The novel method of lateral flow immunoassay (LFI) may be a cost-effective way to identify patients with chronic hepatitis B virus (HBV) infection, according to data presented at American Society of Microbiology (ASM) Microbe 2019, held June 20-24 in San Francisco, California.

Chronic HBV infection affects an estimated 248 million people worldwide and leads to more than 600,000 deaths annually. An emerging clinical biomarker identified in the management of chronic HBV infection is the hepatitis B virus core-related antigen (HBcrAg), which is a 149 amino acid shared region that is present in 3 proteins expressed by the HBV precure/core gene: the HBV core antigen, e antigen, and p22cr. Recent evidence has suggested that HBcrAg positivity can predict the risk for HBV reactivation both during treatment and during chemotherapy administration and has suggested that quantitative values of HBcrAg can predict the risk of hepatocellular carcinoma. An LFI has been developed and may be capable of rapid detection of elevated HBcrAg from serum. Therefore, this study examined this novel method of HBcrAg assessment that can be performed at the point of care.

Researchers immunized mice with recombinant HBV core antigen to establish a hybridoma of 24 monoclonal antibodies. By identifying monoclonal antibodies with reactivity to both HBV core and e antigens, which are antigens that share no other epitopes, HBcrAg epitope-specific monoclonal antibodies were verified. HBcrAg LFI and enzyme-linked immunosorbent assay prototypes were developed by pairing HBcrAg monoclonal antibodies. Further, modified point-of-care capable protocols that do not require specialized equipment have been developed.

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Overall, the study author concluded that, “LFI detection of HBcrAg at the [point-of-care] could serve as a way to cost-effectively screen large populations to identify [chronic hepatitis B] patients most in need of antiviral therapy or closer monitoring.”

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Sorensen J. Development of a rapid point of care immunoassay to detect hepatitis B core related antigen to aid the management of chronic hepatitis B infection. Presented at: ASM Microbe 2019; June 20-24, 2019; San Francisco, California. Poster P600.