Mary C Kuhns1, Vera Holzmayer2, Anne L McNamara3, Eva Sickinger4, Jan Schultess5, Gavin A Cloherty6. 1. Infectious Disease Research, Diagnostics Division, Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064, USA. Electronic address: Mary.Kuhns@abbott.com. 2. Infectious Disease Research, Diagnostics Division, Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064, USA. Electronic address: Vera.Holzmayer@abbott.com. 3. Infectious Disease Research, Diagnostics Division, Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064, USA. 4. Research and Development, Diagnostics Division, Abbott GmbH & Co. KG, Max-Planck-Ring 2, 65205 Wiesbaden-Delkenheim, Germany. Electronic address: Eva.Sickinger@abbott.com. 5. Research and Development, Diagnostics Division, Abbott GmbH & Co. KG, Max-Planck-Ring 2, 65205 Wiesbaden-Delkenheim, Germany. Electronic address: Jan.Schultess@abbott.com. 6. Infectious Disease Research, Diagnostics Division, Abbott Laboratories, 100 Abbott Park Road, Abbott Park, IL 60064, USA. Electronic address: Gavin.Cloherty@abbott.com.
Abstract
BACKGROUND: 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). OBJECTIVES: 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. STUDY DESIGN: 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. RESULTS: 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. CONCLUSIONS: The new prototype HBsAg assay will be of diagnostic value in providing improved detection of early acute, late acute, and occult HBV infections.
BACKGROUND: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). OBJECTIVES: 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. STUDY DESIGN: 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. RESULTS: 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. CONCLUSIONS: The new prototype HBsAg assay will be of diagnostic value in providing improved detection of early acute, late acute, and occult HBV infections.
Authors: Anna Kramvis; Kyong-Mi Chang; Maura Dandri; Patrizia Farci; Dieter Glebe; Jianming Hu; Harry L A Janssen; Daryl T Y Lau; Capucine Penicaud; Teresa Pollicino; Barbara Testoni; Florian Van Bömmel; Ourania Andrisani; Maria Beumont-Mauviel; Timothy M Block; Henry L Y Chan; Gavin A Cloherty; William E Delaney; Anna Maria Geretti; Adam Gehring; Kathy Jackson; Oliver Lenz; Mala K Maini; Veronica Miller; Ulrike Protzer; Jenny C Yang; Man-Fung Yuen; Fabien Zoulim; Peter A Revill Journal: Nat Rev Gastroenterol Hepatol Date: 2022-07-20 Impact factor: 73.082
Authors: Michel Bazinet; Victor Pântea; Valentin Cebotarescu; Lilia Cojuhari; Pavlina Jimbei; Mark Anderson; Jeff Gersch; Vera Holzmayer; Carina Elsner; Adalbert Krawczyk; Mary C Kuhns; Gavin Cloherty; Ulf Dittmer; Andrew Vaillant Journal: Hepatol Commun Date: 2020-11-13
Authors: Mary C Kuhns; Vera Holzmayer; Mark Anderson; Anne L McNamara; Silvia Sauleda; Dora Mbanya; Pham T Duong; Nguyen T T Dung; Gavin A Cloherty Journal: Viruses Date: 2021-10-13 Impact factor: 5.048