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

来源：

EMERGING INFECTIOUS DISEASES | 2009年 / 15卷 / 08期

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

页码：1250 / 1259

页数：10

共 20 条

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