NCT04808921

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

Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sky Medical Supplies & Equipments, LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

The clinical performance of the SARS-CoV-2 Antigen Rapid test was evaluated in a prospective clinical study conducted at a single (1) CLIA waiver investigational site in Miami, Florida, U.S. Consenting patients of any age, gender, or race/ethnicity who presented at the test site with COVID-19 like symptoms during the 2021 COVID-19 season were sequentially enrolled and tested. Five (5) minimally trained operators with little laboratory experience and who received no training on use of the SARS-CoV-2 Antigen Rapid test and were, therefore, representative of the intended users performed the study test evaluations. A subject's participation in this study will consist of a single visit. Following the completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number.

Conditions

• SARS-CoV-2
• Covid-19
• Coronavirus

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid Test	Rapid Antigen diagnostic device performance comparative to RT-PCR

Timeline

• Start date: 2021-01-09
• Primary completion: 2021-01-18
• Completion: 2021-01-28
• First posted: 2021-03-22
• Last updated: 2022-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study