COVID-19, Sars-CoV-2 Infection
Conditions
Brief summary
Prospective study that will evaluate the clinical agreement of the Sky Medical™ Rapid Antigen Test compared to SARS-CoV-2 RT-PCR.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTSky Medical™ Rapid Antigen Test
Rapid Antigen Diagnostic Test device performance comparative to RT-PCR.
Sponsors
Sky Medical Supplies & Equipments, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The purpose of this study is to validate the performance of the SARS-CoV-2 Antigen Test bioassay for rapid detection of infection when using a nasopharyngeal swab. A prospective randomized and blinded study to evaluate a rapid point of care bioassay for the detection of virus particles compared with the currently validated RT-PCR detection standard. Nasopharyngeal samples will be collected along with the current standard of care collection.
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Positive Agreement and Negative Percent Agreement | 90 Days | Calculate the performance of the Rapid Antigen Test compared to PCR using swab samples. |
Countries
United States
Contacts
Primary ContactMariana-Kathryn LaParl
Outcome results
None listed