Ministry of Health licenses production of 2 Covid-19 test kits
The Ministry of Health has decided to grant temporary registration numbers for two new coronavirus test kits to put into mass production.
The Ministry of Health has just signed and decided to grant temporary registration numbers for the first two in vitro diagnostic biological products for testing for the coronavirus (SARS-CoV2) in Vietnam.
These two biological products were researched and manufactured by the Military Medical Academy in collaboration with Viet A Technology Joint Stock Company using RT-PCR and Realtime RT-PCR technology to detect the new strain of coronavirus (COVID-19).
The Ministry of Health requires that units with in vitro diagnostic biological products must print the registration number issued by the Ministry of Health on the label and must comply with the provisions of Vietnamese law on the production and trading of in vitro diagnostic biological products. Registration numbers are valid for 6 months from the date of issue.
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| Ministry of Health licenses production of 2 Covid-19 test kits |
The National Institute for Control of Vaccines and Biologicals, Ministry of Health, is responsible for supervising and professionally evaluating the two test kits mentioned above.
Previously, on March 2, the Central Steering Committee for Covid-19 Prevention and Control heard a report on the initial results of the evaluation of the SARS-CoV-2 test kit of the Military Medical Academy in collaboration with Viet A Company.
The evaluation council consisting of 8 scientists from the Ministry of Science and Technology and the Central Institute of Hygiene and Epidemiology recognized the biological testing results of this test kit.
Initial evaluation showed that the 5 test kits had stable sensitivity after 3 repetitions and could detect SARS-CoV2 virus copies.
