An interventional study of Sky Medical™ Rapid Antigen Test in COVID-19 and Sars-CoV-2 Infection, sponsored by Sky Medical Supplies & Equipments, LLC. Status unknown at 1 site in United States. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2022-08-08.
Sponsored by Sky Medical Supplies & Equipments, LLC · Not applicable, Interventional, and Diagnostic
Prospective study that will evaluate the clinical agreement of the Sky Medical™ Rapid Antigen 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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Sky Medical Supplies & Equipments, LLC is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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: Sky Medical™ Rapid Antigen Test
Rapid Antigen Diagnostic Test device performance comparative to RT-PCR.
Percent Positive Agreement and Negative Percent Agreement
Calculate the performance of the Rapid Antigen Test compared to PCR using swab samples.
Time frame: 90 Days
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Sky Medical Supplies & Equipments, LLC