N/A
N=34
MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study
COVID-19 · Influenza A · Influenza B
Bottom Line
View on ClinicalTrials.gov: NCT05732610 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Usability of Quick Reference Instructions (QRI) - Critical Steps — 34; 34; 34; 34 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MGC Health COVID-19 & Flu A+B Home Multi Test (Diagnostic_test); MGC Health COVID-19 & Flu A+B Home Multi Test (2 to 13 y/o) (Diagnostic_test)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Medical Group Care, LLC
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Usability of Quick Reference Instructions (QRI) - Critical Steps |
34; 34; 34; 34; 34; 34 | — |
| PRIMARY Usability of Test Kit |
1.50; 1.62; 1.62; 1.71; 1.53; 1.47 | — |
| PRIMARY Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation |
15; 6; 2; 11 | — |
| PRIMARY Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results |
34; 34; 34; 34; 33; 32 | — |
Summary
The purpose of this study is to evaluate the usability of the MGC Health COVID-19 & Flu A+B Home Multi Test in home use.
Eligibility Criteria
Inclusion Criteria
- An Institutional Review Board (IRB) approved informed consent / assent, if applicable, is signed and dated prior to any study related activities.
- Male and female subjects 2 years of age and older.
- Subject is willing to provide a self-collected nasal swab sample. (If the subject is under the age of 14, an adult lay user will collect the sample.)
- Subject agrees to complete all aspects of the study.
Exclusion Criteria
- Subject has a visual impairment that cannot be restored with glasses or contact lenses.
- Subject has prior medical or laboratory training.
- Subject uses home diagnostics, e.g., glucose meters, HIV tests.
- Subject has prior knowledge of their current COVID-19 or flu infection status.
Data sourced from ClinicalTrials.gov (NCT05732610). 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.