COVID-19 Testing: What are We Doing? What Does it Mean?
Guest Editorial, Dr. Sherri Tenpenny, DO, AOBNMM, ABIHM
In 1965, scientists identified the first human coronavirus; it was associated with the common cold. The Coronavirus family, named for their crown-like appearance, currently includes 36 viruses. Within that group, there are 4 common viruses that have been causing infection in humans for more than sixty years. In addition, three pandemic coronaviruses that can infect humans: SARS, MERS, and now, SARS-CoV-2.
As the news of deaths in China, South Korea, Italy, and Iran began to saturate every form of media 24/7, we became familiar with a new term: COVID-19. To be clear, the name of the newly identified coronavirus is SARS-CoV-2, short for Severe Acute Respiratory Syndrome Coronavirus-2. This virus is associated with fever, cough, chest pain, and shortness of breath, the complex of symptoms that form the diagnosis of COVID-19.
The Trump administration declared a public health emergency on January 31, 2020, then on February 2 placed a ban on the entry of most travelers who had recently been in China. On February 4, Alex Azar, the Secretary of Health and Human Services (HHS) issued a declaration of public health emergency and activated the Public Readiness and Emergency Preparedness Act, otherwise known as the PREP Act. This nefarious legislation provides complete protection of manufacturers from liability for all products, technologies, biologics, or any vaccine developed as a medical countermeasure against COVID-19. For those nervously waiting for the vaccine to become available, be sure to understand the PREP Act before rushing to the get in line.
Calls for testing – to see if a person is or isn’t infected – began soon after the emergency was declared, but performing those tests was initially slow due to an inadequate number of test kits. As the kits became available, those developed by the CDC had a defect: The reagents reacted to the negative control sample, making the test inaccurate and the kits unusable.
In various countries, thousands of test kits purchased from China were found to be contaminated with the SARS-CoV-2 viruses. No one really knows how that happened, but theories spread like wildfire. Could the test kit infect the person being tested? Or, did it mean the test would return a false-positive result, driving up the numbers of those said to be infected so those in power could implement stronger lockdowns and accelerate the hockey-stick unemployment rates? Neither of those questions has been adequately answered.
Mandatory Testing…of what?
Authorities claim that testing is important for public health officials to assess if their mitigation efforts – “shelter in place” and “social distancing” and “wearing a mask” – are making a difference to “flatten the curve.” Officials also claim that testing is necessary to know how many persons are infected within a community and to understand the nature of how coronaviruses spread.
Are these reasons sufficient to give up our health freedom and our personal rights, being tested and shamed in public?
Despite the challenges with test kits, testing began. By the end of March 2020, more than 1 million people had been tested across the US. By May 9, the number tested had grown to over 8.7M. Testing methods include a swab of the nasal passages or by inserting a long, uncomfortable swab through the nose to scrape the back of the throat. Specimens have also been obtained bronchoalveolar lavage, from sputum, and from stool specimens.
The call for mandatory testing has been gathering steam and becoming ever more onerous. In Washington state, Governor Inslee has declared:
Individuals that refuse to cooperate with contact tracers and/or refuse testing, those individuals will not be allowed to leave their homes to purchase basic necessities such as groceries and/or prescriptions. Those persons will need to make arrangements through friends, family, or state provided ‘family support’ personnel.
But what do the results really mean?
Who Should Be Tested
On May 8, 2020, the CDC has listed specific priorities for when testing should be done. As of May 16, more than 11-million samples have been collected and more than 3700 specimens have not yet been evaluated.
- Hospitalized patients with symptoms
- Healthcare facility workers, workers in living settings, and first responders with symptoms
- Residents in long-term care facilities or other congregate living settings, including prisons and shelters, with symptoms
- Persons with symptoms of potential COVID-19 infection, including fever, cough, shortness of breath, chills, muscle pain, new loss of taste or smell, vomiting or diarrhea, and/or sore throat
- Persons without symptoms who are prioritized by health departments or clinicians, for any reason, including but not limited to public health monitoring, sentinel surveillance, or screening of asymptomatic individuals according to state and local plans.
Read that last priority again: That means virtually everyone can be required to get a test.
Is that a violation of your personal rights? And, if you submit to testing, what does a “positive test” actually mean?
Types of Testing: RT-PCR
PCR, short for polymerase chain reaction, is a highly specific laboratory technique. The key to understanding PCR testing is that PCR can identify an individual specific virus within a viral family.
However, a PCR test can only be used to identify DNA viruses; the SARS-CoV2 virus is an RNA virus. Therefore, multiple steps must be taken to “magnify” the amount of genetic material in the specimen. Researchers used a method called RT-PCR, reverse transcription-polymerase chain reaction, to specifically identify the SARS-CoV-2 virus. It’s a complicated process. To read more about it, go here and here.
If a nasal or a blood sample contains a tiny snip of RNA from the SARS-CoV-2 virus, RT-PCR can identify it, leading to a high probability that the person has been exposed to the SARS-CoV-2 virus.
However – and this is important – a positive RT-PCR test result does not necessarily indicate a full virus is present. The virus must be fully intact to be transmitted and cause illness.
RT-PCR Testing: The Importance of Timing
Even if a person has had all the symptoms associated with a coronavirus infection or has been closely exposed to persons who have been diagnosed with COVID-19, the probability of a RT-PCR test being positive decreases with the number of days past the onset of symptoms.
According to a study done by Paul Wikramaratna and others:
For a nasal swab, the percentage chance of a positive test declines from about 94% on day 0 to about 67% by day 10. By day 31, there is only a 2% chance of a positive result.
For a throat swab, the percentage chance of a positive test declines from about 88% on day 0 to about 47% by day 10. By day 31, there is only a 1% chance of a positive result.
In other words, the longer the time frame between the onset of symptoms and the time a person is tested, the more likely the test will be negative.
Repeat testing of persons who have a negative test may (eventually) confirm the presence of viral RNA, but this is impractical. Additionally, repeated testing of the same person can lead to even more confusing results: The test may go from negative, to positive, then back to negative again as the immune system clears out the coronavirus infection and moves to recovery.
And what makes this testing even more confusing is that the FDA admits that “The detection of viral RNA by RT-PCR does not necessarily equate with an infectious virus.”
Let’s break that down:
You’ve had all the symptoms of COVID19, but your RT-PCR test for SARS-CoV-2 is negative.
- Does that mean you’re “good to go” – you can go to work, go to school or you can travel? OR…
- Does that mean your influenza-like illness was caused by some other pathogen, possibly one of the four coronaviruses that have been in circulation for 60 years? OR…
- Does that mean the result is a false-negative and you still have the infection, but it isn’t detectable by current tests? OR…
- Does that mean it was a sample was inadequately taken due to the faulty technique by the technician? OR…
- Does that mean you have not been exposed, and you are susceptible to contracting the infection, and you need to stay in quarantine?
So, what does a “positive” test actually mean? And that’s the problem … No one knows for sure.
Another Type of Testing: Antibodies
According to the nonprofit Foundation for Innovative New Diagnostics (FIND), more than 200 serologic blood tests, to test for antibodies, are either now available or in development.
There are two primary types of antibodies that are assessed for nearly any type of infection: IgM and IgG. While several new testing devices are being touted as a home test, they are not the same as a home pregnancy test or a glucometer to test your blood sugar. The blood spot or saliva specimen can be collected at home, it must then be sent to a laboratory for analysis. It can take a few days – or longer – to get the results. With so many tests in the pipeline, the ability to test at home will be changing over time.
The first antibody to rise is IgM. It rises quickly after the onset of the infection and is usually a sign of an acute, or current, infection. The IgM levels diminish quickly as the infection resolves. The FDA admits they do not know how long the IgM remains present for SARS-CoV-2 as the infection is being cleared.
The interpretation of an IgG antibody is more difficult. This antibody is an indicator of a past infection. The test is often not specific enough to determine if the past infection was caused by the SARS-CoV-2 virus or one of the four common coronaviruses that cause influenza-like illness.
The FDA says:
Because serology testing can yield a negative test result even if the patient is actively infected (e.g., the body has not yet developed in response to the virus) or may be falsely positive (e.g., if the antibody indicates a past infection by a different coronavirus), this type of testing should not be used to diagnose an acute or active COVID-19 infection.
Similarly, the CDC says the following regarding antibody testing:
If you test positive:
- A positive test result shows you have antibodies as a result of an infection with SARS-CoV-2, or possibly a related coronavirus.
- It’s unclear if those antibodies can provide protection (immunity) against getting infected again. This means that we do not know at this time if antibodies make you immune to the virus.
- If you have no symptoms, you likely do not have an active infection and no additional follow-up is needed.
- It’s possible you might test positive for antibodies and you might not have or have ever had symptoms of COVID-19. This is known as having an asymptomatic infection [ie you have a healthy immune system!]
- An antibody test cannot tell if you are currently sick with COVID-19.
If you test negative:
- If you test negative for antibodies, you probably did not have a previous infection. However, you could have a current infection because antibodies don’t show up for 1 to 3 weeks after infection.
- Some people may take even longer to develop antibodies, and some people may not develop antibodies.
- An antibody test cannot tell if you are currently sick with COVID-19.
- Doesn’t the vaccine industry call the IgG a “protective antibody”?
- Isn’t this the marker of immunity they assess after you’ve had an infection with measles or chickenpox or mumps to determine if you are immune to future infections?
- Isn’t this the marker of induced immunity they are trying to achieve by administering a vaccine?
If the FDA does not know if an IgG antibody to SARS-CoV-2 after recovering from the infection is protective against a future infection, then they certainly don’t know if an antibody caused by a vaccine will prevent infection either.
Doesn’t this completely eliminate the theory that antibodies afford protection and antibodies from vaccines are necessary to keep you from getting sick?
Mandatory Testing – New Job Creation
Until we have a vaccine to defeat this dreaded disease, contact tracing in order to understand the full breadth and depth of the spread of this virus is the only way we will be able to get out from under this.
H.R. 6666 would authorize the Secretary of Health and Human Services (HHS), acting through the Director of the CDC to award grants to eligible entities to conduct diagnostic testing and then to trace and monitor the contacts of infected individuals. The contact tracers would be authorized to test people in their homes and as necessary, quarantine people in place.
Where do they intend to do this testing? Besides mobile units to test people in their homes, the bill identifies eight specific locations where the testing and contract tracing could occur: schools, health clinics, universities, churches, and “any other type of entity” the secretary of HHS wants to use.
The bill would allocate $100 billion in 2020 “and such sums as may be necessary for fiscal year 2021 and any subsequent fiscal year during which the emergency period continues.”
But what are they looking for?
- Is your test supposed to be positive – saying you’ve been exposed and you’ve possibly recovered?
- Or is your test supposed to be negative, meaning, you are healthy?
- Or does a completely negative test – negative RT-PCR test and no IgG antibody mean you’re susceptible to infection and you need to stay in quarantine?
The virus is rapidly mutating, which is rather typical of RNA viruses. In a study published in April 2020, researchers have discovered that the novel coronavirus has mutated into at least 30 different genetic variations. If your RT-PCR test is positive, does this identify exposure to the pandemic virus or exposure to one of the genetic variations? The same can be said about the vaccines under development: With each mutation, is the vaccine more likely to be all risk and no benefit when it reaches the market?
What You Can Do
Across the nation, police are being told to not apprehend criminals but instead, to arrest parents at playgrounds, to arrest lone surfers on public beaches, to fine ministers and congregation members sitting in their cars listening to a service on the radio, and to restrict movement by creating one-way sidewalks.
People have had enough. They are beginning to see the huge scam that has been perpetrated on the entire world over a viral infection with a global death rate of 1.4% (meaning, 1.4% of people infected with SARS-CoV-2 have a fatal outcome, while 98.6% recover). This is far fewer deaths than a severe flu season.
We’re already starting to see the thrust to take our power back:
- In Virginia, people went to the beaches en mass, ignoring social distancing and the orders of the Governor to stay home.
- The central California city of Atwater has declared itself a “sanctuary city,” allowing business owners and churches to open, openly defying Democratic California Gov. Gavin Newsom’s coronavirus-related stay-at-home order.
- The truth about wearing masks is starting to come out and people are voting with their feet. Retired neurosurgeon, Dr. Russell Blaylock, warns that not only do face masks fail to protect healthy people from contracting an illness, but they create serious health risks to the wearer.
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