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

NCT05584176 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2023-06-01

Study results available
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Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • New Day Diagnostics

    collaborator NETWORK

  • MP Biomedicals, LLC

    lead INDUSTRY

Principal Investigators

  • Jason Liggett, PhD. · New Day Diagnostics

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-09
Primary Completion
2022-01-21
Completion
2022-01-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05584176 on ClinicalTrials.gov