Confirmation

HLA Antibody Report project - R4 US Core - Define resource bundle - Create resource extensions

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.

Generated file.

Extension of US Core lab result observation to capture attributes specific to solid-phase immuno-assay bead test results. 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 has information about it's corresponding positive and negative controls. 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. bead-info - bead-id - type - control-type - HLA-target-type - HLA-target-serological-specificity - number of beads - sample-raw-MFI - formula - sample-adjusted-MFI - bead-interpretation - bead-plausible - bead-plausible-reason - Ref working-sample-id - Ref negative-control-bead-id - negative-control-serum-raw-MFI - negative-control-serum-adjusted-MFI - Ref negative-control-serum-id - Ref positive-control-bead-id - positive-control-serum-raw-MFI - positive-control-serum-adjusted-MFI - Ref positive-control-serum-id

An HLA Antibody Assay Interpretation contains the overall human interpretation of an entire assay. This includes which antigens specificities are determined to be positive or negative. Components of this observation ------------------------------------ interpretation-context “Clinical Interpretation” reject-assay Boolean if the assay was rejected or not. reject-reason Reason for assay rejection failure-code Failure code generated for assay positive-specificities multi-locus HLA GLstring of all loci and alleles considered positive questionable-specificities multi-locus HLA GLstring of all loci and alleles considered questionable negative-specificities multi-locus HLA GLstring of all loci and alleles considered negative

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DeviceDefinition

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Specimen

Codes relating to HLA immunoassay test results and interpretation