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

Sponsor
MP Biomedicals, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT05584189
Collaborator
EDP Biotech (Other)
99
Enrollment
1
Location
2
Arms
20
Actual Duration (Days)
150.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Rapid SARS-CoV-2 Antigen Test
 N/A

Detailed Description

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
99 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
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 .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 .
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Over the Counter Rapid Antigen Test for Detection of SARS-CoV-2 Virus: Human Usability Study
Actual Study Start Date :
Oct 7, 2021
Actual Primary Completion Date :
Oct 27, 2021
Actual Study Completion Date :
Oct 27, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Device: 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.
Experimental: 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.

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. 30 candidate Ag test self-collections [1 month]

    Lay subjects aged 14-65+ who will perform collection of the candidate Ag self-test kit on themselves under the supervision of qualified site personnel in person.

  2. 30 candidate Ag test collections of another [1 month]

    Lay subjects aged 18-65+ who will perform collection of the candidate Ag self-test kit on another participant aged 2-65+ years under the supervision of qualified site personnel in person

Secondary Outcome Measures

  1. At least one enrollment of a Spanish speaking lay user [1 month]

    At least one lay subject aged 14-65+ who will perform collection of the candidate Ag self-test kit on themselves under the supervision of qualified site personnel in person and/or at least one lay subject aged 18-65+ who will perform collection of the candidate Ag self-test kit on another participant aged 2-65+ years under the supervision of qualified site personnel in person.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 EDP Biotech Corporation Knoxville Tennessee United States 37919

Sponsors and Collaborators

  • MP Biomedicals, LLC
  • EDP Biotech

Investigators

  • Principal Investigator: Jason Liggett, PhD, EDP Biotech

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
MP Biomedicals, LLC
ClinicalTrials.gov Identifier:
NCT05584189
Other Study ID Numbers:
  • EDP-SOP-TNC-013
First Posted:
Oct 18, 2022
Last Update Posted:
Oct 18, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Oct 18, 2022