This study is being conducted to study the use and application of a point-of-care (POC) Covid-19 test developed by Spartan BioSciences and recently approved for clinical use by Health Canada.
This RAPID COVID-19 study is a prospective, unblinded clinical trial. POC testing utilizing the Spartan Cube COVID-19 platform will be performed on a cohort of 2200 hospitalized patients who have been tested for COVID-19. This cohort will be divided into three groups: 1. patients consulted upon by ICU, internal medicine, or cardiology for admission to the hospital 2. patients undergoing cardiac testing and/or procedures 3. patients awaiting surgery The results from the POC test will be compared to the results from the traditional hospital core lab test to determine sensitivity and specificity of the POC test. An additional cohort of 500 quarantined health care workers will have the POC test performed and compared with the results from the traditional hospital core lab test.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
89
Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Sensitivity of POC testing as compared to core lab testing
Specificity, positive/negative predictive values will be derived
Time frame: 3 months
Incidence in which decision making would have been altered by POC testing
examples include: ventilation decisions, use of ICU/isolation rooms, use of PPE, additional testing
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.