| Package | hla.antibody.report |
| Type | StructureDefinition |
| Id | hla-antibody-diagnostic-report.StructureDefinition |
| FHIR Version | R4 |
| Source | https://simplifier.net/resolve?scope=hla.antibody.report@0.1.2&canonical=https://fhir.nmdp.org/ig/HlaAntibodyReport/StructureDefinition/hla-antibody-diagnostic-report |
| URL | https://fhir.nmdp.org/ig/HlaAntibodyReport/StructureDefinition/hla-antibody-diagnostic-report |
| Version | 0.1.0 |
| Status | draft |
| Name | HLAAntibodyDiagnosticReport |
| Title | HLA Antibody Diagnostic Report |
| Description | HLA Antibody Diagnostic Report
Consolidated laboratory report on the execution of solid-phase immunoassay
Based on the work of the HAML working group maintained here: https://github.com/immunomath/haml
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.
Elements:
Assay
A solid-phase-panel analysis.
This includes metadata about the solid phase panel and a series of beads.
Modifications/preparations/dilutions were done to a sample to create a working sample.
Elements:
assay-id: A unique identifier for this assay.
assay-date:
working-sample:
interpretation:
interpretation-software: The software which was used for analysis of the solid-phase-panel results.
interpretation-software-version: The version of the software used for analysis of the solid-phase-panel results.
positive-serum-id: An identifier of the serum used as a positive control.
negative-serum-id: An identifier of the serum used as a negative control.
bead: Individual beads contained within this panel
Raw-MFI-divider: This constant is used for comparing multiple analysis machines.
Note: Sometimes these devices systematically have biases on the same sample, and this constant can be used to calibrate raw-MFI across multiple batches.
Assay Kit
Elements:
kit-manufacturer: The company or institution that developed the kit
kit-description:
catalog-number: A string identifying the specific kit or that was used in this analysis
lot-number: A string identifying the specific lot that was used in this analysis
Assay Interpretation
An Interpretation is where we put the results of an entire assay.
This includes which antigens/specificities are determined to be positive or negative.
Elements:
interpretation-context: “Clinical Interpretation”
reject-assay: Boolean if the assay was rejected or not.
reject-reason: Reason for rejecting entire assay
failure-code: Failure code from 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
Sample and Working Sample
This represents a sample, most likely of blood, which was drawn from a patient.
Elements:
sample-id: A string with a unique identifier for this sample
sample-datetime: A dateTime which identifies the date and (optionally) the time when a sample was drawn.
testing-laboratory: A string with a unique identifier for the laboratory where this sample was drawn
assay: A number of "assay" elements specify an analysis performed on this sample
A working sample is a part of a sample which is subjected to sample preparations and a subsequent solid-phase panel analysis.
Elements:
working-sample-id: A unique identifier for this working sample.
treatment:
dilution:
solid-phase-panel:
A treatment describes a process which was performed on a working sample in preparation for solid phase analysis.
Elements:
method:
A working sample may be diluted in preparation for solid-phase-panel analysis.
This element describes the ratio and substance used for dilution.
Elements:
ratio: This is expected to be a dilution ratio, a floating point number usually between 0 and 1.
diluent: This is a text description of the diluent substance or buffer
Bead Result
A single bead within a solid phase panel.
This bead usually has a specificity, which may be an allele name or a serological specificity.
The bead result has information about it's corresponding positive and negative control beads.
Elements:
----------
bead-info: Structure containing details on the specificity and identifiers of an individual bead
raw-data: Structure containing measured MFI or raw data as measured in the assay.
converted-data: Structure containing converted MFIs, formulas used, and interpretations of bead-specific results.
raw-MFI: Actual measured luminescense from assay
bead-count:
formula: transformation appied to raw-MFI value to derive normalized value for clinical decision making
adjusted-MFI: Derived normalized value for clinical decision making
bead-interpretation: Bead level interpretation of result
bead-plausible: Boolean indicator for specific bead
Bead Interpretation
Elements:
----------
classification-entity: This is the individual or entity who has performed a bead interpretation.
interpretation-reason: This is the reason a bead has been interpreted. For example, a standard MFI threshold (e.g. 500) was used
bead-classification: A text Positive/Negative/Borderline/Unspecified classification.
bead-rank: a numerical bead rank specifying if there was reactivity on this bead. |
| Purpose | Immunoassay of a patient to identify presence of reactive levels of non-self antibodies to be used in the determination of adverse reactions in the selection of unrelated donor transplant. |
| Type | DiagnosticReport |
| Kind | resource |
FHIR