Trial Outcomes & Findings for COVID-19 MP Biomedicals SARS-CoV-2 Ag OTC: Clinical Evaluation (NCT NCT05584176)
NCT ID: NCT05584176
Last Updated: 2023-06-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
332 participants
Primary outcome timeframe
One hour
Results posted on
2023-06-01
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
298
|
34
|
|
Overall Study
COMPLETED
|
298
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COVID-19 MP Biomedicals SARS-CoV-2 Ag OTC: Clinical Evaluation
Baseline characteristics by cohort
| Measure |
Subject 14-65+ Years of Age
n=298 Participants
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
|
At Least 30 Children Between 2 and 13 Years of Age
n=34 Participants
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
|
Total
n=332 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
260 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
260 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
205 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
196 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
211 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
65 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
298 participants
n=99 Participants
|
34 participants
n=107 Participants
|
332 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: One hourPopulation: 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.
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.
Outcome measures
| Measure |
Subject 14-65+ Years of Age
n=176 Participants
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
|
At Least 30 Children Between 2 and 13 Years of Age
n=12 Participants
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
|
|---|---|---|
|
Positive Percent Agreement
|
53 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: One hourPopulation: 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.
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.
Outcome measures
| Measure |
Subject 14-65+ Years of Age
n=176 Participants
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
|
At Least 30 Children Between 2 and 13 Years of Age
n=12 Participants
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
|
|---|---|---|
|
Negative Percent Agreement
|
123 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: One hourPopulation: 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.
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.
Outcome measures
| Measure |
Subject 14-65+ Years of Age
n=176 Participants
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
|
At Least 30 Children Between 2 and 13 Years of Age
n=12 Participants
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
|
|---|---|---|
|
Detection of Asymptomatic Positives
|
3 Participants
|
0 Participants
|
Adverse Events
Subject 14-65+ Years of Age
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
At Least 30 Children Between 2 and 13 Years of Age
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place