EPTIS
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High sensitive CRP

[Ultraszenzitív CRP]

EPTIS factsheet 1226582 | Last revision 2024-10-22 | URL: https://www.eptis.bam.de/pts1226582 https://www.eptis.bam.de/pts1226582

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
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 liquid sample each High sensitive CRP Electro chemiluminescence immunoassay (ECLIA)
Enzyme immunoassay: heterogeneous methods (EIA, ELISA)
Fluorescence immunoassay (FIA), delayed action and enhanced fluorescence immunoassay (DELFIA)
Immunturbidimetry
Chemiluminescence magnetic microcorpuscle immunoassay (CLMIA)
Luminescence enzyme immunoassay (LIA)
Luminescence enhanced enzyme immunoassays (LEIA, LIEMA)
Nephelometry
Radial immunodiffusion (RID, Mancini)
Turbidimetry: other methods
Turbidimetry: two-point
Turbidimetry: peak rate
Turbidimetry: endpoint without reagent blank
Turbidimetry: endpoint with reagent blank
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

Accredited by NAH (National Accreditation Authority) on the basis of ISO/IEC 17043:2010

Operation is commissioned / requested by
Fees and frequency
Participation fee on demand
Regularly operated Yes (six times a year)
Year of first operation 2011
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