4 and older, any sex, with Sars-CoV-2 Infection or COVID-19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Standard Diagnostic Test Outcomes for BinaxNOW at Home Testing as Compared to Nasal Swab PCRPrimary· 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.
Sensitivity
Group
Value
95% CI
BinaxNOW At Home Testing
100
44 – 100
Specificity
Group
Value
95% CI
BinaxNOW At Home Testing
99
92 – 100
Positive Predictive Value
Group
Value
95% CI
BinaxNOW At Home Testing
75
30 – 99
Negative Predictive Value
Group
Value
95% CI
BinaxNOW At Home Testing
100
95 – 100
Frequency Table of Gold-Standard Nasal Swab PCR vs Lollipop Swab PCR COVID-19 Test ResultsPrimary· up to 2 days
Counts of negative and positive Nasal Swab vs. Lollipop Swab PCR COVID-19 tests with kappa statistical value.
Group
Value
95% CI
Negative Nasal Swab PCR
86
Positive Nasal Swab PCR
0
Negative Nasal Swab PCR
2
Positive Nasal Swab PCR
11
Standard Diagnostic Test Outcomes for Lollipop Swab PCR Testing as Compared to Nasal Swab PCRPrimary· 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.
Sensitivity
Group
Value
95% CI
Lollipop Swab PCR Testing
100
74 – 100
Specificity
Group
Value
95% CI
Lollipop Swab PCR Testing
98
92 – 99
Positive Predictive Value
Group
Value
95% CI
Lollipop Swab PCR Testing
85
58 – 96
Negative Predictive Value
Group
Value
95% CI
Lollipop Swab PCR Testing
100
96 – 100
Number of Successfully Completed At-home TestsPrimary· 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).
Group
Value
95% CI
At Home BinaxNOW Test
73
Percent of Participants Who Answer 'Yes' When Asked if Lollipop Swabs Are More Acceptable Than Nasal SwabsPrimary· 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.
Group
Value
95% CI
COVID-19 Tests
92
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Wisconsin, Madison
Last refreshed: 22 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05105789.