HLA Antibody Diagnostic Report Implementation Guide
A consolidated laboratory report based on the work of the HAML Working Group
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- Profiles
- HLA Immunoassay Kit
- HLA Immunoassay Bead Observation
- HLA Immunoassay Bead Interpretation
- HLA Antibody Diagnostic Report
- HLA Immunoassay Working Sample
- HLA Antibody Report Bundle
- Extensions
- Value Sets
- HLA Immunoassay Bead Observation Classification Value Set
- HLA Immunoassay Bead Type Value Set
- HLA Immunoassay Bead Control Type Value Set
- HLA Immunoassay Bead Observation Rank Value Set
- HLA Immunoassay Bead Observation Plausibility Set
- HLA Immunoassay Rejection Reason Value Set
- HLA Immunoassay Failure Code Value Set
- HLA Immunoassay Sample Treatment Value Set
- HLA Immunoassay Sample Diluent Value Set
- Code Systems
Use Case Description
Here is the general use case for this guide
Overview
HLA Antibody Diagnostic Report
A consolidated laboratory report on the execution of solid-phase immunoassay based on the work of the HAML working group, maintained here.
HLA-based antibody assay results and expert interpretation for a solid-phase-panel analysis. This includes metadata about the solid phase panel and a series of beads.
Assay
A solid-phase-panel analysis with modifications/preparations/dilutions applied to a sample to create a working sample.
Elements
assay-id: A unique identifier for this assay
assay-date
working-sample
interpretation
interpretation-software: Software used for analysis
interpretation-software-version: Version of the software used
positive-serum-id: Identifier for the positive control serum
negative-serum-id: Identifier for the negative control serum
bead: Individual beads contained within this panel
Raw-MFI-divider: Constant used for comparing multiple analysis machines
- Note: Devices may have systematic biases on the same sample. This constant helps calibrate raw MFI across batches.
Assay Kit Elements
- kit-manufacturer: Company or institution that developed the kit
- kit-description
- catalog-number: Identifier for the specific kit used
- lot-number: Identifier for the lot used
Assay Interpretation
Interpretation includes the outcome of the assay: which antigens/specificities are positive or negative.
Elements
- interpretation-context:
"Clinical Interpretation"
- reject-assay: Boolean indicating if the assay was rejected
- reject-reason: Reason for rejecting the assay
- failure-code: Failure code from the assay run
- positive-specificities: HLA GLstring of positively reactive HLA
- questionable-specificities: HLA GLstring of questionably reactive HLA
- negative-specificities: HLA GLstring of negatively reactive HLA
Working Sample
A sample (likely blood) drawn from a patient.
Elements
- sample-id: Unique identifier for this sample
- sample-datetime: Date and time when the sample was drawn
- testing-laboratory: Identifier for the lab
- assay: One or more assay elements performed on this sample
Working Sample (Preparation)
A processed portion of the sample prepared for panel analysis.
Elements
- working-sample-id: Unique identifier for this working sample
- treatment: Process performed during preparation
- dilution: Describes dilution ratio and substance used
- solid-phase-panel
- method
- ratio: Dilution ratio (usually between 0 and 1)
- diluent: Description of the diluent substance/buffer
Bead Result
Describes a single bead within a solid phase panel.
Elements
- bead-info: Specificity and identifiers of the bead
- raw-data: Measured MFI or raw data
- converted-data: Converted MFIs, formulas, interpretations
- raw-MFI: Actual measured luminescence
- bead-count
- formula: Transformation applied to raw-MFI
- adjusted-MFI: Normalized value for clinical decision-making
- bead-interpretation: Interpretation of bead result
- bead-plausible: Boolean indicator of bead plausibility
Bead Interpretation Elements
- classification-entity: Person/entity who performed interpretation
- interpretation-reason: Rationale (e.g., MFI threshold of 500)
- bead-classification: Positive / Negative / Borderline / Unspecified
- bead-rank: Numerical rank of bead reactivity