18 and older, any sex, with 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.
Number of Participants With Positive Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator TestPrimary· One hour
The acceptance criteria for this study is Positive Percent Agreement (PPA) greater than or equal to 95% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results
Group
Value
95% CI
Subjects 18+ Years of Age
130
Number of Participants With Negative Results on Both the Q-POC SARS-CoV-2 Assay and the RT-PCR Comparator TestPrimary· One hour
The acceptance criteria for this study is a Negative Percent Agreement (NPA) greater than or equal to 98% in a comparison between the Q-POC SARS-CoV-2 assay and the RT-PCR comparator test results.
Group
Value
95% CI
Subjects 18+ Years of Age
736
Sponsor's own description
Q-POC SARS-CoV-2 moderate complexity PCR test performance evaluation
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT05555030 — COVID-19 iCura SARS-CoV-2 Ag OTC: Clinical Evaluation
· NA
· completed
NCT05334758 — Clinical Performance Evaluation of the Bio-Self™ COVID-19 Antigen Home Test
· NA
· completed
NCT05584176 — COVID-19 MP Biomedicals SARS-CoV-2 Ag OTC: Clinical Evaluation
· NA
· completed
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by QuantuMDx Group Ltd
Last refreshed: 28 February 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/NCT05614011.