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RT-PCR tests for SARS-CoV-2 are invalid and should be retracted

WHO has an information note issued Jauary 20th 2021 asking labs to consider procedures which seems to be of major concern for the WHO 1.

Among those things the WHO states:

WHO reminds IVD users that disease prevalence alters the predictive value of test results; as disease prevalence decreases, the risk of false positive increases 2. ”

In Sweden the authorities presently perform about 250 000 RT-PCR tests per week with 5.4 % positive RT-PCR tests 3.

The WHO information is pinpointing the problem of false positive tests.

This means that we have to calculate additional values like Positive Predicted Value 4 (PPV) and Negative Predicted Value 5 (NPV)

How many of those quarter of a million weekly tests are false positive and how many are false negative tests?

By calculating the PPV and NPV using the published Sensivity value of 0.90 and Specificity value 0.98 6 and the Swedish Public Health Authority (FHM) published percentage of positive RT-PCR tests during week 48 gives the Prevalence of 5.4 %.

By calculating the PPV the result is 0.339 which gives 66 % false positive results 7 and the NPV is 0.932 which gives 7 % false negative results.

By using the highest available proportion of positive tests in December 2020 of 20 % of total tests still gives a PPV of 0.692 equals 31 % false positive tests.

The numbers given by FHM of 13 805 positive RT-PCR tests in week 48 of year 2021 means that only4 680 were truely positive and 9 125 positive RT-PCR tests were falsley positive. Two thirds of all 13 805 tests are falsely positive, they have been tested positvely but do not have SARS-CoV-2 or Covid-19.

This is because when the prevalence in society is low, there are few persons who are infected and infectious in the society.

In Sweden just 0.045% of the population are infected or I have to meet 2,222 other people in a week to even face a risk of getting infected.

But who can tell which 4,680 persons out of 13,805 individuals that were truly positive?

Neither I, you or the Folkhälsomyndigheten have the means to select the infected persons.

The conclusion is that the RT-PCR tests for SARS-CoV-2 are invalid and can not be used for diagnostic purposes and should be retracted from January 20th, 2021.

According to the Swedish Constitution 1st chapter 1st§ 3rd paragraph 8 and 9th § 9take into account everyone's equality before the law and observe objectivity and impartiality.”

Also, the EU judicial system as European Convention of Human Rights and The Charter Of Fundamental Rights Of The European Union (CFREU) forbid states within the EU/EES to break any of the Articles.

Most EU members violate several of the CFREU that is signed as late as December 1st, 2009.

Lockdowns, masks, travel restrictions, mandatory injections quenching our fundamental rights are the dark shadows of Dr Mengele popping up 75+ years after the Nuremberg trials in Germany.

The Swedish Public Health Authority as well as the Government must have been aware of the WHO requirements. Still, they have not taken any action like retraction of the RT-PCR tests retroactively as per January 20th, 2021 which means the authority is either totally ignorant or not following the Swedish Constitution.

In either case the these seemingly malfunctioning authorities should immediately retract the RT-PCR tests and the authorities should be restaffed with knowledgeable persons obeying the Swedish Constitution.

Östervåla, Sweden, December 13th, 2021

Björn Hammarskjöld

Assistant Professor in Pediatrics at Strömstad Academy

 

References:

1WHO Information Notice for Users 2020/05
https://www.who.int/news/item/20-01-2021-who-information-notice-for-ivd-users-2020-05 Downloaded December 11, 2021

2Altman DG, Bland JM. Diagnostic tests 2: Predictive values. BMJ. 1994 Jul 9;309(6947):102. doi: 10.1136/bmj.309.6947.102. 

3Folkhälsomyndigheten Aktuell veckorapport om covid-19 Denna rapport publicerades den 10 december 2021 och redovisar läget för covid-19 till och med vecka 48 (29 november – 5 december 2021). FHM Weekly report week 48
https://www.folkhalsomyndigheten.se/globalassets/statistik-uppfoljning/smittsamma-sjukdomar/veckorapporter-covid-19/2021/covid-19-veckorapport-2021-vecka-48-final.pdf

4PPV = (sensitivity×prevalence + (1 - specificity)×(1 – prevalence)) / (specificity×(1 - prevalence))

5NPV = (1 - sensitivity)×prevalence + specificity×(1 - prevalence)

6Elisa KortelaMaarit J Ahavaet al, Real-life clinical sensitivity of SARS-CoV-2 RT-PCR test in symptomatic patients. PLoS One 2021 May 21;16(5):e0251661. doi: 10.1371/journal.pone.0251661. eCollection 2021

71-0.339=0.661 is 66 %

8Swedish Constitution 1st chapter 1st§ 3rd paragraph “Public power is exercised under the laws.

9Swedish Constitution 1st chapter 9th § “Courts, administrative authorities and others who perform public administration tasks shall take into account in their activities everyone's equality before the law and observe objectivity and impartiality.”