COVID-19 MP Biomedicals Rapid SARS-CoV-2 Antigen Test Usability
Purpose
SARS-CoV-2 rapid antigen over the counter usability study.
Conditions
- Sars-CoV-2 Infection
- COVID-19
Eligibility
- Eligible Ages
- Over 2 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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 or Spanish.
Exclusion Criteria
- Participants who regularly use home diagnostic tests, such as glucose meters, will be excluded. - Persons under 2 years of age will be excluded from participation. - Persons under 14 years of age will be excluded from performing the Rapid SARS-CoV-2 Antigen Test on themselves. - Persons under 18 years of age will be excluded from performing the Rapid SARS-CoV-2 Antigen Test on another qualified participant.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- This is an open-label, prospective study to evaluate the usability of the Rapid SARS-CoV-2 Antigen Test when a lay person conducts the test on themselves or another study participant. Potential subjects will be those presenting for COVID-19 testing. The study will evaluate the layperson usability of the Rapid SARS-CoV-2 Antigen Test by assessing the performance of the Rapid SARS-CoV-2 Antigen Test under the supervision of qualified site personnel, as well as having the testing participant complete assessments measuring .
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental At least 30 persons 14-65+ years of age who test themselves |
Participants between the ages of 14-65+ years will perform candidate Ag self-test kit anterior nasal specimen collection and testing under the supervision of qualified site personnel in person. |
|
|
Experimental At least 30 persons 18-65+ years of age who test another participant |
Participants between the ages of 18-65+ years will perform candidate Ag self-test kit anterior nasal specimen collection on another participant aged 2-65+ years and testing of the candidate Ag self-test kit under the supervision of qualified site personnel in person. |
|
Recruiting Locations
More Details
- NCT ID
- NCT05584189
- Status
- Completed
- Sponsor
- MP Biomedicals, LLC
Detailed Description
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 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 human usability of 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. 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. (See Appendix 1).