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

Primary Purpose

SARS-CoV-2, Covid-19, Coronavirus

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional diagnostic trial for SARS-CoV-2 focused on measuring POC, Antigen

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Provision of informed consent
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.
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.

Sites / Locations

D&H National Research Centers INC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SARS-CoV-2 Antigen Rapid Test

Arm Description

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

Outcomes

Primary Outcome Measures

Percent Positive Agreement and Negative Percent Agreement

Calculate the performance of the antigen test compared to PCR using nasopharyngeal swab samples

Secondary Outcome Measures

Full Information

NCT ID

NCT04808921

First Posted

March 18, 2021

Last Updated

August 3, 2022

Sponsor

Sky Medical Supplies & Equipments, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04808921

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Withdrawn

Why Stopped

As of 11 Oct 2021, IRB oversight for site is terminated. We no longer have IRB Approval to conduct this study.

Study Start Date

January 9, 2021 (Actual)

Primary Completion Date

January 18, 2021 (Actual)

Study Completion Date

January 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sky Medical Supplies & Equipments, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS-CoV-2, Covid-19, Coronavirus

Keywords

POC, Antigen

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SARS-CoV-2 Antigen Rapid Test

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

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

Intervention Description

Rapid Antigen diagnostic device performance comparative to RT-PCR

Primary Outcome Measure Information:

Title

Percent Positive Agreement and Negative Percent Agreement

Description

Calculate the performance of the antigen test compared to PCR using nasopharyngeal swab samples

Time Frame

30 days

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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: Provision of informed consent 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jorge P Amaya, M.D

Organizational Affiliation

D&H National Research Centers INC

Official's Role

Principal Investigator

Facility Information:

Facility Name

D&H National Research Centers INC

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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