Wearable Diagnostic for Detection of COVID-19 Infection

Cohort 1- Exposed/Early Symptomatic Group All adult subjects seeking a COVID-19 test and meeting enrollment criteria will be offered enrollment into this study.

The Inclusion Criteria are:

1. Adults - 18 years of age and older
2. Both genders, all races and ethnic groups
3. English speaking adult subjects only

Cohort 2- Vaccine Group:

Potential subjects seeking the mRNA-based Pfizer/BioNTech and Moderna vaccine

1. Subjects who are scheduled to receive the COVID vaccination series through local and national clinics, health systems and pharmacies.
2. Subjects who become aware of the study through public notices, postings, and advertisements, and other marketing efforts.

Cohort 1- Exposed/ Early Symptomatic Group

Inclusion Criteria:

1. age 18 or older;
2. able to follow the study device wear instructions per the Instructions for Use;
3. no positive viral test within 60 days prior to enrollment; and
4. willing and able to provide written, informed consent.

Exclusion Criteria:

1. pregnant or breastfeeding;
2. wearing a defibrillator or pacemaker;
3. known or suspected cardiac dysrhythmias
4. known or suspected allergy to adhesives;
5. chronic daily use of non-steroidal anti-inflammatory medications (NSAIDs) and antipyretic medications
6. open wounds or infected, irritated, scarred, or inflamed areas of skin on the upper chest preventing placement of the biosensor; and
7. current or planned use of either an investigation pharmaceutical or an investigational device during the study.

Cohort 1- Vaccine Group

Inclusion Criteria:

Subjects seeking the mRNA-based Pfizer/BioNTech and Moderna vaccine series are eligible for the study if they are:

1. Age 18 or older; 12 years of age -17 years of age are approved to participate in the vaccine Cohort portion of the study.
2. scheduled to receive their first and second dose of the Pfizer/BioNTech or Moderna COVID-19 vaccine
3. able to follow the study device wear instructions per the Instructions for Use;
4. no positive viral test within 60 days prior to enrollment; and
5. willing and able to provide written, informed consent.
6. Willing and able to take an oral temperature

Exclusion Criteria:

Potential subjects seeking the mRNA-based Pfizer/BioNTech and Moderna vaccine series will be excluded from the study if they are or have any of the following:

1. pregnant or breastfeeding;
2. wearing a defibrillator or pacemaker;
3. known or suspected cardiac dysrhythmias
4. known or suspected allergy to adhesives;
5. chronic daily use of non-steroidal anti-inflammatory medications (NSAIDs) and antipyretic medications
6. open wounds or infected, irritated, scarred, or inflamed areas of skin on the upper chest preventing placement of the biosensor; and
7. current or planned use of either an investigation pharmaceutical or an investigational device during the study.
8. previously fully vaccinated subjects