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

  1. Krüger, Lisa J.
  2. Klein, Julian A. F.
  3. Tobian, Frank
  4. Gaeddert, Mary
  5. Lainati, Federica
  6. Klemm, Sarah
  7. Schnitzler, Paul
  8. Bartenschlager, Ralf
  9. Cerikan, Berati
  10. Neufeldt, Christopher J.
  11. Nikolai, Olga
  12. Lindner, Andreas K.
  13. Mockenhaupt, Frank P.
  14. Seybold, Joachim
  15. Jones, Terry C.
  16. Corman, Victor M.
  17. Pollock, Nira R.
  18. Knorr, Britta
  19. Welker, Andreas
  20. de Vos, Margaretha
  21. Sacks, Jilian A.
  22. Denkinger, Claudia ORCID logo
  23. Assaad, K.
  24. Fuhs, A.
  25. Harter, C.
  26. Schulze, C.
  27. Schmitt, G.
  28. Klemmer, Anja
  29. Müller, Rico
  30. Fink, Martina
  31. Fougereau, Mathilde
  32. Schirmer, Maximilian
  33. Small, Annika
  34. Meinlschmidt, Matthias
  35. Dürr, Valerie
  36. Schuckert, Alina
  37. Backes, Ann-Kathrin
  38. Steinke, Salome
  39. Ellinghaus, Henrik
  40. Abutaima, Loai
  41. Kollatzsch, Mandy
  42. Wintel, Mia
  43. Kausch, Franka
  44. Hommes, Franziska
  45. Bölke, Alisa
  46. Bernhard, Julian
  47. Hülso, Claudia
  48. Linzbach, Elisabeth
  49. Rössig, Heike
  50. Gertler, Maximilian
  51. Burock, Susen
  52. von dem Busche, Katja
  53. Patberg, Stephanie

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1000 Titel
  • Evaluation of accuracy, exclusivity, limit-of-detection and ease-of-use of LumiraDx™: An antigen-detecting point-of-care device for SARS-CoV-2
1000 Autor/in
  1. Krüger, Lisa J. |
  2. Klein, Julian A. F. |
  3. Tobian, Frank |
  4. Gaeddert, Mary |
  5. Lainati, Federica |
  6. Klemm, Sarah |
  7. Schnitzler, Paul |
  8. Bartenschlager, Ralf |
  9. Cerikan, Berati |
  10. Neufeldt, Christopher J. |
  11. Nikolai, Olga |
  12. Lindner, Andreas K. |
  13. Mockenhaupt, Frank P. |
  14. Seybold, Joachim |
  15. Jones, Terry C. |
  16. Corman, Victor M. |
  17. Pollock, Nira R. |
  18. Knorr, Britta |
  19. Welker, Andreas |
  20. de Vos, Margaretha |
  21. Sacks, Jilian A. |
  22. Denkinger, Claudia |
  23. Assaad, K. |
  24. Fuhs, A. |
  25. Harter, C. |
  26. Schulze, C. |
  27. Schmitt, G. |
  28. Klemmer, Anja |
  29. Müller, Rico |
  30. Fink, Martina |
  31. Fougereau, Mathilde |
  32. Schirmer, Maximilian |
  33. Small, Annika |
  34. Meinlschmidt, Matthias |
  35. Dürr, Valerie |
  36. Schuckert, Alina |
  37. Backes, Ann-Kathrin |
  38. Steinke, Salome |
  39. Ellinghaus, Henrik |
  40. Abutaima, Loai |
  41. Kollatzsch, Mandy |
  42. Wintel, Mia |
  43. Kausch, Franka |
  44. Hommes, Franziska |
  45. Bölke, Alisa |
  46. Bernhard, Julian |
  47. Hülso, Claudia |
  48. Linzbach, Elisabeth |
  49. Rössig, Heike |
  50. Gertler, Maximilian |
  51. Burock, Susen |
  52. von dem Busche, Katja |
  53. Patberg, Stephanie |
1000 Erscheinungsjahr 2021
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2021-08-12
1000 Erschienen in
1000 Quellenangabe
  • 50(2):395-406
1000 Copyrightjahr
  • 2021
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1007/s15010-021-01681-y |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8358901/ |
1000 Publikationsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • 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.
1000 Sacherschließung
lokal
lokal COVID-19/diagnosis [MeSH]
lokal Diagnostic accuracy
gnd 1206347392 COVID-19
lokal Point-of-Care Systems [MeSH]
lokal Antigen-detecting diagnostics
lokal Humans [MeSH]
lokal RNA, Viral [MeSH]
lokal Point-of-care
lokal COVID-19 / SARS-CoV-2
lokal Covid-19
lokal Pandemics [MeSH]
lokal Sensitivity and Specificity [MeSH]
lokal Original Paper
lokal SARS-CoV-2 [MeSH]
1000 Liste der Beteiligten
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