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.