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The Assistance of Genetic Testing - Virus Chapter

Release time:2020-02-12 16:19:00

COVID-19 is rampant, affecting all people's nerves. We always can't help recalling the SARS outbreak in 2003, but with the continuous deepening of virus research and the rapid development of gene sequencing technology, we will not be at a loss in the face of the unknown COVID-19. On the contrary, we have found out the type and structure of novel coronavirus virus at the first time, and even the gene sequence and pathogenesis of the virus. Therefore, a large number of diagnostic kits developed based on this gene sequence have sprung up, providing a strong basis for the diagnosis of COVID-19 at present, and laying a foundation for vaccine research and development. Undoubtedly, when a new and unknown virus emerges, we will largely rely on genetic research and solve many problems through in-depth genetic analysis. Mainly divided into:

1. Confirm the pathogenic microorganisms that cause infectious diseases

2. Diagnosis of pathogens

3. Drugs and vaccines for treating the pathogenic microorganism

1. Gene testing assists in rapid confirmation of viruses

The rapid identification of novel coronavirus largely depends on gene detection technology. With the whole genome sequence of the novel coronavirus, it means that the complete big data of the virus can be obtained, and the growth and spread of the virus can also be dynamically tracked to see if there is any variation at a glance.


2. Genetic testing is crucial for the diagnosis of pathogens

Gene testing has also been designated as one of the diagnostic tools for novel coronavirus. Throughout the 7 novel coronavirus nucleic acid detection kits approved by the State Food and Drug Administration, most of them are diagnosed by RT-PCR. Due to its fast detection speed and high accuracy, RT-PCR method has been widely used in clinical practice due to its great convenience of accurately detecting 96 samples within 2 hours with each instrument. In the fifth edition of the diagnosis and treatment plan for COVID-19, it was pointed out that the positive result of the sample in the RT-PCR novel coronavirus nucleic acid test or the high homology of the sample with the known novel coronavirus after gene sequencing were taken as the diagnostic evidence of the pathogen. Therefore, genetic testing not only provides first-hand information on the evolutionary origin and pathogenic mechanism of viruses, but also provides important basis for the development of specific diagnostic kits.

However, it is worth noting that the problem of false negative nucleic acid detection of COVID-19 has emerged one after another recently. The detection rate of nucleic acid in the nucleic acid detection kit is low, and even multiple repeated tests are required to confirm the diagnosis. This indicates that it is highly likely that some manufacturers have insufficient optimization in the early stages of product development, resulting in insufficient sensitivity and unstable testing results.

Faced with such a situation, Weihe has also taken some countermeasures. To develop a reliable, stable and whole process monitoring quality control for novel coronavirus nucleic acid detection, MS2 phage virus like particles. The protein coat of bacteriophage MS2 can protect its internal RNA from the action of RNase A and DNase I, and maintain the stability of physical and chemical properties for a long time. Therefore, novel coronavirus genes can be wrapped into these virus coats through genetic engineering technology to avoid the degradation of nuclease. The novel coronavirus quality control sample prepared by this method can simulate the whole process of sample processing, nucleic acid extraction and nucleic acid detection in virus particle nucleic acid detection. At the same time, it can conduct quantitative analysis on the viral load, evaluate the detection capability of each manufacturer's kit and laboratory, and promote the laboratory to improve the detection capability of novel coronavirus nucleic acid. With the assistance of group strategies and the contribution of eight parties, there will be more and more remedial methods in the face of the common false negative judgment, in order to jointly respond to this emergency epidemic.


3. Development of Medicinal Vaccines

While medical staff are fighting against COVID-19 on the front line, many countries are also isolating novel coronavirus strains and starting the research and development of vaccines. It can even be said that vaccines are the hope of the whole village. Genetic testing will also be required for verification in the development of attenuated live vaccines and DNA vaccines.

The above only takes the 2019 nCoV as an example to illustrate the important role of genetic testing in confirming the type of pathogen, diagnosis, and vaccine development. Not only viruses, infectious diseases, but also highly anticipated cancers cannot do without genes. In recent years, whole genome technology has developed rapidly due to its fast, high-throughput, and high precision characteristics, but high cost is also a major factor restricting its development. Therefore, targeted sequencing technology has become an important means for people to study target genes. Targeted gene testing is mostly focused on the RT-PCR method mentioned above. The characteristics of fast speed, low initial quantity, and low cost of multiplex PCR technology are increasingly attracting industry attention. Whether it is the whole genome sequencing of the virus or targeted sequencing, genes will be an indispensable technical support in the era of immunotherapy. While providing detailed guidance for each patient's treatment, more comprehensive information is also needed. Promoting the complementarity between macro genomic testing and targeted gene testing is essential for humans to have a comprehensive understanding of diseases and efficiently screen for specific targeted loci. The effective combination of first or second generation sequencing and RT-PCR methods will also become a golden combination for exploring genomic methodology.


Weihe has rich experience in the development of nucleic acid testing kits and a comprehensive multi fluorescence PCR experimental system. At the same time, I am also familiar with the sequencing of the first generation. In the face of this epidemic, developing corresponding nucleic acid testing kits is relatively easy for Weihe. The reason why we did not seize the opportunity in the first place is because we deeply understand that a rigorous research and development requires a complete set of quality control. After all, what the market needs is not the production of nucleic acid test kits, but the quality. A series of situations such as hasty launch without clinical validation and unstable quality can actually make some cases relax their vigilance and expand their social impact. Therefore, just as the construction of MS2, which we focus on this time, can effectively improve the accuracy of the reagent kit, reduce false negatives and false positives in experimental results, Weihe is more willing to follow the actual situation, not violate scientific laws, precipitate and develop a system that meets quality standards, and wait for the flowers to bloom.



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