FACT SHEET FOR HEALTHCARE PROVIDERS
Therma Bright Inc. September 12, 2021
AcuVid™COVID Antigen
Coronavirus
Disease 2021
(COVID-19)
This Fact Sheet informs you of the significant known and
potential risks and benefits of the emergency use of the
AcuVid™COVID Antigen test.
AcuVid™COVID Antigen test is authorized for the detection
of SARS-CoV-2 using direct saliva specimens collected from
individuals who are suspected of COVID-19 by their healthcare
provider within the first six days from the onset of symptoms.
All patients whose specimens are tested with this test
will receive the Fact Sheet for Patients: AcuVid™COVID
Antigen.
What are the symptoms of COVID-19?
Many patients with COVID-19 have developed fever and/or
symptoms of acute respiratory illness (e.g., cough, dyspnea),
although some individuals experience only mild symptoms
or no symptoms at all. The current information available to
characterize the spectrum of clinical illness associated with
COVID-19 suggests that, when present, symptoms include
cough,shortness of breath or dyspnea, fever, chills, myalgias,
headache, sore throat, new loss of taste or smell, nausea or
vomiting or diarrhea. Signs and symptoms may appear any
time from 2 to 14 days after exposure to the virus, and the
median time to symptom onset is approximately 5 days. For
further information on the symptoms of COVID-19 please
see the link provided in “Where can I go for updates and
more information?” section.
Public health officials have identified cases of COVID-19
infection throughout the world, including the United States.
Please check theCDC COVID-19webpage (see link provided in
“Where can I go for updates and more information?” section
at the end of this document) or your local jurisdiction’s
website for the most up to date information.
This test is to be performed only using saliva swab specimens
collected from individuals who are suspected of COVID-19 by
their healthcare provider within the first six days from the onset
of symptoms.
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 Healthcare
Professionals (see links provided in “Where can I go for
updates and more information?” section).
• The AcuVid™COVID Antigen test is to be used to
test sub buccal saliva specimens directly from
collection. The swab provided in the AcuVid™COVID
Antigen test kit is intended to be used to swab the inner cheek,
rubbing around the cheek cavity three times on
each side to obtain adequate sample.
• The AcuVid™COVID Antigen test can be used to
test sub buccal saliva from COVID-19
symptomatic individuals within the first six days of
symptom onset.
• The AcuVid™COVID Antigen Test has received conditional
approval for in home testing in the United States, certified
under the Clinical Testing Improvement Amendments of
1988 (CLIA), 42 U.S.C. §263a, that meet requirements
to perform high, moderate or waived complexity tests.
The AcuVid™COVID Antigen Test is authorized for use
for at home testing; Point of Care (POC), i.e., in patient care settings
operating under a CLIA Certificate of Waiver, Certificate
of Compliance, or Certificate of Accreditation.
Specimens should be collected with appropriate infection
control precautions. Current guidance for COVID-19 infection
control precautions is available at the CDC’s website (see
links provided in “Where can I go for updates and more
information?” section).
Use appropriate personal protective equipment when
collecting and handling specimensfromindividualssuspected
of having COVID-19 as outlined in the CDC Interim Laboratory
Biosafety Guidelines for Handling and Processing Specimens
Associated with Coronavirus Disease 2019 (COVID-19). For
additional information, refer to CDC Interim Guidelines for
Collecting, Handling, and Testing Clinical Specimens from
Persons Under Investigation
Therma Bright Inc. September 12, 2021
AcuVid™COVID Antigen
Coronavirus
Disease 2021
(COVID-19)
This Fact Sheet informs you of the significant known and
potential risks and benefits of the emergency use of the
AcuVid™COVID Antigen test.
AcuVid™COVID Antigen test is authorized for the detection
of SARS-CoV-2 using direct saliva specimens collected from
individuals who are suspected of COVID-19 by their healthcare
provider within the first six days from the onset of symptoms.
All patients whose specimens are tested with this test
will receive the Fact Sheet for Patients: AcuVid™COVID
Antigen.
What are the symptoms of COVID-19?
Many patients with COVID-19 have developed fever and/or
symptoms of acute respiratory illness (e.g., cough, dyspnea),
although some individuals experience only mild symptoms
or no symptoms at all. The current information available to
characterize the spectrum of clinical illness associated with
COVID-19 suggests that, when present, symptoms include
cough,shortness of breath or dyspnea, fever, chills, myalgias,
headache, sore throat, new loss of taste or smell, nausea or
vomiting or diarrhea. Signs and symptoms may appear any
time from 2 to 14 days after exposure to the virus, and the
median time to symptom onset is approximately 5 days. For
further information on the symptoms of COVID-19 please
see the link provided in “Where can I go for updates and
more information?” section.
Public health officials have identified cases of COVID-19
infection throughout the world, including the United States.
Please check theCDC COVID-19webpage (see link provided in
“Where can I go for updates and more information?” section
at the end of this document) or your local jurisdiction’s
website for the most up to date information.
This test is to be performed only using saliva swab specimens
collected from individuals who are suspected of COVID-19 by
their healthcare provider within the first six days from the onset
of symptoms.
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 Healthcare
Professionals (see links provided in “Where can I go for
updates and more information?” section).
• The AcuVid™COVID Antigen test is to be used to
test sub buccal saliva specimens directly from
collection. The swab provided in the AcuVid™COVID
Antigen test kit is intended to be used to swab the inner cheek,
rubbing around the cheek cavity three times on
each side to obtain adequate sample.
• The AcuVid™COVID Antigen test can be used to
test sub buccal saliva from COVID-19
symptomatic individuals within the first six days of
symptom onset.
• The AcuVid™COVID Antigen Test has received conditional
approval for in home testing in the United States, certified
under the Clinical Testing Improvement Amendments of
1988 (CLIA), 42 U.S.C. §263a, that meet requirements
to perform high, moderate or waived complexity tests.
The AcuVid™COVID Antigen Test is authorized for use
for at home testing; Point of Care (POC), i.e., in patient care settings
operating under a CLIA Certificate of Waiver, Certificate
of Compliance, or Certificate of Accreditation.
Specimens should be collected with appropriate infection
control precautions. Current guidance for COVID-19 infection
control precautions is available at the CDC’s website (see
links provided in “Where can I go for updates and more
information?” section).
Use appropriate personal protective equipment when
collecting and handling specimensfromindividualssuspected
of having COVID-19 as outlined in the CDC Interim Laboratory
Biosafety Guidelines for Handling and Processing Specimens
Associated with Coronavirus Disease 2019 (COVID-19). For
additional information, refer to CDC Interim Guidelines for
Collecting, Handling, and Testing Clinical Specimens from
Persons Under Investigation
Comment:
Looks like an announcement is coming this week.