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.
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Authors | Kun-Teng Wang, Shu-Ching Weng, Ching-Pang Chou, Daniel Yang-Chih Shih, Chi-Fang Lo, Der-Yuan Wang |
Journal | Biologicals : journal of the International Association of Biological Standardization
(Biologicals)
Vol. 40
Issue 6
Pg. 445-50
(Nov 2012)
ISSN: 1095-8320 [Electronic] England |
PMID | 22921349
(Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2012 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved. |
Chemical References |
- Hepatitis B Surface Antigens
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Topics |
- Cooperative Behavior
- Hepatitis B
(diagnosis, immunology)
- Hepatitis B Surface Antigens
(blood)
- Humans
- In Vitro Techniques
- Reproducibility of Results
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