|MIATA Version 1 - Module 1-5|
Detailed information about the module updates and their content is contained on the separate Version 1 module pages. References will be updated and added again in the final MIATA version.
Proposal for MIATA Version 1.0
Purpose: Reporting framework for publications of human immune monitoring T cell studies
This proposal is based on the comments to Version 0 received during the public consultation period, consensus workshop and webinars, and follows the concept of defining which information is required or optional, and which should be excluded. In case of optional content, 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
Module 1: Minimal Information on the sample
Optional: In cases donor information is provided, 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.
Optional: 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 further testing.
1C: Cryopreservation and Storage:
Further details on cryopreservation and storage (of great interest would be 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).
1D: Quality of cell material:
An expanded list of details on the quality control of the cell material that was tested (of great interest would be (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).
Module 2: Minimal Information on the Assay
2A: Cell counting:
Optional: Methodology and ranges for additional assessments, if performed (e.g. apoptosis assessment)
2C: The Assay:
Optional: Investigators might want to add references to published recommendations and harmonization guidelines followed if such exists for the assay they report on.
Required: Details on all internal and external controls applied
Module 3: Data acquisition
3A: Equipment and Software
Required: Description of equipment and software versions used for data acquisition
Optional: Information on the routine QC procedure(s)
3B: Acquisition strategy
Required: Display of representative raw data (e.g. FACS plots or ELISpot photos) including negative control and positive response example
Module 4: The (interpretation of) results
4A: Raw data
- is provided (e.g. in main article, supplemental data or online database)
- can be provided per request
- cannot be provided due to confidentiality agreements, corporate policy, other conflicts.
Optional: In case the investigators cannot provide data, the mean, median and ranges of all data presented should be described in order to allow the reader to better understand and interpret results.
4B: Response determination, statistical tests and empirical rules:
- For the assay itself?
- Between time points?
Optional: An explanation for the choice of test(s) applied (Why?)
Module 5: The laboratory environment
5A: General Laboratory Operation
5B: Laboratory Procedure Standardization
Optional: A descriptive statement may be included about the status of the methodological protocols employed (investigative protocols, established laboratory protocols, standard operating protocols, other) used to generate the reported data sets, such as: These studies were performed using ______________ protocols.
5C: Status of Assay Qualification and Validation
Optional: A descriptive statement may be included about the status of the assays employed (general research investigative, qualified, validated, other) used to generate the reported data sets, such as: These studies were performed using _______________ assays.