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WHO approves Covid-19 test kit made by HUST scientists

A COVID-19 diagnostic kit developed by HUST scientists was given the green light for distribution in the European market last May. The World Health Organization also approved the test kit for emergency use. 

The research group, led by senior scientist Le Quang Hoa from the School of Biotechnology and Food Technology at Hanoi University of Science and Technology (HUST), last May obtained the European CE mark for its COVID-19 test kit. 

 

The LAMP-based kit, which uses real-time reverse-transcription loop-mediated isothermal amplification method, can quickly detect the new coronavirus SARS-CoV-2 in droplets obtained from the respiratory tract, said the research group leader. 

 

The kit provides results faster and easier to use than the conventional test using reverse transcription polymerase chain reaction, also known as RT-PCR, Ph.D Le Quang Hoa explained.

 

The RT-LAMP technology has many advantages over RT-PCR technology. First, with the RT-LAMP, the DNA amplification is done at only one constant temperature meanwhile the RT-PCR test needs a wide range of different temperatures in one cycle. That means RT-LAMP tests do not require an expensive thermal cycler. 

 

 

PhD. Le Quang Hoa instructs his student to do an experiment in the laboratory in Febuary 2020. Photo by CCPR.

 

Second, the quantity of DNA amplified in the LAMP technology is so much more than that in PCR. And the process causes a color change visible to naked eyes, indicating that it is easier to run RT-LAMP without the extraction of RNA or polymeric molecule playing biological roles in regulation and expression of genes. 

 

Hence the most important advantage of the RT-LAMP technology is that the investigative procedure in the laboratory is so fast that results can be obtained within 30 minutes, compared with the PCR technique which needs at least 120 minutes, said research leader Le Quang Hoa.

 

He added that the LAMP-based kit has been validated by the National Institute of Hygiene and Epidemiology with sensitivity 100% and specificity 99.6%, compared to the PCR–based COVID-19 kits where specificity is around only 95%.

 

“Tens of thousands of the kits are being produced every day to meet the demands from both local and global markets,” the scientist said. 

 

A third version of the test kit has been done, Le Quang Hoa confirmed, with the reagents to be stored in an ordinary fridge. Without the need of deep freezing, it is less costly to transport the test kits to places as far as Africa and America.

 Graphic Designing by San Le

 

In early December 2019, there was an outbreak of a new virus called severe acute respiratory syndrome coronavirus or SARS-CoV-2 in Wuhan, China. As soon as the year of 2020 began, Le Quang Hoa and his research team started working on the method for SARS-CoV-2 diagnosis. At the time, the team was fully aware of the shortcomings of the then- available RT-PCR test. 

 

By the time a wave of community infections hit Vietnam late July of last year, the second version of RT-LAMP test kit developed by Le Quang Hoa and his team had already been launched and approved by the World Health Organization for emergency use, helping the country to control and contain the virus through rapid detection.

 

According to the Health Ministry, as of January 31, Vietnam has conducted more than 1.5 million tests. Vietnam currently has over 700 COVID-19 active cases, all being isolated for treatment in government facilities.

 

“We are constantly monitoring COVID-19 virus for acquired mutations. It is pretty lucky so far that the primer sets specific to SARS-CoV-2 that we have generated are proved to deliver detection of all variants currently circulating across the world,” Le Quang Hoa said. 

 

Reporting by Dieu Ngoc; Translating by My Hanh; and Editing by Hanh Pham.