COVID-19, Sars-CoV-2 Infection
Conditions
Keywords
testing, diagnosis, schools
Brief summary
This study will target Madison Metropolitan School District (MMSD) school children ages 4-19 and staff who have not had a previous positive COVID-19 test within the past 3 months. It will enroll children and adults for 1-3 days to explore whether serial at-home BinaxNOW testing is feasible and non-inferior to at school single PCR testing for the evaluation of symptomatic individuals with a negative initial BinaxNOW. It will also explore whether lollipop swabs are more acceptable and perform as well as nasal swabs with polymerase chain reaction (PCR) testing.
Detailed description
Study Design: This is a quantitative community-based study, conducted in the K-12 setting with school children 4-19 years old, teachers, and staff. If a participant's initial at-school BinaxNOW test is positive, then they will only complete the lollipop swab for PCR testing. They will NOT do the at-home BinaxNOW test. If a participant's initial at-school BinaxNOW test is negative, then they will complete both the lollipop swab for PCR testing AND an at-home BinaxNOW test approximately 24 hours later. If the participant is unwilling or unable to complete the at-home test, they will be presented with a lollipop swab only option. Aim 1: The investigators will test the hypothesis that serial at-home BinaxNOW testing will be feasible and non-inferior to the single at-school PCR testing program. To do this, the investigators will distribute over-the-counter BinaxNOW antigen tests to volunteer families, and create a protocol to ensure families can perform and report test results accurately to the school. Two key questions will be addressed: 1. Is 'at-home' BinaxNOW testing feasible for families? 2. Is serial 'at-home' BinaxNOW testing non-inferior to 'at-school' single PCR testing? Aim 2: The investigators will test the hypothesis that lollipop swabs are more acceptable to individuals and PCR testing is non-inferior to performing PCR on nasal swabs. To test this hypothesis, the investigators will work with MMSD schools to incorporate a lollipop swab for PCR at the time a symptomatic student or staff receives a nasal swab for PCR that is part of the Department of Health Services (DHS) program. Two key questions will be addressed: 1. Are lollipop swabs more acceptable to individuals when compared to nasal swabs? 2. Will lollipop swabs perform as well as nasal swabs with PCR-based testing? Hypotheses to be tested: * Aim 1.1: At-home BinaxNOW testing will be feasible for families. * Aim 1.2: Serial at-home BinaxNOW testing is non-inferior to at school single PCR testing. * Aim 2.1: Lollipop swabs are more acceptable to individuals than nasal swabs. * Aim 2.2: Lollipop swabs will perform as well as nasal swabs with PCR-based testing. Protocol Amendment 2/4/22 to expand the upper eligible age for children from 14 to 19 years and to recognize the potential supply chain limitations of BinaxNOW tests. If the study team does not have any BinaxNOW tests due to a supply shortage, the BinaxNOW procedures will be dropped and only the lollipop swab will be collected. Protocol Amendment 5/16/22 extends the study timeline and adds a lollipop swab only option.
Interventions
DIAGNOSTIC_TESTBinaxNOW Test
diagnostic test for SARS-CoV-2
DIAGNOSTIC_TESTLollipop swab
A lollipop swab, is an oral swab to collect saliva, sucked on like a lollipop for 20 seconds.
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
Yes
Inclusion criteria
* school children ages 4-19 * MMSD staff * have at least one symptom of COVID-19 * have not had a positive COVID-19 test in the past 3 months * will undergo nasal PCR testing at an MMSD elementary school
Exclusion criteria
* received a positive COVID-19 test in the past 3 months Criteria for inclusion in the final study sample: * Aim 1. Symptomatic participants with a negative at-school BinaxNOW test and nasal PCR results who complete both the lollipop PCR and at-home BinaxNOW tests within 72 hours will be included in the final study sample. * Aim 2. Symptomatic participants who provide a lollipop swab that is successfully resulted. Criteria for exclusion in the final study sample: * Aim 1 * Missing nasal PCR result * Do not successfully complete an at-home BinaxNOW test within 72 hours of the at-school BinaxNOW test * Aim 2 * Missing nasal PCR result * Missing lollipop PCR result
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR | up to 2 days | The primary diagnostic outcome measure will be the negative predictive value (NPV). The kappa values for sensitivity, specificity, positive predictive value (PPV) and NPV of the BinaxNOW at Home testing with respect to PCR nasal swab (gold standard) are reported here. |
| Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results | up to 2 days | Counts of negative and positive Nasal Swab vs. Lollipop Swab PCR COVID-19 tests with kappa statistical value. |
| Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR | up to 2 days | The kappa values for sensitivity, specificity, positive predictive value (PPV) and NPV of the Lollipop Swab PCR with respect to PCR nasal swab (gold standard) are reported here. |
| Number of Successfully Completed At-home Tests | up to 24 hours | Feasibility of 'at-home' BinaxNOW testing will be determined by number of successfully completed at-home tests. At-home test taking will be monitored by study team remotely (via zoom or similar). |
| Percent of Participants Who Answer 'Yes' When Asked if Lollipop Swabs Are More Acceptable Than Nasal Swabs | up to 1 day | To address the acceptability of lollipop swabs vs nasal swabs, the study team will ask participants a binary question: Are lollipop swabs more acceptable to participants when compared to nasal swabs? Yes/No. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from Madison Metropolitan School District from October 2021 to May 2023.
Participants by arm
| Arm | Count |
|---|---|
| COVID-19 Tests If a symptomatic participant's initial at-school BinaxNOW test was positive, then their study participation is complete after providing the lollipop swab for PCR testing.
If a symptomatic participant's initial at-school BinaxNOW test was negative, then they will be asked to complete an at-home BinaxNOW test approximately 24 hours later.
For the at-home BinaxNOW testing, the participant will schedule a follow-up virtual visit with the study coordinator. If they are unable to complete a virtual visit, they will schedule an in-person home visit. They will also be sent home with a BinaxNOW testing kit.
BinaxNOW Test: diagnostic test for SARS-CoV-2
Lollipop swab: A lollipop swab, is an oral swab to collect saliva, sucked on like a lollipop for 20 seconds.
All participants took the gold-standard Nasal Swab PCR test at school. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Laboratory's lab collection device damaged | 1 |
Baseline characteristics
| Characteristic | COVID-19 Tests |
|---|---|
| Age, Categorical <=18 years | 64 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 10 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 | 80 Participants |
| Region of Enrollment United States | 100 participants |
| Sex/Gender, Customized Female | 55 Participants |
| Sex/Gender, Customized Male | 43 Participants |
| Sex/Gender, Customized Prefer Not to Say | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results
Counts of negative and positive Nasal Swab vs. Lollipop Swab PCR COVID-19 tests with kappa statistical value.
Time frame: up to 2 days
Population: 1 device did not function properly, 99 participants had data from both test to analyze
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| BinaxNOW At Home Testing | Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results | Lollipop PCR (Positive) | 2 COVID-19 tests |
| BinaxNOW At Home Testing | Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results | Lollipop PCR (Negative) | 86 COVID-19 tests |
| Positive Nasal Swab PCR | Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results | Lollipop PCR (Negative) | 0 COVID-19 tests |
| Positive Nasal Swab PCR | Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test Results | Lollipop PCR (Positive) | 11 COVID-19 tests |
Comparison: Kappa statistics for Nasal Swab PCR vs Lollipop Swab PCR95% CI: [0.78, 1]
Primary
Number of Successfully Completed At-home Tests
Feasibility of 'at-home' BinaxNOW testing will be determined by number of successfully completed at-home tests. At-home test taking will be monitored by study team remotely (via zoom or similar).
Time frame: up to 24 hours
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| BinaxNOW At Home Testing | Number of Successfully Completed At-home Tests | 73 at home COVID-19 tests |
Primary
Percent of Participants Who Answer 'Yes' When Asked if Lollipop Swabs Are More Acceptable Than Nasal Swabs
To address the acceptability of lollipop swabs vs nasal swabs, the study team will ask participants a binary question: Are lollipop swabs more acceptable to participants when compared to nasal swabs? Yes/No.
Time frame: up to 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BinaxNOW At Home Testing | Percent of Participants Who Answer 'Yes' When Asked if Lollipop Swabs Are More Acceptable Than Nasal Swabs | 92 Participants |
Primary
Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR
The primary diagnostic outcome measure will be the negative predictive value (NPV). The kappa values for sensitivity, specificity, positive predictive value (PPV) and NPV of the BinaxNOW at Home testing with respect to PCR nasal swab (gold standard) are reported here.
Time frame: up to 2 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BinaxNOW At Home Testing | Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR | Sensitivity | 100 kappa value in percentage |
| BinaxNOW At Home Testing | Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR | Specificity | 99 kappa value in percentage |
| BinaxNOW At Home Testing | Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR | Positive Predictive Value | 75 kappa value in percentage |
| BinaxNOW At Home Testing | Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCR | Negative Predictive Value | 100 kappa value in percentage |
Comparison: Negative Predictive Valuep-value: 0.001595% CI: [95, 100]one-sample binomial test
Comparison: Sensitivity H0: Sens-0.99 ≤ 0.05 vs. HA: Sens-0.99 \> -0.05p-value: 0.3308one-sample binomial test
Comparison: Specificity H0: Spec-0.99 ≤ 0.05 vs. HA: Spec-0.99 \> -0.05p-value: 0.0536one-sample binomial test
Primary
Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR
The kappa values for sensitivity, specificity, positive predictive value (PPV) and NPV of the Lollipop Swab PCR with respect to PCR nasal swab (gold standard) are reported here.
Time frame: up to 2 days
Population: 1 device did not function properly, 99 participants had data from both test to analyze
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BinaxNOW At Home Testing | Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR | Sensitivity | 100 kappa value in percentage |
| BinaxNOW At Home Testing | Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR | Specificity | 98 kappa value in percentage |
| BinaxNOW At Home Testing | Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR | Positive Predictive Value | 85 kappa value in percentage |
| BinaxNOW At Home Testing | Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCR | Negative Predictive Value | 100 kappa value in percentage |
Comparison: Sensitivity H0: Sens-0.99 ≤ 0.05 vs. HA: Sens-0.99 \> -0.05p-value: 0.201one-sample binomial test
Comparison: Specificity H0: Spec-0.99 ≤ 0.05 vs. HA: Spec-0.99 \> -0.05p-value: 0.0705one-sample binomial test