Rutgers Pilot for PREDICT- Patient POC Test

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2 testing	Testing for SARS CoV2 Antigen	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.

Primary Outcome Measures

Name	Time	Method
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 Ease of Complying With Protocol	Day 21	Number of participants indicating that it was easy to complete the surveys
Patient Test Completion	Day 1	Percentage of 14 patients with completed SARS-CoV-2 testing
Percentage of Surveys Completed by Patients	Through study completion (21 days)	Percentage of patients with completed pre-visit, triage and post-visit surveys completed