tetano
Editor, Senior Moderator
Infection
. 2021 Aug 12.
doi: 10.1007/s15010-021-01681-y. Online ahead of print.
Evaluation of accuracy, exclusivity, limit-of-detection and ease-of-use of LumiraDx™: An antigen-detecting point-of-care device for SARS-CoV-2
Lisa J Krüger[SUP] 1 [/SUP], Julian A F Klein[SUP] 1 [/SUP], Frank Tobian[SUP] 1 [/SUP], Mary Gaeddert[SUP] 1 [/SUP], Federica Lainati[SUP] 1 [/SUP], Sarah Klemm[SUP] 2 [/SUP], Paul Schnitzler[SUP] 2 [/SUP], Ralf Bartenschlager[SUP] 3 4 [/SUP], Berati Cerikan[SUP] 3 [/SUP], Christopher J Neufeldt[SUP] 3 [/SUP], Olga Nikolai[SUP] 5 [/SUP], Andreas K Lindner[SUP] 5 [/SUP], Frank P Mockenhaupt[SUP] 5 [/SUP], Joachim Seybold[SUP] 6 [/SUP], Terry C Jones[SUP] 7 8 9 [/SUP], Victor M Corman[SUP] 7 8 [/SUP], Nira R Pollock[SUP] 10 [/SUP], Britta Knorr[SUP] 11 [/SUP], Andreas Welker[SUP] 11 [/SUP], Margaretha de Vos[SUP] 12 [/SUP], Jilian A Sacks[SUP] 12 [/SUP], Claudia M Denkinger[SUP] 13 14 [/SUP], ACE-IT Study Group
Collaborators, Affiliations
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: Antigen-detecting diagnostics; Covid-19; Diagnostic accuracy; Point-of-care; SARS-CoV-2.
. 2021 Aug 12.
doi: 10.1007/s15010-021-01681-y. Online ahead of print.
Evaluation of accuracy, exclusivity, limit-of-detection and ease-of-use of LumiraDx™: An antigen-detecting point-of-care device for SARS-CoV-2
Lisa J Krüger[SUP] 1 [/SUP], Julian A F Klein[SUP] 1 [/SUP], Frank Tobian[SUP] 1 [/SUP], Mary Gaeddert[SUP] 1 [/SUP], Federica Lainati[SUP] 1 [/SUP], Sarah Klemm[SUP] 2 [/SUP], Paul Schnitzler[SUP] 2 [/SUP], Ralf Bartenschlager[SUP] 3 4 [/SUP], Berati Cerikan[SUP] 3 [/SUP], Christopher J Neufeldt[SUP] 3 [/SUP], Olga Nikolai[SUP] 5 [/SUP], Andreas K Lindner[SUP] 5 [/SUP], Frank P Mockenhaupt[SUP] 5 [/SUP], Joachim Seybold[SUP] 6 [/SUP], Terry C Jones[SUP] 7 8 9 [/SUP], Victor M Corman[SUP] 7 8 [/SUP], Nira R Pollock[SUP] 10 [/SUP], Britta Knorr[SUP] 11 [/SUP], Andreas Welker[SUP] 11 [/SUP], Margaretha de Vos[SUP] 12 [/SUP], Jilian A Sacks[SUP] 12 [/SUP], Claudia M Denkinger[SUP] 13 14 [/SUP], ACE-IT Study Group
Collaborators, Affiliations
- PMID: 34383260
- DOI: 10.1007/s15010-021-01681-y
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: Antigen-detecting diagnostics; Covid-19; Diagnostic accuracy; Point-of-care; SARS-CoV-2.