Gazelle COVID-19 is a fluorescent lateral flow immunoassay and accompanying Reader intended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset. The study will be conducted To obtain data to measure the positive percent agreement and negative percent agreement of the Gazelle COVID-19 Test compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).The study will assess Gazelle COVID-19 Test performance using dual mid-turbinate nasal swab samples. This study will primarily assess Gazelle COVID-19 Test performance on symptomatic subjects (within five days of onset of symptoms) at point of care (POC). A subset of asymptomatic subjects will be enrolled after the symptomatic subject enrollment is complete.
Diagnostic Test: Applied Biosystems TaqPath COVID- 19 Combo Kit
Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Symptomatic study:
Inclusion Criteria:
The presence of clinical signs and symptoms consistent with COVID-19. Signs and symptoms
include:
- Fever
- Coughing
- Shortness of breath
- Recent loss of sense of smell or taste
- Chills
- Repeated shaking with chills
- Muscle pain
- Headache
- Sore throat
- Vomiting or diarrhea
- Within 1-5 days of symptom onset
- Informed consent for all the samples will be obtained from the subject or
obtained from the parent/guardian in case the patient is a minor
- All ages
- All genders
- Pregnant women
Exclusion Criteria:
- Severe disease requiring immediate medical intervention
- Inability to tolerate sampling procedure (nasal swab)
- Failure to provide informed consent
- Nasal deformities preventing sampling by swab
- Ongoing nosebleeds or use of a nasal spray within the last 4 hours.
- Asymptomatic patients
Asymptomatic study:
Inclusion criteria:
- Present to the facility for a COVID-19 test without symptoms
- Informed consent for all specimens will be obtained from the patient or obtained from
the parent/guardian in case the patient is a minor
Exclusion Criteria:
Exclusion criteria include one or more of the following:
- Severe disease requiring immediate medical intervention
- Inability to tolerate sampling procedure
- Is below 2 years old
- Failure to provide informed consent
- Nasal deformities preventing sampling by swab
- Ongoing nosebleeds or use of a nasal spray within the last 4 hours.
- Presence of typical symptoms of COVID-19 (fever, sore throat, fatigue, etc.)
Northwest Pathology drive thru site, Bellingham International Airport
Bellingham, Washington, United States
Investigator: Bri Spencer
Bri.Spencer@nwlaboratory.com
PRIYA THOTA, MD
2162339405
p.thota@hemexhealth.com
David Bell, MD
d.bell@hemexhealth.com
Ryan Robert Fortna, MD, PhD, Principal Investigator
Northwest Pathology