POCT: SARS-CoV-2
[POCT: SARS-CoV-2]
EPTIS factsheet 1271523 | Last revision 2024-10-08 | URL: https://www.eptis.bam.de/pts1271523 https://www.eptis.bam.de/pts1271523
| 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 | The content of the scheme: SARS-CoV-2 antibody (IgG, IgM, total antibody) and antigen determination and interpretation of results. Additional information: Qualitative results are evaluated in the scheme. Individual and special delivery: in a foam box with refrigerant, express delivery. | ||||||||||||||||||
| Keywords | |||||||||||||||||||
| Product groups |
Health care / medical devices
Human test material |
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| Testing fields |
Medical analysis
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| Technical details | |||||||||||||||||||
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| 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 |
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| Operation is commissioned / requested by | |||||||||||||||||||
| Fees and frequency | |||||||||||||||||||
| Participation fee | on demand | ||||||||||||||||||
| Regularly operated | Yes (four times a year) | ||||||||||||||||||
| Year of first operation | 2020 | ||||||||||||||||||
| Contact details of the PT provider | |||||||||||||||||||
| Provider | Contact person | ||||||||||||||||||
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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 |
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If you find any mistakes please contact the responsible EPTIS coordinator in Hungary,
Ms Eszter Mezey.
Ms Eszter Mezey.