N/A N=99 Diagnostic

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

Sars-CoV-2 Infection · COVID-19

Bottom Line

View on ClinicalTrials.gov: NCT05584189 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2023

Primary outcome: Primary: 30 Candidate Ag Test Self-collections — 53; 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Rapid SARS-CoV-2 Antigen Test (Device)
Age: Pediatric, Adult, Older Adult · 2+ yrs
Sex: All
Sponsor: MP Biomedicals, LLC
Primary completion: Oct 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY 30 Candidate Ag Test Self-collections	53; 0	—
PRIMARY 30 Candidate Ag Test Collections of Another	0; 46	—
SECONDARY At Least One Enrollment of a Spanish Speaking Lay User	3; 0	—

Summary

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05584189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.