HLA Antibody Diagnostic Report Implementation Guide

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

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HLA Immunoassay Codes

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
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