POCT Pregnancy Testing
[POCT Pregnancy Testing]
EPTIS Ringversuch Nr. 1177217 | Letze Änderung 2024-09-24 | URL: https://www.eptis.bam.de/pts1177217 https://www.eptis.bam.de/pts1177217
| Name des Anbieters | ||||||||||
| Name des Anbieters | Weqas Weqas | |||||||||
| Ansässig in | United Kingdom | |||||||||
| Sprache(n) | ||||||||||
| Anmerkungen | The Programme aims to assess the performance of organisations measuring Urine and Serum/ whole blood human chorionic gonadotrophin (hCG) for confirmation of pregnancy (classical high sensitivity test) and for professional healthcare providers using low sensitivity or multilevel rapid tests to exclude ongoing pregnancy after medical abortion treatment. Urine Pregnancy Programme Three samples of liquid human urine covering an appropriate physiological range are distributed bimonthly. Fresh filtered human urine from pregnant and non-pregnant volunteers is used, with additional female human urine spiked with Human Chorionic Gonadotrophin to increase the pathological range. The standard volume is 1mL aliquots, however this can be increased and dispensed into wide neck tubes to those participants using wick-based assay systems. Participants can submit both quantitative and qualitative results. Serum HCG Programme Three serum samples spiked with hCG are distributed bimonthly, participants can submit quantitative and qualitative results. Performance Assessment: The programme is designed to assess both laboratory and method performance, including, sensitivity, interferences, bias, within and between batch imprecision and antigen excess. Key Features: - Suitable for qualitative and quantitative assays. - Suitable for urine and serum/ whole blood hCG methods. - Suitable for manual or automated lateral flow methods. - Suitable for classical pregnancy testing or determination of outcome after ToP. - Increased volume dispensed into wide neck tubes available for those using lateral flow dip stick assays. - Challenging samples at or near lower limits of detection/ Ag excess to assess sensitivity and Hook effect. - Programme assess both laboratory and method performance, including, sensitivity, interferences, bias, within and between batch imprecision. For more information: https://www.weqas.com/services/eqa/pregnancy-testing/ or contact@weqas.com | |||||||||
| Klassifizierung | ||||||||||
| Produktgruppen |
Health care / medical devices
|
|||||||||
| Prüfgebiete |
Medical analysis
|
|||||||||
| Technische Einzelheiten | ||||||||||
|
||||||||||
| Ringversuchsziele | ||||||||||
| Zielgruppe des Ringversuchs | The Pregnancy Testing programme is a bimonthly programme available to both POCT and Laboratory sites. | |||||||||
| Relevante Rechtsvorschriften oder Normen | Accreditation by UKAS on the basis of ISO/IEC 17025, 17043 and 15195 | |||||||||
| 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: 3 x 1.0mL. ) | |||||||||
| Der Ringversuch wird durchgeführt seit | 2001 | |||||||||
| 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.