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MeSH Disease

HGNC Genes

SARS-CoV-2 proteins

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    Evaluation of accuracy, exclusivity, limit-of-detection and ease-of-use of LumiraDx™ - Antigen-detecting point-of-care device for SARS-CoV-2

    Authors: Lisa Johanna Krüger; Julian A.F. Klein; Frank Tobian; Mary Gaeddert; Federica Lainati; Sarah Klemm; Paul Schnitzler; Ralf Bartenschlager; Berati Cerikan; Christopher Neufeldt; Olga Nikolai; Andreas Lindner; Frank P. Mockenhaupt; Joachim Seybold; Terry C. Jones; Victor Max Corman; Nira M Pollock; Britta Knorr; Andreas Welker; Margaretha de Vos; Jilian A Sacks; Claudia M. Denkinger

    doi:10.1101/2021.03.02.21252430 Date: 2021-03-05 Source: medRxiv

    BackgroundRapid antigen-detecting tests (Ag-RDTs) for severe acute respiratory syndrome coronavirus 2 MESHD (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. Materials and MethodsThis multi-centre diagnostic accuracy study investigated performance of the microfluidic immunofluorescence LumiraDx assay, enrolling symptomatic and asymptomatic participants with suspected SARS-CoV-2 infection MESHD. Participants collected a supervised nasal mid-turbinate ( NMT HGNC) 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. ResultsStudy conduct was between November 2nd 2020 and January 21st 2021. 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. ConclusionThe LumiraDx assay showed excellent analytical sensitivity, exclusivity and clinical specificity with good clinical sensitivity using supervised NMT HGNC self-sampling.

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MeSH Disease
HGNC Genes
SARS-CoV-2 Proteins


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