covid-19 icura sars-cov-2 ag otc: clinical evaluation

Conditions: SARS-CoV-2 Infection; COVID-19

Summary: sars-cov-2 rapid antigen over the counter clinical performance evaluation.

coronavirus disease (covid-19) is a disease caused by a newly discovered coronavirus, severe acute respiratory syndrome coronavirus 2 (sars-cov-2)1. the sars-cov-2 is a β-coronavirus, which is enveloped non-segmented positive-sense rna virus 22. it is spread by human-to-human transmission via droplets or direct contact, and infection has been estimated to have mean incubation period of 6.4 days and a basic reproduction number of 2.24-3.58. among patients with pneumonia caused by sars-cov-2, fever was the most common symptom, followed by cough. on 11 march 2020, the covid-19 outbreak was characterized as a pandemic by the who. since then, over 70 million people worldwide have been infected with the virus with over 1.5 million deaths attributed to the virus5. laboratory testing for sars-cov-2 is currently being performed to determine if an individual has active infection via detection of viral rna or if an individual has an immune response to the virus from a previous infection via detection of antibodies. specimen collection is a crucial first step in the evaluation of an individual's sars-cov-2 infection status. the goal of this project is to evaluate a candidate ag self-test kit for over the counter (otc) use. study subjects under edp supervision, either in-person or via video conference, will collect and test anterior nasal swab samples and a study representative will collect and ship a nasopharyngeal swab sample for comparator pcr testing. the candidate ag self-test kit collection and testing methodology is viewed as a convenient and inexpensive method to test clinical specimens for sars-cov-2 and otc access will improve the availability of covd-19 testing. the icura covid-19 antigen rapid home test (candidate test) is a rapid antigen (ag) immunochromatography based one step in vitro test intended to detect nucleocapsid antigen from the sars-cov-2 virus that causes covid-19. it is designed for over the counter (otc) rapid qualitative determination of sars-cov-2 virus antigen in anterior nasal swabs from individuals within 14 days of symptom onset or without symptoms or other epidemiological reasons to suspect covid-19 infection. this test is for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older.

Eligibility criteria:
inclusion criteria: * lay subjects greater than 2 years old that do not know their current covid-19 status and can complete the consent/assent process in both written and spoken english may be included in the study. exclusion criteria: * subjects less than 2 years old will be excluded. * participants that are or were medial and/or laboratory professionals will be excluded. * participants that cannot read and understand english will be excluded. * high risk individuals will not be excluded unless they are too young or have prior training or experience that would exclude them. * participants who refuse to sign the informed consent/assent form(s) will be excluded.