This Trial is a Clinical Performance Validation Study That Will Evaluate the Clinical Agreement of the Sky Medical™ Rapid Antigen Test Comparing the Antigen Rapid Test to RT-PCR

Status unconfirmed · Not applicable

Conditions studied: COVID-19, Sars-CoV-2 Infection

In brief

Prospective study that will evaluate the clinical agreement of the Sky Medical™ Rapid Antigen Test compared to SARS-CoV-2 RT-PCR.

Key facts

Study ID

NCT05491993

Run by

Sky Medical Supplies & Equipments, LLC

People needed

200

Starts

2022-02-22

Expected to finish

2023-01-11

Last updated by the study team

2022-08-08

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of informed consent.
• Subject is 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 last 14 days prior to onset of symptoms.
• Subject is an appropriate candidate for Nasopharyngeal sample collection.
• Subject is willing to provide Nasopharyngeal 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.

Where it is running

• American Research Labs — Lake Worth, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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