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All the time,Chronic hepatitis B is a major public health problem facing China. At present, there are about 70 million people infected with hepatitis B virus and about 30 million chronic hepatitis B patients in China. Poor treatment of chronic hepatitis B then progresses to diseases such as liver cirrhosis and liver cancer, bringing a heavy medical burden to the country. According to the “Hepatitis B Elimination Plan by 2030” proposed by the WHO in 2016, China is still facing huge challenges to achieve the goal of reducing hepatitis B mortality by 65% by 2030.
A major focus of the prevention and treatment of hepatitis B is to accurately detect the level of the virus. However, the existing indicators (HBV DNA and HBsAg etc.)Can not reflect the actual effect of antiviral. In addition, interferon treatment also has no indicators to accurately predict the efficacy, and there is a lack of effective indicators to guide the withdrawal of drugs to predict the risk of recurrence.
Specifically, in the treatment of chronic hepatitis B, most patients currently use interferon and nucleotide analogues (Nucleostide Analogues, NA) for antiviral treatments that cannot achieve a complete cure. NA can inhibit the replication of HBV virus DNA, but cannot reduce the level of cccDNA. Therefore, although the serum HBV DNA is negative in most patients receiving NA treatment, this does not mean that HBV has lost the ability to replicate. After stopping treatment, it may bring the risk of HBV reactivation.
In contrast, HBV RNA plays an important role in the replication process of hepatitis B virus. In particular, pg RNA is used as a template for reverse transcription of the viral core during the replication process. Its particularity has been paid more and more attention and can be applied to (1)Curative effect monitoring, accurately reflecting the therapeutic effect and disease progress;(2) Early prediction of the effect of interferon treatment, guiding the selection and adjustment of treatment plans;(3) Evaluate the risk of recurrence after stopping the drug, and guide the follow-up treatment plan.
Therefore, this indicator has been written into a number of domestic and foreign clinical authoritative guidelines or expert consensus.For example, the European Association of Liver Diseases (EASL 2017) proposed that serum HBV RNA has a strong correlation with cccDNA in the liver, which is an important indicator for the study of cccDNA transcription activity. In NAs antiviral drug withdrawal, HBV RNA quantification can help predict Virology rebounded.The Chinese Guidelines for Prevention and Treatment of Chronic Hepatitis B (2019 Edition) also mentioned that the value of HBV RNA in assessing the risk of recurrence after NAs withdrawal is worthy of in-depth study.
HBV RNA used in the clinical diagnosis and treatment of hepatitis B virus is included in multiple clinical guidelines
now,The fully automatic high-sensitivity HBV RNA quantitative product independently developed by Rendu Biotech was approved by the National Medical Products Administration (NMPA) and officially went on the market (registration certificate number: National Machinery Note 2013400174), becoming the first domestically marketed HBV RNA quantitative product.
According to the team,The detection platform supports the original tube of the blood collection tube on the machine, which automatically completes all the steps of nucleic acid extraction, nucleic acid amplification and data analysis to obtain results. The whole process does not require manual operation, achieving a true “sample in, result out”; in addition, It can realize assembly line detection, which can be completed in 90 minutes.
NMPA website information announcement
In addition, the product uses patented technology-Specific target capture technologyLike “fishing”, only HBV RNA is extracted, but HBV DNA is not extracted. Therefore, there is no need to use DNase to remove DNA, avoiding HBV RNA loss and greatly improving detection sensitivity.The lower detection limit is 50 copies/ml.
Research and comparative data show that: Compared with the detection rate of traditional RT-PCR technology, the specific target capture technology is more than 10% higher; in addition, its nucleic acid amplification link also uses patented technology, introducing “tag” T7 promoter to bind to HBV RNA Under the action of T7 polymerase, only the target HBV RNA is amplified specifically, eliminating the interference of HBV DNA.
On the industry side, 36Kr learned that Sunshine Biotech and Hotview Biotechnology have also developed relevant HBV RNA detection reagents, among which, Hotview Bio-related products have also received national priority approval.