Immunhistochemistry
[Immunhisztokémia]
EPTIS factsheet 1278478 | Last revision 2024-10-11 | URL: https://www.eptis.bam.de/pts1278478 https://www.eptis.bam.de/pts1278478
| PT provider | |||||||
| PT provider | QualiCont In Vitro Diagnostic Quality Control Nonprofit Ltd. QualiCont In Vitro Diagnostic Quality Control Nonprofit Ltd. | ||||||
| Based in | Hungary | ||||||
| Language(s) | English, Hungarian | ||||||
| Remarks | Unstained paraffin slides are sent to the participants. Task: routine staining and detection of immunohistochemical marker molecules on the formaldehyde-fixed paraffin embedded sections distributed by QualiCont (2-2 unstained slides per test/per survey) and on slides of the similar tissue/tumour created in their own laboratory (in-house). Reporting of results: the technical details of the stained sections and the methods are to be sent electronically via Internet. The evaluations and the Certificates are available electronically, too. The following slides are sent in each survey: IHC/1 Repeated marker asked usually through 4 consecutive surveys Immunhistochemical reaction – QualiCont (slide sent by the organiser) IHC/2 Repeated marker asked usually through 4 consecutive surveys Immunhistochemical reaction – In-house (own slide) IHC/1-2 (1 from the list): Epithelial-marker, Muscle-marker, Endothelial-marker, Leukocyte-marker, Proliferation marker, Hormone receptor (ER), Her-2 oncoprotein IHC/3 – Various markers by QualiCont in every survey Immunhistochemical reaction – QualiCont (slide sent by the QualiCont) IHC/4 – Various markers by QualiCont in every survey Immunhistochemical reaction – In-house (own slide) IHC/3-4 (1 from the list above or below): hormone receptor (PgR), B-lymphocyte, T-lymphocyte, Hodgkin-lymphoma, Prostate-epithelial marker, Melanoma-marker, Endocrine marker, Mesothelioma-marker Evaluation of slides: four independent assessors using a consultation microscope evaluate the slides without influencing each other. Score: 1-5 (not acceptable – excellent) In case of 3 or lower score, critical remark is given, which refers to the nature of the error, or its probable cause. Archiving: database management program Processing: technical details of staining methods, evaluation data, remarks Feedback: evaluation sheets, diagrams, statistical analysis | ||||||
| Keywords | |||||||
| Product groups |
Health care / medical devices
Human test material |
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| Testing fields |
Medical analysis
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| Technical details | |||||||
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| Aims of the PT scheme | |||||||
| Target group of participants | In vitro medical laboratories | ||||||
| Linked to specific legislation / standards | ISO 15189 – Medical laboratories – Requirements for quality and competence ISO/TS20658:2017 – Medical laboratories – Requirements for collection, transport, receipt and handling of samples VIM3 – Vocabulaire International de Métrologie WHO – Guidance on regulations for the Transport of Infectious Substances | ||||||
| Additional, subsidiary aims | validation of testing methods | ||||||
| Number of participants | |||||||
| Accredited or otherwise reviewed by a 3rd party | |||||||
| Operation is commissioned / requested by | |||||||
| Fees and frequency | |||||||
| Participation fee | on demand | ||||||
| Regularly operated | Yes (four times a year) | ||||||
| Year of first operation | |||||||
| Contact details of the PT provider | |||||||
| Provider | Contact person | ||||||
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QualiCont In Vitro Diagnostic Quality Control Nonprofit Ltd.
Feketesas u. 19-21. I/7 6720 Szeged Hungary Phone: +36 30 462 5864 Fax: Web: http://www.qualicont.com/qc/index_en.html http://www.qualicont.com/qc/index_en.html |
Ms. Eszter Mezey
Phone: +36 30 462 5864 Fax: Email: mail@qualicont.com mail@qualicont.com |
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If you find any mistakes please contact the responsible EPTIS coordinator in Hungary,
Ms Eszter Mezey.
Ms Eszter Mezey.