Views:1 Author:Site Editor Publish Time: 2021-11-09 Origin:Site
The new star member of Tianlong Intelligent Manufacturing Family, Tianlong's Hepatitis B Virus (HBV) DNA PCR Kit (PCR Fluorescent Probe Method) independently developed by Tianlong (supported by China's National Science and Technology Major Project), gained approval by the National Medical Products Administration (NMPA) of China.
Ultra-Sensitive
Features
Ultra-Sensitive:
Limit of detection (LOD): 5IU/mL, able to detect HBV at relatively low viral load levels;
Precise Quantification：
Quantitative range:15IU/mL-1.0×109IU/mL, designed for clinical applications;
Easy to operate:
Automation-ready working with compatible automated nucleic acid extraction systems of Tianlong;
Reliable:
Covering eight subtypes of HBV; internal quality control to monitor the whole process.
Tianlong's Ultra-Sensitive Automated HBV-DNA PCR Detection Solution
Tianlong’s ultra-sensitive automated HBV-DNA PCR detection solution includes a series of automated nucleic acid extraction and detection instruments and kits independently developed by Tianlong based on the magnetic bead method and real-time PCR technology, with the whole automated HBV-DNA PCR detection time optimized in about two hours.
Clinical Significance:
Early diagnosis of Occult hepatitis B virus (HBV) infection (OBI)
More accurate determination of the starting point of hepatitis B treatment and the timing of drug discontinuation
Accurate evaluation of the effect of antiviral treatment
Prediction of the risk of drug resistance for timely treatment adjustment
Authoritative Guidelines
Guidelines | Sensitivity requirements for HBV-DNA detection |
China Guidelines for Prevention and Treatment of Chronic Hepatitis B (2019) | HBsAg-negative patients treated with a single-tablet regimen (STR) of TDF or the TDF+ETV combination therapy (<15 IU/mL) |
American Association for the Study of Liver Diseases (AASLD) 2018 Guidelines | HBV-DNA detection using real-time PCR technology, at the sensitivity of 5-10 IU/mL |
European Society of Liver Diseases (EASL) 2017 Guidelines | For patients taking nucleosides, HBV-DNA reduced to the level that cannot be detected by real-time PCR method (<10 IU/mL) |
WHO Guidelines for the Prevention, Care and Treatment of Persons with Chronic Hepatitis B Infection (2015) | HBV-DNA <15 IU/mL defined as below the lower limit of detection |
Asia Pacific Clinical Practice Guidelines (APASL) Guidelines for Management of HBV Infection 2015 | After antiviral treatment, HBV-DNA reduced to 10 IU/mL, defined as an indicator of recovery from the primary lesion |
According to WHO Global Hepatitis Report 2017, about 257 million people worldwide live with Hepatitis B Virus (HBV). Together with global efforts, Tianlong has always been ready to eliminate viral hepatitis with constant innovation and the development of products.
