| MIATA Module 1, Version 1.0 |
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31.03.2010 Proposal for Module 1 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 1: Minimal Information on the sample
Proposal for Version 1.0, Module 1A: Donor: Required to report: It should not be required to provide any information on the donor. Optional: Investigators might want to provide specific details whenever there is a strong specific scientific rationale for doing so to enable better understanding of the T cell assay results. In cases donor information is provided there was strong agreement in the comments from the public consultation period that it might be generally interesting to report (i) age, (ii) gender, (iii) ethnical background and (iv) diagnosis of the studied population as all these “conditions” have been shown to generally influence immune reactivity of tested donors. This can be considered for reporting into a database. Exclude: Too detailed information that might allow trailing back to an individual patient.
Specific comments to Module 1A: The necessity to provide additional details on the donors critically depends on the specific study setting. Information on the donors would primarily be needed to understand the study itself but is not needed to understand how the assay was performed.
Proposal for Version 1.0, Module 1B: Source Required to report: - the source of the cell material and collection methodology (e.g. Heparin blood vs. lymph node biopsy vs. tumor infiltrating lymphocytes), - mean time laps between drawing and processing (e.g. <8h, <24h, not known), - method for cell processing (e.g. density gradient centrifugation). Optional: Investigators might want to provide an extended list of details on the source and method for cell processing as well as equipment and reagents used for preparing the cell material for freezing or further testing whenever there is a strong specific scientific rationale for doing so to enable better understanding of the experiment. Added Reference: 2A
Specific comments to Module 1B: It has been clearly shown in the literature that (i) collection methodology, (ii) time laps between drawing and storage, (iii) method for cell processing can critically influence T cell function.
Proposal for Version 1.0, Module 1C: Cryopreservation and Storage Required to report: - use fresh or frozen material - In case of cryopreservation, basic information on devices, process and media used for freezing and thawing cell material - temperature cell material was stored at Optional: Investigators might want to provide an extended list of details on cryopreservation and storage whenever a strong scientific rationale exists for doing so to enable better understanding of the T cell assay results. In cases more information is provided it would be of great interest to know (i) the mean time lapse between freezing and testing in time ranges (e.g. 3 years of storage time before testing) and details on the conditions for storage (e.g. -80°C vs. liquid nitrogen and/or transport to central lab).
Specific comments to module 1C: All measures taken to prepare cells for storage (=freezing), to store cells and to prepare cells for testing after storage (=thawing) should finally support cell viability and immunologic function. It has been clearly shown in the literature that (i) cryopreservation medium, (ii) methodology for freezing and thawing, and (iii) conditions for storage and transport can critically influence T cell functions.
Proposal for Version 1.0, Module 1D: Quality of cell material: Required to report: - mean recovery and viability of cell material, - method to determine the cell recovery and viability Optional: Investigators might want to provide an expanded list of details on the quality control of the cell material that was tested whenever a strong specific scientific rationale exists for doing so to enable better understanding of the experiment. In cases when more information is provided there was strong agreement in the comments from the public consultation period that it would be of great interest to know (i) specific cut-offs for recovery and viability (if applicable), (ii) how material was treated that did not reach the cut-off and (iii) the mean time laps at which viability was tested relative to the time of thawing and the experiment.
Specific comments to module 1D: Quality of cell material considered as being very important and most critical aspect of whole module 1 (“Characterization of important starting material of immunoassay”).
1: Bull M, Lee D, Stucky J, Chiu YL, Rubin A, Horton H, and McElrath MJ (2007) Defining blood processing parameters for optimal detection of cryopreserved antigen-specific responses for HIV vaccine trials. J Immunol Methods 322:57-69
2. Kierstead LS, Dubey S, Meyer B, Tobery TW, Mogg R, Fernandez VR, Long R, Guan L, Gaunt C, Collins K, Sykes KJ, Mehrotra DV, Chirmule N, Shiver JW, and Casimiro DR (2007) Enhanced rates and magnitude of immune responses detected against an HIV vaccine: effect of using an optimized process for isolating PBMC. AIDS Res Hum Retroviruses 23:86-92
2A: Smith SG, Joosten SA, Verscheure V, Pathan AA, McShane H, Ottenhoff TH, Dockrell HM, Mascart F. Identification of major factors influencing ELISpot-based monitoring of cellular responses to antigens from Mycobacterium tuberculosis. PLoS One. 2009 Nov 24;4(11):e7972.
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