Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag ULTRA Test (ASPIRE-2) (ASPIRE-2)
COVID-19
About this trial
This is an interventional diagnostic trial for COVID-19
Eligibility Criteria
Inclusion Criteria
- Subject may be of any age or gender.
Preliminary assessment of the subject by the Investigator/designee should be suggestive of COVID-19 at the time of the study visit. The subject must present as symptomatic, meaning they have exhibited one or more of the following signs and symptoms for eligibility: fever, cough, shortness of breath, difficulty breathing, muscle pain, headache, sore throat, chills, repeated shaking with chills, new loss of taste or smell congestion or runny nose, diarrhea, nausea or vomiting. The onset of these symptoms will be recorded and will be within the last twelve (12) days.
or The subject is asymptomatic and is neither currently exhibiting signs or symptoms of SARS-CoV-2 nor has experienced signs or symptoms within the past fourteen (14) days, and has not knowingly been exposed to someone with a positive test result within the last fourteen (14) days
- Participant (or parent/legal guardian) capable and willing to give informed consent/assent.
Exclusion Criteria
- The subject underwent a nasal wash/aspirate as part of standard of care testing during this study visit.
- 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.
- Subjects undergoing treatment currently and/or within the past thirty (30) days of the study with medication to treat novel Coronavirus SARS-CoV-2 like illness symptoms, which may include but is not limited to Remdesivir or convalescent plasma therapy for SARS-CoV-2.
- The subject has previously participated in this research study.
Sites / Locations
- Cahaba Research, Inc.
- Advanced Investigative Medicine
- Healthy Life Research, Inc.
- The Machuca Foundation, Inc.
- Cyn3rgy Research
- Zion Urgent Care
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Other
Other
Other
Group A: Sample Collection
Group B: Sample Collection
Group C: Sample Collection
Group D: Sample Collection
2x Nasopharyngeal Swab Sample Collection
1x Nasopharyngeal Swab and 2x Nasal Swab Sample Collection
1x Nasopharyngeal Swab and 2x Nasal Swab Sample Collection for sample pooling
2x Nasal Swab Sample Collection