FOR YOUR EDUCATION There Are 3 COVID-19 FDA-EUA Test Lists - Rapid Antigen, Lab-Required PCR & Antibody
AcuVid Covid-19 Rapid Antigen Saliva Test will make the 1st list below ... once it receive FDA-EUA
FDA-EUA TEST LIST #1:
RAPID ANTIGEN TESTS (<15 minutes)
There are only 20 Companies with 20 Antigen Tests that have 35 different use case submissions with FDA-EUA. All these 20 tests are NASAL tests, not one Saliva antigen test in the group. This is the list that Therma Bright’s AcuVid COVID19 Rapid Antigen Saliva Test will be on once it secures FDA-EUA.
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
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FDA-EUA TEST LIST #2:
LAB REQUIRED PCR/MOLECULAR TESTS (>2-24 hour turn around)
Note PCR tests require labs and high tech chemical analysis machines to process the sample… to get CT Cycle Time … which helps in determining the contagiousness of the person. Typically 2-24 hour turn around, if clinic has a machine or have to send to a lab.
There are about 25+ saliva tests on the extensive 260+ PCR tests, however these all require lab work on the saliva to run though machines.
This is NOT test list (PCR) that the ACUVID COVID-19 RAPID ANTIGEN SALIVA TEST will be found on.
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
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FDA-EUA TEST LIST #3: ANTIBODY/IMMUNOLOGY TEST (>2-24 hour turn around)
The antibody tests …the Serology Test (aka blood tests) which also that require labs and high tech chemical analysis machines to determine if people have antibodies.
FDA-EUAs Serology and Other Adaptive Immune Response Tests:
A total of 88 Serology & Other Antibody/Immune Tests used for COVID-19… mainly for detecting antibodies that a person may have to determine “immunity level” and if vaccines and vaccine booster shots are required. Or this test can determine if the person is Asymptomatic. These serology tests will tell the person if they had Covid-19 but were never aware they had it.
This is NOT a test list (Antibody) that the ACUVID COVID-19 RAPID ANTIGEN SALIVA TEST will be found on.
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-serology-and-other-adaptive-immune-response-tests-sars-cov-2
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All in all…. & most important
THERMA BRIGHT’S ACUVID COVID-19 RAPID ANTIGEN SALIVA TEST WILL BE -
1) ONE OF A SELECT FEW OF RAPID ANTIGEN TEST FROM A SMALL ELITE GROUP . THERMA BRIGHT WILL BE THE 21st COMPANY WITH THE 21st FDA-EUA RAPID TEST ONCE APPROVED… (its really a small group of winners)
2) SALIVA-BASED SETS IT MORE APART .... ACUVID WILL BE THE ONLY FDA-EUA COVID-19 RAPID ANTIGEN SALIVA TEST ONCE APPROVED.
3) NO MORE DEEP DIVE ESCAVATING WITH A SWAB "WAY, WAY UP YOUR NOSTRIL.. ...and we all know how much Canadians love to deep drill mine. Well, sorry guys and gals. No need for deep drill mining for your boogers with this test. Lol!!!