description: HER2/ERBB2 In Situ Hybridization (FISH) Bericht. Basiert auf LOINC Panel 74885-5.
package_name: de.medizininformatikinitiative.kerndatensatz.mtb
derivation: constraint
name: MII_PR_MTB_INSITUHYBRIDIZATION_HER2
type: Observation
elements:
  code:
    elements:
      coding:
        array: true
        min: 2
        index: 0
        slicing:
          slices:
            spezifisch:
              match: {}
              schema:
                mustSupport: true
                pattern:
                  type: Coding
                  value: {code: 49683-6, system: 'http://loinc.org', display: ERBB2 gene copy number/Chromosome 17 copy number in Tissue by FISH}
                _required: true
                index: 1
              min: 1
              max: 1
  value:
    short: HER2/CEP17 Ratio
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de-DE}
        - {url: content, valueString: HER2/CEP17 Verhaeltnis}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: HER2/CEP17 Ratio}
    choices: [valueRatio]
    index: 3
    slicing:
      slices:
        valueRatio:
          match: {}
          schema:
            short: HER2/CEP17 Ratio
            _short:
              extension:
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: de-DE}
                - {url: content, valueString: HER2/CEP17 Verhaeltnis}
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: en}
                - {url: content, valueString: HER2/CEP17 Ratio}
            choices: [valueRatio]
            index: 3
  valueRatio:
    type: Ratio
    short: HER2/CEP17 Ratio
    _short:
      extension:
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: de-DE}
        - {url: content, valueString: HER2/CEP17 Verhaeltnis}
      - url: http://hl7.org/fhir/StructureDefinition/translation
        extension:
        - {url: lang, valueCode: en}
        - {url: content, valueString: HER2/CEP17 Ratio}
    choiceOf: value
    index: 4
    slicing:
      slices:
        valueRatio:
          match: {}
          schema:
            type: Ratio
            short: HER2/CEP17 Ratio
            _short:
              extension:
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: de-DE}
                - {url: content, valueString: HER2/CEP17 Verhaeltnis}
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: en}
                - {url: content, valueString: HER2/CEP17 Ratio}
            choiceOf: value
            index: 4
  method:
    pattern:
      type: CodeableConcept
      value:
        coding:
        - {code: '1303773004', system: 'http://snomed.info/sct', display: Fluorescence in situ hybridization technique (qualifier value)}
    index: 5
  component:
    index: 6
    slicing:
      slices:
        gene-studied:
          match: {}
          schema:
            index: 6
            elements:
              value:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: 'HGNC:3430', system: 'http://www.genenames.org/geneId', display: ERBB2}
                choices: []
                index: 8
        biomarker-category:
          match: {}
          schema:
            index: 9
            elements:
              value[x]:
                elements:
                  coding:
                    elements:
                      code:
                        pattern: {type: Code, value: inSituHybridization}
                        index: 10
        target-signals:
          match: {}
          schema:
            short: ERBB2 Signale pro Zellkern
            _short:
              extension:
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: de-DE}
                - {url: content, valueString: ERBB2 Signale pro Zellkern}
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: en}
                - {url: content, valueString: ERBB2 signals per cell nucleus}
            mustSupport: true
            index: 11
            elements:
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: 74860-8, system: 'http://loinc.org', display: ERBB2 gene copy number/nucleus in Tissue by FISH}
                index: 12
              value:
                choices: [valueQuantity]
                index: 14
              valueQuantity: {type: Quantity, choiceOf: value, index: 15}
              value[x]:
                elements:
                  unit:
                    pattern: {type: String, value: '#'}
                    index: 16
                  system:
                    pattern: {type: Uri, value: 'http://unitsofmeasure.org'}
                    index: 17
        reference-signals:
          match: {}
          schema:
            short: CEP17 Signale pro Zellkern
            _short:
              extension:
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: de-DE}
                - {url: content, valueString: CEP17 Signale pro Zellkern}
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: en}
                - {url: content, valueString: CEP17 signals per cell nucleus}
            mustSupport: true
            index: 18
            elements:
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: 74861-6, system: 'http://loinc.org', display: Chromosome 17 copy number/nucleus in Tissue by FISH}
                index: 19
              value:
                choices: [valueQuantity]
                index: 21
              valueQuantity: {type: Quantity, choiceOf: value, index: 22}
              value[x]:
                elements:
                  unit:
                    pattern: {type: String, value: '#'}
                    index: 23
                  system:
                    pattern: {type: Uri, value: 'http://unitsofmeasure.org'}
                    index: 24
        cells-counted:
          match: {}
          schema:
            short: Anzahl gezählter Zellkerne
            _short:
              extension:
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: de-DE}
                - {url: content, valueString: Anzahl gezaehlter Zellkerne}
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: en}
                - {url: content, valueString: Number of counted cell nuclei}
            mustSupport: true
            index: 25
            elements:
              code:
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: 62361-1, system: 'http://loinc.org', display: 'Cells counted [#]'}
                index: 26
              value:
                choices: [valueQuantity]
                index: 28
              valueQuantity: {type: Quantity, choiceOf: value, index: 29}
              value[x]:
                elements:
                  unit:
                    pattern: {type: String, value: '#'}
                    index: 30
                  system:
                    pattern: {type: Uri, value: 'http://unitsofmeasure.org'}
                    index: 31
package_version: 2026.0.1
class: profile
kind: resource
url: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-insituhybridization-her2
base: https://www.medizininformatik-initiative.de/fhir/ext/modul-mtb/StructureDefinition/mii-pr-mtb-insituhybridization
version: 2026.0.1