Catharine Sturgeon
Dr.
UK NEQAS (Edinburg)], Royal Infirmary of Edinburgh
United Kingdom
Catharine Sturgeon is a UK National Health Service Consultant Clinical Scientist in the Department of Laboratory Medicine in the Royal Infirmary of Edinburgh, where she participates in the Department’s interpretative service in the specialist areas of oncology and endocrinology and also directs the UK National External Quality Assessment Service (UK NEQAS) [Edinburgh] centre, which undertakes monthly assessment of the quality of analytical testing for a range of specialised biomarkers in more than 1000 clinical laboratories worldwide. The remit of the service is scientific and educational as well as regulatory, with the primary aims of reducing harm to patients from erroneous test results, improving the quality of laboratory tests and encouraging best practice. She has been an active member of International Federation of Clinical Chemistry Working Groups to improve standardisation of biomarkers including human chorionic gonadotrophin, growth hormone, pregnancy associated plasma protein A and parathyroid hormone and is currently chairperson of the Clinical Laboratory Standards Institute (CLSI) group developing the first CLSI guidelines for tumor markers.
Topics
Standardisation of home pregnancy tests - A view from UK NEQAS
Quality in Laboratory Medicine
Direct-to-Consumer Testing
6.2.2026 13:00 - 13:30 | Hall 208
This lecture reviews what is required to ensure that home pregnancy tests are reliable and fit for purpose, whether used in a laboratory setting or by lay users. Relevant considerations include how the formats of devices are described, description of the isoforms of human chorionic gonadotrophin recognised and the units of measurement, as well as specimen requirements. Assessment of analytical accuracy, sensitivity and reproducibility must be carefully undertaken and clearly defined in technical data sheets. Assessment of clinical accuracy should provide users with information about how accurately the test will identify pregnancy status and clear definition of how that pregnancy status is defined. Advantages and potential disadvantages of highly sensitive home pregnancy tests will be discussed. As home pregnancy tests are developed primarily for lay users who generally will have little practical experience of laboratory testing, clear instructions, robust methods and straightforward interpretation of the results are essential. Results from the UK National External Quality Assessment Service (UK NEQAS) Pregnancy Testing scheme provide some evidence as to how well these requirements are fulfilled in practice.
