EPTIS
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Rheumatoid factor + CCP

[Rheumatoid faktor + CCP]

EPTIS factsheet 1278690 | Last revision 2024-10-21 | URL: https://www.eptis.bam.de/pts1278690 https://www.eptis.bam.de/pts1278690

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 Rheumatoid Arthritis. 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 each CCP (Cyclic Citrulline Peptide) Enzyme immunoassay (ELISA)
Immunturbidimetry
Nephelometry
MCV (Mutated Citrullinated Vimentin) Enzyme immunoassay (ELISA)
Indirect Immunofluorescence test (IIFT)
Nephelometry
Rheumatoid factor IgM Enzyme immunoassay (ELISA)
Indirect Immunofluorescence test (IIFT)
Nephelometry
Rheumatoid factor IgG Enzyme immunoassay (ELISA)
Indirect Immunofluorescence test (IIFT)
Nephelometry
Rheumatoid factor IgA Enzyme immunoassay (ELISA)
Indirect Immunofluorescence test (IIFT)
Nephelometry
Rheumatoid factor Enzyme immunoassay (ELISA)
Indirect Immunofluorescence test (IIFT)
Nephelometry
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