COVID-19, Influenza
Conditions
Brief summary
The purpose of this research is to determine if the use of a new device can accurately detect a virus infection.
Detailed description
GRIP has developed a novel, graphene-based detection system for potential use in point-of-care settings. This study will compare the performance of the GRIP device to routine PCR testing for detection of COVID-19 and influenza viruses. When patients present for routine testing for COVID-19 and influenza, they will also have a separate nasal swab collected that will be tested by the GRIP point-of-care device.
Interventions
DEVICEGRIP Electronic Diagnostic Chip
Graphene-based point-of-care device for detection of respiratory viruses (e.g., COVID-19 and influenza) from a nasal swab
DIAGNOSTIC_TESTLaboratory-based nucleic acid amplification tests (NAATs)
Polymerase Chain Reaction (PCR) analysis for detection of viruses (e.g., Roche cobas SARS-CoV-2 or influenza A/B) from nasal swab
Sponsors
Department of Health and Human Services
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients being tested for COVID 19 or Influenza
Exclusion criteria
* Patients \< 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive Percent Agreement | One hour | Percent of nasal swabs to report positive results for respiratory virus for both the GRIP device and NAAT routine clinical testing |
| Negative Percent Agreement | One hour | Percent of nasal swabs to report negative results for respiratory virus for both the GRIP device and NAAT routine clinical testing |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Novel, Graphene-based, Point-of-care Device Subjects will receive one additional nasal swab at the same time as clinical collection.
GRIP Electronic Diagnostic Chip: Graphene-based point-of-care device for detection of respiratory viruses (e.g., COVID-19 and influenza) from a nasal swab
Laboratory-based nucleic acid amplification tests (NAATs): Polymerase Chain Reaction (PCR) analysis for detection of viruses (e.g., Roche cobas SARS-CoV-2 or influenza A/B) from nasal swab | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Novel, Graphene-based, Point-of-care Device |
|---|---|
| Age, Continuous | 45.8 years STANDARD_DEVIATION 16.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 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 | 2 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Negative Percent Agreement
Percent of nasal swabs to report negative results for respiratory virus for both the GRIP device and NAAT routine clinical testing
Time frame: One hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Novel, Graphene-based, Point-of-care Device | Negative Percent Agreement | 44 percent of nasal swabs |
Primary
Positive Percent Agreement
Percent of nasal swabs to report positive results for respiratory virus for both the GRIP device and NAAT routine clinical testing
Time frame: One hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Novel, Graphene-based, Point-of-care Device | Positive Percent Agreement | 52 percent of nasal swabs |