Diagnostic Performance of Fujirebio Lumipulse G HBcrAg Immunoassay in Hepatitis B

The Fujirebio Lumipulse G hepatitis B core-related antigen (HBcrAg) immunoassay on the Fujirebio LUMIPULSE G1200 analyzer shows significant differences in HBcrAg levels depending on hepatitis B antigen (HBeAg) status, clinical phase, and treatment status, according to results published in the Journal of Clinical Virology.

The study aimed to evaluate the diagnostic performance of the Fujirebio Lumipulse G HBcrAg immunoassay on the Fujirebio LUMIPULSE G1200 analyzer. The researchers used 3 HbeAg-positive hepatitis B virus (HBV) samples to assess the analytical performance. They used subpanels of 54 confirmed acute hepatitis A virus, chronic hepatitis C virus, acute hepatitis E virus, B19, acute cytomegalovirus, and Epstein-Barr virus infections to assess diagnostic specificity. They investigated diagnostic sensitivity in well-defined HBV-positive patient groups, including treated, untreated, and immunocompromised patients.

The results indicated that the Lumipulse G HBcrAg immunoassay provided a linear measurement at a dilution between 1:100 and 1:10,000.

In 6 of 54 samples, the researchers observed nonspecific reactivity in sera from acute cytomegalovirus, Epstein-Barr virus, and HEV infections. Of these, 2 had >3 log U/mL.

The researchers measured the highest levels of HBcrAg in HBeAg-positive patients; this was true among treated, untreated, and immunocompromised patients.

The researchers found that HBcrAg has a limited applicability for distinguishing between patients with resolved HBV infections and false-positivity reactivity to solitary anti-HBc.

“Before implementing the assay in clinical practice, additional research in larger patient cohorts should be carried out,” the researchers wrote.

Reference

van Halewijn GJ, Geurtsvankessel CH, Klaasse J, et al. Diagnostic and analytical performance of the hepatitis B core related antigen immunoassay in hepatitis B patients. J Clin Virol. 2019;114:1-5.