Recently, the innovative product "Lumipulse® G HBsAg-Quant" of Fujirebio Inc. is approved by China NMPA.

The Lumipulse® G HBsAg-Quant consists of antibody-conjugated particles, enzyme-labeled antibodies, and sample processing solution. It is used for the qualitative and quantitative in vitro detection of Hepatitis B Surface Antigen (HBsAg) in human serum or plasma.

Compared with similar products on the market, this product offers higher sensitivity, enabling the detection of HBsAg even at low concentrations in the early stages of Hepatitis B virus infection, thus facilitating early diagnosis and treatment.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.