N/A N=129 Diagnostic

NOWDx Test for the Detection of Antibodies to COVID-19

COVID-19 · SARS-CoV-2 · Coronavirus

Bottom Line

View on ClinicalTrials.gov: NCT04690413 ↗

Enrolled (actual)

129

Serious AEs

0.0%

Results posted

Oct 2022

Primary outcome: Primary: Percentage of Clinical Agreement Between NOWDx COVID-19 Test and Emergency Use Authorized or FDA Cleared Comparator. — 91.5; 95.4 percentage of results matching PCR

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: NOWDx COVID-19 Test (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NOWDiagnostics, Inc.
Primary completion: Dec 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Clinical Agreement Between NOWDx COVID-19 Test and Emergency Use Authorized or FDA Cleared Comparator.	91.5; 95.4	—

Summary

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).

Eligibility Criteria

Inclusion Criteria

Persons ≥18 years old;
Persons who have tested positive or negative (within 6 days) for COVID-19 with an emergency use authorized molecular (PCR) test and can furnish said test report.

Exclusion Criteria

Persons <18 years old;
Persons who have previously participated in a NOWDx study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04690413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.