PREDICT-DHCW: Rutgers Pilot for Dental Health Care Worker SARS-CoV-2 Testing
Study Details
Study Description
Brief Summary
10 asymptomatic DHCWs in 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 DHCWs' perceptions of safety and adoption of risk mitigation behavior. Following a baseline survey, finger-prick blood samples were collected twice two weeks apart using an innovative microsampling technique that replaces the need for venipuncture. Samples were processed using an in-house ELISA assay to detect IgM and IgG directed against the Receptor Binding Domain (RBD) of the Spike protein. Weekly Rapid Antigen testing of nasal swab specimens was used to document Antigen negativity during the study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
10 asymptomatic DHCWs in the Oral Medicine clinic, Rutgers School of Dental Medicine, with no history of documented COVID-19 infection or viral exposure, were enrolled in the DHCW arm of the study. The DCHWs underwent triage that included self-reported symptoms, temperature check and obtaining a pulse oximeter reading at every study time-point (See DHCW Arm in Results Section). Weekly Rapid Antigen testing of nasal swab specimens was used to document Antigen negativity during the study (BD Veritor Plus Analyzer, BD Sciences). The DHCWs' perceptions of safety and adoption of risk mitigation behavior were interrogated. Following a baseline survey, finger-prick blood samples were collected twice two weeks apart using avolumentric absorptive microsampling with a Neoteryx Mitra cartridge device (https://www.neoteryx.com) device that allows for self-sampling by non-specialized personnel (https://doi.org/10.1101/2021.07.09.21260266). Briefly, this microsampler allows for volumentric absorption of 10-30 μl of blood depending on selected size. Following the collection, microsamplers were dried and kept within the protective cassettes at room temperature for maximum period of 2 weeks from the collection date. Each microsampler tip (20µl in the present study) was added to 200 μl VAMS extraction buffer (1x PBS (Corning) supplemented with 1% bovine serum albumin (Roche Diagnostics, Mannheim, Germany) and 0.5% Tween20 (Sigma, MO, USA) in a 1 ml deep-well 96 well plate (Greiner bio-one-780261). The plate was then covered with an adhesive seal and incubated 16 hours at 40C on a shaker at 250 rpm. The resulting eluates were heat inactivated at 560C for 60 minutes and centrifugation to collect the supernatant (eluate). Eluates were further processed for an in-house ELISA assay to detect IgM and IgG directed against the Receptor Binding Domain (RBD) of the SARS-CoV-2 Spike protein as described (https://doi.org/10.1101/2021.07.09.21260266)..
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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 and antibody to the virus as described. |
Device: Testing for SARS CoV2 Antigen and Antibody
Antigen testing: Rapid Antigen testing (Point-of-care) Antibody testing: ELISA testing of microsampling 'finger-prick' specimen DHCW Survey for adoption of risk mitigation practices and for perceptions of safety
|
Outcome Measures
Primary Outcome Measures
- Dental Health Care Worker (DHCW) willingness to participate in the study [Day 1]
Ratio of DHCW consenting to DHCW approached
- DHCW willingness/ability to follow through with the study Surveys, Triage and Testing [Day 28]
Percentage of DHCWs who complete the study
- DHCW Test Completion [Day 28]
Percentage of DHCWs with completed SARS-CoV-2 test completed
- DHCW Ease of Complying with Protocol [Day 28]
Questions on survey asking ease at start-of-study, end-of-study
- Percentage of surveys completed by DHCW [Through study completion (3 months)]
Percentage of participants with complete Start-of-study, Triage and End-of-Study surveys
Eligibility Criteria
Criteria
Inclusion Criteria:
- Dental healthcare workers (DHCW)s employed at Rutgers School of Dental Medicine
Exclusion Criteria:
- Previous participation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rutgers School of Dental Medicine | Newark | New Jersey | United States | 07103 |
Sponsors and Collaborators
- Rutgers, The State University of New Jersey
- National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
- Principal Investigator: Cecile A Feldman, DMD, MBA, Rutgers School of Dental Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- 1. American Dental Association COVID-19 Toolkit - Update to Office Procedures During COVID-19. https://www.ada.org/-/media/project/ada-organization/ada/ada-org/files/resources/coronavirus/update_to_office_procedures_during_covid19.pdf accessed on November 11, 2021.
- Estrich CG, Mikkelsen M, Morrissey R, Geisinger ML, Ioannidou E, Vujicic M, Araujo MWB. Estimating COVID-19 prevalence and infection control practices among US dentists. J Am Dent Assoc. 2020 Nov;151(11):815-824. doi: 10.1016/j.adaj.2020.09.005.
- Shirazi S, Stanford CM, Cooper LF. Testing for COVID-19 in dental offices: Mechanism of action, application, and interpretation of laboratory and point-of-care screening tests. J Am Dent Assoc. 2021 Jul;152(7):514-525.e8. doi: 10.1016/j.adaj.2021.04.019. Epub 2021 May 4. Erratum In: J Am Dent Assoc. 2021 Sep;152(9):719.
- Pro2020002896
- X01DE030407