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

Not Applicable

Withdrawn

• Conditions: SARS-CoV-2; Covid-19; Coronavirus
• Interventions: Diagnostic Test: Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid Test

• Registration Number: NCT04808921
• Lead Sponsor: Sky Medical Supplies & Equipments, LLC

Brief 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.

Study Timeline

• Study Start: 2021-01-09
• Primary Completion: 2021-01-18
• Study Completion: 2021-01-28
• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-22
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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:

2. Provision of informed consent

3. 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.

4. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2 Antigen Rapid Test	Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid Test	The same group of patients participated in two arms of the study, one arm was for obtaining data on the rapid antigen test for COVID-19, the comparator arm was to obtain data from the RT-PCR

Primary Outcome Measures

Name	Time	Method
Percent Positive Agreement and Negative Percent Agreement	30 days	Calculate the performance of the antigen test compared to PCR using nasopharyngeal swab samples

Trial Locations

Locations (1)

D&H National Research Centers INC; 🇺🇸 Miami, Florida, United States