the virus that
causes COVID-19 based on your signs and symptoms
(e.g., fever, cough, difficulty breathing), and/or because:
· You live in or have recently traveled to a place
For the most up to date information on COVID-19 where transmission of COVID-19 is known to occur;
please visit the CDC Coronavirus Disease 2019 or
(COVID-19) webpage: · You have been in close contact with an individual
suspected of or confirmed to have COVID-19
https://www.cdc.gov/COVID19
Testing of the samples will help find out if you may have
COVID-19.
What are the known and potential risks and benefits
What is COVID-19?
of the test?
COVID-19 is caused by the SARS-CoV-2 virus which is
a new virus in humans causing a contagious respiratory
Potential risks include:
illness. COVID-19 can present with a mild to severe
illness, although some people with COVID-19 may have
no symptoms at all. Older adults and people of any age · Possible discomfort or other complications that can
who have underlying medical conditions have a higher happen during sample collection.
risk of severe illness from COVID-19. Serious outcomes · Possible incorrect test result (see below for more
of COVID-19 include hospitalization and death. The information).
SARS-CoV-2 virus can be spread to others not just while
one is sick, but even before a person shows signs or Potential benefits include:
symptoms of being sick (e.g., fever, coughing, difficulty
breathing, etc.). A full list of symptoms of COVID-19 can · The results, along with other information, can help
be found at the following link: your healthcare provider make informed
https://www.cdc.gov/coronavirus/2019-ncov/symptoms- recommendations about your care.
testing/symptoms.html. · The results of this test may help limit the spread of
COVID-19 to your family and those you come in
contact with.
Where can I go for updates and more information? The most up-to-date information on
COVID-19 is available at the CDC General webpage: https://www.cdc.gov/COVID19. In addition,
please also contact your healthcare provider with any questions/concerns.
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FACT SHEET FOR PATIENTS Coronavirus
Co-Diagnostics, Inc. Updated: March 14, 2023 Disease 2019
Logix Smart Coronavirus Disease 2019 (COVID-19) Kit (COVID-19)
What does it mean if I have a positive test result? there are no adequate, approved, available alternatives.
If you have a positive test result, it is very likely that you The EUA for this test is supported by the Secretary of
have COVID-19. Therefore, it is also likely that you may Health and Human Service’s (HHS’s) declaration that
be placed in isolation to avoid spreading the virus to circumstances exist to justify the emergency use of in
others. You should follow CDC guidance to reduce the vitro diagnostics for the detection and/or diagnosis of the
potential transmission of disease. virus that causes COVID-19. This EUA will remain in
effect (meaning this test can be used) for the duration of
There is a smaller possibility that this test can give a the COVID-19 declaration justifying the emergency use
positive result that is wrong (a false positive result) of in vitro diagnostics, unless it is terminated or revoked
particularly when used in a population without many by FDA (after which the test may no longer be used).
cases of COVID-19. Your healthcare provider will work
with you to determine how best to care for you based on What are the approved alternatives?
the test results along with medical history, and your Any tests that have received full marketing status (e.g.,
symptoms. cleared, approved), as opposed to an EUA, by FDA can
be found by searching the medical device databases
What does it mean if I have a negative test result? here:https://www.fda.gov/medical-devices/device-advice-
A negative test result means that the virus that causes comprehensive-regulatory-assistance/medical-device-
COVID-19 was not found in your sample. databases. A cleared or approved test should be used
instead of a test made available under an EUA, when
However, it is possible for this test to give a negative appropriate and available. FDA has issued EUAs for
result that is incorrect (false negative) in some people other tests that can be found at:
with COVID-19. You might test negative if the sample https://www.fda.gov/emergency-preparedness-and-
was collected early during your infection. You could also response/mcm-legal-regulatory-and-policy-
be exposed to COVID-19 after your sample was framework/emergency-use-authorization
collected and then have become infected.
This means that you could possibly still have COVID-19
even though the test result is negative. If your test is
negative, your healthcare provider will consider the test
result together with all other aspects of your medical
history (such as symptoms, possible exposures, and
geographical location of places you have recently
traveled) in deciding how to care for you.
It is important that you work with your healthcare
provider to help you understand the next steps you
should take.
Is this test FDA-approved or cleared?
No. This test is not yet approved or cleared by the
United States FDA, but it has been issued an
Emergency Use Authorization (EUA). FDA may issue an
EUA when certain criteria are met, which includes that
Where can I go for updates and more information? The most up-to-date information on
COVID-19 is available at the CDC General webpage: https://www.cdc.gov/COVID19. In addition,
please also contact your healthcare provider with any questions/concerns.
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