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. 2021 May 21;13(6):951. doi: 10.3390/v13060951

Table 1.

Summary of Novel HBV Biomarkers and Available Laboratory Tests.

HBV Biomarker Summary of Uses and Limitations Laboratory Tests Available
Serum HBV RNA
  • -

    Surrogate of cccDNA transcriptional activity

  • -

    Serum HBV RNA levels can be used to differentiate HBeAg-negative phases of CHB

  • -

    Prediction of HBeAg seroconversion

  • -

    Prediction of SVR in patients on peg-IFN and/or NAs

  • -

    Larger cohorts and improved sensitivity required

  • -

    No standardized assay to date
  • -

    In-house developed RACE-based RT-qPCR, standard RT-qPCR, and ddPCR

  • -

    Abbott Diagnostics HBV RNA test (in development)
HBcrAg
  • -

    Correlates with cccDNA

  • -

    Levels can distinguish between active and inactive disease

  • -

    Prediction of HBeAg or HBsAg seroconversion, development of cirrhosis

  • -

    Monitoring of response to treatment

  • -

    Many factors may lead to faulty interpretation (i.e., anti-HBe, mutations affecting expression of HBeAg)

  • -

    Limited availability of assay

  • -

    Should be further investigated with larger and more diverse cohorts
  • -

    Fujirebio, Inc. CLEIA HBcrAg assay

  • -

    Fujirebio, Inc. iTACT-HBcrAg
HBV-NRAg
  • -

    Higher sensitivity than PreS1 manual ELISAs

  • -

    Highly correlates with HBV DNA positivity

  • -

    Positivity associated with liver abnormalities

  • -

    Qualitative test

  • -

    Clinical utility remains to be further evaluated with larger cohorts
  • -

    Wantai NRAg manual ELISA
qHBsAg
  • -

    Monitoring of response to treatment and SVR

  • -

    Prediction of HBsAg loss

  • -

    Prediction of development of liver fibrosis and HCC

  • -

    May reflect cccDNA levels in the liver
  • -

    Abbott Diagnostics Architect HBsAg QT

  • -

    Roche Diagnostics Elecsys HBsAg II

  • -

    DiaSorin LIAISON-XL Murex HBsAg Quant

  • -

    NIBSC standard available (IU/mL)
Ultrasensitive HBsAg
  • -

    Limit of detection 0.2–5 mIU/mL

  • -

    Early detection of acute infection

  • -

    To monitor for reactivation or subclinical levels of HBsAg following seroclearance

 Qualitative:
  • -

    Abbott Diagnostics HBsAg Next Qualitative

  • -

    Abbott Diagnostics HBsAg Next Confirmatory assay

Quantitative:
  • -

    Fujirebio, Inc. Lumipulse HBsAg-HQ

  • -

    Sysmex Co., HBsAg ICT-CLEIA
qAHBc
  • -

    Correlates with ALT during treatment

  • -

    Prediction of development of liver fibrosis and necro-inflammation

  • -

    Monitoring treatment and SVR

  • -

    Identification of occult HBV

  • -

    Wantai assay has narrow range of quantification
  • -

    Wantai qAHBc manual ELISA (total AHBc)

  • -

    Fujirebio, Inc. Lumipulse® G HBcAb-N (AHBc IgG)

  • -

    NIBSC standard available (IU/mL)