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One of the criticisms of seroepidemiology especially during the 2009 pandemic was that the comparability of results was limited by a lack of standardisation in the investigative protocols, the epidemiological data collected and the laboratory methods used.
The Laboratory Working Group of CONSISE has been trying to standardise the laboratory assays used in seroepidemiology by essentially three approaches:
- Develop consensus assay protocols for serology assays
- Examine the agreement between assay results of different laboratories when consensus protocols are used
- Examine the impact of antibody standards produced from different sources on inter-laboratory agreement
Two main methods are used for influenza serology: Haemagglutination-Inhibition (HI) and Microneutralization (MN) assay. Several protocols exist for each method and therefore the CONSISE Laboratory Working Group has reviewed the members’ protocols for MN and HI assays. The group has developed two consensus protocols for MN and a consensus protocol for the HI assay of A(H1N1)pdm09 virus. A collaborative study comparing the two MN protocols, namely the 2-day ELISA-based and the 3-day haemagglutination (HA) assay-based methods has demonstrated that for assays of the A(H1N1)pdm09 virus, the two assays are comparable and therefore either of these CONSISE consensus protocols can be recommended. It is planned to examine the consensus HI assay by collaborative study in the next few months.
The consensus assay protocols are available below:
These documents were created by members of CONSISE and are distributed under the “Creative Commons Attribution-NonCommercial-ShareAlike 3.0” (http://creativecommons.org/licenses/by-nc-sa/3.0/). You can freely copy, adapt, distribute and transmit under the conditions that: the original source is attributed; the work is not used for commercial purposes, and any altered forms of this document are distributed freely under the same conditions. We encourage you to provide feedback on the use of these protocol templates here.