The lateral flow method, as an analytical technology, offers high specificity and increasing sensitivity, making it a valuable tool in point-of-care testing environments. However, the number of test kit components and inconvenient workflows can lead to usability issues, potentially resulting in a 10% loss of valid results, especially in self-testing scenarios. [1] To mitigate this, clear instructions, error-free sample preparation, and a simplified workflow are crucial for ensuring reliable testing outcomes. [2] Addressing the risk of user errors is best accomplished through thoughtful medical device design. Therefor a complete redesign is needed towards more compact and easier to use systems to address the common pain points of traditional lateral flow test systems. And especially the upcoming methods of isothermal amplification combined with lateral flow assays will only have an impact on the on on-site testing market if the device design allows error- and contamination-free workflows.
Literature:
[1] Acceptability, Usability, and Performance of Lateral Flow Immunoassay Tests for Severe Acute Respiratory Syndrome Coronavirus 2 Antibodies: REACT-2 Study of Self-Testing in Nonhealthcare Key Workers. Davies, B. Open Forum Infectious Diseases, November 2021, Volume 8, Issue 11
[2] Lateral flow test engineering and lessons learned from COVID-19. Budd, J. Nat Rev Bioeng 2023, 1 13–31