N/A
Completed N=99
COVID-19 MP Biomedicals Rapid SARS-CoV-2 Antigen Test Usability
Source: ClinicalTrials.gov NCT05584189 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: 30 Candidate Ag Test Self-collections — 53; 0 Participants
Summary
SARS-CoV-2 rapid antigen over the counter usability study.
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 | — |
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.
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. Informational only — not medical advice.