Diagnostic tests that determine if someone has an active COVID-19 infection fall into two categories: antigen tests, which are mostly used for rapid testing, and molecular PCR tests.
Molecular PCR serves as the gold standard of COVID-19 diagnostic testing. Molecular tests detect genetic material – the RNA – of the coronavirus and are sensitive enough to need only a very tiny amount of it.
Until now, the best PCR tests generally required trained personnel, specific reagents and expensive machines. ‘Gold Standard PCR Tests’ like the ones used by Reliant Health Services / GetTestedNow.com are highly sensitive, highly specific and close to 100% accurate.
This test is able to pick up very small amounts of viral RNA very early in an infection, so there is a low chance for false negatives, including among pre-symptomatic and asymptomatic COVID-19 cases. PCR is considered the gold standard for many viruses we’ve seen in the past.
Reliant does not use antigen tests. Until now, the majority of rapid diagnostic tests have been antigen tests. They are taken with a nasal or throat swab and detect a protein that is part of the coronavirus. These tests are particularly useful for identifying a person who is at or near peak infection. Antigen tests are less expensive and generally faster. The downside is that they can be less accurate. That means, if a person is not near peak infection – but is still contagious – the tests may come back negative. Depending on the quality of the antigen test and the test takers, false negatives could be as high as 40%. Simply put, the coronavirus replicates itself by putting its genetic material inside our cells. If someone is tested at the stage when the virus is still replicating inside the cells, it has not produced sufficient protein or shed in large enough amounts to be detected yet by antigen testing.
Antigen tests can also produce false positives. The concern is false positives could be caused by the presence of other viruses, improper collection techniques, or other substances produced by the body during infection interfering with the results.
These are not considered diagnostic tests that can determine if someone has an active COVID-19 infection. They use blood samples to look for antibodies produced by a person’s immune system to help fight off COVID-19. These can detect if someone had a past COVID-19 infection but not if they still are positive for the virus.
Reliant’s non-invasive PCR test for SARS-CoV-2
Saliva testing can allow earlier detection to identify people who may not know they are contagious. In addition, because patients spit into a tube or cup, saliva testing is safer for healthcare workers than taking swabs. The greatest scientific advantage is that nasal and oral swabs only collect the surface area where the swab goes, which may not be the place with most viral load. In contrast, the virus occurs throughout a saliva sample, so the test is more trustworthy.
Using saliva to test for viral infection was not something previously tried therefore was not an FDA approved testing option. Swabs had been the traditional approved standard. As testing exponentially accelerated supplies became limited and it became clear additional options needed to be discovered. A groundbreaking study done by Rutgers University determined saliva to be 100% equal to swabs for COVID-19 detection and in many cases, it proved to be a better, more sensitive option. This was further validated by an additional study done by Yale University researchers.
This delivered EUA approval for Rutgers to use saliva for SARS-CoV- 2 testing based on the very specific and documents protocols they used.
What makes the Saliva collection unique:
Engineered to reduce at-home user and self-collection errors
Preservation chemistry is 100% bacteriostatic extending sample shelf-life
Consistently delivers higher quality and quantities of DNA for medical, genetic, and molecular diagnostic testing
Protects and suspends viral RNA transcripts for sensitive and specific analysis
Chemistry inactivates the live virus helping to shield healthcare professionals and clinicians from exposure
Proven to stabilize & protect SARS-CoV-2 viral RNA during specimen transport in all extreme temperatures for 14 days
Here are a few articles regarding our PCR saliva testing info for review:
The following documents are provided to conform with applicable requirements set forth in the Act and FDA regulations.
Reliant’s labs are:
- Certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a and meet requirements to perform high-complexity tests
- Accredited by the College of American Pathologists.
- Meet the safety level of ‘Biosafety Level 3 (BSL-3),’ as specified by the CDC.