VN Covid-19 test kit permitted to be sold in Europe
A NEW Covid-19 test kit developed by researchers of Hanoi University of Science and Technology has been granted certification that allows the biological product to be sold in the European market.
The university said the test kit is one of the very first in the world that uses RT-LAMP to detect the Sars-CoV-2 pathogen that causes Covid-19.
Led by Dr Le Quang Hoa, a lecturer of the university’s School of Biotechnology and Food Technology, and Dr Nguyen Le Thu Ha from Innogenex International Science and Technology Ltd Co, the research team found the reverse transcription loop-mediated isothermal amplification (RT-LAMP) technique could be used to detect the novel coronavirus.
Testing results could be seen with the naked eye thanks to the changes in the colour of the indicator chemicals.
The RT-LAMP technique can produce results within 30 minutes while the RT-PCR test kits which are also developed by V i e t n a me s e r e s e a r c h e r s require about 120 minutes.
Moreover, the kit does not give out false positives for other types of coronavirus such as Sars-CoV, Mers-CoV, HKU4, HKU1, OC43 or 229E which cause other diseases.
Dr Hoa said under the framework of a study by the Vietnamese Ministry of Health, his team and Sao Thai Duong JSC produced two versions of the biological products RT-LAMP Covid-19.
The first version of the test kit was licensed by the health minister for temporary circulation so that it could be used for testing at the Institute of Hygiene and Epidemiology. The test kits work in all cases and produce exact results.
Hoa said that the second version was developed with reduced imported materials and used domestic equivalents.
He added that the second version had received CE-IVD certification (European CE Marking for In-Vitro Diagnostic devices), which allows distribution across Europe, on May 25.
The letters “CE” are from the French phrase “Conformite Europeene” which means “European Conformity”.
CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.
CE Marking is required for all in-vitro diagnostic (IVD) devices sold in Europe. CE Marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (98/79/EC) and that the device may be legally commercialised in the EU.
Hoa told online newspaper dantri.com.vn: “This is the only Covid-19 test kit utilising the RT-LAMP technique to receive CE-IVD certification.”
He said his team was developing the third version of the test kit in a freeze-dried form, which helps simplify transportation, thus helping them to send the test kits to Covid-19hit areas in the Americas and Africa which face shortages of testing equipment.