Research & Evaluation of LumiraDx SARS-CoV-2 (COVID-19) Point of Care Ab Test
Completed
Conditions studied: Covid19
In brief
Evaluation of the agreement between fingerstick samples, venous blood, serum and plasma samples when using the LumiraDx SARS-CoV-2 Ab Test against the reference method, using standard qualitative comparison techniques.
Key facts
- Study ID
- NCT04597047
- Run by
- LumiraDx UK Limited
- People needed
- 42
- Starts
- 2020-07-09
- Expected to finish
- 2020-09-03
- Last updated by the study team
- 2026-06-15
Who can join
Age: 2 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female subjects aged ≥ 2 years.
- The subject must have a documented SARS-CoV-2 PCR test in the past 7-30 days. (subjects must be 14+ days post symptom onset at the time of recruitment).
- Written informed consent must be obtained prior to study enrollment.
- A subject who is 18 years or older must be willing to give written informed consent and must agree to comply with study procedures.
- The Legal Guardian or Legal Authorized Representative of a subject who is under the age of 18 must give written informed consent and agree to comply with study procedures. Active written assent should be obtained from children of appropriate intellectual age (as defined by the IRB).
You may not qualify if…
- Skin lesions or conditions that would preclude a fingerstick and or a venous blood draw.
- The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
- The subject has previously participated in this research study.
Where it is running
- Eclipse Clinical Research — Tucson, Arizona, United States
- Centura Health Physician Group, Northglenn Office — Northglenn, Colorado, United States
- Professional Research Network of Kansas — Wichita, Kansas, United States
- Physicians Quality Care of Jackson — Jackson, Tennessee, United States
Full record on ClinicalTrials.gov
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