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POCT Respiratory Virus

[POCT Respiratory Virus]

EPTIS factsheet 1144039 | Last revision 2024-10-01 | URL: https://www.eptis.bam.de/pts1144039 https://www.eptis.bam.de/pts1144039

PT provider
PT provider Weqas Weqas
Based in United Kingdom
Language(s) English
Remarks 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
Keywords
Product groups Health care / medical devices
Testing fields Medical analysis
Technical details
Test item Tested property Testing method
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)
Aims of the PT scheme
Target group of participants A number of POCT devices used for rapid screening of respiratory viral infections including seasonal influenza are now widely available.
Linked to specific legislation / standards ISO/IEC 17043
Additional, subsidiary aims validation of testing methods
Number of participants
Accredited or otherwise reviewed by a 3rd party

Accredited by UKAS on the basis of ISO/IEC 17043

Operation is commissioned / requested by
Fees and frequency
Participation fee https://www.weqas.com/participantzone/subscription-charges/
Regularly operated Yes (Frequency: Bimonthly. Samples: 2 x 1.0mL)
Year of first operation 2021
Contact details of the PT provider
Provider Contact person
Weqas
Unit 6, Parc Ty Glas
CF14 5DU Cardiff
United Kingdom

Phone: 44 (0) 2920 314750
Fax:
Web: http://www.weqas.com http://www.weqas.com
Laura Lloyd-Lewis
Phone: 44 (0) 29218 32884
Fax:
Email: laura.lloyd-lewis@wales.nhs.uk laura.lloyd-lewis@wales.nhs.uk
If you find any mistakes please contact the responsible EPTIS coordinator in United Kingdom, Mr Savvas Xystouris. Mr Savvas Xystouris.
Any questions or problems? Please contact us at eptis@bam.de.
Application version: 1.23-SNAPSHOT.20230502124635-7925ae379a631fc1ececff45d2921c8db38877d5