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Prospective samples will be collected to evaluate the agreement between a EUA RT-PCR test as the comparator method against the Nanomix eLab® system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUA RT-PCR positive |
| ||
| EUA RT-PCR negative |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional) | Diagnostic Test | COVID-19 Rapid Antigen Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate clinical agreement between an EUA RT-PCR methodology and the Nanomix eLab® COVID-19 Rapid Antigen Panel | An analysis of the result from subjects who have been or will be tested by EUA RT-PCR will be performed to establish the sensitivity by positive percent agreement (PPA) and the specificity by negative percent agreement (NPA) of the Nanomix eLab® COVID-19 Rapid Antigen Panel and a confirmatory EUA RT-PCR method. | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include both symptomatic and asymptomatic subjects. Although to enrich for COVID-19 positive subjects, the study will preferentially identify and enrolled subjects who have been or will be tested by EUA RT-PCR including those who are symptomatic or hospitalized with symptoms, specifically those within 7-days of symptom onset that meet the study enrollment inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Tina Landess | Nanomix | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanomix | Emeryville | California | 94608 | United States |
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Nasal sample (without cells/ RNA/DNA) will be aliquoted and stored at Sponsor for potential future analysis/ projects.
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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