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Evaluation of accuracy, exclusivity, limit-of-detection and ease-of-use of LumiraDx™: An antigen-detecting point-of-care device for SARS-CoV-2.
Krüger, Lisa J; Klein, Julian A F; 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; Denkinger, Claudia M.
  • Krüger LJ; Division of Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
  • Klein JAF; Division of Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
  • Tobian F; Division of Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
  • Gaeddert M; Division of Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
  • Lainati F; Division of Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany.
  • Klemm S; Virology, Heidelberg University Hospital, Heidelberg, Germany.
  • Schnitzler P; Virology, Heidelberg University Hospital, Heidelberg, Germany.
  • Bartenschlager R; Department of Infectious Diseases, Molecular Virology, Centre for Integrative Infectious Diseases Research (CIID), Heidelberg University Hospital, Heidelberg, Germany.
  • Cerikan B; German Centre for Infection Research (DZIF), Partner site Heidelberg University Hospital, Heidelberg, Germany.
  • Neufeldt CJ; Department of Infectious Diseases, Molecular Virology, Centre for Integrative Infectious Diseases Research (CIID), Heidelberg University Hospital, Heidelberg, Germany.
  • Nikolai O; Department of Infectious Diseases, Molecular Virology, Centre for Integrative Infectious Diseases Research (CIID), Heidelberg University Hospital, Heidelberg, Germany.
  • Lindner AK; Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Institute of Tropical Medicine and International Health, Berlin, Germany.
  • Mockenhaupt FP; Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Institute of Tropical Medicine and International Health, Berlin, Germany.
  • Seybold J; Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Institute of Tropical Medicine and International Health, Berlin, Germany.
  • Jones TC; Medical Directorate, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Corman VM; Institute of Virology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • Pollock NR; German Centre for Infection Research (DZIF), Partner Site Charité, Berlin, Germany.
  • Knorr B; Centre for Pathogen Evolution, Department of Zoology, University of Cambridge, Cambridge, UK.
  • Welker A; Institute of Virology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
  • de Vos M; German Centre for Infection Research (DZIF), Partner Site Charité, Berlin, Germany.
  • Sacks JA; Department of Laboratory Medicine, Boston Children's Hospital, Boston, MA, USA.
  • Denkinger CM; Department of Public Health Rhein Neckar Region, Heidelberg, Germany.
Infection ; 50(2): 395-406, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1353740
Preprint
This scientific journal article is probably based on a previously available preprint. It has been identified through a machine matching algorithm, human confirmation is still pending.
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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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Infection Year: 2022 Document Type: Article Affiliation country: S15010-021-01681-y

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Infection Year: 2022 Document Type: Article Affiliation country: S15010-021-01681-y