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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-09

Study Completion Date

2021-01-28

Brief Summary

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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.

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Detailed Description

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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

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SARS-CoV-2 Covid-19 Coronavirus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The purpose of this study is to validate the performance of the SARS-CoV-2 Antigen Test bioassay for rapid detection of infection when using a nasopharyngeal swab. A prospective randomized and blinded study to evaluate a rapid point of care bioassay for the detection of virus particles compared with the currently validated RT-PCR detection standard. Nasopharyngeal samples will be collected along with the current standard of care collection.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid Test

Intervention Type DIAGNOSTIC_TEST

Rapid Antigen diagnostic device performance comparative to RT-PCR

Interventions

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Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid Test

Rapid Antigen diagnostic device performance comparative to RT-PCR

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No