3.9 Article

International Laboratory Comparison of Influenza Microneutralization Assays for A(H1N1) pdm09, A(H3N2), and A(H5N1) Influenza Viruses by CONSISE

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CLINICAL AND VACCINE IMMUNOLOGY
卷 22, 期 8, 页码 957-964

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AMER SOC MICROBIOLOGY
DOI: 10.1128/CVI.00278-15

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资金

  1. Australian Government Department of Health
  2. Area of Excellence Scheme of the University Grants Committee of Hong Kong at the University of Hong Kong [AoE/M-12/96]
  3. UK Medical Research Council
  4. United States Armed Forces Health Surveillance Center's Global Emerging Infections Surveillance and Response System for the Naval Medical Research Center
  5. Naval Health Research Center
  6. Italian Ministry of Health
  7. IFPMA (International Federation of Pharmaceutical Manufacturers Associations)
  8. Juvaris Bio-Therapeutics, Inc.
  9. Bill and Melinda Gates Foundation
  10. Glaxo SmithKline
  11. Medical Research Council [MR/K010174/1B, MR/K010174/1] Funding Source: researchfish
  12. MRC [MR/K010174/1] Funding Source: UKRI

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The microneutralization assay is commonly used to detect antibodies to influenza virus, and multiple protocols are used worldwide. These protocols differ in the incubation time of the assay as well as in the order of specific steps, and even within protocols there are often further adjustments in individual laboratories. The impact these protocol variations have on influenza serology data is unclear. Thus, a laboratory comparison of the 2-day enzyme-linked immunosorbent assay (ELISA) and 3-day hemagglutination (HA) microneutralization (MN) protocols, using A(H1N1) pdm09, A(H3N2), and A(H5N1) viruses, was performed by the CONSISE Laboratory Working Group. Individual laboratories performed both assay protocols, on multiple occasions, using different serum panels. Thirteen laboratories from around the world participated. Within each laboratory, serum sample titers for the different assay protocols were compared between assays to determine the sensitivity of each assay and were compared between replicates to assess the reproducibility of each protocol for each laboratory. There was good correlation of the results obtained using the two assay protocols in most laboratories, indicating that these assays may be interchangeable for detecting antibodies to the influenza A viruses included in this study. Importantly, participating laboratories have aligned their methodologies to the CONSISE consensus 2-day ELISA and 3-day HA MN assay protocols to enable better correlation of these assays in the future.

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