Evaluation of accuracy, exclusivity, limit-of-detection and ease-of-use of LumiraDx™: An antigen-detecting point-of-care device for SARS-CoV-2.
Authors
Krüger, Lisa J
Klein, Julian AF
Tobian, Frank
Gaeddert, Mary
Lainati, Federica
Klemm, Sarah
Schnitzler, Paul
Bartenschlager, Ralf
Cerikan, Berati
Neufeldt, Christopher J
Nikolai, Olga
Lindner, Andreas K
Mockenhaupt, Frank P
Seybold, Joachim
Jones, Terry C
Corman, Victor M
Pollock, Nira R
Knorr, Britta
Welker, Andreas
de Vos, Margaretha
Sacks, Jilian A
ACE-IT Study Group
Publication Date
2022-04Journal Title
Infection
ISSN
0300-8126
Publisher
Springer Science and Business Media LLC
Volume
50
Issue
2
Pages
395-406
Language
en
Type
Article
This Version
VoR
Metadata
Show full item recordCitation
Krüger, L. J., Klein, J. A., Tobian, F., Gaeddert, M., Lainati, F., Klemm, S., Schnitzler, P., et al. (2022). Evaluation of accuracy, exclusivity, limit-of-detection and ease-of-use of LumiraDx™: An antigen-detecting point-of-care device for SARS-CoV-2.. Infection, 50 (2), 395-406. https://doi.org/10.1007/s15010-021-01681-y
Description
Funder: Ministry of Science, Research and Arts of the State of Baden-Wuerttemberg
Funder: University Hospital Heidelberg
Funder: University Hospital Charité - Universitätsmedizin Berlin
Funder: World Health Organization; doi: http://dx.doi.org/10.13039/100004423
Funder: Universitätsklinikum Heidelberg (8914)
Abstract
PURPOSE: Rapid antigen-detecting tests (Ag-RDTs) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can transform pandemic control. Thus far, sensitivity (≤ 85%) of lateral-flow assays has limited scale-up. Conceivably, microfluidic immunofluorescence Ag-RDTs could increase sensitivity for SARS-CoV-2 detection. METHODS: This multi-centre diagnostic accuracy study investigated performance of the microfluidic immunofluorescence LumiraDx™ assay, enrolling symptomatic and asymptomatic participants with suspected SARS-CoV-2 infection. Participants collected a supervised nasal mid-turbinate (NMT) self-swab for Ag-RDT testing, in addition to a professionally collected nasopharyngeal (NP) swab for routine testing with reverse transcriptase polymerase chain reaction (RT-PCR). Results were compared to calculate sensitivity and specificity. Sub-analyses investigated the results by viral load, symptom presence and duration. An analytical study assessed exclusivity and limit-of-detection (LOD). In addition, we evaluated ease-of-use. RESULTS: The study was conducted between November 2nd 2020 and 4th of December 2020. 761 participants were enrolled, with 486 participants reporting symptoms on testing day. 120 out of 146 RT-PCR positive cases were detected positive by LumiraDx™, resulting in a sensitivity of 82.2% (95% CI 75.2-87.5%). Specificity was 99.3% (CI 98.3-99.7%). Sensitivity was increased in individuals with viral load ≥ 7 log10 SARS-CoV2 RNA copies/ml (93.8%; CI 86.2-97.3%). Testing against common respiratory commensals and pathogens showed no cross-reactivity and LOD was estimated to be 2-56 PFU/mL. The ease-of-use-assessment was favourable for lower throughput settings. CONCLUSION: The LumiraDx™ assay showed excellent analytical sensitivity, exclusivity and clinical specificity with good clinical sensitivity using supervised NMT self-sampling. TRIAL REGISTRATION NUMBER AND REGISTRATION DATE: DRKS00021220 and 01.04.2020.
Keywords
Original Paper, DRKS00021220, DRKS, COVID-19 / SARS-CoV-2, SARS-CoV-2, Covid-19, Diagnostic accuracy, Antigen-detecting diagnostics, Point-of-care
Sponsorship
UK Department of International Development (300341-102)
Unitaid (2019-32-FIND MDR)
NIAID-NIH CEIRS (HHSN272201400008C)
Identifiers
s15010-021-01681-y, 1681
External DOI: https://doi.org/10.1007/s15010-021-01681-y
This record's URL: https://www.repository.cam.ac.uk/handle/1810/335398
Rights
Licence:
http://creativecommons.org/licenses/by/4.0/
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