Prospective study that will evaluate the clinical agreement of the Sky Medical™ RapidAntigen Test compared to SARS-CoV-2 RT-PCR.
Clinical performance characteristics of the Sky Medical™SARS-CoV-2 Antigen Rapid test was
compared to a Reference Extracted EUA SARS-CoV-2 RT-PCR. The test kit was evaluated in
the U.S in which patients were sequentially enrolled and tested. Symptomatic subjects
were enrolled within six days of the onset of symptoms from a multi-site prospective
clinical study. A total of 69 Nasopharyngeal samples, were tested in one (1) CLIA waived
investigational site by five (5) minimally trained operators in the U.S during the 2022
COVID-19 season.
NP swab specimens collected from the patients with COVID-19 like symptoms in the U.S
during the 2022 COVID-19 season and stored in BD universal transport media tube were
provided by our site in the U.S. All the NP swab specimens were confirmed as positive or
negative and validated with Ct value by the FDA EUA RT-PCR as a comparator method prior
to the study. A total of 69 samples consisting of 39 confirmed positive nasopharyngeal
(NP) swabs, 30 confirmed negative NP swab specimens were collected. The specimens were
aliquoted, randomized, and blinded into sample panels that were tested by each operator,
using the instructions provided by the Quick Reference Instructions (QRI).
All the study samples were randomized and assigned with a unique study subject ID by the
sponsor prior to testing at the study site. The expected results of the samples were
completely blinded to the operators. All the samples were tested by five (5) operators
according to the Quick Reference Instructions only.
Diagnostic Test: Sky Medical™ Rapid Antigen Test
Rapid Antigen Diagnostic Test device performance comparative to RT-PCR.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
American Research Labs
Lake Worth, Florida, United States
Investigator: Sri Madireddy, PhD
Contact: 561-801-5835
sri@celestamedical.com
Investigator: Sri Madireddy, PhD
Mariana-Kathryn LaParl
(954)804-3760
MarianaLaParl@skymedical.us
Sri Madireddy, PhD, Principal Investigator