Fact Sheet for Healthcare Providers, Logix Smart Coronavirus Disease 2019 (COVID-19) Kit — Co-Diagnostics
Summary
A Fact Sheet for Healthcare Providers from Co-Diagnostics, Inc. for the Logix Smart Coronavirus Disease 2019 (COVID-19) Kit, updated March 14, 2023. It states the test is authorized for lower and upper respiratory tract fluids collected from individuals suspected of COVID-19, in laboratories certified under CLIA, 42 U.S.C. §263a, to perform high complexity tests. The fact sheet explains what positive and negative results mean, the risks of false positive and false negative results, and that clinical performance has not been established in all circulating variants. It describes the test as made available under an FDA Emergency Use Authorization (EUA) and lists CDC and FDA resources and the adverse event reporting route through FDA Form 3500.
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“Fact Sheet for Healthcare Providers, Logix Smart Coronavirus Disease 2019 (COVID-19) Kit — Co-Diagnostics.”
Original at www.fda.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/fda-codx-logix-smart-covid-19-kit-hcp-factsheet-19fc2e2f39/
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FACT SHEET FOR HEALTHCARE PROVIDERS Coronavirus
Co-Diagnostics, Inc. Updated: March 14, 2023 Disease 2019
Logix Smart Coronavirus Disease 2019 (COVID-19) Kit (COVID-19)
This Fact Sheet informs you of the significant known and
potential risks and benefits of the emergency use of the This test is to be performed only using lower
Logix Smart Coronavirus Disease 2019 (COVID-19) Kit. respiratory tract fluids (e.g. bronchoalveolar lavage,
sputum, tracheal aspirate), and upper respiratory
The Logix Smart Coronavirus Disease 2019 (COVID-19) tract fluids (e.g. nasopharyngeal and oropharyngeal
Kit is authorized for use with lower respiratory tract fluids
(e.g. bronchoalveolar lavage, sputum, tracheal aspirate),
swabs) collected from individuals suspected of
and upper respiratory tract fluids (e.g. nasopharyngeal COVID-19 by their healthcare provider.
and oropharyngeal swabs) collected from individuals
suspected of COVID-19 by their healthcare provider.
What do I need to know about COVID-19 testing?
Current information on COVID-19 for healthcare
providers is available at CDC’s webpage, Information for
All patients whose specimens are tested with this Healthcare Professionals (see links provided in “Where
assay will receive the Fact Sheet for Patients: Co- can I go for updates and more information?” section).
Diagnostics, Inc. - Logix Smart Coronavirus
· The Logix Smart Coronavirus Disease 2019
Disease 2019 (COVID-19) Kit.
(COVID-19) Kit can be used to test lower respiratory
tract fluids (e.g. bronchoalveolar lavage, sputum,
tracheal aspirate), and upper respiratory tract fluids
(e.g. nasopharyngeal and oropharyngeal swabs).
What are the symptoms of COVID-19? · The Logix Smart Coronavirus Disease 2019
Many patients with COVID-19 have developed fever (COVID-19) Kit should be ordered for the detection
and/or symptoms of acute respiratory illness (e.g., of SARS-CoV-2 in individuals suspected of COVID-
cough, dyspnea), although some individuals experience 19 by their healthcare provider.
only mild symptoms or no symptoms at all. The current · The Logix Smart Coronavirus Disease 2019
information available to characterize the spectrum of (COVID-19) Kit is authorized for use in laboratories
clinical illness associated with COVID-19 suggests that, certified under the Clinical Laboratory Improvement
when present, symptoms include cough, shortness of Amendments of 1988 (CLIA), 42 U.S.C. §263a, that
breath or dyspnea, fever, chills, myalgias, headache, meet requirements to perform high complexity tests.
sore throat, new loss of taste or smell, nausea or
vomiting or diarrhea. Signs and symptoms may appear Specimens should be collected with appropriate infection
any time from 2 to 14 days after exposure to the virus, control precautions. Current guidance is available at the
and the median time to symptom onset is approximately CDC’s website (see links provided in “Where can I go for
5 days. For further information on the symptoms of updates and more information?” section).
COVID-19 please see the link provided in “Where can I
go for updates and more information?” section. When collecting and handling specimens from
individuals suspected of being infected with the virus that
Public health officials have identified cases of COVID-19 causes COVID-19, appropriate personal protective
throughout the world, including the United States. Please equipment should be used as outlined in the CDC
check the CDC COVID-19 webpage (see link provided in Interim Laboratory Biosafety Guidelines for Handling and
“Where can I go for updates and more information?” Processing Specimens Associated with Coronavirus
section at the end of this document) or your local Disease 2019 (COVID-19). For additional information,
jurisdictions website for the most up to date information. refer to CDC Interim Guidelines for Collecting, Handling,
and Testing Clinical Specimens from Persons Under
Investigation (PUIs) for Coronavirus Disease 2019
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
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FACT SHEET FOR HEALTHCARE PROVIDERS Coronavirus
Co-Diagnostics, Inc. Updated: March 14, 2023 Disease 2019
Logix Smart Coronavirus Disease 2019 (COVID-19) Kit (COVID-19)
(COVID-19) (see links provided in “Where can I go for
updates and more information?” section). When diagnostic testing is negative, the possibility of a
false negative result should be considered in the context
What does it mean if the specimen tests positive for of a patient’s recent exposures and the presence of
the virus that causes COVID-19? clinical signs and symptoms consistent with COVID-19.
A positive test result for COVID-19 indicates that RNA The possibility of a false negative result should
from SARS-CoV-2 was detected, and therefore the especially be considered if the patient’s recent
patient is infected with the virus and presumed to be exposures or clinical presentation indicate that COVID-
contagious. Laboratory test results should always be 19 is likely, and diagnostic tests for other causes of
considered in the context of clinical observations and illness (e.g., other respiratory illness) are negative.
epidemiological data (such as local prevalence rates and
current outbreak/epicenter locations) in making a final If COVID-19 is still suspected based on exposure history
diagnosis and patient management decisions. Patient together with other clinical findings, re-testing with an
management should be made by a healthcare provider alternative method should be considered by healthcare
and follow current CDC guidelines. providers in consultation with public health authorities.
Additional testing may be helpful to ensure testing was
The Logix Smart Coronavirus Disease 2019 (COVID-19) not conducted too early.
Kit has been designed to minimize the likelihood of false
positive test results. However, it is still possible that this Risks to a patient of a false negative test result include:
test can give a false positive result, even when used in delayed or lack of supportive treatment, lack of
locations where the prevalence is below 5%. In the event monitoring of infected individuals and their household or
of a false positive result, risks to patients could include other close contacts for symptoms resulting in increased
the following: a recommendation for isolation of the risk of spread of COVID-19 within the community, or
patient, monitoring of household or other close contacts other unintended adverse events.
for symptoms, patient isolation that might limit contact
with family or friends and may increase contact with The performance of this test was established based on
other potentially COVID-19 patients, limits in the ability the evaluation of a limited number of clinical specimens.
to work, delayed diagnosis and treatment for the true The clinical performance has not been established in all
infection causing the symptoms, unnecessary circulating variants but is anticipated to be reflective of
prescription of a treatment or therapy, or other the prevalent variants in circulation at the time and
unintended adverse effects. location of the clinical evaluation. Performance at the
time of testing may vary depending on the variants
All laboratories using this test must follow the standard circulating, including newly emerging strains of SARS-
testing and reporting guidelines according to their CoV-2 and their prevalence, which change over time.
appropriate public health authorities.
What is an EUA?
What does it mean if the specimen tests negative for The United States FDA has made this test available
the virus that causes COVID-19? under an emergency access mechanism called an
A negative test result for this test means that SARS- Emergency Use Authorization (EUA). The EUA is
CoV-2 RNA was not present in the specimen above the supported by the Secretary of Health and Human
limit of detection. However, a negative result does not Service’s (HHS’s) declaration that circumstances exist to
rule out COVID-19 and should not be used as the sole justify the emergency use of in vitro diagnostics (IVDs)
basis for treatment or patient management decisions. It for the detection and/or diagnosis of the virus that
is possible to test a person too early or too late during causes COVID-19.
SARS-CoV-2 infection to make an accurate diagnosis
via Logix Smart Coronavirus Disease 2019 (COVID-19) An IVD made available under an EUA has not
Kit. undergone the same type of review as an FDA-approved
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
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FACT SHEET FOR HEALTHCARE PROVIDERS Coronavirus
Co-Diagnostics, Inc. Updated: March 14, 2023 Disease 2019
Logix Smart Coronavirus Disease 2019 (COVID-19) Kit (COVID-19)
or cleared IVD. FDA may issue an EUA when certain
criteria are met, which includes that there are no
Where can I go for updates and more information?
adequate, approved, available alternatives, and based
on the totality of scientific evidence available, it is CDC webpages:
reasonable to believe that this IVD may be effective in General: https://www.cdc.gov/coronavirus/2019-ncov/index.html
diagnosing COVID-19. Symptoms:
https://www.cdc.gov/coronavirus/2019-ncov/symptoms-
The EUA for this test is in effect for the duration of the testing/symptoms.html
COVID-19 declaration justifying emergency use of IVDs, Healthcare Professionals:
unless terminated or revoked (after which the test may https://www.cdc.gov/coronavirus/2019-ncov/hcp/
no longer be used). Information for Laboratories: https://www.cdc.gov/coronavirus/2019-
nCoV/lab/index.html
What are the approved available alternatives? Laboratory Biosafety: https://www.cdc.gov/coronavirus/2019-
Any tests that have received full marketing status (e.g., nCoV/lab/lab-biosafety-guidelines.html
Isolation Precautions in Healthcare Settings:
cleared, approved), as opposed to an EUA, by FDA can
https://www.cdc.gov/infectioncontrol/guidelines/isolation/index.html
be found by searching the medical device databases Specimen Collection: https://www.cdc.gov/coronavirus/2019-
here: https://www.fda.gov/medical-devices/device- nCoV/lab/guidelines-clinical-specimens.html
advice-comprehensive-regulatory-assistance/medical- Infection Control: https://www.cdc.gov/coronavirus/2019-
device-databases. A cleared or approved test should be ncov/php/infection-control.html
used instead of a test made available under an EUA,
when appropriate and available. FDA has issued EUAs
for other tests that can be found at: FDA webpages:
https://www.fda.gov/emergency-preparedness-and- General: www.fda.gov/novelcoronavirus
EUAs: (includes links to patient fact sheet and manufacturer’s
response/mcm-legal-regulatory-and-policy-
instructions) https://www.fda.gov/medical-devices/coronavirus-
framework/emergency-use-authorization. disease-2019-covid-19-emergency-use-authorizations-medical-
devices/in-vitro-diagnostics-euas
Co-Diagnostics, Inc.:
2401 Foothill Drive, Suite D
Salt Lake City, UT 84109
Customer & Technical Support:
Phone: (801) 438-1036
Email: info@co-dx.com
Website: www.co-dx.com
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
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