COVID-19 MP Biomedicals SARS-CoV-2 Ag OTC: Clinical Evaluation
SARS-CoV-2 rapid antigen over the counter clinical performance evaluation
Full Title of Study: “Over the Counter Rapid Antigen Test for Detection of SARS-CoV-2 Virus: Clinical Evaluation”
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: January 21, 2022
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.
- Device: 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.
- Device: RT-PCR Test
- High sensitivity RT-PCR COVID-19 Test
Arms, Groups and Cohorts
- Experimental: 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.
- Experimental: 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.
Clinical Trial Outcome Measures
- Positive Percent Agreement
- Time Frame: 2 months
- 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
- Negative Percent Agreement
- Time Frame: 2 months
- 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
- Detection of Asymptomatic Positives
- Time Frame: 2 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 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.
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 2 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- MP Biomedicals, LLC
- EDP Biotech
- Provider of Information About this Clinical Study
- Overall Official(s)
- Jason Liggett, PhD., Principal Investigator, EDP Biotech
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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.
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