title: Collaborative study to establish a proficiency panel of hepatitis B surface antigens for evaluating in vitro diagnostics.
abstract: Hepatitis B virus (HBV) infection is a critical health issue. In hospitals, in vitro diagnostic devices (IVDs) are used to detect HBV infections. The Taiwan Food and Drug Administration has prepared a candidate hepatitis B surface antigen (HBsAg) proficiency panel as an analytical standard to evaluate the sensitivity of the postmarketing surveillance of HBV IVDs. The sensitivity and stability of the proficiency panel, which comprises 5 HBsAg positive sera (SN-A to E) and 1 negative serum, was determined by a collaborative study involving 8 collaboratories. The potency of the candidate proficiency panel was consistent among all collaboratories. The potencies of sera SN-A to E in semiquantitative and quantitative analyses were 2.823-0.011 and 2.229-0.009 IU/mL, respectively. The mean coefficients of variation (CV) of intra and interday precision among the collaboratories were <7%. Accelerated degradation and long-term storage tests were used as stability assays. The candidate HBsAg proficiency panel exhibited good stability under different storage conditions, while all CVs were <6%. In conclusion, this candidate HBsAg proficiency panel is credible and reliable. Therefore, it can be used for postmarketing surveillance of HBV IVDs and quality assessment by clinical researchers and IVD manufacturers.
authors.affiliation: Section of Biologics & Advanced Therapeutic Product Analysis, Division of Research and Analysis, Food and Drug Administration, Department of Health, Executive Yuan, Taiwan, ROC.
authors.forename: Kun-Teng
authors.initials: KT
authors.lastname: Wang
authors.forename: Shu-Ching
authors.initials: SC
authors.lastname: Weng
authors.forename: Ching-Pang
authors.initials: CP
authors.lastname: Chou
authors.forename: Daniel
authors.initials: D
authors.lastname: Yang-Chih Shih
authors.forename: Chi-Fang
authors.initials: CF
authors.lastname: Lo
authors.forename: Der-Yuan
authors.initials: DY
authors.lastname: Wang
mesh_terms: D003299:Cooperative Behavior; D006509:Hepatitis B / Q000175:diagnosis* / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006801:Humans; D066298:In Vitro Techniques; D015203:Reproducibility of Results
chemical_list: D006514:Hepatitis B Surface Antigens