The collaboration between the School of Biotechnology and Food Technology (SBFT) under the Hanoi University of Science and Technology and Innogenex International Science and Technology Co. Ltd. has resulted in the achievement.

In efforts to deal with the spread of nCoV epidemic, the research team, led by Dr. Le Quang Hoa, and Innogenex have announced the latest result in forming the quick test kit based on RT-LAMP (Reverse Transcription-Loop-mediated Isothermal Amplification) technology, a nucleic acid isothermal amplification technique specifically used to detect the RNA of pathogenic viruses.

With the newly-formed test kit, it is known that Vietnam is the first country to successfully produce the RT-LAMP quick test kit for detecting the 2019-nCoV, which helps to shorten testing time and simplify the analytical process, that is applicable right from at district-level hospitals.

A study within less than a month

Previously, to test the suspected nCoV cases, Vietnam applied a gene sequencing test method that took 3-5 days. Then, with the World Health Organisation (WHO) test sample combined with molecular biology testing method, the time for needed to test for the new coronavirus in Vietnam decreased to less than 9 hours. In the world, the standard real-time polymerase chain reaction (real-time PCR) method recommended by the WHO takes about 3 hours to get results.

Sharing with Nhan Dan Newspaper, Dr. Le Quang Hoa, Head of the SBFT’s Gene Technology Laboratory, said his 10-member team had started a study on rapid detection of nCoV from January 15, right after China announced the genome sequence of the new strain of coronavirus.

Right before the Lunar New Year (in late January), the team designed the primers of the colour-changing RT-LAMP reaction to detect viral RNA specificity and completed the synthesis of artificial genes for the genetic material of this pathogen.

Over the last 10 days, the research team completed the process of producing their biological product to ensure sensitivity and specificity equivalent to the standard real-time PCR method which is recommended by WHO.

The team who successfully produced the new rapid test kit for nCoV in Vietnam. (Photo: NDO/Thao Le)

Detecting positive nCoV cases in only 15-30 mins

Dr. Hoa said that the principle of RT-LAMP method applied by the group is nucleic acid isothermal amplification technique, in which the reverse transcription and amplification phase are performed at a single temperature, with amplification of DNA up to over a billion times. In particular, a positive reaction is detected directly based on the discoloration of the solution, which helps to shorten and simplify the analysis process. The total analysis time is only 70 minutes, which consists of two stages: RNA extraction of the virus (30 minutes), and preparation and conducting RT-LAMP reaction (40 minutes).

“RT-LAMP reaction only needs 30 minutes to conclude whether the sample is positive for RNA of 2019-nCoV or not. For strong positive samples, they can be detected only within 15 minutes,” said Dr. Hoa.

Another outstanding advantage of the RT-LAMP bio-product over the standard real-time PCR is its simplicity, with no complicated equipment required. This helps in that the RT-LAMP test kit can be used right from in district hospitals and field hospitals when there is an outbreak, thus localising the epidemic and limiting its spread.

In particular, the production cost for the new test kit is only at VND350,000 (over US$15), while the production cost of the real-time PCR test kit is VND1 million. Compared to other molecular biology techniques, the RT-LAMP requires simple devices with only a thermostatic tank for on-site application, while the kit is also highly sensitive and specific, equivalent to the real-time PCR one.

Hoa added that due to the lack of access to real patient samples, the team has not yet determined the accuracy of their kit on clinical specimens. However, when it is performed on faked samples using artificial synthetic RNA, the results obtained were accurate.

“We hope that the Ministries of Health and Science and Technology to support the research team so that we can test the kit and determine its exact ratio in the near future to serve the epidemic control right from the district hospitals,” Hoa said.

His team is seeking to coordinate with specialised units of the Ministry of Health to conduct the inspection as well as to make contact with businesses to transfer technology to produce the biological product.

On a laboratory scale, the team can produce about 2,000 test kits per day. In the next two weeks, the kit is expected to be applied in practice after being thoroughly tested.