COVID-19, SARS-CoV2 Infection
Conditions
Brief summary
SARS-CoV-2 rapid antigen over the counter clinical performance evaluation
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 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.
Interventions
Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person. Comparator NP samples shall be collected at least 15 minutes prior to Ag samples with at least 15 minutes between nasal collections including collections that may occur prior to study enrollment. Comparator samples will be collected first by qualified personnel at a study site or physician's office using an FDA authorized nasopharyngeal swab collection kit and SARS-CoV-2 molecular assay.
DEVICERT-PCR Test
High sensitivity RT-PCR COVID-19 Test
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 sensitivity and specificity 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 performance of the Rapid SARS-CoV-2 Antigen Test by comparing it to a high sensitivity EUA SARS-CoV-2 RT-PCR assay to calculate both the positive percent agreement (PPA, or sensitivity) and the negative percent agreement (NPA, or specificity).
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Percent Agreement | One hour | The acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to eighty percent in a comparison between the Rapid SARS-CoV-2 Antigen Test and RT-PCR comparator test results. The PPA was defined as the proportion of true positive tests, defined by a concordant candidate and comparator test result of positive, out of all positive candidate test results. |
| Negative Percent Agreement | One hour | The acceptance criteria for this study is Negative Percent Agreement (NPA) greater than or equal to ninety-eight percent in a comparison between the Rapid SARS-CoV-2 Antigen Test and RT-PCR comparator test results. The NPA was defined as the proportion of true negative tests, defined by a concordant candidate and comparator test result of negative, out of all negative candidate test results. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Asymptomatic Positives | One hour | Number of participants with a positive PCR comparator result, but reported no symptoms or epidemiological reasons to suspect COVID-19 infection within the past 14 days. This will be compared to their Rapid SARS-CoV-2 Antigen Test result to determine the ability of the Rapid SARS-CoV-2 Antigen Test to detect individuals who are infected but are not symptomatic. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subject 14-65+ Years of Age Participants will have a nasopharyngeal swab sample collected by trained study site personnel for testing on a high sensitivity EUA SARS-CoV-2 RT-PCR assay to compare the result to the result of the Rapid SARS-CoV-2 Antigen Test. The participant will then self-collect or, if both are over 18, collect from another study participant an anterior nasal swab sample and test using the Rapid SARS-CoV-2 Antigen Test.
iCura COVID-19 Antigen Rapid Home Test: Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person. Comparator NP samples shall be collected at least 15 minutes prior to Ag samples with at least 15 minutes between nasal collections including collections that may occur prior to study enrollment. Comparator samples will be collected first by qualified personnel at a study site or physician's office using an FDA authorized nasopharyngeal swab collection kit and SARS-CoV-2 molecular assay.
RT-PCR Test: High sensitivity RT-PCR COVID-19 Test | 298 |
| At Least 30 Children Between 2 and 13 Years of Age Participants 2-13 years of age will have a nasopharyngeal swab sample collected by trained study site personnel for testing on a high sensitivity EUA SARS-CoV-2 RT-PCR assay to compare the result to the result of the Rapid SARS-CoV-2 Antigen Test. The parent or legal guardian of the child will collect an anterior nasal swab sample from the child and perform the Rapid SARS-CoV-2 Antigen Test.
iCura COVID-19 Antigen Rapid Home Test: Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person. Comparator NP samples shall be collected at least 15 minutes prior to Ag samples with at least 15 minutes between nasal collections including collections that may occur prior to study enrollment. Comparator samples will be collected first by qualified personnel at a study site or physician's office using an FDA authorized nasopharyngeal swab collection kit and SARS-CoV-2 molecular assay.
RT-PCR Test: High sensitivity RT-PCR COVID-19 Test | 34 |
| Total | 332 |
Baseline characteristics
| Characteristic | Subject 14-65+ Years of Age | At Least 30 Children Between 2 and 13 Years of Age | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 34 Participants | 34 Participants |
| Age, Categorical >=65 years | 38 Participants | 0 Participants | 38 Participants |
| Age, Categorical Between 18 and 65 years | 260 Participants | 0 Participants | 260 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 13 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | 65 Participants | 5 Participants | 70 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 196 Participants | 15 Participants | 211 Participants |
| Region of Enrollment United States | 298 participants | 34 participants | 332 participants |
| Sex: Female, Male Female | 178 Participants | 27 Participants | 205 Participants |
| Sex: Female, Male Male | 120 Participants | 7 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 298 | 0 / 34 |
| other Total, other adverse events | 0 / 298 | 0 / 34 |
| serious Total, serious adverse events | 0 / 298 | 0 / 34 |
Outcome results
Primary
Negative Percent Agreement
The acceptance criteria for this study is Negative Percent Agreement (NPA) greater than or equal to ninety-eight percent in a comparison between the Rapid SARS-CoV-2 Antigen Test and RT-PCR comparator test results. The NPA was defined as the proportion of true negative tests, defined by a concordant candidate and comparator test result of negative, out of all negative candidate test results.
Time frame: One hour
Population: Of the 332 samples collected across four sites in Tennessee and Florida, 188 met inclusion/exclusion criteria and had valid comparator RT-PCR data including ct values from NP swabs. There were an additional 59 samples which met inclusion/exclusion criteria and have valid comparator RT-PCR data, but the comparator swabs were collected by AN swab instead of NP swab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subject 14-65+ Years of Age | Negative Percent Agreement | 123 Participants |
| At Least 30 Children Between 2 and 13 Years of Age | Negative Percent Agreement | 10 Participants |
Primary
Positive Percent Agreement
The acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to eighty percent in a comparison between the Rapid SARS-CoV-2 Antigen Test and RT-PCR comparator test results. The PPA was defined as the proportion of true positive tests, defined by a concordant candidate and comparator test result of positive, out of all positive candidate test results.
Time frame: One hour
Population: Of the 332 samples collected across four sites in Tennessee and Florida, 188 met inclusion/exclusion criteria and had valid comparator RT-PCR data including ct values from NP swabs. There were an additional 59 samples which met inclusion/exclusion criteria and have valid comparator RT-PCR data, but the comparator swabs were collected by AN swab instead of NP swab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subject 14-65+ Years of Age | Positive Percent Agreement | 53 Participants |
| At Least 30 Children Between 2 and 13 Years of Age | Positive Percent Agreement | 2 Participants |
Secondary
Detection of Asymptomatic Positives
Number of participants with a positive PCR comparator result, but reported no symptoms or epidemiological reasons to suspect COVID-19 infection within the past 14 days. This will be compared to their Rapid SARS-CoV-2 Antigen Test result to determine the ability of the Rapid SARS-CoV-2 Antigen Test to detect individuals who are infected but are not symptomatic.
Time frame: One hour
Population: Of the 332 samples collected across four sites in Tennessee and Florida, 188 met inclusion/exclusion criteria and had valid comparator RT-PCR data including ct values from NP swabs. There were an additional 59 samples which met inclusion/exclusion criteria and have valid comparator RT-PCR data, but the comparator swabs were collected by AN swab instead of NP swab.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Subject 14-65+ Years of Age | Detection of Asymptomatic Positives | 3 Participants |
| At Least 30 Children Between 2 and 13 Years of Age | Detection of Asymptomatic Positives | 0 Participants |