The SARS-CoV-2 detection kit developed by the Institute of Biotechnology has been successfully tested and meets WHO standards, enabling Vietnam to proactively respond to the COVID-19 pandemic.
After an intensive period of research, the team led by Assoc. Prof. Dr. Đong Van Quyen, Deputy Director of the Institute of Biotechnology under the Vietnam Academy of Science and Technology (VAST), and Assoc. Prof. Dr. Dinh Duy Khang, successfully created a SARS-CoV-2 detection kit.
Following internal testing at the Institute of Biotechnology, on March 2 the kit also received external validation from the Military Institute of Preventive Medicine, Ministry of National Defense.
The diagnostic kit was verified to have sensitivity and specificity equivalent to the WHO-standard realtime RT-PCR kits, with:
100% specificity
Sensitivity of 5 copies per reaction
This research confirms that Vietnam has mastered advanced technology and is fully capable of producing realtime RT-PCR kits domestically—an important achievement at a time when imported kits were scarce worldwide.
The kit was developed using realtime RT-PCR, the “gold standard” technology recommended by WHO for diagnostic test development. Primers and probes were designed based on key genes and genomic regions of SARS-CoV-2 isolated in Vietnam, sequenced by the research team.
Materials used for kit validation included RNA extracted from SARS-CoV-2 samples from Vietnamese patients (provided by the National Institute of Hygiene and Epidemiology). Viral genes and genomic segments were cloned from these RNA samples to serve as templates for research and primer-probe design. The team also used RNA samples from human respiratory viruses provided by Military Hospital 108 and the Military Institute of Preventive Medicine.
According to VAST representatives, the academy will collaborate with the Military Institute of Preventive Medicine to mass-produce the kits for large-scale testing.
Experts emphasize that Vietnam’s successful development of a SARS-CoV-2 detection kit—matching WHO-standard realtime RT-PCR performance—carries profound significance, helping the country proactively conduct screening and diagnosis.
In addition to the results announced by VAST’s Institute of Biotechnology, several other Vietnamese research institutions are also developing SARS-CoV-2 detection kits. The Ministry of Science and Technology has assigned:
The Vietnam Military Medical Academy in collaboration with Viet A Technology Corporation to develop RT-PCR and realtime RT-PCR test kits
Phu Sa Biochemical Co., Ltd. with the Pasteur Institute Ho Chi Minh City and Can Tho Center for Scientific and Technological Advancement to create a rapid detection system for SARS-CoV-2
Hanoi University of Science and Technology, which also announced a successful SARS-CoV-2 test kit, though not based on the WHO-recommended realtime RT-PCR technology