Comparison between Basic Performances of HISCL™ Hepatitis B Core Antibody Reagent and Other Reagents

• Comparison between Basic Performances of HISCL™ Hepatitis B Core Antibody Reagent and Other Reagents

AUTHOR(S)

Kumiko OONE, Tomoya IWASE, Takako INOUE, Fumiyasu KOIKE, Satomi KANI,
Yukio WAKIMOTO, Takaaki GOTO, Shigeru SATO and Yasuhito TANAKA

Department of Central Clinical Laboratory, Nagoya City University Hospital
Department of Virology & Liver Unit, Nagoya City University Graduate School of Medical Sciences

SUMMARY

Hepatitis B virus (HBV) reactivation has emerged as a major health concern. It is associated with the use of potent immunosuppressants, including rituximab, in patients with resolved HBV infection who are negative for the hepatitis B surface antigen (HBsAg). The importance of using a hepatitis B core antibody (anti-HBc) kit as a screening tool for such patients has been re-evaluated. We performed a fundamental evaluation of the Sysmex HISCL Anti-HBc assay reagent and compared it with other chemiluminescent reagents using a chemiluminescent enzyme immunoassay. The results indicated that the overall performance of the HISCL Anti-HBc assay reagent was satisfactory. However, each of the study reagents demonstrated both false-negative and false-positive results at times, suggesting that qualitative analysis of near-cutoff or low-titer samples can be a challenge regardless of the reagent used. Although the anti-HBc test is a useful screening tool for patients who have resolved HBV infection and are negative for HBsAg, performing it alone may provide limited accuracy in patients with reduced antibody titers.