EPTIS
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POCT HIV

[POCT HIV]

EPTIS factsheet 142690 | Last revision 2024-05-22 | URL: https://www.eptis.bam.de/pts142690 https://www.eptis.bam.de/pts142690

PT provider
PT provider Weqas Weqas
Based in United Kingdom
Language(s)
Remarks The Weqas POCT HIV Programme was specifically developed for 4th generation assays; to assess the user’s ability to correctly identify both HIV Antibodies and Ag, and assess the diagnostic accuracy of the methods using samples mimicking the different clinical presentations. HIV-1 p24 antigens are found on the surface of HIV cells approximately 12 to 26 days after exposure and before HIV antibodies are produced, allowing for earlier detection of the virus. The sample matrix is ‘off the clot’ human serum tested negative for HIV, Hepatitis B and C at donor level which is spiked with a non-infective source of recombinant HIV markers (p24 Ag, HIV-1 Ab and HIV-2 Ab) at varying concentrations. Three samples are distributed bimonthly. Performance Assessment The programme is designed to assess both user and method performance, including limit of detection, sensitivity and specificity. The scores broadly reflect clinical importance, where a correct result (in agreement with interpretive comment) is given a score of 0. A score of 3 or 4 is assigned for incorrectly identified results, where 4 represents a gross misclassification of the result. A negative result for a positive sample is given a score of 3 to 4 depending on the concentration of the positive sample. A positive result for a negative sample is given a score of 3. Key Features: - Liquid human serum samples require no pre-analytical preparation. - Samples are prepared with a non-infective source of recombinant HIV markers (p24 Ag, HIV-1 Ab and HIV-2 Ab) to mimic different clinical presentations. - Developed for 4th generation assays, the user’s ability to identify both Abs and Ag are assessed. - Simple qualitative reports for end users. For more information: https://www.weqas.com/services/poct-eqa/poct-hiv/ or contact@weqas.com
Keywords
Product groups Health care / medical devices
Testing fields Medical analysis
Technical details
Test item Tested property Testing method
Off the clot human serum p24 Antigen Routine testing methods (recommended)
HIV-1 Antibody Routine testing methods (recommended)
HIV-2 Antibody Routine testing methods (recommended)
Aims of the PT scheme
Target group of participants Recommended for rapid community testing including Point of Care testing (POCT) increases testing rates in at-risk groups and should be commissioned as part of local HIV testing programmes.
Linked to specific legislation / standards Accreditation by UKAS on the basis of ISO/IEC 17025, 17043 and 15195
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: 3 x 0.5mL. )
Year of first operation 2010
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