Reproducibility of Serologic Assays for Influenza Virus A (H5N1)

被引:118
作者
Stephenson, Iain [1 ]
Heath, Alan [2 ]
Major, Diane [2 ]
Newman, Robert W. [2 ]
Hoschler, Katja [3 ]
Junzi, Wang [6 ]
Katz, Jacqueline M. [4 ]
Weir, Jerry P. [5 ]
Zambon, Maria C. [3 ]
Wood, John M. [2 ]
机构
[1] Univ Leicester, Leicester, Leics, England
[2] Natl Inst Biol Stand & Controls, Potters Bar EN6 3QG, Herts, England
[3] Hlth Protect Agcy, Colindale, England
[4] Ctr Dis Control & Prevent, Atlanta, GA USA
[5] US FDA, Rockville, MD 20857 USA
[6] Natl Inst Control Pharmaceut & Biol Prod, Beijing, Peoples R China
关键词
MF59-ADJUVANTED INFLUENZA; HUMAN SERA; ANTIBODY; VACCINE;
D O I
10.3201/eid1508.081754
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
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.
引用
收藏
页码:1250 / 1259
页数:10
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