covid-19 mp biomedicals sars-cov-2 ag otc: clinical evaluation

Conditions: SARS-CoV2 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). the sars-cov-2 is a β-coronavirus, which is enveloped non-segmented positive-sense rna virus 2. 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 virus. 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 rapid sars-cov-2 antigen test 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 second nasopharyngeal swab sample for comparator pcr testing. the rapid sars-cov-2 antigen test 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 covid-19 antigen rapid test device detects sars-cov-2 viral antigens through visual interpretation of color development. anti-sars-cov-2 antibodies are immobilized on the test region of the nitrocellulose membrane. anti-sars-cov-2 antibodies conjugated to colored particles are immobilized on the conjugated pad. a sample is added to the extraction buffer which is optimized to release the sars-cov-2 antigens from specimen. during testing, the extracted antigens bind to anti-sars-cov-2 antibodies conjugated to colored particles. as the specimen migrates along the strip by capillary action and interacts with reagents on the membrane, the complex will be captured by the anti-sars-cov-2 antibodies at the test region. excess colored particles are captured at the internal control zone. the presence of a colored band in the test region indicates a positive result for the sars-cov-2 viral antigens, while its absence indicates a negative result. a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking is working.

Eligibility criteria:
inclusion criteria: * the study population will include subjects from 2 years old to greater than 65 years old. * lay subjects who perform the test on themselves must be able to read, write, speak, and understand english. exclusion criteria: * subjects less than 2 years old will be excluded. * participants who regularly use home diagnostic tests, such as glucose meters, or are trained medical or laboratory professionals will be excluded. * persons under 14 years of age will be excluded from performing the rapid sars-cov-2 antigen test on themselves. * persons under 2 years of age will be excluded from participation. * persons under 18 years of age will be excluded from performing the rapid sars-cov-2 antigen test on another qualified participant.