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Pregnancy Testing

[Pregnancy Testing]

EPTIS factsheet 142682 | Last revision 2024-05-22 | URL: https://www.eptis.bam.de/pts142682 https://www.eptis.bam.de/pts142682

PT provider
PT provider Weqas Weqas
Based in United Kingdom
Remarks 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
Product groups Health care / medical devices
Testing fields Medical analysis
Technical details
Test item Tested property Testing method
Filtered urine from pregnant and non-pregnant volunteers. Off the clot serum. Urine hCG Routine testing methods (recommended)
Serum hCG Routine testing methods (recommended)
Aims of the PT scheme
Target group of participants The Pregnancy Testing programme is a bimonthly programme available to both POCT and Laboratory sites.
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 1.0mL. )
Year of first operation 2001
Contact details of the PT provider
Provider Contact person
Unit 6, Parc Ty Glas
CF14 5DU Cardiff
United Kingdom

Phone: 44 (0) 2920 314750
Web: http://www.weqas.com http://www.weqas.com
Laura Lloyd-Lewis
Phone: 44 (0) 29218 32884
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