04.08.2010 Proposal for Module 2 of MIATA Version 1.0 (based on Consensus workshop and comments from the public consultation period)

Purpose: Reporting framework for publications of human immune monitoring T cell studies  

Module 2: Minimal Information on the Assay

Proposal for Version 1.0, Module 2A: Cell counting: 

Required to report:

-          Cell recovery and viability ranges for all samples used in the reported studies, at all crucial time points (e.g. after thawing, after resting)

-          Methodology applied

Optional:

Investigators might want to provide additional information whenever there is a scientific rationale for doing so to enable better understanding of the T cell assay results. For example, if additional assessments were performed (e.g. apoptosis assessment), reporting on methodology and ranges should be considered.

Exclude:

Request for detailed values of recovery and viability for each sample.

References added: 5A

Specific comments to Module 2A:

It could be considered to move the entire content of sub-module 2A to Module 1 (sub-module 1D).

Proposal for Version 1.0, Module 2B: Medium/serum: 

Required to report:

-          the medium and serum (if applicable) used (source, cat #),

-          whether the medium or serum was pretested.

Exclude:

Request to report performance characteristics from pretesting because no standards exist for actual comparison of media or sera

References added: 8A and 8B 

Proposal for Version 1.0, Module 2C: The Assay: 

Required to report:

-          details about assay procedures including all reagents and materials used, that would allow the repetition of the assay by others and the understanding of results reported;

-          details about treatment procedures of cells (e.g. in vitro stimulation, overnight resting)

Optional:

Investigators might want to add references to published recommendations and harmonization guidelines followed if such exists for the assay they report on, and if the reference enables better understanding of the T cell assay results.

Exclude:

The overview options for assay procedures.

Specific comments to module 2C:

This sub-module is the central part of MIATA.

It should be elaborated on options for detailed reporting in the final version of MIATA, e.g.:

-          use supplementary part of journals (it is free)

-          referral to publications that contain the detailed assay information (this requires the publication of assay details at least once)

-          disapproval of referrals to papers that do not contain the detailed assay description

-          discussion of the option of a MIATA-related web site to store the assay details which can be used for referencing 

Proposal for Version 1.0, Module 2D: Controls 

Required to report:

Details on all internal and external controls applied

Exclude:

The request for quality assurance of controls. 

5. Smith JG, Joseph HR, Green T, Field JA, Wooters M, Kaufhold RM, Antonello J, and Caulfield MJ (2007) Establishing acceptance criteria for cell-mediated-immunity assays using frozen peripheral blood mononuclear cells stored under optimal and suboptimal conditions. Clin Vaccine Immunol 14:527-537

5A. Lenders K, Ogunjimi B, Beutels P, Hens N, Van Damme P, Berneman ZN, Van Tendeloo VF, Smits EL. The effect of apoptotic cells on virus-specific immune responses detected using IFN-gamma ELISPOT. J Immunol Methods. 2010 May 31;357(1-2):51-4.

6. Janetzki S, Panageas KS, Ben-Porat L, Boyer J, Britten CM, Clay TM, Kalos M, Maecker HT, Romero P, Yuan J, Kast WM, and Hoos A (2008) Results and harmonization guidelines from two large-scale international Elispot proficiency panels conducted by the Cancer Vaccine Consortium (CVC/SVI). Cancer Immunol Immunother 57:303-315

7. Janetzki S, Cox JH, Oden N, and Ferrari G (2005) Standardization and validation issues of the ELISPOT assay. Methods Mol Biol 302:51-86

8. Martinuzzi E, Scotto M, Enee E, Brezar V, Ribeil JA, van Endert P, and Mallone R (2008) Serum-free culture medium and IL-7 costimulation increase the sensitivity of ELISpot detection. J Immunol Methods 333:61-70

8A. Janetzki S, Price L, Britten CM, van der Burg SH, Caterini J, Currier JR, Ferrari G, Gouttefangeas C, Hayes P, Kaempgen E, Lennerz V, Nihlmark K, Souza V, Hoos A. Performance of serum-supplemented and serum-free media in IFNgamma Elispot Assays for human T cells. Cancer Immunol Immunother. 2010 Apr;59(4):609-18. Epub 2009 Nov 6.

8B. Mander A, Gouttefangeas C, Ottensmeier C, Welters MJ, Low L, van der Burg SH, Britten CM. Serum is not required for ex vivo IFN-gamma ELISPOT: a collaborative study of different protocols from the European CIMT Immunoguiding Program. Cancer Immunol Immunother. 2010 Apr;59(4):619-27. Epub 2010 Jan 6.

9. Britten CM, Gouttefangeas C, Welters MJ, Pawelec G, Koch S, Ottensmeier C, Mander A, Walter S, Paschen A, Muller-Berghaus J, Haas I, Mackensen A, Kollgaard T, thor SP, Schmitt M, Giannopoulos K, Maier R, Veelken H, Bertinetti C, Konur A, Huber C, Stevanovic S, Woelfel T, and van der Burg SH (2008) The CIMT-monitoring panel: a two-step approach to harmonize the enumeration of antigen-specific CD8+ T lymphocytes by structural and functional assays. Cancer Immunol Immunother 57:289-302

10. Britten CM, Janetzki S, Ben Porat L, Clay TM, Kalos M, Maecker H, Odunsi K, Pride M, Old L, Hoos A, and Romero P (2009) Harmonization guidelines for HLA-peptide multimer assays derived from results of a large scale international proficiency panel of the Cancer Vaccine Consortium. Cancer Immunol Immunother. 2009 Oct;58(10):1701-13. Epub 2009 Mar 4.

11. Maecker HT and Trotter J (2006) Flow cytometry controls, instrument setup, and the determination of positivity. Cytometry A 69:1037-1042

12. Currier JR, Kuta EG, Turk E, Earhart LB, Loomis-Price L, Janetzki S, Ferrari G, Birx DL, and Cox JH (2002) A panel of MHC class I restricted viral peptides for use as a quality control for vaccine trial ELISPOT assays. J Immunol Methods 260:157-172

13. Maecker HT, Dunn HS, Suni MA, Khatamzas E, Pitcher CJ, Bunde T, Persaud N, Trigona W, Fu TM, Sinclair E, Bredt BM, McCune JM, Maino VC, Kern F, and Picker LJ (2001) Use of overlapping peptide mixtures as antigens for cytokine flow cytometry. J Immunol Methods 255:27-40

14. Maecker HT, Frey T, Nomura LE, and Trotter J (2004) Selecting fluorochrome conjugates for maximum sensitivity. Cytometry A 62:169-173

15. Currier JR, Galley LM, Wenschuh H, Morafo V, Ratto-Kim S, Gray CM, Maboko L, Hoelscher M, Marovich MA, and Cox JH (2008) Peptide impurities in commercial synthetic peptides and their implications for vaccine trial assessment. Clin Vaccine Immunol 15:267-276