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A Polish company from Lublin has registered Real Time PCR rapid molecular tests for the detection of SARS-CoV-2 coronavirus. They are to be used in Polish laboratories, and will also go to other European countries. As the manufacturer argues, they are more stable than those already available on the market. What else are they better than already available?
The Lublin company BioMaxima SA already offers two tests used in the diagnosis of SARS-CoV-2 coronavirus infections. First it was developed rapid immunochromatographic testwhich allows the detection of IgM and IgG antibodies to the coronavirus in the blood. It has been available in Poland for several weeks, but now the company is starting to sell it also in other European Union countries. We wrote about quick screening tests for people suspected of being infected with coronavirus in early March.
Now a new coronavirus detection test has been registered at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL). This time it is rapid molecular test performed with the Real Time PCR method. It is made in a laboratory environment and is intended for use in patients with symptoms of COVID-19 disease.
Read: WHO’s appeal to all countries: test, test, test
The new molecular test is based on the recommendations of WHO and CDC (American Centers for Diesease Control), so it uses the Real Time PCR method. This means that the test allows diagnostics to be carried out under laboratory conditions.
The Real Time PCR molecular test allows for the analysis of genetic material in real time. For the test it is used a sample taken from a patient with symptoms of COVID-19: pharyngeal and nasopharyngeal swab, sputum, tracheal aspirate, bronchoalveolar lavage, blood, urine or stool. The virus genetic material is extracted from a given sample using the real-time PCR technique. Reverse transcriptase and fluorescent probes are also used. The examination detects RNA sequences that are unique to the SARS-CoV-2 coronavirus.
Molecular test for SARS-CoV-2 coronavirus BioMaxima developed in Lublin in cooperation with a Spanish biotechnology company. According to the validation studies of the Spanish National Reference Center, the sensitivity and specificity of the test kit is to be over 99%.
Unlike other RT-PCR tests, the research method proposed by the Polish company is to allow for faster results – the waiting time for the result is 2 hours. Another issue is the sensitivity of the test. As we read in the company’s official announcement, in the case of the quick test proposed by the company, it is higher than in comparable systems.
As far as the discussed rapid RT-PCR test is concerned, it is new the possibility of transporting and storing the set in room conditions, which became possible thanks to reagents with increased stability. For many other diagnostic tests, it is necessary to keep the temperature cool, and therefore use dry ice and freezers.
Incorrect storage of reagents, even for short periods, increases the risk of false negative test results. Their greater durability and adaptation to room temperatures may facilitate the transport of tests, especially in the summer.
In addition to reducing the number of COVID-10 cases through proper health prevention, which is called for by international (WHO, CDC) and national organizations (GIS, Ministry of Health), more and more attention is paid to the importance of coronavirus tests. This issue was referred to by Łukasz Urban, President of the Management Board of BioMaxima SA:
“It is increasingly recognized around the world that the key to limiting the spread of a pandemic as well as minimizing mortality among infected patients is as extensive and early testing as possible. I am thinking of both screening tests, where the rapid test for the presence of antibodies in the blood, already offered by BioMaxim, is a real alternative to the screening test with temperature measurement, which is still used in many places, and about the new confirmatory genetic test, which we have just submitted to the URPL. »
The president of the company also draws attention to the importance of the number of tests performed and the inconvenient waiting time for results.
– The RT-PCR test we are introducing to the market is distinguished by high sensitivity and speed, which gives the health care system a real opportunity to increase the number of tests performed, reducing their time even twice as compared to some currently used PCR tests – says Urban.
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.
Read also:
- Fake tests for coronavirus. The sharp reaction of diagnosticians
- Coronavirus Tests – Genetic and Immunological. How do they work?
- Coverage of the COVID-19 coronavirus [MAP]