EPTIS
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Virus serology: Hepatitis B – I.

[Vírus szerológia: Hepatitis B – I.]

EPTIS factsheet 1260441 | Last revision 2024-10-07 | URL: https://www.eptis.bam.de/pts1260441 https://www.eptis.bam.de/pts1260441

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 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 1 mL lyophilised serum each HBsAG (OD, S/CO, quantitative, interpretation) Anti-complement immune fluorescence test
Chemiluminescence (ChLIA), enhanced chemiluminescence immunoassay (ECI)
Chemiluminescence immunoassay (CLIA)
Chemiluminescence magnetic microcorpuscle immunoassay (CLMIA)
Chromatography immunoassay
EIA
Electro chemiluminescence immunoassay (ECLIA)
ELFA-technology (Enzyme Linked Fluroescence Assay)
Enzyme immunoassay: heterogeneous methods (EIA, ELISA)
Immune fluorescence test (IFT)
Immunoblot (Western Blot)
ISAGA (Immunosorbent Agglutination Assay)
KBR
Luminescence enhanced enzyme immunoassays (LEIA, LIEMA)
Microcorpuscle-enzyme immunoassay (MEIA)
Anti-HBsAG (OD, S/CO, quantitative, interpretation) Anti-complement immune fluorescence test
Chemiluminescence (ChLIA), enhanced chemiluminescence immunoassay (ECI)
Chemiluminescence immunoassay (CLIA)
Chemiluminescence magnetic microcorpuscle immunoassay (CLMIA)
Chromatography immunoassay
EIA
Electro chemiluminescence immunoassay (ECLIA)
ELFA-technology (Enzyme Linked Fluroescence Assay)
Enzyme immunoassay: heterogeneous methods (EIA, ELISA)
Immune fluorescence test (IFT)
Immunoblot (Western Blot)
ISAGA (Immunosorbent Agglutination Assay)
KBR
Luminescence enhanced enzyme immunoassays (LEIA, LIEMA)
Microcorpuscle-enzyme immunoassay (MEIA)
Anti-HBcAG (OD, S/CO, quantitative, interpretation) Anti-complement immune fluorescence test
Chemiluminescence (ChLIA), enhanced chemiluminescence immunoassay (ECI)
Chemiluminescence immunoassay (CLIA)
Chemiluminescence magnetic microcorpuscle immunoassay (CLMIA)
Chromatography immunoassay
EIA
Electro chemiluminescence immunoassay (ECLIA)
ELFA-technology (Enzyme Linked Fluroescence Assay)
Enzyme immunoassay: heterogeneous methods (EIA, ELISA)
Immune fluorescence test (IFT)
Immunoblot (Western Blot)
ISAGA (Immunosorbent Agglutination Assay)
KBR
Luminescence enhanced enzyme immunoassays (LEIA, LIEMA)
Microcorpuscle-enzyme immunoassay (MEIA)
Aims of the PT scheme
Target group of participants In vitro medical laboratories
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/IEC 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 1999
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