Results and harmonization guidelines from two large-scale international Elispot proficiency panels conducted by the Cancer Vaccine Consortium (CVC/SVI).

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State: Public
Version: author
Serval ID
serval:BIB_E87E0BAA4113
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Results and harmonization guidelines from two large-scale international Elispot proficiency panels conducted by the Cancer Vaccine Consortium (CVC/SVI).
Journal
Cancer Immunology, Immunotherapy
Author(s)
Janetzki S., Panageas K.S., Ben-Porat L., Boyer J., Britten C.M., Clay T.M., Kalos M., Maecker H.T., Romero P., Yuan J., Kast W.M., Hoos A.
Working group(s)
Elispot Proficiency Panel of the CVC Immune Assay Working Group
Contributor(s)
Anderson R., Bercovici N., Boyer J., Britten C., Brockstedt D., Caterini J., Cerundolo V., Chen W., Clay T., Darnell R., Dubey S., Ermak T., Gnjatic S., Harrop R., Healey D., Houghton A., Jaeger E., Janssen W., Jones L., Kast WM., Kaufman J., Knuth A., Konur A., Kos F., Kunle O., Manson K., Matijevic M., Miyahara Y., Musselli C., Olson W., Panicali D., Parida S., Parker J., Pohla H., Pride M., Rappaport R., Reay P., Rivoltini L., Romero P., Schiltz P., Shiku H., Slingluff C., Smith J., Speiser D., Swanlund D., Vajdy M., Van der Aa A., Weber J., Woelfel T., Wolchok J.
ISSN
0340-7004 (Print)
ISSN-L
0340-7004
Publication state
Published
Issued date
2008
Peer-reviewed
Oui
Volume
57
Number
3
Pages
303-315
Language
english
Notes
Publication types: Guideline ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
The Cancer Vaccine Consortium of the Sabin Vaccine Institute (CVC/SVI) is conducting an ongoing large-scale immune monitoring harmonization program through its members and affiliated associations. This effort was brought to life as an external validation program by conducting an international Elispot proficiency panel with 36 laboratories in 2005, and was followed by a second panel with 29 participating laboratories in 2006 allowing for application of learnings from the first panel. Critical protocol choices, as well as standardization and validation practices among laboratories were assessed through detailed surveys. Although panel participants had to follow general guidelines in order to allow comparison of results, each laboratory was able to use its own protocols, materials and reagents. The second panel recorded an overall significantly improved performance, as measured by the ability to detect all predefined responses correctly. Protocol choices and laboratory practices, which can have a dramatic effect on the overall assay outcome, were identified and lead to the following recommendations: (A) Establish a laboratory SOP for Elispot testing procedures including (A1) a counting method for apoptotic cells for determining adequate cell dilution for plating, and (A2) overnight rest of cells prior to plating and incubation, (B) Use only pre-tested serum optimized for low background: high signal ratio, (C) Establish a laboratory SOP for plate reading including (C1) human auditing during the reading process and (C2) adequate adjustments for technical artifacts, and (D) Only allow trained personnel, which is certified per laboratory SOPs to conduct assays. Recommendations described under (A) were found to make a statistically significant difference in assay performance, while the remaining recommendations are based on practical experiences confirmed by the panel results, which could not be statistically tested. These results provide initial harmonization guidelines to optimize Elispot assay performance to the immunotherapy community. Further optimization is in process with ongoing panels.
Keywords
Cancer Vaccines/immunology, Cell Survival/immunology, Clinical Laboratory Techniques/standards, Clinical Laboratory Techniques/statistics & numerical data, Enzyme-Linked Immunosorbent Assay/standards, Health Surveys, Humans, International Cooperation, Laboratories/standards, Leukocyte Count, Leukocytes, Mononuclear/immunology, Peptides/immunology, Quality Control, Reference Standards, Reproducibility of Results, Sensitivity and Specificity, Societies
Pubmed
Web of science
Open Access
Yes
Create date
28/01/2008 11:28
Last modification date
20/08/2019 16:11
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