CARLSBAD, CA -- March 29, 2021 --
InvestorsHub NewsWire -- OPTEC
International, Inc. (OTC Pink: OPTI),
a
developer
of UV and UV-C safety products using related advanced technologies
specific to Personal Protection Equipment (PPE),
today
announced the company is now
preparing and stockpiling FDA
EUA
approved
inventory
for the launch of the Antigen 10-minute
rapid
test kits
to be
made available for use at home & business nationwide.
Due to a recent FDA
relaxation of the "emergency
use" (EUA)
rules
applicable for Rapid Test Kit use,
most FDA/EUA
approved
Antigen and Antibody Test Kits will soon be
available
for purchase by consumers
and businesses,
both online and over the counter at affordable prices
compared to the current
Medical
facility/Pop-Up medical staff
supervised locations
with 24–72-hour
results.
OPTEC
is
providing
2 versions of the Nasal
CoV-2
Antigen FDA EUA
authorized 10-minute
rapid
test kits. The
kits are clinically
proven
to be
reliable and accurate (Clinical evaluation: Positive Percent
Agreement (PPA): 88.37% (95% CI: 75.52% – 94.93%), Negative Percent
Agreement (NPA): 100% (95% CI: 94.25% – 100%),
The
Nasal
swab tests detect viral shedding of the RNA of the virus.
Using
the Antigen Rapid Test Kits provides
the
ability for all
necessary
resources
to help keep the
pandemic at
bay for
personal
family
satisfaction, business
employee
monitoring,
schools,
senior care centers, medical
&
dental facilities,
government divisions
and more.
OPTEC
will be
offering both versions of the Antigen
10
Minute Nasal Rapid
Test
Kits:
online, via distributors,
media channels and
bulk
PPE networks
upon
receipt of final
approval
by FDA.
What
is an EUA? The United States FDA
has made this test available under an emergency access mechanism
called an Emergency Use Authorization (EUA). The EUA is supported
by the Secretary of Health and Human Service's (HHS's) declaration
that circumstances exist to justify the emergency use of in vitro
diagnostics (IVDs) for the detection and/or diagnosis of the virus
that causes the
pandemic.
Important
Links:
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#covid19ivdTemplates.
https://subscriber.politicopro.com/article/2021/03/fda-opens-door-to-widespread-at-home-covid-19-tests-3987603
ACTUAL
ARTICLE (link
above).
FDA opens door to widespread at-home Covid-19 tests
By
David Lim
03/16/2021 03:19 PM EDT
The
Food and Drug Administration will allow some developers of Covid-19
tests to market their products for regular at-home use without
first studying how well the tests perform in people without
symptoms.
The
agency's announcement Tuesday is aimed at making it easier to
screen Americans returning to school and work, senior FDA
regulators said.
"We
believe this effort will pave the way for further expanding the
availability of tests authorized for screening asymptomatic
individuals, help bolster existing and new testing programs and
increase consumer access to testing," FDA medical device director
Jeff Shuren and diagnostics director Tim Stenzel said in a
statement.
Some
rapid Covid-19 tests are less accurate in people without symptoms
than in those with symptoms. But the FDA's new policy takes into
account that repeated testing over time, for screening purposes,
can improve the overall accuracy of results.
Companies
can apply for permission to market an over-the-counter test for use
at home or at point-of-care if there is evidence the test performs
well in people with symptoms of Covid-19 and if repeated testing
can help mitigate false results. The agency is issuing a new
template for test developers seeking an emergency use authorization
for a screening test that is used for repeated testing.
"It is
important to note that testing, even serial testing, is of limited
value if it is not combined with appropriate mitigations for
individuals who test positive (such as quarantine), good contact
tracing, and effective behavioral protocols (such as mask wearing,
hand washing and social distancing), even for individuals who test
negative," an FDA fact sheet about the new policy
states.
Background: Some public
health groups, including the Rockefeller Foundation, and public
health experts such as Harvard University's Michael Mina, have
argued for months that increasing the availability of Covid-19
tests could help bring the Covid-19 pandemic under
control.
What's next: FDA
also released a fact sheet that aims to help groups setting up
screening testing programs. The Biden administration is working to
stand up four coordinating centers across the country to increase
testing in K-8 schools and underserved settings.
"The
fact sheet will help schools, workplaces, communities and other
locations as they are selecting a test for screening and help them
understand the difference between tests used for diagnosis of
suspected COVID-19 compared to those used for screening
asymptomatic individuals," Shuren and Stenzel said.
About
OPTEC International, Inc.
With
Locations in Carlsbad and Vista, California, OPTEC
International is a
developer and manufacturer of electronic LED, Ultraviolet (UV)
& UV-C safety products and related advanced technologies and
PPE (Personal Protection Equipment) products. The company's
Safe-Scan product line is being launched at a time when HR
directors and facilities managers are experiencing extreme concern
with respect to keeping environments safe during the global
pandemic crisis and the safe reopening of the U.S. economy. For
more information, visit:
www.optecintl.com
www.z2o.com
OPTEC
International,
Inc. investor relations at:
www.optecintl.com/investor
Safe
Harbor Statement: Safe harbor from
liability established by the Private Securities Litigation Reform
Act of 1995. These forward-looking statements generally can be
identified by phrases such as Opti, OPTEC or its management
"believes," "expects," "anticipates," "foresees," "forecasts,"
"estimates" or other words or phrases of similar import. Similarly,
statements herein that describe the Company's business strategy,
outlook, objectives, plans, intentions, or goals also are
forward-looking statements. All such forward-looking statements are
subject to certain risks and uncertainties that could cause actual
results to differ materially from those in forward-looking
statements. OPTEC International Inc.
OPTEC
International, Inc.
Investor Relations
Contact:
Andrew
Barwicki
516-662-9461 /
Andrew@barwicki.com
SOURCE: Optec
International, Inc.
Optec (CE) (USOTC:OPTI)
Historical Stock Chart
From Nov 2024 to Dec 2024
Optec (CE) (USOTC:OPTI)
Historical Stock Chart
From Dec 2023 to Dec 2024
