Tommi Vaskivuo

Challenges and Opportunities in Developing Saliva-Based Consumer Tests

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.