China-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its in-house developed hepatitis B virus RNA (HBV RNA) assay kit, utilizing the PCR fluorescence probe method. This approval marks a significant milestone for Hotgen in expanding its diagnostic capabilities for hepatitis B.
Product Overview
The HBV RNA assay kit is designed for the quantitative determination of hepatitis B virus RNA (HBV RNA) in human serum samples in vitro. Research data have indicated that HBV RNA levels in peripheral blood serum can reflect the transcriptional activity of the HBV virus in the liver. Importantly, HBV RNA can still be detected in some samples where serum HBV DNA levels are below the detection limit. Additionally, during nucleos(t)ide analog (NA) therapy, serum HBV RNA can serve as one of the predictors for HBeAg-negative conversion, offering valuable insights for clinical treatment and management of hepatitis B.-Fineline Info & Tech