At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Q-POC SARS-CoV-2 Assay (Q27001) Clinical Performance Study Plan
In Brief
A clinical study evaluating RT-PCR Test and Real-time PCR Test for COVID-19. Completed, enrolled 877 participants across 3 sites.
Detailed Summary
Q-POC SARS-CoV-2 moderate complexity PCR test performance evaluation
Study Details
Timeline
Interventions
High sensitivity RT-PCR COVID-19 Test. A healthcare professional will take a sample per subject for the comparator test, following the manufacturer's Instructions For Use (IFU) in one nostril.
Mid-turbinate nasal swab samples will be taken from the opposite nostril that was not swabbed for the comparator sample using Copan FLOQ swabs and placed into MSwab buffer. In instances where opposite nostrils cannot be swabbed for both the comparator and the candidate tests, a 15-minute waiting period to allow for viral reloading will occur before collecting the candidate test sample.