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Thus far, sensitivity (\u2264\u200985%) of lateral-flow assays has limited scale-up. Conceivably, microfluidic immunofluorescence Ag-RDTs could increase sensitivity for\n                      <jats:italic>SARS-CoV-2<\/jats:italic>\n                      detection.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      This multi-centre diagnostic accuracy study investigated performance of the microfluidic immunofluorescence LumiraDx\u2122 assay, enrolling symptomatic and asymptomatic participants with suspected\n                      <jats:italic>SARS-CoV-2<\/jats:italic>\n                      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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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\u2122, resulting in a sensitivity of 82.2% (95% CI 75.2\u201387.5%). Specificity was 99.3% (CI 98.3\u201399.7%). Sensitivity was increased in individuals with viral load\u2009\u2265\u20097 log10 SARS-CoV2 RNA copies\/ml (93.8%; CI 86.2\u201397.3%). Testing against common respiratory commensals and pathogens showed no cross-reactivity and LOD was estimated to be 2\u201356 PFU\/mL. The ease-of-use-assessment was favourable for lower throughput settings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The LumiraDx\u2122 assay showed excellent analytical sensitivity, exclusivity and clinical specificity with good clinical sensitivity using supervised NMT self-sampling.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number and registration date<\/jats:title>\n                    <jats:p>DRKS00021220 and 01.04.2020<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s15010-021-01681-y","type":"journal-article","created":{"date-parts":[[2021,8,12]],"date-time":"2021-08-12T08:05:02Z","timestamp":1628755502000},"page":"395-406","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["Evaluation of accuracy, exclusivity, limit-of-detection and ease-of-use of LumiraDx\u2122: An antigen-detecting point-of-care device for SARS-CoV-2"],"prefix":"10.1007","volume":"50","clinical-trial-number":[{"clinical-trial-number":"drks00021220","registry":"10.18810\/drks"}],"author":[{"given":"Lisa J.","family":"Kr\u00fcger","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julian A. 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All participants provided written informed consent prior to inclusion in the study. The study was registered in the German clinical trial registry with the registration number DRKS00021220.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Written informed consent was obtained from all individual participants included in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}}]}}