The Vinmec Research Institute of Stem Cell and Gene Technology under Hanoi-based Vingroup has successfully developed two sets of SARS-CoV-2 test kits which reach the same quality as the diagnostic biological products recommended by the World Health Organization (WHO), the Government Portal reported.
|The VinKit SARS-CoV-2 Multiplex RT-PCR kit increases the testing speed by two times compared to other commercially available kits. Photo: VGP|
The difference between the two sets, VinKit SARS-CoV-2 RT-PCR 1.0 and VinKit SARS-CoV-2 Multiplex RT-PCR, is the testing process. While the VinKit SARS-CoV-2 RT-PCR 1.0 kit is operated with three independent reactions to confirm the results, the VinKit SARS-CoV-2 Multiplex RT-PCR set combines three independent reactions into one to save biology products, time, and cost, while minimizing operational steps and technical errors.
The two test kits' development was based on the technological process of the US Centers for Disease Control and Prevention (US CDC), approved by the FDA (US Food and Drug Administration) in March.
Independent testing results from Vietnam's National Institute of Hygiene and Epidemiology and the National Institute for Vaccines and Biologicals show that the two sets of Vinkit are stable, 100% accurate on clinical samples, equivalent to the diagnostic bio-products recommended by the WHO.
According to testing agencies, VinKit SARS-CoV-2 Multiplex RT-PCR not only achieves a 100% accuracy but also meets the criteria of clinical specificity, clinical sensitivity, analytical specificity (not cross-contaminated with other virus strains), equivalent to those recommended by WHO and CDC.
According to Dr. Nguyen Thanh Liem, director of the Vinmec Research Institute of Stem Cell and Gene Technology, the VinKit SARS-CoV-2 Multiplex RT-PCR kit is capable of integrating the “3 in 1” reaction.
Especially, the VinKit SARS-CoV-2 Multiplex RT-PCR kit helps reduce two thirds of the technical steps and increase the testing speed by two times compared to other commercially available kits while ensuring high accuracy with low cost. This is important in the Covid-19 pandemic control and prevention.
"We are currently urgently implementing the production process and procedures for issuing registration numbers for mass production," Liem said.
The SARS-CoV-2 testing kits are the second production project of Vingroup to cope with the Covid-19 pandemic. In May 2020, a ventilator developed by Vinsmart under Vingroup with a localization rate of up to 70% was licensed by the Ministry of Health, and donated to Russia and Ukraine with which Vingroup Chairman Pham Nhat Vuong has long-standing ties.