ArticleInfectious diseases and therapy2021
A Rapid, High-Sensitivity SARS-CoV-2 Nucleocapsid Immunoassay to Aid Diagnosis of Acute COVID-19 at the Point of Care: A Clinical Performance Study.
Article in Infectious diseases and therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04557046 (A Multicenter COVID-19 Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 Ag Test at Point of Care Testing Sites), which is not on this map. Cited by 34 papers, 5 of them syntheses that pooled it.
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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.
A Multicenter COVID-19 Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 Ag Test at Point of Care Testing Sites
Who cites it
34 citing papers in PubMed, 5 syntheses or guidelines pooled it, 74 citations in OpenAlex.
- The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Antigen Testing (January 2023).Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Guideline
- Clinical accuracy of instrument-based SARS-CoV-2 antigen diagnostic tests: a systematic review and meta-analysis.Virology journal · 2024Pooled 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
- Opportunities and Challenges in Gas Sensor Technologies for Accurate Detection of COVID-19.Biosensors · 2025Review
- 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
- Development of nucleocapsid-specific monoclonal antibodies for SARS-CoV-2 and their ELISA diagnostics on an automatic microfluidic device.Sensors and actuators. B, Chemical · 2023Article
- 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
- Merging microfluidics with luminescence immunoassays for urgent point-of-care diagnostics of COVID-19.Trends in analytical chemistry : TRAC · 2022Review
- Current trends in COVID-19 diagnosis and its new variants in physiological fluids: Surface antigens, antibodies, nucleic acids, and RNA sequencing.Trends in analytical chemistry : TRAC · 2022Review
- Performance Evaluation of the Microfluidic Antigen LumiraDx SARS-CoV-2 and Flu A/B Test in Diagnosing COVID-19 and Influenza in Patients with Respiratory Symptoms.Infectious diseases and therapy · 2022Article
- Clinical Performance of Self-Collected Nasal Swabs and Antigen Rapid Tests for SARS-CoV-2 Detection in Resource-Poor Settings.Biomedicines · 2022Article
- Performance of Antigen Detection Tests for SARS-CoV-2: A Systematic Review and Meta-Analysis.Diagnostics (Basel, Switzerland) · 2022Review
- ESCMID COVID-19 guidelines: diagnostic testing for SARS-CoV-2.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2022Article
- Diagnostic Performance of Antigen Rapid Diagnostic Tests, Chest Computed Tomography, and Lung Point-of-Care-Ultrasonography for SARS-CoV-2 Compared with RT-PCR Testing: A Systematic Review and Network Meta-Analysis.Diagnostics (Basel, Switzerland) · 2022Review
- The Coronavirus Disease 2019 Spatial Care Path: Home, Community, and Emergency Diagnostic Portals.Diagnostics (Basel, Switzerland) · 2022Article
- LumiraDX SARS-CoV-2 Antigen Test for Diagnosing Acute SARS-CoV-2 Infection: Critical Literature Review and Meta-Analysis.Diagnostics (Basel, Switzerland) · 2022Review
- Performance of the LumiraDx Microfluidic Immunofluorescence Point-of-Care SARS-CoV-2 Antigen Test in Asymptomatic Adults and Children.American journal of clinical pathology · 2022Article
- The University of Padua salivary-based SARS-CoV-2 surveillance program minimized viral transmission during the second and third pandemic wave.BMC medicine · 2022Article
Corrections and comments
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Authors and funding
10 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe LumiraDx severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen test, which uses a high-sensitivity, microfluidic immunoassay to detect the nucleocapsid protein of SARS-CoV-2, was evaluated for diagnosing acute coronavirus disease 2019 (COVID-19) in adults and children across point-of-care settings (NCT04557046).
methodsTwo paired anterior nasal swabs or two paired nasopharyngeal swabs were collected from each participant. Swabs were tested by the LumiraDx SARS-CoV-2 antigen test and compared with real-time polymerase chain reaction (rt-PCR; Roche cobas 6800 platform). Sensitivity, specificity and likelihood ratios were calculated. Results were stratified on the basis of gender, age, duration of symptoms, and rt-PCR cycle threshold.
resultsOut of the 512 participants, aged 0-90 years, of this prospective validation study, 414 (81%) were symptomatic for COVID-19 and 123 (24%) swabs were positive for SARS-CoV-2 based on rt-PCR testing. Compared with rt-PCR, the 12-min nasal swab test had 97.6% sensitivity and 96.6% specificity, and nasopharyngeal swab had 97.5% sensitivity and 97.7% specificity, within 12 days of symptom onset, representing the period of infectivity. All (100%) samples detected within 33 rt-PCR cycles were also identified using the antigen test. Results were consistent across age and gender. The user error rate of the test system when used by minimally trained operators was 0.7% (95% confidence interval [CI] 0.1-3.7%).
conclusionThe rapid, high-sensitivity assay using nasopharyngeal or anterior nasal sampling may offer significant improvements for diagnosing acute SARS-CoV-2 infection in clinic- and community-based settings.
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Registered trials
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.