tetano
Editor, Senior Moderator
Clin Vaccine Immunol. 2016 Jan 27. pii: CVI.00613-15. [Epub ahead of print]
[h=1]Standardization of Hemagglutination Inhibition Assay for Influenza Serology Allows for High Reproducibility Between Laboratories.[/h] Zacour M[SUP]1[/SUP], Ward BJ[SUP]2[/SUP], Brewer A[SUP]2[/SUP], Tang P[SUP]3[/SUP], Boivin G[SUP]4[/SUP], Li Y[SUP]5[/SUP], Warhuus M[SUP]6[/SUP], McNeil SA[SUP]7[/SUP], LeBlanc JJ[SUP]7[/SUP], Hatchette TF[SUP]8[/SUP]; Public Health Agency of Canada and Canadian Institutes of Health Influenza Research Network (PCIRN).
[h=3]Author information[/h]
[h=3]Abstract[/h] Standardization of hemagglutination inhibition (HAI) assay for influenza serology is challenging. Poor reproducibility of HAI results from one laboratory to another is widely cited, limiting comparisons between candidate vaccines in different clinical trials and posing challenges for licensing authorities. In this study we standardized HAI materials, methods, and interpretive criteria across five geographically dispersed laboratories of a multi-disciplinary influenza research network, then evaluated intra-laboratory and inter-laboratory variations in HAI titers by repeatedly testing standardized panels of human serum samples. Duplicate precision and reproducibility between assays within laboratories were 99.8% (99.2-100%) and 98.0% (93.3%-100%), respectively. In 98.9% (95-100%) of samples the results were within two-fold of all-laboratory consensus titres and 94.3% (85-100%) of the samples were within two-fold compared to our reference laboratory. Low-titre samples showed the greatest variability, between both assays and sites. Classification of seroprotection (titre ≥40) was accurate in 93.6% or 89.5% of cases, when compared to consensus or reference laboratory classification, respectively. This study shows that with careful standardization processes, high reproducibility of HAI results between laboratories is indeed achievable.
Copyright ? 2016, American Society for Microbiology. All Rights Reserved.
PMID: 26818953 [PubMed - as supplied by publisher]
[h=1]Standardization of Hemagglutination Inhibition Assay for Influenza Serology Allows for High Reproducibility Between Laboratories.[/h] Zacour M[SUP]1[/SUP], Ward BJ[SUP]2[/SUP], Brewer A[SUP]2[/SUP], Tang P[SUP]3[/SUP], Boivin G[SUP]4[/SUP], Li Y[SUP]5[/SUP], Warhuus M[SUP]6[/SUP], McNeil SA[SUP]7[/SUP], LeBlanc JJ[SUP]7[/SUP], Hatchette TF[SUP]8[/SUP]; Public Health Agency of Canada and Canadian Institutes of Health Influenza Research Network (PCIRN).
[h=3]Author information[/h]
[h=3]Abstract[/h] Standardization of hemagglutination inhibition (HAI) assay for influenza serology is challenging. Poor reproducibility of HAI results from one laboratory to another is widely cited, limiting comparisons between candidate vaccines in different clinical trials and posing challenges for licensing authorities. In this study we standardized HAI materials, methods, and interpretive criteria across five geographically dispersed laboratories of a multi-disciplinary influenza research network, then evaluated intra-laboratory and inter-laboratory variations in HAI titers by repeatedly testing standardized panels of human serum samples. Duplicate precision and reproducibility between assays within laboratories were 99.8% (99.2-100%) and 98.0% (93.3%-100%), respectively. In 98.9% (95-100%) of samples the results were within two-fold of all-laboratory consensus titres and 94.3% (85-100%) of the samples were within two-fold compared to our reference laboratory. Low-titre samples showed the greatest variability, between both assays and sites. Classification of seroprotection (titre ≥40) was accurate in 93.6% or 89.5% of cases, when compared to consensus or reference laboratory classification, respectively. This study shows that with careful standardization processes, high reproducibility of HAI results between laboratories is indeed achievable.
Copyright ? 2016, American Society for Microbiology. All Rights Reserved.
PMID: 26818953 [PubMed - as supplied by publisher]