Trial Outcomes & Findings for A Study of the GRIP Influenza and SARS-CoV-2 POC Assays (NCT NCT05674370)

Last Updated: 2024-03-21

Results Overview

Percent of nasal swabs to report positive results for respiratory virus for both the GRIP device and NAAT routine clinical testing

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

One hour

Results posted on

2024-03-21

Participant milestones
Measure	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
Overall Study STARTED	45
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	2

Withdrawal data not reported

A Study of the GRIP Influenza and SARS-CoV-2 POC Assays

Baseline characteristics by cohort
Measure	Novel, Graphene-based, Point-of-care Device n=45 Participants 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
Age, Continuous	45.8 years STANDARD_DEVIATION 16.6 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 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	1 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	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

Timeframe: One hour

Percent of nasal swabs to report positive results for respiratory virus for both the GRIP device and NAAT routine clinical testing

Outcome measures
Measure	Novel, Graphene-based, Point-of-care Device n=27 nasal swabs 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
Positive Percent Agreement	52 percent of nasal swabs

Timeframe: One hour

Percent of nasal swabs to report negative results for respiratory virus for both the GRIP device and NAAT routine clinical testing

Outcome measures
Measure	Novel, Graphene-based, Point-of-care Device n=27 nasal swabs 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
Negative Percent Agreement	44 percent of nasal swabs

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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