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

Sponsor
Sky Medical Supplies & Equipments, LLC (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04808921
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
19
Actual Duration (Days)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid Test
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Diagnostic
Official Title:
Rapid Diagnostic Test for Detection of SARS-CoV-2 Antigen
Actual Study Start Date :
Jan 9, 2021
Actual Primary Completion Date :
Jan 18, 2021
Actual Study Completion Date :
Jan 28, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

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

Outcome Measures

Primary Outcome Measures

  1. Percent Positive Agreement and Negative Percent Agreement [30 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 D&H National Research Centers INC Miami Florida United States 33155

Sponsors and Collaborators

  • Sky Medical Supplies & Equipments, LLC

Investigators

  • Principal Investigator: Jorge P Amaya, M.D, D&H National Research Centers INC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sky Medical Supplies & Equipments, LLC
ClinicalTrials.gov Identifier:
NCT04808921
Other Study ID Numbers:
  • SKYCOV001
First Posted:
Mar 22, 2021
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Sky Medical Supplies & Equipments, LLC
POC
Antigen
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Aug 5, 2022