Last reviewed · How we verify
NCT04557046: ASPIRE
Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag Test
Status unknown
NA
Last updated 26 December 2023
What this trial tests
NA trial testing Nasal Swab in Covid19 in 1,134 participants. Status unknown.
Timeline
26 June 2020
Primary endpoint
24 March 2021
24 March 2021
31 March 2024
Quick facts
| Lead sponsor | LumiraDx UK Limited |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 1,134 |
| Start date | 26 June 2020 |
| Primary completion | 24 March 2021 |
| Estimated completion | 31 March 2024 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- Nasal Swab — full drug profile →
- Nasopharyngeal swab — full drug profile →
- Throat swab
- Fingerstick
- Saliva specimen
Conditions studied
- Covid19 — all drugs for Covid19 →
Sponsor
LumiraDx UK Limited — full company profile →
Who can join
Eligibility, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Performance of the LumiraDx SARS-CoV-2 Ag assay will be assessed by comparison to a reference method.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
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.
Drain PK, Ampajwala M, Chappel C, Gvozden AB, et al · · 2021 · cited 51× · PMID 33629225 · DOI 10.1007/s40121-021-00413-x -
Performance of the LumiraDx Microfluidic Immunofluorescence Point-of-Care SARS-CoV-2 Antigen Test in Asymptomatic Adults and Children.
Drain P, Sulaiman R, Hoppers M, Lindner NM, et al · · 2022 · cited 20× · PMID 34668536 · DOI 10.1093/ajcp/aqab173 -
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.
Ellis JE, Guest P, Lawson V, Loecherbach J, et al · · 2022 · cited 5× · PMID 36152227 · DOI 10.1007/s40121-022-00696-8 -
Diagnostic accuracy of rapid point-of-care tests for diagnosis of current SARS-CoV-2 infections in children: A systematic review and meta-analysis
Fujita-Rohwerder N, Beckmann L, Zens Y, Verma A. · · 2021 · cited 1× · DOI 10.1101/2021.08.11.21261830 -
Performance evaluation of the LumiraDx SARS-CoV-2 & Flu A/B Test in diagnosing COVID-19 and influenza in patients with respiratory symptoms
Ellis J, Guest P, Lawson V, Loecherbach J, et al · · 2022 · DOI 10.1101/2022.07.20.22277845
Verify or expand the search:
- PubMed search for NCT04557046
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other LumiraDx UK Limited trials
Trials by the same sponsor.
- NCT05787444 — Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Test in Detecting and Differentiating Severe Acute Respiratory · unknown
- NCT05728970 — Performance Evaluation of the LumiraDX SARS-CoV-2 Ag Ultra and LumiraDX SARS-CoV-2 & Flu A/B Tests at Point of Care (POC · completed
- NCT05568966 — Collection of Blood Samples for New Diagnostic Devices 2 · NA · recruiting
- NCT05506618 — Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag ULTRA Test (ASPIRE-2) · NA · unknown
- NCT05403853 — A Performance Evaluation of the Lumiradx Point of Care HbA1c Device · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04557046 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by LumiraDx UK Limited
- Last refreshed: 26 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04557046.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing