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

NCT05584189 | Completed Results FDA Device

• 1 other identifier: EDP-SOP-TNC-013
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sars-CoV-2 Infection; COVID-19

Outcome Measures

Primary Outcomes (2)

• 30 Candidate Ag Test Self-collections

  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.

  One Hour

• 30 Candidate Ag Test Collections of Another

  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

  One Hour

Secondary Outcomes (1)

• At Least One Enrollment of a Spanish Speaking Lay User

  One Hour

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

Rapid SARS-CoV-2 Antigen 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.

At least 30 persons 14-65+ years of age who test themselves; At least 30 persons 18-65+ years of age who test another participant

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MP Biomedicals, LLC: lead
• New Day Diagnostics: collaborator

Study Sites (1)

EDP Biotech Corporation

Knoxville, Tennessee, 37919, United States

Location

Related Publications (3)

• 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.

  PMID: 32113704 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.

  PMID: 32169119 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.

  PMID: 32081636 BACKGROUND

Related Links

• Johns Hopkins University Center for Health Security Website. 2020.
• WHO. 2022

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dana Hummel
• Organization: MP Biomedicals

Dana.Hummel@mpbio.com

8008540530

Study Officials

• Jason Liggett, PhD

  New Day Diagnostics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 .

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 18, 2022
• Study Start: October 7, 2021
• Primary Completion: October 27, 2021
• Study Completion: October 27, 2021
• Last Updated: June 2, 2023
• Results First Posted: June 2, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)