NCT04987918

Gazelle COVID-19 Test Clinical Accuracy Protocol

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Hemex Health · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Gazelle COVID-19 is a fluorescent lateral flow immunoassay and accompanying Reader intended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset. The study will be conducted To obtain data to measure the positive percent agreement and negative percent agreement of the Gazelle COVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).The study will assess Gazelle COVID-19 Test performance using dual mid-turbinate nasal swab samples. This study will primarily assess Gazelle COVID-19 Test performance on symptomatic subjects (within five days of onset of symptoms) at point of care (POC). A subset of asymptomatic subjects will be enrolled after the symptomatic subject enrollment is complete.

Conditions

• Covid19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Applied Biosystems TaqPath COVID- 19 Combo Kit	Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

Timeline

• Start date: 2021-08-20
• Primary completion: 2022-12-15
• Completion: 2022-12-30
• First posted: 2021-08-03
• Last updated: 2022-08-10

Locations

1 site across 1 country: United States