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Research & Evaluation of LumiraDx SARS-CoV-2 (COVID-19) Point of Care Ab Test

CompletedN/A

Sponsor: LumiraDx UK Limited

Conditions: Covid19

Interventions: Capillary Collection & Testing, Venous Draw & Testing

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 2 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Male and female subjects aged ≥ 2 years.
2. 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).
3. Written informed consent must be obtained prior to study enrollment.

   1. A subject who is 18 years or older must be willing to give written informed consent and must agree to comply with study procedures.
   2. 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).

Exclusion Criteria:

1. Skin lesions or conditions that would preclude a fingerstick and or a venous blood draw.
2. 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.
3. The subject has previously participated in this research study.

Locations (4)

Tucson, Arizona, United States
Northglenn, Colorado, United States
Wichita, Kansas, United States
Jackson, Tennessee, United States