COVID-19, SARS-CoV-2 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)1. The SARS-CoV-2 is a β-coronavirus, which is enveloped non-segmented positive-sense RNA virus 22. 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 a Candidate Ag self-test kit 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 nasopharyngeal swab sample for comparator PCR testing. The Candidate Ag self-test kit 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 iCura COVID-19 Antigen Rapid Home Test (candidate test) is a rapid antigen (Ag) immunochromatography based one step in vitro test intended to detect nucleocapsid antigen from the SARS-CoV-2 virus that causes COVID-19. It is designed for over the counter (OTC) rapid qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs from individuals within 14 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. This test is for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older.
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.
DIAGNOSTIC_TESTRT-PCR Test
High sensitivity RT-PCR COVID-19 Test
Sponsors
Paragon Rx Clinical, Inc.
iCura Diagnostics, LLC
New Day Diagnostics
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 iCura COVID-19 Antigen Rapid Home 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 iCura COVID-19 Antigen Rapid Home 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
* Lay subjects greater than 2 years old that do not know their current COVID-19 status and can complete the consent/assent process in both written and spoken English may be included in the study.
Exclusion criteria
* Subjects less than 2 years old will be excluded. * Participants that are or were medial and/or laboratory professionals will be excluded. * Participants that cannot read and understand English will be excluded. * High risk individuals will not be excluded unless they are too young or have prior training or experience that would exclude them. * Participants who refuse to sign the informed consent/assent form(s) will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Percent Agreement | 3 months | The acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to eighty percent in a comparison between the iCura COVID-19 Antigen Rapid Home TestRT-PCR comparator test results |
| Negative Percent Agreement | 3 months | The acceptance criteria for this study is a Negative Percent Agreement (NPA) greater than or equal to ninety-eight percent in a comparison between the iCura COVID-19 Antigen Rapid Home Test and the RT-PCR comparator test results. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Asymptomatic Positives | 3 months | 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 iCura COVID-19 Antigen Rapid Home Test result to determine the ability of the iCura COVID-19 Antigen Rapid Home Test to detect individuals who are infected but are not symptomatic. |
Countries
United States
Outcome results
None listed