期刊
EMERGING INFECTIOUS DISEASES
卷 15, 期 8, 页码 1250-1259出版社
CENTERS DISEASE CONTROL
DOI: 10.3201/eid1508.081754
关键词
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资金
- Nobilon
- NexBio
- CSL Biotherapies
- Sanofi-Pasteur
- Baxter
- Novartis
- MRC [G0700846] Funding Source: UKRI
- Medical Research Council [G0700846] Funding Source: researchfish
Hemagglutination-inhibition (HI) and neutralization are used to evaluate vaccines against influenza virus A (H5N1); however, poor standardization leads to interlaboratory variation of results. A candidate antibody standard (07/150) was prepared from pooled plasma of persons given clade 1 A/Vietnam/1194/2004 vaccine. To test human and sheep antiserum, 15 laboratories used HI and neutralization and reassortant A/Vietnam/1194/2004, A/turkey/Turkey/1/2005 (clade 2.2), and A/Anhui/1/2005 (clade 2.3.4) viruses. Inter-laboratory variation was observed for both assays, but when titers were expressed relative to 07/150, overall percentage geometric coefficient of variation for A/Vietnam/1194/2004 was reduced from 125% to 61% for HI and from 183% to 81% for neutralization. Lack of reduced variability to clade 2 antigens suggested the need for clade-specific standards. Sheep antiserum as a standard did not reliably reduce variability. The World Health Organization has established 07/150 as an international standard for antibody to clade 1 subtype H5 and has an assigned potency of 1,000 IU/ampoule.
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