Hanoi (VNA) – Two more SARS-CoV-2 test kits produced by Vietnam have been approved by the European Union and listed by the World Health Organisation (WHO) as eligible for emergency use, one of which can produce results in just 30 minutes.
The new test kits, One-step RT-PCR COVID-19 Kit Thai Duong and RT-Lamp COVID-19 Kit Thai Duong, were developed by the National Institute for Control of Vaccine and Biologicals and the Hanoi University of Science and Technology.
Both kits are manufactured by Sao Thai Duong (Sunstar) SJC. They received approval from the Ministry of Health on May 17.
The kits cut four hours off the testing process and can be used in local and field hospitals. Positive specimens are detectable by the naked eye and depicted by the colour change of the reaction.
The RT-LAMP technique can produce results within 30 minutes while the RT-PCR test kits require about 120 minutes.
The One-step RT-PCR COVID-19 Kit Thai Duong Version 1.0 was certified by the National Institute of Hygiene and Epidemiology as meeting standards in sensitivity, specificity and stability and eligible for wide use in COVID-19 response.
Meanwhile, the RT-Lamp COVID-19 Kit Thai Duong is one of the very first in the world that use RT-LAMP to detect the novel coronavirus.
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 Company, the research team found the reverse transcription loop-mediated isothermal amplification (RT-LAMP) technique could be used to detect the virus.
According to Hoang Duc Thao, President of the Vietnam Association of Science and Technology Enterprises, the RT-Lamp COVID-19 Kit is simple to use and suitable for mass testing at disadvantaged regions where there is a lack of modern testing facilities and highly skilled medical laboratory technicians.
It has gained large interest from European and American countries who are looking to scale up the testing.
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 Le Quang Hoa said that within the framework of a study by Vietnam’s Health Ministry, his team and Sunstar JSC produced two versions of the biological products RT-LAMP COVID-19.
The first version of the test kit has been licensed by the Health Ministry 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 French phrase "Conformité Européene" which means "European Conformity". The 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 Product Directives. CE marking is required for all in vitro diagnostic (IVD) devices sold in Europe, indicating 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,” said the researcher.
Hoa 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, who face shortages of testing equipment./.
