Repeat Testing for SARS-CoV-2
Repeat Saliva Testing for SARS-CoV-2 Using RT-LAMP Assay
5 other identifiers
interventional
464
1 country
1
Brief Summary
The purpose of this research study is to determine if high-frequency, rapid turn-around SARS-CoV-2 surveillance testing with this assay is feasible and able to be optimized to enable isolation and follow-up diagnostic testing. This test will be performed at various locations in the Madison, Wisconsin area using a mobile laboratory or standard lab space for processing. Saliva samples can be collected and processed at these locations or participants can self-collect at home and drop their samples off at designated locations for same day processing. Up to 10000 participants will be recruited for this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable covid19
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 29, 2020
CompletedFirst Submitted
Initial submission to the registry
October 6, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedResults Posted
Study results publicly available
January 19, 2022
CompletedJanuary 20, 2022
January 1, 2022
6 months
October 6, 2020
December 27, 2021
January 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participant Phone Surveys Conducted
All participants with a potential finding of clinical significance (a result indicated the possible presences of SARS-CoV-2 in the saliva sample) will be contacted by phone approximately 1 week after the finding and asked if they received a follow-up diagnostic test and if they self-isolated after receiving the clinician's notification. There will be 2 attempts at obtaining answers. The investigators hope to receive at least 10 survey responses. This is a measure of surveillance feasibility.
up to 1 week after test
Number of Minimally Trained Personnel Who Achieve Assay Proficiency
Successfully trained staff achieve "proficiency" by correctly differentiating blinded positive and negative samples. This is measure of the simplicity of the assay. Training personnel will take place over several months, proficiency should be determined within the same day as personnel are trained.
up to 1 day
Study Arms (1)
Repeat Testing for SARS-CoV-2
EXPERIMENTALAnyone over the age of 5yrs old with consent to provide a saliva sample for SARS-CoV-2 assay will be eligible to participate. Assay takes 20 minutes.
Interventions
saliva assay test for high concentrations of SARS-CoV-2
Eligibility Criteria
You may qualify if:
- Willing to provide informed consent.
- Willing to provide informed consent and spit into a vessel (i.e cup or tube).
- Individuals at least 18 years old or between 5-17 years old and have a parent or legal guardian present to consent.
- Adult subjects must have decision-making capacity to provide consent on their own behalf.
- Participants must be able to speak English
You may not qualify if:
- Participants must not have visual or hearing impairments, or low literacy, that would prevent them from reading the consent form and interacting with a member of the research team to ask questions and receive responses during the consent process.
- Under 18 years of age with no parent or legal guardian present or under the age of 5 yrs
- Cannot speak English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin
Madison, Wisconsin, 53711, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kristi Hall
- Organization
- University of Wisconsin - Madison
Study Officials
- PRINCIPAL INVESTIGATOR
David O'Connor, PhD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2020
First Posted
October 8, 2020
Study Start
September 29, 2020
Primary Completion
March 31, 2021
Study Completion
March 31, 2021
Last Updated
January 20, 2022
Results First Posted
January 19, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data from this study may be requested from other researchers 7 years after the completion of the primary endpoint by contacting David O'Connor at the University of Wisconsin -Madison.
Participants will consent to having their data (not their name) and viral sequences shared with the public via manuscripts, presentations and online databases; the study team will share that with other researchers when needed. Samples can be shared with UW researchers internally and non UW researchers through the Material Transfer Agreement process.