2020 · Victor M. Corman, Christian Drosten and colleagues
Detection of 2019 Novel Coronavirus (2019-nCoV) by Real-Time RT-PCR
What this work is
The January 2020 paper that set out the first PCR test for the new coronavirus. With no virus sample in hand, the authors designed primers from genetic sequences in public databases and checked the test against synthetic RNA made from those same sequences. They report the test as sensitive and specific, and it became the template for testing worldwide.
Then and now
Corman, Drosten and colleagues showed that primers built from database sequences matched synthetic RNA made from the same sequences. That paper became the basis for testing the whole world, and case counts and the pandemic response rested on it. The test matched its own template, and nobody has seen the virus.
Verdict
UNSCIENTIFIC
Neither the paradigm nor the work inside it passes. The verdict is unscientific.
1·This work · inside the paradigm
UNSCIENTIFIC
Does not follow the scientific method within Virology.
2·Paradigm · Virology
UNSCIENTIFIC
Fails the tests. The worse layer decides.
How the verdict is decided
The verdict grades both layers: the paradigm this work assumes, and how the work was carried out inside it. Both must be scientific for the whole thing to be scientific. A clean method inside an unscientific paradigm is unscientific. An unscientific method inside a better paradigm is unscientific. A split on either layer is mixed. The worse layer decides.
1·This work
Did this work test its claim with methods that are independent, falsifiable, and non-circular?
UNSCIENTIFIC
This study claims a lab test can reliably detect the new coronavirus in patient samples, even though it was designed without any virus sample from any patient. All three tests fail.
Independently Verifiable
Fail
The machine gave off a fluorescence curve, and the model told them the curve meant the new coronavirus, with no patient sample ever proving a virus was in the tube.
Falsifiable
Fail
The assay was validated against synthetic RNA copies of the same sequences the primers were built from, so a match was guaranteed and no result could count against the test.
Non-Circular
Fail
The primers were built from downloaded sequences, the positive control was synthetic RNA made from those same sequences, and the match between the two was reported as proof the test works.
Why
The only readout is a fluorescence curve, and the model says the curve is the virus. The positive control was synthetic RNA made from the same sequences the primers came from, so a match was guaranteed and no result could count against the test. That guaranteed match is then reported as proof the test works, which closes the loop.
2·Paradigm · Virology
Does the framework this work assumes pass the three tests?
UNSCIENTIFIC
Independently Verifiable
Fail
A virology test ends in a fluorescence curve or a dying cell culture, and only the model can say that curve or that dying is a virus.
Falsifiable
Fail
When the test finds nothing in a sick person, the field says low viral load or a new variant, and no negative result has ever been accepted as proof viruses do not exist.
Non-Circular
Fail
Each new test is built from the sequences of earlier claimed viruses, so the tools that find viruses are made from the claims they are supposed to confirm.
Why
This paper shows the field's method in its purest form. A virus nobody has isolated, defined by sequences in a database, used to build primers, which are then used to detect the virus in the same sequences. The field never put the entity at risk. When this assay's claimed virus never arrived in a sample for the authors to check against, the protocol was deployed worldwide anyway. When sick people test negative, the answer is low viral load. When healthy people test positive, the answer is asymptomatic infection. When the primers miss, the answer is a variant. The model treats a tagged chemical signal as the disease itself, instead of asking what damaged the patient's lungs in the first place. The signal is real. The virus is the naming.
From the work
In the present case of 2019-nCoV, virus isolates or samples from infected patients have so far not become available to the international public health community.
Design and validation were enabled by the close genetic relatedness to the 2003 SARS-CoV, and aided by the use of synthetic nucleic acid technology.
Before public release of virus sequences from cases of 2019-nCoV, we relied on social media reports announcing detection of a SARS-like virus. We thus assumed that a SARS-related CoV is involved in the outbreak.
In four individual test reactions, weak initial reactivity was seen but they were negative upon retesting with the same assay... it was concluded that this initial reactivity was not due to chemical instability of real-time PCR probes but most probably to handling issues.