The new kit utilizes the reverse transcription loop-mediated isothermal amplification (RT-LAMP) technique to detect the novel coronavirus using the naked eye, based on color changes of indicator chemicals. A sample could be processed within 30 minutes using the new kit, as opposed to around 120 mins required for RT-PCR test kits, previously developed by Vietnam.
Experiments showed the new kit does not give out false positives based on other types of coronavirus, including SARS-CoV (which causes SARS) and MERS-CoV (which causes MERS). It also does not require the use of complex equipment.
The new kit was developed by a research team at Hanoi University of Science and Technology (HUST), Innogenex International Technology Science Company and associates. Research begun when the COVID-19 epidemic first broke out in China’s Wuhan City, where the first COVID-19 cases were officially recorded last December.
The research team undertook multiple experiments to develop the kit, with initial success confirmed in February. The team has since developed two versions of the kit. The first received a temporary distribution license by the Ministry of Health to be used in screening tests at the National Institute of Hygiene and Epidemiology.
The second version was developed with reduced imported materials in favor of domestic equivalents. This version has received CE-IVD certification (European CE Marking for In Vitro Diagnostic devices), which allows distribution across Europe, on May 25. This is the only COVID-19 test kit utilizing the RT-LAMP technique to receive CE-IVD certification, according to researchers.
A third version is being developed in a freeze-dried form, which helps simplify transportation as the product would no longer need to be frozen for preservation. Such an advantage would help test kits reach COVID-19 areas in America and Africa, said researchers.
Previously, Vietnam Military Medical University and Viet A Technologies, with research funding from the Ministry of Science and Technology, developed a COVID-19 test kit utilizing the reverse transcription polymerase chain reaction (RT-PCR) technique, which detects the novel coronavirus in droplets obtained from the respiratory tract and blood. This kit received CE certification and a Certificate of Free Sale from the U.K., which allows their sale in Europe. It has also been recognized by the Emergency Use Listing procedure (EUL) of WHO.
Vietnam has confirmed 328 COVID-19 infections so far, with only 26 active cases left.