Improved detection of early acute, late acute, and occult Hepatitis B infections by an increased sensitivity HBsAg assay

• Published in: Journal of clinical virology 2019-09, Vol.118, p.41-45
• Main Authors: Kuhns, Mary C., Holzmayer, Vera, McNamara, Anne L., Sickinger, Eva, Schultess, Jan, Cloherty, Gavin A.
• Format: Article
• Language: English
• Subjects: Hepatitis B surface antigen; Hepatitis B surface antigen mutations; Hepatitis B virus; Occult hepatitis B
• ISSN: 1386-6532; 1873-5967
• DOI: 10.1016/j.jcv.2019.08.001

•Gaps remain in detection of early acute, late acute, and occult HBV infection.•A new Abbott ARCHITECT/Alinity HBsAg assay improves detection of HBV infection.•The new assay improved detection of early acute HBV by 36.4%.•The new assay detected late acute HBV infection longer than current assays.•The new HBsAg assay increased detection of occult HBV by 10.9%. Hepatitis B surface antigen (HBsAg) is the primary marker for diagnosis of acute and chronic hepatitis B. Although HBsAg assays have undergone continuous improvement, gaps remain in the detection of early and late acute infection and occult hepatitis B infection (OBI). The performance of a prototype, improved sensitivity HBsAg assay run on the ARCHITECT and Alinity instruments was evaluated for detection of early and late acute infection and OBI. Seventy seven early acute samples [positive only for hepatitis B viral DNA (HBV DNA)], twelve seroconversion panels spanning late acute infection, and 101 occult samples (HBsAg negative, positive for HBV DNA and anti-HBc) were tested with the prototype assay and ARCHITECT HBsAg Qualitative II. HBsAg gene sequencing was performed to determine genotype and mutations in the immunodominant region. Compared with ARCHITECT HBsAg Qualitative II, the prototype assay showed increased detection of NAT yield samples (28/77, 36.4%,), late acute samples (≥13 days longer detection of HBsAg for 6/12 panels), and OBI samples (11/101, 10.9%). HBsAg sequence data were obtained for 62 samples. Genotypes represented were A1, A2, B2, B4, C1, C2, C5, D3, E, and H. HBsAg escape mutations were found in 4.8% of NAT yield and 38.9% of OBI samples sequenced. Prototype assay values for 188 samples were equivalent on the ARCHITECT and Alinity instruments. The new prototype HBsAg assay will be of diagnostic value in providing improved detection of early acute, late acute, and occult HBV infections.