Rutgers Pilot for PREDICT- Patient POC Test

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rutgers Pilot for Pragmatic Return to Effective Dental Infection Control Through Triage and Testing (PREDICT)- Patient POC Test

Conditions
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SARS CoV 2 Infection

Intervention / Treatment
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* Device: Testing for SARS CoV2 Antigen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot study to assess feasibility of testing asymptomatic dental patients for SARS-CoV-2 antigen using Rapid Antigen point-of-care testing
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SARS-CoV-2 testing<br>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. | Device: Testing for SARS CoV2 Antigen<br>* Device: Testing for SARS CoV2 Antigen Antigen testing: Rapid Antigen testing (Point-of-care)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient willingness to follow through with the study surveys, triage and testing | Percentage of patients who complete the study | Day 1 | 
| Patient test completion | Percentage of patients with completed SARS-CoV-2 testing | Day 1 | 
| Patient ease of complying with protocol | Questions on survey on how easy it was to complete pre-visit and post-visit formalities | Day 1 | 
| Percentage of surveys completed by patients | Percentage of patients with completed pre-visit, triage and post-visit surveys completed | Through study completion (3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Point-of-care testing, Asymptomatic patients, Perception of safety, Feasibility