Official Title
Rapid, Onsite COVID-19 Detection
Brief Summary

The purpose of this research study is to evaluate and improve a rapid COVID-19 test. The test is designed to identify people who are most contagious and likely to spread the virus to others. This test will be performed at various locations in the Madison 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. Results of potential findings of clinical significance will be communicated to the participants by a physician with appropriate expertise on the study team. Individuals with a potential finding of clinical significance will be encouraged to self-isolate and obtain a diagnostic test at their earliest convenience. No results will be given if the test is negative. If the participant consents, advanced molecular testing such as PCR or viral sequencing can be done and results can be shared via online databases, presentations and publications along with the date, site and county of collection to help facilitate tracking the spread of the virus.

Detailed Description

Virtually all COVID-19 RNA assays require centralized laboratories. Samples collected in

locations including public testing sites, workplaces, nursing homes, and residential housing

are transported to centralized laboratories for testing, leading to lengthy delays in results

reporting. The window of maximal contagiousness is thought to be only a few days, so these

delays create the risk of excess transmission. Current testing methods are painful, which

encourages testing hesitancy. Rapid, onsite detection of SARS-CoV-2 RNA from non-invasive

saliva could overcome these issues and provide a pathway to high-throughput detection of

people at the greatest risk of SARS-CoV-2 transmission but the logistics of such a testing

program require real-world prototyping.



The investigators have developed a simple test to detect high concentrations of SARS-CoV-2 in

saliva with assays that require no specialized equipment and can be completed in one hour.

This assay is not diagnostic for SARS-CoV-2; instead, it specifically identifies saliva

samples that have high amounts of viral RNA that are correlated with live virus shedding.

Many samples that would be identified as SARS-CoV-2 by diagnostic qRT-PCR would be negative

with this saliva assay. Conversely, detection of RNA in saliva is a potential finding of

clinical significance, so participants with that result will be contacted by a medical

professional to discuss potential follow-up with their own health care provider, including a

possible independent diagnostic testing.



Because the assay requires no specialized equipment, it can be performed at the site of

sample collection using a portable laboratory that fits in the backseat of a car. The

prototype testing will take place in a variety of settings that may include parking lots,

workplaces, nursing homes and residential housing. Participants will be asked to consent to

provide a saliva sample that will be tested for SARS-CoV-2 RNA levels consistent with live

virus shedding. The consent document will explicitly state that this is not a diagnostic test

for SARS-CoV-2 but that a potential finding of clinical significance should be discussed with

a medical professional. Participants can opt-out of receiving any results at the time of

consent and can provide samples for the sole purpose of contributing to community

surveillance and assay development. Paper consent forms will be reviewed and signed and held

by team members in a secure location (locked box at the collection site) until taken back to

the AIDS Vaccine Research Laboratory for storage. Participants will then spit into a coded

vessel (e.g., cup or tube). Samples should be at least 1ml (~¼ teaspoon) and will be assayed

for the presence of SARS-CoV-2 RNA using the aforementioned detection assay; the presence of

high concentrations of SARS-CoV-2 RNA is indicated by a colorimetric change from pink to

yellow/orange.

Enrolling by invitation
COVID-19
SARS-COV2

Device: Rapid Onsite COVID-19 Detection
saliva assay test for high concentrations of SARS-CoV-2
Rapid Onsite COVID-29 Testing

Eligibility Criteria

Inclusion Criteria: - Willing to provide informed consent - Willing to provide informed consent and spit into a vessel - Individuals at least 5 years of age and have a parent or legal guardian present to consent if under 18 years - Adult participants must have decision-making capacity to provide consent on their own behalf. - Participants must be able to speak English

Exclusion Criteria: - Under 18 years of age with no parent or legal guardian present or under the age of 5 yrs - 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

Eligibility Gender
All
Eligibility Age
Minimum: 5 Years
Countries
United States
Locations

University of Wisconsin
Madison, Wisconsin, 53711

David O'Connor, PhD
Principal Investigator
University of Wisconsin, Madison

University of Wisconsin, Madison
National Institutes of Health (NIH)
AIDS Vaccine Research Lab
NCT Number
Keywords
rapid detection
assay
Saliva
Coronavirus