Collaborative study to establish a proficiency panel of hepatitis B surface antigens for evaluating in vitro diagnostics
| Autor: | Der-Yuan Wang, Kun-Teng Wang, Chi-Fang Lo, Ching-Pang Chou, Shu-Ching Weng, Daniel Yang-Chih Shih |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Oncology
medicine.medical_specialty HBsAg Postmarketing surveillance Bioengineering In Vitro Techniques medicine.disease_cause Hepatitis b surface antigen Applied Microbiology and Biotechnology In vitro diagnostic Food and drug administration Internal medicine medicine Potency Humans Cooperative Behavior Pharmacology Hepatitis B virus Hepatitis B Surface Antigens General Immunology and Microbiology business.industry Reproducibility of Results General Medicine Hepatitis B In vitro Immunology business Biotechnology |
| Zdroj: | Biologicals : journal of the International Association of Biological Standardization. 40(6) |
| ISSN: | 1095-8320 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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