Global7Diagnostics (2)

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Title: Global7Diagnostics (2)

1
Global 7 Diagnostics

2
About Us

3
COVID-19 Testing Saliva Direct

Regularly testing large numbers of people plays a
huge role in monitoring the transmission of
SARS-CoV-2. Ramping up testing for effective
SARS-CoV-2 surveillance has faced several
barriers such as uncomfortable nasal swabs,
testing supply chain shortages, and delays in
test results.
Saliva Direct is a new testing method for testing
people suspected of SARS-CoV-2 infection. The new
method still relies on a similar molecular
process as earlier tests (RT-qPCR), however, it
has unique advantages.
Saliva Direct is a qualitative test for the
detection of nucleic acid from SARS-CoV-2 in
saliva collected without preservatives in a
sterile container from individuals suspected of
COVID-19 by their healthcare provider. Saliva
Direct was developed by the Yale School of Public
Health (YSPH) and has received an Emergency Use
Authorization from the United States Food and
Drug Administration (FDA). FDA limits the
emergency use of Saliva Direct testing only to
high-complexity CLIA-certified laboratories
formally designated as authorized laboratories by
YSPH under the EUA 202097.

4
Cont.

Saliva-based Comfort. You no longer have to
stick an uncomfortable swab up your nose, which
increases testing compliance. This also protects
healthcare workers from potential exposure to
sick patients. Extraction-free The
time-consuming and expensive nucleic acid
extraction step is not needed with SalivaDirect?.
This allows for cheaper and quicker test results.
Flexible While many labs have similar equipment
and testing methods, they still rely on expensive
reagents and time-consuming processes.
SalivaDirect? relies on easily-accessible
reagents from many different companies, whereas
most test protocols rely on one company
Saliva-based Comfort. You no longer have to
stick an uncomfortable swab up your nose, which
increases testing compliance. This also protects
healthcare workers from potential exposure to
sick patients.
Extraction-free The time-consuming and expensive
nucleic acid extraction step is not needed with
SalivaDirect?. This allows for cheaper and
quicker test results.
Flexible While many labs have similar equipment
and testing methods, they still rely on expensive
reagents and time-consuming processes.
SalivaDirect? relies on easily-accessible
reagents from many different companies, whereas
most test protocols rely on one company