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HLA Antibody Diagnostic Report Implementation Guide

A consolidated laboratory report based on the work of the HAML Working Group

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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