What is the serological test, and how does it work?
Serological tests are now being developed and can help give us a broader picture of COVID-19 infection spread. Unlike molecular tests, serological tests can identify those that were infected and have recovered.
There are many rapid serological tests being offered by well-meaning doctors who may be unaware that many of these inexpensive tests made in other countries have not undergone rigorous standards to ensure their accuracy. In one such test widely offered in the US, subsequent tests showed that the false-negative rate was as high as 30%.
We carefully selected the serological test we offer based on having undergone validation by infectious disease experts at UCLA and SUNY with a false negative rate of less than 10% and a false positive of 3%. Immunity is confirmed to be 100% accurate. Our test also includes detection for the presence of the COVID-19 N antigen to minimize confusion with previous infections with other Corona or SARS virus.
We also have taken the additional step of offering Microfluidic PCR as a means of confirming positive results and providing more accurate information as to the stage of infection and evidence of the bodies ability to create antibodies to cause immunity to develop.
How is the serological test administered?
Serological tests rely on detecting antibodies in a blood sample, through a simple finger prick with results in less than 15 minutes.
These tests do not require special equipment to process the results, which allows them to be used in laboratories or at point-of-care.
What’s the science behind it?
The rapid response serological tests typically use a technique called enzyme-linked immunological assay (ELISA), which detects the presence of these antibodies to the virus.
When you’re exposed to the virus, your body develops antibodies, which can take several days to over a week. Antibodies are proteins your body makes when mounting a response against invading germs.
- A worker is IgG+ and IgM- has immunity and are safe to return to work
- A worker is IgM+ is in the early phase of infection and needs to self-isolate and be tested by PCR followed by self-isolation and Re-test in 14 days and look for seroconversion to IgG.
- A worker is IgM/IgG negative, have not been exposed
How long does it take to get results?
Serological tests are typically much faster than standard molecular tests, returning results in as few as 10 to 15 minutes.
What exactly does the serological test tell you?
Since it can take several days for the body to develop an antibody response to the virus, serological tests may not be useful in identifying a current infection alone. They have the potential of producing a false negative, a false result when you actually have the infection.
However, they can identify individuals who have had the infection and have recovered, suggesting that those people are now immune to the virus. It is still unclear how long any immunity lasts and if reinfection is possible.
How accurate are serological tests?
Serological test development is allowed under current FDA policy, but until recently, the FDA wasn’t authorizing them like they do molecular tests. Instead, companies developing serological tests were simply required to notify the FDA and include the following information on test results:
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in those individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- This test has not been approved by the FDA
COVID Rapid Result Serum Testing:
- Serum blood test to determine the presence of Antibody/Antigen IgM and IgG.
- Positive: + IgM and + IgG
- Early stage: + IgM
- Late stage: + IgM, + IgG
- Negative: – IgM, – IgG
- Immune: + IgG
- Positive Results confirmed by approved PCR Testing as rapid Testing not approved by the FDA as diagnostic.
Our IRB approved study is being conducted to help determine the accuracy of rapid serological testing as a screening tool and as cross-referenced to PCR and to determine if therapies such as IV micronutrient replacement, supplements, IV Hydrogen Peroxide, EBO2, and other functional medicine protocols (which have been claimed in some studies to enhance immune support and decrease inflammation and Cytokine storm) have an impact on the likelihood of severe complications related to COVID-19 infection.
- Study Protocol offered:
- Consultation and Study Protocol Consent offered via Telemedicine or in office by appointment only.
- Review Rapid Serology and PCR Test Results
- Review labs for current inflammatory markers and micronutrient status
- Review potential Functional Medicine Protocols as it may apply to each individual’s unique situation
- Follow-up in person or via Telemedicine
Call, Text or Live Chat with us for more information about COVID Rapid Result Serum Testing: (480) 998-7999