COVID-19 Molecular OTC At Home Test

The objective of this study is to evaluate the a molecular, OTC/At-Home COVID-19 Test in individuals presenting at a medical facility. In eligible subjects, nasal samples will be collected for use with the at-home molecular COVID-19 Test, which will be compared to the Zymo® rRT-PCR test results obtained via samples specified by the sponsor (e.g., AN [anterior nares] swab) to determine accuracy of the at-home/OTC molecular COVID-19 Test in detecting COVID-19 in participants.

Inclusion Criteria:Individuals suspected of COVID-19 disease by a healthcare provider or individuals who have tested positive within the past 2 - 7 calendar days with a confirmed positive COVID-19 testIndividuals able to self-administer the investigational test either upon themselves or upon their child (under fourteen (14 years of age) as a parent or guardianIndividuals willing and able to provide informed consent or obtain consent from legal authorized representative (LAR)Exclusion Criteria:If symptomatic, individuals with self-declared symptoms greater than 7 days (plus/minus 1 day, if symptoms start not definite)Subject does not understand or is not able and willing to sign the study informed consentUnwilling or unable to collect the required sample typesEnrolled in a study to evaluate an investigational drugEating/drinking/smoking 30 minutes prior to specimen collectionPrisoner or under incarcerationHave contraindications to the collection of nasal specimens from the nares/nostrils, such as but not limited to nasal ulcers or nasal surgery within 3 months prior to sample collectionUnable to dedicate adequate time (up to 90 minutes total visit) for testingHave prior medical or laboratory trainingHave prior recent experience (e.g. more than 3 tests in the past 6 months) with self-collection or self-testing (including infectious disease home tests)