| Title: |
Evaluation of SARS-CoV-2 lateral flow device sensitivity: a comparison of systematic laboratory assessments with manufacturer-reported sensitivity |
| Authors: |
Kulasegaran-Shylini, Raghavendran; Bown, Abbie; Collinge, Tom; Sienkiewicz, Alex; Eyre, David W; Crook, Derrick; Walker, Sarah; Bell, John; Williamson, Deborah A; Oliver, Isabel; Wilcox, Mark; Hill, Sue; Peto, Tim; Vipond, Richard; Hopkins, Susan; Fowler, Tom |
| Source: |
EClinicalMedicine , 87 , Article 103454. (2025) |
| Publisher Information: |
Elsevier |
| Publication Year: |
2025 |
| Collection: |
University College London: UCL Discovery |
| Subject Terms: |
SARS-CoV-2; Lateral flow device; COVID-19 |
| Description: |
BACKGROUND: Self-testing for SARS-CoV-2 infection using lateral flow devices (LFDs) was a key component of the COVID-19 pandemic response; however, LFD performance has shown a high degree of variability. Between August 2020 and July 2023, the UK Health Security Agency (UKHSA), including predecessor organisations, undertook a three-phase SARS-CoV-2 test development and evaluation programme to independently evaluate commercially available SARS-CoV-2 LFDs, incorporating standardised laboratory assessment of test sensitivity. Here we describe results from a comparison of UKHSA laboratory assessment findings with manufacturer-reported LFD sensitivity data. METHODS: The UKHSA assessed the sensitivity of LFDs, by laboratory testing of surplus clinical samples from a secondary healthcare setting. These data were compared with manufacturer-reported clinical sensitivity data and analytical sensitivity (limit of detection [LOD; 50% tissue culture infectious dose [TCID50]/mL]) from LFD instructions for use (IFU). FINDINGS: UKHSA-determined LFD sensitivity ranged from 32 to 83%. Of 86 LFDs assessed, 73 included device sensitivity data in the manufacturers’ IFU that claimed clinical sensitivity ≥85%, and 49 claimed clinical sensitivity ≥95%. No evidence of correlation was observed between manufacturer-reported test sensitivity and UKHSA determined test sensitivity, and no evidence of correlation was observed between manufacturer-reported test LOD and UKHSA-determined test sensitivity. INTERPRETATION: UKHSA-determined LFD sensitivity ranged from 32 to 83%. Of 86 LFDs assessed, 73 included device sensitivity data in the manufacturers’ IFU that claimed clinical sensitivity ≥85%, and 49 claimed clinical sensitivity ≥95%. No evidence of correlation was observed between manufacturer-reported test sensitivity and UKHSA determined test sensitivity, and no evidence of correlation was observed between manufacturer-reported test LOD and UKHSA-determined test sensitivity. FUNDING: This study was funded by UK Department of Health and ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| Relation: |
https://discovery.ucl.ac.uk/id/eprint/10212527/ |
| Availability: |
https://discovery.ucl.ac.uk/id/eprint/10212527/7/Walker_Evaluation%20of%20SARS-CoV-2%20lateral%20flow%20device%20sensitivity_VoR.pdf; https://discovery.ucl.ac.uk/id/eprint/10212527/ |
| Rights: |
open |
| Accession Number: |
edsbas.2EE5C251 |
| Database: |
BASE |