COVID-19 MP Biomedicals Rapid SARS-CoV-2 Antigen Test Usability

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-07

Study Completion Date

2021-10-27

Brief Summary

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SARS-CoV-2 rapid antigen over the counter usability study.

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Detailed Description

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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 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 human usability of 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. 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. (See Appendix 1).

Conditions

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Sars-CoV-2 Infection COVID-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

This is an open-label, prospective study to evaluate the usability 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 layperson usability of the Rapid SARS-CoV-2 Antigen Test by assessing the performance of the Rapid SARS-CoV-2 Antigen Test under the supervision of qualified site personnel, as well as having the testing participant complete assessments measuring .

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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At least 30 persons 14-65+ years of age who test themselves

Participants between the ages of 14-65+ years will perform candidate Ag self-test kit anterior nasal specimen collection and testing under the supervision of qualified site personnel in person.

Group Type EXPERIMENTAL

Rapid SARS-CoV-2 Antigen Test

Intervention Type DEVICE

Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.

At least 30 persons 18-65+ years of age who test another participant

Participants between the ages of 18-65+ years will perform candidate Ag self-test kit anterior nasal specimen collection on another participant aged 2-65+ years and testing of the candidate Ag self-test kit under the supervision of qualified site personnel in person.

Group Type EXPERIMENTAL

Rapid SARS-CoV-2 Antigen Test

Intervention Type DEVICE

Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.

Interventions

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Rapid SARS-CoV-2 Antigen Test

Candidate Ag self-test kit anterior nasal specimen collection and testing will be done under the supervision of qualified site personnel in person.

Intervention Type DEVICE

Eligibility Criteria

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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 or Spanish.

Exclusion Criteria

* Participants who regularly use home diagnostic tests, such as glucose meters, will be excluded.
* Persons under 2 years of age will be excluded from participation.
* Persons under 14 years of age will be excluded from performing the Rapid SARS-CoV-2 Antigen Test on themselves.
* Persons under 18 years of age will be excluded from performing the Rapid SARS-CoV-2 Antigen Test on another qualified participant.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes