April 24, 2020 © Moira Dolan MD
FDA allows marketing of it, but has “not formally approved” testing for antibodies to the virus causing CoVID.
That is because no one has validated the test. The manufacturer Cellex, Inc. is the only one to have tested its own product.
There is not much public information on this company, but Dun & Bradstreet indicates Cellex has 5 total employees.
Negative results do not rule out past infection; antibodies might not have had enough time to form, or the virus could have had mutations, and thus fail to be recognized by the antibodies screened for in the test.
The new coronavirus, like all other viruses, mutates, or undergoes small changes in its genetic structure.
A study published in National Science Review in early March 2020 demonstrated that SARS-CoV-2 had already mutated: 70% of the blood samples from 103 confirmed Wuhan cases were ‘L’ type, more virulent, and 30% were ‘S’ type, less virulent.
The study also documented that the prevalence of the more virulent ‘L’ strain decreased after early January.
By April 2020, at least 8 strains had been identified.
This is exactly the behavior expected of a virus when it runs through a population unhindered.
The virus is not trying to kill us, for the excellent reason that it cannot replicate without using the cellular machinery inside a live host.
Therefore, from the the viewpoint of the virus, it’s trying to replicate itself as many times as it can. For a virus, ‘survival’ means getting better at spreading, not getting better at killing.
This occurred with the viral infection called measles, and contributed to 15-fold lower death rates from 1917 to 1960 in measles-infected persons, well before the first vaccine was given in 1963. See the graph on page 85 of this CDC document.
So while vaccines can claim credit for decreased cases of measles since 1963, they cannot claim credit for the lion’s share of the reduced death rates when viewed across decades.
The natural decline in measles deadliness was due to the virus mutating, at the same time that the host population grew more familiar with it and developed natural, long lasting antibodies, without any dependence of vaccination.
A negative or non-reactive result can also occur if the quantity of antibodies to the SARS-CoV-2 virus present in the specimen is below the detection limit of the assay.
Also, false positives can occur due to cross-reactivity with antibodies from previous infections, ”such as from other coronaviruses, or from other causes,” the package insert states, without further specifics.
At least one commercial lab site indicates that positive results on its antibody test may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. There is the potential to detect antibodies to a coronavirus strain that had caused a common cold a person had 10 years ago.
Most concerning is that the FDA waived good manufacturing practice requirements for Cellex.
In plain language, the test manufacturer does not have to adhere to basic regulations for the methods, facilities, and controls used in manufacturing the test. This includes certain minimum requirements for supervision and quality control.
In summary, line up for the CoVID antibody test with eyes wide open by knowing that the company’s claims have not been validated.
Links to other CoVID news:
Diamond Princess: Surprisingly very low case fatality ratio and case infection fatality ratio.
California can schedule elective surgeries.
States begin to loosen restrictions.
Hydroxycholoroquine ineffective in VA study.