Dr Lê Quang Hoà (in black) and his team developed the COVID-19 test kit RT-LAMP to detect SARS-CoV-2. —Photo dantri.com.vn

HÀ NỘI — A new COVID-19 test kit developed by researchers of Hà Nội University of Science and Technology has been granted a certification that allows the biological product to be sold in the European market.

According to the university, the test kit is one of the very first in the world that uses RT-LAMP to detect SARS-CoV-2 that causes COVID-19.

Led by Dr Lê Quang Hoà, a lecturer of the university’s School of Biotechnology and Food Technology, and Dr Nguyễn Lê Thu Hà from Innogenex International Science and Technology Ltd Company, 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 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 Vietnamese researchers 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 Lê Quang Hoà said that under the framework of a study by Việt Nam’s Health Ministry, his team and Sao Thái Dương Joint-stock Company 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.

Hoà 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 French phrase "Conformité Européene" 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.  

“This is the only COVID-19 test kit utilising the RT-LAMP technique to receive CE-IVD certification,” the researcher told online newspaper dantri.com.vn.

Hoà said that 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-19-hit areas in America and Africa which face shortages of testing equipment. — VNS