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The Trouble With PCR Tests

PCR cycle threshold (11-37) and positive cell culture (black line, 100% to 0%). The colored bars
indicate the number of positive cell cultures per ct per week a er infection (1 to 3 weeks).
(Jafaar/Raoult)
Published: October 4, 2020
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Already in mid-March, SPR explained that the highly sensitive PCR tests are
prone to producing false-positive results and their individual predictive value
may easily drop below 50%.

The issues with PCR tests are numerous:

1. There can be large-scale test kit contamination, as both the US and the

UK (and several African countries) discovered during the early phase of the
pandemic.

2. There can be testing site or lab contamination, which has led to countless
false positive results, school closures, nursing home quarantines,
canceled sports events, and more.

3. The PCR test can react to other coronaviruses. According to lab

examinations, this happens in about 1% to 3% of cases if only one target
gene is tested, as is the case in many (but not all) labs and as the WHO
itself has recommended to avoid ambiguous positive/negative test
results.

4. The PCR test can detect non-infectious virus fragments weeks a er an

active infection, or from an infection of a contact person, as the US CDC
confirmed.

5. The PCR test can detect viable virus in quantities too small to be
infectious (see below).

If the virus is not widespread in a population, and there is no test kit or lab
contamination, and labs test for at least two target genes, the risk of a false-
positive result is low. This is why, for instance, New Zealand at times had no
positive PCR tests for weeks despite frequent testing.

But if there is an ongoing infection wave, or if there has been a recent

infection wave, or if labs test only for one gene sequence or struggle with
contamination, things get more complicated.

A PCR test is amplifying samples through repetitive cycles. The lower the virus
concentration in the sample, the more cycles are needed to achieve a positive
result. Many US labs work with 37 to 40 cycles, while many European labs
work with 30 to 40 cycles.

The research group of French professor Didier Raoult has recently shown that
at a cycle threshold (ct) of 25, about 70% of samples remained positive in cell
culture (i.e. were infectious); at a ct of 30, 20% of samples remained positive;
at a ct of 35, 3% of samples remained positive; and at a ct above 35, no
sample remained positive (infectious) in cell culture (see diagram).

This means that if a person gets a “positive” PCR test result at a cycle
threshold of 35 or higher (as applied in most US labs and many European
labs), the chance that the person is infectious is less than 3%. The chance
that the person received a “false positive” result is 97% or higher.

(Note that the exact figures depend on the test and lab in question, and that if
a sample was already positive at a lower cycle threshold (e.g. 20), chances of
infectiousness are much higher.)

Juliet Morrison, a virologist at the University of California, Riverside, explained

to the New York Times: “Any test with a cycle threshold above 35 is too
sensitive. I’m shocked that people would think that 40 could represent a
positive. A more reasonable cutoff would be 30 to 35.” According to the New
York Times, up to 90% of positive tests at a cycle threshold of 40 would be
negative at a ct of 30.

On the other hand, a negative result at a cycle threshold above 35 still does
not exclude a covid infection, due to the problem of false negatives (e.g.
sample taken improperly or too early). More recently, US researchers found
that single-gene tests were false-negative due to new mutations.
 The above considerations are valid at the individual level. At the aggregate
level, if the adjusted number of positive PCR tests is suddenly increasing, this
certainly indicates an infection wave. The problem then is that in many
places, PCR testing has been catching at most 10% of all infections.

In conclusion, while PCR tests at high-risk places like hospitals, nursing

homes and other sensitive locations are vital and undisputed, the benefit of
mass PCR testing in the general population, which is costing mid-sized
countries billions, may be somewhat more debatable.

See also: Are you infectious if you have a positive PCR test result for COVID-
19? (Oxford CEBM)

See also

Facts about Covid-19

Studies on Covid-19 lethality

On the origin of SARS-CoV-2

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