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Coronavirus testing by RT-PCR for PLN 500 without leaving your home – such an offer has recently appeared on the web. We check what this test is about, whether its results can be trusted and what the Ministry of Health’s position on commercial research is.
Ministry of Health on paid tests
The editors of MedTvoiLokony each day receive questions about is it possible to perform paid tests to detect coronaviruswhich proves a very high demand for this type of services. The position of the National Health Fund is clear: “It is the doctor who decides whether to test for coronavirus. The World Health Organization (WHO) does not recommend commercial testing ». The introduction of the virus diagnostics price list at the Provincial Infectious Hospital in Warsaw at the end of February met with strong opposition from the Minister of Health. The current position of the ministry in an interview with Medonet was presented by the spokesman of the Ministry of Health, Wojciech Andrusiewicz:
Our recommendation is to conduct tests under the auspices of the Ministry of Health on medical indications, on orders from sanitary and epidemiological stations and doctors. There is a risk that a person who is infected with the coronavirus may come to a private laboratory. Is a private station able to isolate such a person during the examination and waiting for the result, and then transport them safely, even to the nearest hospital? If there is no such possibility, it is dangerous both for that person and for the local community. We can guarantee the quality of tests performed only by those laboratories that we have in our records and which perform tests commissioned by hospitals or sanitary and epidemiological stations. In the case of laboratories that perform commercial research, we cannot give such a guarantee.
The diagnosis of the SARS-CoV-2 coronavirus is a multi-stage procedure during which special precautions should be taken, because the tests are performed on potentially infectious material. The tests must be validated and fully reliable, have the appropriate certificates required by the World Health Organization. WHO allows for the diagnosis of coronavirus at the moment only molecular diagnostics with the real-time PCR technique (RT-PCR).
- About how exactly the coronavirus screening is going, we spoke to the laboratory diagnostician: read the text.
Even serological tests, which are only a screening test, do not give reliable results. They are not recommended for diagnostic purposes «due to an insufficient amount of data on, inter alia, the dynamics of the immune response to infection and the diagnostic value of the available tests for the detection of IgM / IgG antibodies »(the position of Prof. Katarzyna Dzierżanowska-Fangrat, national consultant in the field of medical microbiology). The same is true of rapid molecular tests recently registered by the FDA.
Private laboratories are already testing
The current ministerial list of laboratories that carry out texts for coronavirus is 59 facilities (as of April 7). There are also private laboratories among them. Krakow’s Diagnostyka was the first private company to establish cooperation with the Ministry of Health. However, this company only performs tests for hospitals and other medical facilities. It does not collect samples at its collection points – for epidemiological reasons. The ALAB laboratories network also performs SARS-CoV-2 tests only for medical entities, although – as we learn on the hotline – it plans to introduce serological tests for private individuals in the future.
Meanwhile, the Gdańsk-based company GeneMe, which is not yet on the list of the Ministry of Health, in cooperation with the Foundation for Perspektywy “Goal”, has already started conducting commercial tests for the presence of the SARS-CoV-2 coronavirus under the slogan #KONTRAkoronavirus. The test can be performed by any adult person – even if they do not have any symptoms of infection. The company declares that the tests are carried out using the molecular RT-PCR method (recommended by WHO).
On the action page we read:
A swab sample taken from the nose is used for diagnostics using the swab included in the ordered set. The test is performed using the RT-real time PCR method with the use of certified diagnostic kits with CE and IVD certificates, compliant with the recommendations and recommendations of the World Health Organization (WHO). It consists in detecting the presence of the RdRp gene and the E gene. Thanks to this, the presence of the virus can be confirmed or denied.
The package for the coronavirus detection test is ordered via the website kontaktoronawirus.pl. You have to pay PLN 500 for it. The person who orders the test kit must after receiving the parcel take a swab for testing yourselfand then hand it over to the foundation’s volunteer who will deliver the material to the laboratory. Results within 48 hours are sent to the customer’s e-mail address.
There are at least two serious doubts about the GeneMe offer. The first concerns the reliability of the results (which are sometimes distorted, e.g. due to incorrect sampling, which happens quite often), and the second concerns the safety related to the way the material is transported. We turned to GeneMe for details. Aleksandra Miedzianowska – a representative of the company – explained:
– We are aware that the swab may be taken incorrectly – we inform customers on this topic. Our team has developed an internal control procedure that shows if the swab has been taken correctly by detecting the human RNAse P gene. This allows us to request another swab from people who did it incorrectly. The material is transported in a specially designed buffer that inactivates the virus and protects the virus RNA during transport.
– Reagents used to perform the tests they come from kits developed by us, which have been reported to the Office of Medicinal and Biocidal Products and have the required certificates. Certificates can be made available to all interested parties – Miedzianowska assured. – The GeneMe company is a laboratory that has so far dealt with genetic tests on the highest quality equipment for RT-real time PCR analysis. We use, among others from Roche thermocyclers – we read on the company’s Facebook.
According to the information we obtained from Aleksandra Miedzianowska, GeneMe contacted the Ministry of Health regarding the implementation of tests for sanitary and epidemiological stations and medical facilities. However, no decision was made on this matter and the talks were not finalized. Nevertheless, the offer of the company, which has been receiving orders for tests for several days, is already enjoying great popularity. “Finally, there is an option in the Tri-City that you do not have to wait 7 days for the result and spend time in a tent in front of the hospital” – one Facebook user is pleased.
This does not mean, however, that the idea of the Gdańsk company met with a completely positive reception. There are also extremely different opinions:
“Commercial testing against the current systemic shortages and public threat is an ethically questionable initiative at best. I condemn me as a doctor and as a person dealing with the popularization of medical knowledge »- writes another commenting.
See also:
- Coronavirus in children. Largest study on COVID-19 in children. What was established?
- Who is the Coronavirus Killing? [PODCAST]
Noble goals, but the result is only informative
The company’s cooperation with a foundation that deals with the distribution of tests is quite enigmatic. «The test cannot be bought. The Foundation provides the opportunity to perform the test after donating a donation worth PLN 500 »- informs GeneMe. The money flowing into the account is to be used to support people who “found themselves in a difficult situation caused by the coronavirus epidemic”. Only this information is available on the #KONTRAkoronawirus campaign website. What percentage of this “donation” will go to charity? What kind of help is this about? Which groups will it target? The president of the foundation – Bartosz Kowalski – asked by us about the details, he replies:
– The amount paid by a person who wants to be tested privately will contribute to our campaign and thus contribute to the purchase of tests for medical personnel and the most needy people who are not able to perform them. If we are allowed to do so, we would also like to organize psychological help for people affected by the current situation, and this is our main goal. All proceeds from the #KONTRAkoronavirus campaign will be donated to charity.
As Bartosza Kowalski explains, the price of PLN 500 includes the cost of delivering the collection kit to the client, collecting the smear from the door of his apartment, preparing logistics, customer service hotline, training and equipping drivers with personal protective equipment, as well as transporting potentially infectious material. In addition to single tests, the foundation offers packages to companies that would like to purchase a larger number of kits and donate them to hospitals. It also offers other “bricks”: protective masks for PLN 25-35.
However, it is worth paying attention to one quite important fact. The GeneMe company reserves that the test result is for information purposes onlywhich means that receiving a positive result is not tantamount to a referral to quarantine or treatment, just as a negative result does not release people who are undergoing it from quarantine. Nobody signs the results and the laboratory does not download the data of the people who are tested. The only thing you can count on is the foundation’s statement. Will anyone who makes such a statement at a sanitary and epidemiological station or an infectious disease hospital be taken seriously, since the laboratory is not on the Ministry of Health’s list?
– For us, a positive test result means that someone is a carrier of the virus. Such a person is asked to report this fact to the relevant services. The Foundation for Perspectives “Cel” will also report positive results. We would like the results of our tests to be treated responsibly by both customers and sanitary and medical services, says Aleksandra Miedzianowska.
In the Q&A section of the #KONTRAkoronavirus action page, you can find a question about what a person who receives a positive test result should do. The organizers … refer to the hotline of the National Health Fund.
Medical laboratory and research laboratory
The GeneMe Laboratory is a research facility, and therefore it is not listed in the register of the Pomeranian Voivodship Office in Gdańsk, or in the records of the National Chamber of Laboratory Diagnosticians (KIDL), Gazeta Wyborcza found. As Prof. Maciej Szmitkowski, national consultant in the field of laboratory diagnostics, a scientific laboratory is not the same as a medical diagnostic laboratory, it is not supervised by medical consultants or KIDL inspectors.
We asked KIDL if such a laboratory could do diagnostics.
– In the current legal situation, any entity wishing to perform laboratory tests, also in the field of SARS-CoV-2 virus detection, must be registered by the competent voivode and reported to the records kept by the National Council of Laboratory Diagnosticians. The team for the coordination of the network of COVID laboratories, which was appointed by the Minister of Health on April 3, 2020, will be responsible for the coordination of the network of laboratories performing these tests – said attorney Maciej Niezabiotowski, head of the Legal Department of KIDL.
According to the information from the Sanepid Department of Gdańsk provided to the journalist of Gazeta Wyborcza, the validation of GeneMe tests has not been completed. The reporting path has also not been established.
The editorial board recommends:
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- Our safety is now in their hands. Diagnostics explain how the presence of the coronavirus is checked
- Why isn’t everyone who has symptoms of coronavirus undergoing testing?
Have a question about the coronavirus? Send them to the following address: [email protected]. You will find a daily updated list of answers HERE: Coronavirus – frequently asked questions and answers.
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