EPTIS
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Gammopathies

[Gammopátiák]

EPTIS factsheet 1276245 | Last revision 2026-03-20 | URL: https://www.eptis.bam.de/pts1276245 https://www.eptis.bam.de/pts1276245

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 QualiCont has had accredited status as the QualiCont as a Proficiency Test Provider complies with the criteria of MSZ EN ISO/IEC 17043:2010 standard since 26 March 2014. The QualiCont has been accredited according to the MSZ EN ISO/IEC 17043:2023 standard since 18 December 2025. Our Company is a Proficiency Testing Provider Organisation accredited by NAH (National Accreditation Authority) under the NAH-8-0002/2023 registration number. As the result of the accreditation process performed by NAH, our Company has accredited status until 9 March 2028. QualiCont Nonprofit Kft. has been operating its quality management system since 2001. Our Company successfully passed the renewal audit on 6th May, 2025. The certificate is valid until 28 May 2028. Our Company has been assessed and certified as meeting the requirements of ISO 9001:2015 standard for the following activities: Planning, organization and management of proficiency testing (external quality assessment) and the related supporting services for in vitro medical diagnostic laboratories and investigators on other human and veterinary medicine.
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 1 mL plasma each Gammopathies Immune electrophoresis
Immune fixation
IgA Chemiluminescence immunoassay (CLIA)
Chemiluminescence magnetic microparticle immunoassay (CLMIA)
Electro chemiluminescence immunoassay (ECLIA)
ELFA-technology (Enzyme Linked Fluroescence Assay)
Enzyme immunoassay: heterogeneous methods (EIA, ELISA)
Enzyme immunoassay: homogeneous methods (EMIT)
Fluorescence immunoassay (FIA), delayed action and enhanced fluorescence immunoassay (DELFIA)
Immune electrophoresis
Immune fixation
Immunological method (after predilution)
Immunological method (without predilution)
Immunoradiometric assay (IRMA)
Immunturbidimetry
Luminescence enhanced enzyme immunoassays (LEIA, LIEMA)
Luminescence enzyme immunoassay (LIA)
MEIA Technology
Missile electrophoresis (Laurell)
Multilayer film (MF-FIA)
Nephelometry
Radial immunodiffusion (Mancini), endpoint
Radial immundiffusion (Mancini), not endpoint
Radioimmunoassay (RIA)
Turbidimetry: endpoint with reagent blank
Turbidimetry: endpoint without reagent blank
Turbidimetry: laser photometer DT
Turbidimetry: other methods
Turbidimetry: peak rate
Turbidimetry: two point
IgG Chemiluminescence immunoassay (CLIA)
Chemiluminescence magnetic microparticle immunoassay (CLMIA)
Electro chemiluminescence immunoassay (ECLIA)
ELFA-technology (Enzyme Linked Fluroescence Assay)
Enzyme immunoassay: heterogeneous methods (EIA, ELISA)
Enzyme immunoassay: homogeneous methods (EMIT)
Fluorescence immunoassay (FIA), delayed action and enhanced fluorescence immunoassay (DELFIA)
Immune electrophoresis
Immune fixation
Immunological method (after predilution)
Immunological method (without predilution)
Immunoradiometric assay (IRMA)
Immunturbidimetry
Luminescence enhanced enzyme immunoassays (LEIA, LIEMA)
Luminescence enzyme immunoassay (LIA)
MEIA Technology
Missile electrophoresis (Laurell)
Multilayer film (MF-FIA)
Nephelometry
Radial immunodiffusion (Mancini), endpoint
Radial immundiffusion (Mancini), not endpoint
Radioimmunoassay (RIA)
Turbidimetry: endpoint with reagent blank
Turbidimetry: endpoint without reagent blank
Turbidimetry: laser photometer DT
Turbidimetry: other methods
Turbidimetry: peak rate
Turbidimetry: two point
IgM Chemiluminescence immunoassay (CLIA)
Chemiluminescence magnetic microparticle immunoassay (CLMIA)
Electro chemiluminescence immunoassay (ECLIA)
ELFA-technology (Enzyme Linked Fluroescence Assay)
Enzyme immunoassay: heterogeneous methods (EIA, ELISA)
Enzyme immunoassay: homogeneous methods (EMIT)
Fluorescence immunoassay (FIA), delayed action and enhanced fluorescence immunoassay (DELFIA)
Immune electrophoresis
Immune fixation
Immunological method (after predilution)
Immunological method (without predilution)
Immunoradiometric assay (IRMA)
Immunturbidimetry
Luminescence enhanced enzyme immunoassays (LEIA, LIEMA)
Luminescence enzyme immunoassay (LIA)
MEIA Technology
Missile electrophoresis (Laurell)
Multilayer film (MF-FIA)
Nephelometry
Radial immunodiffusion (Mancini), endpoint
Radial immundiffusion (Mancini), not endpoint
Radioimmunoassay (RIA)
Turbidimetry: endpoint with reagent blank
Turbidimetry: endpoint without reagent blank
Turbidimetry: laser photometer DT
Turbidimetry: other methods
Turbidimetry: peak rate
Turbidimetry: two point
Free light chains type kappa Immune electrophoresis
Immune fixation
Immunological method (after predilution)
Immunological method (without predilution)
Immunoradiometric assay (IRMA)
Nephelometry
Radial immunodiffusion (Mancini), endpoint
Turbidimetry: endpoint with reagent blank
Turbidimetry: endpoint without reagent blank
Turbidimetry: laser photometer DT
Turbidimetry: other methods
Turbidimetry: peak rate
Turbidimetry: two point
Free light chains type lambda Immune electrophoresis
Immune fixation
Immunological method (after predilution)
Immunological method (without predilution)
Immunoradiometric assay (IRMA)
Nephelometry
Radial immunodiffusion (Mancini), endpoint
Turbidimetry: endpoint with reagent blank
Turbidimetry: endpoint without reagent blank
Turbidimetry: laser photometer DT
Turbidimetry: other methods
Turbidimetry: peak rate
Turbidimetry: two point
Kappa / lambda ratio Immune electrophoresis
Immune fixation
Immunological method (after predilution)
Immunological method (without predilution)
Immunoradiometric assay (IRMA)
Nephelometry
Radial immunodiffusion (Mancini), endpoint
Turbidimetry: endpoint with reagent blank
Turbidimetry: endpoint without reagent blank
Turbidimetry: laser photometer DT
Turbidimetry: other methods
Turbidimetry: peak rate
Turbidimetry: two point
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 (four 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