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Flu season over.
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Adaptive Biotechnologies has developed a clinical test called T-Detect COVID Test that can identify a T-cell response to the SARS-CoV-2 virus, indicating recent or prior infection This study aims to evaluate the potential cross-reactivity of the T-Detect COVID test in participants presenting with viral upper respiratory tract infections within the assay's intended use population and testing positive for seasonal coronavirus.
Prospective ascertainment of a minimum of 10 individuals exhibiting symptoms of viral upper respiratory tract infections, between the ages of 18-89 residing within the United States and being tested for SARS-CoV-2 infection during the 2021-2022 cold and flu season (~Nov. 2021 - May 2022).
Participants will complete an electronic screening questionnaire to determine eligibility, be consented, and scheduled for a study visit that will be conducted by study staff or mobile phlebotomist. The identification and recruitment of participants will protect privacy and be free of undue influence. Biological samples, including blood samples and nasopharyngeal swabs, will be collected via mobile phlebotomy in participant's homes with proper safety precautions in place. Study metadata and questionnaire information will be self-reported and/or recorded by study staff as applicable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Cross-Reactive Cohort | Ages 18-89, Exhibiting symptoms compatible with a viral upper respiratory tract infection at the time of screening. Lab test confirming
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| Measure | Description | Time Frame |
|---|---|---|
| Cross-Reactivity of T-Detect COVID | Adaptive Biotechnologies Corporation has developed a clinical test called T-Detect COVID, which is intended to identify a T-cell response to the SARS-CoV-2 virus, indicating recent or prior infection. This study will assess the clinical performance of the T-Detect COVID test in participants presenting with symptoms of a viral upper respiratory tract infections. Eligible participants must have proof of negative result from an Emergency Use Authorization approved Reverse transcription-polymerase chain reaction (RT-PCR) assay and positive result with Clinical Laboratory Improvement Amendment (CLIA) validated assay for other seasonal coronaviruses. | 15-100 days from symptoms onset |
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Inclusion Criteria:
Exclusion criteria:
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Recruiting individuals ages 18-89 at the time of screening are exhibiting symptoms compatible with a viral upper respiratory tract infection and obtain negative test result for SARS-CoV-2. Eligible participants must also test positive for one of the following common seasonal coronaviruses: NL63, 229E, OC43, and HKU1 via Respiratory Panel test.
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| Name | Affiliation | Role |
|---|---|---|
| Darcy Gill | Adaptive Biotechnologies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adaptive Biotechnologies | Seattle | Washington | 98102 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |