EPTIS
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Detection of bacterial respiratory pathogens

[Bakteriális légúti kórokozók kimutatása]

EPTIS factsheet 1260431 | Last revision 2024-10-21 | URL: https://www.eptis.bam.de/pts1260431 https://www.eptis.bam.de/pts1260431

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 Task: isolation and identification at species level of the bacterial respiratory pathogen(s) responsible from the given – occasionally lower & upper respiratory – samples, which can be responsible for the given disease, based on the anamnestic data, as well as determination of the antibiotic susceptibility. Interpretation of report towards the clinician, information about additional (e.g. epidemiological) tasks. If no pathogenic bacteria are found in the sample, report what further tests you would ask for.
Keywords
Product groups Health care / medical devices
Human test material
Testing fields Medical analysis
Technical details
Test item Tested property Testing method
1 lyophilized bacterial culture Identified bacteria Conventional biochemical methods
VITEK
API/ATB
REMEL
PHOENIX
MALDI-TOF MS
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 (two times a year)
Year of first operation 2020
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