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
• assay-kit
• working-sample
• assay-interpretation
• negative-serum: Reference for the negative control serum
• positive-serum: Reference for the positive control serum
• target-bead-observation: Individual beads contained within this panel
• control-bead-observation: Individual beads contained within this panel

Assay Kit Elements

• kit-manufacturer: Company or institution that developed the kit
• kit-description
• solid-phase-panel
• catalog-number: Identifier for the specific kit used
• lot-number: Identifier for the lot used
• interpretation-software: Software used for analysis
• interpretation-software-version: Version of the software used
• 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 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
• negative-specificities: HLA GLstring of negatively reactive HLA
• positive-specificities: HLA GLstring of positively reactive HLA
• questionable-specificities: HLA GLstring of questionably reactive HLA

Working Sample

A sample (likely blood) drawn from a patient.

Elements

• working-sample-id: Unique identifier for this sample
• sample-datetime: Date and time when the sample was drawn
• testing-laboratory: Identifier for the lab

Working Sample (Preparation)

A processed portion of the sample prepared for panel analysis.

Elements

• treatment: Process performed during preparation
• method: Ex. dilution
• diluent: Description of the diluent substance/buffer
• ratio: Dilution ratio (usually between 0 and 1)

Serum

Control serum for assay.

Elements

• serum-id: Unique identifier for this sample
• control-type: Negative or positive control serum

Target Bead Result

Describes a single bead within a solid phase panel.

Elements

• bead-info: Specificity and identifiers of the bead
• bead-type: Target
• sample-ref: Working sample
• 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

Target 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

Control Bead Result

Describes a single control bead within a solid phase panel.

Elements

• bead-info: Specificity and identifiers of the bead
• target-bead-ref: Target bead reference of the control bead
• sample-ref: Working sample, negative or positive control serum
• bead-type: Negative or positive control bead
• raw-MFI: Actual measured luminescence
• bead-count
• formula: Transformation applied to raw-MFI
• adjusted-MFI: Normalized value for clinical decision-making