Clinical trial NCT05732610: MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study
Official title: MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Influenza A
Influenza B
Keywords: COVID-19
Flu A
Flu B
Influenza
Lead sponsor: Medical Group Care, LLC
Sponsor class: INDUSTRY
Collaborators: name: CSSi Life Sciences
First posted: 2023-02-17
Enrollment: 34
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: DIAGNOSTIC

Brief 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).

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.

Primary outcomes:
measure: Usability of Quick Reference Instructions (QRI) - Critical Steps
timeFrame: 1 hour
measure: Usability of Test Kit
timeFrame: one hour
measure: Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation
timeFrame: 1 hour
measure: Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: L&A Morales Healthcare
state: Florida
Study officials:
affiliation: CSSi LifeSciences
name: Janice Cattano, RN, MSN
role: STUDY_DIRECTOR
References: