N/A
Completed N=332
COVID-19 MP Biomedicals SARS-CoV-2 Ag OTC: Clinical Evaluation
SARS-CoV2 Infection · COVID
Source: ClinicalTrials.gov NCT05584176 ↗
Enrolled (actual)
332
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Positive Percent Agreement — 53; 2 Participants
Summary
SARS-CoV-2 rapid antigen over the counter clinical performance evaluation
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Positive Percent Agreement |
53; 2 | — |
| PRIMARY Negative Percent Agreement |
123; 10 | — |
| SECONDARY Detection of Asymptomatic Positives |
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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05584176). 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.