Gencurix Releasing New Coronavirus Diagnostic Kit in the EU
SEOUL, South Korea, March 20, 2020 /PRNewswire/ -- A new diagnostic kit for the COVID-19, developed by Gencurix (KONEX 229000), will be available soon in Europe.
GenePro COVID-19 Detection Test, developed in accordance to the WHO (World Health Organization) guidance for 'Laboratory testing for 2019 novel Coronavirus (2019-nCoV)', and has been CE-IVD certified in compliance with European regulations for in-vitro-diagnostics (IVD) tests. Consequently, diagnosis of COVID-19 by this test kit will be made possible across Europe.
Gencurix is a molecular diagnostics company which has been developing and producing PCR(Polymerase Chain Reaction)-based diagnostic kits for many years in South Korea. Based on their accumulated R&D and development capabilities for diagnostic kits, Gencurix has been developing diagnostic products with better performance. Their COVID-19 test kit is also expected to have superior accuracy to existing test kits.
SARS-CoV-2 is a RNA virus which causes COVID-19. It can be detected by nucleic acid amplification technologies including PCR. The primers used must be specific to the targeted sequences in the RNA of the virus. By designing specific primers which can solely detect SARS-CoV-2, GenePro COVID-19 Detection Test has significantly reduced false results other COVID-19 tests have. It minimizes false negative and false positive results with improved primer design, which allows accurate determination with amplification results.
In order to detect a small number of viruses in samples precisely by using Real-time PCR, it is important to select enzyme required for composition of cDNA and PCR amplification. Gencurix has differentiated its test kit from competitive products using low-priced enzyme by using Thermo Fisher's high performance enzymes, 'SuperScript III RT/Platinum Taq DNA polymerase', which enable to achieve higher sensitivity and specificity.
Also, RNA positive control is used for improved detection accuracy, which monitors whether overall process has completed successfully. Many COVID-19 test kits are using DNA positive control, but it is likely to be impossible to monitor its overall PCR process as they cannot look into errors during the reverse transcription process. On the other hand, GenePro COVID-19 Detection Test, using RNA positive control, can monitor the whole test process including DNA amplification to real-time PCR process and detect any error.
Developing the test kit to detect COVID-19, Gencurix has also considered user's convenience. This test applies one-step real-time PCR system and only requires a RNA template. All reagents required for cDNA synthesis and qPCR analysis are included in the kit. Lastly, the result can be checked within 90 minutes after RNA extraction, which enables faster diagnosis.
COVID-19 is spreading around the world rapidly and experts view that active precaution of epidemics and high-quality detection testing are the main keys to end this situation. Gencurix has capacity to produce over three million test kits per month and plans to distribute these test kits to Asia, North America, South America, Middle-East as well as Europe.
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