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POCT Respiratory Virus

[POCT Respiratory Virus]

EPTIS Ringversuch Nr. 1144039 | Letze Änderung 2024-10-01 | URL: https://www.eptis.bam.de/pts1144039 https://www.eptis.bam.de/pts1144039

Name des Anbieters
Name des Anbieters Weqas Weqas
Ansässig in United Kingdom
Sprache(n) English
Anmerkungen The viral testing targets in POCT platforms can be single, dual or multiplex; the most common being targeted for Influenza A (and subtypes) Influenza B, SARS-Cov-2, and Respiratory Syncytial Virus (RSV). Platforms tend to be based on nucleic acid amplification technologies (NAAT), which generally have improved sensitivity compared to first generation Antigen based devices. Two liquid human serum samples are distributed monthly over an extended autumn and winter season with a minimum of 16 samples distributed over the year covering a wide viral load. The samples consist of inactivated virus in a stabilising buffer which may contain Influenza A (either / both H1N1 and H3N2 subtypes), influenza B, RSV, SARS-Cov-2 or no virus. A range of differing viral loads are distributed including samples with single or multiple viruses. The mean Threshold Cycle value (Ct) is also provided for the Real-time PCR (polymerase chain reaction) methods as an estimate of the viral load, however data collected from participants on this parameter is not scored. The programme assesses the ability of the laboratory / POCT site to correctly identify the virus (es) present in the sample, the sensitivity and specificity of the test at the individual site and the overall performance of the method. The qualitative scores broadly reflect clinical importance, where the manufacturer quoted sensitivities of the methods / devices, are also considered. A correct identification of the virus (es) is given a score of 0. A sliding scale score of between 3 and 5 is assigned for incorrectly identified results, where 5 represented a gross misclassification of the result. Key Features: - Liquid stable samples are supplied ready to use; no pre-analytical preparation is required. - Qualitative reporting for SARS-CoV-2 Ag (RNA), Influenza A, Influenza B and RSV available. For more information: https://www.weqas.com/services/poct-eqa/poct-respiratory-virus/ or contact@weqas.com
Klassifizierung
Produktgruppen Health care / medical devices
Prüfgebiete Medical analysis
Technische Einzelheiten
Prüfobjekt Prüfeigenschaft Prüfmethode
Buffered material spiked with inactivated virus SARS-CoV-2 Ag (RNA) Routine testing methods (recommended)
Influenza A Routine testing methods (recommended)
Influenza B Routine testing methods (recommended)
RSV Routine testing methods (recommended)
Ringversuchsziele
Zielgruppe des Ringversuchs A number of POCT devices used for rapid screening of respiratory viral infections including seasonal influenza are now widely available.
Relevante Rechtsvorschriften oder Normen ISO/IEC 17043
Weitere Ziele validation of testing methods
Teilnehmerzahl
Anbieter unabhängig überprüft (akkreditiert, benannt, anerkannt)

Akkreditiert durch UKAS auf der Grundlage von ISO/IEC 17043

Die Durchführung des Ringversuchs ist in Auftrag gegeben durch
Kosten
Teilnahmegebühr https://www.weqas.com/participantzone/subscription-charges/
Regelmässig durchgeführt Ja (Frequency: Bimonthly. Samples: 2 x 1.0mL)
Der Ringversuch wird durchgeführt seit 2021
Kontaktdaten des Anbieters
Anbieter Kontaktperson
Weqas
Unit 6, Parc Ty Glas
CF14 5DU Cardiff
United Kingdom

Telefon: 44 (0) 2920 314750
Fax:
Web: http://www.weqas.com http://www.weqas.com
Laura Lloyd-Lewis
Telefon: 44 (0) 29218 32884
Fax:
E-Mail: laura.lloyd-lewis@wales.nhs.uk laura.lloyd-lewis@wales.nhs.uk
Haben Sie einen Fehler entdeckt? Bitte wenden Sie sich an den zuständigen EPTIS Koordinator für United Kingdom, Mr Savvas Xystouris. Mr Savvas Xystouris.
Haben Sie Fragen? Senden Sie uns eine E-Mail: eptis@bam.de.
Anwendungsversion: 1.23-SNAPSHOT.20230502124635-7925ae379a631fc1ececff45d2921c8db38877d5