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

NCT04808921 | Withdrawn FDA Device

• 1 other identifier: SKYCOV001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2; Covid-19; Coronavirus

Keywords

POC; Antigen

Outcome Measures

Primary Outcomes (1)

• Percent Positive Agreement and Negative Percent Agreement

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

  30 days

Study Arms (1)

SARS-CoV-2 Antigen Rapid Test

EXPERIMENTAL

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

Interventions

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

Rapid Antigen diagnostic device performance comparative to RT-PCR

SARS-CoV-2 Antigen Rapid Test

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Sky Medical Supplies & Equipments, LLC: lead

Study Sites (1)

D&H National Research Centers INC

Miami, Florida, 33155, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jorge P Amaya, M.D

  D&H National Research Centers INC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: January 9, 2021
• Primary Completion: January 18, 2021
• Study Completion: January 28, 2021
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)