in Vitro Detection (IVD) Kit specialized for SARS COV-2 (2019-nCOV)
Rapid, Practical, Secure
NC Genetics unit, which carries out advanced genetic and biotechnology studies within the structure of Nanografi Nano Teknoloji A.Ş., performs R&D studies in this field and provides effective, fast and reliable answers to the needs of the sector. The NG Genetics unit, which has proven itself in biotechnology studies, continues its high technology development and problem solving activities on issues that have become the common problem of humanity.
As Sars-Cov-2 disease, which continues its negative effects all over the world, has spread, the importance of diagnostic tools for rapid intervention and treatment has increased. The biotechnology unit within nanography has also entered the process of developing a test kit that is fast and easy to read and does not require special equipment, taking this requirement into consideration and started the production of a user-friendly, fast and reliable n-FasT™ test kit.
The n-FasT™ diagnostic kit was developed for Covid-19, based on the reverse transcription loop-mediated isothermal amplification (RT-LAMP) technique, which reveals the reaction result quickly and visibly without dependence on PCR devices, which are difficult to acquire and difficult to use.
The n-FasT SARS-CoV-2 diagnostic kit, produced by Nanografi Nano Teknoloji AŞ experts, has the Lamp method, which is among the most reliable detection methods. The reaction that reveals the diagnosis result for Covid-19 in a fast, practical and safe way yields results with a colorimetric method based on colour change. n-FasT differs from all other kits with the opportunity to give results below the patient within 30 minutes in application and result interpretation.
The n-FasT diagnostic kit, which shows the reaction result rapidly without being dependent on PCR devices, which are difficult to use and maintain, has been approved by Hacettepe University with 97 % success rate in clinical studies. The practical, fast and safe Covid-19 diagnostic kit that develops has a Quicklysis Buffer system to eliminate time loss arising from RNA isolation. Dark pink color after execution according to the reaction protocol Covid-19 Negative, yellow colour Covid-19 indicates positive status.
Independent clinical trials have been carried out by Hacettepe University with a success rate of 97 % within the processes related with n-FasT diagnosis kit, for which all scientific and bureaucratic procedures were completed successfully, and these results were considered by Public Health General Directorate, and compatibility was stated, and accredited by Ministry of Health, Turkish Pharmaceuticals and Medical Devices Authority to Product Tracking System, and all necessary permits and procedures for its circulation have been completed.
The n-FasT diagnostic kit clinical trials have been carried out by independent laboratories and academicians, who are experts in the field, and its compliance conditions have been completed, and it has been documented that it meets all the conditions for domestic and international use.
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