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

1A: Donor:

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.

1B: Source:

Required:

• 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: 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:

Required:

• 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:

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:

Required:

• mean recovery and viability of cell material
• method used to determine the cell recovery and viability

Optional:

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:

Required:

• 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: Methodology and ranges for additional assessments, if performed (e.g. apoptosis assessment)

2B: Medium/serum:

Required:

• the medium and serum (if applicable) used (source, cat #),
• whether the medium or serum was pretested.

2C: The Assay:

Required:

• 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.

2D: Controls:

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

Optional:

• Detailed explanation on gating strategy.
• In case an uncommon strategy was applied comment on why the specific strategy was chosen.
• Investigators might want to provide information on instrument settings, method and reagents applied for compensation whenever it enables better understanding of the experiment.
• A statement should be given about the review process of raw data for data consistency and plausibility.

Module 4: The (interpretation of) results

4A: Raw data

Required:

• Description of how raw data were processed and interpreted, including averages (medians) and data ranges for both antigens and background reactivity levels and event counts.
• Accessibility of raw data, e.g.

- 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:

Required:

• How was the threshold for positive reactivity defined:

- For the assay itself?

- Between time points?

• Statement whether response definition criteria were pre-defined (before study), or post-hoc (after data were collected)
• A description of statistical tests or empiric rules applied
• A description of parameters, software and software version applied
• A statement on whether any data was excluded from the analysis, and if so the reason for the exclusion.

Optional: An explanation for the choice of test(s) applied (Why?)

Module 5: The laboratory environment

5A: General Laboratory Operation

Optional:

• A general descriptive statement may be included about how laboratory operations are guided (GMP, GLP, GcLP, exploratory research, other), such as: These studies were conducted in a laboratory that operates under _________ principles.
• A general statement stating any laboratory accreditations and certifications (CLIA, CAP, other) may be included.

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.