Confirmation

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

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](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. --- 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 ---

Extension

HLA Immunoassay Control Bead Observation Extension of US Core lab result observation to capture attributes specific to solid-phase immunoassay bead test results. A single bead within a solid phase panel. The bead MUST have a specificity which may be an allele name or a serological specificity. The bead MUST reference the working-sample specimen The bead MUST reference it's corresponding target bead observation The bead MUST have information about it's control purpose (positive or negative control. positive negative serum or working-sample) Control Bead Result Describes a single control bead within a solid phase panel. Elements * **bead-info** Specificity and identifiers of the bead * **sample-ref** Working sample * **bead-type** Negative or positive control bead * **HLA-target-type** * **HLA-target-serological-specificity** * **raw-MFI** Actual measured luminescence * **bead-count** * **formula** Transformation applied to raw-MFI * **adjusted-MFI** Normalized value for clinical decision-making * **target-bead-ref** Target bead reference of the control bead * **control-serum-id-ref Negative or positive control serum

Bundle

HLA Immunoassay Target Bead Observation 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. The bead MUST have a specificity which may be an allele name or a serological specificity. The bead MUST reference the working-sample specimen The bead MAY be referenced by 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** * **bead-type** Target bead type * **HLA-target-type** * **HLA-target-serological-specificity** * **number of beads** * **raw-MFI** * **formula** * **adjusted-MFI** * **bead-interpretation** * **bead-plausible** * **bead-plausible-reason** * **working-sample-id** Reference

HLA Immunoassay Interpretation Extension of HL7 observation to capture interpretation attributes specific to solid-phase immunoassay test results. 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

HLA Immunoassay Working Sample Extension of US Core Specimen 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)

HLA Immunoassay Kit Extension of the HL7 Device resource Details about the assay kit used to create the results inlcuded in the referenced HLA Antibody Diagnostic Report 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.

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