EPTIS
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Faecal diagnostics: FOB

[Széklet diagnosztika: széklet vér (FOB)]

EPTIS factsheet 1216781 | Last revision 2024-11-25 | URL: https://www.eptis.bam.de/pts1216781 https://www.eptis.bam.de/pts1216781

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 liquid samples Haemoglobin (qualitative) Electro chemiluminescence immunoassay (ECLIA)
Enzyme immunoassay: heterogeneous methods (EIA, ELISA)
Immune chromatography
Haemoglobin (quantitative) Cyanmethemoglobin, according to DIN 58931 standard
Electro chemiluminescence immunoassay (ECLIA)
Enzyme immunoassay: heterogeneous methods (EIA, ELISA)
Immune chromatography
Other (modified) cyanmethemoglobin methods
Oxyhemoglobin
Photometric, cyanide-free method
Sodium-dodecyl-sulphate (SDS)-, Sodium lauryl sulphate (SLS) method
Aims of the PT scheme
Target group of participants In vitro medical laboratories & general practitioners (adults & children)
Linked to specific legislation / standards 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 17043:2010

Operation is commissioned / requested by
Fees and frequency
Participation fee on demand
Regularly operated Yes (four times a year)
Year of first operation 2015
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