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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04808921
• Other study ID #: SKYCOV001
• Status: Withdrawn
• Phase: N/A
• Start date: January 9, 2021
• Est. completion date: January 28, 2021

Study information

• Verified date: August 2022
• Source: Sky Medical Supplies & Equipments, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 28, 2021
• Est. primary completion date: January 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Up to 200 subjects will be screened, consented, and enrolled to obtain a minimum of 60 eligible candidates. In order to be eligible to participate in this study, an individual

must meet all of the following criteria:

1. Provision of informed consent

2. Subject is a suspected case of COVID-19 by clinical criteria: a patient with acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia) AND with no other etiology that fully explains the clinical presentation, with or without a history of close contact with a confirmed or probable COVID-19 case in the 14 days prior to onset of symptoms.

3. Subject is an appropriate candidate for Nasopharyngeal sample collection. d/. Subject is willing to provide nasopharyngeal swab samples. Exclusion Criteria:An individual who meets the following criterion will be excluded from

participation in this study:

1. Individuals who present with 10 or greater days of COVID-19 Related Symptoms, (Fever, Cough, Fatigue, Decreased Appetite, Shortness of Breath, Myalgia) or post-defervescence and/or convalescence.

Related Conditions & MeSH terms

• Coronavirus
• Covid-19
• SARS-CoV-2

Intervention

Diagnostic Test:
• Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid Test
Rapid Antigen diagnostic device performance comparative to RT-PCR

Locations

Country	Name	City	State
United States	D&H National Research Centers INC	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sky Medical Supplies & Equipments, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Positive Agreement and Negative Percent Agreement	Calculate the performance of the antigen test compared to PCR using nasopharyngeal swab samples	30 days