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| Name | Class |
|---|---|
| New Day Diagnostics | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subject 14-65+ years of age | Experimental | 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. |
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| At least 30 children between 2 and 13 years of age | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iCura COVID-19 Antigen Rapid Home Test | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One hour |
| 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. | One hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Liggett, PhD. | New Day Diagnostics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accel Research | DeLand | Florida | 32720 | United States | ||
| Daniel Sarkis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32113704 | Background | Rothan HA, Byrareddy SN. The epidemiology and pathogenesis of coronavirus disease (COVID-19) outbreak. J Autoimmun. 2020 May;109:102433. doi: 10.1016/j.jaut.2020.102433. Epub 2020 Feb 26. | |
| 32169119 | Background | Guo YR, Cao QD, Hong ZS, Tan YY, Chen SD, Jin HJ, Tan KS, Wang DY, Yan Y. The origin, transmission and clinical therapies on coronavirus disease 2019 (COVID-19) outbreak - an update on the status. Mil Med Res. 2020 Mar 13;7(1):11. doi: 10.1186/s40779-020-00240-0. |
| Label | URL |
|---|---|
| WHO. 2022. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | One hour |
|
One hour
This study was deemed to have a less than significant risk by IRB assessment, and not sites reported any adverse events during or after the study enrollment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dana Hummel | MP Biomedicals | 8008540530 | 7019 | Dana.Hummel@mpbio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 1, 2021 | Mar 20, 2023 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2021 | May 4, 2023 | SAP_005.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form for Adults and Minors 14-17 Years | Nov 12, 2021 | Feb 1, 2023 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Assent Form for Subjects 7-13 Years of Age | Nov 4, 2021 | Feb 1, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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).
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|
| RT-PCR Test | Device | High sensitivity RT-PCR COVID-19 Test |
|
| One hour |
| Gainesville |
| Florida |
| 32607 |
| United States |
| Accel Research Site St. Petersburg | St. Petersburg | Florida | 33709 | United States |
| EDP Biotech Corporation | Knoxville | Tennessee | 37919 | United States |
| 32081636 | Background | Lai CC, Shih TP, Ko WC, Tang HJ, Hsueh PR. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Mar;55(3):105924. doi: 10.1016/j.ijantimicag.2020.105924. Epub 2020 Feb 17. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
|
|
| 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. | 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. | Posted | Count of Participants | Participants | One hour |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | One hour |
|
|
|
| 0 |
| 298 |
| 0 |
| 298 |
| 0 |
| 298 |
| EG001 | 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 | 0 | 34 | 0 | 34 | 0 | 34 |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |