PRODUCT
Hepatitis B Viral DNA Quantitative Fluorescence Diagnostic Kit (fast HBV, PCR-Fluorescence Probing)


Abstract

Hepatitis B virus (HBV) infection remains a global public health problem with changing epidemiology due to several factors including vaccination policies and migration. 

An estimated 257 million people are living with hepatitis B virus infection (defined as hepatitis B surface antigen positive). But there is still limited access to diagnosis and treatment of hepatitis B in many resource-constrained settings. In 2015, of the 257 million people living with HBV infection, 9% (22 million) knew their diagnosis. Of those diagnosed, the global treatment coverage was only 8% (1.7 million). Many people are diagnosed only when they already have advanced liver disease. In May 2016, The World Health Assembly adopted the first "Global Health Sector Strategy on Viral Hepatitis, 2016-2020". The strategy has a vision of eliminating viral hepatitis as a public health problem and this is encapsulated in the global targets of reducing new viral hepatitis infections by 90% and reducing deaths due to viral hepatitis by 65% by 2030.

Sansure has developed Hepatitis B Viral DNA Quantitative Fluorescence Diagnostic Kit (fastHBV) with the foresight which agrees with WHO to provide patients living with HBV infection with an affordable, accessible and sustainable alternative to diagnose HBV, monitor disease progression, and assess the stage of liver disease and eligibility for treatment. 


Product performance

The diagnostic kit uses a nucleic acid lysis buffer to allow rapid lysis and release of HBV-DNA from a serum or plasma specimen. By applying real-time fluorescence quantitative PCR technology, this test utilizes a pair of specific primers which are designed to target at a conserved sequence of HBV-DNA, a specific fluorescence probe, accompanied with PCR mix,to achieve quantitative detection of HBV-DNA through fluorescent signal changes.

It eliminates the need to extract DNA in specimens during the entire test process. It only needs to add the serum or plasma specimen directly to PCR reaction tube and thoroughly mix it with DNA lysis buffer, which then can be used as the template for PCR amplification. This avoids laboratory contamination which occurs often during routine DNA extraction process.

The PCR detection system uses UNG enzyme + dUTP contamination-proof system, which can fully degrade possible unwanted side-products, to avoid a false positive result. The PCR detection system uses an internal control, which monitors the presence of PCR inhibitors in test specimens by detecting whether the internal control signal is normal, to avoid a false negative result.


CFDA Marked, CE Pending


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