Status:
WITHDRAWN
Performance Evaluation of SARS-COV-2 (Covid-19) Antigen Rapid Test
Lead Sponsor:
Sky Medical Supplies & Equipments, LLC
Conditions:
SARS-CoV-2
Covid-19
Eligibility:
All Genders
Phase:
NA
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 compariso...
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. Consentin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04808921
Start Date
January 9 2021
End Date
January 28 2021
Last Update
August 5 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
D&H National Research Centers INC
Miami, Florida, United States, 33155