Performance Evaluation of SARS-COV-2 (Covid-19) Antigen Rapid Test

NCT04808921 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-08-05

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04808921 on ClinicalTrials.gov