HANOI, Vietnam, April 28, 2020 /PRNewswire/ -- 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.
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. However, 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%. Bart Buxton, the CEO of 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.
In response to the false-negative result is errors being committed when samples are taken, experts of the National Institute for Control of Vaccine and Bilogicals 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, 35 positive samples, and 30 mimic positive samples. The new test kit has proved to have a 100% sensitivity, 100% specificity, and agreement ratio as 100% following the process recommended by WHO. The test kit will be available for use at the end of April 2020.
Dr. Doan Huu Thien, head of the research group, says: "False-negative results can be caused by errors when collecting samples or the low virus level in the samples. False-negative results have damaging effects for the community. Therefore, the aim of our research is to develop a biological kit which has high sensitivity, which detect the virus even at low level, and high specificity, which does not have cross reactions with other viruses and bacteria in human respiratory tracks, and 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.
The primer and probe sequences included in the kit have been examined and compared with 533 genome sequences which are notified in the gene banks of GenBank and GISAID as of March 15th, 2020. Among the nine primer and probe sequences used to amplify specific target genes of SARS-CoV-2, there are six sequences which have 100% similarity with identified SARS-CoV-2 strains. Only two sequences have one mismatch at the middle of primer and one sequence has three mismatches at the middle of primer. Those mismatch points do not affect the diagnostic results of the kit. Applying multiple primers and probes reduce the rate of false-negative results when mutated strains appear which prevent successful amplification procedure when having only one target gene."
It must be said that Vietnam is one of the countries with the best track record in dealing with the SARS-COV-2 pandemic. The country got its first confirmed case of coronavirus the same day as the USA got its own first and despite the fact that it shares a long land border with China, Vietnam has up until now only 268 positive cases and of which 171 have been declared free from the virus and with none fatality. The Vietnamese government as well as experts have repeatedly announce their readiness to share their experiences and knowledge in combating the pandemic with any other countries.
About the producer of the kit:
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.
SOURCE SUNSTAR Joint Stock Company