SARS-CoV2 Infection
Conditions
Keywords
Dental Healthcare Worker, Testing, Seroprevalence, Perception of Safety, Adoption of risk mitigation practice
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.
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)..
Interventions
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
Sponsors
Study design
Intervention model description
Pilot study to assess feasibility of testing dental healthcare workers for seropositivity and antigen positivity for SARS-CoV-2 (Rapid Antigen point-of-care testing).
Eligibility
Inclusion criteria
* Dental healthcare workers (DHCW)s employed at Rutgers School of Dental Medicine
Exclusion criteria
* Previous participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of DHCW With Complete Surveys | Through study completion (3 months) | Number of participants with complete Start-of-study, Triage and End-of-Study surveys |
| DHCW Willingness/Ability to Follow Through With the Study Surveys, Triage and Testing | Day 28 | Percentage of Dental Healthcare workers (DHCW)s who complete the study steps of surveys, triage and testing |
| DHCW Test Completion | Day 28 | Percentage of DHCWs with completed SARS-CoV-2 test completed |
| DHCW Ease of Complying With Protocol | Day 28 | Number of DHCWs who reported ease of complying with protocol as their choices on questions on the survey enquiring ease at start-of-study, end-of-study |
| Dental Health Care Worker (DHCW) Willingness to Participate in the Study | Day 1 | Number of Dental Health Care Workers (DHCWs) approached to enroll 10 consenting subjects to participate in the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Positive Antibody Testing | 28 days | Number of participants who tested positive for antibody to SARS-CoV2 |
| Number of DCHWs Who Reported Feeling Safe and Comfortable Reporting to Work | 28 days | Percentage of dental healthcare workers who responded feeling safe and comfortable reporting to work in the survey presented in the pilot study |
| SARS CoV2 Rapid Antigen Testing (Point-of-care)- Number of Participants Who Tested Positive | 28 days | Number of participants testing positive for SARS CoV2 using a point-of-care Rapid Antigen Testing |
Countries
United States
Participant flow
Recruitment details
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. Study participation ranged from January- February 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 and antibody to the virus as described.
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 the adoption of risk mitigation practices and for perceptions of safety | 10 |
| Total | 10 |
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 | 9 Participants |
| Age, Continuous | 39.9 years STANDARD_DEVIATION 14.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Dental Health Care Worker (DHCW) Willingness to Participate in the Study
Number of Dental Health Care Workers (DHCWs) approached to enroll 10 consenting subjects to participate in the study
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 Testing | Dental Health Care Worker (DHCW) Willingness to Participate in the Study | 10 Participants |
DHCW Ease of Complying With Protocol
Number of DHCWs who reported ease of complying with protocol as their choices on questions on the survey enquiring ease at start-of-study, end-of-study
Time frame: Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 Testing | DHCW Ease of Complying With Protocol | 9 Participants |
DHCW Test Completion
Percentage of DHCWs with completed SARS-CoV-2 test completed
Time frame: Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 Testing | DHCW Test Completion | 10 Participants |
DHCW Willingness/Ability to Follow Through With the Study Surveys, Triage and Testing
Percentage of Dental Healthcare workers (DHCW)s who complete the study steps of surveys, triage and testing
Time frame: Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 Testing | DHCW Willingness/Ability to Follow Through With the Study Surveys, Triage and Testing | 10 Participants |
Number of DHCW With Complete Surveys
Number of participants with complete Start-of-study, Triage and End-of-Study surveys
Time frame: Through study completion (3 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 Testing | Number of DHCW With Complete Surveys | 10 Participants |
Number of DCHWs Who Reported Feeling Safe and Comfortable Reporting to Work
Percentage of dental healthcare workers who responded feeling safe and comfortable reporting to work in the survey presented in the pilot study
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 Testing | Number of DCHWs Who Reported Feeling Safe and Comfortable Reporting to Work | 10 Participants |
Positive Antibody Testing
Number of participants who tested positive for antibody to SARS-CoV2
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 Testing | Positive Antibody Testing | 5 Participants |
SARS CoV2 Rapid Antigen Testing (Point-of-care)- Number of Participants Who Tested Positive
Number of participants testing positive for SARS CoV2 using a point-of-care Rapid Antigen Testing
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS-CoV-2 Testing | SARS CoV2 Rapid Antigen Testing (Point-of-care)- Number of Participants Who Tested Positive | 0 Participants |