EPTIS
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Liverspecific autoantibodies / GBM

[Májspecifikus autoantitestek / GBM elleni antitest]

EPTIS factsheet 1278574 | Last revision 2024-10-11 | URL: https://www.eptis.bam.de/pts1278574 https://www.eptis.bam.de/pts1278574

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 Clinical applicability: Diagnostics and monitoring of autoimmune hepatic syndromes and autoimmune Glomerulopathies. Qualitative results are evaluated in the scheme.
Keywords
Product groups Health care / medical devices
Human test material
Testing fields Medical analysis
Technical details
Test item Tested property Testing method
2 samples of 0.5 mL lyophilised serum/plasma each Antibodies against mitochondria (AMA) Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
Antibodies against mitochondria (AMA-M2) Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
Antibodies against smooth muscles (SMA) Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
Antibodies against LKM-1 Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
Anti GBM Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
Aims of the PT scheme
Target group of participants In vitro medical laboratories
Linked to specific legislation / standards CLSI GP44-A4 – Procedures for Handling and Processing of Blood Specimens for Common Laboratory Tests ILAC_G8:09/2019 – Guidelines on Decision Rules and Statements of Conformity 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 (two times a year)
Year of first operation
Contact details of the PT provider
Provider Contact person
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
If you find any mistakes please contact the responsible EPTIS coordinator in Hungary, Ms Eszter Mezey. Ms Eszter Mezey.
Any questions or problems? Please contact us at eptis@bam.de.
Application version: 1.23-SNAPSHOT.20230502124635-7925ae379a631fc1ececff45d2921c8db38877d5