PLOS Medicine publishes systematic review and meta-analysis of more than 60 SARS- CoV-2 antigen tests: Ranks LumiraDx’s SARS-CoV-2 Ag Test as most sensitive and accurate

August 18, 2021

A new living systematic review and meta-analysis of SARS-CoV-2 antigen tests, currently including 133 clinical and analytical accuracy studies across 61 Antigen tests was just completed by Lukas Brümmer, Stephan Katzenschlager and Claudia Denkinger, all with Heidelberg University Hospital, along with other collaborators from Heidelberg, Muenster, Hamburg, Mannheim, FIND and Boston Children’s Hospital to inform national and international bodies including WHO*, ECDC, and RKI. The analysis reveals that LumiraDx – an instrument based microfluidic test – showed the highest overall accuracy.

Key findings include:

  • Across all meta-analyzed studies, when Ag-RDTs were performed according to manufacturers’ recommendations, they showed a sensitivity of 76.3% (95% CI 73.1% to 79.2%), with LumiraDx (sensitivity 88.2% [95% CI 59.0% to 97.5%]) and, of the instrument-free Ag-RDTs, Standard Q (74.9% sensitivity [95% CI 69.3% to 79.7%]) performing best.
  • Independent validations are important because the analysis highlights the variability in results between tests (which is not reflected in the manufacturer-reported data).
  • The accuracy achievable by the best-performing Ag-RDTs, combined with the rapid turnaround time compared to RT-PCR, suggests that these tests could have a significant impact on the pandemic if applied in thoughtful testing and screening strategies.
  • Out of all assessed tests, LumiraDx showed the highest accuracy.

The full paper may be found here.

The study was supported by funding from FIND and WHO amongst others.

*RKI – Robert Koch Institute, ECDC – European Centre for Disease Prevention and Control, FIND- Foundation of New Diagnosticsm, WHO - World Health Organisation

Funding: The study was supported by the Ministry of Science, Research and Arts of the State of Baden-Wuerttemberg, Germany (no grant number; https://mwk.baden-wuerttemberg.de/de/startseite/) and internal funds from the Heidelberg University Hospital (no grant number; https://www.heidelberg-university-hospital.com/de/) to CMD. Further, this project was funded by United Kingdom (UK) aid from the British people (grant number: 300341-102; Foreign, Commonwealth & Development Office (FCMO), former UK Department of International Development (DFID); www.gov.uk/fcdo), and supported by a grant from the World Health Organization (WHO; no grant number; https://www.who.int) and a grant from Unitaid (grant number: 2019-32-FIND MDR; https://unitaid.org) to Foundation of New Diagnostics (FIND; JAS, SC, SO, AM). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.