Performance Evaluation of SARS-COV-2 (Covid-19) Antigen Rapid Test
Withdrawn before enrolling · Not applicable
Conditions studied: SARS-CoV-2, Covid-19, Coronavirus
In brief
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.
Key facts
- Study ID
- NCT04808921
- Run by
- Sky Medical Supplies & Equipments, LLC
- People needed
- 0
- Starts
- 2021-01-09
- Expected to finish
- 2021-01-28
- Last updated by the study team
- 2022-08-05
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
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.
- Exclusion Criteria:An individual who meets the following criterion will be excluded from participation in this study:
- 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.
Where it is running
- D&H National Research Centers INC — Miami, Florida, United States
Full record on ClinicalTrials.gov
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