Vietnam Announces New COVID-19 Test Kit Eliminating Gross Error Caused by Incorrect Collection of Samples

HANOI,Vietnam,April 28,2020 -- 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.

The production of the test kit "RT-PCR COVID-19 Thai Duong" by Vietnamese science and technology company SUNSTAR JSC (Sao Thai Duong) will start at the end of April 2020. The test kit has the ability to addresses false-negative test results.

According to Worldometers,there are a total of seventeen million COVID-19 tests being performed globally and of them about two million results are positive which means more than ten million are negative. These negative test results are a source of increasing concern as in many cases,the patients clearly display the symptoms but still their tests show negative result. Studies based on 866 tests performed in China and published on MedRXiV show that suspected false-negative test results can be as high as 30%. McLaren,a Miami-based American health management firm,claims that approximately 20% of patients who have been tested in clinics have received false-negative results.

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.

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,35positive 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 thehuman respiratory tracks,and agreement ratio as 100% following the process recommended by WHO. Itcan 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."

Vietnam is one of the countries with the best track record in dealing with the SARS-COV-2 pandemic. Despitesharinga long land border with China,Vietnam has up until now only 268 positive cases and 171 of them have been declared free from the virus and with none fatality. The Vietnamese government as well as experts have announcedtheir readiness to share their experiences and knowledge in combating the pandemic with any other countries.

Production and launch of the test kit will take place at the end of April 2020. Sao Thai Duong JSC (English name SUNSTAR JSC) was founded in the year 2000 by two pharmacists who are currently serving as the company's CEOs. SUNSTAR JSC is a household name in Vietnam with more than 130 products (personal care,cosmetics,food supplements,pharmaceuticals) in more than 16 countries in Asia,the EU,and North America.

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