COVID-19, Diagnostic Test
Conditions
Brief summary
This study is being done to see if collecting saliva samples with a lollipop collection method works as well as nasopharyngeal samples for COVID-19 polymerase chain reaction (PCR) testing. 225 COVID-positive participants aged 4 years and above admitted to a hospital in the Madison, Wisconsin metropolitan area will be enrolled over a 6 month period.
Detailed description
This is a prospective quantitative study evaluating the utility of a novel method of saliva collection for COVID-19 testing. Primary Objective * To determine the performance characteristics of oral lollipop swabs compared to Nasal Pharyngeal (NP) swabs for diagnosing COVID-19 via PCR molecular testing. Secondary Objectives * To identify clinical characteristics of patients when there are discordant results for NP and oral lollipop test results.
Interventions
DEVICELollipop
An oral lollipop swab will be obtained by placing a flocked swab into the mouth and sucking on the swab for 20 seconds as one would suck on a lollipop
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to understand and the willingness to provide verbal informed consent, if 18 years or older. If 4-17 years old, ability to understand and the willingness to provide verbal assent, plus have a parent or legal guardian present who can provide verbal informed consent. * Willing to comply with all study procedures and be available for the duration of the study. * Admitted to UW Health University Hospital or UW Health Kids American Family Children's Hospital. * Individuals at least 4 years of age. * Verified COVID-19 according to positive NP PCR test criteria. * Enroll within 47 hours of the diagnostic NP swab; lollipop swab collected within 48 hours of the diagnostic NP swab. * Either personally able or have a parent or legal guardian able to verbally answer questions in English about clinical symptoms, exposures, and other health and demographic information.
Exclusion criteria
* Unable to suck on a swab. * Previous participation in this study. * Require translation services for medical care. * Not suitable for study participation due to other reasons at the discretion of the investigators or their designee.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tabulated Results From Nasopharyngeal (NP) vs Lollipop Swab-based PCR Covid-19 Tests | 1 study visit (data collected in 20 seconds) | Count of tests that detected COVID-19. |
| Sensitivity: True Positive Rate | 1 study visit (data collected in 20 seconds) | NP vs. lollipop swab-based PCR COVID-19 tests. The True Positive Rate is the number of True Positive test results divided by the number of true positives and false negatives. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Discordant Test Results | 1 study visit (data collected in 20 seconds) | All participants were confirmed COVID-19 positive by nasal-swab PCR test to be eligible for this study. Participants all took a COVID-19 test via lollipop-swab. Reported here are the number of participants who did not test positive for COVID-19 via the lollipop-swab device (discordant results). |
| Summary of COVID-19 Clinical Characteristics by Participant Count | 1 study visit (data collected up to 15 minutes) | Count of participants who were: asymptomatic, symptomatic for less that 5 days, symptomatic for 5 days or greater, reported symptom days but ultimately determined to be asymptomatic by study team. Data collected via participant survey on the day of testing. |
| Summary of COVID-19 Clinical Characteristics by Discordant Results | 1 study visit (data collected in up to 10 minutes) | Of those with discordant results, how many were asymptomatic, symptomatic for less that 5 days, symptomatic for 5 days or greater, or reported symptom days but ultimately determined to be asymptomatic by study team. Data collected via participant survey on the day of testing. |
Countries
United States
Participant flow
Recruitment details
COVID-19 positive participants were enrolled at UWHealth from April to May 2023.
Participants by arm
| Arm | Count |
|---|---|
| COVID-19 Positive Participants Participants were determined to be COVID-19 positive by NP PCR test for eligibility and subsequently tested for COVID-19 with Lollipop Swab PCR by placing a flocked swab into the mouth and sucking on the swab for 20 seconds as one would suck on a lollipop. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | COVID-19 Positive Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Sensitivity: True Positive Rate
NP vs. lollipop swab-based PCR COVID-19 tests. The True Positive Rate is the number of True Positive test results divided by the number of true positives and false negatives.
Time frame: 1 study visit (data collected in 20 seconds)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NP Swab Results | Sensitivity: True Positive Rate | 23.5 percentage |
Primary
Tabulated Results From Nasopharyngeal (NP) vs Lollipop Swab-based PCR Covid-19 Tests
Count of tests that detected COVID-19.
Time frame: 1 study visit (data collected in 20 seconds)
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| NP Swab Results | Tabulated Results From Nasopharyngeal (NP) vs Lollipop Swab-based PCR Covid-19 Tests | Covid-19 Detected | 17 COVID-19 tests |
| NP Swab Results | Tabulated Results From Nasopharyngeal (NP) vs Lollipop Swab-based PCR Covid-19 Tests | Covid-19 Not Detected | 0 COVID-19 tests |
| Lollipop Swab Results | Tabulated Results From Nasopharyngeal (NP) vs Lollipop Swab-based PCR Covid-19 Tests | Covid-19 Detected | 4 COVID-19 tests |
| Lollipop Swab Results | Tabulated Results From Nasopharyngeal (NP) vs Lollipop Swab-based PCR Covid-19 Tests | Covid-19 Not Detected | 13 COVID-19 tests |
Secondary
Number of Participants With Discordant Test Results
All participants were confirmed COVID-19 positive by nasal-swab PCR test to be eligible for this study. Participants all took a COVID-19 test via lollipop-swab. Reported here are the number of participants who did not test positive for COVID-19 via the lollipop-swab device (discordant results).
Time frame: 1 study visit (data collected in 20 seconds)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NP Swab Results | Number of Participants With Discordant Test Results | 13 Participants |
Secondary
Summary of COVID-19 Clinical Characteristics by Discordant Results
Of those with discordant results, how many were asymptomatic, symptomatic for less that 5 days, symptomatic for 5 days or greater, or reported symptom days but ultimately determined to be asymptomatic by study team. Data collected via participant survey on the day of testing.
Time frame: 1 study visit (data collected in up to 10 minutes)
Population: Participants with discordant COVID-19 test results. 1 participant described symptoms that the study team determined were unrelated to COVID-19, and this participant is reported as asymptomatic here.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NP Swab Results | Summary of COVID-19 Clinical Characteristics by Discordant Results | Asymptomatic | 7 Participants |
| NP Swab Results | Summary of COVID-19 Clinical Characteristics by Discordant Results | Symptomatic for less than 5 days | 2 Participants |
| NP Swab Results | Summary of COVID-19 Clinical Characteristics by Discordant Results | Symptomatic for 5 days or greater | 4 Participants |
Secondary
Summary of COVID-19 Clinical Characteristics by Participant Count
Count of participants who were: asymptomatic, symptomatic for less that 5 days, symptomatic for 5 days or greater, reported symptom days but ultimately determined to be asymptomatic by study team. Data collected via participant survey on the day of testing.
Time frame: 1 study visit (data collected up to 15 minutes)
Population: 1 participant described symptoms that the study team determined were unrelated to COVID-19, and this participant is reported as asymptomatic here.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NP Swab Results | Summary of COVID-19 Clinical Characteristics by Participant Count | Asymptomatic | 7 Participants |
| NP Swab Results | Summary of COVID-19 Clinical Characteristics by Participant Count | Symptomatic for less than 5 days | 3 Participants |
| NP Swab Results | Summary of COVID-19 Clinical Characteristics by Participant Count | Symptomatic for 5 days or greater | 7 Participants |