NEW ERA IN COVID-19 DIAGNOSTIC KITS

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Minister of Industry and Technology Mustafa Varank announced that PCR tests used in the detection of the COVID-19 virus will now give better quality results. Stating that RNA-based reference materials were produced by TÜBİTAK National Metrology Institute (UME) in order to obtain better quality results from PCR tests, Minister Varank said, "Thus, the accuracy rate of PCR tests will increase. In addition, the materials produced will also be used in the internal quality control of PCR kits."

Minister Varank stated that they requested these reference materials from equivalent institutes in order to make comparisons and said, "However, they put forward excuses. This, of course, motivated our researchers even more. We started a project to produce these reference materials ourselves for the use of our country's laboratories and kit manufacturers. In a short period of 3 months, we completed our work. Unlike RNA-based reference materials that were not even given to us for comparison, we produced our domestic and national materials that are dust and temperature resistant in a more innovative form."

HOW DOES THE PCR TEST WORK?

In PCR tests, which are widely used around the world to detect the COVID-19 virus, the measurement consists of two different steps. In the first step, an enzyme translates the RNA of the virus into cDNA. In the second step, the translated cDNA (conjugated DNA) is amplified with another enzyme, resulting in a positive signal in the PCR test.

NEW REFERENCE MATERIAL

The National Metrology Institute (UME), which operates under TÜBİTAK, the relevant organization of the Ministry of Industry and Technology, has developed a new reference material to improve the quality of measurements in PCR tests used for COVID-19 diagnosis in Turkey. These new RNA-based reference materials enable the control of both steps in the PCR test, ensuring the quality of the measurements.

WILL ALSO CARRY OUT QUALITY CONTROL

RNA-based reference materials produced by TÜBİTAK UME can be used as internal quality control material for the control of both enzyme steps in measurements made in laboratories. In addition, manufacturers will be able to add this material to PCR kits as RNA-based positive quality control material to ensure the reliability of their kits.

FROM COOLING TO DISTRIBUTION

TÜBİTAK UME Director Dr. Mustafa Çetintaş explained that they guarantee the quality of PCR tests performed with reference materials produced with domestic and national facilities and said, "The most important contribution of this material is that it does not need any cooling process. We can easily distribute the material to stakeholders within the country without exposing it to the cooling process."

NEW CAPABILITY GAINED

The work carried out in TÜBİTAK UME laboratories has also led to the establishment of an infrastructure and technical experience. The laboratories have reached the capability to produce new RNA reference materials in a very short time in case the COVID-19 virus mutates or another virus emerges.

PRODUCED WITH THE SUPPORT OF EAST MARMARA DEVELOPMENT AGENCY

Referans Malzemeler received support from the East Marmara Development Agency with the project titled "TR42/20/COVID/0035: 2019-production of Diagnostic Kit Reference Material for Rapid and Reliable Diagnosis of the 2019-nCoV Virus" within the scope of the "Combating COVID-19 and Resilience Program". After the 3-month project process, one thousand 250 reference materials were produced in 2 different forms as "Frozen" and "Lyophilized".

TO PLACE AN ORDER

Information and order forms for RNA-based reference materials, rm.ume.tubitak.gov.tr/urun_grup.aspx?p=4 can be accessed from the link.

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