COVID-19, Influenza A, Influenza B
Conditions
Keywords
COVID-19, Flu A, Flu B, Influenza
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).
Interventions
DIAGNOSTIC_TESTMGC Health COVID-19 & Flu A+B Home Multi Test
self-collected direct anterior nares swab samples
DIAGNOSTIC_TESTMGC Health COVID-19 & Flu A+B Home Multi Test (2 to 13 y/o)
adult lay user collected anterior nares swab sample
Sponsors
CSSi Life Sciences
Medical Group Care, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation | 1 hour | Assess the usability of the QRI based upon observer evaluation. |
| Usability of Quick Reference Instructions (QRI) - Critical Steps | 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 | 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) - Interpretation of Example Test Results | 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. |
Countries
United States
Participant flow
Recruitment details
Thirty-four (34) subjects were screened and enrolled into the study. There were no screen failures or early terminations.
Participants by arm
| Arm | Count |
|---|---|
| Usability Data Set 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. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Usability Data Set |
|---|---|
| Age, Customized < 14 years | 15 Participants |
| Age, Customized ≥ 14 years | 19 Participants |
| Education College graduate | 3 Participants |
| Education High school graduate | 6 Participants |
| Education Pre-high school | 20 Participants |
| Education Some college | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 32 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
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.
Time frame: 1 hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usability Data Set | Usability of Quick Reference Instructions (QRI) - Critical Steps | Swab each nostril, rotating swab against nostril at least 5 times. | 34 participants |
| Usability Data Set | Usability of Quick Reference Instructions (QRI) - Critical Steps | Rotate nasal swab in sample collection tube liquid at least 5 times. | 34 participants |
| Usability Data Set | 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 Data Set | Usability of Quick Reference Instructions (QRI) - Critical Steps | Squeeze the sample collection tube while removing the nasal swab. | 34 participants |
| Usability Data Set | Usability of Quick Reference Instructions (QRI) - Critical Steps | Press the nozzle lid firmly onto the sample collection tube. | 34 participants |
| Usability Data Set | 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 Data Set | Usability of Quick Reference Instructions (QRI) - Critical Steps | Do not move or lift the test cassette. | 34 participants |
| Usability Data Set | Usability of Quick Reference Instructions (QRI) - Critical Steps | Read the results between 15 and 20 minutes. | 34 participants |
Primary
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.
Time frame: 1 hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usability Data Set | Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results | Image 1 - invalid test (no lines) | 34 Participants with correct interpretation |
| Usability Data Set | Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results | Image 2 - positive Flu A | 34 Participants with correct interpretation |
| Usability Data Set | 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 Data Set | 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 Data Set | Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results | Image 5 - positive Flu B | 33 Participants with correct interpretation |
| Usability Data Set | 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 Data Set | Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results | Image 7 - negative | 34 Participants with correct interpretation |
| Usability Data Set | 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 Data Set | 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 Data Set | Usability of Quick Reference Instructions (QRI) - Interpretation of Example Test Results | Image 10 - positive COVID-19 | 34 Participants with correct interpretation |
Primary
Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation
Assess the usability of the QRI based upon observer evaluation.
Time frame: 1 hour
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Usability Data Set | Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation | Negative | 15 Participants |
| Usability Data Set | Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation | Positive Flu A | 6 Participants |
| Usability Data Set | Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation | Positive Flu B | 2 Participants |
| Usability Data Set | Usability of Quick Reference Instructions (QRI) - Subject Test Result and Observer Confirmation | Positive COVID-19 | 11 Participants |
Primary
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
Time frame: one hour
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usability Data Set | 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 |
| Usability Data Set | Usability of Test Kit | How easy or difficult was it to open the test cassette package? | 1.62 Mean score on a scale |
| Usability Data Set | 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 |
| Usability Data Set | 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 |
| Usability Data Set | 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 |
| Usability Data Set | 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 |
| Usability Data Set | 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 |
| Usability Data Set | 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 |
| Usability Data Set | 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 |
| Usability Data Set | Usability of Test Kit | How easy or difficult was it to read the test results? | 1.26 Mean score on a scale |
| Usability Data Set | 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 |