Rapid and sensitive detection of hepatitis B virus by lateral flow recombinase polymerase amplification assay.

Hepatitis B virus (HBV) infection is a major public health priority. In the present study, a lateral flow strip combined with the recombinase polymerase amplification (LF-RPA) assay was developed and evaluated for rapid HBV detection. A primer/probe pair targeting the conserved region of the HBV genome was designed and applied to the LF-RPA. TheRPA was achieved at the isothermal temperature of 39℃ for 30 min, and the RPA products were detected using the LF test. DNA extraction, RPA reaction and endpoint detection will take about 70 min. The LF-RPA assay could detect HBV at as low as 10 copies/reaction, with no cross-reactions with other common pathogens. The LF-RPA assay was performed on 85 samples. Of these, 36 samples tested HBV positive, whereas 49 were negative. Similar results were obtained using the conventional polymerase chain reaction method. Thus, the newly developed LF-RPA assay can be an improved diagnostic tool for rapid and simple HBV detection.