Pitfalls found in SARS CoV-2 specific test performance

Genekam Biotechnology AG, Germany has developed a number of real time PCR kits to detect the coronaviruses and other viral targets. FR475 is one of the first kit developed to detect SARS CoV-2 (Wuhan strain) in Jan, 2020.

One of the important methods to detect the SARS CoV-2 is polymerase chain reaction (PCR). There are a number of real time PCR tests, which are recommended from World health organization (WHO). Usually, the WHO recommended test should give correct results. During the comparison between WHO test for N gene and ready to use PCR kit FR475 of Genekam Biotechnology AG, it was found that WHO test gave false positive in the negative samples and correct positive results in positive samples. As this method is used from many laboratories as in-house method and many commercial companies around the world have developed their kits based on WHO tests. The results of this research work are showing that there should be around 30% false positive results as well as there are problems of reproducibility of the results, hence there is a need that the laboratories run the tests to show that these in-house or commercial assays are free from these pitfalls. This study also may indicate why we have so many symptomless cases, hence this must be investigated.

The questions will be now how many tests are false positive in the world? People paid a lot of money for a real time PCR test for coronaviruses and they may not be getting the accurate results. Such inaccurate results may have forced many people to go for stress conditions like self-isolation and may lose the wages.

Here is the link of our research, which can be read and the laboratories along with commercial companies should run their tests to exclude the possibilities that these are not giving false positive results in this way one can build the trust among the users and end pandemic outbreak quickly. One can use FR475 Kit from Genekam to make the comparison.

Press release Pitfalls found in SARS CoV2 (.pdf)

Press release Pitfalls found in SARS CoV2 (.docx)

Link: Pitfalls found in SARS CoV-2 specific test performance during the comparison between WHO recommended method and a commercial test (figshare.com)

Genekam Coronavirus PCR kit detects samples with different mutations like Omicron and delta without loss of performance.

Duisburg, 13.01.2022: Coronaviruses are getting mutated, hence there are different mutations like B 1.1.529, B1.1.671, B.1.17, P1and B1.135. These mutations are causing that many PCR tests do not give the correct  results, hence it leads to false results. Therefore, many manufacturers around the world as well as FDA have given the warnings as approved kits do not give correct results. Even CDC tests have been removed from the FDA list of emergency approvals.  Omicron variant has a lot of mutations in the genome of the virus; hence many kits may not be able to detect this.

In Germany, there is very hot discussion going about the quality of rapid tests to detect these mutations today and it is being found that antigen tests have very low quality leading to many wrong results. This may indicate why we have so high incidences of infections around the world?

Genekam developed one of the first PCR for detection kit FR475 for SARS CoV-2 in Jan, 2020. This kit FR475 detects the samples with different mutations like Omicron, delta, Alfa etc perfectly, therefore these mutations have no impact on the results conducted with Genekam kit. This kit has been used last year in many countries as the countries using Genekam kit have last year very low incidents of coronaviruses, but with the time, WHO/CDC/FDA/CE approved kits came on the market, after that the incidents have increased so strongly that many countries lost their grip on the spreading of this virus.

These mutations are increasing with time; therefore all kits being used in coronaviral pandemic outbreak must give an assurance that approved kits or methods from CDC and WHO detects coronaviruses (SARS Co-V, Wuhan strain) properly and mutations does not have any impact on their performance.

Recent research work from Genekam is showing that some primers and probes for NP gene may like to give false wrong results as these in house kits are recommended from the world leading organization like WHO. It shows that one must have very good knowledge to develop a good assay for coronaviruses and laboratories must conduct their own quality control. Many laboratories are using such primers and probes; hence these laboratories must be screened for accuracy of their results.

Genekam FR475 kit is not the only one, which is giving excellent results. In 2016, Genekam created double check for Zika viruses as there are many strains, which are not being detected through normal commercial kits of many manufacturers. In 2017, Genekam kit for Influenza virus H5N1 outperformed the other kits in UEA as it detects samples from Africa, which were infected with H5N1 against the other commercial kits, which were fail to detect such infected samples.

The tests were conducted in a laboratory in Abu Dubi. These examples show as this is very important to have a deep knowledge of virology to develop an excellent kit. Many of companies developing kits for pandemic viruses do not have any deep knowledge of virology, but they get approval from FDA, WHO and EU, hence it is time to compare the performance of different kits available on the market, so that poor quality kits (many of them are coming from big biotech companies) are removed from the market, but authorities are not interested to do this, hence this must be discussed in the press. Genekam is requesting such action for last 6 years. European countries have taken no action till today against such kits for coronaviruses as they are part of diagnostics. European community must access these kits for their ability to detect the Omicron, delta and other mutations.

Major mutations N501Y, E484K, N417N/T along many dozens of other common and rare mutations are matter of concern as N501Y occurs in receptor binding domain leading to increase in rate of binding between the receptors ACE2 and virus. It means rate of transmission will increase strongly. As these are mutations in spike and nucleoprotein regions, hence the immunity can decrease and recovered persons can reinfect, such mutations may lead to have negative effect on vaccination as well as therapies available now. Therefore, it is important that laboratories use PCR kits, which detect samples with mutations too to provide good results. It is possible with Genekam FR475.

Genekam Biotechnology AG is a German company focusing on pandemic viruses for last 16 years as it has large number of tests for different pandemic outbreak causing viruses like Influenza, Zika, Ebola, dengue, coronaviruses and Rift valley virus. It is working on developing the therapeutic antibodies and small molecules to cure these viruses one day. It develops and manufactures its products in Germany.

Duisburg, 14.12.2021: Die Genekam Biotechnology AG hat ein Molekül entwickelt, das erfolgreich gegen  Coronaviren wirkt. Dieses in der Herstellung sehr preisgünstige Molekül  hat eine besondere Bedeutung für die Prävention. Bei Einnahme der Moleküle wird die Infektion verhindert, falls eine Infektion stattfinden sollte, würde diese Infektion einen sehr milden Verlauf haben. Während der Infektion (ohne Einnahme des Moleküls) haben die Leute normalerweise Symptome wie sehr schmerzhaftes Jucken im Hals (sehr starkes Nadelstichgefühl im Halsbereich). Gegen dieses schmerzhafte Nadelstichgefühl gibt es keine wirksame Therapie. Sobald man dieses Powermolekül genommen hat, werden diese schmerzhaften Symptome und andere Symptome, wie Husten verschwinden. Es gibt so gut wie keine Nebenwirkungen. Es hat auch einen positiven Effekt auf den Zuckerhaushalt des Körpers. Das Molekül wirkt auch gegen andere Coronaviren und bietet die Möglichkeit, die Breakthrough-Infektionen unter Kontrolle zu bringen. Das Molekül wird in Tröpfchenform eingenommen. Die Haltbarkeit wird noch geprüft, aber sie sollte bei mehreren Jahren liegen.

Für Angehörige des Gesundheitssystems, Polizei und Bundeswehr und andere, die viel Kontakt zu anderen Menschen haben, ist das Molekül eine Lösung. Die Wirkung des Powermoleküls wird durch zusätzliche Maßnahmen wie das Tragen einer Maske noch verstärkt.

Eine weitere wichtige Anwendung des Moleküls ist, dass Journalisten, die bei Interviews oder in Talkshows  ständig in Kontakt mit anderen Personen und Politikern kommen, das Risiko durch diese Powermoleküle für sich selbst und die Teilnehmer herabsetzen können. Andere Beispiele sind Landtag bzw. Bundestag, wo die Politiker sich treffen müssen und durch Einnahme dieses Moleküls eine Infektion verhindern können. Dieses Powermolekül kann auch dazu beitragen, dass die Bürger sich nur einmal die Woche oder alle zwei Woche testen lassen müssen, falls sie dieses täglich nehmen. Dadurch werden 2G und 3G überflüssig. Das Molekül kann auch die Breakthrough-Infektionen verhindern, dadurch kann man die Erfolgsrate der Impfungen verbessern und es  kann auch dazu beitragen, dass man Zeit gewinnt, damit die Wissenschaft die Impfstoffe verbessern kann. Auch für Straßenbahnfahrer und Piloten kann das  Molekül hilfreich sein, da sie  mit weniger Risiken ihrem Beruf nachgehen können. Für Angehörige des  Gesundheitssystems, die viel Kontakt mit erkrankten Personen haben, kann das Molekül eine sehr große Bedeutung haben. 

Dieses Powermolekül kann auch eine  große Hilfe für Ungeimpfte werden, damit sie sich gegen die Infektion schützen können, bis ein besserer Impfstoff verfügbar ist, dem sie vertrauen können. 

Die Genekam Biotechnology AG ist eine auf Virologie spezialisierte Firma und war immer eines der ersten Unternehmen, das Lösungen für beispielsweise die Vogelgrippe, Schweinegrippe, Ebola Viren, MERS Viren (Middle East Respiratory Syndrome Virus: SARS Virus) entwickelt hat. Genekam hat circa 700 verschiedene Testsysteme für Viren, Antibiotikumresistenz-Stämme, Malaria, Dengue, Mycobacterium tuberculosis (TB) etc. Des Weiteren wird versucht, Stammzelllösungen zu entwickeln. Genekam entwickelt und produziert die Produkte in Deutschland (Standort: Duisburg). Zurzeit versucht Genekam, zusammen mit einem Partner aus den USA potentielle therapeutische Moleküle und Impfstoffe gegen Viren zu entwickeln.

Genekam Biotechnology AG has developed one of first world´s magnetic beads ELISA test
as point of care assay for coronaviruses, which is 1000 times more sensitive and can be
finished within 50 minutes against the routine ELISA method, which takes hours to be
performed and give the results with low sensitivity.

Moreover, it can be performed anywhere in the world against the conventional ELISA and
PCR tests, which need special instruments, hence they can be performed only in special
laboratories. Cost of Genekam test is Euro 1 against PCR test, where the costs are Euro 8.
Magnetic beads are being used in medicine to perform a number of tasks e.g. isolation of
RNA and cell separation for development of immunotherapies. Genekam biotechnology AG
has been developing a number of solutions based on magnetic beads. ELISA is one of
common serological methods, which is being used to detect antibodies as well as antigens
for last many decades. ELISA method needs a plastic plate and it takes 7 hours to 2 days
to be performed. It needs instruments as the plates must be kept at particular temperatures.
Therefore, ELISA is being performed in professional laboratories.

Genekam has developed magnetic beads ELISA, which can be performed in anywhere e.g.
in small clinics in the world like in Africa or remote areas of Saudi Arabia as point of care
ELISA can help to detect the cases of coronaviruses as early as possible and the results
can be read with naked eyes also along with reading the results with the machine This
method has biggest advantage against PCR method, where one has to collect the sample
and send to laboratory to perform the diagnosis leading to loss of valuable time as during
this time, the viruses spread while treatment and prevention cannot start properly.
Genekam magnetic beads ELISA is going to change this. Magnetic beads ELISA is far
better than rapid tests, which have very low sensitivity against ELISA even and problem of
cross reactivity as this month studies conducted in Germany shows that rapid tests from
one of biggest biotech company has 70% sensitivity for coronaviruses.

Genekam magnetic beads ELISA can change this because remote rural areas can have
now an access to excellent quality testing system. This test does not need any power
supply and can be performed at room temperature against PCR, where the chemicals must
be frozen. Genekam magnetic beads ELISA detects the presence of antibodies. It can also
indicate whether the person is exposed to coronaviruses infection along with indicating that
the active disease is being developing because infected person is going to develop
symptoms. The cost Euro 1 per test of Genekam magnetic beads ELISA is lower than
ELISA as well as PCR tests. Genekam is trying to develop a new version of this test, where
the cost may go down to 30 cents per test against the ELISA 3 Euro and PCR test 8 Euro.
Genekam Biotechnology AG is a German company focusing on pandemic viruses for last
16 years as it has large number of tests for different pandemic outbreak causing viruses
like Influenza, Zika, Ebola, dengue, coronaviruses, Rift valley virus. It is working on
developing the therapeutic antibodies and small molecules to cure these viruses one day.
It develops and manufactures its products in Germany

Coronaviruses are getting mutated, hence there are different mutations like B117, P1 and
B1.135. These mutations are causing that many PCR tests do not give the correct the
results, hence it leads to false results. Therefore, many manufacturers around the world
as well as FDA have given the warnings as approved kits do not give correct results.
Genekam developed one of the first PCR for detection kit FR475 for SARS CoV-2 in Jan,
2020. This kit FR475 detects the samples with different mutations perfectly, therefore
these mutations have no impact on the results conducted with Genekam kit. This kit has
been used last year in many countries as the countries using Genekam kit have last year
very low incidents of coronaviruses, but with the time, WHO/CDC/FDA/CE approved kits
came on the market, after that the incidents have increased so strongly that many
countries lost their grip on the spreading of this virus. These mutations are increasing with
time; hence all kits being used in coronaviral pandemic outbreak must give an assurance
that approved kits or methods from CDC and WHO detects coronaviruses (SARS Co-V,
Wuhan strain) properly and mutations does not have any impact on their performance.

Genekam FR475 kit is not the only one, which is giving excellent results. In 2016,
Genekam created double check for Zika viruses as there are many strains, which are not
being detected through normal commercial kits of many manufacturers. In 2017,
Genekam kit for Influenza virus H5N1 outperformed the other kits in UEA as it detects
samples from Africa, which were infected with H5N1 against the other commercial kits,
which were fail to detect such infected samples. The tests are conducted in a laboratory in
Abu Dubi. These examples show as this is very important to have a deep knowledge of
virology to develop an excellent kit. Many of companies developing kits for pandemic
viruses do not have very deep knowledge of virology, but they get approve from FDA,
WHO and EU, hence it is time to compare the performance of different kits available on
the market, so that poor quality kits (many of them are coming from big biotech
companies) are removed from the market, but authorities are not interested to do this,
hence this must be discussed in the press. Genekam is requesting such action for last 6
years.

Major mutations N501Y, E484K, N417N/T along many dozens of other common
mutations are matter of concern as N501Y occurs in receptor binding domain leading to
increase in rate of binding between the receptors ACE2 and virus. It means rate of
transmission will increase strongly. As these are mutations in spike and nucleoprotein
regions, hence the immunity can decrease and recovered persons can reinfect, such
mutations may lead to have negative effect on vaccination as well as therapies available
now. Therefore, it is important that laboratories use PCR kits, which detect samples with
mutations too to provide good results. It is possible with Genekam FR475. Genekam
Biotechnology AG is a German company focusing on pandemic viruses for last 16 years
as it has large number of tests for different pandemic outbreak causing viruses like
Influenza, Zika, Ebola, dengue, coronaviruses and Rift valley virus. It is working on
developing the therapeutic antibodies and small molecules to cure these viruses one day.
It develops and manufactures its products in Germany