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 | ||||||||||||
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| 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 | ||||||||||||
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| Product groups |
Health care / medical devices
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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 | 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 |
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| 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 | ||||||||||||
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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 |
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If you find any mistakes please contact the responsible EPTIS coordinator in United Kingdom,
Mr Savvas Xystouris.
Mr Savvas Xystouris.