Gazelle COVID-19 Test Clinical Accuracy Protocol

Symptomatic study: Inclusion Criteria: The presence of clinical signs and symptoms consistent with COVID-19. Signs and symptoms include: * Fever * Coughing * Shortness of breath * Recent loss of sense of smell or taste * Chills * Repeated shaking with chills * Muscle pain * Headache * Sore throat * Vomiting or diarrhea * Within 1-5 days of symptom onset * Informed consent for all the samples will be obtained from the subject or obtained from the parent/guardian in case the patient is a minor * All ages * All genders * Pregnant women Exclusion Criteria: * Severe disease requiring immediate medical intervention * Inability to tolerate sampling procedure (nasal swab) * Failure to provide informed consent * Nasal deformities preventing sampling by swab * Ongoing nosebleeds or use of a nasal spray within the last 4 hours. * Asymptomatic patients Asymptomatic study: Inclusion criteria: * Present to the facility for a COVID-19 test without symptoms * Informed consent for all specimens will be obtained from the patient or obtained from the parent/guardian in case the patient is a minor Exclusion Criteria: Exclusion criteria include one or more of the following: * Severe disease requiring immediate medical intervention * Inability to tolerate sampling procedure * Is below 2 years old * Failure to provide informed consent * Nasal deformities preventing sampling by swab * Ongoing nosebleeds or use of a nasal spray within the last 4 hours. * Presence of typical symp…