ArticleInfection2022
Evaluation of accuracy, exclusivity, limit-of-detection and ease-of-use of LumiraDx™: An antigen-detecting point-of-care device for SARS-CoV-2.
Article in Infection, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
28 citing papers in PubMed, 8 syntheses or guidelines pooled it.
- Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.The Cochrane database of systematic reviews · 2025Pooled it
- Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: a systematic review and meta-analysis.Virology journal · 2024Pooled it
- Performance of self-performed SARS-CoV-2 rapid antigen test: a systematic review and meta-analysis.Frontiers in public health · 2024Pooled it
- Comparing SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing/self-sampling with molecular and professional-use tests: a systematic review and meta-analysis.Scientific reports · 2023Pooled it
- Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection.The Cochrane database of systematic reviews · 2022Pooled it
- Accuracy of rapid point-of-care antigen-based diagnostics for SARS-CoV-2: An updated systematic review and meta-analysis with meta-regression analyzing influencing factors.PLoS medicine · 2022Pooled it
- Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis.PLoS medicine · 2021Pooled it
- Nasal swab is a good alternative sample for detecting SARS-CoV-2 with rapid antigen test: A meta-analysis.Travel medicine and infectious diseasePooled it
- Key Insights into Respiratory Virus Testing: Sensitivity and Clinical Implications.Microorganisms · 2025Review
- Comparison of a Commercial SARS-CoV-2 Rapid Antigen Test with Real-Time PCR.Infectious diseases & clinical microbiology · 2024Article
- Innovative COVID-19 Point-of-Care Diagnostics Suitable for Tuberculosis Diagnosis: A Scoping Review.Journal of clinical medicine · 2024Article
- The evaluation of a rapid microfluidic immunofluorescence antigen test in detecting the infectiousness of COVID-19 patients.BMC infectious diseases · 2023Article
- Feedback on the Implementation of a Rapid and Connectable Point-of-Care COVID-19 Antigen Test in an Emergency Department.Diagnostics (Basel, Switzerland) · 2023Article
- Rapid Antigen and Antibody Microfluidic Immunofluorescence Assays Compared to Culture, PCR, and Laboratory Reference Tests: Performance in a Longitudinal Cohort.The Journal of infectious diseases · 2023Article
- Evaluation of a Sample-to-Result POCKIT Central SARS-CoV-2 PCR System.Diagnostics (Basel, Switzerland) · 2023Article
- The Diagnostic Accuracy of SARS-CoV-2 Nasal Rapid Antigen Self-Test: A Systematic Review and Meta-Analysis.Life (Basel, Switzerland) · 2023Review
- Sars-Cov-2 antigen tests predict infectivity based on viral culture: comparison of antigen, PCR viral load, and viral culture testing on a large sample cohort.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2023Article
- The utility of SARS-CoV-2 nucleocapsid protein in laboratory diagnosis.Journal of clinical laboratory analysis · 2022Review
- LumiraDX SARS-CoV-2 Antigen Test for Diagnosing Acute SARS-CoV-2 Infection: Critical Literature Review and Meta-Analysis.Diagnostics (Basel, Switzerland) · 2022Review
- Rapid Antigen Test LumiraDxInternational journal of environmental research and public health · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors.
Funding
Abstract
purposeRapid 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.
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. 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.
resultsThe 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.
conclusionThe 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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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.