A collaborative study to establish the 1st WHO International Standard for Epstein-Barr virus for nucleic acid amplification techniques
| Autor: | Dianna E. Wilkinson, Alan Heath, Philip D. Minor, Jacqueline F. Fryer |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Herpesvirus 4 Human 030106 microbiology Bioengineering medicine.disease_cause Applied Microbiology and Biotechnology Cell Line Epstein–Barr virus 03 medical and health sciences International Standard Mice EBV Immunology and Microbiology(all) hemic and lymphatic diseases Medicine Potency Animals Humans Dna viral Reference standards Hepatitis B virus Pharmacology General Immunology and Microbiology business.industry International standard General Medicine Nucleic acid amplification technique Hepatitis B medicine.disease Virology 030104 developmental biology Nat DNA Viral Standardisation business NAT Nucleic Acid Amplification Techniques Biotechnology |
| Zdroj: | Biologicals : journal of the International Association of Biological Standardization. 44(5) |
| ISSN: | 1095-8320 |
| Popis: | Nucleic acid amplification techniques (NAT) are routinely used for clinical diagnostics and monitoring hepatitis B virus (HBV) infections, and are implemented on a voluntary basis for blood screening. A collaborative study was performed to evaluate a replacement WHO International Standard for HBV for the standardization of NAT. Two lyophilised HBV candidates were evaluated by 16 laboratories worldwide, alongside the existing HBV International Standard. The overall mean potency estimates for the candidate samples 1 and 2, relative to sample 3 (2nd HBV International Standard), from quantitative assays, were 5.93 and 5.98 log10 International Units (IU)/mL respectively. The variability in individual laboratory mean estimates for samples 1–3 for quantitative assays was ∼0.3 log10 IU/mL. The inter-laboratory variability for qualitative assays was higher. Accelerated thermal degradation studies indicate that both lyophilised candidates are stable and suitable for long-term use. Overall, the results suggested that both candidates were suitable as replacement International Standards. Sample 1 (NIBSC code 10/264) was established as the 3rd WHO International Standard for HBV for NAT with an assigned potency of 850,000 IU/mL (∼5.93 log10 IU/mL), when reconstituted in 0.5 mL of nuclease-free water. It is intended for the calibration (in IU) of secondary reference materials used in HBV NAT. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect