CARLSBAD, CA -- April 8, 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
has
applied for CLIA certification
to ensure the
test results are meeting and exceeding industry standards for
clinical laboratory testing
of the medical related products distributed by the
company.
What is CLIA
"The
Clinical Laboratory Improvement Amendment
(CLIA) has been the industry standard ever since
its beginning
that started in 1966; the reason for the birth of CLIA was due to
elevated laboratory
testing
errors. CLIA began as regulations for primarily hospital
laboratories,
and independent laboratories.
Through the years, there have been a few regulations passed to for
CLIA, in
order for it
become more encompassing of different laboratories,
and the level of testing they were conducting. Since the
implementation
of
these amendments, and regulations, the quality of
laboratory
testing
has been on the rise, with quality deficiencies
on the
downfall.
CLIA
certified
entities
have stringent standards they must meet in
order to maintain
their status as a CLIA certified
facility.
The
CDC, CMS, and FDA all support CLIA, and encourage consumers to look
for this certification when it comes to Laboratory
testing,
and tests.
This certification
is beneficial for our COVID Antigen & Antibody tests, as it
provides consumers with the peace of mind in knowing their test is
certified, and meets the federal regulations, and quality standards
of the country."
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.
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.oraldna.com/trends-in-salivary-testing/index.php/2018/03/09/definition-clia-certified-cap-accredited-what-does-this-mean/
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
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
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.