Performance Evaluation of SARS-COV-2 (Covid-19) Antigen Rapid Test
NCT04808921 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2022-08-05
Summary
The SARS-CoV-2 Antigen Rapid Test is a bioassay intended for rapid point-of-care detection of the SARS-CoV-2 virus. Performance of the SARS-CoV-2 Antigen Rapid Test assay will be assessed by comparison to a reference method.
Conditions
- SARS-CoV-2
- Covid-19
- Coronavirus
Interventions
- DIAGNOSTIC_TEST
-
Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid Test
Rapid Antigen diagnostic device performance comparative to RT-PCR
Sponsors & Collaborators
-
Sky Medical Supplies & Equipments, LLC
lead INDUSTRY
Principal Investigators
-
Jorge P Amaya, M.D · D&H National Research Centers INC
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-09
- Primary Completion
- 2021-01-18
- Completion
- 2021-01-28
- FDA Device
- Yes
Countries
- United States
Study Locations
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