NCT05732610

MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Medical Group Care, LLC · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

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.

Detailed description

The MGC Health COVID-19 \& Flu A+B Home Multi Test is a lateral flow immunochromatographic antibody assay intended for the simultaneous qualitative detection and differentiation of the nucleocapsid antigen from SARS-CoV-2, influenza A and/or influenza B directly from anterior nasal swab specimens obtained from individuals, who are suspected of respiratory viral infection within five (5) days of symptom onset. This test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult lay user collected anterior nares swab samples from individuals aged 2 to 13 years. The objective of the study is to determine the usability of the MGC Health COVID-19 \& Flu A+B Home Multi Test in a simulated home use environment. This is an open label study to evaluate the usability of the MGC Health COVID-19 \& Flu A+B Home Multi Test using information from the Quick Reference Instructions (QRI).

Conditions

• COVID-19
• Influenza A
• Influenza B

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MGC Health COVID-19 & Flu A+B Home Multi Test	self-collected direct anterior nares swab samples
DIAGNOSTIC_TEST	MGC Health COVID-19 & Flu A+B Home Multi Test (2 to 13 y/o)	adult lay user collected anterior nares swab sample

Timeline

• Start date: 2023-02-14
• Primary completion: 2023-02-28
• Completion: 2023-03-02
• First posted: 2023-02-17
• Last updated: 2024-05-02
• Results posted: 2024-05-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study