18 and older, any sex, with COVID-19 or SARS-CoV-2. 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.
Percentage of Clinical Agreement Between NOWDx COVID-19 Test and Emergency Use Authorized or FDA Cleared Comparator.Primary· 1 day
Calculate positive percent agreement (PPA) and negative percent agreement (NPA) between NOWDx COVID-19 Test and emergency use authorized or FDA cleared COVID-19 PCR Test.
PPA
Group
Value
95% CI
Persons Tested With Investigational Device
91.5
NPA
Group
Value
95% CI
Persons Tested With Investigational Device
95.4
Sponsor's own description
This study is designed to compare the performance of the NOWDx COVID-19 Test to an emergency use authorized PCR test result. The intent is to show the rapid test device is comparable to a currently marketed device. The NOWDx COVID-19 Test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to SARS-CoV-2 in human whole blood (venous and fingerstick).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT04799392 — NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons
· NA
· terminated
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Other NOWDiagnostics, Inc. trials
Trials by the same sponsor.
NCT04294030 — NOWDx Test for the Diagnosis of Herpes Simplex Virus Type 2
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NCT05063344 — NOWDx Test for the Diagnosis of Syphilis
· completed
NCT04799392 — NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons
· NA
· terminated
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NOWDiagnostics, Inc.
Last refreshed: 1 March 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/NCT04690413.