Coronavirus, Covid-19, SARS-CoV-2
Conditions
Keywords
POC, Antigen
Brief summary
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.
Detailed description
The clinical performance of the SARS-CoV-2 Antigen Rapid test was evaluated in a prospective clinical study conducted at a single (1) CLIA waiver investigational site in Miami, Florida, U.S. Consenting patients of any age, gender, or race/ethnicity who presented at the test site with COVID-19 like symptoms during the 2021 COVID-19 season were sequentially enrolled and tested. Five (5) minimally trained operators with little laboratory experience and who received no training on use of the SARS-CoV-2 Antigen Rapid test and were, therefore, representative of the intended users performed the study test evaluations. A subject's participation in this study will consist of a single visit. Following the completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject will receive a unique study identification number.
Interventions
DIAGNOSTIC_TESTXiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid Test
Rapid Antigen diagnostic 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
Healthy volunteers
No
Inclusion criteria
1\. 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: 1. Provision of informed consent 2. 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. 3. 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: 1\. 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 | 30 days | Calculate the performance of the antigen test compared to PCR using nasopharyngeal swab samples |
Countries
United States
Outcome results
None listed