COVID-19NCT05732610

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

A study testing MGC Health COVID-19 & Flu A+B Home Multi Test and MGC Health COVID-19 & Flu A+B Home Multi Test (2 to 13 y/o) in people with COVID-19 and Influenza A, run by Medical Group Care, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 2 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19, Influenza A, Influenza B
What is being tested?: MGC Health COVID-19 & Flu A+B Home Multi Test and MGC Health COVID-19 & Flu A+B Home Multi Test (2 to 13 y/o)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 14 Feb 2023to 2 Mar 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

L&A Morales Healthcare
Miami, Florida, 33142

Other trials in United States

About this study

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.

Read the 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
Being tested: MGC Health COVID-19 & Flu A+B Home Multi Test, MGC Health COVID-19 & Flu A+B Home Multi Test (2 to 13 y/o)
Keywords: COVID-19, Flu A, Flu B, Influenza
Medical subject headings: COVID-19, Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05732610
Study group	Role	What they receive
Individuals - ages 14 and older	Experimental	This test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older. Receives: Diagnostic Test: MGC Health COVID-19 & Flu A+B Home Multi Test
Individuals - ages 2 to 13	Experimental	This kit is intended for non-prescription home use with self-collected direct anterior nares swab samples. If the subject is under the age of 14, an adult lay-user will collect the sample. Receives: Diagnostic Test: MGC Health COVID-19 & Flu A+B Home Multi Test (2 to 13 y/o)

What is being measured

The primary outcome is the main question the study is designed to answer.

Usability of Quick Reference Instructions (QRI) - Critical Steps
Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation. The observer completed an observation form for each subject assessing whether the subject or adult lay user completed each critical task, and whether the task was performed correctly.
Measured: 1 hour
Usability of Test Kit
Assess the usability of the kit for home use based upon subject evaluation. adult lay users filled out a questionnaire regarding the ease of understanding the instructions provided by the QRI for obtaining the sample, performing the test, and reading and interpreting the results, and the ease of completing each task.
The subject or adult lay user used the following 5-digit score to answer the questions:
1. Very easy to understand
2. Fairly easy to understand
3. Easy
4. Fairly difficult to understand
5. Very Difficult
Measured: one hour
Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation
Assess the usability of the QRI based upon observer evaluation.
Measured: 1 hour
Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results
Assess the usability of the QRI. Subjects or adult lay users were presented with 10 sample images of test results: 1 negative test, 7 positive tests, and 2 invalid tests.
Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 20232 Mar 2023

First posted17 Feb 2023
Study start14 Feb 2023
Primary completion28 Feb 2023
Study completion2 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
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).
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05732610
Sponsor's protocol ID: MGC-1001
Status last verified: Apr 2024
First submitted: 15 Feb 2023
Last updated: 2 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study
ClinicalTrials.gov ID: NCT05732610
Acronym / sponsor ID: MGC-1001
Conditions: COVID-19, Influenza A, Influenza B
Keywords: COVID-19, Flu A, Flu B, Influenza
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Medical Group Care, LLCIndustry (pharma, biotech, devices)
Collaborators: CSSi Life Sciences
Study start: 14 Feb 2023 (actual)
Primary completion: 28 Feb 2023 (actual)
Study completion: 2 Mar 2023 (actual)
First posted: 17 Feb 2023 (actual)
Results: Posted 2 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 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).

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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).

Arm	Type	Receives
Individuals - ages 14 and older	Experimental	Diagnostic Test: MGC Health COVID-19 & Flu A+B Home Multi TestThis test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older.
Individuals - ages 2 to 13	Experimental	Diagnostic Test: MGC Health COVID-19 & Flu A+B Home Multi Test (2 to 13 y/o)This kit is intended for non-prescription home use with self-collected direct anterior nares swab samples. If the subject is under the age of 14, an adult lay-user will collect the sample.

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MGC Health COVID-19 & Flu A+B Home Multi Testself-collected direct anterior nares swab samples	Diagnostic test	Individuals - ages 14 and older
MGC Health COVID-19 & Flu A+B Home Multi Test (2 to 13 y/o)adult lay user collected anterior nares swab sample	Diagnostic test	Individuals - ages 2 to 13

Primary outcome

Usability of Quick Reference Instructions (QRI) - Critical Steps
Time frame: 1 hour
Assess the usability of the Quick Reference Instructions (QRI) based upon observer evaluation. The observer completed an observation form for each subject assessing whether the subject or adult lay user completed each critical task, and whether the task was performed correctly.
Usability of Test Kit
Time frame: one hour
Assess the usability of the kit for home use based upon subject evaluation. adult lay users filled out a questionnaire regarding the ease of understanding the instructions provided by the QRI for obtaining the sample, performing the test, and reading and interpreting the results, and the ease of completing each task. The subject or adult lay user used the following 5-digit score to answer the questions: 1. Very easy to understand 2. Fairly easy to understand 3. Easy 4. Fairly difficult to understand 5. Very Difficult
Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation
Time frame: 1 hour
Assess the usability of the QRI based upon observer evaluation.
Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results
Time frame: 1 hour
Assess the usability of the QRI. Subjects or adult lay users were presented with 10 sample images of test results: 1 negative test, 7 positive tests, and 2 invalid tests.

Results and safety

Results posted to the registry on 2 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Individuals - Ages 14 and Older	19	19
Individuals - Ages 2 to 13	15	15

Primary outcome: Usability of Quick Reference Instructions (QRI) - Critical Steps

Time frame: 1 hour. Number. Unit: participants

Measure	Usability Data Set n = 34
Swab each nostril, rotating swab against nostril at least 5 times.	34
Rotate nasal swab in sample collection tube liquid at least 5 times.	34
Lift swab out of the liquid in collection tube and squeeze the tube against the swab tip 3 times.	34
Squeeze the sample collection tube while removing the nasal swab.	34
Press the nozzle lid firmly onto the sample collection tube.	34
Transfer 3 drops from the sample collection tube into the sample well of the test cartridge.	34
Do not move or lift the test cassette.	34
Read the results between 15 and 20 minutes.	34

Primary outcome: Usability of Test Kit

Time frame: one hour. Mean (Full Range). Unit: Mean score on a scale

Measure	Usability Data Set n = 34
Overall, how easy or difficult was it to understand the instructions to conduct the test?	1.50 (1 to 3)
How easy or difficult was it to open the test cassette package?	1.62 (1 to 3)
How easy or difficult was it to remove the sealed film covering from the sample collection tube?	1.62 (1 to 3)
How easy was it to understand how to collect the sample from your nose or from another person?	1.71 (1 to 3)
How easy or difficult was it to understand the instructions to swirl the swab in the collection tube	1.53 (1 to 3)
How easy was it understand how to lift the swab out of the liquid and squeeze in the collection tube	1.47 (1 to 3)
How easy or difficult was it to insert the nozzle lid onto the sample collection tube?	1.32 (1 to 3)
How easy was it to understand to add the sample from the collection tube to the sample well	1.24 (1 to 3)

Primary outcome: Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation

Time frame: 1 hour. Count of participants. Unit: Participants

Measure	Usability Data Set n = 34
Negative	15
Positive Flu A	6
Positive Flu B	2
Positive COVID-19	11

Primary outcome: Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results

Time frame: 1 hour. Number. Unit: Participants with correct interpretation

Measure	Usability Data Set n = 34
Image 1 - invalid test (no lines)	34
Image 2 - positive Flu A	34
Image 3 - positive COVID-19, Flu A, and Flu B	34
Image 4 - invalid test (Flu A line, no C line)	34
Image 5 - positive Flu B	33
Image 6 - positive Flu A, and Flu B	32
Image 7 - negative	34
Image 8 - positive COVID-19 and Flu A	19

Adverse events

Time frame: 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usability Data Set	0 of 34 (0%)	0 of 34 (0%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janice Cattano, RN, MSN study director

CSSi LifeSciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Usability of Quick Reference Instructions (QRI) - Critical Steps (time frame: 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05732610.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2024.