In-vitro Diagnostic for Covid-19

• RT-PCR Covid-19 Kit Thai Duong Version 1.0: Experts estimate that false-negative results can cause damages globally amounting to billions of dollars. This is an issue which must be addressed if efforts to stop the pandemic are to be successful. 

The primary cause of false-negative result is errors being committed when samples are taken. As a solution to this problem, experts of the National Institute for Control of Vaccine and Biologicals of Vietnam (NICVB) have developed a new RT-PCR diagnostic kit under the name RT-PCR COVID-19 Thai Duong, which besides the use of diagnostic target genes, contain an internal control to detect human DNA in samples. Clinical samples which have been incorrectly collected will give insufficient DNA result and will be excluded. This way, there will be a significant improvement of the percentage of false-negative results. 

Production and launch of the test kit RT-PCR COVID-19 Thai Duong will take place at the end of April 2020 and are carried out by Vietnamese science and technology company SUNSTAR Joint Stock Company. 

Based on a research project at the NICVB, during the past three months, the test kit has completed trials at the National Institute of Hygiene and Epidemiology (NIHE) and the National Hospital for Tropical Diseases (NHTD) using 150 negative clinical samples, 35 positive samples, and 30 mimic positive samples. 

Dr. Doan Huu Thien, the head of the research group, says: “The new test kit has proved to have a 100% sensitivity, which detect the virus even at low levels, 100% specificity, which prevents cross reactions with other viruses and bacteria in the human respiratory tracks, and agreement ratio as 100% following the process recommended by WHO. It can even detect errors in the collection of samples as well as safeguarding the entire diagnostic process. The kit includes 9 primer and probe sequences to detect 3 target genes of beta coronavirus including SARS-CoV, SARS-CoV-2 and bat SARS-CoV. Amplification result and the limit of detection of 3 target genes equal to Realtime RT-PCR multiple primer of the biological kit.”