Development of sensitive and specific loop-mediated isothermal amplification combined with lateral flow device for the rapid detection of hepatitis B virus infection

Hepatitis B virus is a highly infectious blood borne microbial pathogen that causes several hepatic complications like liver cirrhosis and hepatocellular carcinoma. Several methods are available for the detection of HBV, but every method has their own merits and demerits, which restrict their use in clinical laboratories. The aim of this present study is the development of rapid, inexpensive, sensitive, and specific loop-mediated isothermal amplification followed by lateral flow device (LFD) for detection of HBV in blood specimens. Methods HBV standard plasma panels and donor plasma specimens were used to evaluate the assay. HBV DNA was extracted by using QiAamp DNA Blood Mini Kit. Amplification was carried out at constant temperature 63 degrees C for 60 min. LAMP end products were analyzed by using ESE LAMP tube scanner, gel electrophoresis, UV-lamp, and lateral flow device. Results HBV-LAMP-LFD assay revealed sensitivity of 92% (138/150) of HBV positive plasma specimens. Specificity of HBV-LAMP-LFD was calculated 100%. Conclusion Our study concludes that HBV-LAMP-LFD is rapid, easy to use, sensitive, and specific point-of-care diagnostic assay for the detection of hepatitis B virus in blood samples. This assay can be used in resource-limited settings as well as in HBV endemic areas.