Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag ULTRA Test (ASPIRE-2)

Study Overview
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Brief Summary
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Performance of the LumiraDx SARS-CoV-2 Ag ULTRA assay will be assessed by comparison to a reference method

Detailed Description
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The study is a prospective, multi-center study. One (1) reference laboratory and approximately six (6) geographically diverse POC (Point of Care) locations (e.g. physician office laboratories, urgent cares, emergency departments, outpatient clinics, drive through testing sites or research centers) in the U.S. will participate in the study. Testing in the reference laboratory will be performed by trained laboratory personnel. Testing at the POC sites will be performed by non-laboratory health professionals who are representative of typical intended use operators (e.g. nurses, physician assistants, medical assistants, etc.). Each site will have a minimum of one (1) untrained intended use operator who will perform testing under this protocol. A subject's participation in this study will consist of a single visit. Following completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number. Subjects will have nasopharyngeal or nasal or throat swabs collected. Specimens will be obtained from each subject enrolled using standard collection methods. The LumiraDx SARS-CoV-2 Ag ULTRA Test will be performed at POC sites by intended use operators (e.g. nurses, physician assistants, medical assistants, etc.). Each site will have a minimum of one (1) untrained intended use operator who will perform testing under this protocol. The LumiraDx SARS-CoV-2 Ag ULTRA Test will be performed at the site on the same day as the date of collection using one swab for each subject enrolled. A central laboratory will perform reference testing. Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) will be estimated for the LumiraDx SARS-CoV-2 Ag ULTRA Test results as compared with the reference Test. A minimum of thirty (30) positive SARS-CoV-2 are required, but it is likely because of the prevalence of SARS-CoV-2 in the population, that a greater number of negatives will be obtained during the prospective collection of positive samples; therefore, approximately four-hundred (400) subjects will be enrolled. A minimum of thirty (30) negative samples are required.

Official Title
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A Multicenter COVID-19 Study Conducted to Evaluate the Performance of the LumiraDx SARS-CoV-2 Ag ULTRA Test at Point of Care Testing Sites

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: Nasal Swab
* Diagnostic Test: Nasopharyngeal swab


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subject are asked to provide nasal swab or nasopharyngeal swab samples
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A: Sample Collection<br>2x Nasopharyngeal Swab Sample Collection | Diagnostic Test: Nasopharyngeal swab<br>* Collection of one more nasopharyngeal swabs<br>|
| Other: Group B: Sample Collection<br>1x Nasopharyngeal Swab and 2x Nasal Swab Sample Collection | Diagnostic Test: Nasal Swab<br>* Collection of one more nasal swabs<br>Diagnostic Test: Nasopharyngeal swab<br>* Collection of one more nasopharyngeal swabs<br>|
| Other: Group C: Sample Collection<br>1x Nasopharyngeal Swab and 2x Nasal Swab Sample Collection for sample pooling | Diagnostic Test: Nasal Swab<br>* Collection of one more nasal swabs<br>Diagnostic Test: Nasopharyngeal swab<br>* Collection of one more nasopharyngeal swabs<br>|
| Other: Group D: Sample Collection<br>2x Nasal Swab Sample Collection | Diagnostic Test: Nasal Swab<br>* Collection of one more nasal swabs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance Evaluation | Evaluation of performance of the device versus a reference method using standard qualitative comparison techniques (Percent Agreement) | 4 months |