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Update 23.07.2020:
With the specificity from the INSTAND interlaboratory comparison
(see below) of 99.3%, it is still not possible to calculate meaningful
figures - a publication from June, in which Christian Drosten, among
others, participated and which examined the specificity of RT-PCR
under conditions of "real" (laboratory) life (Matheeussen 2020),
resulted in a false positive rate of 0.58%. If this is taken as a basis, the
above figures are obtained.
But of course, the same applies to the RKI as the Bavarian LGL freely
admitted: whether testing is done with one or two targets, whether
positive results are cross-checked... All this is not known in Berlin at
the RKI as well as in Erlangen at the LGL.
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Update 28.06.2020: Meanwhile, the total positive test results of RT-
PCR are regionally so low that they cannot be brought into agreement
with the specificity of the INSTAND interlaboratory test (99.3%) -
what can be the reason for this?
RT-PCR can in principle detect two different gene sequences
("targets") for SARS-CoV-2 and, if both sequences are detected in one
sample, achieves specificities of almost 100%.
However, in a publication of March 19, 2020, the WHO has decreed
for regions affected by the pandemic that the detection of only one of
the targets is sufficient for the sample to be found "positive": "In areas
where COVID-19 virus is widely spread a simple algorithm might be
adopted in which, for example, screening by rRT-PCR of a single
discriminatory target is considered sufficient. (WHO 19.03.2020) This
results - due to the missing double determination - naturally in a
significantly lower specificity and thus a significantly higher rate of
false-positive results.
This generous offer of the WHO was of course accepted by numerous
laboratories (fewer determinations means: less costs), the MVZ
Augsburg even got an article in an Austrian newspaper (Wochenblick
17.05.2020) via its blog entry of 03.04. (the entry has been deleted
from the laboratory's blog in the meantime, but was definitely still
there on 18.05.)
It is not known how many laboratories issue positive results for the
detection of one target, how many determine both targets from the
beginning and how many at least positive tests with one target are
then checked with the other (retesting as described in the article of the
NZZ below) - this double determination or retesting obviously
increases the specificity relevantly beyond 99.3%.
To which value? Here RKI, PEI & Co are silent... .
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Update 15.06.2020: Here you can download a small Excel-calculator
to calculate the number of false-positive test results from the RKI's
figures on tests and positive test results and see how other values for
sensitivity and specificity affect these figures. You can then also see
(via the PPW) how low the significance of a positive test result is at
present.
And here - from minute 13:10 - you can see that the (very obviously
difficult) topic has meanwhile even reached the Federal Ministry of
Health:
1. The test should reliably find all those who are really ill/infected,
i.e. not to overlook anyone - this is called the sensitivity of a
test.
2. The test should reliably find only those who are really ill, i.e. who
are not positive in anyone who is not ill/infected - this is called the
specificity of a test.
The sensitivity and specificity of a test are its characteristics and are
usually documented and published (at least to a professional
audience) as part of the regulatory approval process.
All test procedures suffer from two dilemmas:
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