COVID-19 MP Biomedicals SARS-CoV-2 Ag OTC: Clinical Evaluation

NCT05584176 | Completed Results FDA Device

• 1 other identifier: EDP-SOP-TNC-014
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 4

Brief Summary

SARS-CoV-2 rapid antigen over the counter clinical performance evaluation

Conditions

SARS-CoV2 Infection; COVID-19

Outcome Measures

Primary Outcomes (2)

• Positive Percent Agreement

  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. The PPA was defined as the proportion of true positive tests, defined by a concordant candidate and comparator test result of positive, out of all positive candidate test results.

  One hour

• Negative Percent Agreement

  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. The NPA was defined as the proportion of true negative tests, defined by a concordant candidate and comparator test result of negative, out of all negative candidate test results.

  One hour

Secondary Outcomes (1)

• Detection of Asymptomatic Positives

  One hour

Study Arms (2)

Subject 14-65+ years of age

EXPERIMENTAL

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.

Device: iCura COVID-19 Antigen Rapid Home Test; Device: RT-PCR Test

At least 30 children between 2 and 13 years of age

EXPERIMENTAL

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.

Device: iCura COVID-19 Antigen Rapid Home Test; Device: RT-PCR Test

Interventions

iCura COVID-19 Antigen Rapid Home 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. 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.

At least 30 children between 2 and 13 years of age; Subject 14-65+ years of age

RT-PCR Test DEVICE

High sensitivity RT-PCR COVID-19 Test

At least 30 children between 2 and 13 years of age; Subject 14-65+ years of age

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Accel Research

DeLand, Florida, 32720, United States

Location

Daniel Sarkis

Gainesville, Florida, 32607, United States

Location

Accel Research Site St. Petersburg

St. Petersburg, Florida, 33709, United States

Location

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 sensitivity and specificity 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 performance of the Rapid SARS-CoV-2 Antigen 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).

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 18, 2022
• Study Start: December 9, 2021
• Primary Completion: January 21, 2022
• Study Completion: January 21, 2022
• Last Updated: June 1, 2023
• Results First Posted: June 1, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)