In early 2020 when an outbreak of pneumonia of “unknown etiology” was reported in Wuhan, China, a report was published in the journal EUROSURVEILLANCE on the detection of a novel coronavirus which later came to be identified as COVID-19.
Since viruses cannot be grown in a lab dish (that is because viruses can only replicate inside a living cell), they cannot be cultured and multiplied like a bacteria sample. So, the polymerase chain reaction (PCR) test was utilized and is the standard test to confirm COVID-19 infection today.
PCR involves a method to rapidly produce millions to billions of copies of a specific DNA sample sufficient enough for analysis, given that coronaviruses are only 80-220 nanometers in size. COVID-19 is reported to be 120 nanometers in diameter. (A nanometer = 1 billionth of a meter) Here is an electron micrograph image of a coronavirus.
A viral genome sequence was released to laboratories for analysis and the conclusion was it was “very closely related to members of a viral species termed severe acute respiratory syndrome (SARS).” Based upon reliable confirmation of the PCR test using “virus isolates,” the PCR test became the standard test for COVID-19.
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The PCR test was initially validated by real viral isolates from the prior SARS (severe acute respiratory syndrome) outbreak of 2003.
However, researchers concede: “In the present case of 2019-nCoV (COVID-19), virus isolates or samples from infected patients have so far not become available to the international public health community.”
In other words, the scientific community did not have a complete virus to use to confirm COVID-19, only a “viral genome sequence,” a snippet of genetic material “very closely related” to COVID-19.
That was January 2020. Fast forward to December 2020. The FDA published a guidebook for PCR testing of COVID-19, marked “for emergency use only.” The title of the publication is: CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, and was initially published in February, 2020, and then re-published in July.
On page 42 of that document it says this:
Since no quantified virus isolates of the 2019-nCoV were available for CDC use at the time the test was developed and this study conducted, assays designed for detection of the 2019-nCoV RNA were tested with characterized stocks of in vitro transcribed full-length RNA of known titer spiked into a diluent consisting of a suspension of human A549 cells and viral transport medium (VTM) to mimic clinical specimen.