Trial Outcomes & Findings for MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study (NCT NCT05732610)
NCT ID: NCT05732610
Last Updated: 2024-05-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
1 hour
Results posted on
2024-05-02
Participant Flow
Thirty-four (34) subjects were screened and enrolled into the study. There were no screen failures or early terminations.
Participant milestones
| Measure |
Individuals - Ages 14 and Older
This test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older.
MGC Health COVID-19 \& Flu A+B Home Multi Test: self-collected direct anterior nares swab samples
|
Individuals - Ages 2 to 13
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.
MGC Health COVID-19 \& Flu A+B Home Multi Test (2 to 13 y/o): adult lay user collected anterior nares swab sample
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
15
|
|
Overall Study
COMPLETED
|
19
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study
Baseline characteristics by cohort
| Measure |
Usability Data Set
n=34 Participants
A total of 34 subjects were enrolled in the study. There were 15 subjects ranging in age from 2 to 13. The collection and result interpretation for these subjects under 14 were done by an adult lay user.
|
|---|---|
|
Age, Customized
< 14 years
|
15 Participants
n=5 Participants
|
|
Age, Customized
≥ 14 years
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
|
Education
Pre-high school
|
20 Participants
n=5 Participants
|
|
Education
High school graduate
|
6 Participants
n=5 Participants
|
|
Education
Some college
|
5 Participants
n=5 Participants
|
|
Education
College graduate
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 hourAssess 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.
Outcome measures
| Measure |
Usability Data Set
n=34 Participants
A total of 34 subjects were enrolled in the study. There were 15 subjects ranging in age from 2 to 13. The collection and result interpretation for these subjects under 14 were done by an adult lay user.
|
|---|---|
|
Usability of Quick Reference Instructions (QRI) - Critical Steps
Swab each nostril, rotating swab against nostril at least 5 times.
|
34 participants
|
|
Usability of Quick Reference Instructions (QRI) - Critical Steps
Rotate nasal swab in sample collection tube liquid at least 5 times.
|
34 participants
|
|
Usability of Quick Reference Instructions (QRI) - Critical Steps
Lift swab out of the liquid in collection tube and squeeze the tube against the swab tip 3 times.
|
34 participants
|
|
Usability of Quick Reference Instructions (QRI) - Critical Steps
Squeeze the sample collection tube while removing the nasal swab.
|
34 participants
|
|
Usability of Quick Reference Instructions (QRI) - Critical Steps
Press the nozzle lid firmly onto the sample collection tube.
|
34 participants
|
|
Usability of Quick Reference Instructions (QRI) - Critical Steps
Transfer 3 drops from the sample collection tube into the sample well of the test cartridge.
|
34 participants
|
|
Usability of Quick Reference Instructions (QRI) - Critical Steps
Do not move or lift the test cassette.
|
34 participants
|
|
Usability of Quick Reference Instructions (QRI) - Critical Steps
Read the results between 15 and 20 minutes.
|
34 participants
|
PRIMARY outcome
Timeframe: one hourAssess 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
Outcome measures
| Measure |
Usability Data Set
n=34 Participants
A total of 34 subjects were enrolled in the study. There were 15 subjects ranging in age from 2 to 13. The collection and result interpretation for these subjects under 14 were done by an adult lay user.
|
|---|---|
|
Usability of Test Kit
How easy or difficult was it to understand the instructions to swirl the swab in the collection tube
|
1.53 Mean score on a scale
Interval 1.0 to 3.0
|
|
Usability of Test Kit
How easy was it understand how to lift the swab out of the liquid and squeeze in the collection tube
|
1.47 Mean score on a scale
Interval 1.0 to 3.0
|
|
Usability of Test Kit
How easy or difficult was it to insert the nozzle lid onto the sample collection tube?
|
1.32 Mean score on a scale
Interval 1.0 to 3.0
|
|
Usability of Test Kit
How easy was it to understand to add the sample from the collection tube to the sample well
|
1.24 Mean score on a scale
Interval 1.0 to 3.0
|
|
Usability of Test Kit
How easy or difficult was it to add the 3 drops into the test cassette?
|
1.24 Mean score on a scale
Interval 1.0 to 3.0
|
|
Usability of Test Kit
How easy or difficult was it to read the test results?
|
1.26 Mean score on a scale
Interval 1.0 to 3.0
|
|
Usability of Test Kit
How easy was it to understand the instructions on how to interpret the results of the test?
|
1.24 Mean score on a scale
Interval 1.0 to 3.0
|
|
Usability of Test Kit
Overall, how easy or difficult was it to understand the instructions to conduct the test?
|
1.50 Mean score on a scale
Interval 1.0 to 3.0
|
|
Usability of Test Kit
How easy or difficult was it to open the test cassette package?
|
1.62 Mean score on a scale
Interval 1.0 to 3.0
|
|
Usability of Test Kit
How easy or difficult was it to remove the sealed film covering from the sample collection tube?
|
1.62 Mean score on a scale
Interval 1.0 to 3.0
|
|
Usability of Test Kit
How easy was it to understand how to collect the sample from your nose or from another person?
|
1.71 Mean score on a scale
Interval 1.0 to 3.0
|
PRIMARY outcome
Timeframe: 1 hourAssess the usability of the QRI based upon observer evaluation.
Outcome measures
| Measure |
Usability Data Set
n=34 Participants
A total of 34 subjects were enrolled in the study. There were 15 subjects ranging in age from 2 to 13. The collection and result interpretation for these subjects under 14 were done by an adult lay user.
|
|---|---|
|
Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation
Negative
|
15 Participants
|
|
Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation
Positive Flu A
|
6 Participants
|
|
Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation
Positive Flu B
|
2 Participants
|
|
Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation
Positive COVID-19
|
11 Participants
|
PRIMARY outcome
Timeframe: 1 hourAssess 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.
Outcome measures
| Measure |
Usability Data Set
n=34 Participants
A total of 34 subjects were enrolled in the study. There were 15 subjects ranging in age from 2 to 13. The collection and result interpretation for these subjects under 14 were done by an adult lay user.
|
|---|---|
|
Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results
Image 1 - invalid test (no lines)
|
34 Participants with correct interpretation
|
|
Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results
Image 2 - positive Flu A
|
34 Participants with correct interpretation
|
|
Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results
Image 3 - positive COVID-19, Flu A, and Flu B
|
34 Participants with correct interpretation
|
|
Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results
Image 4 - invalid test (Flu A line, no C line)
|
34 Participants with correct interpretation
|
|
Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results
Image 5 - positive Flu B
|
33 Participants with correct interpretation
|
|
Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results
Image 6 - positive Flu A, and Flu B
|
32 Participants with correct interpretation
|
|
Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results
Image 7 - negative
|
34 Participants with correct interpretation
|
|
Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results
Image 8 - positive COVID-19 and Flu A
|
19 Participants with correct interpretation
|
|
Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results
Image 9 - positive COVID-19 and Flu B
|
31 Participants with correct interpretation
|
|
Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results
Image 10 - positive COVID-19
|
34 Participants with correct interpretation
|
Adverse Events
Usability Data Set
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place