EPTIS
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Antinuclear antibodies (ANA, anti-ENA, anti-dsDNA)

[Antinukleáris antitestek (ANA, anti-ENA, anti-dsDNA)]

EPTIS factsheet 1278501 | Last revision 2024-10-11 | URL: https://www.eptis.bam.de/pts1278501 https://www.eptis.bam.de/pts1278501

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 systemic autoimmune diseases (ANA). 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 ANA Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
Anti-U1-snRNP (anti-RNP-70) Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
Anti-Sm Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
Anti-Sm-RNP Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
Anti-SS-A (Ro52) Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
Anti-SS-A (Ro60) Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
Anti-SS-A (total) Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
Anti-SS-B Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
Anti-Topoisomerase I (anti-Scl 70) Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
Anti-His-tRNA-Synthetase (anti-Jo1) Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
CENP B Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
ENA screen Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
Anti-ds-DNA Enzyme immunoassay (ELISA)
Immunoblot/Western blot/dot blot
Indirect Immunofluorescence test (IIFT)
Radioimmunoassay (RIA)
Hep-2/2000/2010 fluorescence pattern 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