COVID-19, Sars-CoV-2 Infection
Conditions
Brief summary
SARS-CoV-2 rapid antigen over the counter usability study.
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).
Interventions
DEVICERapid SARS-CoV-2 Antigen Test
Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.
Sponsors
New Day Diagnostics
MP Biomedicals, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
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 .
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30 Candidate Ag Test Self-collections | One Hour | Lay subjects aged 14-65+ who will perform collection of the candidate Ag self-test kit on themselves under the supervision of qualified site personnel in person. |
| 30 Candidate Ag Test Collections of Another | One Hour | Lay subjects aged 18-65+ who will perform collection of the candidate Ag self-test kit on another participant aged 2-65+ years under the supervision of qualified site personnel in person |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| At Least One Enrollment of a Spanish Speaking Lay User | One Hour | At least one lay subject aged 14-65+ who will perform collection of the candidate Ag self-test kit on themselves under the supervision of qualified site personnel in person and/or at least one lay subject aged 18-65+ who will perform collection of the candidate Ag self-test kit on another participant aged 2-65+ years under the supervision of qualified site personnel in person. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Rapid SARS-CoV-2 Antigen Test: Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person. | 53 |
| 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.
Rapid SARS-CoV-2 Antigen Test: Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person. | 46 |
| Total | 99 |
Baseline characteristics
| Characteristic | At Least 30 Persons 14-65+ Years of Age Who Test Themselves | At Least 30 Persons 18-65+ Years of Age Who Test Another Participant | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 6 Participants | 0 Participants | 6 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 42 Participants | 87 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 42 Participants | 91 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 5 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 7 Participants | 8 Participants |
| Race (NIH/OMB) White | 37 Participants | 34 Participants | 71 Participants |
| Sex: Female, Male Female | 26 Participants | 24 Participants | 50 Participants |
| Sex: Female, Male Male | 27 Participants | 22 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 46 |
| other Total, other adverse events | 0 / 53 | 0 / 46 |
| serious Total, serious adverse events | 0 / 53 | 0 / 46 |
Outcome results
Primary
30 Candidate Ag Test Collections of Another
Lay subjects aged 18-65+ who will perform collection of the candidate Ag self-test kit on another participant aged 2-65+ years under the supervision of qualified site personnel in person
Time frame: One Hour
Population: The first arm of the trial was analyzed under the first primary outcome measure. This is why the number is 0 for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| At Least 30 Persons 14-65+ Years of Age Who Test Themselves | 30 Candidate Ag Test Collections of Another | 0 Participants |
| At Least 30 Persons 18-65+ Years of Age Who Test Another Participant | 30 Candidate Ag Test Collections of Another | 46 Participants |
Primary
30 Candidate Ag Test Self-collections
Lay subjects aged 14-65+ who will perform collection of the candidate Ag self-test kit on themselves under the supervision of qualified site personnel in person.
Time frame: One Hour
Population: The second arm of the trial was analyzed under the second primary outcome measure. This is why the number is 0 for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| At Least 30 Persons 14-65+ Years of Age Who Test Themselves | 30 Candidate Ag Test Self-collections | 53 Participants |
| At Least 30 Persons 18-65+ Years of Age Who Test Another Participant | 30 Candidate Ag Test Self-collections | 0 Participants |
Secondary
At Least One Enrollment of a Spanish Speaking Lay User
At least one lay subject aged 14-65+ who will perform collection of the candidate Ag self-test kit on themselves under the supervision of qualified site personnel in person and/or at least one lay subject aged 18-65+ who will perform collection of the candidate Ag self-test kit on another participant aged 2-65+ years under the supervision of qualified site personnel in person.
Time frame: One Hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| At Least 30 Persons 14-65+ Years of Age Who Test Themselves | At Least One Enrollment of a Spanish Speaking Lay User | 3 Participants |
| At Least 30 Persons 18-65+ Years of Age Who Test Another Participant | At Least One Enrollment of a Spanish Speaking Lay User | 0 Participants |