SARS CoV 2 Infection
Conditions
Keywords
Screening, Point-of-care testing, Asymptomatic patients, Perception of safety, Feasibility
Brief summary
A pilot study was initiated to assess feasibility of testing asymptomatic dental patients presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine for SARS-CoV-2 viral antigen using a point-of-care (POC) Rapid Antigen test. 14 subjects with upcoming appointment at the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in a study that interrogated patients' perceptions of safety and feedback regarding their testing experience. All 14 patients expressed initial interest, however, 10 patients completed informed consent and completed study procedures. Institutional Clinical Laboratory Improvement Amendments (CLIA) certification of waiver was obtained prior to conducting the study. Communicable Diseases Reporting and Surveillance System (CDRSS) registration and training were completed to enable reporting results of the POC test.
Detailed description
A pilot study was initiated to assess feasibility of testing asymptomatic dental patients presenting to the Oral Medicine Clinic at Rutgers School of Dental Medicine for SARS-CoV-2 viral antigen using a point-of-care (POC) Rapid Antigen test. 14 subjects with upcoming appointment at the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in a study that interrogated patients' perceptions of safety and feedback regarding their testing experience. All 14 patients expressed initial interest, however, 10 patients completed informed consent and completed study procedures on their appointments, the remaining 4 patients did not present for their appointment. Following initial interest in participation over the phone, the subjects completed a pre-visit survey prior to their upcoming appointment. The day prior to their visit, a phone triage was completed and repeated as they checked in for their appointment. A nasal sample was collected and processed using the FDA EUA authorized Rapid Antigen Test BD Veritor Plus Analyzer, BD Sciences. An end-of-study survey was collected to assess patients' feedback about their experience and their perception of safety.
Interventions
DEVICETesting for SARS CoV2 Antigen
Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care)
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using Rapid Antigen point-of-care testing
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Dental Patients with upcoming appointment at the Oral Medicine Clinic at Rutgers School of Dental Medicine
Exclusion criteria
* Patients previously participating in the study * Patients unwilling to have their de-identified data made available to researchers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Willingness to Follow Through With the Study Surveys, Triage and Testing | Through study completion, an average of 21 days | Percentage of 14 patients who complete the study |
| Patient Test Completion | Day 1 | Percentage of 14 patients with completed SARS-CoV-2 testing |
| Patient Ease of Complying With Protocol | Day 21 | Number of participants indicating that it was easy to complete the surveys |
| Percentage of Surveys Completed by Patients | Through study completion (21 days) | Percentage of patients with completed pre-visit, triage and post-visit surveys completed |
Countries
United States
Participant flow
Recruitment details
14 asymptomatic dental patients with upcoming appointments at the Oral Medicine Clinic, Rutgers School of Dental Medicine, were enrolled. Study participation took place in between December 2020 and January 2021.
Participants by arm
| Arm | Count |
|---|---|
| SARS-CoV-2 Testing There is only one arm in this study- the study is a non-randomized pilot. All the subjects will be tested for SARS CoV 2 viral Antigen as described.
Testing for SARS CoV2 Antigen: Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care) | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | SARS-CoV-2 Testing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 45.9 years STANDARD_DEVIATION 17.55 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Patient Ease of Complying With Protocol
Number of participants indicating that it was easy to complete the surveys
Time frame: Day 21
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 Testing | Patient Ease of Complying With Protocol | 10 Participants |
Primary
Patient Test Completion
Percentage of 14 patients with completed SARS-CoV-2 testing
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 Testing | Patient Test Completion | 10 Participants |
Primary
Patient Willingness to Follow Through With the Study Surveys, Triage and Testing
Percentage of 14 patients who complete the study
Time frame: Through study completion, an average of 21 days
Population: 14 patients enrolled in the study. The percentage of 14 patients who completed the study is tabulated
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SARS-CoV-2 Testing | Patient Willingness to Follow Through With the Study Surveys, Triage and Testing | 71.42 percentage of participants |
Primary
Percentage of Surveys Completed by Patients
Percentage of patients with completed pre-visit, triage and post-visit surveys completed
Time frame: Through study completion (21 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 Testing | Percentage of Surveys Completed by Patients | 10 Participants |