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Tianlong's Ultra-Sensitive HBV PCR Kit Gained NMPA Approval

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.

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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.

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Clinical Significance:

  1. Early diagnosis of Occult hepatitis B virus (HBV) infection (OBI)

  2. More accurate determination of the starting point of hepatitis B treatment and the timing of drug discontinuation

  3. Accurate evaluation of the effect of antiviral treatment

  4. 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.


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